Int Urogynecol J (2014) 25 (Suppl 1):S1–S240 DOI 10.1007/s00192-014-2429-3
2014 AUGS-IUGA Scientific Meeting, July 22–26, 2014, Washington DC: Oral Presentations
# The International Urogynecological Association 2014
Podium Presentations PP 01 A RANDOMIZED COMPARISON OF INCONTINENCE PROCEDURES PERFORMED CONCOMITANTLY WITH ABDOMINAL SACRAL COLPOPEXY: THE BURCH VERSUS MID-URETHRAL SLING TRIAL E. C. TRABUCO1, C. J. KLINGELE 1, R. BLANDON 2, J. A. OCCHINO 1, M. E. MCGREE 3, A. L. WEAVER 3, M. A. LEMENS 1, J. B. GEBHART 1; 1 OBSTETRICS AND GYNECOLOGY, Mayo Clinic, Rochester, MN, 2OBSTETRICS AND GYNECOLOGY, SAINT LUKE’S Hosp. OF KANSAS CITY, Univ. OF MISSOURI KANSAS CITY SCHOOL OF MEDICINE, KANSAS CITY, MO, 3DIVISION OF BIOMEDICAL STATISTICS AND INFORMATICS, Mayo Clinic, Rochester, MN. Introduction: The CARE trial demonstrated that stress continent women have significantly less bothersome stress incontinence symptoms following sacrocolpopexy combined with a Burch urethropexy compared to sacrocolpopexy alone.1 However, it is not clear which surgical approach to address urinary incontinence is optimal in women who have symptomatic SUI and are undergoing sacrocolpopexy. Objective: To compare the efficacy and safety of Burch retropubic urethropexy and retropubic mid-urethral sling (MUS) in women with symptomatic stress (SUI) or stress predominant mixed incontinence (MUI) undergoing concomitant pelvic floor repairs with a sacrocolpopexy. Methods: IRB-approved, randomized, single-blinded trial comparing Burch with MUS in women with symptomatic urinary incontinence and prolapse undergoing a sacrocolpopexy. Patients were randomized using a dynamic allocation approach to achieve balance between intervention groups regarding age, BMI, history of prior
incontinence surgery, pre-operative diagnosis, and prolapse stage. Two primary outcomes were assessed at 6 weeks and 6 months during a medical visit and with completion of validated questionnaires. Patients were objectively continent if at follow-up they 1) had a negative standardized stress test performed by a masked observer; 2) no interim re-treatment for stress urinary incontinence; and 3) no self-reported urinary incontinence (International Consultation on Incontinence Questionnaire2- short form score of 0). As SUI surgery is not meant to address urge incontinence, patients were considered to have stress-specific continence if they fulfilled criteria 1 and 2 above and 3) had no self-reported stress-related leakage of urine (“never” or “rarely” response to all 6 questions from the SUI subscale of the Medical, Epidemiological, Social Aging questionnaire).3 Comparisons were evaluated using the chi-square test or Fisher’s exact test, as appropriate. Results: There was no difference in age, BMI, history of prior incontinence surgery, pre-operative diagnosis, prolapse stage, or baseline incontinence severity between groups. Six-month follow-up was available on 104 patients (92 %) of the 113 patients randomized (53/57 MUS and 51/56 Burch). Although there was no difference in Objective: continence between MUS and Burch patients with complete 6-month follow-up (66.0 % (35/53) vs. 54.9 % (28/51), p=0.25), patients who had a MUS had higher stress-specific continence at 6 months (81.1 % (43/ 53) vs. 62.7 % (32/51); p=0.04). The findings remained consistent when the patients lacking follow-up were classified as failures for each outcome (Objective: continence: 61.4 % (35/57) vs. 50.0 % (28/56), p=0.22; stress-specific continence: 75.4 % (43/57) vs. 57.1 % (32/56), p=0.04). There was no difference in the rate of de novo urge incontinence between MUS and Burch (10.7 % (3/28) vs. 7.7 % (2/26), p=0.99). Amongst patients with baseline urgency urinary incontinence (answered “a few times a month” or worse to question 6 of the overactive bladder
S2
symptom score [22 MUS and 22 Burch]), 77.3 % of the MUS patients had improvement in, 13.6 % reported no change, and 9.1 % had exacerbation of their symptoms, compared to 59.1, 27.3, and 13.6 %, respectively, for the Burch patients (p=0.52). Patients who had a MUS procedure had higher satisfaction (answered “somewhat” or “completely”: 93.8 % vs. 72.3 %: p=0.005), higher patient perception of improvement (rated 10 on 10-point VAS: 71.4 % vs. 51.1 %, p=0.04) and were more likely to report having had a successful surgery for SUI (rated 10 on a 10-point VAS: 72.3 % vs. 47.8 %; p=0.02). There was no difference in patient global impression of severity, the rate of complications or mesh exposures between groups. Conclusions: In women with baseline SUI undergoing concomitant prolapse repairs with a sacrocolpopexy, MUS resulted in greater patient satisfaction and higher urinary continence rates compared to Burch retropubic urethropexy. References: 1. L. Brubaker et al., N Engl J Med 354, 1557 (Apr 13, 2006). 2. K. Avery, J. Donovan, T. Peters, et al., Neurourol Urodyn 23, 322 (May 24, 2004). 3. A. Diokno, B. Brock, M. Brown, et al., J Urol 136, 1022 (Nov, 1986). Disclosure Block: Emanuel Trabuco: No disclosures. CHRISTOPHER KLINGELE: No disclosures. ROBERTA BLANDON: No disclosures. JOHN OCCHINO: No disclosures. MICHAELA MCGREE: No disclosures. AMY WEAVER: No disclosures. MAUREEN LEMENS: No disclosures. JOHN GEBHART: Elsevier: Book royalties, Royalty. UpToDate: Royalties, Royalty.
PP 02 ASSESSMENT OF VOIDING AFTER SLING (AVAS): A RANDOMIZED TRIAL OF TWO METHODS OF POST-OPERATIVE CATHETER MANAGEMENT AFTER MIDURETHRAL SLING SURGERY FOR STRESS URINARY INCONTINENCE IN WOMEN E. TUNITSKY-BITTON1, A. M. MURPHY 2, M. D. BARBER 1, H. B. GOLDMAN 2, S. VASAVADA 2, J. JELOVSEK 1; 1 Center for Female Pelvic Medicine and Reconstructive Surgery, Cleveland Clinic, Cleveland, OH, 2Center for Female Urology and Reconstructive Pelvic Surgery, Cleveland Clinic, Cleveland, OH. Introduction: Midurethral sling (MUS) surgery is an effective treatment for stress urinary incontinence (SUI). About 35 % of patients are discharged home with an indwelling catheter (1). The challenge for surgeons is avoiding postoperative urinary retention while minimizing the use of catheters and their associated risks. A commonly described
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
voiding trial uses a low post-void residual (PVR) as specific criterion for discharge without a catheter. This method has never been directly compared to alternative Methods: of catheter management. A single observational study evaluated participants who underwent retrograde fill and after voiding were asked to give a subjective evaluation of their force of stream (FOS) utilizing a visual analog scale (2). Despite variable post-void residual volumes, none of the 114 participants re-presented with urinary retention concluding that the FOS method of voiding evaluation was safe for outpatient MUS surgery. Objective: This was a double-blinded randomized trial comparing two Methods: of assessing voiding function after outpatient MUS surgery: a standard voiding trial (SVT) compared to subjective assessment of FOS. The primary outcome was the rate (%) of catheterization in the 6-week postoperative period. Secondary outcomes were post-operative pain, satisfaction with the surgery, and efficacy of treatment using validated questionnaires. Methods: Patients undergoing outpatient MUS surgery were recruited for this study. Participants were randomized immediately after the surgery in the post anesthesia recovery unit. All participants underwent a standard protocol in the recovery room that involved backfilling the bladder with 300 ml of fluid and allowing the patient to void within 30 min. Voided volume (VV) was measured and PVR volume was determined using a bladder scanner. All participants were also asked to assess their voiding using a FOS visual analog scale. Participants in the SVT group were discharged without the catheter if the VV was over 200 ml and PVR volume was ≤1/3 of the total volume. Participants in the FOS group were discharged without a catheter if their subjective evaluation of the FOS was ≥50 % of baseline (scale range: 0–120 %). Participants’ characteristics and baseline validated questionnaires (ISI and UDI-6) were collected assessing urinary symptoms. Participants also answered telephone questionnaires that assessed post-operative pain, analgesic medication use, urinary symptoms, and satisfaction at 2–4 days, 7–9 days and 6 weeks postoperatively. A sample size of 51 participants per group was determined to provide 80 % power to detect a 10 % difference in the rate of catheterization between the two groups. Results: 106 participants enrolled in the study (54 in the SVT group and 52 in the FOS group). 56 % percent of participants underwent a retropubic sling while 46 % had a transobturator sling with no difference between the groups (56 % TVT in SVT group; 52 % in FOS group, p=0.69) (Table 1). The overall postoperative catheterization rate was 27 % (FOS: 26.9 %; SVT: 24.1 %; p=0.76). All participants had their catheter removed 7–9 days postoperatively. None of the participants in either group who were discharged without a catheter required catheter reinsertion at a later point after the surgery. Three participants
S3
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
underwent sling revision (1 in FOS and 2 in SVT group). FOS score demonstrated moderate correlation with voided volume amounts (Spearman rho = 0.52, p<0.001). Baseline to 6 weeks postoperatively within group UDI-6 scores (81.2 ± 20.5 to 32.2 ± 33.6; mean difference −49.01, p<0.001) and ISI scores decreased (7.36±4.3 to 1.48±2.2 mean difference −5.9, p<0.001) with no significant difference between the groups. 65 % of participants (n=16) who were discharged with a catheter when asked ‘What was the worst part of your experience,’ responded ‘catheter.’ Conclusion: Subjective evaluation of FOS that is ≥50 % compared to a patient’s baseline results in similar rates of postoperative catheterization as a standard voiding trial while avoiding the need for measuring PVR after outpatient MUS surgery. Utilizing a patient’s subjective assessment of FOS may simplify postoperative care after these surgeries in the outpatient setting.
References: 1. Obstet Gynecol. 2008 Mar;111(3):611–21 2. Neurourol Urodyn. 2010 Feb 29,(2): 68 Table 1: Summary of results Force of Stream (FOS) (52)
Standard Voiding Trial (SVT) (54)
p value
200 (0–400)
275 (0–500)
0.16 0.53
Perioperative evaluation Amount voided (ml) Post Void Residual (ml)
107.5 (0–544)
66 (0–600)
FOS (%)
70 (0–110)
85 (0–120)
0.40
Discharged with a catheter ISI score
13 (26 %)
13 (25.5 %)
0.95
6 (0–12)
6 (0–12)
0.83
UDI-6 score
85.0 (33.3–100) 83.3 (16.7–100) 0.44
Postoperative evaluation: Day 2–4 General pain (0–10) 2 (0–7)
1 (0–9)
0.65
Urethral and vaginal pain 2 (0–7) (0–10) Urinary urgency 11 (22.5 %)
2 (0–8)
0.38
10 (19.2 %)
0.69
Presence of a catheter
5 (10.2 %)
6 (11.32 %)
0.86
FOS (%)
100 (50–110)
100 (20–120)
0.85
0 (0–7)
0.26
Postoperative evaluation: Week 6 General pain (0–10)
0 (0–5)
Urethral and vaginal pain 0 (0–1) (0–10) Urinary urgency 23 (48.9 %)
0 (0–4)
0.13
15 (30.6 %)
0.07
Presence of a catheter
0
0
FOS (%)
100 (40–120)
100 (75–120)
0.56
ISI score UDI-6
0 (0–8) 33.3 (0–100)
0 (0–8) 19.4 (0–100)
0.80 0.13
Continuous data presented as Median (range), Student T-test; Categorical data presented as number (%), Wilcoxon SignedRanks Test FOS: Force of Stream, based on a visual analog scale 0– 120 %, where 100 % is the baseline 1 Disclosure Block: Elena Tunitsky-Bitton: Ethicon: One of the study submitted was ‘Investigator initiated, partially sponsored’. I am not personally a consultant for the company., Grant/ Research Support. Alana Murphy: No disclosures. Matthew Barber: Targacept: Contracted Research, Grant/ Research Support. UptoDate: For on-line chapters, Royalty. Elsevier: for book Hysterectomy for Benign Disease, Royalty. Howard Goldman: Pfizer: Advisory Committee Member, Honoraria. Medtronic: Consultant, Consulting Fee. Allergan: Speaker, Honoraria. Uroplasty: Speaker, Honoraria. Astellas: Speaker, Honoraria. Sandip Vasavada: Allergan: Advisory Committee Member, Consulting Fee. Medtronic: Advisory Committee Member, Consulting Fee. Boston Scientific: Consultant, Consulting Fee. J. Eric Jelovsek: No disclosures.
PP 03 MINIARC MONARC SUBURETHRAL SLING IN WOMEN WITH STRESS URINARY INCONTINENCE—AN RCT—24 M FOLLOW UP J. LEE1, A. ROSAMILIA 2, P. DWYER 1, Y. N. LIM 3, D. ULRICH 4; 1 Mercy Hosp. for Women, Melbourne, Australia, 2Monash Hlth., Monash Univ. & Cabrini Hospita, melbourne, Australia, 3Mercy Hosp. for Women, Heidelberg, Australia, 4 Med. Univ. Graz, Graz, Austria. Background: Single incision midurethral slings (MUS), such as Miniarc, were introduced to reduce post operative pain, and improve recovery. We set out to examine if Miniarc had at least equivalent Objective: cure rates against Monarc at 24 m follow up Objective: to evaluate and compare Objective:, subjective and functional outcomes after Miniarc or Monarc suburethral sling in women with stress urinary incontinence (SUI) at 24 m Methods: Women who had SUI or urodynamic stress incontinence (USI) were randomised, in a 1:1 ratio, to receive either Miniarc or Monarc. Women with intrinsic sphincter deficiency, previous MUS, untreated detrusor overactivity or significant voiding dysfunction were excluded. Assuming an Objective: cure rate of 85 % for Monarc, this RCT was powered (80 %) to detect a
S4
clinical difference of 15 %, and allows for an attrition of 15 % with a sample size of 220, using a one sided α of 0.05. Computer generated random allocation was concealed and stratified to centre. Surgeons or patients were not blinded once allocation was revealed. Patients were seen at 6 w, 6 m, 12 m and 24 m with a clinical examination. Standardised proformas together with validated tools, including ICIQ UI SF, ICIQ OAB, PISQ12, IIQ7, PGII and 24 pad weigh, were used to facilitate prospective collection of data to evaluate Objective:, subjective and outcomes following surgery. Objective: cure was defined as negative urodynamic stress or cough stress test (CST) at follow up. Subjective cure was defined as absence of patient reported SUI at follow up. Surgeries were performed, according to manufacturer’s instructions, by surgeons who had already performed at least 10 Miniarc, which was tensioned to snug. Urodynamic studies were performed pre operatively and 6 m post operatively. Definitions, outcome measures and standardised reporting adhered to IUGA/ICS terminology, IUGA & CONSORT guidelines. Institution ethics approval was obtained and the trial was registered with the ANZCTR (ACTR N12608000624381). Outcomes were compared with Pearson χ2 or Fischer Exact test for categorical data and Student t test or Wilcoxon rank-sum for continuous data as appropriates. Results: 282 women were assessed for eligibility, of which 42 declined participation, 2 indicated a preference to Miniarc (refused randomisation), and 14 were excluded post randomisation (3 did not meet criteria, 10 withdrawn from surgery, 1 unfit). 235 women aged 31–81 (51.6 ± 9.71) received Miniarc (112) or Monarc (113). Median parity was 2 (0–7), mean BMI 27.5 ± 5.6 (15–47). Table 1 showed balanced baseline characteristics. There was no statistically significant difference between two treatment arms for known confounders, which included age, parity, BMI, prior medical history, baseline symptom severity (excluding PGI-S), urodynamic diagnosis, vaginal topography and types of concomitant prolapse surgeries. Monarc patients reported more symptom severity on PGI-S at baseline. Multivariate logistic regression for confirmed baseline PGI-S or surgeon type did not independently affect final outcome, confirming results of bivariate analysis. Table 2 demonstrated no statistically significant difference in the subjective (absence of SUI) or Objective: (absence of USI or CST) cure rates between Miniarc and Monarc at 6, 12 or 24 m. Within both Miniarc and Monarc groups, there was a statistically significant improvement at 6, 12 and 24 m for ICIQ UI, ICIQ OAB, PISQ12, IIQ7, PGII scores and 24 h pad weigh (6 m).
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
At 12 m the miniarc arm has a lower proportion using antimuscarinics, which was not seen at 24 m. At latest follow up, 3 in Miniarc and 3 in Monarc group underwent repeat surgery for SUI (TVT). Two women had repeat surgery 6 m after their Miniarc operation and one at 12 m. In contrast, two women had repeat surgery 12 m after their Monarc operation and 1 at 24 m. There were no sling loosening, division or excision in either arm. There was a single case of mesh exposure (7 mm, excised) in a patient who underwent concurrent anterior compartment mesh repair. Conclusions: Two years results suggest comparable cure rates between Miniarc and Monarc, with longer follow up planned.
Table 1: Baseline Characteristics—MiniMo
Age (y) M ± sd
MiniArc (n=112) 52.2±10.0
Monarc (n=113) 51.0±9.4
P Value 0.33
Parity #
2 (2,3)
2 (2,3)
0.68
BMI M ± sd
27.4±5.8
27.6±5.5
0.71
Menopause (%)
50 (44.6)
49 (43.4)
0.89
Prev Hysterectomy (%)
25 (22.4)
22 (19.4)
0.79
Prev POP Surgery (%)
8 (7.1)
6 (5.3)
0.6
Prev SUI Surgery (%)
4 (3.6)
2 (1.8)
0.68
Chest Neuro DM CT (%)
18 (16.2)
19 (16.8)
>0.99
ICIQ UI SF #
13 (10,16)
14 (10,16)
0.37
Anti Muscarinic Use (%)
17 (14.4)
16 (14.2)
>0.99
ICIQ OAB #
5 (3,8)
5 (3,8)
0.72
PISQ 12 #
33 (28,37)
33 (29,38)
0.91
Not sexually Active (%)
21 (18.8)
23 (20.7)
0.74
IIQ 7 #
9 (5,13)
9 (5,12)
0.65
PGI S #
3 (2,3)
3(3,3)
0.04
24 h Pad (g) M ± sd
21.1±33.9
28.5±43.1
0.22
USI
99 (90.0)
100 (90.9)
>0.99
DO
11 (10.0)
5 (4.5)
0.19
MUCP
40.3±15.5
40.9±17
0.79
ALPP
107±29.0
109.8±51.5
0.65
Ba
−1.47±1.10
−1.29±1.20
0.24
Bp
−1.28±1.19
−1.18±1.45
0.57
C Concomitant POP
−6.05±1.82 44
−5.92±2.56 54
0.62 0.23
VH ± A/P or AP
23
35
0.44
Ant Mesh or ASC
5
4
Post only ± mesh
16
15
Table 2: subjective Objective: and functional outcomes after Miniarc Monarc at 24 m
S5
0.58 0.46 0.90 1 (1,2)
0.89 4.2±4.4
1 (1,2) 3 (3,3) 2 (1,2)
1 (1,2)
9 (5,12) 0 (0,5)
1 (1,2)
4.9±10.1
9 (5,13)
3 (2,3)
21.1±33.9
IIQ 7 #
PGI I #
24 h Pad M ± sd
1 (1,2)
23 (20.4) 21/83 (25.3) 21 (18.8) Not Sexually active
26/95 (27.4) 25/103 (24.3)
0 (0,4)
33 (28,37) PISQ 12 #
0 (0,3)
33 (29,38) 37 (33,41) 36 (33,40)
5 (3,8) ICIQ OAB #
37 (35,41)
5 (3,8) 3 (2,5) 3 (2,5)
17 (14.4) OAB Meds
3 (1,4)
14 (10,16)
16 (14.2 %)
4 (0,8)
10/56 (17.9)
4 (0,7)
10/92 (10.9)
13 (10,16) ICIQ UI SF #
4 (0,6)
28.5±43
0.71
0.48 0.62 0.64
0.70 1 (0,3) 0 (0,3)
23/75 (30.7) 22/95 (23.2) 29/103 (28.2)
0 (0,3)
0.88
0.27 0.06 38 (34,42) 38 (33,41) 39 (33,41)
0.91
1.0
0.26 0.57 3 (2,5) 3 (2,5)
0.48
0.28
3 (2,5)
0.034
0.61 0.77
0.52
3 (0,6)
9/56 (16.1)
3 (0,6)
15/95 (15.8)
3 (0,6)
14/96 (14.6)
82/95 (86.3) 51/57 (89.5) 84/89 (94.4) 77/95 (81.1) Obj Cure
73/90 (81.1) 95/103 (92.2) 105/110 (95.5) Subj Cure
5/87 (5.70)
0.29
1.0 0.43
73/83 (87.9)
44/50 (88.0)
97/103 (94.2)
87/90 (96.7)
99/107 (92.5)
0.50
Between groups 24 m
Between groups 6m 0.4 24 m 12 m
Between groups 12 m 0.78
P value Monarc Monarc
6m Baseline N=113 24 m
Miniarc
12 m
Miniarc Miniarc
Baseline 6 m N=112 (#Median (25 %,75 %)
Miniarc
Monarc
Monarc
P value
P value
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Disclosure Block: Joseph Lee: AMS: investigator led RCT, contracted research, Grant/Research Support. BSCI: investigator led RCT, contracted research, Grant/Research Support. anna rosamilia: AMS: Research grant, Grant/Research Support. Boston Scientific: research grant, Grant/Research Support. astellas: Speaker, Honoraria. Peter Dwyer: Allergan: Advisory Committee Member, Consulting Fee. American Medical Systems: research grant to urogyn dept for support RCT, Grant/Research Support. Yik Lim: American Medical Systems: Member of research team, Grant/Research Support. Boston Scientific: Member of research team, Grant/Research Support. Daniela Ulrich: Astellas: Speaker, Travel Grant.
PP 04 REPEAT TREATMENTS WITH ONABOTULINUMTOXINA PROVIDE LONG-TERM IMPROVEMENTS IN SYMPTOMS OF OVERACTIVE BLADDER IN FEMALE PATIENTS WITH URINARY INCONTINENCE WHO ARE INADEQUATELY MANAGED BY AN ANTICHOLINERGIC T. RECHBERGER1, M. PARSONS 2, S. GUARD 3, Y. ZHENG 4, D. GINSBERG 5; 1 Med. Univ., Lublin, Poland, 2Birmingham Women’s Hosp. NHS Fndn. Trust, Birmingham, United Kingdom, 3Allergan., Ltd, Marlow, United Kingdom, 4Allergan, Bridgewater, NJ, 5 USC Inst. of Technology, Los Angeles, CA. Introduction: Overactive bladder (OAB) with urinary urgency incontinence (UUI) is disproportionately more common in women than in men.1 Anticholinergics are the first-line pharmacotherapy for OAB; however, nearly 70 % of patients discontinue treatment within a year of initiation, most commonly due to insufficient efficacy and/or intolerable side effects.2 OnabotulinumtoxinA 100U was found to be effective and well tolerated in the treatment of OAB patients with urinary incontinence (UI) who were inadequately managed by an anticholinergic therapy, in 2 large placebo-controlled multicenter phase 3 trials, and is presently the only approved botulinum toxin for the treatment of OAB. Objective: To evaluate the long-term efficacy and safety of onabotulinumtoxinA 100U in the female subpopulation of patients from an interim analysis of a large multicenter extension study of the two placebo-controlled phase 3 trials. Methods: Patients who completed either of the two phase 3 studies (in which they received up to 2 onabotulinumtoxinA treatments) could enter a 3-year extension study in which they received multiple intradetrusor onabotulinumtoxinA 100U treatments (each treatment administered as 20 injections of 0.5 mL/injection). Treatment schedules were dependent upon
S6
individual patient request/need for retreatment; hence, the number of treatments needed to maintain symptom control varied for each patient. Data were integrated across the phase 3 and extension studies and were analyzed by onabotulinumtoxinA treatment cycle (number of onabotulinumtoxinA treatments received). Change from study baseline at week 12 in OAB symptoms of UI episodes (coprimary endpoint), micturition frequency, and urgency were evaluated in the female subpopulation. Volume voided/ micturition, duration of treatment effect, adverse events (AEs) and use of clean intermittent catheterization (CIC) were also assessed. Results: A total of 749 female patients entered the extension study, with 502 patients followed for 2 years or more. As of June 2013, median follow-up was 127 weeks (2.4 years). Discontinuation rates due to AEs/lack of efficacy were low (4.3 %/4.5 %). Results are presented for treatment cycles 1–5 since they provide a sufficient number of patients to yield an interpretable result as of this interim analysis. The mean baseline voiding parameters were: 5.58 UI episodes/day, 11.59 micturitions/day and 8.42 urgency episodes/day. Reductions in UI episodes/day were consistently observed at week 12 following repeat onabotulinumtoxinA 100U treatments: reductions were −3.32, −3.71, −3.87, −3.21, and −3.25 (treatment cycles 1–5). The proportions of patients who achieved ≥50 % reduction in UI episodes/day with repeat treatment in cycles 1–5 were 68.1, 70.9, 72.1, 64.5, and 63.3 %, respectively. Other OAB symptoms were also consistently reduced over repeated onabotulinumtoxinA treatments; reductions in the frequency of micturition episodes were −2.59, −2.94, −2.83, −2.41 and −2.82, and reductions in urgency episodes were −3.87, −4.11, −4.22, −3.62 and −3.96 (treatment cycles 1–5). A consistent increase in volume voided/micturition was noted with repeat treatment: 53.5, 58.7, 57.9, 52.0 and 52.7 mL over 5 treatment cycles, respectively. Median duration of effect was 24.1, 33.4, 27.9, 24.3, and 23.7 weeks (treatment cycles 1–5). Urinary tract infection was the most common AE in each treatment cycle (29.6, 28.8, 28.4, 21.3, and 19.5 %), and no change was observed in the AE profile over time. CIC rates were 4.1, 3.6, 4.3, 4.5 and 3.1 % (treatment cycles 1–5). Conclusions: Repeat treatment with onabotulinumtoxinA 100U provided consistent and sustained improvements in OAB symptoms in female OAB patients with UI who were inadequately managed by an anticholinergic therapy. OnabotulinumtoxinA was well tolerated, with a consistent safety profile over repeated treatments with no new safety signals. References: 1. World J Urol (2003) 20: 327–336. 2. Scan J Urol (2013) Epub ahead of print; doi:10.3109/ 21681805.2013.814707.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Disclosure Block: Tomasz Rechberger: Astellas: Advisory Committee Member, Consulting Fee. Allergan: Advisory Committee Member, Consulting Fee. Johnson@Johnson: Speaker, Honoraria. Matthew Parsons: Pfizer: Consultant, Travel Grant. Steven Guard: Allergan Ltd: Employee, Salary. Yan Zheng: No disclosures. David Ginsberg: Allergan: Scientific Medical Advisor, Consulting Fee. Allergan: Speaker’s Bureau, Honoraria.
PP 05 2014 COCHRANE REVIEW: MINIMALLY INVASIVE SYNTHETIC SUBURETHRAL SLING OPERATIONS FOR STRESS URINARY INCONTINENCE IN WOMEN A. FORD1, L. ROGERSON 2, J. OGAH 3; 1 Gynaecology, Bradford Royal Infirmary, Bradford, United Kingdom, 2Urogynaecology, Leeds Teaching Hosp., Leeds, United Kingdom, 3Gynaecology, Univ. Hosp. of Morecambe Bay Trust, Barrow-In-Furness, United Kingdom. Introduction: Urinary incontinence (SUI) is a common condition affecting up to 30 % of women. Minimally invasive synthetic suburethral sling operation is increasing the primary surgical method to treat. Objective: This meta-analysis of Randomised Controlled Trials summarises the evidence of the effects of minimally invasive sub-urethral sling surgery in the management of stress urinary incontinence in women. This is a major update of the 2009 review Methods: All Randomised Controlled Trials that evaluated the surgical interventions for stress urinary incontinence, and were published or presented prior to February 2014, were identified from MEDLINE, CINAHL, the Cochrane Central Register of Controlled Trials (CENTRAL) hand searching of journals, major conference proceedings. Exclusions were traditional, single incision slings, and colposuspension. Data was extracted independently by two reviewers, a meta-analysis was performed and evidence based conclusions were made Results: Eighty-four randomised controlled trials were included (8946 women). When transobturator route (TOR) was compared with retropubic route (RPR) in the short-term (12 months), subjective cure rate was similar at 1792/2215 (81 %) after TOR as compared to 1818/2194 (83 %) following RPR (RR 0.98, 95 % CI 0.95 to 1.00), in 28 trials. There was also no significant difference in short-term Objective: cure rate (RR 0.98, 95 % CI 0.96 to 1.00), in 34 trials that assessed this outcome. Medium and long-term (≥60 months) cure rates (RR 0.98, 95 % CI 0.93 to 1.04) & (RR 1.00, 95 % CI 0.94 to 1.08) respectively also demonstrated no significant difference. Bladder perforation was less likely to occur at 5/2685 (0.2 %) after TOR as compared to 132/2646 (5 %) following RPR (RR
S7
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
0.13, 95 % CI 0.08 to 0.21). Less likely to occur with TOR was major vascular injury (RR 0.31, 95 % CI 0.16 to 0.62) and postoperative voiding dysfunction (RR 0.49, 95 % CI 0.39 to 0.63). The mean operating time, blood loss and length of hospital stay were shorter with the TOR. There were significantly higher rates of groin pain at 75/1373 (5.5 %) after TOR as compared to 33/1348 (2.5 %) following RPR (RR 2.14, 95 % CI 1.45 to 3.15). There were similar rates of tape extrusion (RR 1.10, 95 % CI 0.73 to 1.64), de novo urgency/urgency incontinence (RR 1.00, 95 % CI 0.81 to 1.23), and repeat incontinence surgery (RR 1.26, 95 % CI 0.81 to 1.95). We were unable to perform meta-analysis for the impact on women’s quality of life (Qol) due to the use of a wide variety of Qol assessment tools. When ‘Inside-out’ (medial-lateral) transobturator route was compared with the ‘Outside-in’ (lateral-medial) transobturator routes there were no significant differences in the outcomes of relevance for either method in the short or medium-term. Six studies with 507 women assessed short-term subjective cure rates (RR 1.00, 95 % CI 0.94 to 1.06) and seven studies with 819 women assessed short-term Objective: cure rates (RR 0.99, 95 % CI 0.95 to 1.04). Six studies with 794 women assessed bladder perforation rates and found for ‘inside out’ approach the rate was 0.2 % compared with 1 % for ‘outsidein’ (RR 0.38, 95 % CI 0.07 to 1.9). Three studies assessed vaginal perforation rates with a significantly lower rate (3 %) found in the ‘inside-outside’ tapes compared to 12 % in the ‘outside-inside’ (RR 0.25, 95 % CI 0.12 to 0.53). Seven studies with 930 women assessed postoperative voiding dysfunction rates and found ‘inside out’ had a 6 % voiding dysfunction rate compared with 4 % for ‘outside-in’ (RR 1.48, 95 % CI 0.85 to 2.58). Seven studies with 835 women assessed tape extrusion showing the rate for ‘inside out’ was 1.2 % compared with 2.4 % for ‘outside-in’ (RR 0.52, 95 % CI 0.20 to 1.40). Similarly no significant difference between the rates of groin pain and de novo urgency/urgency incontinence at 12 % vs. 10 % (RR 1.18, 95 % CI 0.77 to 1.82), & 8 % vs. 6 % (RR 1.33, 95 % CI 0.66 to 2.68) respectively was proven Conclusions: The availability of medium term and more recently some long term data; there is evidence that monofilament macroporous transobturator tapes are as effective as their retropubic tapes with lower rate of bladder perforation and postoperative voiding dysfunction but higher rates of groin pain. Of note is that these complications in most cases are of short duration. ‘Inside-out’ transobturator tapes are as efficacious as the ‘outside-in’ transobturator tapes. Higher rates of vaginal perforations with the ‘outside-in’ tapes did not translate into more tape extrusions. In the few trials which evaluated Qol there was evidence of improvement when compared to baseline scores with no difference between the groups. Reporting of more long-term evidence from the included trials is to be encouraged to alert us to long-term efficacy and the
presence or absence of late complications from the insertion of these tapes. References: 1. Cochrane Database Syst Rev 2009;CD006375 2. Neurourol Urodyn. 2011 Mar;30(3):284–91 Disclosure Block: ABIGAIL FORD: No disclosures. LYNNE ROGERSON: Astellas: Fully paid for meeting to Berlin to EUGA, Fully paid for meeting to Berlin to EUGA. JOSEPH OGAH: No disclosures.
PP 06 A RANDOMIZED CONTROL STUDY COMAPRING TENSION FREE VAGINAL TAPE (TVT) AND MONARC TRANS-OBTURATOR TAPE IN THE TREATMENT OF WOMEN WITH URODYNAMIC STRESS INCONTINENCE (USI) AND INTRINSIC SPHINCTER DEFICEINCY (ISD) WITH A MEAN FOLLOW UP OF 60 MONTHS J. ALVAREZ1, L. SCHIERLITZ 1, P. DWYER 1, A. ROSAMILIA 2, C. MURRAY 1, J. LEE 1; 1 Mercy Hosp. for Women, Melbourne, Australia, 2Monash Hlth., Monash Univ. & Cabrini Hospita, melbourne, Australia. BACKGROUND: Stress urinary incontinence (SUI) is a condition which greatly affects a women’s quality of life. The most severe type of SUI is considered to be the one associated with intrinsic sphincter deficiency (ISD). Currently the main line of treatment is the mid-urethral slings being the retropubic and transobturator the most commonly used. The aim of the study is to compare the long term efficacy of these two slings among the most severe group. OBJECTIVE: The aim of this study is to compare the efficacy of tension-free vaginal tape (TVT) versus trans-obturator tape in the treatment of women with stress urinary incontinence (SUI) and intrinsic sphincter deficiency at 5-year follow-up. METHODS: From Feb. 2004 to Feb. 2007, 164 women were randomized to either TVT or transobturator tape after diagnosis of urodynamic stress incontinence and intrinsic sphincter deficiency. Intrinsic sphincter deficiency was diagnosed by a Maximum urethral closure pressure of <20 cm H2O and/or ALPP <60 cm H2O. Pre-operative work-up included complete urogynaecological history, physical examination, multichannel urodynamics, 24-hour pad test, 3 day bladder diary and UDI-6 SF questionnaire. Patients were followed up yearly with urogynaecological history, physical examination which included cough test and UDI-6. Concomitant pelvic organ prolapse was not an exclusion criterion. The primary outcome assessed at 5-year follow-up was symptomatic stress
S8
incontinence requiring repeat surgery. Informed consent as well as ethical approval for the ethics committee was obtained. RESULTS: Demographic data, surgical details, 6-month as well as 3-year follow up data has already been published. Eighty-two women were randomized on each group. Mean follow up was 63 months for the TVT group and 64 months for the Trans-obturator group. Following a minimum of 5 years since the closure of the recruitment period 19 of the 82 (23.2 %) women in the trans-obturator tape group had undergone repeat surgery to correct SUI compared with three of the 82 (3.7 %) in the TVT group (P=0.001). The time to repeat surgery given as median (25th to 75th percentile) was 24 months (12 to 52) in the 19 Monarc patients compared to 82 months (43 to 82) in the three TVT patients that required repeat surgery (p=0.028). The difference in failure times was tested using log-rank test: p<0.001. The quality-of-life outcomes did show an improvement in both groups before and after surgery but no difference between the two slings in the Urogenital Distress Inventory short form. All patients who underwent repeat surgery underwent retropubic mid urethral sling. CONCLUSION: The long-term cure rates for retropubic (TVT) are significantly greater than for transobturator tape in women with urodynamic stress incontinence and intrinsic sphincter deficiency. Urethral functions tests such as urethral closure pressure and Valsalva leak point pressures are of value in determining what surgery to perform. Disclosure Block: Julio Alvarez: No disclosures. Lore Schierlitz: No disclosures. Peter Dwyer: Allergan: Advisory Committee Member, Consulting Fee. American Medical Systems: research grant to urogyn dept for support RCT, Grant/Research Support. anna rosamilia: AMS: Research grant, Grant/Research Support. Boston Scientific: research grant, Grant/Research Support. astellas: Speaker, Honoraria. Christine Murray: No disclosures. Joseph Lee: AMS: investigator led RCT, contracted research, Grant/Research Support. BSCI: investigator led RCT, contracted research, Grant/Research Support.
PP 07 SINGLE -INCISION SLING OPERATIONS FOR URINARY INCONTINENCE IN WOMEN. A COCHRANE REVIEW A. K. NAMBIAR 1, J. D. CODY 2, S. T. JEFFERY3; 1 Urology, Morriston Hosp., Swansea, United Kingdom, 2 Cochrane Incontinence Review Group, Univ. of Aberdeen, Aberdeen, United Kingdom, 3Urogynaecology, Univ. of Cape Town, Cape Town, South Africa. Introduction: Single incision slings were developed to reduce the risk of the retropubic and transobturator slings.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Objective: To assess the effectiveness of single-incision sling procedures for stress urinary incontinence in women. Methods: We searched the Cochrane Incontinence Group Specialised Trials Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE in process, and handsearching of journals and conference proceedings (searched 6 February 2013), ClinicalTrials.gov (searched 20 September 2012), WHO International Clinical Trials Registry Platform (ICTRP) (searched 20 September 2012) and the reference lists of relevant article. Randomised or quasi-randomised controlled trials in women with urodynamic stress incontinence, symptoms of stress incontinence or stress-predominant mixed urinary incontinence, in which at least one trial arm involves one of the new singleincision slings. The definition of a single-incision sling is “a sling that does not involve either a retropubic or transobturator passage of the tape or trocar and involves only a single vaginal incision (i.e. no exit wounds in the groin or lower abdomen)”. At least two review authors performed abstract and full-text screening, data abstraction and risk of bias assessment. Data was analyzed as detailed in the Cochrane Handbook. Results: 32 trials involving 3427 women were included. Incontinence rates for the single-incision slings are worse than for retropubic slings (121/292, 41 % versus 72/281, 26 %; RR 2.08 95 % CI 1.04 to 4.14). Duration of operation is slightly shorter for mini-slings but with a higher risk of de novo urgency (RR 2.86 95 % CI 1.33 to 6.12). MiniArc more often requires repeat surgery or additional procedures to obtain adequate benefit (RR 2.40 95 % CI 0.81 to 7.12). TVT-Secur was shown to have inferior incontinence rates compared to inside-out transobturator slings (RR 2.55, 95 % CI 1.93 to 3.36), was more likely to provide no improvement compared to inside-out (I/O) slings (RR 4.80, 95 % CI 2.00 to 11.55), and was more likely to require repeat procedures to cure incontinence (RR 5.86 95 % CI 2.00 to 17.21). It was also more likely to require additional procedures to treat complications of the index surgery after TVT-Secur compared to I/O transobturator slings (RR 2.15, 95 % CI 1.04 to 4.43). There were significantly more adverse events with TVT-Secur, specifically a higher risk of vaginal erosion (RR 3.75, 95 % CI 1.42 to 9.86), more bladder/urethral erosion (RR 17.79, 95 % CI 1.06 to 298.88]) and higher blood loss (mean difference 18.79 95 % CI 3.70 to 33.88). Post-operative pain was less common with TVT-Secur (RR 0.29, 95 % CI 0.20 to 0.43), and the rates of long-term pain or were also marginally lower, but the clinical significance of this difference is questionable. There was not enough evidence to identify a difference in incontinence rates after other single-incision slings compared to inside-out or outside-in transobturator slings. Duration of operation was marginally shorter for single-incision slings compared to transobturator slings, but only by approximately 2 min and with significant heterogeneity in the comparison.
S9
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
The risk of post-operative and long-term groin/thigh pain was slightly lower with single-incision slings, but overall there was not enough evidence to suggest a significant difference in adverse events after single-incision slings compared to transobturator slings. There was not enough evidence to conduct a meaningful sensitivity analysis of all other single-incision slings compared to transobturator slings as all the confidence intervals were wide. The only significant differences were in the rates of post-operative and long-term pain, and in duration of operation, which marginally favoured singleincision slings. Overall these results show that TVT-Secur is considerably inferior to inside-out transobturator slings, but more evidence is required to make any reliable comparisons between other single-incision slings and transobturator slings. Comparing one single-incision sling to another, there was not enough evidence to suggest a significant difference between any of the slings in any of the comparisons made. Conclusions: TVT-Secur should no longer be used for the treatment of stress incontinence and has already been withdrawn from the market. There is not enough evidence on other single-incision slings compared to retropubic or transobturator slings to make any reliable comparisons. More adequately powered and high quality trials with longer term follow-up are required to answer this question. Trials should also clearly describe the fixation mechanism of these single-incisions slings: it is apparent that, although clubbed together as a single group, there is a significant difference in fixation mechanisms that may influence outcomes. References: N/A Disclosure Block: Arjun Nambiar: Astellas Pharma: Funding to attend conferences/meetings, Travel Grant. Pfizer: Funding to attend conferences/meetings, Travel Grant. Glaxo Smithkline: Funding to attend conferences/meetings, Travel Grant. June Cody: No disclosures. Stephen Jeffery: Boston Scientific: Speaker, Travel Grant. Bard: Surgical Training, Travel Grant. Coloplast: Surgical training, Travel Grant. Karl Storz: Speaker, Support to run a local workshop. Covidien: Speaker, Support to run a local workshop.
PP 08 RANDOMIZED TRIAL OF A COMPARISON OF THE EFFICACY OF TVT-O AND SINGLE INCISION TAPE AJUST IN THE TREATMENT OF STRESS URINARY INCONTINENT WOMEN - ONE-YEAR FOLLOW UP J. MASATA1, A. MARTAN 2, K. SVABIK 3, P. HUBKA 4, R. EL HADDAD 5;
1
Obstet. Gynecol., Obstet. Gynecol. Dpt., GUH and Charles Univ., Prague, Czech Republic, 2Dpt. of Obstet. and Gynecol., 1st Faculty of Med., Prague, Czech Republic, 3Charles Univ. in Prague, Gen. Univ. H, Prague, Czech Republic, 4Gen. Univ. Hosp. and 1st Faculty of Med, Prague, Czech Republic, 5Dep. of Gyn./Obstetrics, Gen. Univ. Hospit, Prague, Czech Republic. Introduction: The first generation of single incision tapes had lower efficacy compared to standard Methods: This was explained with reference to the fixed length of the tape and the type of tape introducer. The problem may be solved with single incision tapes, which have adjustable length and a special anchoring mechanism (Ajust). It is important to establish whether these new, less invasive surgical procedures really do minimize the unfavourable impact of surgical procedures on patients while achieving a comparable curative effect. Objective: The aim of this study was to compare the efficacy of the use of tension-free vaginal tape - obturator (TVT-O) and single incision tension-free vaginal tape - Ajust in the treatment of urodynamic stress urinary incontinence (USI) at 1year follow up. Methods: Between May 2010 and May 2012 100 women with proven urodynamic stress urinary incontinence were included in this randomized trial. For randomization the envelope technique was used. Before enrolment in the study all patients signed to indicate their informed consent. The patients were randomized into a TVT-O group (50) and an Ajust group (50). Based on prestudy statistical calculations it was indicated that the required sample size in each group was 45 patients. All patients underwent a complete urogynecological investigation before the procedure (clinical examination, urodynamics, ultrasound examination), and they filled in the ICIQ and iQol questionnaires; after surgery, to evaluate their satisfaction with the procedure, VAS and Likert scales were added. Surgery was only offered if conservative therapy had been unsuccessful. Exclusion criteria were: predominant urge incontinence, urodynamic detrusor instability, previously failed antiincontinence surgery, previous radiotherapy, postvoid residual volume (PVR) greater than 100 ml, bladder capacity less than 300 ml, stage III or IV pelvic organ prolapse according to the International Continence Society pelvic organ prolapse quantification system, planned concomitant surgery, age <18. The peri-operative complications were monitored. The intensity and length of postoperative pain was monitored using the visual analogue scale. The patients underwent an examination 3 months and 1 year after surgery. Results: There were no significant differences in age, body mass index, parity, or history of surgery for gynecological disorders among the study participants. Preoperative urodynamic and QoL parameters were also not significantly different (Table 1). There were no serious perioperative complications in either of the two groups. In the Ajust group there was a significantly
S10
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
lower intensity and shorter duration of postoperative pain compared to the TVT-O group (Table 2). At 1-year follow up 47 patients were evaluated in the TVT-O group and 49 in the Ajust group. No differences in subjective cure rates and Objective: cure rates was observed (Table 3); the rates for no subjective stress leakage rates were 88.5 % in the Ajust group and 91.5 % in the TVT-O group, while the figure for negative stress test was 89.8 % in the Ajust group and 87.2 in the TVT-O group. In each group one failure and no tape protrusion was observed. In the Ajust group two patients mentioned de novo pain during intercourse (clinical examination revealed palpable painful anchor in the obturator membrane: one patient required surgical removal of the anchor). Conclusions: At 1-year follow up we did not find any statistical difference between subjective and Objective: outcome for single incision tape Ajust and TVT-O. In the Ajust group lower intensity and shorter duration of postoperative pain were observed. The major weakness of our study is that this is a single centre study on a selected patient population: larger multicentre studies are necessary to prove the results. References: Table 1 Pre-operative patient characteristics TVT-o
Ajust
N
50
50
Age, years
58.9±12.4 27.9±4.4
55.8±10.2 27.3±4.8
2±0.6
2.0±0.9
Prior Hysterectomy n/%
17 (34 %)
16 (32 %)
Mixed UI n/%
23 (46 %)
22 (44 %)
ICIQ
14.6±2.5
14.7±2.5
iQoL
41.0±17.8
38.5±18.4
BMI, kg/m2 Parity
Table 2 Postoperative pain profile (VAS) Ajust 50
pa
N
TVT-o 47
Day 1 mean
53.1±28.9
33.2±25.3
0.09 %
Day 2 mean
37.6±27.1
21.3±22.7
0.16 %
Day 3 mean
28.4±25.4
14.8±18.9
0.2 %
Day 4 mean Day 7 mean
18.0±19.9 7.9±11.1
7.6±14.7 3.9±10.7
0.2 % 1.18 %
Mean duration of pain
6.4±3.6
4.5±3.0
0.48 %
Table 3 One-year subjective and Objective: follow up, Quality of life
N
TVT-o
Ajust
47
49
p
TVT-o
Ajust
p
Length of follow-up days ICIQ iQoL VAS Subjective stress negative
445.0±157.6 2.4±3.6 91.5±11.2 95.1±16.1 43 (91.5 %)
451.8±127.6 2.2±3.6 88.5±12.8 92.7±16.6 44 (89.8 %)
NSa NSa NSa NSa NS
De novo Urgency Objective cure rates Stress test negative
4 (8.5 %)
5 (10.2 %)
NSb
41 (87.2 %)
44 (89.8 %)
NSb
a
Mann–Whitney test bFishertest
Disclosure Block: Jaromir Masata: No disclosures. Alois Martan: Ethicon Womens Health and Urology: Preceptor, Honoraria. Bard: Preceptor, Honoraria. Astelas: Consultant, Consulting Fee. Kamil Svabik: Johnson @ Johnson: Speaker, Travel Grant. Grant Agency of the Ministry of Health of the Czech Republic, grant NT 12147–4: Research Support, Grant/Research Support. Charles University in Prague - UNCE 204024: Employee, Grant/Research Support. Petr Hubka: No disclosures. Rachid El Haddad: This work was supported by the Grant Agency of the Ministry of Health of the Czech Republic, grant NT 12147–4 and by Charles University in Prague - UNCE 204024: Government organisations support, Government organisations support.
PP 09 READABILITY OF PATIENT INFORMATION PAMPHLETS IN UROGYNECOLOGY K. M. REAGAN1, D. O’SULLIVAN 2, C. LASALA 1; Female Pelvic Medicine and Reconstructive Surgery, Hartford Hosp., Hartford, CT, 2Research Administration, Hartford Hosp., Hartford, CT.
1
Introduction: Patient education is critical to the field of Urogynecology. While a majority of patient education is accomplished as a discussion between the physician and patient, education pamphlets and handouts are a common supplement. Pamphlets may be developed independently but are more commonly industry sponsored or sponsored by national organizations. In Urogynecology, these organizations include: The American Congress of Obstetrics and Gynecology (ACOG), American Urogynecologic Society (AUGS), and the American Urological Association (AUA). The National Institute of Health (NIH) has recommended that health-related material be written at a fourth- to sixth-grade level to maximize comprehension (1). Despite this, prior studies in women’s health have shown that patient education pamphlets are often written at a reading level above the recommended level (2–6). There are no studies that evaluate
S11
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
the readability of patient education information targeted at Urogynecology patients. Objective: The purpose of this study is to determine the reading level of frequently used patient information pamphlets and documents in the field of Urogynecology. Methods: Urogynecology pamphlets were identified from online academic sources (ACOG, AUA, AUGS), online industry sources, and from industry-sponsored pamphlets found in the Hartford Hospital Urogynecology division. Readability was determined using 4 different accepted formulas: Flesch-Kincaid Grade Level, SMOG Index, Coleman-Liau Index and Gunning Fog index. The scores were calculated using an online calculator (http://www. readability-score.com). The Flesch-Kincaid Grade Level uses word length and sentence length to calculate readability. The SMOG index uses the number of sentences and polysyllabic words. In 2010, Fitzsimmons et al. published a study that suggested that SMOG be the preferred measure of readability for consumer-oriented healthcare material (7). The Coleman-Liau index uses the number of characters and sentence length for the readability calculation. The Gunning Fog index is based on a calculation involving the average sentence length and polysyllabic words. For documents that were available online, the entire document (excluding graphs, glossaries, information on male issues, and sections entitled “information about the foundation” or “where to get more information”) was entered into an online readability calculator. For pamphlets that were only available in hard copy, approximately 200 words were taken from the introductory section of the pamphlet. All documents were evaluated using the four different readability formulas, and the average of the four scores was calculated. A two-sided, two-sample t-test was used to compare reading level scores between the documents. Results: Of the 40 documents reviewed, only a single pamphlet met the NIH recommended reading level. This document, developed by AUA, and was specifically designated as a “Low Literacy Brochure”. The remainder of the patient education pamphlets, from both industrysponsored and academic-sponsored sources, consistently rated above the recommended reading-level for maximum comprehension. When taking the mean of the 4 scores for each document, the average reading-level all 40 documents was 12th grade. The average reading-level according to the SMOG-index was the 10th grade. Documents from the Pelvic Floors Disorders (PFD) foundation (AUGS sponsored) were consistently rated above the 10th grade level. Krames patient education documents rated at the 10th grade level or below. Other industry sponsored documents consistently rated at the 11th grade level or above. Documents from the AUA ranged from the 6th grade level to the 12th grade level.
Table 1 - Readability Scores (Avg) Document Title
Document Source
Average of 4 reading scores (grade level)
Low Literacy brochure: Do you have an Overactive Bladder (OAB)? Pelvic Organ Prolapse (1)
AUA Foundation 6.0
8.3
Preparing for Surgery
KRAMES PATIENT EDUCATION KRAMES PATIENT EDUCATION PFD online
Bowel control problems Painful Bladder, Interstitial Cystitis Preparing for surgery
ACOG 9.1 AUA Foundation 9.3 Website ACOG 9.8
Strengthening your pelvic floor muscles Interstitial Cystitis
AUA Foundation Website KRAMES PATIENT EDUCATION KRAMES PATIENT EDUCATION AUA Foundation
10.1
AUA
11.0
Urinary incontinence
ACOG
11.0
Loss of Bladder Control (Urinary Incontinence) Your Resource Guide to Stress Urinary Incontinence
AUA Foundation 11.1 Website AMERICAN 11.7 MEDICAL SYSTEMS ICA 11.7
Understanding Urinary Tract Infections
Pelvic Organ Prolapse (2)
8.4
9.1
10.2
10.3
Its Time to Talk About SUI - A 10.9 Patient’s Guide to SUI Loss of Bladder Control, Bladder AUA Foundation 11.0 Prolapse Website Pelvic support problems ACOG 11.0 Stress urinary incontinence
Interstitial Cystitis & Diet Surgery for stress urinary incontinence Interstitial Cystitis
ACOG
11.7
ICA
11.8
Bladder Control Problems Bladder Control Part 2: Longterm Therapy Macroplastique: Urethral Bulking Agent - A Minimally Invasive Alternative For The Treatment Of Stress Urinary Incontinence Loss of Bladder Control (Surgery to Treat Urinary Incontinence) Your Guide to Treatment for Urinary Incontinence Surgery for pelvic organ prolapse
PFD online MEDTRONIC
11.9 12.0
UROPLASTY
12.0
AUA Foundation 12.4 Website BOTOX 12.6 ACOG
12.9
Prevention
PFD online
13.3
Mesh Information for Patients with Pelvic Floor Disorders Restore Your Confidence
PFD online
13.4
CALDERA MEDICAL
13.5
S12 Document Title
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240 Document Source
Types of Surgery
PFD online
Average of 4 reading scores (grade level) 13.6
Bladder Control Part 1: Evaluation Incontinence Care That Is Beyond Advanced Preventing Bladder Control Problems Types of Prolapse
MEDTRONIC
13.8
Hartford Hospital 13.9 PFD online
14.1
PFD online
14.5
Stress Urinary Incontinence Pelvic Organ Prolapse
PFD online PFD online
14.7 14.9
Elevate Prolapse Repair System
AMERICAN MEDICAL SYSTEMS PFD online
15.0
Overactive Bladder and Urge Urinary Incontinence Your Resource Guide to Pelvic Organ Prolapse Prolapse Treatment
AMERICAN MEDICAL SYSTEMS PFD online
15.8 16.4
17.0
Conclusions: The majority of patient education pamphlets, from both industry-sponsored and academic-sponsored sources, are above the reading level recommended by the NIH for maximum patient comprehension. Future work should be done to improve the educational resources available to patients by simplifying the verbiage in these documents. References 1) http://www.nlm.nih.gov/medlineplus/etr.html. 2) Obstet Gynecol. 1999;93(5):771–74 3) Obstet Gynecol. 1989;74:955–60 4) Int J of Gynecol Obstet. 2001;73:177–78 5) Int J Gynecol Obstet. 1992;38:227–230 6) Am J Obstet Gynecol. 2007;197:674.e1-674.e5 7) J R Coll Physicians Edinb. 2010;40(4):292–96 Disclosure Block: Krista Reagan: No disclosures. David O’Sullivan: No disclosures. Christine LaSala: No disclosures.
PP 10 STANDARD VS MNEMONIC Counseling FOR FECAL INCONTINENCE: A RANDOMIZED CONTROLLED TRIAL S. B. CICHOWSKI, G. DUNIVAN, Y. KOMESU, R. G. ROGERS; Univ. of New Mexico, Albuquerque, NM. Introduction: Women with fecal incontinence (FI) significantly alter their lifestyle to cope with symptoms. First-line FI
therapeutic options include behavioral therapy, medications and dietary changes. Through qualitative Methods: we identified that a key gap in FI treatment was patient’s ability to recall and implement first-line therapies. Mnemonics are a memory aid and have been used to help physicians remember treatment regimens, but have not been used in counseling for FI. From our qualitative work, we created a mnemonic to help patients recall first-line treatments for FI (Figure 1). Objective:To determine if women who underwent mnemonic counseling (MC) had better recall of first-line FI therapies, greater satisfaction with physician counseling, and greater improvement in FI symptoms and quality of life at 2 months when compared to a group who underwent standard counseling (SC). Methods: Treatment naive women with FI for >3 months were recruited from an academic Urogynecology clinic prior to receiving FI treatment counseling. All women gave written informed consent and were masked to the recall aim of this study. In order to standardize both study arms, physicians used scripted counseling. Women underwent physical exams and completed the Quality of the Physician-Patient Interaction (QQPPI), a validated measure of clinical encounter satisfaction, recorded FI treatment options they recalled and completed the Fecal Incontinence Severity Index (FISI) and Manchester Health Questionnaire (MHQ) immediately after counseling and again at 2 months. A sample size of 41/arm was adequate to detect a 40 % difference in recall of specific therapies with 80 % power and α=0.05 at 2 months. Results: Ninety women consented for participation, were randomized and completed baseline questionnaires; 47 to SC and 43 to MC. At baseline women did not differ in age (57.2± 12.2 vs 59.5±10.9, p=0.35), ethnicity (50 vs 60 % nonHispanic white, p=0.79), education (35 vs 37 % some college or higher, p=1.0), Stage ≥ 2 prolapse (70 vs 74 %, p=0.97), or urinary incontinence (93 vs 86 %, p=0.30), although the MC group had slightly higher BMI (33.1±8.8 vs 29.0±6.9, p= 0.01). On rectal exam there was no difference in presence of hemorrhoids (30 vs 33 %, p=0.82), dovetail sign (40 vs 33 %, p=0.52), clinically determined sphincter defect (19 vs 18 %, p=0.85), anal resting tone (2.3±1.0 vs 2.6±1.0 p=0.11) or anal squeeze tone both on a 5 point scale (2.3±1.2 vs 2.6±1.4, p=0.34). At baseline, FISI (34.1±10.4 vs 32.3±11.9, p=0.47) and MHQ (32.0±20.5 vs 39.0±23.8, p=0.35) scores were not different between groups. Immediately post-counseling, the MC group reported higher satisfaction on QQPPI (66.4±6.5 vs 62.2±10.7, p=0.03) and recalled more FI therapies (3.4± 2.2 vs 1.7±1.2 therapies, p<0.001). Eight-eight percent (79/90) of randomized women followedup 2 months after counseling. Two month recall of FI treatments was not different between groups (2.3±1.6 MC vs 1.8± 1.0 SC therapies; p=0.08). Both groups reported significant improvement in the FISI at 2 months (mean score change −7.4 ±13.3 SC, p=0.001 and −4.33±11.1 MC, p=0.03), although between group differences were not different (p=0.20). At
S13
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
2 month follow up, the MC group reported greater improvement on total MHQ, emotional and role limitations scores when compared to the SC group. (Table 1) Item analysis of FI therapies recalled showed that the MC group had significantly better recall of “routine bowel habits” (p=0.03). Conclusions: FI counseling with a mnemonic aid improved patient satisfaction with the physician encounter and resulted in improved FI specific quality of life compared to women who received standard counseling at 2 months. Table 1: Outcome Measures Standard counseling
Standard Counseling
Standard counseling
Mnemonic Counseling
Mnemonic Counseling
Mnemonic Counseling
Intergroup Comparison
Intergroup Comparison
Baseline N=47
2 months N=40
p-value
Baseline N=43
2 months N=39
p-value
Baseline p-value
2 Months p-value
QQPPI
62.2±10.7
NA
NA
66.4±6.5
NA
NA
0.03
NA
MMQ total scores Incontinence Impact Role Limitations Physical Limitation Social Limitation Personal Relationships Emotions
32.0±20.5
35.3±25.2
0.30
40.0±22.7
35.6±21.8
0.008
0.14
0.02
58.0±22.8
49.4±31.3
0.07
66.3±24.3
60.3±24.1
0.29
0.09
0.41
26.3±27.2
33.1±33.0
0.26
37.8±30.0
28.8±24.9
0.049
0.06
0.02
32.1±31.9
40.4±38.7
0.13
43.6±37.8
41.4±31.4
0.49
0.17
0.11
22.5±27.8
22.7±29.1
0.97
27.1±29.9
25.6±28.9
0.80
0.56
0.91
20.7±30.0
24.4±34.7
0.48
26.2±32.7
20.5±31.9
0.08
0.36
0.07
35.3±31.6
38.3±33.4
0.38
45.3±30.1
34.8±28.2
0.01
0.13
0.03
Sleep
18.5±25.7
22.2±26.5
0.30
30.6±31.8
25.3±29.0
0.13
0.053
0.07
Severity
44.8±24.7
50.6±30.0
0.18
49.5±23.8
45.3±27.0
0.052
0.35
0.06
Outcome Measure
FISI
34.1±10.4
27.5±10.3
0.001
32.4±11.8
28.0±13.7
0.03
0.47
0.2
# Therapies recalled
1.7±1.2
1.8±1.0
0.78
3.4±2.2
2.3±1.6
0.002
<0.001
0.08
References: N/A Disclosure Block: Sara Cichowski: No disclosures. Gena Dunivan: Pelvic Floor Disorders Network (PFD): Member of PFDN - NIH supported grant to conduct research studies, Grant/Research Support. Yuko Komesu: No disclosures. Rebecca Rogers: American Medical Systems: DSMB chair for TRANSFORM trial, Honoraria. McGraw-Hill: Editor for textbook, Royalty. UptoDate: Author for prolapse chapter, Royalty.
PP 11 A COMPREHENSIVE ASSESSMENT OF THE EPIDEMIOLOGY OF PELVIC FLOOR DISORDERS AMONG WOMEN WITH BREAST, LUNG AND COLORECTAL CANCERS C. P. CHUNG1, N. T. CHUNG 2, S. L. NEUHAUSEN 2, H. MA 2, D. DEAPEN 3, C. A. CLARKE 4, H. ANTON-CULVER 5, L. BERNSTEIN 2, J. V. LACEY 2; 1 Surgery, City of Hope Med. Ctr., Duarte, CA, 2Population Sciences, City of Hope Med. Ctr., Duarte, CA, 3Preventive Medicine, Univ. of Southern California, Los Angeles, CA, 4 Cancer Prevention Inst. of California, Fremont, CA, 5Epidemiology, Univ. of California, Irvine, Irvine, CA. Introduction: Several survey studies have shown higher rates of pelvic floor disorders (PFD) after the diagnosis and treatment of gynecological cancer. Very few studies have examined the risk of developing PFDs after the diagnosis of breast, lung, or colorectal cancers, which are the three common cancers among women. Better information on the epidemiology of PFDs among cancer survivors is needed to improve prevention and control of PFDs. The California Teachers Study (CTS) is a large-scale prospective study that includes detailed data on PFDs among women. To address current gaps in the understanding of the epidemiology and etiology of PFDs, we analyzed the incidence of developing PFD after the diagnosis and treatment of common cancers among women in the CTS. Objective: To calculate population-based incidence rates of PFDs among women with breast, lung, or colorectal cancers and to determine whether the rate of PFDs among those cancer survivors is higher than the rate of PFDs among women without cancer. Methods: The CTS began in 1995–1996 when 133,479 female public school teachers and administrators, ages 22–90 years old at baseline, completed an extensive selfadministered questionnaire that included demographics, personal health factors, reproductive history, medical history and medication use, and lifestyle factors such as diet, physical activity, and body weight. Since 1995–1996, the cohort has been followed continuously, with 4 additional follow-up questionnaires and annual linkages with national registries to identify deaths and changes of address. Most CTS participants live in California, and annual linkages with statewide registries provide essentially complete ascertainment of all cancers and hospitalizations among study participants who reside in California. Incident cancers, including date, histology, stage, and grade, were identified via linkage with the California Cancer Registry. Data on discharge diagnoses of and procedures to treat PFDs, including pelvic organ prolapse, urinary incontinence, fecal incontinence, pelvic pain, were obtained via
S14
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
linkage with inpatient hospitalization records based on ICD-9CM and procedure codes. Dates of PFDs were based on the first recorded diagnosis of or procedure for a PFD. We restricted this analysis to the 124,468 CTS participants who lived in California at study entry. Participants were followed from study entry until the development of a PFD, death, withdrawal from the study, emigration from California, or end of study (12/31/2010). We calculated age-adjusted incidence rates, standardized to the US 2000 population. We used Cox proportional hazards regression models to quantify the relative risk of PFDs among cancer survivors vs. cancer-free CTS participants. Results: From study entry through 12/31/2010, a total of 6522 PFDs occurred among 114,112 women with no history of cancer. There were 368 PFDs among 7263 women with breast cancer; 56 among 1290 women with lung cancer; and 138 among 1803 women with colorectal cancer. Annual incidence rates of PFDs were 244 among women with no history of cancer; 259 among breast cancer survivors; 352 among colorectal cancer survivors, and 1186 among lung cancer survivors (Table). Annual age-adjusted incidence rates of PFDs, standardized to US 2000 population. Rate per 100,000 person- 95 % Confidence years Limits Women without cancer Breast cancer survivors Colorectal cancer survivors Lung cancer survivors
244 259
201–287 201–318
352
276–428
1186
187–2186
In Cox proportional hazards regression models adjusted for age and race, breast cancer survivors were significantly more likely than women without cancer to develop a PFD (Hazard ratio (HR), 1.17, 95 % confidence interval (CI) 1.06–1.31). Approximately half of the PFDs among breast cancer survivors occurred during the first 5 years after diagnosis. The HRs and 95 % CIs for colorectal and lung cancers were 2.05 (1.70– 2.48) and 2.29 (1.73–3.01), respectively. Conclusion: In this large, prospective study among women, breast cancer survivors, colorectal cancer survivors, and lung cancer survivors were each statistically significantly more likely than women without cancer to develop a PFD. These increases could reflect shared etiology, the side effects of treatment (either surgical or systemic), or other factors; the observation that half of the PFDs among breast cancer survivors occurred during the first 5 years of survivorship and half occurred more than 5 years later suggests that PFD etiology is multi-factorial among cancer survivors. Identifying populations at higher risk of developing PFDs can generate the
information needed to risk-stratify patients to enable improved detection, treatment, and prevention of PFDs among cancer survivors. Disclosure Block: Christopher Chung: No disclosures. Nadia Chung: No disclosures. Susan Neuhausen: University of Utah: Royalties from discoveries of BRCA1 and BRCA2, Royalty. Huiyan Ma: No disclosures. Dennis Deapen: No disclosures. Christina Clarke: Genentech: Independent contractor, contracted research, Independent contractor, contracted research. Hoda Anton-Culver: No disclosures. Leslie Bernstein: No disclosures. James Lacey: No disclosures.
PP 12 PATIENT-FOCUSED WEBSITES RELATED TO STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE: A DISCERN QUALITY ANALYSIS O. F. DUENAS1, K. ODELL 2, P. KANDADAI 3, F. MICHAEL 4, D. PATTERSON 1, J. SAINI 5; 1 Univ. of Massachusetts, Worcester, MA, 2UMass, 3Obstetrics and Gynecology, Urogynecology Division, Univ. of Massachusetts, Worcester, MA, 4Univ. of Masschusetts, Worcester, MA, 5Univ. of Massachusetts Med. Ctr., Worcester, MA. Introduction: In 2007, 84 % of US adult Internet-users reported searching for medical information online. Recent controversies in the lay literature regarding treatment for pelvic organ prolapse (POP) and stress urinary incontinence (SUI) have stimulated patient concerns about management options.1 While there are many websites providing medical information, the quality and accuracy of these websites vary. This may be true even for the websites of professional societies and US government organizations frequently referenced by providers. The DISCERN instrument is a validated instrument created to rate the quality of written consumer health information related to treatment options.2 This instrument has been used to evaluate the quality of medical websites but there are no reports of its use to evaluate websites related to POP or SUI. Objective: To evaluate the quality of information presented on English-language websites regarding treatment options for POP and SUI using a validated instrument. Methods: Utilizing the International Urogynecology Association (IUGA) list of continence societies worldwide, Englishlanguage, patient-focused websites related to POP and SUI were identified. Sites were also identified through Google search, using the terms “professional organizations stress urinary incontinence” and “professional organizations prolapse,” and through provider nomination.
S15
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
The DISCERN instrument consists of 16 structured questions assessing the reliability and quality of consumer health information. Each item is scored using an ordinal Likert scale of 1 to 5, with 5 being the highest score. The scores are then summed to provide a maximum attainable score of 80, where a higher score is associated with higher quality of information. The websites were evaluated by faculty at an academic medical center, including 4 faculty members of the urogynecology division, 2 urogynecology fellows, 3 urologists, and 1 obstetrician gynecologist. The websites were independently evaluated and no compensation was provided. Results: From the IUGA continence societies worldwide list, 47 websites were identified. Five provided patient information in English. Eight additional websites were identified from the Google search or provider nomination. One website provided information only for POP (rectocele), 5 for SUI, and 7 for both. Results are presented in Table 1. The lowest mean total score for any website was 38.7 and the highest mean total score was 61.5 across all the websites. There were no statistically significant differences in the website mean total scores (p value <0.40 for POP and 0.14 for SUI). For websites covering both topics, POP scores were generally higher than SUI scores, but not statistically significantly different (p value <3.75). The overall quality item scores were also not significantly different (SUI: p<0.923; POP: p<0.813). Missing information most commonly included lack of clear Objectives, sources, and information related to the expected outcome of no intervention. Conclusions: Available English-language professional websites written to inform patients about management choices for SUI and POP miss key components of quality patient information. Table 1. DISCERN scores for SUI and POP SUI DISCERN scores for SUI Website
ACOGa AAFPb APTAc AUAd AUGSe CFf FDAg ICSh IUGAi NAFCj NIAk NIHl
Total mean score 49.85 43.8. 44 60.83 53.62 43.4 38.75 45 55.28 61.5 44.66 47.85
Standard deviation
Min
Max
Mean overall quality item score
11.4 10.22 12.21 12.12 13.33 13.04 7.22 16.44 11.26 16.39 8.71 17.32
36 32 29 47 35 29 28 16 40 40 32 28
72 59 59 75 68 61 43 73 70 78 53 78
2.87 1.85 2 3.57 2.88 2 2 2.55 3.62 4.42 2.42 2.125
49.48
13.85
16
78
2.69
DISCERN scores for SUI All combined websites for SUI DISCERN scores for POP 53.12 ACOGb 55 ASCRm d 50.57 AUA 54.6 AUGSe 41 FDAg 53 ICSh 55.83 IUGAi l 46.8 NIH All combined 51.85 websites for POP
13.96 8.33 14.44 16.19 4.69 13.68 6.82 11.81 11.98
38 40 34 35 36 34 50 31 31
72 64 71 80 47 71 66 64 80
3.25 3.75 3.06 3.33 2.4 2.62 3.57 2.3 3.03
a
American Congress of Obstetricians and Gynecologists American Academy of Family Physicians c American Physical Therapy Association d American Urological Association e American Urogynecologic Society f Continence Foundation g Federal Drug Administration h International Continence Society i International Urogynecological Association j National Association For Continence k National Institutes of Aging l National Institutes of Health m American society of colorectal surgeons b
References: 1. J Med Internet Res 2003;5(4):e24 2. J epidemiol Community Health 1999; 53(2):105–111 Disclosure Block: Omar Duenas: No disclosures. Katharine ODell: No disclosures. Padma Kandadai: No disclosures. flynn michael: No disclosures. Danielle Patterson: No disclosures. Jyot Saini: No disclosures.
PP 13 PREVALENCE OF OBSTRUCTIVE SLEEP APNEA DETECTED BY THE BERLIN QUESTIONNAIRE IN PATIENTS WITH NOCTURIA ATTENDING A UROGYNECOLOGY UNIT S. ZEBEDE, D. LOVATSIS, M. ALARAB, H. P. DRUTZ; Obstetrics and Gynecology/Urogynecology and Reconstructive Pelvic Surgery, Mount Sinai Hosp.. Univ. of Toronto, Toronto, Canada. Introduction: Nocturia is a common reason for referral to a Urogynecology clinic. It has been associated with several
S16
chronic conditions including obstructive sleep apnea (OSA).1 The pathophysiological link between nocturia and OSA has been well delineated but the prevalence of this condition in patients with nocturia is unknown, with some pilot studies suggesting a very high incidence.2,3 Objective: To determine the prevalence of sleep apnea in patients with nocturia compared to patients without nocturia, in a group of women referred to a Urogynecology unit. Methods: After Ethics approval, a prospective case control study including 81 cases and 79 controls was conducted. Sample size calculation indicated a need for 72 patients in each group for a two sided confidence level, with alpha 5 % and power 80 %. All consecutive newly referred patients were asked to participate. All patients completed the Nocturia, Nocturia Eneuresis and Sleep Interruption Questionnaire (NNES-Q) and the Berlin OSA questionnaire. The NNES-Q questionnaire was used to define cases and controls: cases were defined as sleep interruption due to an urge to void 2 or more times. The Berlin questionnaire was used to classify patients into 2 categoires: high risk of having OSA and low risk of having OSA. A medical history and a urogynecological examination, as well as multichannel urodynamic test were done. Univariate analysis was first performed, followed by logistic regression (LR) to assess the association between nocturia and OSA, as well as other possible variables associated with nocturia. Results: Fifty (61.7 %) of the cases were classified as high risk of having OSA compared to only 19 (24.1 %) in the control group (logistic regression, OR 2.9, 95 % CI 1.29– 6.52, p=0.01). Other variables found to be statistically significant by logistic regression were high BMI, over active bladder and low bladder capacity (<300 cc). Age, menopausal status, urogenital atrophy, parity, prolapse stage, prior pelvic surgery, and diabetes were not found to be significant in the logisitic regression analysis. Of the cases, 10 (12.3 %) reported having a positive history of OSA proven by polysomnography compared to none in the control group. NNES-Q showed that cases were more bothered by getting awakened (6.86±2.31 vs. 2.81±3.06 P<.001). Eneuresis was also more common in the cases: 35 (43.2 %) vs. 9 (11.4 %) (p<.001). Demographics are shown in table 1. Conclusions: Patients with nocturia showed significantly a higher risk of having OSA. All patients with nocturia should be screened for OSA. More research is needed to determinate which is the best screening tool in this population. References: 1) Eur Urol. 2012 Nov;62(5):877–90 2) Sleep Med Rev. 2003 Oct;7(5):403–11 3) Am J Obstet Gynecol. 2008 May;198(5):598.e1–5.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
*p-value = univariate analysis, prior to multivariate (LR) **not statistically significant by (LR) Case N=81 Control N=79 p-value* Age
56.94±15.13
51±16
.02**
BMI Gravity
28.85±6.18 2 (0–8)
24.75±4.77 2 (0–9)
<.001 .79
Vaginal delivery Previous pelvic surgery Postmenopausal
65 (80.2 %) 17 (21.0 %)
65 (82.3 %) 17 (21.5 %)
.74 .94
57 (70.4 %)
43 (54.4 %)
.04**
smokers Diabetic
6 (7.4 %) 11 (13.6 %)
7 (8.9 %) 4 (5.1 %)
.58 .07
Disclosure Block: Salomon Zebede: No disclosures. Danny Lovatsis: No disclosures. May Alarab: No disclosures. Harold Drutz: Cook Myosite: I am the site PI for a study on the use of autologous myosites to treat SUI (Cook Myosite Female SUI Study 10– 019, Grant/Research Support.
PP 14 THE IMPACT OF MENTAL HEALTH CONDITIONS ON INCIDENCE AND REMISSION OF OVERACTIVE BLADDER C. S. BRADLEY1, I. E. NYGAARD 2, S. L. HILLIS 1, J. C. TORNER 3, X. LU 1, A. G. SADLER 1; 1 Comprehensive Access and Delivery Research and Evaluation (CADRE) Center, Iowa City VA Hlth. Care System, Iowa City, IA, 2Univ. of Utah, Salt Lake City, UT, 3Epidemiology, Univ. of Iowa, Iowa City, IA. Introduction: Mental health (MH) conditions, such as depression and anxiety, commonly co-occur in women with overactive bladder (OAB), but temporal relationships between these outcomes have not been well-studied and the mechanism behind this association is unknown. The Women Veterans Urinary Health Study1, a nationwide longitudinal study in recently deployed women veterans, was designed to better understand relationships between OAB and MH conditions. Objective: Study Objectives were to 1) estimate 1-year incidence and remission of OAB and 2) identify the impact of baseline depression, anxiety, posttraumatic stress disorder (PTSD) and history of sexual assault on OAB incidence and remission rates. Methods: Participants of this prospective study included women veterans recently separated from military service who had completed deployment to Iraq or Afghanistan within 2 years of study enrollment. Eligible women were identified through the Defense Manpower Data Center and recruited by mail and
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
telephone. Telephone screening confirmed participants were ambulatory, community-dwelling veterans and excluded those with urinary tract fistula, congenital abnormality or cancer; pelvic radiation; spinal cord injury; multiple sclerosis; Parkinson’s disease; stroke or current/recent pregnancy. Data collection included computer-assisted telephone interviews performed at enrollment and 1 year later. The interview assessed urinary symptoms and current treatment; depression, anxiety and PTSD symptoms; socio-demographic variables; a lifetime history of sexual assault (LSA) and deployment-related factors. MH outcomes were identified based on current symptoms using validated, diagnostic questionnaires (including Patient Health Questionnaire and PTSD Checklist). OAB was identified if at least moderately bothersome urgency urinary incontinence and/or urinary frequency symptoms were reported (on Urogenital Distress Inventory items). Statistical analyses included bivariate comparisons (chi squared and t tests) and logistic regression, using propensity scores and traditional Methods: to adjust for confounding. Results: Participants were 1107 women who completed both baseline and 1-year interviews. The mean (SD) age and BMI were 32.0 (8.9) years and 25.5 (4.4) kg/m2. Most served in the regular (active component) military (87 %), rather than from the Guard/Reserves and 21 % were commissioned officers. Race included 690 (62.3 %) white, 206 (18.6 %) black, 119 (10.8 %) Hispanic and 49 (4.4 %) Asian. Half (583 (53 %)) were nulliparous and most (652 (58.9 %)) reported very good or excellent general health. 399 (36.0 %) were currently employed. Depression, anxiety and PTSD were identified at baseline in 102 (9.2 %), 218 (19.7 %) and 188 (17.0 %), respectively, and LSA in 287 (25.9 %). At baseline, 242 women (22 %) met criteria for OAB. Of 865 women without baseline OAB, 91 reported new OAB at 1 year (1-year incidence rate (95 % CI) = 10.5 % (8.6 %, 12.8 %)). Of 241 women with baseline OAB, 89 women did not meet criteria for OAB at follow-up (1-year remission rate (95 % CI) = 36.9 % (30.8 %, 43.4 %)). OAB treatment was uncommon and not associated with remission: 12 of 243 (4.9 %) women with and 14 of 863 (1.6 %) without baseline OAB reported currently taking medication for bladder problems at 1 year. On univariate analysis, new (incident) OAB was more likely to occur in women with baseline anxiety (21.0 % vs. 8.8 %, p<0.0001), PTSD (18.7 % vs. 9.4 %, p<0.01) and LSA (16.1 % vs. 8.5 %, p<0.01). In an adjusted model, anxiety and LSA predicted incident OAB at 1 year (adj OR (95 % CI) 2.4 (1.4, 4.1) and 1.7 (1.0, 2.8), respectively), while PTSD did not. On univariate analysis, remission of OAB at 1 year occurred less often in those with baseline depression (19.2 % vs. 41.3 % in women without baseline depression, p<0.01) and anxiety (28.7 % vs. 42.2 % in women without baseline anxiety, p=0.03). After adjusting for other covariates, only depression was associated with lower odds of 1-year OAB remission (adj OR (95 % CI) 0.37 (0.16, 0.83)).
S17
Conclusions: The 1-year incidence of OAB in this younger women veteran population was 11 %, and OAB symptoms resolved in one-third of women after 1 year. Baseline anxiety symptoms and lifetime history of sexual assault increased the risk of new OAB 1 year later. Depression occurring with OAB decreased the likelihood of OAB remission. The etiology of OAB is multi-factorial, and optimal therapy relies on improving our understanding of OAB mechanisms. Results from this large, longitudinal study strongly support the link between OAB and mental health in some women, thus opening the door to the development of new OAB preventive and therapeutic modalities related to this association. References: 1. Journal of Urology. 2013 Dec 5. doi:10.1016/j.juro.2013.11. 100. [Epub ahead of print]. Disclosure Block: Catherine Bradley: No disclosures. Ingrid Nygaard: No disclosures. Stephen Hillis: No disclosures. James Torner: No disclosures. Xin Lu: No disclosures. Anne Sadler: No disclosures.
PP 15 DOES PELVIC FLOOR MUSCLE TRAINING ENHANCE PELVIC FLOOR MUSCLE RECOVERY? AN ASSESSOR BLINDED RANDOMIZED CONTROLLED TRIAL G. HILDE1, J. STAER-JENSEN 2, F. SIAFARIKAS 2, M. ELLSTROM ENGH 3, K. BO 1; 1 Department of Sports Medicine, Norwegian Sch. of Sport Sci., Oslo, Norway, 2Department of Obstetrics and Gynaecology, Akershus Univ. Hosp., Lørenskog, Norway, 3Department of Obstetrics and Gynaecology, Akershus Univ. Hosp., Lørenskog, Norway. Introduction: The pelvic floor muscles (PFM) play an important role in pelvic organ support and for staying continent. Major defects of the levator ani (LA) muscle have shown to appear within a range of 13–36 % among primiparous women delivering vaginally. Early active rehabilitation is standard treatment after muscle injury within sports medicine, and training is believed to be important in speeding up tissue healing. To which extent postpartum pelvic floor muscle training (PFMT) can enhance LA muscle recovery is not known. Objective: The aim of the present study was to investigate changes in levator hiatus (LH) area after postpartum PFMT in primiparous women with and without major LA defects. Methods: This was an assessor blinded randomised controlled trial (RCT). One hundred and seventy-five primiparous women who delivered vaginally were included 6 weeks after delivery (baseline), and stratified on major LA muscle defects before being randomized to training or control. Major defects of the LA muscle were defined as an abnormal insertion of the muscle
S18
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
toward the pubic bone and diagnosed by transperineal ultrasound using tomographic imaging (1). All participants were taught how to contract the PFM correctly. The control group participants received no further intervention, whereas the training group participants attended a weekly supervised PFMT class and performed daily home training (2). The intervention period was 16 weeks, and post-intervention assessments were performed 6 months after delivery. Primary outcomes were LA muscle defect status, and LH area at rest, during maximal contraction, and during maximal Valsalva. Outcomes were assessed by 3D/4D transperineal ultrasound. Within-group comparisons were analyzed by paired-sample t-test. Betweengroup comparisons were analyzed by independent-samples ttest, and relative risk (Mantel-Haenszel). P-values<0.05 were considered significant. Intention to treat analysis was applied. Results: The mean age of the participants was 29.8 years (SD 4.1). Fifty-five women were diagnosed with major LA defects and 120 without such defects. Fifteen women (8.6 %) were lost to follow up. Seven of the 175 women (4 %) were not able to contract the PFM. The number of women with major LA muscle defects was significantly reduced from 27 to 14 in the PFMT group (48 % reduction) and from 28 to 17 in the control group (39 % reduction). The between-group difference was not significant, RR 0.85 (95 % CI 0.53 to 1.37). Table 1. shows change in LH area at rest, during maximal contraction and maximal Valsalva from 6 weeks to 6 months after delivery. No significant differences were found when comparing PFMT versus control, neither in the major LA muscle defect stratum nor in the stratum without such defects. LH area was significantly reduced within groups in both strata during maximal contraction (p<0.01). LH area was also reduced within groups during maximal Valsalva (p<0.01), with the exception of the PFMT group with major defects. For LH area at rest, a significant reduction was seen in women with no major LA muscle defects, but not in women with such defects. Table 1. Changes from 6 weeks to 6 months postpartum of the levator hiatus (LH) area at rest, during maximal contraction, and during maximal Valsalva in women randomized to PFMT or
Major LA muscle defect stratum (n=55) PFMT Control MD P-value (n=27) (n=28) LH area at rest (cm ) ↓0.68 (−0.28 to 1.65) ↓0.87 (−0.09 to 1.83) −0.19 (−1.52 to 1.14) 0.777 2
LH area at maximal contraction (cm2) LH area at maximal Valsalva (cm2)
↓1.98 (1.20 to 2.76)
↓1.62 (0.75 to 2.49)
↓1.27 (−1.16 to 3.70) ↓3.49 (1.35 to 5.62)
0.36 (−0.78 to 1.50)
0.532
−2.22 (−5.37 to 0.93) 0.164
No major LA defect stratum (n=120) PFMT (n=60) LH area at rest (cm2) ↓0.87 (0.39 to 1.34)
Control (n=60) ↓1.46 (0.89 to 2.04)
−0.59 (−1.33 to 0.15) 0.115
↓1.47 (1.14 to 1.79)
↓1.57 (1.21 to 1.93)
−0.11 (−0.58 to 0.37) 0.663
↓3.30 (2.00 to 4.59)
↓2.60 (1.66 to 3.55)
0.69 (−0.89 to 2.27)
LH area at maximal contraction (cm2) LH area at maximal Valsalva (cm2)
MD
P-value
0.388
Control. Mean differences (MD) with 95 % CI and corresponding P-values are presented. LA = levator ani. ↓ means reduction. Conclusions: Regardless of PFMT the prevalence of major LA muscle defects in primiparous women was significantly reduced from 6 weeks postpartum to 6 months. This was also the case for a narrowed LH area during PFM contraction. Postpartum PFMT did to prove to enhance PFM recovery more than natural remission after one initial session of thorough instruction on how to contract the PFM correctly. References: 1) Int Urogynecol J 2011 Jun;22(6):699–7042) Neurourol Urodyn 1990;9:489–502. Disclosure Block: Gunvor Hilde: No disclosures. Jette Staer-Jensen: No disclosures. Franziska Siafarikas: No disclosures. Marie Ellstrom Engh: No disclosures. Kari Bo: No disclosures.
PP 16 HOW MUCH IS THE CORRECT EXECUTION OF MANUAL PERINEAL PROTECTION DEPENDENT ON THE SIZE OF THE FETAL HEAD? V. KALIS1, M. JANSOVA 2, L. LOBOVSKY 3, L. HYNCIK 2, J. KARBANOVA 1, Z. RUSAVY 1; 1 Department of Obstetrics and Gynecology, Med. Faculty in Pilsen, Charles Univ. in Prague, Pilsen, Czech Republic, 2 New Technologies - Research Centre, Univ. of West Bohemia, Pilsen, Czech Republic, 3NTIS - New Technologies for the Information Society, Faculty of Applied Sciences, Univ. of West Bohemia, Pilsen, Czech Republic. Introduction: One of the main goals of MPP is the reduction of focal perineal tension on the posterior fourchette by its distribution over a wider surface area. Recently, simulation of vaginal delivery on a novel biomechanical model showed a significant reduction in perineal tension when an appropriate modification of MPP was made. Further testing using an average-sized realistic molded fetal head with molded biparietal diameter (mBPD = 91 mm) and molded suboccipito-bregmatic diameter (mSOBD = 94 mm) revealed that the application of the fingers on the perineal skin together with their coordinated movement plays an important role in the extent of the reduction. The most effective MPP modification was the initial position of fingers 12 cm apart (x=±6) and 2 cm anteriorly from the posterior fourchette (y=+2) with bilateral 1 cm movement towards the midline (Δx=1) and no vertical movement (Δy=0). Objective: The aim of this study was to evaluate whether the most effective MMP modification remains most effective also in cases with substantially smaller or larger fetal head. A finite element biomechanical model was used to
S19
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
analyze and compare the perineal tension during vaginal delivery in 7 modifications of manual perineal protection (MPP) and the “hands off” technique for 3 different sizes of the fetal head. Methods: Previously designed finite element model was used for the experiment. The model enables depiction of the stretching and movement of the perineal tissue around the fetal head during the simulation of vaginal delivery. The fingers were applied when the antero-posterior diameter of the vaginal introitus was 7 cm and the transverse diameter was 5.3 cm. Determination of the exact finger placement location on the perineum (focus of the finger imprint [x,y]) was done using a coordinate system at an axial plane of the perineum and fetal head with an origin at the posterior fourchette [0,0]. The coordinate x and y axes were defined as horizontal and vertical lines meeting at the origin. Coordinated movement between the fingers was performed along these axes [Δx,Δy] (see Figure).
Effectiveness of MMP modifications for different fetal head sizes Simulation
Normal head (mBPD = 91 mm)
Small head (mBPD = 87 mm)
Large head (mBPD = 95 mm)
Perineal tension at fetal head expulsion [%] 0 Hands off 100
Order of Perineal effectiveness tension at fetal head expulsion [%] 8 100
Order of Perineal effectiveness tension at fetal head expulsion [%] 7 100
8
A
72.1
1
82.47
1
70.05
1–2
B
77.9
2
85.72
2
76.04
3
C
81.1
3
88.97
3
70.05
1–2
D
85.3
4
90.91
4–5
82.03
4
E
85.8
5
90.91
4–5
85.72
6
F
88.4
6–7
93.51
6
82.49
5
G
88.4
6–7
101.3
8
88.95
7
Order of effectiveness
The final position of fingers 2 cm anteriorly from the fourchette (y = +2) consistently remains most effective in reducing the perineal tension regardless of the size of the fetal head. The extent of the movement of fingers along x-axis contributes to the effectiveness of MPP. The effectiveness of presented modifications is the most significant in case of delivery simulations with larger head. Here, the most effective MMP modification reduced the maximum perineal tension below values observed in a simulation of “hands off” delivery in case of the smaller fetal head. Conclusions: Exact placement and coordinate movement of the fingers on the perineum when executing MPP is of high importance. However, after the adequate performance of MPP had been adopted, the same style could be applied for all deliveries regardless of the fetal weight. Hence the most effective execution of MPP should be universally clinically practicable.References: N/A Disclosure Block: Vladimir Kalis: No disclosures. Magdalena Jansova: No disclosures. Libor Lobovsky: No disclosures. Ludek Hyncik: No disclosures. Jaroslava Karbanova: No disclosures. Zdenek Rusavy: No disclosures.
Three sizes of the fetal head mimicking different birth weights were used for perineal tension measurements. Seven most effective MPP modifications calculated for the normal head (mBPD 91 mm, mSOBD 94 mm) (see Figure) were subsequently used in a delivery simulation of a smaller (mBPD 87 mm, mSOBD 90 mm) and a larger (mBPD 95 mm, mSOBD 98 mm) fetal head. The perineal tension was always measured during the videosimulation when the suboccipito-bregmatic circumference was passing between the fourchette and lower edge of the pubic bone. Results: The order of effectiveness of modifications of MPP was nearly identical for all 3 sizes of fetal head (see Table).
PP 17 REDUCING OBSTETRIC ANAL SPHINCTER INJURIES USING PERINEAL SUPPORT A PRELIMINARY EXPERIENCE M. NAIDU, A. H. SULTAN, R. THAKAR; Department of Urogynaecology and Pelvic Floor Dysfunction, Croydon Univ. Hosp., Croydon, United Kingdom. Introduction: Perineal trauma is a major health issue as it is associated with significant morbidity. Up to 40 % of women who have a repair of a 3rd/4th degree tear [Obstetric anal sphincter injuries (OASIS)] develop anal incontinence [1]. Recent years have witnessed a gradual increase in the
S20
incidence of OASIS. A recent survey in the UK has revealed rates as high as 8 %. By contrast, in Finland it has essentially remained stable at 0.3–0.6 % over the past 15 years. This has been attributed to the use of traditional Methods: of perineal support during delivery of the fetal head and shoulders]. When Laine et al. introduced this method of delivery [2], combined with restricted use of episiotomy, the rate of OASIS fell significantly from 4.03 to 1.17 % in four Nordic hospitals who adopted this method [3]. Based on this data we, decided to introduce this obstetric intervention package with a view to reducing perineal trauma. Objective: Our aim was to evaluate if this intervention program could reduce the rate of OASIS in our institute. Method: In February 2013 two trainers from Norway were invited to train members of the obstetric team. A tutorial on diagnosis of anal sphincter trauma was carried out. Theoretical and practical sessions using pelvic models and patients on the technique of perineal support during the vaginal delivery was carries out. Further mandatory training of the midwives and doctors continued within the department by a trained doctor and midwife (trained to teach this technique). All the members of staff were instructed to support the perineum during vaginal delivery (both spontaneous vaginal and assisted delivery). Data was collected before and after the intervention. The data was analysed with SPSSv21. The categorical variables was analysed using Chi square test and continuous variables were analysed using the unpaired T test. Results: 171 midwives and 31 doctors, were trained during this intervention period with ongoing mandatory refresher training. From January 2012 to January 2013, a total of 4651 women delivered, of which 3413 were vaginal deliveries and 156 sustained OASIS (4.57 %). Following the intervention, from February to December 2013, 3632 women delivered, 2711 women had a vaginal delivery and 98 sustained OASIS (3.60 %). Figure 1 shows the trend of OASIS rates before and after intervention. There was a 23 %(p=0.06) reduction in OASIS rates after the intervention with an increase in labial tears [59 % increase (p=<0.001)]. An increase in the OASIS rate in October 2013 coincided with appointment of new medical staff who subsequently underwent training. There was a significant reduction in the severity of perineal tears following this intervention (Table 1). The baseline characteristics of the population compared before and after the intervention are shown in Table 1. Conclusion: This interventional study shows that active perineal support at the time of vaginal delivery can reduce the severity of perineal trauma. Longer-term follow-up with continuous reinforcement of the intervention programme may significantly improve our OASIS rates similar to the Nordic countries. The increase in rates when untrained staff started working on the labour ward highlights that there is an urgent need for structured training of medical staff on proper perineum support during vaginal delivery of both the head and shoulders.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
References: Obstet Gynecol 2010; 116(4): p. 901–8 Table 1: Baseline characteristics of the population before and after intervention Baseline characteristics Total vaginal deliveries (denominator) OASIS rate 3a perineal tear 3b perineal tear 3c perineal tear
2012 3413 156(4.57 54(34.61 63(40.38 29(18.58
%) %) %) %)
2013 2711
P value
98(3.60 %) 41(41.83 %) 42(42.85 %) 11(11.22 %)
0.06a 0.27a
4th degree
11(7.05 %)
Minor tears (3a/3b tears) Major tears (3c/4th degree tears) Episiotomy Labial tears Induction Epidural Primiparous Multiparous
117 (74.52 %) 83 (84.69 %) 40 (25.48 %) 15 (15.31 %)
0.06a
733(22.66 %) 134(4.36 %) 930(21.48 %) 998(23.05 %) 1499(34.63 %) 2812(64.97 %)
564(20.80 %) 174(5.86 %) 740(18.71 %) 868(21.94 %) 1547(39.12 %) 2369(59.90 %)
0.08a <0.001a 0.002a 0.23a <0.001a
38.5(2.24)
39(2.09)
<0.001b
3257.8 (602)
3264.3 (587.5) 0.62b
Mean gestational age (weeks) (SD) Birthweight(grams) (SD)
4(4.08 %)
a - Chi square test b - Unpaired T test Disclosure Block: MADHU NAIDU: No disclosures. ABDUL SULTAN: No disclosures. RANEE THAKAR: No disclosures. PP 18 DOES MEDIOLATERAL EPISIOTOMY DURING OPERATIVE VAGINAL DELIVERY DECREASE THE RISK OF OBSTETRIC ANAL SPHINCTER INJURIES? - A TEN YEAR ANALYSIS OF A NATIONAL REGISTRY J. VAN BAVEL1, L. DE VRIES 2, J. DE VOGEL 3, C. W. HUKKELHOVEN 2, D. A. GIETELINK 1, B. W. MOL 4, J. W. DE LEEUW 5, D. N. PAPATSONIS 1; 1 Obstetrics and gynecology, Amphia Hosp., Breda, Netherlands, 2The Netherlands Perinatal Registry, Utrecht, Netherlands, 3Obstetrics and gynecology, Albert Schweitzer Hosp., Dordrecht, Netherlands, 4Obstetrics and gynecology, Academic Med. Ctr., Amsterdam, Netherlands, 5Obstetrics and gynecology, Ikazia Hosp., Rotterdam, Netherlands. Introduction: Operative vaginal delivery is a risk factor for Obstetrical Anal Sphincter Injuries (OASIS). There is nonconclusive evidence whether mediolateral episiotomy (MLE)
S21
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
is protective against OASIS. Previous studies suggested that MLE may have a protective effect on developing OASIS during operative vaginal delivery (1,2). In contrast, other studies suggested that the liberal use of MLE has no risk reducing effect on the occurrence of OASIS in operative vaginal delivery (3). Objective: To assess whether mediolateral episiotomy is independently associated with OASIS in women undergoing an operative vaginal delivery. Methods: We performed a retrospective cohort study using data from the Netherlands Perinatal Registry, containing information on almost all deliveries in the Netherlands. We studied 170974 women who delivered live born infants by an operative vaginal delivery between 2000 and 2010. Women with preterm delivery, stillbirth, multiple gestation, transverse position, and breech delivery were excluded from the analysis, as were women who underwent both forceps and vacuum, and women who had a median episiotomy. The primary outcome was OASIS (RCOG classification grade 3 and 4 perineal ruptures). We compared OASIS in women who had an operative vaginal delivery with and without MLE. Multivariate logistic regression analysis was used to control for differences in baseline characteristics, i.e. parity, fetal position, birthweight, duration of the second stage of labor, induction of labour, augmentation with oxytocin, use of pain medication and indication for intervention during delivery. Results: A total of 170,974 women with an operative vaginal delivery were included in the study. In deliveries with MLE (n = 144,543), 85 % was primiparous, 15 % multiparous, 93 % had a vacuum delivery and 7 % a forceps delivery. Without MLE (n=26,341), 65 % was primiparous, 35 % multiparous, 96 % had a vacuum delivery and 4 % a forceps delivery. In primiparae with vacuum deliveries (Table 1), OASIS occurred in 2.5 % of the women with MLE versus 14.0 % in women without MLE. In multiparae these percentages were 2.1 % and 7.5 % respectively. In primiparae the adjusted OR for the association of MLE with OASIS was 0.14; 95 % CI: 0.13–0.15 and the number needed to treat was 9; in multiparae the adjusted OR for the association of MLE with OASIS was 0.22; 95 % CI: 0.20–0.25, and number needed to treat 19. Forceps deliveries are shown in Table 2. In primiparae the risk of OASIS was 3.4 % versus 26.7 % with or without MLE. The adjusted OR for the association of MLE with OASIS was 0.09; 95 % CI: 0.07–0.11. In multiparae the risk of OASIS was 2.6 % versus 14.2 % with or without MLE. The adjusted OR for the association of MLE with OASIS was 0.14; 95 % CI: 0.08– 0.22. The number needed to treat for the use of a MLE with forceps delivery to prevent 1 anal sphincter was 4 in the primiparous group and 9 in the multiparous group.
Conclusions: In women undergoing operative vaginal delivery, the use of mediolateral episiotomy is associated with a large reduction of the risk of OASIS. References: (1) de Leeuw JW, de WC, Kuijken JP, Bruinse HW. Mediolateral episiotomy reduces the risk for anal sphincter injury during operative vaginal delivery. BJOG 2008; 115(1):104–108. (2) De Vogel J, Van der Leeuw-Van Beek A, Gietelink D et al. The effect of a mediolateral episiotomy during operative vaginal delivery on the risk of developing obstetrical anal sphincter injuries. Am J Obstet Gynecol 2012;206:404.e1-5. (3) Murphy DJ, Macleod M, Bahl R, Goyder K, Howarth L, Strachan B. A randomised controlled trial of routine use of episiotomy at operative vaginal delivery: a multicentre pilot study. BJOG 2008;115:1695–1703.
Table 1. Multivariate analysis of the risk of developing OASIS in vacuum deliveries (=159,340) Multiparity (n=29.183)#
Primiparity (n=130.157)* Adjusted
MLE No MLE
Adjusted
OASIS/n OR 95 % CI (%) 2830/113 0,14 0,13 0,15 619 (2,5 %) 2 317/16 ref ref ref 515 (14,0 %)
OASIS/n (%) 416/20 246 (2,1 %) 667/8 927 (7,5 %)
OR
95 % CI
0,22 0,20
0,25
ref
ref
ref
*23 missing values #10 missing values Table 2 Multivariate analysis of the risk of developing OASIS in forceps deliveries (n=11,629) Primiparity (n=9.855)
Multiparity (n=1.773)*
Adjusted
MLE No MLE
OASIS/n* (%) 314/9 204 (3,4 %) 174/651 (26,7 %)
OR
0,09 0,07 ref
Adjusted
95 % CI
ref
OASIS/n* (%) 0,11 38/1 470 (2,6 %) ref 43/303 (14,2 %)
OR
95 % CI
0,14 0,09
0,23
ref
ref
ref
*1 missing values Disclosure Block: Jeroen van Bavel: No disclosures. Lotte de Vries: No disclosures. Joey de Vogel: No disclosures. Chantal Hukkelhoven: No disclosures. Dirk Gietelink: AMS: Consultant, Consulting Fee. AMS: Scientific Medical Advisor, taking part on going RCT elevate procedure. Ben Mol: No disclosures. Jan De Leeuw: No disclosures. Dimitri Papatsonis: No disclosures.
S22
PP 19 VAGINAL DELIVERY OR CESAREAN SECTION: CONTRIBUTIONS OF THE MATERNAL SOFT TISSUE AND BONY PELVIS A. NORRIS-JACOB1, T. REICHNER 2, A. J. HOLLAND 1, A. THURMOND 2, W. GREGORY 1; 1 OHSU, Portland, OR, 2Siker Med. Imaging, Portland, OR. Introduction: The cesarean delivery rate has risen over the past several decades. Factors that are incompletely understood include maternal characteristics that contribute to delivery outcome. With the use of dynamic MRI, the relationships of the soft tissue structures to the bony pelvis can be measured at various stages of strain including at rest, with kegel, or with valsalva. Looking at these relationships may enable us to predict who will have a successful vaginal delivery and who may deliver by cesarean section. Unfortunately imaging studies to date have been limited to the antepartum period compared to postpartum. We are not aware of any previous studies looking at the pelvises of women prior to first pregnancy compared to postpartum. Objective: The goal of this study was to explore intrinsic factors of the soft tissue and bony parts of the maternal pelvis that may contribute to either vaginal delivery or cesarean section. Methods: This study is part of an ongoing prospective cohort study entitled “Pelvic Floor Nerve Injury Following Childbirth” involving nulliparous women age 40 or younger who were actively planning pregnancy in subsequent 12–24 months. Prior to conception all participants underwent a high-resolution two-dimensional, T2weighted pelvic MRI with 3-D reconstruction in supine position during rest. Dynamic MRI sequences were also obtained in the sagittal plane during kegel and valsalva. We measured the bony pelvis in the sagittal plane including obstetric conjugate, interspinous diameter, midpelvis and the reference lines pubococcygeal line (PCL) and sacrococcygeal to inferior pubis point (SCIPP) line. Using PCL and SCIPP as reference lines, we measured biometry of the puborectalis muscle, levator hiatus, bladder neck, pubourethral angle, and retrovesical angle. We calculated differences (excursions) between rest, kegel and valsalva states, and we compared those who went on to deliver vaginally vs cesarean delivery using unpaired T-test. The same subjects also completed validated symptom and Quality of Life questionnaires, as well as a comprehensive pelvic exam comprising supine POPQ and muscle strength and coordination (Brink) scale. Labor and delivery details were collected. Pregnancy and delivery were managed by
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
each participant’s selected provider. Cesarean section without labor was defined as no dilation past 4 cm. Results: Of the 135 women recruited, 77 women had successfully delivered by vaginal delivery (total n=59, 54 spontaneous, 4 vacuum, 1 forceps) or by cesarean delivery (total n=18; 5 prior to labor, 7 Stage 1, 6 Stage 2). The mean age was 30.8 (SD = 3.9) years, mean body mass index was 24.1 (SD = 4.3) kg/m2, 84 % were Caucasian, no current smokers. There was no difference between groups of the mean gestational age at time of delivery (39 weeks or 277 days) or mean birth weight (3387 [SD = 572] g). In women who went on to deliver by cesarean delivery or vaginal delivery, there were no significant differences between the pre-pregnancy POPQ exams; Brinks scale; bony pelvis measurements during rest, kegel, or valsalva; or soft tissue measurements during rest or kegel. There were significant differences in soft tissue measurements during valsalva in those who went on to deliver vaginally or by cesarean section (see table). There was greater soft tissue excursion from rest to valsalva and from kegel to valsalva in pre-pregnancy measurements of those who went on to deliver by cesarean section compared to vaginal birth (see table). These measurements include the levator hiatus anterior-posterior diameter, anorectal descent, hiatal angle, bladder neck descent, pubourethral angle, and retrovesical angle.
Levator hiatus Valsalva diameter (cm) Total excursion Anorectal Valsalva descent (cm) Total excursion Hiatal angle Valsalva (degrees) Total excursion Bladder neck Valsalva descent (cm) Total excursion Pubourethral Valsalva angle Total (degrees) excursion Retrovesical Valsalva angle Total (degrees) excursion
Vaginal Delivery 5.4 (1.0) 0.68 (0.8)
Cesarean Delivery 6.3 (1.1) 1.6 (1.0)
Pvalue
2.6 (1.1) 1.3 (0.9)
3.5 (1.2) 2.3 (1.1)
0.01 0.004
0.009 0.002
28.6 (9.0)
33.6 (9.0)
0.05
12.4 (7.4)
17.9 (9.0)
0.01
−0.87 (1.0)
0.14 (0.9)
<0.001
1.5 (1.1)
2.8 (1.0)
<0.001
84.9 (28.3)
115.4 (29.6)
<0.001
32.9 (25.3)
63.3 (23.6)
<0.001
165.3 (19.5)
173.6 (20.8)
0.14
20.8 (18.1)
34.1 (16.5)
0.008
Mean (SD) Conclusions: For those who went on to deliver by cesarean section compared to vaginal delivery, we found seemingly counterintuitive pre-pregnancy results. We demonstrate a greater descent of the soft tissues with valsalva and greater tissue
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
excursion from kegel to valsalva in those who went on to deliver by cesarean section. There were no differences in the bony pelvis or soft tissue measurements at rest or with kegel in either group. Interestingly these results suggest greater tissue plasticity in those who go on to deliver by cesarean section. References: Female Pelvic Medicine & Reconstructive Surgery (2010) 16(4): 242–245 Aust N Z J Obstet Gynaecol (2003) 43(1): 70–74 Obstet Gynecol (2009) 113(6): 1272–1278
Disclosure Block: Audra Norris-Jacob: No disclosures. Terri Reichner: Disclosure Not Provided. Amanda Holland: No disclosures. Amy Thurmond: No disclosures. W. Thomas Gregory: Uroplasty: Contracted Research to institution, Grant/Research Support. PP 20 TRACKING NEUROPHYSIOLOGIC CHANGES TO PELVIC FLOOR MUSCLES - BEFORE PREGNANCY AND FOLLOWING DELIVERY W. GREGORY, J. LIM, A. HOLLAND, A. L. CLARK; Obstetrics and Gynecology, OHSU, Portland, OR. Introduction: Evidence is mounting that Pelvic Floor Disorders (PFDs) are highly associated with parity. Exactly what injury occurs (and where) during pregnancy and delivery is still not fully characterized, but injury to the pelvic floor muscles (avulsion, myopathic changes) and nerves (neuropathy) are likely. Objective: We wished to measure changes in pelvic floor neurophysiologic parameters before and after a 1st pregnancy for the puborectalis (PR) muscles and external anal sphincter (EAS). We additionally wished to compare these changes between cesarean delivery (CD) and vaginal delivery (VD), & to see if similar changes were noted between PR & EAS. Methods: This is a prospective cohort study (Jan 2008 to Dec 2011) of nulliparous, nonpregnant women less than 40 years old who were actively planning pregnancy in the ensuing 12– 24 months. We performed a battery of standardized evaluations prepregnancy (V1), 6 weeks (V2) & 6 months postpartum (V3). These evaluations included: validated questionnaires; POPQ exam; pelvic floor muscle assessment; 3D ultrasounds (transperineal & endoanal); static and dynamic MRIs. We also completed comprehensive pelvic floor neurophysiologic exams that included sacral reflexes (clitoro-anal, urethralanal, bladder-anal) and concentric needle electromyography (EMG) of the right & left PR muscle and EAS. Filters were
S23
set at 5 Hz & 10 kHz. Gain was 100–500 μV/div; sweep speed was 10 ms/div. We utilized the multi-MUaP algorithm on a 2channel EMG system from Medtronic. The resulting MUaP parameters were for each MUaP: duration, amplitude, area, phases (>4 phases = polyphasia), turns. T-tests and chisquared tests were used & Pearson correlations were performed for any given visit. We compared parameters among the 3 time points, & between those who subsequently had VD vs CD using the repeated measures general linear model in SPSS v 22. Results: We enrolled 135 women. 87 became pregnant & 77 (57 %) carried to 3rd trimester & delivered. 84 % were White. In the 77 women, the mean (SD) age was 30.8 (3.9) years & mean BMI was 24.1 (4.3) kg/m2. As expected, the median scores for relevant baseline symptom severity and bother questionnaires were extremely low or zero. Similarly, mean scores in relevant clinical exam findings indicated good pelvic floor support and function. There were no differences in these scores between those who ultimately had a CD vs VD. Of the 77 women who carried to the 3rd trimester, there were 59 VDs (5 operative), 18 CDs (5 prior to labor, 7 Stage 1, 6 Stage 2). The mean fetal weight was 3387 (572) grams, the mean gestational age was 277 (10) days and not different between CD and VD. 73/77 (94 %) returned for V2 and 70/ 77 (91 %) returned for V3. Sixty-three (82 %) and 60 (78 %) completed V2 and V3 needle EMG respectively, and 56 women (73 %) had EMG performed at both V2 and V3. Correlation of left to right MUP parameters ranged from 0.1 to 0.5, therefore each muscle side was analyzed independently (not combined). Mean duration of MUaPs increased in both EAS PR between prepregnancy and 6 months postpartum (p<0.001). Mean amplitude of MUaPs followed a more variable pattern. There was no difference between CD and VD for the EAS, but significant differences were seen between CD and VD at the PR (Table).
Conclusions: Neurophysiologic parameters change following pregnancy. The changes demonstrate features of neuropathic changes at the EAS (via pudendal nerve), & are not different
S24
between CD & VD. However the same pattern is not true for the PR, and there is a striking difference between those who had a CD vs VD. For the PR, the data may suggest that there is a mixed pattern of neuropathy & myopathy following VD with only neuropathic features in those who undergo a CD. Although not reported here, we plan to further correlate these changes with the MRI and ultrasound data obtained. References: N/A Disclosure Block: W. Thomas Gregory: Uroplasty: Contracted Research to institution, Grant/Research Support. Jeong Lim: No disclosures. Amanda Holland: No disclosures. Amanda Clark: No disclosures.
PP 21 BIOGRAFT ADDITION TO POSTERIOR SYNTHETIC MESH DURING LAPAROSCOPIC SACRAL COLPOPERINEOPEXY: A RANDOMIZED CONTROLLED CLINICAL TRIAL J. PARK1, N. C. KASSIS 2, G. K. STEELE 3, P. J. WOODMAN 4, D. S. HALE 4; 1 SCPMG- Kaiser Permanente Fontana, Fontana, CA, 2Division of Female Pelvic Medicine and Reconstructive Surgery, Indiana Univ. Hlth., Indianapolis, IN, 3Department of Epidemiology, Indiana Univ., Indianapolis, IN, 4Indiana Univ. Hlth., Indianapolis, IN. Introduction: Sacral colpopexy is a procedure that effectively resolves prolapse in any compartment for majority of patients. The sacral colpoperineopexy is a modification of the sacral colpopexy with complete posterior wall support down to the perineal body with the use of mesh to replace damaged connective tissue. The Cochrane Database states there is no evidence to support graft use in the repair of posterior compartment defects due to conflicting evidence regarding the postoperative anatomic outcomes and the potential risk of mesh exposure. Objective: The primary Objective: of this study is to compare the anatomic success of a rectocele repair augmented with porcine biograft versus a site-specific repair without the porcine biograft for patients undergoing laparoscopic sacral colpoperineopexy. Secondly, this study aims to see if there is a difference in mesh exposure rates and quality of life measures between the two groups. Methods: In this randomized controlled clinical trial, the participants were women aged 31–77 years with symptomatic prolapse (≥stage 2) undergoing laparoscopic sacral colpoperineopexy between September 2009 and June 2011. A computer-generated randomization
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
schedule allocated the participants into 1 of 2 groups—the rectocele repair augmented with porcine biograft group (PG) or the site-specific rectocele repair without the porcine biograft group (NPG). The participants were blinded to treatment allocation throughout the 2-year study follow-up. The surgeons were blinded to the allocation until the start of the procedure. A nurse, blinded to the patient’s treatment assignment, performed pelvic examinations (with POP-Q measurements) at 6 weeks, 6 months, 1- and 2-years after surgery. The participants also completed the PFDI-20, PFIQ-7 and PISQ-12 questionnaires preoperatively, and at the 6 months, 1-year and 2-year visits. A sample size of 100 (50 per group) allowed for a conclusion with a difference of 20 % between the groups with 95 % confidence, 80 % power using a one-tail test. Of the 172 women eligible for the study, 109 women were randomized and 63 women were excluded. There were 36 women who declined to participate resulting in a 75 % recruitment rate. Of the 109 women who were randomized, 56 women were allocated to the NPG and 53 women were allocated to the PG. The number of participants analyzed in the NPG was 53 (95 %), 51 (91 %), and 43 (77 %); and in the PG was 48 (91 %), 44 (83 %) and 38, (72 %) at 6 months, 1- and 2-years, respectively. Chi-square, t-tests and regression analyses were used to determine statistically significant differences between the groups. Results: There were no statistically significant differences in baseline demographics, preoperative prolapse stages and concomitant surgical procedures between the 56 women in the NPG and 53 women in the PG. There was no statistically significant difference in overall post-op prolapse stages between NPG and PG at 6 months (t=−0.8, p=0.4), 1-year (t=−0.4, p=0.7) and 2-years (t=−0.1, p=1). In particular looking at the posterior support, similarly there was no statistically significant difference in posterior post-operative prolapse stages between NPG and PG at 6 months (t=1.2, p=0.3), 1-year (t=0.4, p=0.7) and 2-years (t=−0.2, p=0.9). For both groups, the quality of life measures improved at 6 months, 1 and 2 years compared to baseline. For the PFDI-20, the mean change for NPG and PG was 78 and 82 points, 81 and 82 points, and 89 and 92 points, at 6 months, 1 and 2-year, respectively. For the PFIQ-7, the mean change for NPG and PG was 59 and 57 points, 61 and 57 points, and 64 and 64 points at 6 months, 1 and 2-year, respectively. For the PISQ-12, there was no significant change from baseline to 6 months, 1 and 2-year follow-up for either group. For mesh exposure rates, at the 6-month follow up in the NPG there were 0 (0 %) exposures and in the PG there were 5 (10 %) which was statistically significant (χ2=5.8, p=0.02). There were no new mesh exposures at the 1-year follow up. At
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
the 2-years follow up, there was one new mesh exposure in the NPG (2.4 %) and one new mesh exposure in the PG (2.5 %), which was not found to be statistically significant (χ2=0.008, p=0.9). Conclusions: Compared to other studies, the anatomic outcomes were not significantly worse with the rectocele repair augmented by porcine biograft, though there was a higher incidence of mesh exposure at 6-month follow-up with the use of the porcine biograft. Since there was no significant postoperative anatomic difference between the porcine augmented rectocele repair and the site-specific rectocele repair and there was a higher mesh exposure rate in the porcine augmented group, the porcine biograft does not offer a significant benefit in anatomic outcomes for laparoscopic sacral colpoperineopexy. References: none Disclosure Block: Jean Park: No disclosures. Nadine Kassis: No disclosures. Gregory Steele: No disclosures. Patrick Woodman: No disclosures. Douglass Hale: Allergan: Investigator, Grant/ Research Support. Up to Date: Reviewer, Royalty. AUGS: Board Member, Travel Grant. ACOG: Representative of ACOG for the Gyn Committee at the American College of Surgeons, Travel Grant.
PP 22 POSTOPERATIVE BOWEL HABITS IN WOMEN FOLLOWING VAGINAL RECONSTRUCTIVE SURGERY A. BALLARD1, C. PARKER-AUTRY 1, C. LIN 2, A. D. MARKLAND 3, D. ELLINGTON 1, H. E. RICHTER 1; 1 Univ. of Alabama at Birmingham, Birmingham, AL, 2Center for Clinical and Translational Science (CCTS), Univ. of Alabama at Birmingham, Birmingham, AL, 3Univ. of Alabama at Birmingham, Birmingham VA, Birmingham, AL. Introduction: Recently published data showed no difference with regards to surgeon satisfaction of the operative field quality between women receiving a bowel preparation preoperatively (clear liquid diet and 2 enemas) and those allowed a regular diet the day prior to undergoing vaginal surgery for pelvic organ prolapse (POP) reconstructive surgery. Additionally, patients were more satisfied and had less side effects when not subjected to the bowel preparation and dietary alterations. Return to bowel function and symptoms associated with bowel movements after surgery is of concern for these women, as are gastrointestinal symptoms such as nausea and fecal urgency.
S25
Objective: This is a planned secondary analysis from a randomized trial, where women were assigned to enemas/clear liquid diet versus normal diet without bowel preparation. (1) We wished to characterize the impact of bowel preparation as it related to time to first bowel movement and describe post-operative bowel habits in acohort of women undergoing vaginal POP reconstructive surgery. Methods: This randomized trial enrolled women scheduled to undergo vaginal prolapse surgery with at a minimum, a planned apical suspension and posterior compartment repair. Other prolapse and incontinence surgery was allowed. Women were excluded if they had colorectal cancer, inflammatory bowel disease, a history of bowel resection, neurological disorders, undergoing chemotherapy or radiation, or were pregnant. Women with symptoms indicative of colonic inertia (fewer than 3 bowel movements a week, Rome III guidelines) were also excluded. All participants were instructed to eat nothing after midnight on the day of surgery. Participants randomized to the bowel preparation group were instructed to intake a clear-liquid diet and to self-administer 2 saline enemas (institutional standard) in the late afternoon the day prior to surgery. Participants randomized to no intervention were allowed a regular diet the day prior to surgery. The surgeons were blinded to the patient treatment assignment. Subjects completed a 7-day bowel diary prior to surgery and a 14 day bowel diary following surgery. Women were considered having completed the dairy, and thus included in the analysis, if they completed both the 7 day pre-operative and 10 of 14 days postoperative diary. The time of day, daily number of bowel movements, pain and urgency associated with the bowel movement, episodes of fecal incontinence and the use of medications to assist with bowel movements were recorded by the subjects. Anti-emetic medications administered while in the hospital were recorded and included for analysis in subjects both with and without bowel diaries. Demographics and clinical characteristics were summarized using descriptive statistics and compared between groups with and without bowel preparation by Pearson chi-squared test/Fisher’s exact test or Student’s t-test as appropriate. A p-value<0.05 was considered statistically significant in two-tailed statistical tests. Results: 150 women were enrolled and randomized, 5 women withdrew or had surgery cancelled. 121 women completed the 21 day bowel diary. Demographic, clinical and intraoperative characteristics were similar between groups (Table 1). The mean time to first BM was similar between the bowel prep and control group (81.2± 28.9 v 78.6±28.2). On the day of their first postoperative BM, there were no differences between groups regarding pain or fecal urgency with defecation and stool transit times were similar (Table 2). While participants in the control group were more likely to report daily fiber use compared
S26
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
to the treatment group, laxative use was similar between the groups. There was no difference in the use of postoperative antiemetics between the 2 groups. Conclusions: Bowel preparation for vaginal reconstructive surgery does not affect the return of bowel function and other bowel symptoms postoperatively compared to no bowel preparation. In addition, the lack of bowel preparation does not impact the risk of painful defecation postoperatively. This information may be used to inform patients regarding expectations for bowel function after vaginal reconstructive surgery. References: 1. Obstet Gynecol. 2014 Feb;123:232–8. Table 1. Clinical-Demographic Characteristics Characteristic Age, mean (SD)
Bowel Prep (n=61) 61.5 (10.4)
Control (n=60) 59.7 (10.1)
p-value 0.346
Parity (SD)
2.4 (1.03)
2.32 (1.1)
0.828
Baseline fecal leakage, n(%)
17 (28.3)
15 (24.6)
0.641
Baseline fecal urgency, n(%)
42 (70)
36 (59)
0.207
Apical suspension
58 (96.7)
61 (100)
0.244
Posterior repair
57 (95)
59 (96.7)
0.680
Table 2. Post-operative Bowel Activity and Antiemetic use Variable Time to first bowel movement, mean ± SD, (h) Pain, n (%) yes
Bowel Prep (N=61) 81.2±28.9
Control (N=60) 78.6±28.2
p-value 0.847
10 (16)
17 (28)
0.167
Fecal leakage, n (%), yes
22 (36.1)
24 (40)
0.762
Fecal urgency, n (%), yes
32 (52.5)
29 (48.3)
0.124
Greater than 1
56 (93.3)
59 (96.7)
0.439
Osmotic
51 (85)
50 (82)
0.653
Docusate
16 (26.7)
19 (31.2)
0.587
Stimulant
11 (18.3)
10 (16.4)
0.778
Fiber
3 (5)
13 (21.3)
0.008*
30 (48.4) *N=62
37 (55.2) *N=67
0.4374
Laxative use n(%)
Antiemetic use, n (%), yes
Disclosure Block: Alicia Ballard: No disclosures. Candace Parker-Autry: No disclosures. Chee Paul Lin: No disclosures. Alayne Markland: No disclosures. David Ellington: St. Jude Medical, Inc.: Stock Shareholder, Spouse is a shareholder of St. Jude Medical, Inc. and receives Stock Options annually per employer. Holly Richter: Pelvalon: Consultant, Consulting Fee. Pelvalon: Fecal incontinence, Grant/Research Support. UpToDate: Review of UpToDate articles, Royalty.
PP 23 EFFECT OF PELVIC FLOOR MUSCLE TRAINING IN WOMEN WITH MILD PELVIC ORGAN PROLAPSE M. WIEGERSMA, C. M. PANMAN, B. J. KOLLEN, M. Y. BERGER, Y. LISMAN - VAN LEEUWEN, J. H. DEKKER; General Practice, Univ. of Groningen, Univ. Med. Ctr. Groningen, Groningen, Netherlands. Introduction: Pelvic organ prolapse (POP) is common in elderly women. Treatment options are pelvic floor muscle therapy (PFMT), pessary treatment or surgical correction. In mild POP, PFMT and watchful waiting are often used. The evidence on the effectiveness of PFMT in the treatment of mild POP is scarce1. Objective: To evaluate the effect of PFMT compared to watchful waiting in women aged ≥55 years with a symptomatic mild POP. Methods: For this RCT, women aged ≥55 years were recruited in 20 Dutch primary care practices. Exclusion criteria were current POP treatment or treatment in the past year, malignancy of pelvic organs, current treatment for another gynecological disorder, severe/ terminal illness, impaired mobility, cognitive impairment, and insufficient command of Dutch language. Women screening positive for at least one pelvic floor symptom were subjected to a physical examination performed by a research physician. Patients with a mild POP (leading edge above the hymen) were randomized to PFMT or watchful waiting. All participants gave written informed consent. PFMT was instructed by a registered pelvic physiotherapist and tailored to the needs of each patient. Follow-up was scheduled for 3 months after the start of treatment. Primary outcome was improvement in pelvic floor symptoms, measured with the Pelvic Floor Distress Inventory-20 (PFDI-20, score 0–300)2. A ≥25 % reduction in PFDI-20 score was considered to be clinically relevant. Secondary outcome was change in POP-Q stage3. Analyses were done according to the intention-to-treat principle. In this abstract the results of complete case analyses (both baseline data and follow-up data available) are presented. To test the difference in PFDI-20 scores within each group (baseline versus follow-up scores) a paired samples t-test was used. The mean PFDI-20 difference score (baseline score minus follow-up score) was compared between groups using an independent samples ttest. The number of patients who improved one or more POP-Q stages was compared between groups for each compartment (anterior, posterior and apical) using Chi2 tests. A significance level of p < 0.05 was used for all tests.
S27
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Results: In total, 142 patients were randomized to PFMT and 145 patients were randomized to watchful waiting. The mean follow-up was 3.7±1.0 months after the start of treatment for patients randomized to PFMT and 3.5±1.3 months after randomization for watchful waiting. Baseline characteristics of patients are shown in Table 1. Table 1 Baseline characteristics Watchful waiting
PFMT
Mean BMI ± SD (kg/m2) Mean parity ± SD
142 64.0±6.5 26.6±4.8 2.4±1.1
145 64.5±6.8 27.0±4.7 2.4±1.2
Previous hysterectomy (%) PFDI-20 score; mean ± SD*
24 (16.9) 57.6±30.3
30 (20.7) 65.6±40.7
n Mean age ± SD (years)
* Complete cases only In total, 114 complete cases were included in the PFMT group and 125 complete cases in the watchful waiting group. Complete case analyses showed an improvement in PFDI-20 score in both treatment groups (PFMT −18.4±27.8 points (28.0 %); p<0.001, watchful waiting −6.4±20.0 points (11.1 %); p=0.001). Improvement in the PFMT group was clinically relevant, improvement in de watchful waiting group was not. The PFMT group showed greater improvement in PFDI-20 score compared to the watchful waiting group (mean difference −12.0; 95 % CI −18.3– −5.8; p<0.001). Table 2 Numbers of patients with anterior, posterior and uterus/vault prolapse in each treatment group at baseline [frequency; (%); n] Watchful waiting
PFMT
n
142
145
Anterior prolapse
131 (92.2)
136 (93.8)
Posterior prolapse Uterus/vault prolapse
47 (33.1) 30 (21.1)
44 (30.6) * 30 (20.8) *
difference in improvement in the posterior and apical compartments (Table 3). Table 3 Number of patients improving 1 or more POP-Q stage(s) between baseline and follow-up [frequency; (%); n] Compartment n
Watchful waiting 128
PFMT 107
p-value†
Anterior Posterior
20 (15.6) 14 (10.9)
29 (27.1) 10 (9.4)*
0.031 0.706
Compartment Uterus/vault
Watchful waiting 20 (15.7)*
PFMT 15 (14.0)
p-value† 0.712
†
Chi2 test * 1 missing Conclusions: In women aged ≥55 years with a mild symptomatic POP, PFMT results in a clinically relevant improvement of pelvic floor symptoms and is significantly more effective in relieving pelvic floor symptoms than watchful waiting. PFMT results in greater improvement of anterior POP-Q stage compared to watchful waiting. References 1. Cochrane Database Syst Rev 2011;12:CD003882 2. Am J Obstet Gynecol 2005;193(1):103–13 3. Am J Obstet Gynecol 1996;175(1):10–7 Disclosure Block: Marian Wiegersma: No disclosures. Chantal Panman: No disclosures. Boudewijn Kollen: No disclosures. Marjolein Berger: No disclosures. Yvonne Lisman - Van Leeuwen: No disclosures. Janny Dekker: No disclosures.
PP 24 THE EFFECT OF SACROSPINOUS HYSTEROPEXY VERSUS HYSTERECTOMY ON HEALTH-RELATED QUALITY OF LIFE, FUNCTIONAL OUTCOME AND SEXUAL FUNCTIONING IN TREATMENT OF UTERINE PROLAPSE: A RANDOMIZED STUDY
* 1 missing Table 2 shows the distribution of anterior, posterior and apical POP among patients in each treatment group at baseline. POPQ measurements at both baseline and follow-up were available for 107 patients in the PFMT group and for 128 in the watchful waiting group. In the PFMT group more patients showed improvement of 1 or more POP-Q stage(s) in the anterior compartment (27.1 % vs. 15.6 % in the watchful waiting group, p = 0.031). There was no
R. J. DETOLLENAERE 1 , J. DEN BOON 1 , J. STEKELENBURG 2, K. B. KLUIVERS 3, M. VIERHOUT 4 , H. W. VAN EIJNDHOVEN 1; 1 Isala, Zwolle, Netherlands, 2Medisch Centrum Leeuwarden, Leeuwarden, Netherlands, 3Radboud Univ. Med. Ctr., Nijmegen, Netherlands, 4RadboudUMC, Nijmegen, Netherlands. Objective: The aim of this RCT was to determine whether sacrospinous hysteropexy (SH) is non-inferior to vaginal
S28
hysterectomy (VH) in treatment of uterine descent POP-Q stage ≥ 2. This abstract focuses on quality of life, functional outcome and sexual functioning 12 months after surgery. Background: Several studies have shown that SH in case of uterine prolapse is a safe and effective alternative to VH.1 However, no sufficient powered randomized trials comparing both techniques have been performed so far. Methods: From November 2009 to March 2012 208 eligible women with uterine descent POP-Q stage ≥ 2 or higher were randomized to SH and VH in an open label non-inferiority multicenter RCT (4 non-academic hospitals). Women with previous prolapse surgery were excluded. Randomization was performed using computer-generated randomization tables and was stratified by centre and stage of prolapse. SH was performed unilaterally to the right sacrospinous ligament. In both groups additional anterior and/or posterior colporrhaphy or incontinence surgery was performed when indicated. At baseline and 12 months follow-up health related quality of life and functional outcome were assed with the Short-Form Health Survey (SF-36), Urogenital Distress Inventory (UDI), the Defecatory Distress Inventory (DDI), the Incontinence Impact Questionnaire (IIQ) and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12). The sample size was calculated for the primary outcome measurement anatomical outcome. 104 women per group were needed to provide 80 % power to test the hypothesis that SH is non-inferior to VH with a recurrence rate of 3 % in both interventions and a non-inferiority margin of 7 % at 12 months follow-up, anticipating a 10 % loss to follow-up. Results: Of the 208 enrolled women, 103 were assigned to SH and 105 to VH. At 12 months follow-up no statistical differences in SF-36, UDI, DDI and IIQ scores were found between SH and VH. All the domain scores of these questionnaires improved significantly after surgery in both groups except for the DDI domain incontinence (SH, VH), flatus (SH) and SF-36 domains social functioning (SH, VH), role limitations due to emotional problems (SH, VH), mental health (SH, VH), role limitations due to physical problems (VH) and general health perception (VH). At baseline 67 % in the SH group (63/94) and 68 % in the VH group (67/98) responded they were sexually active. After 12 months follow-up 71 % (64/90) in the SH group and 76 % (69/91) in the VH group were sexually active. Among the patients who completed the PISQ-12 before and after surgery, there was significant improvement in PISQ scores in either the SH (p=0.001) and VH group (p=0.001). Conclusions: Among women with uterine prolapse sacrospinous hysteropexy was non-inferior regarding healthrelated quality of life, functional outcome and sexual functioning at 12 months follow-up. References: 1. Nat Rev Urol 2010; 7:626–33 Domain scores of the urinary distress inventory (UDI), defecation distress inventory (DDI), incontinence impact
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
questionnaire (IIQ) and Short Form-36 before and 12 months after surgey Before surgery
12 months after surgery
SH VH SH VH p (n=102) (n=104) (n=97) (n=100) UDI domain scores Overactive bladder
26 (25)
24 (22)
9 (13)
Urinary incontinence 23 (27) Obstructive 20 (26) micturition Genital prolapse 52 (27)
18 (21) 20 (24)
11 (16) 10 (20) 4 (10) 6 (17)
9 (17)
0.99 0.62 0.32
56 (27)
1 (7)
1 (5)
0.95
24 (25)
24 (23)
6 (12)
6 (13)
0.65
Obstipation Obstructive defecation Pain
12 (22) 10 (17)
7 (14) 7 (12)
4 (8) 4 (8)
3 (8) 4 (8)
0.60 0.63
8 (20)
5 (14)
2 (8)
2 (7)
0.52
Incontinence
5 (13)
5 (11)
5 (13)
5 (15)
0.90
Flatus
28 (32)
33 (28)
21 (28) 26 (26)
0.22
Mobility
23 (24)
17 (19)
7 (12)
10 (18)
0.20
Physical
20 (26)
17 (22)
6 (15)
7 (16)
0.61
Social
13 (16)
9 (14)
3 (7)
3 (8)
0.94
Embarrassment
11 (17)
11 (19)
3 (10)
6 (16)
0.13
Emotion
16 (20)
14 (20)
3 (9)
6 (14)
0.14
Physical functioning
72 (22)
76 (20)
85 (19) 83 (20)
0.41
Social functioning
84 (20) 61 (43)
85 (21) 77 (38)
59 (19) 88 (18) 82 (36) 83 (31)
0.52 0.75
Pain DDI domain scores
IIQ domain scores
SF-36 domain scores
Role limitations due to physical problems Role limitations due to emotional problems Mental health
84 (31)
84 (37)
91 (25) 87 (31)
0.38
79 (15)
78 (16)
82 (13) 81 (14)
0.72
Vitality
66 (19)
68 (17)
71 (16) 73 (15)
0.59
Bodily pain
76 (23)
79 (20)
85 (23) 87 (19)
0.46
General health perception Health change
71 (17)
72 (17)
75 (19) 74 (18)
0.74
73 (20)
46 (15)
77 (23) 74 (23)
0.34
Data are means (standard deviation) UDI and DDI: 0=not bothersome and 100=most bothersome IIQ: 0=best quality of life and 100=worst quality of life SF-36: 0=worst quality of life and 100=best quality of life Disclosure Block: Renée Detollenaere: No disclosures. Jan den Boon: Astellas: Scientific Medical Advisor, Consulting Fee. Astellas: writing an e learning on incontinence for general practioners, Consulting Fee. Jelle Stekelenburg: No disclosures. Kirsten
S29
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Kluivers: No disclosures. Mark Vierhout: Astellas: Advisory Committee Member, Consulting Fee. Hugo van Eijndhoven: Johnson&Johnson: trainer, Honoraria. AMS: trainer, Honoraria. BARD: trainer, Honoraria. PP 25 TRADITIONAL REPAIR VERSUS MESH AUGMENTATION: ESTIMATING THE TRADE-OFF BETWEEN REOPERATION FOR MESH EXPOSURE VS REOPERATION FOR RECURRENT PROLAPSE A. A. DIETER1, A. C. WEIDNER 2, M. WILLIS-GRAY 1, A. G. VISCO 1, E. R. MYERS 1; 1 Department of Obstetrics & Gynecology, Duke Univ. Med. Ctr., Durham, NC, 2Duke Univ., Durham, NC. Introduction: Transvaginal placement of permanent mesh for treatment of vaginal vault prolapse (VVP) may reduce the incidence of reoperation for recurrent prolapse compared to traditional VVP repair. However, mesh-based techniques are associated with specific complications, such as exposure or erosion, which may also require additional surgery. Patients and clinicians need to weigh the trade-off between the “harm” of surgery for mesh-related complications that require reoperation versus the “benefit” of a potential reduced need for repeat prolapse repair. Objective: To estimate the number of additional surgeries for mesh exposure or erosion relative to prevented reoperation for recurrent prolapse based on current evidence. Methods: We used a Markov state-transition model to estimate the cumulative 24-month probabilities of surgery for mesh exposure/erosion or recurrent prolapse after either traditional or mesh-based primary VVP repair. Using data from two systematic reviews that included a range of various mesh augmentation procedures,1,2 we derived estimates for the probability of each type of event by converting the published event rate (the percentage of events divided by reported follow-up time in months) to a monthly probability. This method allows 1) adjustment for the marked difference in follow-up time between published results of the two types of primary procedures, and 2) accounting for the effect of variability in follow-up time across studies via repeated sampling from these distributions (Monte Carlo simulation) by using the reported distributions of both the percentage of events and follow-up time. We calculated the mean, median, and 95 % CI for the probability of each type of surgery, as well as the incremental “harm/benefit” ratio, defined as: [mesh erosion surgeries/(recurrent prolapse surgeries mesh group – recurrent prolapse surgeries traditional repair group)].
We varied the probability of mesh erosion in sensitivity analysis to identify a threshold where erosion surgeries were equivalent to prevented surgeries for recurrent prolapse. Results: The Table illustrates model estimates of the cumulative probability of recurrent prolapse and erosion compared to reported estimates with varying follow-up times,1 as well as estimated 24 month probability based on 100,000 model runs. Confidence intervals are wide, primarily because the wide range of reported follow-up times decreases the precision of the estimated likelihood of surgery within a given time period. The mean incremental “harm/benefit” ratio was 5.0 (95 % CI 0.4,33.5)—in other words, 5 women undergoing primary VVP repair with mesh would undergo surgery for erosion within 24 months for every woman who avoided reoperation for recurrent prolapse within the same time frame. Holding reoperation for recurrence constant, the 24-month probability of surgery for erosion would need to be less than 1.3 % for the harm/benefit ratio to be less than 1.0; only 14 % of the 100,000 simulations met this threshold. TABLE: Cumulative probability of surgery for recurrent prolapse or mesh erosion OUTCOME
TRADITIONAL
MESH
Recurrent prolapse surgery Reported1
3.9 % (32 month follow-up)
1.3 % (17 month follow-up)
Modeled
3.9 %(32 month follow-up)
1.3 % (17 month follow-up)
Model validation
Mesh erosion (includes non-surgical) Reported1
−
5.8 % (17 month follow-up)
Modeled
−
5.5 % (17 month follow-up)
24 month estimates (modeled) Recurrent prolapse surgery Surgery for erosion
Mean
Median
95 % CI
Mean
Median
95 % CI
3.8 %
3.3 %
1.3 %,8.8 %
2.7 %
2.2 %
0.6 %,7.9 %
−
−
−
7.3 %
6.0 %
1.5 %,20.6 %
Conclusions: Based on the best available evidence, there is a substantially greater likelihood that a woman undergoing mesh repair for VVP will undergo reoperation for exposure or erosion than avoid reoperation for recurrent prolapse. When interpreting our results, it is important to consider that our model-based approach to estimating outcomes relies on the available data; indirect comparisons of mostly small observational studies may include procedures and materials that do not reflect current practice. The literature would be strengthened by explicitly reporting time-to-event Methods: such as survival analysis in future studies, which would allow accounting for differences in follow-up time in estimating the likelihood of harms and benefits. Time-to-event data would also help patients and clinicians understand
S30
if the likelihood of important outcomes changed over time since primary surgery. Models are most useful research tools when the available evidence is limited, particularly when more than one outcome is important for clinical decision-making. Our approach can help with the planning and analysis of prospective studies to evaluate the outcomes of different approaches to VVP repair. References: 1. Obstet Gynecol 2009;113:367–73. 2. Int Urogynecol J 2011;22:789–98. Disclosure Block: Alexis Dieter: No disclosures. Alison Weidner: GenProbe: spouse, Grant/Research Support. GlaxoSmithKline: spouse, Grant/Research Support. Merck: Consultant, Consulting Fee. College of American Pathologists: Consultant, Consulting Fee. Marcella Willis-Gray: No disclosures. Anthony Visco: No disclosures. Evan Myers: Gen-Probe/Hologic: Grant support, evaluation of HPV RNA testing for cervical cancer screening, Grant/Research Support. Merck, Inc: Advisory Committee Member, Honoraria. AbbVie, Inc: Consultant, Consulting Fee. GSK, Inc: Evaluation of reproductive outcomes after treatment of HPV-related cervical disease, Grant/Research Support. BMS, Inc: Consultant, Consulting Fee.
PP 26 vRANDOMIZED CONTROLLED TRIAL OF PROPHYLACTIC URETERAL STENT PLACEMENT DURING UTEROSACRAL LIGAMENT SUSPENSION R. C. CHAN 1 , S. FLETCHER 2 , D. ANTOSH 1 , R. KHAVARI 1, J. STEWART 1, J. CHEN 1, J. ZURAWIN 1, J. FLORES 1, K. REEVES 1; 1 Houston Methodist Hosp., Houston, TX, 2kaise permanente, Santa Rosa, CA. INTRODUCTION: Ureterosacral ligament suspension (USLS) is an effective procedure to treat prolapse of the vaginal vault at the time of or following hysterectomy. While the ureterosacral ligaments (USL) provide strong and anatomically correct attachment points for repair, they lie in close proximity to the ureters. The rates of ureteral injury with USLS from kinking or obstruction have been estimated to occur in 4 to 11 % of cases respectively. Prophylactic ureteral stent placement is commonly used by gynecologic oncologists and colorectal surgeons when performing extirpative surgery within the pelvis. Currently, there is no published study
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
regarding the use of intraoperative ureteral stents with the USLS procedure. OBJECTIVE: This prospective randomized study aims to evaluate whether placement of prophylactic ureteral stents can aid surgeons in avoiding injury to the ureters at the time of USLS suspension suture placement. METHODS: We performed a prospective randomized controlled trial of prophylactic ureteral stent placement in women undergoing USLS for pelvic organ prolapse (POP) at our institution from April 2010 and November 2013. Women with stage II-IV POP undergoing USLS apical suspension with or without total vaginal hysterectomy (TVH) were invited to participate. Patients were randomized to intraoperative ureteral stent placement in the operating room prior to USLS surgery or no stent placement. Our primary outcome was intraoperative ureteral injury with kinking or obstruction during USLS. Intraoperative ureteral injury was assessed by administration of intravenous blue dye with cystoscopy to confirm bilateral efflux from both ureteral orifices following tying the suspension sutures. RESULTS: 93 patients were randomized in our study (47 no stents and 46 with pre-USLS stents). There was no difference in age between groups. Preoperative and postoperative degree of vault, anterior, and posterior prolapse in the stent and no-stent groups are shown in table 1. One patient in the stents group was excluded from analysis because her procedure was aborted secondary to dense adhesions. One patient in the no stents group was excluded from analysis because she only underwent a cystocele repair. Three out of 45 patients (6.7 %) in the stents group had a ureteral injury. 4 out of 46 patients (8.7 %) in the no-stent group had a ureteral injury (p-value=0.51). Prolapse assessment with POP-Q staging was performed at 1 and 3 months postoperatively. 1 month post-operative support was similar in the patients with stents group compared to patients without stents for Ba (p=0.0891), Bp (p=0.5268), and C (p=0.2866) points. CONCLUSIONS: The addition of prophylactic ureteral stent placement does not confer an ability to reduce ureteral injury. Although the ureter can easily be identified during the USLS procedure with the stent in place, often times, there is not enough room to place the suspension suture and feel the ureter simultaneously limiting the effectiveness of prophylactic ureteral stent placement. Our rates of ureteral injury were consistent with the existing literature. Table 1. POP-Q points for anterior wall support (Ba), Posterior wall support (Bp), Apical support (c), and total vaginal length (TVL) for pre-operative and 1 month post-operative.
S31
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Pre-op No Stent 40
p-value
Post-op Stent 37
Post-op No Stent 21
p-value
Number
Pre-op Stent 42
Ba
1.19±2.81
0.427±1.87
0.1484
−2.2±1.0
−1.6±1.14
0.0891
Bp
0.31±2.86
−1.375±1.17
0.0303
−2.54±0.69
−2.42±0.62
0.5268
C
0.89±4.92
−2.4±4.1
0.1346
−3.3±7.20
−5.07±5.10
0.2866
TVL
8.94±2.81
9.59±0.99
0.1650
8.26±3.20
6.90±4.89
0.2645
Disclosure Block: Robert Chan: No disclosures. sophie fletcher: No disclosures. Danielle Antosh: No disclosures. Rose Khavari: No disclosures. Julie Stewart: No disclosures. Jiong Chen: No disclosures. Jonathan Zurawin: No disclosures. Juan Flores: No disclosures. Keith Reeves: No disclosures. PP 27 NATIVE TISSUE REPAIR VERSUS MESH FOR TRAN S-VAGINAL PROLAPSE SURGERY: 5-YEAR FOLLOW-UP RCT R. SINGH, A. CORNISH, M. P. CAREY; Department of Urogynaecology, Royal Womens Hosp., Melbourne, Victoria, Australia. Introduction: There is a paucity of published data on the long-term safety and effectiveness of trans-vaginal mesh in prolapse surgery when compared to native tissue repair. The role of mesh in trans-vaginal prolapse surgery has come into sharp focus following FDA warning about safety concerns. Even though the rate of trans-vaginal mesh usage has declined dramatically since the FDA warning, long-term studies, including studies with negative outcomes, will always play an important role in our understanding the surgical management of pelvic organ prolapse. Objective: To compare the long term (5-year) anatomic and functional outcomes of vaginal prolapse repair with mesh augmentation versus native tissue repair in an RCT study. Methods: An RCT study of 129 women with ≥ Stage II prolapse requiring both anterior and posterior vaginal compartment repair randomized to either native tissue repair (no mesh group) or vaginal repair mesh augmentation (mesh group) in both anterior and posterior compartments. Mean age of 59.1 years in the mesh group and 57.6 years in the no mesh group. The rates of prior prolapse surgery and hysterectomy were not significantly different between the two groups. The decision to include only subjects who required repair of both anterior and posterior compartments was chosen to avoid the potential confounding effect of different compartment being repaired in different participants. Gynemesh (Ethicon, NJ) was used in the mesh group. An oval shaped mesh with lateral straps was used in the anterior compartment with the straps
inserted into the paravaginal spaces on each side. A Yshaped mesh was used in the posterior compartment with the straps of the mesh placed onto each sacrospinous ligament. Participants underwent a mid-urethral sling, vaginal hysterectomy and/or sacrospinous ligament fixation as required. As previously reported, there was no significant differences between the groups with respect to additional surgery.1 A clinical POP-Q examination by a blinded assessor and functional outcomes using QOL instruments were administered at each follow up. The primary outcome was Objective success based on POP-Q examination. The 5-year primary outcome was altered to include anatomic success defined as the leading edge of vagina ≤ 0 cm relative to the hymen as well as the original primary outcome measure of the leading edge of vagina ≤ −2 cm relative to the hymen. Secondary outcomes included functional outcomes, complications and QOL questionnaires. Participants were reviewed at 6 months, 12 months, and 5 years. The 6 and 12-month data have previously been reported. 1 Results: At 5 years, 55 participants returned for follow up; 27 in the mesh group and 28 in the no mesh group. Based on the original criteria of Objective: success with the leading edge of vagina ≤ −2 cm relative to the hymen, the Objective success rate was 59.25 % (16/27) in the mesh group versus 39 % (11/28) in the no mesh group and was not significant (P=0.13). Based on a definition of success of the leading edge of vagina ≤ 0 cm relative to the hymen the success rate was 96 % (26 of 27 patients) in the mesh group and 95.4 % (27 of 28 patients) in the no mesh group and was not significant (P=0.18). There was no significant difference in the functional outcomes (including sexual function) and rates of surgical re-intervention for prolapse between the two groups at 6 months, 12 months or 5 years. The cumulative mesh exposure rate at 5 years of 7 % (5.9 % requiring surgical intervention) was only slightly higher than the 5.6 % rate reported at 12 months. Conclusions: At 5 years, the Objective anatomic success rate for vaginal prolapse surgery is not significantly different with mesh augmentation compared to native tissue repair. This finding was similar to a recently publish 5-year follow up of 27,809 women undergoing vaginal prolapse surgery using either mesh or native tissue repair.2 Functional and QOL outcomes were also similar in both groups. The routine use of mesh to augment trans-vaginal prolapse surgery is not supported by this study. The number of participants returning for follow-up at 5 years (42.6 %) is typical of long-term surgical studies. References: 1. BJOG 2009; 116: 1380–1386. 2. Int Urogynecol J. 2013 Aug; 24(8):1279–85.
S32
Disclosure Block: Ruchi Singh: No disclosures. Ann Cornish: No disclosures. Marcus Carey: No disclosures.
PP 28 RISK FACTORS FOR PELVIC ORGAN PROLAPSE (POP) PROGRESSION IN A PROSPECTIVE COHORT OF SYMPTOMATIC WOMEN ACTIVELY SEEKING TREATMENT J. PIZARRO-BERDICHEVSKY1, A. PATTILLO 2, M. ARELLANO ALBORNOZ 3, H. B. GOLDMAN 4; 1 Urogynecology Unit, Obstetrics and Gynecology Division; Female Urology, H. Dr. Sotero del Rio; Pontificia Univ. Catolica de Chile; Cleveland Clinic, Cleveland, OH, 2Urogynecology Unit, Obstetrics and Gynecology Division, H. Dr. Sotero del Rio; Pontificia Univ. Catolica de Chile, Santiago, Chile, 3Urogynecology Unit, H. Dr. Sotero del Rio, Santiago, Chile, 4cleveland clinic, cleveland, OH. Introduction: There is minimal data on progression of POP in symptomatic women. At our institution, many patients may wait months or years for surgery. We prospectively describe the natural evolution of POP in this group of patients comparing the patients who developed progression with those that did not progress, and evaluating risk factors for progression. Materials and Methods: A prospective cohort of patients at an urogynecology unit was evaluated between July 2008 and June 2013. Women with symptomatic (symp) POP having 2 or more POP-Q examinations in follow-up (FU) (still awaiting surgery or prior to surgery) were included. Changes of ≥ ±2 cm in the POP-Q measurements of either points Ba, Bp or C between initial and FU exam were defined as clinically significant.. Risk factors for progression were analyzed between both groups. Mutivariate analysis was planned including the dichotomous variables with p values<0.09 in the univariate analysis. Results: 392 patients met the inclusion criteria. Median FU was 9 months. At FU the following POPQ changes were noted: 47.5 % progressed, 8.7 % regressed and 43.8 % did not change. Same compartment progression was observed in 21.7 %, 7.1 % and 23 % in the Ba, Bp and C points respectively. When the leading edge was the anterior compartment, 48 % of the progressions were related to the C point only. Univariate comparison at baseline between non progression (n=206) and progression (n=186) is shown in table 1. The groups were statistically significantly different at baseline in regards to the degree of anterior compartment descent and the presence of the leading edge beyond the hymen (72.8 % vs 81.7 %). There were
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
no differences in terms of apical prolapse. Staging at baseline and follow up for both groups is shown in table 2. Worse anterior POP and leading edge beyond the hymen were the only baseline factors that were associated with a statistically higher risk of progression. Details of the compartment that progressed are shown in table 3. A multiple logistic regression analysis including the following variables was performed for POP progression: history of previous hysterectomy, active tobacco use and leading edge beyond the hymen. The only variable statistically significant was leading edge beyond the hymen with an OR of 2.1 (IC 95 % 1.3–3.4). Conclusion: In our knowledge this is the first description of POP progression risk factors of symptomatic women actively seeking treatment. The evolution of symp POP is progression in more than 45 % of patients. 48 % with Ba POP had significant progression of the apex (C point). When the leading edge is beyond the hymen the chances to progress are increased by two fold. Table 1: Univariate analysis for Progression risk factors Variables
No POP Progression n=206 Age 60.6±10.3 Parity 3 (2–4) Forceps Delivery 29.1 % (60) Newborn Mx Weight 3800 (3350–4030) Hx AH/VH 15 % (31) Menopause Status 83.1 % (163) Age at menopause 48 (44–50)
POP Progression n=186 62.1±10.3 3 (2–4) 21.5 % (40) 3800 (3400–4100) 8.6 % (16) 83.7 % (155) 49 (42.5–50)
p Value 0.14 a 0.17 b 0.1 c 0.5 b 0.071 c 0.98 c 0.33 b
Previous POP Surgery Previous SUI Surgery Active Tobacco users Sexually active POPQ at Baseline
9.7 % (20) 4.8 % (10) 25.7 % (53) 61.9 % (125)
6.9 % (13) 1.6 % (3) 18.3 % (34) 53.8 % (100)
0.43 c 0.13 c 0.09 c 0.13 c
Aa Ba C Ap Bp Leading Edge Beyond the Hymen Apical Defect 1 Follow up (Months between POPQ)
0 (−1–1) 1 (0–3) −4 (−5–1) −2 (−3–0) −2 (−3–0) 72.8 % (150)
1 (0–2) 2 (1–4) −4 (−5–1) −2 (−3–0) −2 (−3–0) 81.7 % (152)
0.001 b <0.001 b 0.68 b 0.08 b 0.07 b 0.048 c
54.4 % (112) 9 (7–13)
54.8 % (102) 10 (7–14)
0.99 c 0.28 b
a: t-Test, b: Mann–Whitney U, c: Chi-Square 1: Apical defect was defined as descent of the C point more than half of TVL
S33
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Table 2: POPQ staging at baseline and follow up. No POP Progression and POP progression patients
Stage
No POP Progression n=206 Baseline Follow Up
POP Progression n=186 Baseline Follow Up
0 I
0.5 % (1) 0.5 % (1)
0.5 % (1) 0.5 % (1)
0 1 % (2)
0 0
II III
41.3 % (85) 52.4 % (108)
42.2 % (87) 52.4 % (108)
30.6 % (57) 60.2 % (112)
16.1 % (30) 65.6 % (122)
IV
5.3 % (11)
4.4 % (9)
8 % (15)
18.3 % (34)
Table 3: Clinically significant POPQ changes by initial leading edge compartment
Progression Compartment
Leading Edge at Baseline Anterior Posterior
Apical
POP Progression
POP Progression
POP Progression
n=153 (79 %) n=13 (7 %)
n=26 (14 %)
anterior only
11 (7.2 %)
3 (23.1 %)
5 (19.2 %)
posterior only
24 (15.8 %)
0 (0 %)
8 (30.8 %)
apical only
73 (48 %)
7 (53.8 %)
2 (7.7 %)
Anterior+Posterior
4 (2.6 %)
1 (7.7 %)
3 (11.5 %)
anterior+Apical
18 (11.8 %)
2 (15.4 %)
1 (3.8 %)
Posterior+Apical
10 (6.6 %)
0 (0 %)
3 (11.5 %)
All
12 (7.9 %)
0 (0 %)
4 (15.4 %)
Same compartment
33 (21.7 %)
1 (7.7 %)
10 (38.5 %)
Disclosure Block: Javier Pizarro-Berdichevsky: No disclosures. Alejandro Pattillo: Johnson & Johnson: Occasional funding for attending meetings, Travel Grant. Marco Arellano Albornoz: No disclosures. howard goldman: Pfizer: Advisory Committee Member, Honoraria. Medtronic: Consultant, Consulting Fee. Allergan: Speaker, Honoraria. Uroplasty: Speaker, Honoraria. Astellas: Speaker, Honoraria.
PP 29 ABDOMINAL SACRAL COLPOPEXY VERSUS SACROSPINOUS LIGAMENT FIXATION: A COST-EFFECTIVENESS ANALYSIS M. S. OHNO1, M. L. RICHARDSON 1, E. R. SOKOL 2; 1 Obstetrics and Gynecology, Stanford Univ., Stanford, CA, 2 Stanford Univ., Stanford, CA. Objective: Surgical correction of vaginal apical prolapse can be performed abdominally or transvaginally with no clear consensus on the optimal approach. We investigated the cost-effectiveness of abdominal sacral
colpopexy (ASC) compared to sacrospinous ligament fixation (SSLF) for apical prolapse repair. Background: Advanced prolapse generally requires surgical correction of the apex for optimal results. Broadly speaking, the abdominal approach has better results at the expense of longer operating and recovery times while the transvaginal approach is less expensive with a shorter recovery but is generally associated with poorer outcomes. While exact estimates are not available, a recent review suggests that 80–90 % of procedures are performed vaginally (Int Urogynecol J, 2013). To date there have been no published cost-effectiveness analyses comparing ASC to SSLF to determine if the improved outcomes of ASC justify the increased expense. Methods: A decision-analytic model was created to compare ASC to SSLF using TreeAge Pro (2013). Outcomes included in the model were: post-operative stress urinary incontinence (SUI) with a possible option for post-operative mid-urethral sling (MUS) placement, recurrence of prolapse with possible re-operation, and post-operative dyspareunia. All probabilities, costs and benefits were derived from the literature. Costs were reported in 2013 US$. Utilities were applied at a discount rate of 3 % over 2 years to generate quality adjusted life years (QALYs). Baseline costs were: $13,460 for ASC, $10,653 for SSLF, and $4,640 for MUS. Baseline probabilities included a post-operative SUI rate of 30 % for ASC and 35 % for SSLF, a rate of pursuing MUS placement for occult SUI of 36 % for ASC and 60 % for SSLF, a prolapse recurrence rate of 3.6 % for ASC and 15 % for SSLF, and a postoperative dyspareunia rate of 16 % for ASC and 36 % for SSLF. Baseline utilities included 0.71 for SUI, 0.75 for recurrent prolapse, and 0.9 for post-operative dyspareunia. The cost-effectiveness threshold was set to $50,000 per QALY for the incremental costeffectiveness ratio (ICER). Base-case, threshold, and one-way sensitivity analyses were performed. Results: At baseline, ASC is more expensive than SSLF ($13,988 vs $11,950) but more effective (QALY 1.53 vs 1.45) and is cost-effective (ICER $24,574/QALY) at 2 years. ASC is no longer cost-effective if it costs more than $15,620. These results were most sensitive to the probability of postoperative occult SUI and subsequent treatment with MUS. ASC was not cost-effective if the rate of post-operative SUI was above 36 % after ASC or below 28 % after SSLF or if the rate of MUS placement for post-operative SUI was above 60 % after ASC or below 13 % after SSLF. Furthermore, ASC was not cost-effective if: a) the rate of recurrent prolapse was above 15 % after ASC or below 4 % after SSLF or b) if the rate of post-operative dyspareunia was above 59 % after ASC or below 19 % after SSLF.
S34
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Conclusions: Abdominal sacral colpopexy (ASC) can be a cost-effective method to repair apical prolapse compared to sacrospinous ligament fixation (SSLF) if it costs less than $15,620, or has incremental cost over SSLF of less than $5,854. However, ASC is no longer cost-effective if the rate of post-operative SUI after SSLF is less than 28 % or if the rate of MUS placement after SSLF is less than 13 %.
References Cochrane Database of Systematic Reviews 2013, Issue 4. Art. No.: CD004014. Int Urogynecol J 2013;24:1815–1833. J Urol 2013;190(4):1306–12. Table 1. Outcomes of abdominal sacral colpopexy (ASC) versus sacrospinous ligament fixation (SSLF) for apical prolapse repair Abdominal sacral colpopexy
Sacrospinous ligament fixation
Cost
$13,988
$11,950
Effectiveness
1.53
1.45
ICER* ($/QALY)
$24,574 More expensive More effective
Less expensive
Cost-effective
Less effective
*ICER = incremental cost-effectiveness ratio; costeffectiveness threshold set at $50,000/QALY
Disclosure Block: Mika Ohno: No disclosures. Monica Richardson: No disclosures. Eric Sokol: Pelvilon: Scientific Medical Advisor, Ownership Interest. American Medical Systems: Consultant, Consulting Fee.
PP 30 NEGATIVE IMPACT OF POLYPROPYLENE MESH ON VAGINAL SMOOTH MUSCLE MYOCYTES IS REDUCED WITH COMPOSITE MESH CONTAINING REGENERATIVE EXTRACELLULAR MATRIX R. M. SHAFFER, R. LIANG, P. A. MOALLI; Department of OB/GYN/RS, Univ. of Pittsburgh, Pittsburgh, PA. Introduction: Implanting Gynemesh PS by abdominal sacrocolpopexy (ASC) causes atrophy of smooth muscle cells and muscle bundles, reduced contractility, and altered structural protein levels of primate vagina. We have shown attenuation of these effects on a macroscopic level by adding an extracellular matrix bioscaffold. Objective: To describe the micromorphologic impact of ASC grafts: polypropylene mesh alone (GYN) (Gynemesh PS, Ethicon), a regenerative ECM alone (ECM) (6-ply, MatriStem porcine urinary bladder, ACell), or a composite of Gynemesh and ECM (ECM+GYN) (2-ply, ACell). Methods: Female middle-aged rhesus macaques (n=17) had hysterectomy and ASC, with GYN, ECM, or ECM+GYN. Sham animals had ASC surgery with no graft. The meshvagina complex (MVC) was harvested at 12 weeks. Analysis was performed on immunofluorescence-labeled smooth muscle cell membranes (caveolin-3, Santa Cruz), smooth muscle actin (αSMA, Sigma), and the nuclear label DAPI. Five randomly chosen fields per section were imaged with fluorescence and confocal microscopy, with muscularis width, smooth muscle bundles, and cells analyzed. T-tests were used for continuous variables and ANOVA for group comparisons. Results: MVCs analyzed included 5 GYN, 5 Sham, 3 ECM and 4 ECM+GYN. There was no difference in age, BMI, gravity, or parity. Vaginal wall muscle thickness was found to be significantly different between GYN (865.5 μm) and the Sham and ECM+GYN groups (1557.5 and 1688.1 μm, p < .01) and but not different from ECM (1345.7 μm, p=.50). Individual smooth muscle cells were significantly smaller for GYN (2.8 μm) than for the other three groups (Sham 3.6 μm, ECM 3.5 μm, ECM+GYN 3.3 μm; p<.01). More GYN and ECM smooth muscle bundles were small and <10 μm compared to Sham (p<.01); this was not different between Sham and ECM+GYN. Conclusions: GYN alone behaves differently than as a composite with ECM. Vaginal smooth muscle cells appeared normal after implantation of ECM or ECM+GYN. However, the normalization of bundles and muscularis thickness seen in the ECM+GYN group did not occur with the ECM alone. This research suggests that synthetic grafts with an ECM component may be superior to mesh alone grafts, but that the benefits of ECM are lost when multiple layers are employed.
S35
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
References: N/A
PP 31 HISTOMORPHOLOGY AND INTEGRITY OF THE DISRUPTED EXTERNAL ANAL SPHINCTER AFTER ADMINISTRATION OF MYOGENIC STEM CELL-LADEN HYDROGEL SCAFFOLD IN AN ANIMAL MODEL I. MONTOYA1, B. SMITH 1, J. F. ACEVEDO 1, P. KELLER , L. TANG 2, R. WORD 3, C. WAI 1; 1 Obstetrics and Gynecology, Univ. of Texas Southwestern Med. Ctr., Dallas, TX, 2Bioengineering, Univ. of Texas at Arlington, Arlington, TX, 3Univ TX Southwestern Med Ctr, Dallas, TX. 1
Disclosure Block: Rebecca Shaffer: No disclosures. Rui Liang: No disclosures. Pamela Moalli: ACell: We received supplementary funding to support the cost of animals to complete the 3rd aim of our R01, Grant/Research Support.
Introduction: Previously, we demonstrated that local injection of myogenic stem cells at the time of external anal
S36
sphincter (EAS) repair resulted in superior contractile function of the sphincter at 90 days compared with repair alone. Without repair, EAS function was not improved by stem cell therapy at any time point. Utilization of bioscaffolds after tissue injury may be useful in situations where there is a tissue defect that needs to be bridged, as in the case of a persistently disrupted anal sphincter. More recently, we showed that the addition of a biogel scaffold to myogenic stem cells appears to improve contractile responses in an injured, non-repaired EAS with sustained improvement over time. It was unknown whether the increases in contractile force seen in stem cell-laden biogel scaffold were accompanied by increases in muscle volume or resulted from improvement of histomorphologic properties. Objective: To evaluate the effect of myogenic stem cells administered with a hydrogel matrix scaffold on histologic characteristics and volume of striated muscle of the EAS after transection without repair. Methods: Histologic analysis was performed on anal sphincters of 80 young female rats that previously underwent anal sphincter transection without repair followed 2 weeks later by injection at the transection site with one of four randomized treatment groups: 1) nothing (control), 2) a Polyethylene glycol-based hydrogel matrix scaffold combined with phosphate-buffered saline (matrix), 3) a hydrogel matrix scaffold combined with myoblast stem cells (3.2×10^6) (matrix + SC), or 4) Type I collagen (2 mg/ml) (collagen). Sphincter complexes from animals euthanized at 30 d (n=40) or 90 d (n=40) after treatment and previously evaluated for neurophysiologic function were processed for histology and analyzed for possible disruption. The relationship between muscular disruption & maximal electrical field stimulation (EFS) of sphincters was evaluated. Five sphincters were randomly selected from each treatment group for volumetric analysis. The volume was computed from 5 um serial sections at 100 um intervals throughout the entire sphincter complex using Image J software (v1.47, NIH). Unoperated time-matched animals (n=10 per group) were also studied for each of the 2 time points. Statistical analysis was performed using ANOVA, Fisher exact and Student’s t-test as appropriate, with P≤0.05 considered significant. Results:0While 100 % of non-repaired sphincters were histologically disrupted by 90d, 80 % of sphincters treated with matrix + SC, and 100 % of those treated with collagen appeared histologically intact at 90 d. This finding of the matrix + SC and the collagen groups having a higher proportion of intact sphincters correlated with a larger sphincter force generation in response to maximal electrical field stimulation in
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
both groups, compared with non-repaired controls (matrix + SC, 7.28±0.72 g/sphincter and collagen, 8.51±2.09 g/sphincter vs. non-repaired controls, 4.09±0.8 g/sphincter, P≤0.04, respectively). Compared with 30d after treatment, sphincter striated muscle volume was greater at 90d for matrix (15.9± 1.6 mm^3 vs 26.2±1.2 mm^3, P=0.001) and matrix + SCtreated animals (20.8±4.1 mm^3 vs 33.9±3.0 mm^3, P= 0.008). At 90d, matrix + SC treated animals had higher sphincter striated muscle volumes compared to non-repaired controls (33.9±3.0 mm^3 vs 19.6±2.8 mm^3, P=0.001) and collagen-treated animals (33.9 ± 3.0 mm^3 vs 20.65 ± 0.89 mm^3, P=0.001). Conclusions: In this non-repaired anal sphincter animal model after injury, treatment with a hydrogel matrix bioscaffold, with or without myogenic stem cells, increased striated muscle sphincter volume over time. The addition of myogenic stem cells to a hydrogel matrix scaffold demonstrated histologic evidence of sphincter repair by 90d and correlated with increased contractile force. Together with the findings of our previous work, the results from this current study provide further evidence that a myogenic stem cell-laden biogel scaffold might be beneficial in the wound healing of the disrupted anal sphincter, and hypothesize that it may act as a bridge between injured sphincter ends, promoting activation of satellite cells and endogenous repair of the striated muscle complex. References: None. Disclosure Block: Ignacio Montoya: No disclosures. Benjamin Smith: No disclosures. jesus acevedo: No disclosures. Patrick Keller: No disclosures. Liping Tang: No disclosures. R. Ann Word: No disclosures. Clifford Wai: No disclosures.
PP 32 A KEY ELASATIN PROTEASE, MMP-9, IS ELEVATED IN PRIMIPAROUS WOMEN ONE YEAR AFTER DELIVERY S. L. PALCSEY1, S. OLIPHANT 2, A. L. NOLFI 3, P. MOALLI 4; 1 Magee Womens Res. Inst., Pittsburgh, PA, 2Little Rock, AR, 3 Univ. of Pittsburgh, Pittsburgh, PA, 4Magee-Womens Hosp., Pittsburgh, PA.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
INTRODUCTION: Pregnancy and parturition are known risk factors for developing pelvic organ prolapse (POP) later in life. Increased parity has been shown to further increase risk but the first birth may have the greatest impact. Vaginal tissue remodeling is a continuous process and represents a delicate balance between synthesis of major structural proteins, such as collagen and elastin, and their breakdown. This balance is necessary to maintain integrity of vaginal tissue. In pregnancy, increased elastin protease activity is necessary to achieve sufficient distension of the vagina for delivery; yet persistently elevated protease activity may predispose to POP. Previously, we showed that primigravidas with higher total elastase activity in the first trimester were more likely to go on to successfully achieve a vaginal delivery; however, it was not clear which specific elastases were responsible for this activity and how the activity of specific elastases is impacted by parturition. OBJECTIVE: To quantify and compare endogenous levels of the active form of a key elastin protease, MMP-9, in primigravidas across trimesters of pregnancy and 12 months post partum and to correlate MMP-9 levels with anatomical and delivery outcomes to identify women who may be most at risk for developing a PFD. METHODS: Following IRB approval, a cohort of nulliparous gravidas were enrolled in the 1st trimester of pregnancy. Participants were recruited from 2010 to 2012 at two tertiary academic centers. Eligible women were ≥ 18 years of age with an ultrasound-confirmed, single gestation between 8 and 13 weeks at time of enrollment, no prior pregnancy lasting 20 or more weeks, and had plans both to deliver at study site hospital and remain in the area for at least 1 year postpartum. During study visits, a Pelvic Organ Prolapse Quantification exam (POP-Q) was performed. Successful vaginal delivery (VD) was defined as delivery without Cesarean, forceps or vacuum, shoulder dystocia, 3rd/4th degree perineal laceration, or length of 2nd stage labor >120 min. In addition, we collected vaginal fluid swabs from the posterior and lateral fornices to obtain vaginal epithelial cells. Vaginal fluid swabs were processed, supernatant collected, and protein concentration determined using the Bio Rad Protein Assay (Hercules, CA). Halt proteinase inhibitor cocktail (Thermo Fisher Scientific, Pittsburgh, PA) was added to each sample to preserve proteinase activity. A Fluorokine E Human Active MMP-9 kit (R&D systems, Minneapolis,
S37
MN) was used for detection of endogenous MMP-9 activity in the sample. Data was analyzed using a four-parameter regression curve (Masterplex ReaderFit, Miraibio, San Francisco, CA). Appropriate statistical analysis was performed with significance level set at 0.05. RESULTS: 173 women were enrolled in 1st trimester. Data were available for 149 (86 %) at 3rd trimester, 150 (87 %) at delivery, and 78 (45 %) at 1 year postpartum with several still scheduled for this visit at the time of this abstract. MMP-9 activity data were collected from 157 1st trimester, 148 3rd trimester, and 75 1 year postpartum samples. Median MMP-9 activity levels in 1st trimester were 242 ng MMP-9/mg protein (IQ range 19.3, 893.5), 130.5 ng MMP-9/mg protein (IQ range 14.5, 863.5) in 3rd trimester, and 557 ng MMP-9/mg protein (IQ range 100.1, 900) postpartum. MMP-9 activity levels were significantly higher in the postpartum period compared to both the first trimester and 3rd trimester (p=0.005 and p<0.001 respectively), with no differences noted between 1st and 3rd trimester levels (p=0.674). No associations were found between MMP-9 activity and successful vaginal delivery in any of the study time points. CONCLUSIONS: MMP-9 a key elastin protease is elevated at 1 year post partum in primiparous women. As increased MMP-9 has been found in full thickness vaginal biopsies in women with > stage I prolapse and MMP-9 has been shown to precede the onset of prolapse in murine models of POP, the data strongly suggest that vaginal tissue remodeling homeostasis is disrupted after delivery with an increased tendency toward elastin degradation. The agreement with previous animal models suggests a mechanism by which parturition increases risk of POP. REFERENCES: Budatha et al. Extracellular matrix proteases contribute to progression of pelvic organ prolapse in mice and humans. J Clin Invest. 2011 May 2; 121(5): 2048–2059. Disclosure Block: Stacy Palcsey: No disclosures. Sallie Oliphant: No disclosures. Alexis Nolfi: No disclosures. Pamela Moalli: ACell: We received supplementary funding to support the cost of animals to complete the 3rd aim of our R01, Grant/ Research Support.
S38
PP 33 STATIC MECHANICAL LOADING INFLUENCES THE EXPRESSION OF EXTRACELLULAR MATRIX PROTEINS AND CELL ADHESION MOLECULES IN VAGINAL FIBROBLASTS DERIVED FROM WOMEN WITH AND WITHOUT SEVERE PELVIC ORGAN PROLAPSE O. SHYNLOVA1, Y. RYBAK 2, H. KUFAISHI 3, H. P. DRUTZ 1, M. ALARAB 4; 1 Mount Sinai Hosp., Toronto, Canada, 2 LunenfeldTanenbaum Res. Inst., Toronto, Canada, 3 LunenfeldTanenbaum Research Institute, Mount Sinai Hosp., Toronto, Canada, 4Mount sinai Hosp., Toronto, Canada Introduction: We reported earlier that primary human vaginal fibroblasts (HVFs) derived from patients with advanced Pelvic Organ Prolapse (POP) display differential proliferative characteristics, attachment to extracellular matrix (ECM) and react differently to mechanical loading by changing the expression of proteins involved in elastin and collagen metabolism (i.e. LOX family, MMPs, TIMPs) vs HVFs derived from asymptomatic control women. Cell adhesion molecules (CAMs), including transmembrane integrin molecules that transmit mechanical signals, form the structural link between ECM proteins and the cytoskeleton. Abnormalities in cellmatrix and cell-cell interactions may predispose women to POP. We hypothesized that POP-HVFs will have an altered expression of ECM, integrin receptors, and CAMs, when compared to control-HVFs. Objective: We aim to compare the expression of ECM components, cell-matrix adhesion proteins involved in mechanotransduction in HVFs derived from premenopausal POP patients vs asymptomatic controls, and to study the effect of continuous static mechanical stretch on their expression. Methods: Premenopausal women undergoing total hysterectomy for benign conditions were recruited as controls, while women with advanced POP (POP-Q stage ≥3) were recruited as patients. HVFs were isolated by enzymatic digestion of vaginal biopsies, seeded on 6well collagen I (COLI)-coated bioflex® plates, and subjected to static mechanical loading at 25 % elongation for 24 h. Total RNA was extracted and converted to cDNA; samples from POP and controls were pooled and the expression of 84 genes was analyzed by Human ECM and Adhesion Molecules RT2 Profiler PCR array. To confirm transcript level changes, qPCR analysis was performed in triplicate on individual human vaginal cDNA samples using specific primers to quantify collagens’, integrins’ and CAMs’ gene expression. Quantity means were normalized to three housekeeping genes. Results: (1) Up-regulation of contactin gene (CNTN1), as well as alpha and beta family integrins (ITGA1,
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
ITGA2, ITGA4, ITGA6, ITGA8 ITGA11, ITGB1), that are components of collagen receptors (A1B1, A2B1), the ligand for VCAM1 (A4B1), was detected in nonstretched POP-HVFs when compared to control-HVFs (p<0.05). Interestingly, transcript levels of ICAM1 and VCAM1, basement membrane constituents laminin (LAMA1, A2, C1, C3), collagen IV (COL4A2), and fibrilassociated collagen XV (COL15A1) were significantly down-regulated in non-stretched POP-HVFs as compared to control-HVFs. (2) Importantly, majority of integrin transcripts were further up-regulated in mechanically stretched POP-HVFs, whereas transcripts encoding COL1,3,4,5,7,11,14,15 were down-regulated by static mechanical stretch in POP-VFs. Immunoglobulin superfamily genes CNTN1, ICAM1 and VCAM1 were not affected by mechanical loading. Changes in gene expression were highly reproducible, as evidenced by consistent results obtained between PCR array and qPCR assay. Conclusions: Under static conditions, HVFs derived from POP patients showed differential expression in a majority of the transcripts we examined as compared to HVFs derived from control women with normal pelvic support. Mechanical loading was able to sustain or magnify these changes. Altogether, our results may provide a probable mechanism by which risk factors that induce stretch of the pelvic floor alter ECM composition of vaginal tissue and cell-ECM interaction which may contribute to the weakening of pelvic organ support in pre-menopausal patients. We speculate that (1) the change in ECM composition, accompanied by a misbalanced cell-ECM interaction, is a pre-existing condition in patients genetically predisposed to prolapse, and that (2) increased mechanical loading of the pelvic floor will further alter the quality of pelvic floor ECM, resulting in the development of POP. References: NA
S39
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Disclosure Block: Oksana Shynlova: No disclosures. Yaryna Rybak: No disclosures. Hala Kufaishi: No disclosures. Harold Drutz: Cook Myosite: I am the site PI for a study on the use of autologous myosites to treat SUI (Cook Myosite Female SUI Study 10–019, Grant/Research Support. May Alarab: No disclosures.
PP 34 HUMAN UROTHELIAL CELLS: NEW DISCOVERIES FROM AN IN VITRO MODEL P. T. LE1, C. S. FOK 2, M. M. PEARCE 3, S. ZHANG 1, A. J. WOLFE 3, L. BRUBAKER 4; 1 Microbiology and Immunology, Loyola Univ. Chicago, Stritch Sch. of Med., Maywood, IL, 2Univ. of Minnesota, Minneapolis, MN, 3Loyola Univ. Chicago, Maywood, IL, 4 Loyola Univ. Chicago Stritch Sch. of Medici, Maywood, IL Introduction: Human urinary disorders are generally studied in rodent models due to a lack of an appropriate in vitro culture model of primary human urothelial cells (HUCs). Current human cell culture models are often derived from immortalized cancer cell lines, which likely do not share characteristics with healthy human urothelium Objective: We aimed to develop an in vitro culture model of primary HUC model using human bladder biopsies; we further describe the functional characteristics of these HUCs. Methods: Following IRB approval, intraoperative bladder biopsies were obtained at the end of urogynecologic surgery. After 2 h of incubation in culture media to loosen the lamina propria, the urothelium layer was separated under dissecting microscope, cut into 1 × 1 cm2 fragments and used to propagate HUCs using an explant technique. We assessed morphology and heterogeneity of the generated HUCs and characterized their cell membrane structural proteins. Transmission electron microscopy (TEM) was used to assess ultrastructure and compare to ex vivo urothelium tissue. The generated HUCs were further characterized using immunofluoresence multi-color flow cytometry. Expression of muscarinic receptors, enzyme acetyltransferases, cytokines, chemokines and cytokine receptors was measured by quantitative RT-PCR. Results: The biopsies were feasible and uncomplicated in all participants. The primary HUCs displayed the cobblestone morphology of epithelial cells and urothelial heterogeneity, including large, fully differentiated superficial umbrella cells with a bi-nucleus, and smaller immature basal and intermediate cells. Double-immunofluorescence staining revealed cells that expressed uroplakins and
cytokeratin 20 (structural proteins specific to umbrella cells). Ultrastructure studies demonstrated organelles unique to umbrella cells: discoid fusiform vesicles and multivesicular bodies with exosomes. TEM also detected intricate basolateral interactions between two adjacent cells, reinforced with scattered desmosomes, ultrastructures that are identical to ex vivo urothelium tissue. Multi-color flow cytometry showed uniform expression of epithelial cell adhesion molecule (EpCAM), β4-integrin and intercellular adhesion molecule (ICAM), confirming epithelial nature. Based on expression of the adhesion molecule CD44, we detected two distinct cell populations which correspond to the superficial umbrella cells (CD44lo/neg) and basal cells (CD44pos). Furthermore, the CD44pos HUCs express the Toll-like receptor 4 (TLR4) along with its co-receptor CD14, while the CD44lo/neg cells express TLR4, but not CD14, suggesting the possibility that these two distinct cell populations respond to the TLR4 ligand, bacterial lipopolysaccharide, through distinct signal pathways. Functionally, these primary HUCs express both M1 and M2 muscarinic receptors and the carnitine acetyltransferase (CarAT), but not choline acetyltransferase (ChAT), indicating that HUCs can synthesize acetylcholine and respond to it in an autocrine fashion. We also discovered that HUCs express both forms of the IL22 receptor, the membrane-associated (IL22RA1) and the soluble (IL22RA2) forms. They also express the cytokines IL7, IL15, IL23p19 and the chemokine CCL20, which are required for the development of IL22-producing cells and their recruitment to the bladder submucosa, respectively. Since IL22 has been shown as a critical cytokine for epithelial functions in the gastrointestinal tract and skin13, these data suggest a potential role of IL22 and IL22producing cells in human urothelial cell biology. Conclusions: IL22 receptor expression, not been previously described in HUCs, was unequivocally demonstrated in this primary HUC system. Our culture model clearly generates functional HUCs suitable for the study of human urinary tract disorders, including interactions between urothelium and innate immune cells. This human model can replace animal models for study of human urothelium functions. References: 1. Semin. Immunopathology 32:17–31, 2010. 2. Immunity 21:241–254, 2004 3. J. Exp. Med. 206:1465–1472, 2009. Disclosure Block: Phong Le: No disclosures. Cynthia Fok: No disclosures. Meghan Pearce: No disclosures. Shubin Zhang: No disclosures. Alan Wolfe: Astellas Scientific and Medical Affairs, Inc: I am PI on a investigator initiated grant, Grant/Research Support. Linda Brubaker: No disclosures.
S40
PP 35 DYNAMIC ASSESSMENT OF SLING FUNCTION ON 2D TRANSPERINEAL ULTRASOUND: IS IT CORRELATED WITH OUTCOMES ONE YEAR FOLLOWING RETROPUBIC MIDURETHRAL SLING SURGERY? A. HEGDE, G. NOGUEIRAS, V. AGUILAR, G. DAVILA; Cleveland Clinic Florida, Weston, FL Objective: To correlate dynamic assessment of sling function (deformability, location of sling and concordance of urethral movement with sling) using 2D and 3D transperineal ultrasound with outcomes following retropubic midurethral sling surgery. Background: The importance of dynamic in vivo sling function characteristics, especially location, in ensuring continence is controversial. Studies that have challenged the importance of sling location have often studied the TVT retropubic sling (1). Our hypothesis is that, due to its retropubic location, the TVT sling procedure may be associated with increased tape tension and urethral compression, which may compensate for any inappropriate sling location while still maintaining continence. Methods: This is a prospective cohort study of 94 patients who underwent retropubic midurethral sling surgery (TVT, Ethicon, Bridgewater, NJ) at our center between August 2009 and March 2012. All the enrolled patients underwent 2D dynamic assessment as well as 3D ultrasound using the transperineal transducer 8802 of the BK Medical Profocus Ultraview ultrasound machine (Peabody, MA) by a fellow who was blinded to the treatment outcomes. A composite outcome measure was used to determine treatment failure: positive urine leakage on cough stress test (250 ml) and a positive response to question 3 of the UDI-6 questionnaire. The 30 s 3D volumes obtained at rest, 6 s 3D volumes in the sagittal plane obtained on maximal Valsalva, and 2D films obtained during cough and Valsalva maneuvers in each patient were analyzed. The deformability of the sling on Valsalva, the concordance of urethral movement with the sling and location of the sling was noted in each patient Results: 64 (68.1 %) patients had successful outcome at the 1 year follow-up visit (group A) and 30 (31.8 %) patients had failed sling surgery (group B). The two groups were similar with respect to their demographic data of age, BMI, parity, smoking history, severity of stress incontinence, urodynamic parameters and median weeks of follow up (p>0.05). The rates of concomitant prolapse surgery, including anterior repair were similar between the two groups (p>0.05). When compared with group B, group A had a significantly greater number of patients in whom the sling deformed on Valsalva (flat at rest and curved into a c-shape on Valsalva), the urethral
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
movement was concordant with the sling and the sling was located beneath mid urethra (p<0.05; table 1). The urethrovesical junction moved distal to the sling in 8 (26.7 %) patients in Group B who had discordant movement of the urethra relative to the sling. In the 3 patients in Group B in whom the sling deformed on Valsalva and the urethra moved in a concordant manner with the sling (table 2), the sling was located beneath proximal urethra at maximal Valsalva. In all the 17 (56.6 %) patients in Group B in whom the urethra moved in a concordant manner with the sling, the sling did not deform on dynamic assessment and was located beneath the proximal urethra. In all the 31 (48.4 %) patients in Group A in whom the sling remained either flat or curved, the urethra moved concordant with the sling and the sling was located beneath mid urethra. Conclusions: On 2D and 3D transperineal ultrasound, the best outcomes following retropubic midurethral sling surgery are found to be associated with midurethral location at maximal Valsalva and concordance of urethral movement with the sling followed by deformability of the sling on dynamic assessment. Reference: 1. Acta Obstet Gynecol Scand 2004; 83(10): 904–908. Table 1: In vivo characteristics of the sling as seen on 2D transperineal ultrasound Variable
Group A Group B Odds ratio n=64 n n=30 n (95 % CI) (%) (%) Deformability of the sling
p value*
Flat to C shape 33 (51.6) 6 (20) 4.26 (1.54–11.81) 0.005 on Valsalva No change Remains flat 23 (35.9) 11 (36.7) Remains 8 (12.5) 13 (43.3) curved Concordance of urethral movement with sling on Valsalva Concordant
64 (100)
Discordant 0 UVJ moves 0 distal to the sling Location of sling
20 (66.7) 116.41 (6.72–2017.96) 10 (33.3) 8 (26.7)
Mid urethra
49 (76.6) 0 (0)
Altered location -
0
Proximal to UVJ -
8 (26.7)
15 (23.4) 22 (73.3)
Proximal urethra
*p value: Fisher Exact test
194.81 (11.24– 3374.93)
0.001
0.0003
S41
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Table 2: Deformability of sling and concordance of urethral movement with sling during Valsalva maneuver considered together Deformability of sling
Group Group p A N (%) B N (%) value*
Movement of urethra relative to sling Change from flat to Concordant C shape (n=39) Discordant
33 (84.6) 3 (7.7) 0 3 (7.7)
Total Remains flat (n= 34) Total
Concordant Discordant
33 23 (67.6) 0 23
6 6 (17.6) 5 (14.7) 11
Remains curved (n=21)
Concordant Discordant
8 (38.1) 0
11 (52.4) 0.42 2 (9.5)
8
13
Total
0.009
0.01
*p value: Chi Square test Disclosure Block: Aparna Hegde: No disclosures. G. Mayte Nogueiras: No disclosures. Vivian Aguilar: No disclosures. G. Willy Davila: Astellas: Speaker, Honoraria. Warner-Chilcott: Speaker, Honoraria. AMS: Speaker, Honoraria. AMS: Scientific Medical Advisor, Intellectual Property Rights. Pfizer: Investigatorinitiated research grant, Grant/Research Support.
PP 36 AN M1 PRO-INFLAMMATORY PROFILE PERSISTS IN TISSUE EXCISED FROM WOMEN WITH MESH COMPLICATIONS YEARS AFTER MESH INSERTION A. L. NOLFI1, B. BROWN 1, S. L. PALCSEY 2, L. C. TURNER 3, P. MOALLI 4; 1 Department of Bioengineering, Univ. of Pittsburgh, Pittsburgh, PA, 2Magee Womens Res. Inst., Pittsburgh, PA, 3Fellow in the Division of Urogynecology, Dept of Obstetrics, Gynecology and Reprodcutive Scienes, Magee Womens Hosp., Pittsburgh, PA, 4Magee-Womens Hosp., Pittsburgh, PA. OBJECTIVE: of this study was to define the host inflammatory response to mesh in patients undergoing mesh excision and to determine differences in this response in patients from whom mesh was excised for pain vs mesh exposure. INTRODUCTION: Mesh complications may be driven by the localized host foreign body response with the macrophage as the predominant cell type. We hypothesize that implantation of prolapse mesh results in polarization of local macrophages toward an M1 pro-inflammatory phenotype (vs an M2 pro-remodeling reconstructive phenotype) and that this response varies according to nature of the complication with mesh exposure being associated with a heightened proinflammatory response relative to mesh removed for pain.
METHODS: Twenty-seven mesh-vaginal tissue complexes excised from women (15 sling and 12 prolapse mesh) for a mesh complication were compared to full thickness vaginal biopsies from 30 age, menopausal status, and BMI-matched control women without mesh. Indication for mesh removal was exposure (n=15) vs pain (n=12). Meshes were explanted 34.43±24.75 months following the index surgery (range of 4.5– 93 months). Prior to surgery, baseline demographic data, medical history and a POP Q exam were obtained. Patients also completed quality of life questionnaires. After tissue acquisition, tissue extracts were processed, and M1 pro-inflammatory (TNFα, IL-12p70, and IL-12p40p70) vs M2 pro-remodeling (IL-10 and IL-4) cytokines, and the M1 pro-inflammatory CXCL10 vs M2 pro-remodeling CCL17 chemokines were quantified by ELISA. For analysis, the amount of each individual cytokine and ratios of [(M2 pro-remodeling)/(M1 tissue proinflammatory)] cytokines and chemokines were calculated. Amounts of proenzyme and active forms of MMP-2 and MMP-9 were determined by gelatin zymography and a fluorescent substrate degradation assay. Frozen mesh-tissue sections were triple labeled with the pan-leukocyte marker CD45, panmacrophage marker CD68, and DAPI and with the M1 proinflammatory macrophage marker CD86, proremodeling M2 macrophage marker CD206, and DAPI. Sections were imaged using a Nikon Eclipse Multispectral Imaging Microscope. Statistical analysis was performed using the Kruskal-Wallis test with Mann–Whitney post-hoc comparisons utilizing a Bonferroni-adjusted significance level (p=0.05). RESULTS: In tissue containing mesh, CD45+68+ inflammatory cells surrounded each mesh fiber consistent with a macrophage predominant response. Within the CD45+68+ population, CD86+ pro-inflammatory M1 macrophages predominated in all mesh specimens. Both M1 pro-inflammatory and M2 proremodeling cytokines and chemokines were dramatically increased in mesh explants as compared to non-mesh tissue (Table 1). Ratios of M2 pro-remodeling/M1 pro-inflammatory cytokines were increased in no mesh controls as compared to tissue with mesh (p=0.004). For MMP-9, both active and zymogen forms were increased in mesh patients (p<0.001), and for MMP-2, the active form was significantly higher than values seen in non-mesh patients (p=0.031). Within the mesh patients, women who had mesh removed due to an exposure had 69.4 % higher active MMP-9 (p=0.060) and 88.4 % higher pro-MMP-9 (p=0.035) as compared to controls. CONCLUSION: In women with a mesh complication, mesh induces a marked pro-inflammatory response that persists years after mesh implantation as indicated by the presence of macrophages and a pro-inflammatory cytokine profile. Among women with complications, mesh exposure is associated with an increase in the expression of MMP-9 indicating ongoing tissue destruction. Further studies are needed to determine whether this response is similar in women who do not experience a mesh complication.
S42
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Table 1. Comparison of designated cytokine, chemokine, proenzyme and active form of matrix metalloproteinase (MMP) in mesh vs native tissue and between mesh excised for exposure vs pain. Values are mean ± standard deviation. Cytokine*
Chemokine*
MMP
Parameter IL-4
Mesh 3.32±0.86
No mesh 2.80±0.56
P 0.011
Exposure 3.31±0.97
Pain 3.33±0.74
P 0.951
IL-10 TNF-a
17.73±9.95 15.96±6.39
12.21±5.93 7.48±2.22
0.016 <0.001
19.32±11.67 15.95±5.01
15.76±7.31 15.98±8.04
0.365 0.993
IL-12p70
2.07±0.47
1.69±0.29
0.001
2.04±0.56
2.11±0.34
0.719
IL-12p40p70 (M2/M1)
28.51±16.43 1.21±0.56
13.02±7.22 1.63±0.48
0.001 0.004
31.74±20.24 1.27±0.64
24.49±9.23 1.14±0.46
0.263 0.560
CXCL10 CCL17
62.53±71.83 33.94±38.15
18.49±61.06 4.67±3.68
0.015 <0.001
71.38±86.87 38.44±49.24
51.47±48.50 28.31±17.13
0.486 0.504
(M2/M1) Active MMP-9**
0.77±0.61 4.80±3.55
0.66±0.60 1.61±2.20
0.486 <0.001
0.71±0.69 6.06±4.67
0.85±0.81 3.58±1.34
0.555 0.060
Pro-MMP-9** Active MMP-2 ***
3.52±2.91 1.55±1.62
1.15±1.68 0.73±0.78
<0.001 0.031
4.86±3.46 1.34±0.85
2.59±1.66 1.76±0.44
0.035 0.533
Pro-MMP-2***
1.21±0.85
1.32±0.97
0.639
0.99±1.01
1.42±0.61
0.227
* pg per 40 ug protein, **ng per 15 μg total protein; ***arbitrary units Disclosure Block: Alexis Nolfi: No disclosures. Bryan Brown: No disclosures. Stacy Palcsey: No disclosures. Lindsay Turner: No disclosures. Pamela Moalli: ACell: We received supplementary funding to support the cost of animals to complete the 3rd aim of our R01, Grant/Research Support.
PP 37 METABONOMICS TO IDENTIFY NEW BIOMARKERS IN PATIENTS WITH OAB A. BALACHANDRAN1, Z. XIN 2, K. J. BLADON 3, R. LOO 4, S. WILDMAN 5, J. DUCKETT 1; 1 Obstetrics and Gynaecology, Medway Martime Hosp., Kent, United Kingdom, 2Kent Univ., Chatham, United Kingdom, 3 Medway Sch. of Pharmacy, Chatham, United Kingdom, 4 Universities of Kent and Greenwich, Chatham, United Kingdom, 5Urinary System Physiology Unit, Medway Sch. of Pharmacy, Kent, United Kingdom Introduction: Metabonomics is “the quantitative measurement of the dynamic multi-parametric metabolic response of living systems to pathophysiological stimuli” resulting in the identification of biomarkers. The aetiology of OAB is multifactorial and elusive. It has been hypothesised that chemical agents in the urine or cytokines may also be raised in OAB. Previous study in this area has relied on testing urine for known substances such as Nerve Growth Factor (NGF) [1]. Using metabonomics, urine can be tested to identify differences in patients with OAB from a control group without OAB. To the best of our knowledge this is the first reported use of Ultra-Performance Liquid Chromatography - Mass Spectrometry (UPLC-MS) in the field of OAB.
Objective: The aim of this study is to identify suitable new biomarkers in the urine of patients with OAB, which may lead to the development of new therapeutic targets and/or improve diagnosis. Methods: Urine was collected from 30 women presenting with drug-resistant OAB to a urogynaecology clinic in secondary care. All patients had been treated with more than one drug therapy (mean = 2, range = 1–6) and had failed to respond to conservative treatments with bladder training and fluid re-education. Mid-stream urine (MSU) samples were frozen (−80 °C) within 1 h of collection. Control patients (n=30) were identified from staff members. All control patients reported no symptoms and scored 0 when completing an ICIQ short-form questionnaire. Urine specimens were prepared by diluting 1:2 with UPLC grade water, then chromatographic separation was performed on a HSS T3 Acquity® column using gradient elution in positive mode ionization. UPLC-MS data was analyzed by multivariate statistics. Results: The mean (±SD) age of the OAB and control group was 58.5±11.0 and 47.4±10.7, respectively. Orthogonal partial least square-discriminant analysis (OPLS-DA) comparison was made between OAB and control to identify potential markers that differentiated between the two groups. The OPLS-DA score plot showed clear separation between the two groups with a modal predictability (Q2Yhat) of 45.5 %, P=4.6×10− 4. Six metabolites dominated the OAB group whilst several other metabolites were down-regulated (see figure). Conclusions: We demonstrate significant differences between the urine of patients with drug-resistant OAB compared to controls. Moreover we demonstrate that metabolic profiling may offer i) an alternative non-invasive diagnostic tool, and ii) insight into the metabolic states of OAB providing ‘clues’ to its aetiology. These are exciting new markers that require
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
identification and may potentially be useful as biomarkers for diagnosis and management of OAB. References: Rachaneni A, Arya P & Latthe P. Urinary Nerve Growth Factor: A Biomarker of Detrusor Overactivity: A Systematic Review. 2013. Int Urogynaecol J. Oct 24(10): 1603–9
Disclosure Block: Aswini Balachandran: No disclosures. Zou Xin: No disclosures. Kallie Bladon: No disclosures. Ruey Leng Loo: No disclosures. Scott Wildman: No disclosures. Jonathan Duckett: Astellas: Advisory Committee Member, Consulting Fee. Astellas: Speaker, Honoraria. Astellas: research funding, Grant/Research Support. Astellas: Commercial research funding, Commercial research funding. PP 38 DO ULTRASOUND FINDINGS OF LEVATOR ANI “AVULSION” CORRELATE WITH ANATOMICAL FINDINGS: A MULTICENTRE CADAVERIC STUDY A. DA SILVA 1 , A. DIGESU 1 , C. DELL’UTRI 2 , P. PIFFAROTTI 2, H. FRITSCH 3, R. CARTWRIGHT 4, V. KHULLAR 4; 1 Imperial Coll. NHS Trust, London, United Kingdom, 2 Mangiagalli Hosp., Milan, Italy, 3Department of Anatomy, Histology and Embryology Division of Clinical and Functional Anatomy, Dept. of Anatomy, Histology and Embryology Div. of Clinical and Functional Anatomy, Innsbruck, Austria, 4 Imperial Coll. London, London, United Kingdom Introduction: A region of hypoechogenicity adjacent to the pelvic sidewall, as detected using 3D-translabial ultrasound (USS) and other imaging modalities, has been denoted as an “avulsion” by some authors. The term, “avulsion”, has been used as imaging appears to show the detachment of the pubovisceral (puborectalis/ pubococcygeus) muscle (PVM) from its insertion
S43
following childbirth. This ultrasound finding has been proposed to be associated with pelvic organ prolapse (POP) and reoccurrence after surgery, counterintuitively, it has been shown to be associated with a decreased risk of urinary incontinence and has no link with anorectal dysfunction. The prevalence of “avulsion” has only been documented using imaging and digital palpation techniques to date with its prevalence varying significantly depending on the technique used. In addition, the imaging appearance of “avulsion” has never been validated against anatomical dissection findings, which are usually the gold standard for determining anatomical structures. Objective: To evaluate the prevalence of PVM “avulsion” and to compare the 3D imaging finding of “avulsion” with the anatomical structures on cadavers. Methods: Female cadavers were recruited in three countries. The PVM anatomy of each cadaver was studied using 3Dtranslabial USS by an experienced sonographer prior to dissection. Axial plane tomographic ultrasound imaging (TUI) using 2.5 mm slice intervals were obtained and an “avulsion” was confirmed if discontinuity of the PVM was identified in at least two slices as per standard recommendations. A separate observer, blinded to the USS findings, then dissected each cadaver to directly visualise the area where the PVM inserts bilaterally. Macroscopic attachment or detachment of the PVM was noted and the dimensions including the PVM to symphysis distance as well as the width of the PVM attachment were measured using a dial calliper. The intra and interobserver reliability of USS findings and anatomical measurements were assessed using the Cohen’s Kappa and Bland & Altman plots respectively. McNemar’s and Mann–Whitney U Tests were used to compare imaging and cadaveric dissection findings. Results: A total of 70 cadavers (mean age at death 77.8; range 29–103 years) were dissected. No “avulsions” were seen on dissection. USS was performed on 31 cadavers. One cadaver was excluded from analysis due to incomplete USS data sets leaving 30 cadavers. “Avulsions” were seen on imaging in 11/ 30 (36.7 %) cadavers; the defect was bilateral in 1/30 (3.3 %) and unilateral in 10/30 (33.3 %). The likelihood of an “avulsion”, as seen on ultrasound, to represent detachment of the PVM from the pelvic sidewall is improbable (McNemar’s X2 = 60.0, P<0.001). A narrower PVM insertion width at dissection was strongly associated with “avulsion” on ultrasound (mean: 4.79 mm vs. 6.32 mm, Z=−3.191, p=0.001). Intraand inter-observer agreement was perfect (K=1.0±0.0) and good (K=0.85±0.142) for anatomical identification of “avulsions” and USS respectively. Agreement between the anatomical measurements was also good as 95 % of measures were within two standard deviations of the mean paired difference. Conclusions: The imaged appearance of an “avulsion” does not represent a true anatomical “avulsion” as confirmed on dissection. The term “avulsion” is deceptive. A number of other possibilities exist for this altered imaging finding. The area of
S44
hypoechogenicity may be due to slice thickness and axial resolution artefacts owing to the inability of the USS machine to resolve the smaller insertion sites. The imaged “avulsion” may be imaging tissue that is ultrasound lucent and therefore does not reflect ultrasound waves. Additionally, early descent of the anterior compartment and PVM could have resulted in a change in the acquisition angle to one that cannot be resolved by the incident reflected ultrasound waves. Larger studies are needed to confirm our preliminary data. Moreover, further attempts at surgically repairing this defect should be avoided, at least until there is a better understanding of the PVM “avulsion”. References: N/A Disclosure Block: Ana Sofia Da Silva: No disclosures. alex digesu: No disclosures. Chiara Dell'Utri: No disclosures. Paola Piffarotti: No disclosures. Helga Fritsch: No disclosures. Rufus Cartwright: Astellas Pharma: Speaker, Honoraria. Vik Khullar: Allergan, Astellas, Pfizer: Scientific Medical Advisor, Consulting Fee. Allergan, Astellas, Pfizer: Speaker, Consulting Fee. Allergan, Astellas, Pfizer: Consultant, Consulting Fee. Allergan, Astellas, Pfizer: Advisory Committee Member, Consulting Fee.
PP 39 THE EFFECT OF MAJOR LEVATOR ANI DEFECTS ON POSTOPERATIVE OUTCOMES AFTER PRIMARY SURGERY FOR PELVIC ORGAN PROLAPSE E. C. CROSBY1, S. DEWALD 1, D. E. FENNER 1, J. O. DELANCEY 2, D. M. MORGAN 2; 1 Obstetrics and Gynecology, Univ. of MIchigan, Ann Arbor, MI, 2Univ. of Michigan, Ann Arbor, MI Introduction: In women with recurrent prolapse, levator defects are found more commonly than in women who have had successful surgery. To-date, however, prospective studies have relatively short-term follow-up and include meshrelated repairs1 or assess defects after surgery2 so that recurrence might affect levator anatomy. Objective: We sought to evaluate longer-term results to see if there were differences in outcomes after primary native-tissue pelvic organ prolapse surgery in women with and without major levator damage determined before surgery. Methods: As part of IRB-approved mechanistic case–control studies of prolapse, levator ani defects were assessed in our unit with magnetic resonance (MR) imaging scan in women who had not had prior pelvic floor surgery. A major LA defect was diagnosed when ≥50 % of the pubovisceral muscle was missing. Women with normal muscles or lesser defects, which are not associated with prolapse, were grouped together for analysis. In the women who subsequently underwent surgical correction of
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
prolapse, levator defect status was not known to the surgeon at the time of surgery. Women were contacted and asked if they would be willing to participate in this new study. If so, they completed the Pelvic Floor Distress Inventory-20 and were invited to return to our unit for an examination. Anatomic outcomes were assessed with the Pelvic Organ Prolapse-Quantification (POP-Q) system and subjective outcomes with the Patient Global Impression of Improvement (PGI-I). Anterior and posterior vaginal support were evaluated according to the proportions with support above, at, and below the hymen for POP-Q points Ba and point Bp, respectively. Apical support was analyzed according to the proportions with descent of Point C > two thirds of total vaginal length. Adjustment for pre-operative prolapse severity was made with multivariable logistic regression. The proportions reporting that they were “much better” or “very much better” on the PGI-I and the mean scores on the PFDI-20 were compared. Chi square analysis and student t-tests were used as was appropriate. Results: With a mean follow up of 6.6±3.1 years, subjective follow up was established with 67 % (89/133) and Objective: follow up with 31.5 % (42/133). Women with and without major defects were similar in demographic characteristics and surgical procedures performed (see Table 1). Women with major defects had significantly lower anterior vaginal support than those without major defects (see Table 2). When adjusted for preoperative prolapse severity, women with defects remained more likely than those with normal support or minor defects to have support at or below the hymen (OR 6.6, 95 % CI 1.6–27.4). LA defects were not associated with differences in postoperative posterior or apical vaginal support. Subjective outcomes assessed by the PFDI-20 and the PGI-I did not differ according to levator ani defect status. Table 1
Age, yrs BMI, kg/m2 Parity, median (IQR)
No major defect N=24 62 27.3
Major defect P N=18 65 0.5 27.3
2 (2–3)
2 (1–2)
0.04
Preoperative POP-Q points (mean location) Ba
1.9
2.0
0.9
C Bp
−1.6 0.5
−1.0 0.6
0.7 0.9
5
6
2
4
0
3
7
8
0 3
1 3
Operations performed VH, no apical suspension VH, uterosacral ligament suspension VH, sacrospinous ligament suspension Sacrospinous ligament suspension (no hysterectomy) Abdominal sacrocolpopexy Anterior and/or posterior repair (no VH or apical suspension)
P=0.5
S45
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Table 2 Outcome
Normal muscles or Minor Defect (<50 % missing muscle) N=24
Major Defect (>50 % missing muscle) N=18
P Value
70.8 % 20.8 %
27.8 % 61.5 %
0.02
8.3 %
27.8 %
91.7 % 4.2 % 4.2 %
83.3 % 5.6 % 11.1 %
0.7
45.8 % 54.2 %
55.6 % 44.4 %
0.5
PFDI-20
34.5±31.9
35.1±27.2
0.9
POPDI-6 PGI-I (percent “much better” or “very much better”)
10.4±15.4 75 %
6.7±9.1 76.5 %
0.4 0.9
Anterior Vagina Ba<0 Ba=0 Ba>0 Posterior Vagina Bp<0 Bp=0 Bp>0 Apical Vagina C>2/3*TVL C<2/3*TVL
Conclusions: Major levator ani defects affect the anterior vaginal support at 6 years after surgery. Subjective outcomes did not differ between those with and without major levator ani defects. Comment: Although our study is limited by the number of women available for analysis it does provide preliminary data that would be helpful in planning a larger trial. References: 1. Ultrasound Obstet Gynecol. 2013 Aug;42(2):230–4. doi:10.1002/uog.12433. 2. Int Urogynecol J. 2012 Jan;23(1):65–71. Disclosure Block: Erin Crosby: No disclosures. Samantha DeWald: No disclosures. Dee Fenner: American Medical Systems: Re se arch g ra nt, Grant/Research Support. John DeLancey: Proctor and Gamble: Consultant, Consulting Fee. Daniel Morgan: Up to Date: Author, Royalty. France Foundation: Author, Royalty.
PP 40 ANTERIOR COLPORRHAPHY: ONE PROCEDURE MANY TECHNIQUES K. ELENSKAIA 1 , W. UMEK 2 , R. LATERZA 1 , E. HANZAL 3; 1 Obstetrics and Gynaecology, Med. Univ. of Vienna, Vienna, Austria, 2Med. Univ. Vienna, Wien, Austria, 3Med. Univ. of Vienna, Vienna, Austria
Introduction: Anterior colporrhaphy is celebrating its 150th birthday (1). The risk of recurrence after cystocele repair seems as high as a century ago (1). A review of the literature shows recurrence rates ranging from 0 up to 92 % (2). A recent survey evaluated the variations of anterior colporrhaphy techniques among members of one national Urogynecologic Society (3). This survey showed that anterior colporrhaphy techniques varied considerably even within a small group of specialized uro-gynecologists. The reason for the wide range in outcomes after anterior colporrhaphy are difficult to examine as long many variations of surgical techniques exist. Objective: To perform a literature-review with the aim to evaluate a possible consensus about the most important step of anterior colporrhaphy: the plication of the vesico-vaginal fascia. Methods: We searched Medline, Embase and Cochrane Database for RCTs involving anterior colporrhaphy published in any language. The search terms were “(anterior AND (colporrhaph* or colporhaph* or repair* or cystocel*) AND vagina*)”. Free terms with truncation and limitation to the publication type RCT were used. The search strategy covered the publication years 1946 to January 27, 2014. Results: The results for the literature search are shown in Flowchart 1. Seventeen (46 %) out of 37 studies used interrupted sutures, the other 20 studies (54 %) did not address this issue at all. 40 % of the studies did not comment on the type of the suture materials used (Table 1). One study commented on the number of stitches, ranging from 4 to 6. Two studies used two figure-of-eight sutures, the rest of 34 (91.9 %) studies did not comment on the number of sutures. From these studies none described the stitches length or the distance between the stiches. Table 2 names the structures, which the authors were reinforcing when performing anterior colporrhaphy. Conclusions: This literature review shows that the surgical technique to perform anterior colporrhaphy is not sufficiently addressed even in well conducted RCTs, conflicting with the CONSORT recommendations (CONsolidated Standards of R eporting TrialsCONSORT). Standardisation of anterior colporrhaphy is needed to be able to compare outcomes between studies. References: 1. Int Urogynecol J (2013) 24:1593–1602 2. Obstet Gynecol (1997) 89:311–318 3. Int Urogynecol J (2011) 22:557–561
S46
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Table 1. Suture characteristics Material
Studies N (%)
vicril PDS Chromic catgut
14 (37.8) 6 (16.2) 2 (5.5)
No name of material Sutures Strength
15 (40.5) N (%)
2-0 0
10 (27.0) 9 (24.3)
0 or 2 not stated
1 (2.7) 17 (46.0)
Table 2. Which structure is being reinforced Name of the layer
N of studies (N=37)
fibromuscular layer pubo-cervical fascia
5 8
fascia
2
fibromuscular layer and fascia
1
endopelvic connective tissue
2
prevesical tissue
1
underlaying muscularis
1
vesical connective tissue
1
double layer: posterior wall of the bladder and paravesical fascia bladder
1
No comment
14
1
Disclosure Block: Ksenia Elenskaia: No disclosures. Wolfgang Umek: Astella: Speaker, Honoraria. Rosa Maria Laterza: Innovacell Biotechnologie - Innsbruck: Consultant, Honoraria. Engelbert
Hanzal: Astellas, Allergan: Advisory Committee Member, Consulting Fee. Johnson & Johnson Gynecare, Astellas, Pfizer, Kwizda, Allergan: Speaker, Travel Grant. Pfizer, Kwizda: Speaker, Consulting Fee.
PP 41 OBSTETRIC ANAL SPHINCTER INJURIES (OASIS): OUTCOME OF PRIMARY REPAIR AND RISK FACTORS FOR ANAL INCONTINENCE R. EL HADDAD, P. HUBKA, K. SVABIK, J. MASATA, A. MARTAN; Charles Univ. in Prague, Gen. Univ. Hosp., Prague, Czech Republic Background and objective: OASIS are a major factor in the development of anal incontinence. Our aim was to assess sonographic findings and risk factors that might correlate with anal incontinence Methods: All consecutive women who sustained OASIS at a tertiary obstetric unit between January 2009 and September 2013 where seen in a dedicated perineal clinic 3–4 days and 3 to 6 months after primary repair. Maternal age, body mass index (BMI), parity, mode of delivery, OASIS grade and repair details were saved from medical records. At follow-up all women were interviewed regarding pain, bowel, urinary and sexual function. They underwent physical examination and transperineal ultrasound. Four dimensional pelvic floor data sets were obtained on rest, Valsalva manoeuvre and on maximal pelvic floor muscle contraction (PFMC) using GE Voluson 730 ultrasound machine with a convex probe RAB (4–8 MHz). On maximal PFMC at least two volumes of the whole anal canal were obtained. As previously described (1) we defined an ultrasonographic anal sphincter defect (ASD) as present if having > 30° radial extension involving at least twothirds of the length of the anal canal i.e. on tomographic ultrasound imaging (TUI) the presence of a defect in 4 of 6 slices. Cohen’s kappa coefficient of 1.0 (p 0.02) suggested a perfect inter-rater agreement between 2 observers. TUI in the axial plane on rest and on maximal PFMC was used to determine the presence of levator ani muscle (LAM) avulsion as previously described (2). The correlation between anal incontinence and ASD, LAM avulsion and the severity of OASIS was assessed. For statistical analysis a Statistica software version 10 was used. Paired sample t-test and Pearson’s chi-square test were used. P-value of <0.05 was considered statistically significant. The local ethics committee approved this study and all women gave a written consent. Results: During the study 21552 deliveries occurred, 13425 were spontaneous vaginal (SV), 141 Vacuum (V) and 199 forceps (F) deliveries. OASIS incidence was 0.8 %, 7.09 % and 13.06 in the SV, V and F group respectively. The overall
S47
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
incidence of OASIS during the study was 1.03 % (143 of 13765 women). 128 women (90 %) underwent the Follow-up visit and 15 women (10.4 %: 5 IIIa, 6 IIIb, 3 IIIc and 1 IV degree tear) didn’t attend. The mean follow-up time was 3.2 months (range 3–6). The Mean age was 31 (range 21– 44), mean BMI 22.4 (21–44), mean parity 1.14 (range 1–2), 86 % being primiparous, mean birth weight 3531 g (2300– 4830). 55 OASIS (42.8 %) were 3a, 38 (29,6 %) 3b, 20 (15.6 %) 3c and 15 (12 %) were fourth-degree. 27 women (21 %) reported defecatory symptoms. 19 had difficulties to control flatus (15 %), 4 had fecal urgency (3 %) and 4 had fecal incontinence (3 %). 9 women (7 %) reported stress urinary incontinence, two (1,5 %) urge incontinence, 4 (3 %) had perineal pain, 33 (25.7 %) weren’t sexually active at follow-up and 34 of 95 (36 %) sexually active had dyspareunia. On imaging ASD was present in 14 (11 %) cases: 10 EAS defects, 4 isolated internal anal sphincter (IAS) defects a 4 combined IAS a EAS defects. 57 % of women with ASD reported defecatory symptoms (8 of 14 cases). 40 % (6/15) and 20 % (4/20) of women who sustained a Fourth and 3c degree tear respectively were symptomatic. The incidence of LAM avulsion was 39 % (n=50). 60 % bilaterally (n=30) and 40 % unilaterally (n=20). Paired t test showed no difference between women with or without defecatory symptoms when assessing measurements of the decrement of the hiatal area, sagittal distance and EAS conference on contraction. Significant association was found between anal incontinence and ASD, LAM avulsion and the severity of OASIS P<0.05 and these 3 parameters were found to be independent risk factors for the presence of defecatory symptoms (table 1) ASD
LAM avulsion
Grade of OASIS
OR 6.66
OR 2.866
OR 4.103
Cl 95 % (2.074– 21.425)
Cl 95 % (1.197– Cl 95 % (1.677– 6.852) 10.039)
P 0.0014
P 0.017
P 0.002
OR 3.71
OR 2.63
OR 3
Cl 95 % (0.999– 13.769)
Cl 95 % (1.035– Cl 95 % (1.107– 6.693) 8.133)
P 0.05
P 0.042
(3a-3b) or (3c-4) Univariate analysis
Multivariate analysis
P 0.031
Table 1: Univariate and multivariate analysis of the association between ASD, LAM avulsion, the grade of OASIS and the presence of defecatory symptoms. Conclusions: 3 months after OASIS primary repair the incidence of ASD on transperineal ultrasound was 11 % and 21 % of women report anal incontinence. Severe OASIS (3c-4), ultrasonographic ASD and LAM avulsion are independent risk factors for anal incontinence. These
findings highlight the importance of identifying and repairing the full extent and all layers of the tear by experienced doctors and the necessity of more research to define and implement Methodsthat might prevent the occurrence of OASIS. References: 1. Ultrasound Obstet Gynecol 2010; 36: 368–374 2. Int Urogynecol J 2011; 22: 699–704 Disclosure Block: Rachid El Haddad: This work was supported by the Grant Agency of the Ministry of Health of the Czech Republic, grant NT 12147–4 and by Charles University in Prague - UNCE 204024: Government organisations support, Government organisations support. Petr Hubka: No disclosures. Kamil Svabik: Johnson @ Johnson: Speaker, Travel Grant. Grant Agency of the Ministry of Health of the Czech Republic, grant NT 12147– 4: Research Support, Grant/Research Support. Charles University in Prague - UNCE 204024: Employee, Grant/Research Support. Jaromir Masata: No disclosures. Alois Martan: Ethicon Womens Health and Urology: Preceptor, Honoraria. Bard: Preceptor, Honoraria. Astelas: Consultant, Consulting Fee. PP 42 CLINICAL EFFICACY AND SAFETY EVALUATION OF A VAGINAL BOWEL CONTROL (VBC) DEVICE FOR THE TREATMENT OF FECAL INCONTINENCE H. E. RICHTER1, C. MATTHEWS 2, M. VARMA 3, M. TAKASE-SANCHEZ 4, D. HALE 5, D. VAN DRIE 6, T. MUIR 7; 1 Univ. of Alabama at Birmingham, Birmingham, AL, 2Univ of North Carolina, Chapel Hill, NC, 3Univ of California, San Francisco, San Francisco, CA, 4Urogynecology Associates, Indianpolis, IN, 5Urogynecology Associates, Indianapolis, IN, 6Grand Rapids Women’s Hlth., Grand Rapids, MI, 7Univ. of Texas Med. Branch, Galveston, TX Introduction: Current treatment options for fecal incontinence (FI), increasingly referred to as Accidental Bowel Leakage (ABL), have limitations in efficacy, morbidity, and cost. The vaginal bowel control (VBC) device is a novel, non-surgical treatment option that consists of a silicone base and posteriorlydirected balloon, designed to reversibly deflect the rectovaginal septum and interrupt the passage of stool (Figure). Objective: of this study was to evaluate the effectiveness and safety of the VBC device for the treatment of FI in women. Methods: This was an IRB-approved, multi-center, prospective, open-label clinical study in women with FI. Inclusion criteria included: age 19–75, history of FI ≥6 months, ≥4 fecal incontinence episodes (IEs) during 2-week bowel diary, and successful fitting. The primary outcome, Treatment Success, was assessed at 1 month after successful fitting and was
S48
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
defined as a 50 % reduction of IEs/week. At the 1-month primary efficacy endpoint, women were invited to continue device use for an optional 8 week extended-wear period. Secondary outcomes included the effect on symptomspecific quality of life utilizing the Fecal Incontinence Quality of Life (FIQOL) and Modified Manchester Health Questionnaire (MMHQ) measures, a Patient Global Impression of Improvement (PGI-I), and adverse events (AEs). Primary analysis for treatment success was intention to treat (ITT), including all women successfully fit and entering treatment; secondary analyses were per protocol analyses which included women who completed 1-month treatment and had no major protocol deviations that would render data unanalyzable. A minimum of 40 subjects provided 80 % power to show a p= 0.025 level of significance with at least 40 % of subjects achieving a 50 % decrease in IEs. Results: Six clinical sites in the United States participated and recruitment occurred from August, 2012-October 2013. 200 women were screened for study eligibility, 61 successfully fit and 61 included in the ITT analysis. Participants had a mean (±SD) age of 60.8±9.4 and mean IEs of 5.9 (±4.5) IEs per week at baseline. ITT analysis revealed a treatment success rate of 78.7 % with at least a 50 % reduction in IEs (Table 1). Per protocol analysis (N=56) revealed a treatment success rate of 85.7 %. Mean weekly IEs were significantly reduced from 5.9 (±4.5) at baseline to 1.1 (±1.5) at 1 month, p<0.0001. FIQOL and MMHQ scores significantly improved across all subscales (Table 2). At 1 month, 86 % of participants considered their bowel condition to be “very much” (32/56, 57 %) or “much” (16/56, 29 %) better. Currently, 30 subjects have completed extended wear, with a success rate of 86.7 %, (26/ 30) with ≥ 50 % improvement of IEs/week at 3 months. 25 device-related AEs were reported: change in urinary incontinence/overactive bladder symptoms (7), discomfort (5), and erythema (4). There were no reported serious AEs. Table 1: Efficacy Outcomes Result
% of ITT subjects with ≥50 % reduction % of PP subjects with ≥50 % reduction % of PP subjects with ≥50 % reduction at 3 months* Mean number of weekly FI episodes
78.7 % (48/61) 85.7 % (48/56) 86.7 % (26/30)*
95 % Confidence Interval 67.1 %, 87.6 % 74.7 %, 93.1 % 70.9 %, 95.6 %
Baseline: 1 month: − 5.9 (±4.6) 1.1 (±1.5)
P Value <.0001† <.0001† − <.0001††
*Extended wear data still being collected; †Exact binomial test; ††Paired t test
Table 2. Symptom Specific Quality of Life FIQOL Subscales (N=56)
MMHQ Subscales (N=56)
Lifestyle (Baseline, 1 month, p value*) Coping Behavior
2.62
3.06
<0.001
1.83
2.28
<0.001
Depression/Self Perception Embarrassment
2.83 1.73
3.27 2.26
<0.001 <0.001
1. Incontinence Impact 2. Role Limitations
71.4 45.8
49.6 29.1
<0.001 <0.001
3. Physical Limitations 4. Social Limitations
49.6 44.5
35.5 31.3
<0.001 <0.001
5. Personal Relationships 6. Emotions
39.4 47.2
29.9 32.3
0.015 <0.001
7. Sleep/Energy 8. Severity Measures
32.4 66.0
24.8 50.0
0.008 <0.001
Conclusions: Use of the VBC device resulted in a marked reduction of fecal IEs at 1 month with significant improvement in symptom-specific quality of life. Adverse events were mild and transient. These initial results are promising, but longer follow-up with increased patient experience is needed. References:
Disclosure Block: Holly Richter: Pelvalon: Consultant, Consulting Fee. Pelvalon: Fecal incontinence, Grant/Research Support. UpToDate: Review of UpToDate articles, Royalty. Catherine Matthews: Pelvalon: Grant funds received for clinical study, Grant/Research Support. AMS: Consultant, Consulting Fee. Madhulika Varma: Pelvalon: Scientific Medical Advisor, Honoraria. Pelvalon: Consultant, Consulting Fee. Michelle Takase-Sanchez: No disclosures. Douglass Hale: Allergan: Investigator, Grant/Research Support. Up to Date: Reviewer, Royalty. AUGS: Board Member, Travel Grant. ACOG: Representative of ACOG for the Gyn Committee at the American College of Surgeons, Travel Grant. Douglas Van Drie: American Medical Systems: Consultant, Consulting Fee. Medtronic Corporatio: Consultant, Consulting Fee. Coloplast Corporation: Consultant, Consulting Fee. Shionogi, Inc: Speaker, Honoraria. Astellas Pharmaceuticals: Speaker, Honoraria. Tristi
S49
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Muir: Pelvalon: Fecal Incontinence, Grant/Research Support. American Medical Systems: Speaker’s Bureau, Honoraria. PP 43 MID- AND LONG TERM EFFICACY AND SAFETY OF RETROPUBIC TVT AND TVT-O: ANALYSIS OF THE LITERATURE G. A. TOMMASELLI1, A. FABOZZI 2, C. FORMISANO 2, C. DI CARLO 2, C. NAPPI 2; 1 Univ. of Naples “Federico II”, Naples, Italy, 2Univ. of Naples, Naples, Italy Introduction: Aim of this systematic review of the literature was to identify studies evaluating the mid- and long term outcomes of retropubic TVT and TVT-O and to determine their efficacy and safety at least 3 to 5 years after surgery. Objective: Retropubic TVT and inside-out TVT-O are widespread procedures for the surgical treatment of female stress urinary, yielding high cure rates. Nevertheless, concerns were raised on their safety, as reported in a recent FDA warning (1) and long-term efficacy has also been questioned. There are a number studies now available in literature reporting on the efficacy and safety of retropubic TVT up to 17 years and up to 7 years for TVT-O (2, 3). Methods: All reports that describe prospective, retrospective, and cohort studies evaluating the mid- and long-term efficacy of retropubic-TVT and TVT-O (Gynecare, Somerville, NJ, USA) in the treatment of SUI were obtained. MEDLINE (1966 to October 2013), EMBASE (1980 to October 2013), National Library of Health, Google Scholar, the citation lists of review articles and included trials were searched. The following keywords were used for the search as text words or subject headings: ‘stress urinary incontinence, continence surgery, tension free tape, TVT, TVT-O and mid urethral sling’. In addition, hand searches of the bibliographies and citation lists of all relevant reviews and primary studies to identify articles not captured by electronic searches. All prospective, retrospective, and cohort studies evaluating the efficacy and/or safety of retropubic TVT with a follow-up of at least 5 years and TVT-O with a follow-up of at least 3 years were included in this analysis. Two authors (G.A.T. and C.F.) performed the selection of trials for inclusion after using the search strategy described previously. For each study, the number of patients enrolled and evaluated at the last followup control, the number of patients excluded or dropped out, the mean follow-up duration were retrieved. Moreover, the definition of Objective:, subjective o combined cure was obtained. Finally, the overall number of patients objectively and/or subjectively cured or improved, along with the number and type of complications, was identified. The overall number of procedures was pooled and an overall Objective and/or subjective cure and success (defined and the number of cured plus improved patients) rates was calculated. The number of complications was
also pooled to identify the rate for each of the following categories of complications: organ injuries (bladder, urethral, bowel), obstruction/retention (any difficulty in micturition, both postoperatively, at short and long-term), urinary tract infection (both transient and recurrent, dysuria), bleeding (peri-operative major bleeding, hematoma formation), erosion/extrusion/exposure (any discontinuation of vaginal mucosa integrity), infection (febrile pathology, wound infection, sepsis), any de novo symptoms of overactive bladder, pain (persistent post-operative pain). 95 % confidence intervals for each outcome were calculated. Results: 79 studies were identified (47 for TVT and 32 for TVT-O). Forty-one articles (22 for TVT and 19 for TVT-O) were excluded: 29 (13 TVT and 16 TVT-O) reported a follow-up less than 5 or 3 years, 6 (4 TVT and 2 TVT-O) were duplicates or ancillary analysis of an included study, 5 (4 TVT and 1 TVT-O) did not report on efficacy and/or safety outcomes or the outcomes were not specified, and one TVT study reported on only 7 cases. Follow-up and efficacy outcomes are reported in Table 1. Cure rates, both Objective and subjective, did not show a significant decrease with time, both for TVT and TVT-O. The most frequent complications were de novo OAB symptoms (12.4 % for TVT and 9.8 % for TVT-O) and obstruction/ retention (11.2 % for TVT and 5.8 % for TVT-O). Erosion rates were 2 % [95 % CI 1.4–2.6] for TVT and 1.5 % [95 % CI 0.8–2.5] for TVT-O. Table 1. Follow-up and efficacy outcomes. Follow-up (range, months)
TVT
TVT-O
60–201
36–90.2
N. patients evaluated last FU
3173
1252
Objective cure rate (range, %)
70.2–98.3
72.9–90.8
pooled objective cure rate (% [95%CI], n)
86.6 [84.6–88.4] (1109/1281)
86.6 [84.1–88.9] (705/814)
Polled objective success rate (% [95%CI], n)
88.1% [84.3–91.2] (319/362)
88.7 [81.4–93.8] (102/115)
Subjective cure rate (range, %)
57.4–89.6
72–92
Polled subjective cure rate (% [95%CI], n)
72.9 [70.8–74.8] (1439–1975)
83.1 [80.4–85.5] (740/891)
Polled subjective success rate (% [95%CI], n)
90.3 [88.8–91.6] (1615/1789)
88.9 [85.4–91.2] (360/405)
Polled composite cure rate (% [95%CI], n)
84.8 [82.6–86.8] (1037/1223)
87.9 [81.0–92.9] (116/132)
Polled composite success rate (% [95%CI], n)
94.4 [93.0–95.7] (1155/1223)
92.3 [49.1–98.4] (36/39)
Conclusions: Long-term follow up confirms the high cure rate and safety of retropubic TVT with minimal deterioration over the years. The lower subjective cure rate may reflect both inconsistent evaluation Methods or the impact of patients suffering from mixed urinary incontinence, who may report subjective failure due to urge incontinence.
S50
References: 1 . h t t p : / / w w w. f d a . g o v / M e d i c a l D e v i c e s / S a f e t y / AlertsandNotices/ucm262435.htm 2. Int Urogynecol J 2013; 24: 1265–9. 3. Int Urogynecol J. 2014;25: 219–25. Disclosure Block: Giovanni Tommaselli: Solace Therapeutics, Inc.: Consultant, Consulting Fee. Ethicon: Consultant, Consulting Fee. Annamaria Fabozzi: No disclosures. Carmen Formisano: No disclosures. Costantino Di Carlo: Bayer: Speaker, Honoraria. Merck, Sharpe & Dome: Speaker, Honoraria. Gedeon Richter: Speaker, Honoraria. Teva: Speaker, Honoraria. Carmine Nappi: No disclosures.
PP 44 URGENCY URINARY INCONTINENCE GENOME WIDE ASSOCIATION STUDY H. E. RICHTER1, N. WHITEHEAD 2; 1 Univ. of Alabama at Birmingham, Birmingham, AL, 2RTI Intl., Research Triangle Park, NC Introduction: Urgency urinary incontinence (UUI) is a prevalent condition of unclear etiology that significantly impacts quality of life. We hypothesized that there are common genetic variants (population frequency ≥ 0.01) that predispose women to UUI. Objective: was to perform a genome-wide association study (GWAS) in a well characterized cohort of post-reproductive Caucasian women to identify common genetic variants associated with UUI. Methods: A two-stage (discovery and replication) GWAS analysis was conducted by the NICHD Pelvic Floor Disorders Network to identify common genetic variants associated with UUI using genotypic and phenotypic data from the Women’s Health Initiative (WHI) GARNET sub-study, obtained from the database of Genotypes and Phenotypes. The GARNET study genotyped 4,894 women with the Illumina Omni Quad 1.0 M chip. To expand the coverage of genetic polymorphisms, genome-wide imputation was performed with IMPUTE2 using the 1000 Genomes ALL Phase I integrated variant set as a reference. Random assignment was used to select subjects for the discovery and replication stages based on a 50:50 split. Controls were WHI participants who had never experienced UI at enrollment and did not develop UUI during the study; cases were defined as women who at any time during the study reported incontinence at least once a month, with symptoms of urgency, and who leaked sufficiently to wet or soak their underpants or clothes. Primary association analyses used logistic regression models to predict UUI case versus control status relative to genome-wide genotype
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
dosages assuming an additive mode of inheritance. Age, obesity, diabetes, and depression were included as covariates in the model. This population provided 80 % power to detect a relative risk of 1.30 with an alpha level of 5×10−8 for an allele frequency of 30 %. Results: 2,241 women met the UUI case definition (N=1,102 in discovery and N=1,133 in replication subsets) and 776 met the definition of control (N=405 in discovery and N=371 in replication subsets). After quality control, a total of 975,508 single nucleotide polymorphisms were available for analysis. Following imputation there were approximately 9,000,000 SNPs with minor allele frequency >0.01. There was no difference in age between cases and controls (66.2 vs 65.7, p= 0.13, respectively). Cases were significantly more likely to be obese (48 % vs 30 %, p<.0001) and diabetic (6 % vs 3 %, P=.006) than controls. Although no single variants were associated with UUI at an alpha level of 5×10−8, in a metaanalysis of the discovery and replication subsets, four genome regions on chromosomes 5, 11, 12 and 18 were associated with UUI at the magnitude of 10−7 (see Manhattan plot). Eight SNPs in one intron of the zinc finger protein 521 (ZFP521) gene on chromosome 18 were significant at this level. Pathway analyses have been initiated. Conclusions: The multiple, significant hits within a single intron of ZFP521 suggest that this gene may be involved in the development of UUI. ZFP521 is associated with stem cells and has been implicated in the control of blood, bone and neural progenitor cells and warrants further investigation. These results provide evidence that both genetic and environmental factors may contribute to the development of UUI. References:
Disclosure Block: Holly Richter: Pelvalon: Consultant, Consulting Fee. Pelvalon: Fecal incontinence, Grant/Research Support. UpToDate: Review of UpToDate articles, Royalty. Nedra Whitehead: No disclosures.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
PP 45 POTENTIAL GENETIC BASIS FOR FAILURE OF LAPAROSCOPIC SACROCOLPOPEXY P. CULLIGAN 1, C. LEWIS 1, S. M. ST LOUIS1, C. SALAMON 1, J. KOMAR 1, J. PAGNILLO 1, N. TREFF 2, D. TAYLOR 2, H. GARNSEY 2, R. SCOTT 2; 1 Atlantic Hlth. System, Morristown, NJ, 2Reproductive Med. Associates of New Jersey, Basking Ridge, NJ Introduction: Sacrocolpopexy is considered by many to be the “gold standard” operation for correction of apical prolapse with success rates reported between 80 and 100 % depending on the techniques employed and definitions of success used1. Our method involves extensive dissection in the vesicovaginal and rectovaginal spaces. We attach a pre-formed Y-mesh down to the level of the trigone anteriorly and the perineal body posteriorly. Using a composite definition of success that includes POP-Q measurements and subjective data, we have reported surgical cure rates of 97 % at 1 year, with our few failures typically occurring in the distal anterior or posterior segments2. Over the years, however, a small group of patients experienced early objective overt failures despite having the extensive procedure described above. These failures could not be explained by differing surgical techniques, poor adherence to post-operative restrictions, or complicated perioperative courses. In other words, the failures in this small group were clinically very difficult to explain. Objective To determine whether a genetic basis may exist for early overt failure of a robotic-assisted laparoscopic sacrocolpopexy. Methods: This was a case–control study approved by the Institutional Review Board at the Atlantic Health System (R11-10-004). We identified and obtained consent for 10 patients who experienced early overt surgical failure - thus making up our group of cases. Each case was Caucasian. We used a random number generator to select 40 patients for our control group from our research database of greater than 500 patients who underwent robotic-assisted laparoscopic sacrocolpopexy and had been objectively and subjectively assessed at our center for ≥ 12 months. Eligible controls were Caucasian; underwent surgery during the same time frame as the cases; had uneventful peri and postoperative courses; and had documented Objective/ subjective surgical success at ≥ 12 months. Those who agreed to participate were mailed buccal swab kits and consent forms. If a potential control patient declined enrollment, another was chosen at random from the database until 40 controls were enrolled. DNA from the 10 cases and 40 controls was isolated from buccal swabs and genotyped on a single nucleotide polymorphism (SNP) array that contains 250,000 markers (NspI
S51
250 K SNP array, Affymetrix, Santa Clara, CA). Correlation/Trend and Cochran-Armitage tests and logistic regression were performed using a statistical software package commonly used in genetics studies (SVS, GoldenHelix, Bozeman, MT). Genotype models (D minor allele, d major allele) were basic allele (D vs d), Genotypic (DD vs dd vs Dd), Additive (dd ->Dd -> DD), Dominant (DD and Dd vs. dd), and Recessive (DD vs (Dd and dd)). Association analysis and quality control filtering was performed using GoldenHelix SVS and p-values were adjusted for multiple testing using the False Discovery Rate (FDR) to control for the expected proportion of incorrectly rejected null hypotheses (“false discoveries”). Baseline demographic and clinical descriptors for the cases and controls were compared using Chi square and t-tests. Results: There were no baseline demographic or clinical differences between the cases and controls, and principal component analysis testing for genotype stratification did not identify any patients as outliers. A SNP located near the ZFYVE16 gene (rs171821) was identified as associated with the group of cases but not the controls with the correlation/ trend test on the basic allele model with an FDR-adjusted pvalue of 0.046. In addition, in the same test, association pvalues of three other SNPs near dbSNP ID rs171821 on Chromosome 5 and also in the ZFYVE16 gene were found in the top 20 ranked SNPs with raw p<0.0001 but did not survive FDR adjustment (with dbSNP IDs rs171821, rs1423113, rs16877757). Conclusions: We identified a SNP near the ZFYVE16 gene (also known as Endofin) on chromosome 5 that is present among a group of women known to have experienced clinically unusual early overt failure following sacrocolpopexy - but is not present in a group of matched controls. We also found three other SNPs in the same general location on chromosome 5 that did not hold up against FDR but whose presence supports the idea that our findings could be meaningful. Endofin encodes an endosomal protein that (among other things) facilitates Transforming Growth Factor beta (TGF-β) which is a family of cytokines that play important roles in growth and development, inflammation and repair and host immunity3. We hope that our findings could lead to screening tests to identify patients who are likely to experience surgical failure, or even target drug therapy towards alteration of this predisposition. References: 1. Obstet Gynecol. 2004 Oct; 104(4):805–23 2. IntUrogynecol J. 2013 Oct; online: doi:10.1007/s00192013-2265-x 3. J. Biol. Chem. 2007, 282:9688–9695
S52
Disclosure Block: Patrick Culligan: Boston Scientific Americal Medical System Intuitive Surgical: research support, Grant/Research Support. AUGS: Board Member, none. Boston Scientific: Consultant, Consulting Fee. CR Bard: Consultant, Honoraria. Origami Surgical StitchKit TM a suture delivery device for robotic cases: Stock Shareholder, Ownership Interest. Christa Lewis: No disclosures. Sarah St Louis: No disclosures. Charbel Salamon: American Medical Systems: Consultant, Consulting Fee. Intuitive Surgical: Consultant, Consulting Fee. Jodie Komar: No disclosures. Jennifer Pagnillo: No disclosures. Nathan Treff: Merck: Speaker, Honoraria. Auxogyn: Speaker, Honoraria. Deanne Taylor: Reproductive Medicine Associates of New Jersey: Employee, Salary. Heather Garnsey: No disclosures. Richard Scott: Ferring Pharmaceutical: Grant Support, Grant/Research Support. Ferring Pharmaceutical: Speaker, Honoraria. Merck USA Pharmaceuticals: Speaker, Honoraria.
PP 46 COULD VAGINAL ESTROGEN APPLICATION PRIOR TO SURGERY REDUCE MESH EXPOSURE IN TRAN SVAGINAL PELVIC FLOOR RECONSTRUCTION WITH MESH? A 2-YEAR RANDOMIZED CONTROLLED TRIAL L. ZHU, Z. SUN; Gynecology, Dept. of Obstetrics and Gynecology, Peking Un, BeiJing, China
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
underwent non medication before surgery. No patients had intra-operative complications such as injury or hemorrhage. The anatomic success rate was 95 % (42/44 vs. 40/42) and the subjective satisfaction rate was 97 % (42/44 vs. 41/42). At 2 year, over 95 % patients (42/44 vs. 40/42) finished followup. Rates of mesh exposure were 16.7 % (7/42) in the vaginal estrogen application group and 17.1 % (7/41) in the non medication, from which we found no significant difference (P > 0.05). Mesh exposure occurred from 1 month to 14 months after surgery (3 in the 14 cases experienced mesh exposure within 6 weeks, 3 within 6 weeks to 6 months, 5 within 6 to 12 months, and 2 after 12 months, exactly), with a mean time of 7 months. It was noteworthy that, 6 patients (2 in medication group, and 4 in non medication group) had thin vaginal epitheliums without mesh exposure within 6 weeks, and 5 of them experienced exposure of mesh after 1 year, finally. Positive vaginal swab results occurred in 12 of 44 patients in the medication group, and in 9 of 42 patients in the medication group. Also, the odds ratio between positive vaginal swab and mesh exposure was 7.02, indicating a higher risk of mesh exposure among those with vaginal swab results positive. Conclusions: Vaginal estrogen application prior to surgery could not reduce mesh exposure rate in transvaginal pelvic floor reconstruction with mesh. A vaginal swab would be offered routinely after prolapse repair with the transvaginal mesh; Vaginal administration of antibiotics combined with estrogen cream post operation, instead of prior to surgery, may help to reduce rates of mesh exposure. References: N/A
Objective: To determine whether vaginal estrogen application prior to surgery reduces mesh exposure in transvaginal pelvic floor reconstruction with mesh. Background Vaginal estrogen can reduce mesh exposure in transvaginal pelvic floor reconstruction with mesh, but it is unclear whether this approach results in better outcomes than no estrogen application pre-operation. Thus, we assess the outcomes vaginal estrogen application pre-operation. Methods: In this randomized, controlled trial, we compared the use of vaginal estrogen application prior to surgery with no estrogen application in women with severe (defined as Pelvic Organ Prolapse Quantification [POP-Q] stage III and IV) or recurrent pelvic organ prolapse. Mesh exposure rate at least 24 months after the surgery was the primary outcome. Secondary outcome measures included the anatomic success rate (defined as POP-Q lower than stage II), the subjective satisfaction rate (defined as absence of symptoms of vaginal bulging), surgical complications, and bacterial infection events related to the procedure (diagnosed on culture from vaginal swab at 6 weeks post operation). Results: Of all 86 women who were randomly assigned to the trial, 44 underwent vaginal estrogen application and 42
Disclosure Block: Lan Zhu: No disclosures. Zhixing Sun: No disclosures.
PP 47 A CALCULATOR FOR RISK PREDICTION OF MESH EXTRUSION IN VAGINAL MESH AUGMENTED REPAIR: A NOVEL TRANSLATIONAL APPROACH TO RISK COUNSELLING AND DECISION MAKING IN UROGYNAECOLOGY D. KARMAKAR 1 , L. HAYWARD 2 , S. LIN 3 , J. SMALLDRIDGE 2; 1 Univ. of Aberdeen, Aberdeen, United Kingdom, 2 Middlemore Hosp., Auckland, New Zealand, 3Middlemore Hosp., Auckland, New Zealand Introduction: The last decade has witnessed a huge volume of contemporary literature addressing mesh related adverse event rates and attempts at identifying factors predisposing to them. The ‘Data mining’ approach has been almost completed untested in urogynaecology. We intend to present a novel mesh extrusion risk calculator that can be used as a
S53
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
scientifically sound counselling tool for patients and an aid to surgical decision making incorporating a predictive modeling approach. Objectives: To generate a statistically sound risk calculating predictive model and software for an individual patients preoperatively based on her demographic, clinical and planned surgical variables. Methods: A long-term audit of a prospective cohort of 218 mesh augmented vaginal repairs between Feb 2005 and July 2013 (8 years) was completed at our centre. This was used as model generation cohort for a detailed secondary analysis for the predictors of mesh extrusion as we found our database to be adequately powered for such an analysis. Statistical Methods SPSS 20.0.0 and R were used for our statistical analysis. After assessing completeness of database, Chi square and Fisher exact test were used as appropriate for categorical variables, and the Breslow and log-rank test for survival curves. The Cox regression model with the dependent outcome as mesh extrusion was performed was applied to get the hazards ratio by sequential univariate analysis shortlisting predictors and multivariate analysis of these deriving the significant predictors of mesh extrusion. A value of P<0.05 was considered to be statistically significant. A P of >/= 0.05 and <0.1 was considered as showing trend. Prognostic contribution for mesh patients having extrusion in future in terms of ‘significant predictors’ were incorporated into a predictive model after assessing need for adequate shrinkage and translation of hazard ratios into scores on the basis of effect size. The final score would be the sum of scores of individual significant predictor in a patient. Recieiver Operating Characteristics (ROC) curves were generated to find risks at different scores and to test discriminatory power of the model. Bootstrapping was done to ascertain model validation internally. The information was encoded in a java platform based software application which can be installed on computers and phones and gives three strata of risk ie red (avoid mesh), orange (caution and individualization) and green (use probably safe) depending on the ROC generated risk level cutoffs Results: Table 1 shows the relation of risk factors for extrusions in terms of their statistical effect size. The predictive modeling yielded 13 significant predictors encompassing demographic, clinical and surgical variables which were integrated into the model. ROC analysis shows good discriminatory power of the model. Bootstrapping provided positive internal validation of the developed model. Table 2 shows the risk cutoffs generated by the model. The software application could be successfully installed in computers and phones. Figure 1 shows a sample snapshot of risk prediction using the software. At this stage, considering these results the model may be considered ‘test ready’ for external validation which would be the gold standard test for the model. Conclusion: Predictive models used as software based counseling tools have been very rarely used in
urogynaecology. This is one of the first attempts at such a statistical modeling in the translational medicine approach. The peer review and external validation in terms of geographical and methological transformability and level of patient acceptance and health economic impact of such tools would be the determinants for the wider use of such innovations. Table 1: Sequential analysis of identified significant predictor variables and their interactions Variable
Hazard Ratios (HR)
95 %Confidence interval (CI)
Mesh type (IntePro/IntePro lite) Parity
2.839
1.022–11.706
0 1
1.046
1.000–2.136
2 3
1.895 2.894
1.319–4.862 1.836–7.098
4
4.111
2.135–8.254
5
4.809
1.476–9.110
6
5.884
1.679–11.237
Previous Hysterectomy
3.059
1.040–4.215
Abdominal
2.772
1.909–3.919
Vaginal
3.299
1.624–4.469
Previous Anterior repair
2.386
1.700–4.519
Previous Posterior repair
2.167
1.252–4.416
3.124
1.436–4.806
1.300
1.010–3.754
Previous NT repair
Previous anterior and posterior repair Constipation Smoking status Past
1.328
1.161–3.127
Current Type of mesh repair
2.274
1.563–4.219
Apogee + Perigee
3.345
1.564–4.927
Concomitant Hysterectomy
1.200
1.015–3.479
Concomitant mid-urethral sling for SUI
1.908
1.432–4.894
Table 2: Risk cutoffs generated by the model Colour Model Predictive value Clinical implication code score Green 5 or LESS Less than 60 % probability Use probably safe of event risk Orange 6–8 60–79 % probability of Caution and event risk individualization Red
9 or more
80 % or more probability for event risk
Avoid mesh
Disclosure Block: Debjyoti Karmakar: No disclosures. Lynsey Hayward: No disclosures. Sylvia Lin: No disclosures. Jackie Smalldridge: No disclosures.
S54
PP 48 OPTIMIZING OPERATING ROOM EFFICIENCY IN ROBOTIC SURGERY O. HARMANLI1, K. JONES 1, S. SOLAK 2, A. BAYRAM 2 , B. YUKSEL 1, F. AL-JEHANI 1; 1 Department of OB/GYN, Tufts Univ. Sch of Med Baystate Med. Ctr., Springfield, MA, 2Univ. of Massachusetts Isenberg Sch. of Management, Amherst, MA Objective: To assess the critical threshold to optimize operating room time for each surgical team member in robotic sacrocolpopexy and to evaluate which combination of team members produces the most efficient surgical team Background: The experience and competence of each surgical team member seems more influential in robotic surgery. This may be because the surgeon is not immediately at the bedside during the major components of the procedure and hence surgical efficiency depends heavily on the other team members. In this study, we sought to ascertain the critical value of each robotic team member in collaboration with operations management experts from the School of Management. Methods: All women who underwent robotic sacrocolpopexy for pelvic organ prolapse at our institution between February 2008 and July 2013 were prospectively entered in a database. Patients having concomitant surgery were excluded with exception of those undergoing a midurethral sling procedure, cystoscopy, lysis of adhesions, or adnexal surgery. Baseline patient information was recorded. We collected information on all robotic team members present at all procedures including years in practice, years in operating room, number of robotic procedures attended. We also recorded the model of the robot, starting time of the procedure, and nursing shift change as they may influence the operating time and other perioperative outcomes. Our primary outcome measure was the Operating (OR) time with each portion of it for each task in the operating room was as it captures all other indices to an extent. We also included perioperative indices and adverse outcomes for secondary analysis. In the descriptive analysis phase, we utilized factor analysis, regression analysis, and analysis of variance. Then prescriptive analysis followed to include data analysis, OR time mapping, and stochastic optimization to identify ‘optimal’ surgical team configuration. Finally, optimization results were analyzed to derive insights and general policies. Results: The database included 359 robotic sacrocolpopexy cases all performed for stage III or IV POP: 159 of them were posthysterectomy, 150 procedures were with total laparoscopic hysterectomies, and 44 with laparoscopic supracervical hysterectomies. Mean age was 58.6. Mean gravidity was 3.3 and mean body mass index was 28. A total of 4 surgeons, 34 first assistants (FA), 20 circulating nurses (CN), 15 scrub technicians (ST), and 59 anesthesiologist/nurse anesthetists were involved.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Each team member’s experience, age, comorbidities and prolapse severity as measured by most protruding point were most influential independent variables. Optimal experience level for each team member was achieved at the following number of robotic procedures: surgeon 44; first assistant 13; scrub technician 66; circulating nurse 56; anesthesia provider 46. Regression analysis revealed that scrub technician and first assistant almost equally played the most significant role within the team. The Surgeon was ranked the third followed by the circulating nurse and anesthesia provider, respectively. Cases which started before 11 am were significantly shorter than those that started after 11 am possibly because there was lunch break and later shift change for cases which extended into the afternoon. OR times were in average 12 min longer in the afternoon. Breaks taken by scrub technicians or the circulating nurses did not make any significant difference. Having a highly experienced anesthesiologist decreased the surgery prep time by about 5 min but not the entire OR time. There was a significant difference (almost 1 h) in robotic docking time between an experienced and inexperienced surgeon. No significant difference was noted when robotic docking time was studies with respect to the experience of first assistants. Some implications of the stochastic model as seen in Table 2 are the following: If a surgeon has low experience, it is better to match him with more experienced FA. If a doctor has high experience, it is fine to match him with less experienced FA and ST. If both the surgeon and FA are not as experienced, it is better to match them with an experienced ST. We also noted that if the ST has low experience in a surgical team, then either the surgeon or the FA should be more experienced. Independent from other team member experiences, it is not recommended to include low experienced ST, FA and surgeon in the same team. Low experienced CN should be matched with an experienced surgeon or vice versa. Conclusion: Operating time in robotic surgery is multifactorial. Experiences of each member of a robotic surgery team are critical. An optimal team can be composed of a variety of combinations of experience levels among the robotic team members.
Table 1. Optimal experience levels for each team member Table 2. Stochastic model revealed team configurations as the most optimal:
S55
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Disclosure Block: Oz Harmanli: No disclosures. Keisha Jones: No disclosures. Senay Solak: No disclosures. Armagan Bayram: No disclosures. Beril Yuksel: No disclosures. Faisal Al-jehani: No disclosures.
PP 49 VENOUS THROMBOEMBOLISM AFTER HYSTERECTOMY: ANALYSIS OF A RARE EVENT IN A STATEWIDE QUALITY IMPROVEMENT COLLABORATIVE C. W. SWENSON, M. B. BERGER, D. M. MORGAN; Obstetrics and Gynecology, Univ. of Michigan, Ann Arbor, MI Introduction: Although reported rates of clinically significant venous thromboembolism (VTE) after hysterectomy are 1.0– 6.5 %, the exact prevalence is unknown due to a paucity of hysterectomy-specific data and studies controlling for risk factors unique to gynecologic surgery [1, 2]. Additionally, current VTE prophylaxis guidelines for gynecologic surgery are largely based on studies from non-gynecologic surgical specialties [3]. While relatively rare, postoperative VTE can cause significant shortand long-term morbidity including death. Hysterectomy-specific risk factors are needed to identify potentially modifiable factors to help reduce the risk of these often preventable events. Objective: The aim of this study was to assess the prevalence of and risk factors for VTE after hysterectomy. Methods: This is a retrospective study analyzing data obtained from a voluntary, statewide surgical quality improvement collaborative including both community and university hospitals and patients from all payers. Demographics and perioperative data were obtained for hysterectomies performed from January 1, 2008 - December 9, 2013. Postoperative VTE was defined as a deep venous thrombosis (DVT) and/or pulmonary embolism (PE) diagnosed within 30 days of hysterectomy. Significant variables related to postoperative VTE were identified using bivariate analyses, then multivariable regression was used to develop a final model for VTE. Results: 19,563 hysterectomies were analyzed. Preoperative SCD use was documented for 98.3 % (12218/12435) and 95.3 % (10207/10714) postoperatively. The rate of postoperative VTE was 0.6 % (118/19,563) with DVT only occurring in 41.5 % (49), PE only in 47.5 % (56) and both DVT and PE occurring in 11 % (13). Of the 118 VTEs, one death was reported. In bivariate analyses, women with, versus without, a postoperative VTE were older (54.0±13.7 vs. 48.6±11.8 years., p<0.001), more likely to be white (65.3 % vs. 34.7 %, p=0.004), of higher BMI (33.9±9.0 vs. 30.7±8.2 kg/m2, p<0.001), more likely to have cancer as the indication for hysterectomy (14.4 % vs. 3.6 %, p<0.001) and more likely to have: hypertension (48.3 % vs. 31.8 %, p<0.001), history of VTE (7.2 % vs. 2.8 %, p=0.046), higher ASA classification (median (interquartile range); 2 (2,3) vs. 2 (2,2), p<0.001), preoperative heparin (30.4 % vs. 14.2 %, p<0.001),
postoperative heparin (17.6 % vs. 8.0 %, p<0.001), abdominal hysterectomy (60.0 % vs. 31.5 %, p<0.001), greater estimated blood loss (EBL) (362.7±427.6 vs. 191.6±400.7 mL, p<0.001) and longer surgical time (3.5±1.3 vs. 2.8±1.1 h, p<0.001) (Table 1). In the final model, variables that remained significant were abdominal hysterectomy (OR 3.29, 95 % CI 2.24–4.83), surgical time (OR 1.60, 95 % CI 1.40–1.82) and cancer as the indication for hysterectomy (OR 3.19, 95 % CI 1.82–5.58) (Table 2). The cstatistic (0.75) and the Hosmer-Lemeshow test (p=0.85) suggest that this model has a high goodness if fit. Conclusions: From this large, statewide cohort, the rate of postoperative VTE after hysterectomy was 0.6 %. Recent efforts to decrease the rate of VTE after hysterectomy have largely focused on the use of perioperative mechanical and pharmaceutical VTE prophylaxis. However, we have identified two potentially modifiable factors for increased VTE risk. Our data suggest that abdominal hysterectomy confers a 3fold odds of postoperative VTE compared to other routes. Additionally, each additional hour of surgical time increases postoperative VTE risk by 60 %. These variables warrant further investigation as possible quality measures to decrease postoperative VTE after hysterectomy. References: 1. Obstet Gynecol, 2007. 110(2 Pt 1): p. 429–40. 2. Obstet Gynecol, 2013. 121(3): p. 654–73. 3. Chest, 2004. 126(3 Suppl): p. 338S-400S. Table 1. Demographics and variables analyzed for postoperative venous thromboembolism (VTE) after hysterectomy Variable
No Postop VTE (N=19445)
Age (yr), mean ± SD Parity, mean ± SD
p value
48.6±11.8
Postop VTE (N=118) 54.0±13.7
<0.001
2.1±1.5
2.3±1.9
0.41
71.1(13819) 18.6 (3613) 10.4 (2013) 30.7±8.2
65.3 (77/118) 0.001 30.5 (36/118) 4.2 (5/118) 33.9±9.0 <0.001
Race White Black Other/Unknown BMI kg/m2, mean ± SD
14.4 (17)
<0.001
Obstetric indication, % (n) Smoker, % (n) HTN, % (n)
Indication cancer, % (n) 3.6 (706) 0.2 (11/7449)
0 (0/45)
1.00
23.2 (4507) 31.8 (6186)
11.9 (14) 48.3 (57)
0.004 <0.001
History of VTE
2.8 (350/12429)
7.2 (5/69)
0.046
2 (2,3)
<0.001
ASA Classification, 2 (2,2) median (interquartile range) Preop VTE Prophylaxis: SCDs Heparin*
99.3(12150/12366) 98.6(68/69) 14.2 (1758/12366) 30.4 (21/69)
1.00 <0.001
SCDs and heparin*
13.9 (1716/12366) 30.4 (21/69)
<0.001
None
1.4 (167/12366)
0.61
1.4 (1/69)
S56
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Variable
No Postop VTE (N=19445)
Postop VTE (N=118)
p value
Postop VTE Prophylaxis SCDs Heparin*
95.3(10141/10646) 97.1 (66/68) 8.0 (849/10646) 17.6 (12/68)
0.77 0.003
SCDs and heparin* None
33.0 (3509/10646) 52.9 (36/68) 2.8 (299/10646) 1.5 (1/68)
<0.001 1.00
Route of Hysterectomy Abdominal Laparoscopic Vaginal
31.5 (6066/19276) 60.0 (66/110) <0.001 55.7(10738/ 36.4 (40/110) 19276) 12.8 (2472/19276) 3.6 (4/110)
EBL (mL), mean ± SD
191.6±400.7
362.7±427.6 <0.001
Surgical time (hours), mean ± SD
2.8±1.1
3.5±1.3
<0.001
*Includes both unfractionated and low-molecular weight heparin. Chi-square and Fisher’s Exact used for categorical variables, Student’s t-test used for continuous variables. Table 2. Variables predictive of postoperative VTE after hysterectomy Variable
Constant Abdominal hysterectomy Surgical time (hours) Indication cancer
Crude Odds Ratio ——
Adjusted Odds Ratio ——
3.27
3.29
1.56
1.60
4.47
3.19
95 % C.I.
Regression coefficient
Standard error
p value
——
−7.24
0.28
<0.001
2.24– 4.83 1.40– 1.82 1.82– 5.58
1.19
0.20
<0.001
0.47
0.07
<0.001
1.16
0.29
<0.001
Performed multivariable regression using the characteristics significantly associated with postoperative VTE in bivariate analyses (Table 1). Disclosure Block: Carolyn Swenson: No disclosures. Mitchell Berger: No disclosures. Daniel Morgan: Up to Date: Author, Royalty. France Foundation: Author, Royalty.
PP 50 THE EFFECT OF VAGINAL INFILTRATION WITH ORNIPRESSIN OR SALINE ON INTRA-OPERATIVE BLOOD LOSS DURING VAGINAL PELVIC FLOOR RECONSTRUCTIVE SURGERY: A RANDOMISED CONTROLLED TRIAL E. W. HENN1, T. NONDABULA 1, D. L. JUUL 2; 1 Dept. Obstetrics, Bloemfontein, South Africa, 2Univ. of the Free State, Bloemfontein, South Africa
Introduction: Pelvic organ prolapse (POP) surgery can often be associated with significant blood loss due to the vascularity of this region. Surgeons universally make use of some form of hydrodissection incorporating a vasoconstrictor which is placed in the anterior and/or posterior fibromuscularis portion of the vaginal epithelium at the time of prolapse surgery (1). This aspect of prolapse surgery has not been subjected to rigorous scientific evaluation before. The vasoconstrictor we use in our unit is Ornipressin (Por-8, Ferring) which is a derivative of arginine vasopressin, an endogenous vasoconstrictor. It increases blood pressure by a direct action on vascular smooth muscle receptors. This is in contrast with epinephrine, a catecholaminergic vasoconstrictor, which produces a more pronounced tachycardia and exaggerated metabolic effect (2). Objective: The primary was to evaluate the effect on intraoperative blood loss between saline alone versus ornipressin/ saline hydrodissection in a single-blind randomised controlled trial setting. The secondary Objective:s were surgeon impression of the efficacy of vasoconstriction during hydrodissection and the effect on blood pressure intra- and post-operatively (recovery area). Methods: Eligible participants were 20–85 years and planned for vaginal POP surgery without mesh under general anesthesia. Group 1 received 80 ml of a solution of 10 IU Ornipressin (Por-8, Ferring) diluted in 200 ml Saline and Group 2 received 80 ml of Saline alone for vaginal infiltration. Allocation of women to either group was determined by randomization using a computer-generated random sequence, which was concealed in consecutively numbered opaque sealed envelopes. These were opened in theatre prior to surgery. The two surgeons performing the procedures were blind to the allocation, but the investigator was not. Blood loss was calculated by measuring volume in the suction bottle, aperture pouch and weighing of any swabs used. The surgeon gave a subjective impression of vasoconstrictor efficacy at the end of the procedure and blood pressure intra- and post-operatively was recorded by the attending anaesthetists. Institutional approval was obtained: ECUFS 107/2012. The outcomes were compared with Fischer’s exact test or Pearsons χ2 for categorical data and the Student t-test or Wilcoxon rank-sum for continuous data as was deemed appropriate by the biostatistician. Results: 40 Participants were randomised to each group. The demographic data were similar for both groups. 4 Participants in Group 2 were excluded (3 had missing data and 1 was randomised without meeting the inclusion criteria) and 76 were analyzed. The median of the total intra-operative blood loss was 44 ml (1–858 ml) in Group 1 and 73 ml (2–328 ml) in Group 2 with a 95 % CI for the median of (−51, −1). The confidence interval was used due to the skewed curve results in terms of the blood loss in Group 1 (1 significant outlying
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
value of 858 ml). There was an adverse effect of Ornipressin on recovery room BP measurement with a statistically higher value in Group 1 compared to Group 2 (p=0.02), but there was no significant difference in intra-operative blood pressure (p=0.39). The surgeons noted a satisfactory effect in 90 % for Group 1 and in 81 % for Group 2 (p=0.133) Conclusions: Ornipressin provides a statistically superior hemostatic effect during POP surgery, but with the side effect of higher blood pressure readings directly postoperatively. References: 1. OBG management 2010;22:12–15 2. Anesth Analg 2000;90(6):1301–1307 Disclosure Block: Etienne Henn: No disclosures. Thando Nondabula: No disclosures. Dr Juul: No disclosures.
PP 51 PREOPERATIVE FUNCTIONAL STATUS AS A PREDICTOR OF POSTOPERATIVE MORBIDITY IN WOMEN UNDERGOING SURGERY FOR PELVIC ORGAN PROLAPSE J. A. GREER1, U. U. ANDY 2, H. S. HARVIE 2, A. L. SMITH 3, G. M. NORTHINGTON 1, L. A. ARYA 1; 1 Obstetrics and Gynecology, Pereleman Sch. of Med. at the Univ. of Pennsylvania, Philadelphia, PA, 2Obstetrics and Gynecology, Perelman Sch. of Med. at the Univ. of Pennsylvania, Philadelphia, PA, 3Surgery, Pereleman Sch. of Med. at the Univ. of Pennsylvania, Philadelphia, PA Objective: Our aim is to determine if preoperative markers of functional status can predict 1) failure to return to baseline functional status and 2) hospital length of stay following surgical treatment for pelvic organ prolapse (POP). Background: Though older women undergoing surgery for POP are at increased risk for worse postoperative outcomes (1), preoperative factors that can identify women at increased risk are not known. Functional status is the ability to perform activities essential to self-care and independent living, such as climbing stairs, running, and desired recreational activities (2). We hypothesize that women with worse functional status before surgery are less likely to return to baseline functional status and more likely to have prolonged length of stay following surgery for POP. Methods: Prospective cohort study of women ≥ 60 years undergoing surgery for POP Stage II or higher. Preoperative functional status was assessed using Activities of Daily Living (ADL), Instrumental Activities of Daily Living (IADL), functional limitations (such as difficulty
S57
walking, climbing, carrying heavy objects), American Society of Anesthesiologist (ASA) class, and history of recent weight loss. Our primary outcome was return to baseline functional status defined as the number of functional limitations within 0.5 SD of baseline functional limitations at 12 weeks postoperatively. We determined the association of preoperative factors with postoperative functional status and number of days in a medical facility, using multivariable linear regression. Results: In 127 women, mean (SD) age was 69.1 (7.1). The median (range) number of functional limitations was 3 (0–10). Of the 127 women, 26 (20.5 %) did not return to baseline function by 12 weeks postoperatively. Women who did not return to baseline functional status were significantly more likely to have Stage IV POP (19.2 % vs 4.8 %, p = .05), urinary incontinence (73.1 % vs 51.2 %, p=.04), and greater number of preoperative functional limitations (5.0±2.0 vs 2.6±2.5, p<.001) than women who returned to baseline functional status. Specific functional imitations identified in women who failed to return to baseline functional status were: walking several city blocks (p<.001), walking one city block (p=.006), climbing several flights of stairs (p=.01), climbing one flight of stairs (p=.01), lifting 10 lb (p=.008), or kneeling, stooping or crouching down (p=.001). On multivariable analysis, presence of at least one preoperative functional limitation predicted a 1.4 (1.2–1.8) increased odds of not returning to baseline functional status after controlling for stage of POP, urinary incontinence, procedures, and surgeon. The median (range) length of stay in a medical facility was 3 (1–15) days. On univariable analysis, preoperative variables significantly associated with length of stay were ASA class III (p=.004), number of functional limitations (p=.05), IADL score (p<.001), weight loss of more than 10 lb (p=.007), and presence of a Dindo class 3 or higher complication (p<.001). On multivariable analysis, after adjusting for the type of surgical procedure, surgeon, and severity of complication, preoperative markers significantly associated with longer length of stay were ASA class III, functional limitations, and weight loss (Table 1). Higher IADL score (indicating higher function) was negatively associated with length of stay and decreased length of stay by 0.76 days. Conclusions: In older women undergoing surgery for POP, preoperative functional status markers are useful predictors for postoperative morbidity. Presence of a preoperative functional limitation can help to identify women at increased risk for failure to return to baseline functional status within 12 weeks of POP surgery. Preoperative functional limitations, ASA class III, and history of recent weight loss also predict increased length of stay following surgery for POP.
S58
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
References: (1) Am J Obstet Gynecol. 2006 May; 194(5):1411–7. (2) Am J Prev Med. 2003; 25(3Sii):112–21. Table 1. Preoperative functional status markers which increase length of stay in a medical facility Preoperative Functional Status Markers
Increased Length of stay (95 % Confidence Interval)
ASA class III Functional limitations
0.74 day (0.13, 1.35) 0.12 day (0.02, 0.21)
Weight loss
0.98 day (0.31, 1.64)
Disclosure Block: Joy Greer: No disclosures. Uduak Andy: No disclosures. Heidi Harvie: No disclosures. Ariana Smith: No disclosures. Gina Northington: Allmed Healthcare Management, Inc.: Consultant, Consulting Fee. Lily Arya: No disclosures. Number:
PP 52 MODELS FOR PREDICTING RECURRENCE AND ADVERSE EVENTS AFTER PELVIC ORGAN PROLAPSE SURGERY J. JELOVSEK; for the NICHD Pelvic Floor Disorders Network, Cleveland, OH Introduction: Choosing a surgical approach to repair pelvic organ prolapse (POP) involves estimating benefits and risks for an individual patient. To date, no tool exists to provide patient-specific, risk-adjusted predictions of developing recurrence or complications after surgery for POP. Instead, average rates are provided based on clinical trials, and clinicians use their expertise to tailor these rates for a specific patient. Objective: The overall objective of this study were to construct and validate statistical models to separately predict patientspecific probabilities of developing recurrent POP and serious adverse events 12 months after POP surgery. Methods: Multivariable logistic models were developed using datasets from the ‘Colpopexy and Urinary Reduction Efforts’ (N=322), ‘Outcomes Following Vaginal Prolapse Repair and Midurethral Sling’ (N=460), and ‘Operations and Pelvic Muscle Training in the Management of Apical Support Loss’ (N=372) trials, and the prospective cohort study ‘Colpocleisis’ (N=144) from the NICHD Pelvic Floor Disorders Network. Model accuracy was measured using the concordance index, which measures the model’s ability to generate a higher predicted probability of the outcome occurring to a patient who has a worse outcome. Thirtyfive candidate risk factors were considered for the models. The variable selection process was done using a step-down method of backwards elimination starting from the full model using a bootstrap bias-corrected concordance index as the stopping
criteria. The removal of each variable was evaluated by determining which variable had the smallest impact on the adjusted R2 and was stopped when the bootstrap concordance index had a change less than 0.001. All concordance indices were internally validated using 1,000 bootstrap samples to correct for bias within the model, and calibration curves where used to measure the relationship between the model’s predicted outcomes against the cohort’s observed outcomes. The bootstrapping method of validation has been shown to be superior to other approaches to estimate internal validity such as split-sample methods Recurrent POP was defined as any POPQ points (Ba, C, or Bp) beyond the hymen or the presence of bothersome bulge symptoms (PFDI question 5) 12 months after surgery, or any POP reoperation (or retreatment) any time up to and including 12 months after surgery. An adverse event was defined as a participant developing ≥ 1 serious adverse event defined in each study during surgery or any time up to and including 12 months after surgery. Results: 1,022 participants were used to predict recurrent POP 12 months after surgery using either an abdominal or vaginal approach. 212 (21 %) experienced recurrent POP 12 months after surgery. When combined together, 9 risk factors accurately discriminated between women who did and did not develop recurrent POP (concordance index = 0.73, 95 % CI 0.70, 0.76). Combined factors that increased the risk of recurrence included: decreasing age, increasing vaginal parity, worse baseline POP (overall POPQ stage, POPQ points C, Ba and GH), no concomitant anterior compartment surgery, no concomitant posterior compartment surgery, and type of POP surgery in order of increasing risk of recurrence: abdominal sacral colpopexy, colpocleisis, and vaginal approaches. All 1,298 patients were used to create the adverse event prediction model. 216 (17 %) experienced at least one serious adverse event by 12 months after surgery. When combined together, 10 risk factors accurately discriminated between who did and did not develop≥1 serious adverse events (concordance index = 0.62, 95 % CI 0.58, 0.66). Combined factors that increased the risk of ≥1 serious adverse event were increasing age, race (other < white < black), no estrogen use, absence of vascular disease, higher cumulative illness rating summary score, no concomitant hysterectomy or oophorectomy, type of anesthesia, limitation of vigorous activities, absence of any lower GI condition, and increasing risk by type of POP surgery (none, colpocleisis, uterosacral ligament suspension, sacrospinous ligament suspension, other suspension types, and abdominal sacral colpopexy). The calibration curves demonstrated that the recurrence model was accurate through a range of predicted probabilities while the complications model was most accurate for predicted complications below 35 %. Conclusions: Two prediction models provide valid individualized estimates for weighing risk of POP recurrence to risk of serious adverse events by surgical approach 12 months after POP surgery.
S59
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
References: None Disclosure Block: J. Eric Jelovsek: No disclosures.
PP 53 EFFICACY OF REPEAT TREATMENT WITH ONABOTULINUM TOXIN FOR REFRACTORY DETRUSOR OVERACTIVITY: SECONDARY ANALYSIS OF OPEN LABEL EXTENSION OF A RANDOMISED TRIAL D. G. TINCELLO1, R. K. OWEN 1, M. C. SLACK 2, C. MAYNE 3, P. TOOZS-HOBSON 4, K. R. ABRAMS 1; 1 Univ. of Leicester, Leicester, United Kingdom, 2 Addenbrooke’s Hosp., Cambridge, United Kingdom, 3Univ. Hosp. of Leicester, Leicester, United Kingdom, 4Birmingham Womens Hosp., Birmingham, United Kingdom Introduction: Botulinum toxin (BoNT) is an established second line treatment for overactive bladder (OAB) and detrusor overactivity (DO). Several randomised studies demonstrate high efficacy with long duration of action and numerous uncontrolled reports support these findings. Some authors have reported the outcomes of repeated injections from these uncontrolled series, suggesting repeat injections are equally effective, although the number of patients included in these reports has been low. Objective: To examine the efficacy of second and third treatments of 200 units of onabotulinum toxin (onaBoNT-A) in women with refractory DO, using data from a large randomised trial. Methods: We conducted a secondary analysis of patient data from a large, placebo controlled randomised trial [2], where women with refractory detrusor overactivity were treated with 200 units of onabotulinum toxin (onaBoNT-A) or placebo. Following 6 months’ blinded follow-up, all patients were offered up to two subsequent active injections of 200 units onaBoNT-A in an open label extension study which continued follow-up for 60 months. Patients completed outcome measures every 6 months, and were able to request additional treatment. After each repeat treatment, an additional set of outcome measures were completed 6 weeks later, superimposed on the six monthly schedule. Each set included a question asking about recurrence of symptoms. We compared the effect of repeated onaBoNT-A injections on time to patient-reported recurrence of symptoms using Cox proportional hazards regression, fitting a marginal model [1] to account for the correlation between the individuals with repeated events. Results: Data from 228 women were included. We analysed a total of 442 observations where symptom
recurrence was reported in 332 instances. Patients receiving a second active injection had a 72 % increased rate of reporting symptom recurrence compared to patients receiving a first active injection (hazard ratio: 1.72, 95 % CI 1.26, 2.33, p= 0.001). Similar results were found for patients receiving a third onaBoNT-A injection compared to patients receiving a first (hazard ratio: 1.84, 95 % CI 1.11, 3.05, p=0.018). (95 % CI)
P>z
Injection Number 1
Hazard Ratio Reference
Standard error −
−
−
2 3
1.72 1.84
0.27 0.47
(1.26,2.33) (1.11,3.05)
0.001 0.018
Conclusions: Existing literature suggests repeat treatment with onaBoNT-A is equally effective compared to first treatments. Our data has compared the “time to return of symptoms” as reported by patients within the context of an RCT and demonstrates that the duration of effect is lower than after primary treatment. We did not perform repeat urodynamic assessments so it is not possible to define whether this is due to a more rapid return of detrusor overcontractility or a restoration of sensory function. These observations have implications for the scheduling of repeat injections among patients who are receiving onaBoNT-A therapy long term. References [1] Eur Urol 2012;62:507–514. [2] Biometrika 68: 373–379 Disclosure Block: Douglas Tincello: Allergan: Speaker, Honoraria. Rhiannon Owen: No disclosures. mark slack: Astellas Pharma: Consultant, Consulting Fee. Johnson and Johnson: Consultant, Consulting Fee. Cambridge Medical Robotics: Board Member, Intellectual Property Rights. Christopher Mayne: Astellas: Advisory Committee Member, Honoraria. American Medical Systems: Speaker, Honoraria. Johnson and Johnson (Ethicon womens health): Speaker, Honoraria. Philip Toozs-Hobson: Allergan: Advisory Committee Member, Consulting Fee. Allergan: Speaker, Honoraria. Astellas: I received financial support to attend IUGA last year, Travel Grant. Keith Abrams: Roche: Advisory Committee Member, Honoraria. AstraZeneca: Advisory Committee Member, Honoraria. Janssen: Advisory Committee Member, Honoraria. Amaris: Consultant, Consulting Fee. OptumInsight: Consultant, Consulting Fee. CreativCeutical: Consultant, Consulting Fee.
S60
PP 54 THE EFFECT OF SOLIFENACIN ON URINARY NERVE GROWTH FACTOR (UNGF) AND BRAIN-DERIVED NEUROTROPIC FACTOR (BDNF) IN WOMEN WITH OVERACTIVE BLADDER AND DETRUSOR OVERACTIVITY: RESULTS FROM THE SHRINK STUDY D. ROBINSON1, A. TUBARO 2, M. KIMBERG 3, M. PLUMMER 3, J. DEVINE 3, P. BOUIC 3, R. VAN TRIGT 4 , R. TRETTER 4, B. STOW 5, G. COMPION 6; 1 Kings Coll. Hosp., London, United Kingdom, 2La Sapienza Univ. of Rome, Rome, Italy, 3Synexa Life Sci., Cape Town, South Africa, 4 Astellas Pharma, Leiden, Netherlands, 5 Astellas Pharma, Chertsey, United Kingdom, 6Astellas Pharma Europe, Chertsey, United Kingdom Objective: Detrusor overactivity (DO) is a hallmark of overactive bladder (OAB) and is diagnosed using urodynamics. This invasive technique carries a risk of urinary tract infection, and thus there is a need for a non-invasive test for the diagnosis of OAB and DO. OAB is defined as urgency with or without urgency incontinence, usually with increased daytime frequency and nocturia, and affects around 13 % of adult women. Studies suggest that urinary nerve growth factor (uNGF) levels may be associated with OAB, and uNGF levels have been shown to change in response to treatment with antimuscarinics.1,2 The evaluations presented here aimed to assess whether solifenacin affects levels of uNGF and urinary brain-derived neurotrophic factor (uBDNF; a key secondary variable), and whether uNGF and/or uBDNF have potential as biomarkers for the diagnosis of DO in OAB and response to antimuscarinic therapy in such patients. Methods: The SHRINK study was a phase IV, randomised, placebo-controlled trial to investigate the effects of solifenacin on bladder wall thickness and uNGF in women with OAB (ClinicalTrials.gov identifier: NCT01093534). Women aged ≥18 years, with OAB symptoms (urinary urgency, frequency, or urgency incontinence) for ≥3 months, a confirmed urodynamic diagnosis of DO, and post-void residual volume <30 ml were eligible for inclusion, regardless of OAB symptom severity. 547 patients were randomised 1:1:1 to receive solifenacin 5 mg, solifenacin 10 mg or placebo for 12 weeks. uNGF and uBDNF were measured at baseline, Week 6 and Week 12 or end of study (EoS), using a modified and analytically validated commercial ELISA assay at a standardised pH. Both uNGF and uBDNF were normalised by creatinine (Cr) level. The primary treatment comparison was the pooled solifenacin treatment group vs. placebo assessments at week 12 (last observation carried forward [LOCF] for imputation of missing values), compared by estimating
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
treatment mean difference and 95 % CI with ANCOVA (treatment group and geographic region as fixed factors, baseline as covariate; treatment difference estimated as contrast) or Wilcoxon rank sum test, depending on data distribution. Results: Results showed that overall, there were no statistically significant effects of pooled solifenacin vs placebo on uNGF/Cr or uBDNF/Cr at Week 12/EoS (p= 0.250; Table), nor for 10 mg or 5 mg solifenacin vs placebo. As data followed a log-normal distribution, the Wilcoxon rank sum test was used as the primary test. An exploratory treatment comparison of 10 mg solifenacin versus placebo in the subgroup of responders (subjects who were wet at baseline and became dry during the study) showed higher uNGF/Cr values in the solifenacin group compared to placebo; the estimated geometric mean value with solifenacin 10 mg (30.6 pg/μmol) was ~31 % higher than with placebo (23.3 pg/μmol, p=0.0217, 95 % CI of geometric mean ratio = 1.04–1.65). There were no statistically significant associations between uNGF or uBDNF and disease characteristics at baseline. Treatment with solifenacin resulted in improvements in urgency micturitions and incontinence episodes (table) reaching statistical significance vs placebo with the 5 mg dose and for the pooled solifenacin group. Pooled solifenacin
Placebo
uNGF/Cr, pg/μmol
n=344
n=176
Baseline, mean (SD), med
33.5 (37.4), 22.7
32.6 (27.5), 24.5
Week 12 LOCF, mean (SD), med uBDNF/Cr, pg/μmol
35.3 (47.3), 24.7
30.4 (26.2), 20.8
n=336
n=170
Baseline, mean (SD), med
187.0 (719.1), 39.5 144.2 (292.6), 40.9
Week 12 LOCF, mean (SD), med Micturition frequency/24 h1 Baseline, mean (SD)
159.2 (431.6), 41.5 116.9 (260.5), 32.8
Week 12 LOCF, mean (SD) Urgency episodes/24 h1,2,3 Baseline, mean (SD)
n=278
n=153
9.06 (4.11)
9.18 (3.39)
7.58 (2.87)* n=257
8.05 (2.76) n=139
4.23 (3.12)
4.25 (2.84)
Week 12 LOCF, mean (SD) 2.27 (2.34) Incontinence episodes/24 h1,2 n=136
2.62 (2.31) n=67
Baseline, mean (SD)
2.11 (2.36)
1.66 (1.78)
Week 12 LOCF, mean (SD)
0.80 (1.79)*
1.00 (1.79)
1
Subjects with post-baseline measurements (can be slightly different for baseline) 2 Subgroup of subjects with criteria present at baseline 3 Patient perception of intensity of urgency scale (PPIUS) grade 3 or 4 *p<0.05 vs placebo; LOCF, last observation carried forward; SD, standard deviation; med, median
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Conclusions: Solifenacin improved urinary symptoms in women with OAB, but there was no association between these improvements and changes in uNGF or uBDNF levels. References: 1. Kuo CH et al., Rev Urol 2010; 12:e69-77. 2. Liu HT et al., BJU Int. 2009; 103:1668–72. Disclosure Block: Dudley Robinson: Astellas: Advisory Committee Member, Honoraria. Pfizer: Consultant, Honoraria. Allergan: Consultant, Honoraria. Ferring: Consultant, Grant/Research Support. SEP: Speaker, Honoraria. Andrea Tubaro: Astellas: Speaker, Honoraria. Pfizer: Speaker, Honoraria. GSK: Speaker, Honoraria. Allergan: Consultant, Honoraria. Bayer: Consultant, Honoraria. AMS: Speaker, Honoraria. Matti Kimberg: No disclosures. Marieth Plummer: No disclosures. Justin Devine: No disclosures. Patrick Bouic: No disclosures. Radboud Van Trigt: Astellas: Employee, Salary. Reiner Tretter: Astellas: Employee, Salary. Bridget Stow: Astellas: Employee, Salary. Gerhard Compion: Astellas: Employee, Salary.
PP 55 LONG-TERM IMPROVEMENTS IN QUALITY OF LIFE FOLLOWING ONABOTULINUMTOXINA TREATMENT IN FEMALE PATIENTS WITH OVERACTIVE BLADDER AND URINARY INCONTINENCE P. K. SAND1, V. KHULLAR 2, M. JOSHI 3, Y. ZHENG 4, V. NITTI 5; 1 Univ. of Chicago, Winnetka, IL, 2Imperial Coll. London, London, United Kingdom, 3Allergan Inc., Irvine, CA, 4 Allergan, Bridgewater, NJ, 5NYU Langone Med. Ctr., New York, NY Introduction: Overactive bladder syndrome (OAB) with urinary incontinence (UI), which is more common in women than in men, has been shown to have a great impact on patients’ quality of life (QOL) (1). OnabotulinumtoxinA is a new treatment option for OAB that has been shown to significantly reduce all symptoms of OAB (including episodes of incontinence, micturition, urgency, and nocturia) and improve QOL in patients who have been inadequately managed by an anticholinergic in 2 placebo-controlled, 24-week, phase 3 trials (2,3). This interim analysis examines whether the improvements in QOL observed following initial onabotulinumtoxinA treatment were sustained over longterm, repeated treatment in the subpopulation of female patients. O b j e c t i v e : To a s s e s s t h e l o n g - t e r m e f f e c t o f onabotulinumtoxinA on QOL in female patients with OAB and UI who were previously inadequately managed by an anticholinergic.
S61
Methods: Patients who completed either of two phase 3, randomized studies of onabotulinumtoxinA 100U for treatm en t o f O A B ( i n w h i c h t h e y r ec e i v e d u p t o 2 onabotulinumtoxinA treatments) were eligible to enter a 3 year extension study and receive multiple intradetrusor onabotulinumtoxinA 100U treatments. Treatment schedules were individualized based upon patient request/need for retreatment so the number of treatments required to maintain symptom control varied for each patient. Data were integrated across the phase 3 and extension studies and analyzed by onabotulinumtoxinA treatment cycle (number of onabolutinumtoxinA treatments received) in the female subpopulation. QOL outcomes included proportion of patients reporting a positive treatment response (improved or greatly improved) on the Treatment Benefit Scale (TBS; co-primary endpoint) and change from baseline in the Incontinence Quality of Life (I-QOL) total summary score and King’s Health Questionnaire (KHQ) Role Limitations (RL) and Social Limitations (SL) domain scores. Improvements in QOL were demonstrated by increases in I-QOL total summary scores and decreases in the KHQ domain scores, where minimal important differences (MID) are +10 and −5 for the two outcome measures, respectively. Adverse events (AEs), including use of clean intermittent catheterization (CIC), were also assessed. Results: A total of 749 female patients entered the extension study, with a median follow-up of 127 weeks (2.4 years). Only treatment cycles 1–5 are being presented for this interim analysis, since they include a sufficient number of patients to yield an interpretable result. Patients’ QOL was impaired at baseline, as evidenced by mean baseline I-QOL scores of 33.6 and mean baseline KHQ RL and SL scores of 64.4 and 43.1, respectively. Twelve weeks after onabotulinumtoxinA treatment, the proportions of patients reporting a positive treatment response on the TBS were 75.0, 82.9, 82.0, 80.4, and 88.1 % (treatment cycles 1–5, respectively). OnabotulinumtoxinA treatment consistently resulted in improvements in total IQOL scores which exceeded the MID by ≥2.5-fold, with mean increases from baseline of 27.1, 29.6, 27.6, 26.1, and 27.7 at week 12 (treatment cycles 1–5, respectively). Consistent improvements in KHQ scores were also observed following repeated onabotulinumtoxinA treatment. Mean decreases from baseline in RL domain scores were −29.0, −33.0, −30.1, −30.6, and −32.5 (treatment cycles 1–5, respectively), which represent a >5-fold change over the MID. Similarly, decreases in SL were −19.0, −20.2, −17.9, −19.3, and −22.7 (treatment cycles 1–5, respectively), which represent a >3-fold change over the MID. The most common AE was urinary tract infection, and no change in AE profile was observed following repeated treatment. The proportions of patients who discontinued the study due to AEs/lack of efficacy were low (4.3 %/ 4.5 %).
S62
Conclusions: Sustained improvements in multiple measures of QOL were observed following repeated onabotulinumtoxinA treatment in female patients with OAB and UI who had been inadequately managed by an anticholinergic. OnabotulinumtoxinA was well tolerated with a consistent safety profile over time. References: 1. BJU Int. 2008; 101: 1388. 2. J Urol. 2013; 189:2186. 3. Eur Urol. 2013; 64:249. Disclosure Block: Peter Sand: Allergan: Advisory Committee Member, Consulting Fee. Astellas: Advisory Committee Member, Consulting Fee. Boston Scientific: Investigator, Grant/Research Support. Ferring: Advisory Committee Member, Consulting Fee. Teva: Advisory Committee Member, Consulting Fee. AltheRx: Advisory Committee Member, Consulting Fee. Vik Khullar: Allergan, Astellas, Pfizer: Scientific Medical Advisor, Consulting Fee. Allergan, Astellas, Pfizer: Speaker, Consulting Fee. Allergan, Astellas, Pfizer: Consultant, Consulting Fee. Allergan, Astellas, Pfizer: Advisory Committee Member, Consulting Fee. Manher Joshi: Allergan, Inc.: Employee, Salary. Allergan, Inc.: Stock Shareholder, Ownership Interest. Yan Zheng: No disclosures. Victor Nitti: Allergan: Advisory Committee Member, Honoraria. Allergan: Speaker’s Bureau, Honoraria. Allergan: Consultant, Consulting Fee. Astellas: Speaker, Honoraria. Astellas: Advisory Committee Member, Honoraria. Coloplast: Consultant, Consulting Fee. American Medical Systems: Consultant, Consulting Fee. Ipsen: Advisory Committee Member, Honoraria. Ipsen: Consultant, Consulting Fee. Ono: Advisory Committee Member, Honoraria. Theracoat: Consultant, Honoraria. Serenity: Advisory Committee Member, Ownership Interest. Serenity: Stock Shareholder, Ownership Interest. Allergan: Investigator clinical trial, Grant/Research Support.
PP 56 COMPARISON OF SAFETY AND EFFICACY OF MIRABEGRON AND SOLOFENACINE IN TREATMENT-NAIVE JAPANESE FEMALE OVERACTIVE BLADDER PATIENTS M. KINJO1, Y. YOSHIMURA 2, Y. SEKIGUCHI 3; 1 Urology, Kyorin Universitiy Hosp., tokyo, Japan, 2Yotsuya Med. Cube, Tokyo, Japan, 3Women’s Clinic LUNA JAPAN, YOKOHAMA, Japan Introduction: Overactive bladder (OAB) is a common health problem and negatively impacts patients’ quality of life (QOL). Anitimuscarinic drugs are predominant pharmacologic treatment for OAB and often have good effect. However, low persistency rate of anticholinergics due to side effects
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
such as dry mouth and constipation, and their poor efficacy seen in some patients had promoted the search for new drugs with improved safety and efficacy. Recently Mirabegron, an orally active β3-adrenoreceptor agonist which produces detrusor relaxation only in the storage phase, has been developed as a new treatment drug for OAB. Several studies have already revealed significant efficacy and good tolerability of this new drug. Dry mouth is well known and the most bothersome side effect of antimuscarinics, it is reported that this side effect seen in Mirabegron is significantly less than antimuscarinics. But the former studies mealy analyzed the occurrence rate of dry mouth and did not show any sensation grade of this side effect. Thus, in this study, we evaluated the perception of dry mouth and constipation observed in patients treated with Mirabegron and Sorifenacin by using scoring questionnaire. We also examined the efficacy of these drugs in the patients with treatment naïve female OAB. Objective: To compare the safety and efficacy of mirabegron and solifenacine in female overactive bladder patients. Methods:A total 135 post-menopausal female treatment-naïve OAB patients who presented to our clinic were enrolled in the study. The design was prospective, randomized two arms with 8week active treatment period. Patients were randomized to receive mirabegron 50 mg, or solifenacine 5 mg once daily for 8 weeks. All patients were subjected to a diagnostic work-up of medical history, physical examination, 3 days voiding chart, and post voided residual (PVR) before starting medication. In order to examine efficacy, tolerability and safety of the drugs, the following parameters were evaluated before and 4 weeks, 8 weeks after the medication; the overactive bladder symptom score (OABSS, scoring the daytime urinary frequency, nighttime urinary frequency, urgency and urge urinary incontinence, validated in Japan), International Consultation of Incontinence Questionnaire of Sort Form (ICIQ-SF), Dry Mouth Scale (DMS, scoring the condition about the dry mouth, validated in Japan), Constipation Assessment Scale Japanese version (CAS, scoring the bowel condition, developed from original to Japanese version). And also before and 8 weeks after, PVR were analyzed. All participants provided oral informed consent before entering the study. For statistical analysis, paired t-test was used and p value <0.05 was considered statistically significant. Results: 104 out of 135 (77.0 %) patients were complete the study. Both of mirabegron (n=56) and solifenacine (n=48) groups were significantly improved after 4 and 8 weeks in OABSS and ICIQ-SF compared to before the treatment (OABSS: mirabegron group;8.3±2.5→5.5±3.0→5.1±3.4, solifenacine group;7.8±5.2→4.9±2.6→3.9±3.1) (p<0.05) (ICIQ-SF: mirabegron group;9.4±5.1→7.4±4.7→6.9±4.8, solifenacine group;8.6±4.5→5.1±4.6→4.6±4.3) (p<0.05). In DMS, there was no change in 4 weeks in mirabegron group (23.7±10.9→22.1±10.2) (NS), but significantly worsened in solifenacine group (24.4±7.3→28.2±7.9) (p<0.05). And at
S63
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
8 weeks, DMS was significantly improved in mirabegron group (23.7±10.9→21.4±104) (p<0.05), but still significantly worsened in solifenacine group (24.4±7.32→27.9±7.9) (p<0.05) compared to DMS in both groups before the medication. There was no change at 4 and 8 weeks in CAS on both of mirabegron and solifenacine groups compared to CAS in both groups before the treatment (mirabegron group;4.1± 2.7→3.9±2.4→3.8±3.0, solifenacine group;4.2±2.2→5.4 ±3.4→4.7±4.0) (NS). There was no significant change in PVR in both groups. Discontinuation because of adverse events was reported in 2 cases (rush and hypertension) in mirabegron group and 3 cases (dry mouth, constipation and rush) in solifenacine group. Conclusions: This study clearly demonstrated that mirabegron and solifenacine significantly improved the OAB symptoms and well tolerated in postmenopausal treatment-naïve female OAB patients. Compared to solifenacine, the side effect was moderate especially in dry mouth in mirabegron. At the best of our knowledge, this is the first clinical study which comapared the antimuscarinic andβ3-adrenoreceptor agonist not only in efficacy but also in side effects by using scoring questionnaire of dry mouth and constipation. References: N/A Disclosure Block: Manami Kinjo: No disclosures. Yasukuni Yoshimura: No disclosures. YUKI SEKIGUCHI: No disclosures.
PP 57 LONG-TERM CHANGE IN URINARY INCONTINENCE AMONG SEVERELY OBESE WOMEN FOLLOWING BARIATRIC SURGERY L. L. SUBAK1, W. C. KING 2, J. CHEN 2, S. H. BELLE 2, A. P. COURCOULAS 3, D. FLUM 4, J. R. PENDER 5, S. K. PIERSON 3, W. J. PORIES 6, K. STEFFEN 7, B. M. WOLFE 8 , A. J. HUANG 9; 1 UCSF OB/GYN & R.S., San Francisco, CA, 2Univ. of Pittsburgh, Pittsburgh, PA, 3Magee-Womens Hosp. of UPMC, Pittsburgh, PA, 4Univ. of Washington, Seattle, WA, 5 (252) 744–4751, Brody Sch. of Med. at East Carolina Universi, Greenville, NC, 6Brody Sch. of Med. at East Carolina Universi, Greenville, NC, 7Neuropsychiatric Res. Inst., Fargo, ND, 8Oregon Hlth.and Sci. Univ., Portland, OR, 9 Univ. of California, San Francisco, San Francisco, CA Objective: To determine change in frequency of urinary incontinence (UI) episodes and UI remission among severely obese women after bariatric surgery. Methods: Of 1931 female participants in the Longitudinal Assessment of Bariatric Surgery-2, 1565 completed a selfadministered UI questionnaire, which assessed UI episodes/ week in the past 3 months, prior to bariatric surgery and at one
or more annual follow-up (FU) assessments within 3 years. Among women with prevalent UI (at least weekly UI episodes) at baseline (BL), generalized linear mixed models (GLMM) were used to estimate change in frequency of UI episodes by type (total, urgency, stress), remission (less than weekly UI episodes at FU) and complete remission (a subset of remission, no UI episodes at FU), with adjustment for multiple comparisons. Mixed-effects ordinal logistic regression and GLMM were used to identify factors independently related to change in frequency and remission, respectively. Results: Among 772 (49 %) women with prevalent UI at BL, median (IQR) age was 49 (40–56) years and body mass index (BMI) was 46.0 (41.9–51.7) kg/m2. On average, they reported 10.9 (95 % CI: 9.8–12.1) UI episodes per week. Most underwent Roux-en-Y gastric bypass (70 %) or adjustable gastric banding (25 %). Median (IQR) percent weight loss was substantial and maintained through 3 years: 30.5 (22.6– 37.5)% at 1 year, 31.0 (22.4–39.0)% at 2 years and 28.6 (20.3–36.6)% at 3 years. UI episodes were significantly fewer at all FU time points than at BL, although the frequency of UI episodes increased after year 1 (Table 1). Similarly, remission was higher at year 1 than at years 2 and 3, but still 61 % at year 3. Approximately one-quarter experienced complete remission at years 1–3 (Table 2). Variables independently associated with reduced UI frequency and with UI remission (p<0.05) were younger age (OR 1.43 and 1.52 per 10 years younger, respectively) and greater weight loss (1.35 and 1.31 per 5 % loss, respectively). Pregnancy in the past year was also associated with lower odds of improvement (0.30) and prior hysterectomy was associated with lower odds of remission (0.64). Race, parity, diabetes status and history of stroke were not independently related to either outcome. Conclusions: Approximately half of women undergoing bariatric surgery had prevalent UI before surgery. During the 3 years after surgery, there was substantial reduction in the frequency of UI episodes, with the majority of women in remission and one in four in complete remission. Improvement in UI appears to be another important benefit of bariatric surgery. Table 1. Modeled mean (95 % CI) UI episodes/week among those with baseline UI (N=772) UI episodes per week
Baseline
Years since bariatric surgery
Total
10.9a (9.8–12.1)
Stress
5.1a
1 year 2.7b (2.2–3.3) 1.2b
2 year 4.0c (3.1–5.0) 1.7c
3 year 4.0c (3.4–4.9) 1.8c
Urgency
3.6a (3.1–4.1)
(1.0–1.5) 1.0b (0.8–1.2)
(1.2–2.4) 1.3b,c (1.1–1.6)
(1.4–2.2) 1.4c (1.2–1.7)
(4.6–5.7)
a, b, c
Within each UI measure, values with the same letter are NOT significantly different (adjusted p>0.05).
S64
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Table 2. Modeled percent (95 % CI) of women with baseline UI (n = 772) who achieved UI remission and complete remission
Remission* Complete remission**
Years since bariatric surgery 1 year 2 years 61.7b 70.3a (65.7–74.5) (56.5–66.6) 24.3a 26.7a (22.9–30.8) (20.6–28.5)
3 years 60.6b (55.3–65.6) 25.0a (21.1–29.3)
*Remission is defined as less than weekly UI episodes over the past 3 months at specified follow-up. **Complete remission (a subset of remission) is defined as no UI episodes over the past 3 months at specified follow-up. a, b Within 1 Disclosure Block: Leslee Subak: No disclosures. Wendy King: No disclosures. JiaYuh Chen: No disclosures. Steven Belle: Rottapharm-Madaus: Grant/research support, Grant/Research Support. Anita Courcoulas: Nutrisystem: Co-Investigator, Grant/Research Support. David Flum: Covidien: Speaker, Travel Grant. Association of Surgeons of Great Britain and Ireland: Speaker, Travel Grant. Nestle Nutrition and Health Sciences: Speaker, Honoraria. BenchMarket Medical, LLC: I am co-owner and part of the leadership team for this company and receive a salary, Ownership Interest. Surgical Consulting, LLC: Consultant, Consulting Fee. Pacira Pharmaceuticals: Consultant, Consulting Fee. American College of Surgeons: Attended a meeting to discuss educational campaign roll out through the American College of Surgeons - hotel and airfare were covered, Travel Grant. John Pender: No disclosures. Sheila Pierson: No disclosures. Walter Pories: Johnson & Johnson: East Carolina University signed a contract with Johnson & Johnson to agree to support my diabetes research. All of the funds go to the university and my salary will not change as a result of this agreement. Nor will there be bonuses or Kristine Steffen: No disclosures. Bruce Wolfe: EnteroMedics: Consultant, Consulting Fee. Ethicon: Consultant, Honoraria. Johnson and Johnson:
Consultant, Honoraria. Alison Huang: Pfizer, Inc.: I have received contracted research funding to conduct research unrelated to urinary incontinence, Grant/Research Support. PP 58 EFFECT OF IRRITANT BEVERAGE INTAKE ON OVERACTIVE BLADDER SYMPTOMS: A RANDOMIZED CONTROLLED TRIAL M. O. SCHIMPF1, J. M. MILLER 2; 1 Obstetrics and Gynecology/Division of Gynecology, Univ. of Michigan, Ann Arbor, MI, 2School of Nursing, Univ. of Michigan, Ann Arbor, MI Objective: Bothersome symptoms of urinary frequency and urgency are common. Typical lay and clinical advice involves beverage intake modification emphasizing “irritating ingredients” to the bladder, but evidence is sparse. We coined the term “potentially irritating beverages” (PIBs) to include ingredients of caffeine, alcohol, artificial sweeteners, carbonated or acidic beverages. We tested the hypothesis that women who received compelling education on exchanging PIBs for nonPIBs in equal volume would experience a significant reduction in symptoms of frequency, urgency and bother compared to a control group educated on healthy eating. Background: In our earlier pilot study we found that an educational intervention emphasizing replacement of PIBs with equal amounts of non-PIBs (e.g. water, milk, herbal teas) improved frequency, urgency and bother symptoms. However, lack of fidelity to maintaining stable total volume intake left it unclear whether a reduction in total intake or in PIB volume was responsible. Methods: The study design was a parallel-group randomized controlled trial with a three-period fixed sequence (baseline, follow-up at 2 weeks and 2 months post-baseline). Sixty-two women were recruited from the community. Inclusion criteria required daily intake of ≥16 oz of PIBs and ≥32 oz total fluids, and screening positive for bothersome symptoms of frequency and urgency. Exclusion criteria included diabetes, use of anticholinergic or diuretic medications, dysuria, frequent UTIs or incontinence surgery within the last year. The educational
S65
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
package for both intervention and control groups was provided by CD for standardization. Only the intervention group received instruction on the potential role of PIBs in frequency/ urgency symptoms, advising them to eliminate all PIBs. Extensive tips and tricks on how to reduce PIBs without reducing total intake volume were provided. The control group received education on healthy eating. Instruments: A 3-day voiding diary with beverage intake detail was collected at each time point. Outcome measures included fidelity to preserving total intake volume, void frequency, and measures of subjective feelings of urgency (1), ability to delay voiding (2) and degree of bother (3). The questionnaires were modified to reflect a single day’s experience. A priori power analysis based on pilot data indicated a sample size of 60 (30 in each group) was needed to provide 80 % power to detect a difference of 1.25 voids/day. Descriptive statistics and general linear models were performed to test prediction of change scores by group assignment. Results: Sample characteristics (N=62) included mean (±SD) age of 46.3±17.8 years, parity of 1.4±1.5 children and BMI of 27.4±6.1. 87 % reported themselves as Caucasian, 75 % with some college education. Results (see Table) show subjects maintained total daily fluid intake and total urine output across the study for both groups. Group assignment was a significant predictor of change in voids per day (frequency) at the 6-week visit, but not at 6 months. Group assignment also predicted change in bother, but only at the 6-month visit; there was no difference at 6 weeks. Perceived urgency and ability to delay voiding were not predicted by group assignment at either follow-up visit.
Variable
Control group
Intervention group
Total fluid intake in 24 h Baseline
72.6±24.1
73.6±27.3
Timepoint 2
70.8±24.7
65.1±23.8
Timepoint 3
64.9±21.6
66.2±27.5
Variable
Control group
Voids per day (mean ± SD) Baseline 8.8±2.9 Timepoint 2 Timepoint 3
8.9±3.3 8.3±4.4
Intervention group 9.5±3.1 8.0±2.9* 7.7±3.0*
Urgency score (scale 1–5, higher scores = worse, mean ± SD) Baseline 2.9±0.6 3.0±0.5 Timepoint 2 Timepoint 3
2.6±0.7 2.7±0.9
2.6±0.8 2.5±0.7
Ability to delay voiding score (scale 0–4, higher scores = worse, mean ± SD) Baseline 2.3±0.7 2.3±0.8 Timepoint 2 Timepoint 3
2.1±0.8 2.0±0.8
2.0±0.9 1.7±0.9
Bother score (scale 8–48, higher scores = worse, mean ± SD) Baseline 17.7±15.4 24.3±16.0 Timepoint 2 Timepoint 3
13.3±10.0 13.8±14.4
16.6±15.9 13.3±12.5*
*randomization group significant predictor of change scores from baseline, p<.05 Conclusions: Educating women on reduction of PIBs, even without reducing overall volume intake, transiently improves frequency and over time improves bother. Urgency and perceived ability to delay voiding are not improved to clinically or statistically significant levels when total volume is maintained. We speculate that anecdotal findings of symptom improvement with beverage management may be due to either total volume reduction of all beverages or perhaps a specific PIB reduction, such as alcohol. Future work will investigate different PIBs as to which beverage has highest impact. Reference: Coyne, 2002 2 De Wachter S, 2003 3 Bower, Moore, and Adams, 2001
Total voided volume in 24 h Baseline Timepoint 2
72.7±27.7 73.5±33.6
66.4±28.0 59.1±28.9
Timepoint 3
64.6±25.8
62.8±42.1
Disclosure Block: Megan Schimpf: No disclosures. Janis Miller: Proctor and Gamble: Consultant, Consulting Fee.
Affiliate Societies
About IUGA IUGA Board Dr. G. Willy Davila President
Professor Bob Freeman Vice-President
Dr. Ranee Thakar Secretary
Dr. Anna Rosamilia Treasurer
Dr. Harry Vervest
Founded in 1975, the International Urogynecological Association (IUGA) is a non-profit international organization dedicated to the advancement of urogynecological knowledge around the world through education and the promotion of basic and clinical research on female pelvic floor disorders.
Educational Programs Developed as part of IUGA’s mission to advance urogynecological knowledge around the world, IUGA’s educational programs and initiatives have resulted in the formation of new national/regional societies, increased involvement from local physicians and most importantly, an increased standard of care for patients around the world. IUGA’s educational activities include: • Regional Symposia • eXchange Programs • Webinars/other e-learning modules
Past President
International Advisory Board Dr. Stephen Jeffery Africa
Dr. Roy Ng Asia
Dr. Yik Lim Oceania/Australasia
Dr. Teresa Mascarenhas Europe
Dr. Bob Shull North America
Dr. Enrique Ubertazzi
Membership As a member of IUGA, you will enjoy a number of benefits that will help you remain on the cutting edge of success in your industry: • Subscription to the International Urogynecology Journal – includes 12 printed issues and online access. • Registration discount for the IUGA Annual Meeting and IUGA Regional Symposia • Eligibility to apply for IUGA Grants that are available only to IUGA members • Access to “Members Only” content on the IUGA website • Access to a network of over 3,000 like-minded professionals worldwide. • 50% off of items in the IUGA online store Membership dues are $150.00 Membership dues are $100.00 for low and lower middle income countries (as defined by the World Bank)
Dr. Dorothy Kammerer-Doak Research & Development
Professor Bernard Haylen Terminology & Standardization
Dr. Alex Digesu Publication
Dr. Alexandros Derpapas Fellows
Dr. Lynsey Hayward
British Society of Urogynaecology (BSUG) Czech Urogynecological Society (UGS) Dutch Society for Urogynecology (NVOG)
Italian Society of Urogynecology(AIUG) Indonesian Urogynecology Association (HUGI) Korean Society of Urogynecology (KUGS) Nucleo Brasileiro de Uroginecologia (NBUG) Philippine Society for Urogynecology and Reconstructive Pelvic Surgery (PSURPS) Portuguese Society of Urogynecology (PSUG) Saudi Urogynecology Group (SUG) Slovak Urogynecologic Society (SUG)
Sociedad Mexicana de Urología Ginecológica (SMUG)
Committee Chairs
Education
Austrian Urogynecology Working Group (AUB)
Sociedad de Obstetricia y Ginecología de Venezuela (SOGV)
Charles A. Shields, Jr.
Dr. Jan Paul Roovers
Australasian Gynaecological Endoscopy and Surgery Society (AGES)
Slovene Society of Urogynecology (SSUG)
Executive Director
Scientific
Asociación Colombiana de Ginecología Urológica (ASCOGUR)
Greek Association of Urogynecology and Pelvic Floor Disorders (GAUPFD)
Latin America
Dr. Dudley Robinson
Arbeitsgemeinschaft für Urogynäkologie und Beckenbodenpathologie (AUG)
Upcoming Meetings
2015 Nice, France Joint meeting with EUGA June 9 - June 13 2016 Cape Town, South Africa Joint meeting with SAUGA July 5-9 2017 Vancouver, Canada June 20 – June 24
Public Relations
For more information about IUGA or to join, visit www.iuga.org
South African Urogynecology Association (SAUGA) Turkish Society of Urogynecology ( TUPRA TUPRA) Urogynaecological Society of Australasia (UGSA UGSA)) Urogynecology & Reconstructive Pelvic Surgery Society of China (URPSSC URPSSC)) Urogynecology and Reconstructive Pelvic Surgery Society of India (URPSSI) Urogynecology Pelvic Floor Dysfunction and Incontinence Association (UPIA UPIA) Urogynecology Peruvian Group (UPG)
S67
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Videos VID 01 INCIDENTAL FINDINGS ON CYSTOSCOPY: A VIDEO TUTORIAL S. M. LENHERR 1 , E. CROSBY 2 , A. PELLETIER CAMERON1; 1 Urology, Univ. of Michigan, Ann Arbor, MI, 2Obstetrics & Gynecology, Univ. of MIchigan, Ann Arbor, MI Objective: Cystoscopy is frequently performed by gynecologists in order to ensure ureteral patency and an intact bladder when performing other concomitant gynecologic procedures. Generally there are no additional findings on cystoscopy, however, when abnormalities arise, they might require urologist evaluation and possible intervention. Our aim was to create a visual library of benign, malignant and foreign body pathologies incidentally encountered on cystoscopy. Methods: Incidental cystoscopic findings were videotaped for educational purposes at the time of surgery. Relevant aspects of each disorder were collected thorough literature review. Clinical relevance: Benign, malignant and foreign body pathologies are commonly encountered on cystoscopy, although some are rare. Benign bladder findings included in this video are squamous metaplasia, duplicated ureteral orifice, ureterocele, Hutch diverticulum, bladder trabeculation, urachal cyst, interstitial cystitis with and without Hunner’s lesion, endometriosis in the bladder, post-wine stain due to Klippel-Trenaunay-Weber syndrome, nephrogenic (mesonephric) metaplasia, and cystitis glandularis (intestinal metaplasia). Malignant findings include papillary urothelial neoplasm of low malignant potential (PUNLMP), high grade superficial urothelial carcinoma, carcinoma in situ (CIS), high grade urothelial carcinoma, and urachal cancer. Foreign body pathologies include edema from ureteral stents and stone encrusted mesh. This video abstract is intended to educate and elucidate some incidental findings seen on female cystoscopy. The identification and description of the abnormality is a useful tool for all gynecologists performing cystoscopy. Many pathologies can be biopsied or treated immediately during the procedure hence early urology consultation for any abnormalities is encouraged. Disclosure Block: Sara Lenherr: Medtronic, Inc.: One time travel grant for Interstim Fellows Course., Travel Grant. Erin Crosby: No disclosures. Anne Pelletier Cameron: medtronic: I am the PI for a medtronic patient registry I do not receive any honoraria or salary support, Grant/Research Support.
VID 02 INTRA-ABDOMINAL PRESSURE CHANGES DURING ACTIVITIES OF DAILY LIVING. HOW MUCH IS TOO MUCH? J. KRUGER 1 , D. QUACH 1 , J. SMALLDRIDGE 2 , L. HAYWARD1, P. NIELSEN1, D. BUDGETT1; 1 Auckland Bioengineering Inst., Auckland, New Zealand, 2 Auckland Bioengineering Inst., Auckland, New Zealand
INTRA-ABDOMINAL PRESSURE CHANGES DURING ACTIVITIES OF DAILY LIVING. HOW MUCH IS TOO MUCH? Objective: of this video is to illustrate the relative changes in intra-abdominal pressure during activities of daily living. The aim is to demonstrate that relative to physiological episodes such as cough or valsalva, there is minimal rise in intraabdominal pressure during many activities which are advised against post-operatively. This information can be used to help develop evidence-based post-operative advice. Methods: We have previously developed a novel intravaginal pressure sensor (IVPS), which has demonstrated repeatable and reproducible pressure measurements with good retention during activity [1]. For the purposes of this video, two participants without prolapse and with intact levator ani muscles, who were age, BMI, and parity matched, were selected to perform the activities. A synchronized trace of the fluctuations in abdominal pressure for each activity, and each participant, is demonstrated in the video. Synchronisation of the video and pressure trace was achieved by implementing a computer-controlled visual cue which could be traced to its precise frame in the video recording, and related to its respective position on the pressure trace. The intra-vaginal pressure sensor was self-inserted above the levator plate to minimise any involuntary pelvic floor muscle contraction which may confound the measurements. Pressure measurements are shown during lying, sitting, and standing as a baseline. Pressure changes are also demonstrated during a pelvic floor muscle contraction. Activities which are commonly restricted following vaginal surgery were simulated in a laboratory setting (www.iuga.org/ www.rcog.org.uk/womens-health/patient-information). These included: & & & & & & &
Carrying a full basket of wet washing (6.9 kg) Carrying and lifting shopping bags (6.4 kg) Picking up and carrying a toddler (14 kg) Lifting a 2 kg bottle of water and pouring Lifting a 5 kg weight above your head Vacuuming Walking at 3 km/h, at 6 km/h and jogging at 8 km/h (on a treadmill)
S68
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Both participants also performed effective coughs and valsalva manoeuvres. Clinical relevance: Post-operative advice to patients, following vaginal surgery, varies widely (IUGA, RCOG). A recent review article [2] has highlighted the need for evidence and consistency in both post surgical advice and in the method of measuring intra-abdominal pressure. Previous work measuring intra-abdominal pressure fluctuations during activities of daily living and exercises show similar trends, despite varying methodology and wide variations of absolute pressures [3]. However, this has not yet translated into changes in clinical practice or any consistency within recommended post operative restrictions or measurement methodology (IUGA; RCOG). The development of a wireless intra-vaginal pressure sensor, in which the pressures are not confounded by fluid filled lines, allows for freedom of movement, and a high frequency response, is likely to be the measurement method of choice when considering pressure changes in a non clinical setting. Our intra-vaginal pressure sensor, and that of Nygaard et al. [4], are both designed to measure IAP using wireless technology. Future work using this technology will provide reliable information on the abdominal pressure fluctuations during activities and exercise. This information will allow the development of evidence-based postoperative and exercise advice. Conclusion: This video provides a visual aid to clinicians, demonstrating the relative changes in IAP during some common activities of daily living and physiological episodes such as cough. In light of the evidence that sedentary behaviour is detrimental to overall health, and the likelihood that some loading of the pelvic floor muscles will aid healing, this visual aid may help to change practice. This information should be used in combination with evidence already published.
VID 03 PELVIC FLOOR TRIGGER POINT INJECTION WITH ONABOTULINUM A TOXIN FOR THE TREATMENT OF SEVERE MYOFASCIAL PELVIC PAIN B. ORASANU 1, S. MAHAJAN2; 1 Urology, Univ. Hosp. Case Med. Ctr., Cleveland, OH, 2Case Western Reserve Univ., Cleveland, OH
References: 1. International Urogynecology Journal: (2013)1–7. doi:10. 1007/s00192-013-2097-8 2. Int Urogynecol J (2013)24 (5): 719–724. doi:10.1007/ s00192-012-2026-2 3. International Urogynecology Journal (2007)18 (12):1481– 1489 4. Neurourology & Urodynamics(2010) 29 (4):532–535
VID 04 SURGICAL MANAGEMENT OF RECURRENT UPPER VAGINAL PROLAPSE FOLLOWING SACRAL COLPOPEXY N. HAYA1, P. O’ROURKE 2, C. MAHER 1; 1 Obstetric and gynaecology, The Royal Brisbane and Women’s Hosp., Brisbane, Australia, 2QIMR Berghofer RBWH Statistics Unit, The Royal Brisbane and Women’s Hosp., Brisbane, Australia
Disclosure Block: Jennifer Kruger: No disclosures. DANIEL QUACH: No disclosures. Jackie Smalldridge: No disclosures. Lynsey Hayward: No disclosures. Poul Nielsen: No disclosures. David Budgett: No disclosures .
Introduction: myofascial pelvic pain (MPP) is a disorder of unclear etiology in which pelvic pain is attributed to short, tight, and tender pelvic floor muscles. The majority of patients respond to conservative treatment with transvaginal pelvic floor physical therapy. In the minority of patients with severe symptoms, refractory to conservative treatments, onabotulinum A toxin has been reported to significantly improve pelvic pain when injected into the pelvic floor muscles. Objectives: to demonstrate our technique for pelvic floor muscle injection with onabotulinum A toxin to treat MPP in women. Methods: in our video demonstration, the procedure is performed on a patient with severe, refractory MPP, in the operating room, under general anesthesia. An animation will better demonstrate our technique for systematic injection of pelvic floor muscles with onabotulinum A toxin. Clinical relevance: pelvic floor injection of onabotulinum A toxin is a straightforward procedure for women with MPP refractory to pelvic floor physical therapy. The procedure is easy to perform and well tolerated by patients. Disclosure Block: Bogdan Orasanu: Allergan: Investigator Initiated Trial Grant, Investigator Initiated Trial Grant. Allergan: Consultant, Consulting Fee. Sangeeta Mahajan: Astellas, Inc: Speaker’s Bureau, Honoraria. Allergan, Inc: Investigator initiated trial research grant, Grant/Research Support.
Introduction: Sacral colpopexy is the procedure of choice for post-hysterectomy vault prolapse [1]. As the procedure is performed more frequently we will undoubtedly be asked to manage patients with recurrent upper vaginal prolapse post sacral
S69
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
colpopexy. There is little or no data available of the plausibility, safety and efficacy of performing repeat sacral colpopexy. Objective: The aims of this video and case series are to demonstrate laparoscopic sacral colpopexy for the management of recurrent upper vaginal prolapse after sacral colpopexy, to determine why the initial sacral colpopexy failed and to describe our outcomes. Material and Methods: All patients with symptomatic upper vaginal prolapse after prior sacral colpopexy presenting between July 2012 and July 2013 were included in this series. Those not suitable for laparoscopic sacral colpopexy were excluded including those with Body Mass Index (BMI) >40 kg/m2, greater than 5 laparotomies or prior pelvic radiation. Prior to surgery patients completed self-administered pelvic floor questionnaire [2] and prolapse findings were recorded in keeping with the Pelvic Organ Prolapse quantification (POP-Q) system. Following the surgery patients were reviewed at 6 weeks and 6 monthly thereafter. The preoperative evaluation was repeated with the addition of the Patients Global Impression of Improvement (PGI-I). Ethics committee approval was obtained (Ref no. 2014.11.115). Results: Five consecutive patients participated with no exclusions and patient characteristics and peri-operative details are listed in Table 1. At pre-operative presentation all patients presented with vault and anterior compartment prolapse with significantly less prolapse on posterior compartment (Table 2). Three out of the five patients required adhesiolysis longer than 45 min, paravaginal repair was performed in two cases and posterior vaginal repair in one case. In all patients the mesh remained secured to the sacrum and was able to be identified at the vault. Insufficient anterior compartment mesh extension was seen in three patients and in two patients the mesh was not in contact with the anterior vaginal wall and lying lateral and right of the vagina. The retroperitoneal dissection was performed medially to the existing mesh and was challenging due to limited mobility of the peritoneum fixed to the mesh. The dissection of the bladder and bowel from the vagina was also challenging due to marked fibrosis in all cases. In one case, that had undergone two prior sacral colpopexies, we excised large volume of the existing mesh. An inadvertent vaginotomy occurred during the paravesical dissection in one case, the vaginal mucosa was sutured and the mesh was placed on top of the sutured area. Significant changes in POP-Q measurements were recorded in all POP-Q grading sites as seen in Table 2. In keeping with the improved anatomical results there were improved scores in the bladder, bowel, and prolapse domains of the pelvic floor questionnaire with no significant change in sexual scores as seen in Table 3. All patients rated the surgery much or very much better on the PGI-I. Conclusions: Anterior/Apical prolapse were identified as the vaginal sites of recurrence after Sacral colpopexy and the recurrence was related to insufficient or misplaced mesh on the vagina at the initial surgery. While the laparoscopic sacral
colpopexy is feasible, safe and effective in this limited series, adhesions and marked fibrosis make this a challenging intervention. Further evaluation is required. Table 1. Demographics and peri-operative outcomes Patient Characteristics Age (Years)
mean (SD) 60.4 (14.6)
Parity BMI Kg/m2 Surgery interval (Months)
3.4 (1.1) 28.0 (2.9) 25.6 (20.5)
Post Op (Months)
8.5 (8.7)
Blood Loss (Ml) Operating Time (Minutes)
140.0 (54.8) 109.0 (14.3)
Table 2. POP- Q evaluation pre- and post surgery: Tests
Pre-opmean (SD)
Post-opmean (SD)
Change in scoremean (SD)
Aa
1.6 (1.3)
−1.8 (0.4)
3.4 (1.5)
Ba
1.8 (1.6)
−1.8 (0.4)
3.6 (1.9)
C
0.6 (4.2)
−8.0 (0.7)
8.6 (4.3)
Ap
−1.8 (0.4)
−2.0 (0.0)
0.2 (0.4)
Bp
−1.8 (0.4)
−2.0 (0.0)
0.2 (0.4)
Table 3: Self-administered female pelvic floor questionnaire: Domain
Pre-opmean (SD)
Post-op mean (SD)
Change in scoremean (SD)
Bladder
10.4 (3.1)
4.4 (1.8)
6.0 (1.4)
Bowel
7.8 (4.1)
2.4 (1.7)
5.4 (3.4)
Prolapse
10.2 (3.2)
6.0 (5.7)
4.2 (3.0)
Sexual Function Total
3.0 (2.8)
2.0 (1.4)
1.0 (1.7)
31.4 (6.5)
14.8 (3.8)
16.6 (6.5)
1. Cochrane Database Syst Rev, 2013. 4: p. CD004014. 2. Int Urogynecol J, 2010. 21(2): p. 163–72. Disclosure Block: Nir Haya: No disclosures. Peter O’Rourke: No disclosures. Christopher Maher: No disclosures.
VID 05 ENTEROCELE INDUCED RECTAL PROLAPSE: A NOVEL FORM OF PELVIC ORGAN PROLAPSE K. L. FERRANTE1, M. J. TOMASSI 2, M. ALPERIN 3, D. D. KLARISTENFELD 2, S. A. MENEFEE 4; 1 Univ. of California, San Diego/Kaiser Permanente, La Jolla, CA, 2Surgery, Kaiser Permanente, San Diego, CA, 3Univ. of California, San Diego, La Jolla, CA, 4Kaiser Permanente, San Diego, CA
S70
Objective: Rectal prolapse affects approximately 0.5 % of the population and occurs most frequently in older individuals of female gender1,2. Rectal prolapse induced by an enterocele in the posterior cul-de-sac has not been previously reported. The objective of this video is to describe for the first time this form of pelvic organ prolapse and its management. Methods: Two patients with complaints of recurrent rectal prolapse were evaluated by the Colorectal and Urogynecologic services at our institution. During the diagnostic workup, they were both found to have enterocele induced rectal prolapse. Dynamic Magnetic Resonance Imaging is presented along with intraoperative images. Both patients underwent an open sacrocolpoperineopexy with polypropylene mesh and mesh-reinforced Moskowitz culdoplasty. Intraoperatively, previous rectopexy was found to be intact and did not require revision in either of the cases. These women remain both subjectively and objectively cured postoperatively. Clinical Relevance: Enterocele induced rectal prolapse should be considered as a differential diagnosis in the setting of recurrent rectal prolapse, especially if the prolapse is primarily anterior. Repeat rectopexies are unlikely to improve symptoms in these patients. Obliteration of the posterior cul-de-sac with sacrocolpoperineopexy and culdoplasty appears to be an effective treatment for this rare condition. References 1. Kairaluoma MV and Kellokumpu IH. Epidemiologic aspects of complete rectal prolapse. Scand J Surg 94;3:207–210, 2005. 2. Nygaard I, Barber MD, Burgio KL, Kenton K, Meikle S, Schaffer J, Spino C, Whitehead WE, Wu J, Brody DJ for the Pelvic Floor Disorders Network. Prevalence of symptomatic pelvic floor disorders in US women. JAMA 300;11:1311– 1316, 2008. Disclosure Block: Kimberly Ferrante: No disclosures. Marco Tomassi: No disclosures. Marianna Alperin: No disclosures. Daniel Klaristenfeld: No disclosures. Shawn Menefee: No disclosures.
VID 06 USE OF A VESSEL LOOP TO ENSURE TUNNEL PATENCY DURING LEFORT COLPOCLEISIS P. L. ROSENBLATT 1, S. G. DESSIE2; 1 Boston Urogynecology Associates, Cambridge, MA, 2Obstetrics and Gynecology, Mount Auburn Hosp., Harvard Univ., Cambridge, MA
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
INTRODUCTION: Approximately twenty percent of women will undergo surgery for prolapse or incontinence during her lifetime (1). Among patients who are not planning future vaginal intercourse and cannot tolerate extensive surgery, colpocleisis is an excellent surgical treatment consistently associated with high rates of patient satisfaction (2). OBJECTIVE: To describe a novel method for maintaining bilateral channel patency for drainage of possible uterine fluid after LeFort colpocleisis. METHODS: This video presents a novel approach to ensuring bilateral channel patency during colpocleisis. The patient is an 88 year old gravida 2 para 2 with stage 4 uterovaginal prolapse who requested surgical correction. She had no desire for future sexual activity and therefore elected to proceed with a LeFort colpocleisis. Using a marking pen, rectangles are drawn on the anterior and posterior vaginal walls. The vaginal epithelium is then dissected off the underlying tissue with sharp dissection after infiltration with local anesthetic. Care is taken the keep the previously marked edges as the borders for dissection. The surgeon attempts to leave the maximum amount of vaginal wall behind on the bladder and rectum by keeping the epithelium dissected away as thin as possible. After the epithelium is removed anteriorly and posteriorly, a blue vessel loop is placed across the cervix and within the lateral channels as they are created with a series of figure of eight stitches. Care is taken to suture around and not through the vessel loop. This is done bilaterally. The anterior and posterior dissected surfaces of the vagina are then reapproximated to involute the vagina until the distal epithelial edges can be brought together. Once the vaginal epithelial edges are closed, the vessel loop is easily pulled through and removed, ensuring channel patency. An extended perineorrhaphy is then performed. CLINICAL RELEVANCE: LeFort colpocleisis precludes future evaluation of the cervix or endometrium. The lateral channels left in the procedure allow an outlet for any future cervical or uterine bleeding or drainage. These channels can easily be accidently closed during the extensive plication that occurs during a colpocleisis. The vessel loop technique demonstrated in this video allows the surgeon to ensure that the bilateral channels remain patent throughout the procedure. REFERENCES: 1. Obstet Gynecol. 2010;116(5):1097–1100. 2. Int Urogynecol J Pelvic Floor Dysfunct. 2008:19(12):1603–1609. Disclosure Block: Peter Rosenblatt: American Medical Systems: Consultant, Consulting Fee. Ethicon Women’s Health: Consultant,
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Consulting Fee. Covidien: Consultant, Consulting Fee. Cook Medical: Intellectual property rights, Royalty. Boston Scientific: Consultant, Consulting Fee. Sybil Dessie: No disclosures.
VID 07 MULTICOMPARTMENTAL ULTRASOUND APPROACH TO ANORECTAL DYSFUNCTION A. C. SANTIAGO1, D. E. WHITE 2, L. H. QUIROZ 3, M. A. NIHIRA 4, S. SHOBEIRI 5; 1 IUGA International Research Fellow, Univ. of Oklahoma Hlth.and Sci. Ctr., Oklahoma City, OK, 2Univ of Oklahoma HSC, Oklahoma City, OK, 3Univ. of Oklahoma Hlth. Sci., Oklahoma City, OK, 4Univ. of Oklahoma, Oklahoma City, OK, 5The Univ. of Oklahoma HSC, Oklahoma City, OK OBJECTIVE: To demonstrate how multicompartmental ultrasound imaging can be utilized in the evaluation of patients with anorectal dysfunction. CLINICAL RELEVANCE: Patients with anorectal dysfunction may present with constipation or anal incontinence. The common causes for such symptoms may be anatomic in nature, which may be difficult to fully evaluate by clinical examination. Even after surgery, persistence of symptoms is common and oftentimes points to the fact that the surgical intervention failed to address the underlying pathology. With current advancements in pelvic floor ultrasonography, we aim to provide a more accurate diagnosis and optimal management for patients with defecatory disorders. The multicompartmental ultrasound approach examines all compartments of the pelvic floor with detailed resolution. It includes detailed anatomic and dynamic functional examinations and can be performed by an experienced physician in a few minutes. METHODS: The three-step multicompartmental ultrasound approach consists of, 1) transperineal or translabial scanning, 2) 360° endovaginal scanning, and 3) 360° endoanal scanning. In this video, dynamic two-dimensional (2-D) and threedimensional (3-D) ultrasound images of patients seen at our institution are included. The common anatomic causes of defecatory dysfunction are best visualized on dynamic transperineal or translabial and endovaginal scans. These include the following: 1) rectocele, 2) enterocele, 3) sigmoidocele, 4) intussusception, and 5) pelvic floor dyssynergy. Each is discussed separately in this video, with special emphasis on how they would appear on ultrasound. 3D volume acquisition and manipulation to evaluate the status of the levator ani muscles and other parameters, such as the levator hiatal dimensions, anorectal angle, and levator plate descent angle, are given emphasis. The different axial plane levels of the anorectal region on 3-D endoanal scans are discussed. Knowledge of these levels can aid the clinician in the detection of localized internal and external anal sphincter defects in patients presenting with anal incontinence.
S71
CONCLUSIONS: Multicompartmental ultrasound imaging, as a valuable tool in the evaluation of patients with anorectal dysfunction, is demonstrated. In reality, the pelvic floor works as a unit and the dysfunction in one compartment can affect the function of the other compartments. The multicompartmental ultrasound approach enables the investigator to visualize what lies behind the skin and arrive at a more accurate diagnosis and provide optimal therapeutic options for patients. Disclosure Block: Andrea Santiago: No disclosures. Dena White: No disclosures. Lieschen Quiroz: No disclosures. Mikio Nihira: American Medical Systems: Consultant, Consulting Fee. American Medical Systems: Contracted Research, Grant/Research Support. Coloplast: Contracted Research, Grant/Research Support. Cook: Contracted Research, Grant/Research Support. POP Medical: Contracted Research, Grant/Research Support. Salix: Contracted Research, Grant/Research Support. Ethicon: Unrestricted Educational Grant, Grant/Research Support. S. Abbas Shobeiri: POP Medical: Consultant, Consulting Fee. Lifecell: Consultant, Consulting Fee.
VID 08 UNUSUAL COMPLICATION FOLLOWING POSTERIOR SYNTHETIC VAGINAL MESH PLACEMENT P. LANG1, S. OLIPHANT 2, J. MIZELL 1, B. AUSTIN 1, S. BARR 1; 1 Obstetrics and Gynecology, Univ. of Arkansas for Med. Sci., Little rock, AR, 2Univ. of Arkansas for Med. Sci., Little Rock, AR Objective: This video demonstrates an uncommon complication of vaginally-placed synthetic prolapse mesh and demonstrates repair of a posterior vaginal mesh perforation through the rectum. Our patient is a 41yo gravida 2 para 2 patient who was referred to our clinic with multiple complaints following placement of a posterior mesh kit for rectocele 5 months earlier by an outside physician. Her surgery was reportedly uncomplicated. She experienced new onset severe pain radiating down her right leg after awakening from surgery, which significantly limited her mobility for several weeks. She also reported severe pelvic pain, dyspareunia and dyschezia with new onset of fecal incontinence, foul-smelling vaginal discharge, vaginal flatus, and diarrhea. Following a course of physical therapy she had moderate improvement in pain, but continued to complain of these vaginal and fecal symptoms.. Vaginal examination revealed tight mesh arms at the vaginal apex which were tender to palpation, particularly on the right, with no evidence of mesh erosion.. Rectal exam was notable for intrarectal mesh palpable traversing the rectal lumen approximately 6 cm from the anal verge. A pelvic MRI demonstrated a rectovaginal fistula with inflammation
S72
surrounding the right sciatic nerve plexus. The patient was taken to the operating room with the assistance of colorectal surgery. She underwent an exploratory laparotomy, removal of mesh in its entirety, primary repair of the two rectal defects and diverting loop ileostomy. She had immediate improvement in her leg and pelvic pain immediately following mesh removal. Six weeks after her mesh removal surgery she returned for takedown of her ileostomy. She is currently doing well with improvement of bowel movements, continence of feces, improvement of her pain, and no recurrence of her vaginal prolapse. Conclusion: This video demonstrates a technique for abdominal removal of trans-rectal mesh injury occurring as a complication of posterior vaginal mesh placement. We discuss our rationale for an abdominal approach to correct this injury and indications and technique for proper placement of posterior vaginal mesh. Disclosure Block: Patrick Lang: No disclosures. Sallie Oliphant: No disclosures. Jason Mizell: No disclosures. Becca Austin: No disclosures. Susan Barr: No disclosures.
VID 09 CHARACTERIZING FEMALE PELVIC FLOOR CONDITIONS BY TACTILE IMAGING H. VAN RAALTE1, V. EGOROV 2; 1 Princeton Urogynecology, Princeton, NJ, 2Artann Lab., Trenton, NJ Objective: To identify new tactile imaging and muscle contraction markers to characterize female pelvic floor conditions. Methods: Vaginal tactile imaging [1, 2], allows 3-D quantitative elasticity assessment of pelvic floor support structures and carries a potential in assessment of surgical repair. We designed a new vaginal tactile imaging probe that images the entire vagina, the pelvic floor support structures and pelvic floor muscle contractions. The probe has an orientation sensor, temperature sensors and 96 pressure sensors positioning every 2.5 mm along the both sides of the probe. The examination procedure includes four steps. Step 1: Probe insertion. This step provides the pressure responses (P) for vaginal anterior and posterior compartments along the entire vaginal length. We can use this information to calculate pressure gradients (grP) and anatomical dimensions. Step 2: Probe elevation. This step provides the pressure responses for the apical anterior and posterior compartments that are related to pelvic floor support structures.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Step 3: Probe rotation. This step provides the pressure patterns for left and right sides of vagina (circumferential tactile image from vaginal walls). Step 4: Pelvic floor muscle contractions. This step provides the muscle dynamic pressure responses (dP) of the pelvic floor muscle contraction recorded from opposite sides along the entire vaginal length. In 2013 we enrolled 22 subjects into an observational casecontrolled study (NCT01848626). Two patients were excluded from the data analysis because they have had previously a pelvic floor surgery. The analyzed dataset included 20 subjects aged from 41 to 70 years. Among them 4 had normal pelvic floor conditions, 8 Stage I, 7 Stage II and 1 Stage IV prolapse. A standard physical examination was performed, including a bimanual pelvic examination, POP-Q quantification, assessment of tissue rigidity and assessment of pelvic floor muscle tone. The tactile imaging data from all the examinations were reviewed in a blinded fashion with no knowledge of the subject’s pelvic floor conditions to avoid bias in the data review process. The clinical information was then added to this data set after the tactile imaging data (pressure, pressure gradients muscle contracting response) were finalized. One-way analysis of variance (ANOVA)(pa), paired t-test (pt), and Pearson’s correlation coefficients (r) were calculated to determine whether the various parameters showed dependence on the pelvic floor conditions. The subjects were asked to complete an assessment of comfort and pain levels for the tactile imaging procedure. Results: Al 22 patients were successfully examined using the Vaginal Tactile Imager. We identified the following parameters as potential markers to characterize the female pelvic floor conditions. The site 1 corresponds to the lower 1/3 of the vagina, site 2 to the upper 1/3, and site 3 to the apical vaginal compartment. Step1 Anterior P site 1 pa =0.030; pt =0.050; r=−0.58 Posterior P site 1 pa =0.153; pt =0.063; r=−0.53 Anterior grP site 1 pa =0.114; pt =0.129; r=−0.52 Posterior grP site 1 pa =0.179; pt =0.077; r=−0.52 Step2 Anterior P site 1 pa =0.006; pt =0.055; r=−0.41 Posterior P site 1 pa =0.160; pt =0.024; r=−0.46 Posterior P site 2 pa =0.547; pt =0.286; r=−0.34 Anterior grP site 1 pa =0.096; pt =0.051; r=−0.56 Posterior grP site 3 pa =0.074; pt =0.284; r=−0.47 Step3 Left + right P site 1 pa =0.182; pt =0.101; r=−0.44 Step4 Anterior dP site 1 pa =0.097; pt =0.208; r=−0.50 Anterior dP site 2 pa =0.222; pt =0.112; r=−0.43 Posterior dP site 1 pa =0.086; pt =0.077; r=−0.52 Posterior dP site 2 pa =0.256; pt =0.132; r=−0.46
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
During step 4 the VTI allows observation contraction capability of 5 pelvic floor muscles. Part of the identified markers also demonstrates correlation with patient age and parity. A typical examination consisting of four steps takes 1–2 min. Fifty four percent of patients classified VTI comfort level as more comfortable than manual palpation, 36 % as the same, and 10 % as less comfortable than manual palpation. 73 % of patients classified VTI pain as none, 24 % as mildly painful and 3 % as a painful. Conclusions: Our findings suggest that the tactile imaging markers such as pressure, pressure gradient and dynamic pressure response during muscle contraction may be used for further quantitative characterization of female pelvic floor conditions. References: 1. IEEE Trans. Biomed. Eng. 2010; 57(7):1736–44. 2. Int. Urogynecology J. 2012; 23(4):459–66. Disclosure Block: Heather van Raalte: Artann Laboratories: Consultant, Grant/ Research Support. AMS: Consultant, Consulting Fee. Ethicon: Consultant, Consulting Fee. BARD: Consultant, Grant/Research Support. Vladimir Egorov: Advanced Tactile Imaging, Inc.: Stock Shareholder, I invested in that company.
VID 10 ROBOTIC ASSISTED PARAVAGINAL REPAIR AT THE TIME OF SACROCOLPOPEXY: A CASE SERIES D. MORRISSEY1, N. GINZBURG 1, P. O’HARE 1, D. EL-KHAWAND 2, K. WHITMORE 3, B. VAKILI 1; 1 Center for Urogynecology and Pelvic Surgery, Christiana Care Hlth. System, Newark, DE, 2Wellspan Hlth., York, PA, 3 Pelvic and Sexual Health Institute, Drexel Univ. Coll. of Med., Philadelphia, PA INTRODUCTION: Current literature by the Pelvic Floor Disorders Network reports symptomatic or anatomic treatment failure in almost one-third of women within 5 years of having a sacrocolpopexy for pelvic organ prolapse (1). Treatment of paravaginal defects at the time of sacrocolpopexy may improve failure rates of the anterior vaginal compartment. OBJECTIVE: The purpose of this video is for surgical education in the performance of a robotic assisted paravaginal repair (RA-PVR) as well as anatomic education in the space of Retzius dissection. The case series serves to evaluate the effectiveness of a RA-PVR at the time of sacrocolpopexy with regards to success of prolapse repair and prevention of anterior vaginal compartment recurrence. METHODS: This study is an observational case series of seven women with symptomatic pelvic organ prolapse who had a RA-PVR at the time of sacrocolpopexy by one surgeon between May and December 2013. All surgeries were performed at a single institution. Pre and postoperative pelvic
S73
exam was performed using the Pelvic Organ Prolapse Quantification system (POP-Q). Surgical outcomes including stage of prolapse, patient global impression of improvement (PGII), and pelvic floor distress inventory (PFDI-46) for urinary distress (UDI), pelvic organ prolapse distress (POPDI) and colorectal anal distress (CRADI) at 3 months postoperative were compared to baseline characteristics. Robotic assisted Burch colposuspension was the antiincontinence procedure of choice given access to the space of Retzius. RESULTS: All patients received a robotic assisted sacrocolpopexy and paravaginal repair. Average age was 65.7 years and average BMI was 27.5. Eighty six percent (6/7) received a concurrent RA-laparoscopic supracervical hysterectomy and 71 % (5/7) had stress urinary incontinence requiring a simultaneous Burch procedure. Of the 7 patients, 1 presented with stage II and 6 or 86 % with stage III/IV apical and anterior wall prolapse, as measured by points C and Ba. At 3 months from surgery 100 % of patients were stage 0/I at the apex while 57 and 43 % had stage 0/I and stage II anterior compartment prolapse respectively. At the 3month examination there were no paravaginal defects and prolapse did not extend beyond the hymen. Finally, patient’s perception of improvement also ranked high with 86 % (6/7) reporting their PGI-I to be “very much better” and 14 % (1/7) perceived their improvement to be “much better” at 3 months from surgery. PFDI scores significantly improved from a baseline mean of 111 to 8 (p=0.028), 134 to 13 (p=0.028), and 48 to 10 (p=0.043) for UDI, POPDI, and CRADI respectively. CONCLUSION: Addressing paravaginal defects at the time of sacrocolpopexy may improve success rates of pelvic organ prolapse repair. Long-term data is needed to compare success to sacrocolpopexy alone. REFERENCES 1. Nygaard I, et al. Long Term Outcomes Following Abdominal Sacrocolpopexy for Pelvic Organ Prolapse. JAMA. 2013;309(19):2016–2024. Disclosure Block: Darlene Morrissey: No disclosures. Natasha Ginzburg: No disclosures. Peter O’Hare: No disclosures. Dominique ElKhawand: No disclosures. Kristene Whitmore: No disclosures. Babak Vakili: Astellas Pharmaceuticals: Speaker’s Bureau, Honoraria.
VID 11 AVOIDING UPPER EXTREMITY NEUROPATHY DURING PELVIC SURGERY K. CHIN1, P. A. MALDONADO 1, J. PHELAN 2, M. CORTON 1; 1 UT Southwestern Med. Ctr., Dallas, TX, 2Cell Biology, UT Southwestern, Dallas, TX
S74
OBJECTIVE: Upper extremity peripheral neuropathy is an infrequent but potentially serious complication of gynecologic surgery. It is generally associated with improper patient positioning or the use of shoulder support devices. The objectives of this video are to review proposed mechanisms of upper extremity nerve injury, demonstrate the brachial plexus anatomy, illustrate patient positions that may increase the risk of neuropathy, describe common presenting symptoms, and discuss strategies to minimize nerve injury. To accomplish these objectives, a combination of cadaver dissections, illustrations and live models were used. METHODS: The brachial plexus was dissected in unembalmed female cadavers and the specimens were placed in positions commonly used during gynecologic surgery. The arms were abducted or tucked at the side of the body and Trendelenburg position and shoulder braces simulated to illustrate the locations and mechanisms by which brachial plexus injury may occur. Simulation of shoulder support devices and downward migration of the body in Trendelenburg, with potential for stretch or compression of the brachial plexus were demonstrated. Live models were used to illustrate proper and improper patient positioning. CLINICAL RELEVANCE: The increasing use of laparoscopic and robotic-assisted technology is often associated with longer operating times and the use of moderate to steep Trendelenburg positioning. Proper patient positioning is a responsibility of the entire surgical team. Reported incidence of upper extremity neuropathy is variable and ranges from 0.05 to 5 %. Although complete resolution of neuropathic symptoms is seen in most patients, perioperative neuropathies may lead to prolonged or permanent impairment and can have a significant negative impact on a patient’s quality of life. Despite careful positioning and padding, upper extremity neuropathies can occur, however an understanding of the brachial plexus anatomy and patient positions that may increase the risk for neuropathy will assist the entire surgical team in supporting safety measures. Disclosure Block: Kathleen Chin: No disclosures. Pedro Maldonado: No disclosures. John Phelan: No disclosures. Marlene Corton: No disclosures.
VID 12 AN INTRODUCTION TO A NEW TECHNOLOGY FOR MEASURING URETHRAL PRESSURES: 3-D HIGH RESOLUTION MANOMETRY A. C. KIRBY1, J. TAN-KIM 2, C. W. NAGER 1; 1 UC San Diego Hlth. System, La Jolla, CA, 2 Kaiser Permanente San Diego, Encinitas, CA Objective: The objective of this video is to introduce a 3dimensional (3-D) high resolution manometry (HRM) system
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
to the field of urogynecology. We sought to demonstrate how to obtain and interpret dynamic urethral pressures with this measurement system and use it to evaluate pre- and postoperative female subjects as well as the directionality of the forces on the urethra. Methods: The 2-dimensional (2-D) HRM catheter is approximately 8-French and has circumferential pressure sensors along 26.5 cm of its length. The miniaturized solid state sensors are 4 mm long with 2 mm of active sensing area separated by 3 mm of flexible molding giving a 7.5 mm on center spacing between each of the 36 sensors. Each individual sensor has 16 pressure sensitive segments circumferentially distributed around it. Computer processing of the signal comes from the pressure sensing elements and calculates average circumferential pressures. The 3-D HRM catheter is approximately 12-French. Eleven centimeter of its length has pressure sensors with eight circumferentially distributed pressure sensitive segments that collect and transmit individual pressure measurements to construct a 3-D pressure map. In this video we introduce the equipment and explain the output display of the 3-D HRM measurement system in two example studies: one in a subject with primary stress incontinence prior to midurethral sling (MUS) surgery and one in a continent subject after MUS. In this video, we present the pre- and postoperative maximum urethral closure pressures (MUCPs) of 21 female subjects with stress urinary incontinence who underwent MUS surgery. We also show 44 subjects who underwent pressure measurements to qualitatively evaluate the 3-D pressure profile of the urethra in an effort to better understand pelvic floor and urethral sphincter physiology. Clinical relevance: Advanced 2-D and 3-D HRM technology to measure urethral pressures under cough and strain conditions without withdrawal techniques provide new insights into the continence mechanism in continent and incontinent women and after continence surgeries. Disclosure Block: Anna Kirby: No disclosures. Jasmine Tan-Kim: No disclosures. Charles Nager: No disclosures.
Oral Posters OP 001 PELVIC ORGAN PROLAPSE IN THE NEONATE: A CASE SERIES AND PROPOSED CLASSIFICATION SYSTEM E. W. HENN1, L. JUUL 1, K. VAN RENSBURG 2; 1 Dept. Obstetrics & Gynecology, Bloemfontein, South Africa, 2 Dept. Obstetrics & Gynecology, Tygerberg, South Africa
S75
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Introduction: To present a case series of two neonates with genital prolapse and propose a literature basedclassification system. Objective: Pelvic organ prolapse (POP) is a condition associated with multiparous and postmenopausal women. Rarely has it been encountered in newborn females (1). Neonatal genital prolapse was first described in 1723 by Conovius (2). It presents as partial or complete uterovaginal prolapse, typically in the first week of life. We received referrals of two very similar cases of newborns with POP. (Table 1) The deliveries occurred in peripheral hospitals and they were referred to the tertiary care hospital with the diagnosis of an interlabial mass. Paediatric examination was normal except for the genital mass. Both babies underwent radiological imaging (MRI and X-ray) which confirmed the absence of spina bifida. Both passed urine and stool normally. The prolapse was diagnosed as uterine and significant oedema was present (Figure 1). This made manual reduction in the ward not possible. Examination under anaesthesia confirmed the complete uterovaginal prolapse and manual reduction was successfully performed at this time. A vaginal gauze tampon was inserted and removed 24 h later as is standard practice for our adult prolapse repairs. The prolapse did not recur prior to hospital discharge. At follow up both mothers reported no further episodes of recurrence. Examination revealed a normal genital hiatus, perineal body and slightly open hymenal
configuration. Further follow up visits have been requested of the mothers. Table 1. Findings
Case 1
Case 2
Gestation Birth weight Presentation
38 weeks 2210 g Breech
38 weeks 2590 g Breech
Mode of delivery
Cesarean Section
Vaginal delivery
Prolapse noted Procedure
Day 1 Manual reduction in theatre
Day 1 Manual reduction in theatre
Timing of procedure Outcome
Day 9 of life No recurrence at 24 months
Day 7 of life No recurrence at 6 months
Methods: A literature review was performed of publications over the last 290 years. Databases searched were Medline, CINAHL, and Web of Science using the keywords genital, prolapse, uterovaginal, procidentia, newborn and neonate in different combinations. All publications which were accessible in either electronic or paper format were considered. Results: The literature can be divided into three distinct periods based on the accessibility thereof. These are 1723 to 1917 (35 cases reported), 1918 to 1960 (5 cases reported), and 1961 to 2014 (27 cases reported). There have been only six case reports of genital prolapse in a newborn without spina bifida in the last 50 years. The majority of cases are due to levator atrophy associated with spina bifida. It becomes apparent that there
S76
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
are two distinct types of neonatal prolapse. We propose a classification system based on this. Type one is associated with neural tube defects (mostly spina bifida with meningocoele/ myelomeningocoele) and Type two occurs in neurologically intact newborns. Table 2 presents the differences between these two types of neonatal genital prolapse. Table 2. Parameter Prevalence
Type 1 70 %
Type 2 30 %
Presentation at delivery Associated finding Presentation
Cephalic or breech
Mostly breech
Meningocoele/ myelomeningocoele Day 2–7 of life
Neurologically normal
Complex reduction procedures Requires surgical repair of neural tube defect Not known
Simple digital reduction
Management Outcome Long term
References: 1. Ashiery Abdelsalam SE, Desouki NM, Abdalaal NA. Use of Foley catheter for management of neonatal genital prolapse: case report and review of the literature. Journal of Pediatric Surgery 2006;41:449–452 2. Findley P, Prolapse of the uterus in nulliparous women. Am J Obstet Dis Wom 1917;75:12–21
Present at birth
Often no further intervention Not known
Conclusions: Neonatal genital prolapse is a rare condition. There are two types. Type 1 is prolapse associated with spina bifida and Type 2 occurs in an otherwise normal baby. Reduction of Type 2 should occur soon after birth. Cervical oedema increases with time and makes the reduction more difficult. For Type 1 cases, one often needs to perform a concomitant surgical procedure to prevent recurrence until the time of repair of the spina bifida.
Disclosure Block: Etienne Henn: No disclosures. Leonard Juul: No disclosures. Kobus van Rensburg: No disclosures.
S77
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
OP 002 CONCOMITANT ANTERIOR REPAIR AND SUBSEQUENT ANTERIOR PROLAPSE AFTER VAGINAL APICAL SURGERY C. W. NAGER; for the Pelvic Floor Disorders Network, UC San Diego Hlth. System, La Jolla, CA Introduction: The indications for concomitant anterior repair at the time of vaginal apical surgery are unclear despite the anterior compartment being the most common site of recurrence. Objective: Our primary aim was to compare anterior compartment prolapse prevalence 1 year after vaginal apical suspension (uterosacral ligament suspension or sacrospinous ligament suspension) in surgical trial participants with vs. without concurrent anterior repair. The secondary aim was to evaluate the mean change of anterior prolapse (point Ba) from pre-op to 12 month follow-up for each group. We hypothesized that concomitant anterior colporrhaphy would be associated with a decreased prevalence of anterior prolapse at 1 year. Methods: This retrospective secondary analysis included subjects enrolled in two Pelvic Floor Disorders Treatment Network surgical trials (OPUS and OPTIMAL) in which concomitant anterior repair was performed at the surgeon’s discretion. OPUS participants were randomized to a TVT or sham TVT at the time of sacrospinous ligament suspension (SSLS) or uterosacral ligament suspension (USLS) for apical prolapse. OPTIMAL participants were randomized to SSLS or USLS and all subjects received a TVT. Using baseline and 12 month POPQ data, subjects were considered an anterior anatomic success when point Ba was ≤0 at 12 months and no pessary use or interval anterior wall surgery was performed prior to 12 months. Results were obtained for all subjects combined and for subjects with less anterior prolapse at baseline (Stage 1&2, Ba ≤ +1) vs. advanced prolapse (Stage 3&4, Ba >+1). Analyses were adjusted for baseline Ba and C. Results: In the combined cohort of subjects in these 2 trials, concomitant anterior repair was done in 133/226 (59 %) of women who underwent SSLS and 308/476 (65 %) who underwent USLS. A similar proportion of OPUS randomization groups (TVT vs. no TVT) underwent concomitant anterior repair. Subjects who had concomitant anterior repair were older, more often post-menopausal, on estrogen, not Hispanic/Latina, had a prior hysterectomy, and had more advanced anterior, but not apical prolapse. For subjects who underwent concomitant anterior repair, Ba improved −1.8 cm in the (Ba ≤ +1) group and −4.5 cm in the (Ba >+1) group compared to −1.4 and −3.8 cm, respectively in
the groups not receiving an anterior repair (p=0.12 for all subjects combined). Table 1 demonstrates the anatomic anterior success rates for each of the vaginal vault suspension procedures with and without anterior repair. Among patients undergoing a SSLS with a preoperative Ba >+1 better success rates were observed for those subjects undergoing an anterior repair (74 % vs 57 %, p=0.02). There was no evidence that success rates improved with an anterior repair in any group undergoing USLS. Conclusion: This retrospective study provides evidence to suggest that patients with more advanced prolapse undergoing a SSLS may have improved anatomic success with a concomitant anterior repair. However in general the indications for concomitant anterior repair remain unclear and subject to surgeon discretion. Table 1. Anterior Anatomic Success Rates for the Overall Group and for Grouping Based on Pre-op Ba Value in the Surgical Groups with and without an Anterior Repair.
SSLS
USLS
Through w/Repair w/o 12 Months Repair Overall group (N) Success
84
95 (81 %)
60 220 (71 %) (81 %)
Adjusted 0.69 p-value Pre-op Ba 69 >+1 (N) Success 51 (74 %) Adjusted p-value
w/Repair w/o w/Repair w/o Repair Repair
118
Adjusted 0.02 p-value Pre-op Ba 49
0.02
Combined
272
154
126 315 (82 %) (81 %)
0.25 40
74
35 70 (88 %) (95 %)
198
25 150 (57 %) (76 %) 0.35
238 186 (78 %)
0.02 71
123
65 114 (92 %) (93 %)
0.51 44
390
111 100 (90 %)
0.49 83
267
61 201 (73 %) (75 %)
127 86 (68 %)
0.02
P-values based on comparing anatomic success between subjects w\ and w\o a repair within and across SSLS and USLS groups adjusting for baseline POPq BA and C. For subgroup analyses by baseline BA severity, pvalues obtained from a model also including categorical baseline severity measure defined by POPq BA and its interaction with repair group Disclosure Block: Charles Nager: No disclosures.
S78
OP 003 RELATIONSHIP BETWEEN PELVIC FLOOR SYMPTOMS AND POP-Q MEASUREMENTS J. MANONAI1, R. WATTANAYINGCHAROENCHAI 2, S. SARIT-APIRAK 3; 1 Department of OB&GYN, Rama VI Road, Faculty of Med. Ramathibodi Hosp., Bangkok, Thailand, 2Ramathibodi Hosp., Mahidol Universtiy, Bangkok, Thailand, 3Faculty of Med. Ramathibodi Hosp., Bangkok, Thailand Introduction: Disorders of the pelvic floor encompass a variety of conditions including pelvic organ prolapse, urinary incontinence, fecal incontinence, and lower urinary tract and gastrointestinal tract emptying abnormalities. Urinary incontinence, voiding dysfunction, and irritative symptoms are commonly related to anterior compartment prolapse. Symptoms that are related to defecatory dysfunction are correlated with posterior wall prolapse. Symptoms of vaginal or pelvic pressure are attributed to all compartments. However, very few studies that define the associations between specific symptoms and objective prolapse on pelvic examination have been published. Objective: To investigate the relationship between pelvic floor symptoms using the Pelvic Floor Bother Questionnaire (PFBQ) and the Pelvic Organ Prolapse Quantification system (POP-Q) measurements. Methods: This was a retrospective study performed in a single Urogynecology Clinic of a tertiary care University Hospital. Institutional review board approval for the study was obtained. Consecutive women seeking care or referred for pelvic floor symptoms were evaluated and included, between January 2011 and December 2012. The PFBQ was selfadministered by and all patients before they were examined by gynecologists according to the POP-Q. Explanatory parameters were Ba, C and Bp as defined by the POP-Q. Pearson’s correlation was used to investigate the relationship between pelvic floor symptoms and POP-Q anatomical findings for anterior, apical and posterior compartments prolapse (Ba, C and Bp). For each symptom outcome, we calculated a receiver operating characteristic (ROC) curve. For each curve, the disease state was determined by the presence or absence of the symptom outcome. The ROC curves were generated by plotting sensitivity versus 1 minus the specificity for all relevant values of the anatomic measurement for the most dependent site of prolapse. We used the ROC curves to estimate the minimum threshold level for the measured anatomic prolapse that would best predict women who had bothersome pelvic floor symptoms. For each ROC curve, we calculated the area under the curve, which is a measure of the probability that the test will allow correct classification for the presence of symptoms. Results: During the study period, 467 patients completed the questionnaire and underwent standardized pelvic
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
examination. The mean age of the patients was 62.0 years (range, 21–99 years). Three hundred ninety-four patients (84.4 %) were postmenopausal. Median parity was 3 (range, 1–11). Forty-eight patients (10.3 %) were nulliparous. Two hundred eighty-six patients (60.2 %) reported the feeling of a bulge in the vagina. Two hundred ninety-five patients (63.2 %) reported stress urinary incontinence; 235 patients (50.3 %) reported urgency urinary incontinence; 235 patients (50.3 %) reported voiding difficulty; and 202 patients (43.2 %) reported anal incontinence. Moderate correlations were found between the vaginal bulge feeling and the increasing severity of anterior and apical compartments prolapse (Table 1). Weak correlations were demonstrated between voiding difficulty and point Ba and point C. Weakly inverse correlations were observed between the increasing severity of all compartment prolapse and frequent urination. For all eight pelvic floor symptoms, the area under the ROC curve was significantly greater than 0.7 in the vaginal bulge feeling and point Ba and point C, suggesting a reasonable ability to predict symptomatic patients. The sensitivity and specificity of the symptom were 82 and 52 % when point Ba was at the hymenal remnant. While they were 61 and 71 % when point C was 4 cm above the hymenal remnant. Table 1 Correlations between pelvic floor bother symptoms and POP-Q findings Symptoms
Ba
C
Bp
1. Stress urinary incontinence
−0.064
−0.084
−0.034
2. Frequent urination
0.156*
0.126*
−0.093*
3. Urgency
−0.073
−0.022
−0.080
4. Urgency urinary incontinence
−0.041
−0.049
−0.047
5. Voiding difficulty
0.141*
0.111*
0.034
6. Vaginal bulge
0.451*
0.379*
0.239*
7. Defecatory difficulty
0.123*
0.085
0.130*
8. Anal incontinence
−0.119*
−0.083
−0.057
Data are expressed as correlation coefficient of Pearson’s correlation *p<0.05 Conclusions: The significant correlations of vaginal bulge feeling and voiding difficulty and point Ba and point C from POP-Q measurement were demonstrated. The specific threshold for vaginal bulge feeling appeared to be at the hymen for anterior vaginal wall prolapse, whereas it was 4 cm above the hymen for apical prolapse. Disclosure Block: Jittima Manonai: No disclosures. Rujira Wattanayingcharoenchai: No disclosures. Sirirat Sarit-apirak: No disclosures.
S79
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
OP 004 EFFECTS OF PELVIC FLOOR MUSCLE TRAINING AND PESSARY TREATMENT IN WOMEN ≥55 YEARS WITH AN ADVANCED PELVIC ORGAN PROLAPSE C. M. PANMAN, M. WIEGERSMA, B. J. KOLLEN, M. Y. BERGER, Y. LISMAN - VAN LEEUWEN, J. H. DEKKER; Univ. of Groningen, Univ. Med. Ctr., Groningen, Netherlands Introduction: Pelvic organ prolapse (POP) is a common disorder in older women. Treatment includes pelvic floor muscle training (PFMT), pessary treatment or surgery. For many older women with POP conservative treatment may be the best option, because co-morbidity and frailty can make surgery undesirable. However, PFMT and pessary treatment have not directly been compared. Objective: To investigate the effect of PFMT compared to pessary treatment in women aged ≥55 years with an advanced POP. Methods: For this RCT, women aged ≥55 years were recruited in 20 Dutch primary care practices. Exclusion criteria were current POP treatment or treatment in the past year, current treatment for another gynecological disorder, malignancy of pelvic organs, impaired mobility, severe/terminal illness, cognitive impairment, and insufficient command of Dutch language. Women who screened positive for ≥1 pelvic floor symptoms underwent a physical examination. Women with an advanced POP (leading edge at/beyond the hymen) were randomized to PFMT or pessary treatment. All participants gave written informed consent. PFMT was adjusted to the need of each patient and was given by a registered pelvic physiotherapist. Pessaries were fitted by a trained research physician. Follow-up was scheduled after 3 months of treatment. Women in whom a pessary fit could not be achieved were excluded. Primary outcome was change in pelvic floor symptoms, measured with the Pelvic Floor Distress Inventory-20 (PFDI-20, range 0–300)1. Secondary outcome was change in POP-Q stage2. Pessaries were removed 24 h before the POP-Q measurement. To test the difference in PFDI-20 scores within each group (baseline versus 3 month follow-up score) a paired samples t-test was used after square root transformation of the data to obtain normal distribution. A ≥25 % reduction in PFDI-20 score was considered to be clinically relevant. An independent samples t-test was used to compare mean PFDI-20 difference scores between groups. A ≥25 % difference was used as the minimal clinical relevant difference between groups. Fisher’s Exact tests were used to compare the number of participants who had improved ≥1 POP-Q stages between groups. A significance level of p<0.05 was used for all tests. In this abstract the results of complete case analyses (both baseline data and follow-up data available) are presented. Results: 160 women were randomized (PFMT n=79, pessary n=81). A pessary was fitted successfully in 47/81 (58 %) women. Baseline characteristics are shown in Table 1.
Table 1 Baseline characteristics
Mean age ± SD (years) Mean BMI ± SD (kg/m2) Mean parity ± SD Previous hysterectomy (%) PFDI-20 score; mean ± SD*
PFMT (n=79) 65.6±6.4 26.7±4.2
Pessary (n=47) 65.9±8.0 25.6±3.6
2.6±1.1 10 (12.7) 62.4±35.7
2.5±0.9 7 (14.9) 54.2±27.1
* Complete cases only Mean follow-up time was 3.4±0.8 months after start of treatment for patients receiving PFMT and 3.3 ± 0.8 months for women in whom a pessary was fitted successfully. Complete case analyses (PFMT n=65; pessary n=42) showed an improvement in PFDI-20 score in the PFMT group (mean difference −7.6±31.4 points (12.2 %); p=0.01). This improvement was significant but not clinically relevant. There was no improvement in symptom score in the pessary group (mean difference −4.3±27.4 points (8.0 %); p=0.24). The difference in improvement between the two groups was not significant (mean difference −0.52; 95 % CI −1.39 0.35; p= 0.58). Table 2 shows the distribution of anterior wall, posterior wall and apical POP in each treatment group at baseline. POP-Q measurements at both baseline and follow-up were available for 69 patients in the PFMT group and for 42 in the pessary group. In the PFMT group more patients showed improvement of ≥1 POP-Q stage(s) in the anterior compartment (26.5 % vs. 7.1 % in the pessary group, p=0.013). There was no difference in improvement in posterior and apical compartments (Table 3). Table 2 Numbers of patients with anterior wall, posterior wall and uterus/vault prolapse in each treatment group at baseline [frequency; (%); n] PFMT (n=79)
Pessary (n=47)
Anterior wall prolapse
74
47
Posterior wall prolapse Uterus/vault prolapse
47 26
28 20
Table 3 Number of patients with improvement of ≥1 POP-Q stage(s) between baseline and follow-up [frequency; (%)] Compartment Anterior
PFMT (n=69) 18 (26.5)†
Pessary (n=42) 3 (7.14)
p-value* 0.013
Posterior
13 (18.8)
Uterus/vault
8 (11.8)†
5 (11.9) 8 (19.5)†
0.43 0.28
*
Fisher’s Exact Test 1 missing Conclusions: In women aged ≥55 years with an advanced symptomatic POP, PFMT results in a significant but not clinically relevant improvement of pelvic floor
†
S80
symptoms after 3 months. There was no difference between PFMT and pessary treatment. PFMT was more effective in improving anterior wall POP than pessary treatment. References: 1. Am J Obstet Gynecol 2005;193(1):103–13 2. Am J Obstet Gynecol 1996;175(1):10–7 Disclosure Block: Chantal Panman: No disclosures. Marian Wiegersma: No disclosures. Boudewijn Kollen: No disclosures. Marjolein Berger: No disclosures. Yvonne Lisman - Van Leeuwen: No disclosures. Janny Dekker: No disclosures.
OP 005 OPTIMIZING SACRAL FIXATION OF MESH: COMPARISON OF SURGICAL TECHNIQUES A. AKL1, L. I. VORONOV 2, M. MURIUKI 2, R. HAVEY 2, A . PAT WA R D H A N 2 , T. VA N D E N B O O M 3 , L . BRUBAKER 4, C. M. FITZGERALD 5, E. R. MUELLER 4; 1 Loyola Univ. Med. Ctr. Stritch Sch. of Med., Maywood, IL, 2 Orthopedic Surgery Muskoloskeletal Research Laboratory, VA, Maywood, IL, 3Pathology, Loyola Univ. Med. Ctr. Stritch Sch. of Med., Maywood, IL, 4Loyola Univ. Chicago Stritch Sch. of Medici, Maywood, IL, 5Loyola Univ. Chicago Med. Ctr., Maywood, IL Introduction: Sacrocolpopexy is a gold standard procedure for correction of vaginal vault prolapse1. When sacrocolpopexy apical failures occur, it is usually due to the mesh pulling off the vaginal wall. However, the other failure site can be the sacral promontory (SP). In this study, we measure the forces associated with failure at the SP. Objective: Our three objectives\s were to 1) measure the force needed to cause failure at the SP (L5-S1) and at S2, 2) describe the dependency between suture number, suture passes and mesh folds on the force needed to cause failure at the SP, and 3) compare how the forces differ for two different types of polypropylene mesh. Methods: A fresh frozen human female cadaveric lumbosacral specimen without known or radiologic spinal pathology was mounted on a metal apparatus and secured from the posterior aspect using cement and iron screws. Sacral sutures were placed at the level of L5-S1 and at S2 at a depth of 2 mm and a width of 10 mm in the mid-anterior longitudinal ligament (ALL). Suture placement was standardized only in the ALL to avoid the disc. The pull-out force direction was calculated to be 10° anteriorly at L5-S1 and 41° posteriorly at S2 based on the direction, angle, and distance of the apex
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
of the vagina to the sacral promontory and S2 on published MRI studies in women after hysterectomy. We tested a single suture (Gore-Tex® THX 22 on a CV-2 needle) with two meshes, Vertessa™ Lite (Caldera Medical, Inc, Orem, Utah) and Mpathy® (Restorelle™, Raynham, MA). We measured pull-out force and mesh stiffness with one vs two sutures and one vs two passes through the mesh, as well as with unfolded and single folded mesh. After testing, sections of the specimen at L5-S1 and S2 were taken to the pathology lab for histology and measurement of ALL maximum thickness. Results: The pull-out force of the ALL varied by sacral level: at S2, the pull-out force was 12.9 Newton (N) and the suture tore through the ALL; however, at L5-S1, the ALL remained intact and the suture broke at 81 N. Table 1 shows the pull-out forces (N) for mesh 1 and 2 under the various conditions described in methods In all scenarios at L5-S1, the mesh failed instead of the suture attachment or the ALL. The weakest pull-out force for mesh was 27 % with the maximum never exceeding 68 % of the L5-S1 suture pull-out force. Most (15/16) mesh scenarios resulted in the mesh tearing around the suture at a force lower than 56 % of the Gore-Tex® single suture pull-out force. The ALL and Gore-Tex® sutures remained intact during all mesh testing at the SP.
Conclusions: Several surgical techniques are associated with stronger sacral mesh attachment during sacrocolpopexy. 1) 2 passes of suture through the mesh 2) Doubling or 2 separate pieces of mesh for the anterior and posterior wall 3) 2 sutures. This information, combined with new information regarding ALL thickness, suggests that surgeons performing sacrocolpopexy should consider incorporating a double thickness of
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
mesh with 2 passes and at least 2 sutures to reduce the risk of sacral failure. References: Obstet Gynecol. 2004; 104: 805–823. Disclosure Block: Ahmed Akl: No disclosures. Leonard Voronov: No disclosures. Muturi Muriuki: No disclosures. Robert Havey: No disclosures. Avinash Patwardhan: Spinal Kinetics, Inc.: Speaker, Honoraria. Aesculap Implant Systems: Consultant, Consulting Fee. Timothy Vandenboom: No disclosures. Linda Brubaker: No disclosures. Colleen Fitzgerald: No disclosures. Elizabeth Mueller: Astellas: Scientific Medical Advisor, Consulting Fee. Allergan: Speaker, Honoraria.
OP 006 APICAL SUSPENSION AT THE TIME OF HYSTERECTOMY FOR UTEROVAGINAL PROLAPSE: A COMPARATIVE ANALYSIS OF 2001 AND 2011 C. O. HUDSON, D. R. KARP, T. L. LOUCKS, G. M. NORTHINGTON; Emory Univ. Sch. of Med., Atlanta, GA Introduction: It is well established that hysterectomy alone is not adequate treatment for the surgical repair of pelvic organ prolapse. Yet the rate at which women with uterovaginal prolapse undergo apical suspension at the time of hysterectomy is largely unknown. Objective: The primary aim of this study was to compare the rate of concomitant apical suspension in women with uterovaginal prolapse undergoing hysterectomy in 2001 and 2011. A secondary aim was to identify factors associated with receiving concomitant apical suspension in 2001 and 2011. Methods: The Nationwide Inpatient Sample is the largest all-payer inpatient dataset in the United States. This database was queried for women with a diagnosis of uterovaginal prolapse who underwent hysterectomy in 2001 and 2011 as identified by ICD-9 diagnosis and procedure codes. Patients were divided into those who did or did not undergo concomitant apical suspension [ICD-9 codes 69.2 (repair of uterine supporting structures) and 70.77/70.78 (vaginal suspension and fixation with or without graft/prosthesis)]. The rates of concomitant apical suspension with hysterectomy in 2001 and 2011 were compared. Factors potentially associated with receiving concomitant apical repair (age, race, income level, route of hysterectomy, and specific hospital characteristics) were evaluated using univariable analysis and multivariate logistic regression for both 2001 and
S81
2011. Variables are presented as means ± standard deviations or numbers (percentages). Results: A total of 19,030 women were included in the analysis (8,510 in 2001 and 10,520 in 2011). In 2011, 3,431 (32.6 %) women receiving a hysterectomy had an apical apical suspension versus 894 (10.5 %) in 2001 (OR 4.12, 95 % CI 3.80–4.47, p<0.0001). In 2001, the mean age in the study cohort was 53.8±14.1 years compared with 56.8± 13.3 years in 2011. Racial distributions were 4,704 (79.4 %) Caucasian, 693 (11.7 %) Hispanic, and 234 (3.9 %) AfricanAmerican in 2001 and 7,022 (75.9 %) Caucasian, 1,307 (14.1 %) Hispanic, and 476 (5.1 %) African-American in 2011. In 2001, routes of hysterectomy were 5,868 (69.0 %) vaginal, 1,593 (18.7 %) abdominal, and 1,046 (12.3 %) laparoscopic and in 2011 were 6,833 (65.5 %) vaginal, 1,076 (10.2 %) abdominal, and 2,585 (24.6 %) laparoscopic. Although the vaginal route was the most common in both years, a concomitant apical suspension was performed more often with abdominal or laparoscopic hysterectomy in both years (p<0.001). In 2001, apical suspension was performed most commonly during abdominal hysterectomy [319(20.0 %)] followed by laparoscopic [103(9.5 %)] and vaginal [472(8.0 %)]. In contrast, the rates of apical suspension in 2011 were [478(44.4 %)] of abdominal, [1136(44.0 %)] of laparoscopic, and [1815(26.5 %)] of vaginal hysterectomies. In both 2001 and 2011, the majority of cases were performed in urban non-teaching hospitals [4393(51.6 %) and 4657(44.6 %)], followed by urban teaching hospitals [2559(30.0 %) and 4537(43.4 %)] and rural hospitals [1558(18.3 %) and 1254(12.0 %)]. On multivariate analysis, increasing age, route of hysterectomy (abdominal and laparoscopic), and undergoing hysterectomy at an academic teaching hospital were independently associated with a higher rate of concomitant apical repair in 2001 and 2011. (Table 1) Patients with median income >$63,000 were more likely to receive an apical suspension in 2011. In 2001, patients in the South were more likely to have concomitant apical repair; however, in 2011, patients in the South were less likely than other regions in the country to undergo an apical repair. Conclusions: Women with uterovaginal prolapse were more likely to receive hysterectomy with concomitant apical suspension in 2011 than in 2001. However, the overall rate of apical suspension remains low (32.6 %) despite strong evidence for its use. Patients undergoing vaginal hysterectomy were particularly unlikely to receive apical suspension. Several factors including age, income, route of hysterectomy, region, and hospital type are significantly associated with likelihood of concomitant apical suspension. Our findings underscore the need to incorporate evidence based practice into widespread clinical use.
S82
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Table 1 Multivariate Model for Concomitant Apical Repair at the time of Hysterectomy 2001
2011
95 % P value OR 95 % P value CI CI 1.03 1.03–1.04 <0.0001 1.02 1.02–1.03 <0.0001 OR
Increasing Age (1 year) Race (Caucasian*)
1.05 0.78–1.40 0.76
1.14 0.99–1.31 0.07
Non Hispanic/ 1.36 1.02–1.80 0.04 Non Caucasian Median Income**
1.00 0.86–1.18 0.96
Hispanic
Level 3
0.93 0.75–1.15 0.52
0.82 0.72–0.92 0.001
Level 2
1.22 0.96–1.53 0.10
0.60 0.53–0.69 <0.0001
Level 1
1.33 0.81–2.11
0.62 0.54–0.72 <0.0001
0.25
Route of Hysterectomy (Vaginal*) Laparoscopic
1.70 1.31–2.20 0.0001
Abdominal
3.24 2.66–3.95 <0.0001 2.55 2.20–2.95 <0.0001
2.52 2.26–2.81 <0.0001
Hospital Type (Urban Non-teaching*) Urban Teaching
1.25 1.02–1.53 0.03
1.53 1.38–1.69 <0.0001
Rural
0.71 0.51–0.97 0.03
0.49 0.40–0.61 <0.0001
Northeast
0.81 0.59–1.10 0.17
1.17 1.02–1.35 0.03
Midwest
0.93 0.71–1.21 0.59
1.84 1.59–2.12 <0.0001
West
0.62 0.51–0.77 <0.0001 1.98 1.76–2.24 <0.0001
Region (South*)
*Reference values **Reporting differences (>$ 45,000 reference in 2001 and >$ 65,000 in 2011); Level 1 = $1–$24,999 (2001) and $1–$38,999 (2011), Level 2=$25,000–34,999 (2001) and $39,000–47,999 (2011), Level 3=$35,000–44,999 (2001) and $48,000–$62,999 (2011) Disclosure Block: Catherine Hudson: No disclosures. Deborah Karp: No disclosures. Tammy Loucks: No disclosures. Gina Northington: Allmed Healthcare Management, Inc.: Consultant, Consulting Fee.
OP 007 IS THAT A RULER IN YOUR POCKET? A RANDOMISED CROSS-OVER DIAGNOSTIC AGREEMENT TRIAL OF UROGENITAL PROLAPSE ASSESSMENT G. THIAGAMOORTHY1, M. ZACCHE’ 1, L. CARDOZO 1, M. NAIDU 2, I. GIARENIS 1, S. SRIKRISHNA 1, D. ROBINSON 3; 1 King’s Coll. Hosp., London, United Kingdom, 2Croydon Univ. Hosp., Croydon, United Kingdom, 3Kings Coll. Hosp., London, United Kingdom Background: The Pelvic Organ Prolapse Quantification (POP-Q) system has been recommended to quantify
prolapse severity and assess surgical outcome. 1 This quantitative assessment of prolapse is measured using a ruler (e.g. POPstixTM) in centimetres. POPstixTM are costly (US$1/ruler) and home-made devices such as swabs and cervical-smear spatulas are used instead. None of these techniques has been shown to be reproducible and may result in imprecise measurements. 2 Objective: The primary aim of this study was to investigate the reliability and reproducibility of digitally measured POPQ (DPOP-Q) compared to POP-Q measured utilising the POPstixTM method (POPstixTMPOP-Q). The secondary aims were to assess the acceptability of the DPOP-Q method compared to the POPstixTM method in terms of duration of the assessment and discomfort felt by the patient. Methods: This was a prospective, randomised cross-over diagnostic agreement trial. Assessors were required to be confident with the POP-Q system and be able to carry this out using both the POPstixTM and DPOP-Q methods During the preparation for the trial, each assessor was required to measure the index finger of their own dominant/examination hand. This was undertaken by using a 15 cm ruler to measure the distance from the tip of their gloved finger to each interphalangeal joint until their metacarpophalangeal joint. This was verified by an independent observer. Women were recruited from a tertiary urogynaecology clinic between July 2012 and January 2013. All women over the age of 18 years, English literate and able to provide informed written consent were invited to participate. Recruitment has now closed. At visit 1, patients were randomised to either POPstixTMPOPQ assessment in modified lithotomy, or DPOP-Q assessments in both modified lithotomy and standing positions. 3 A second blinded clinician then carried out the remaining examination technique on the same patient. All examinations were carried out at maximum Valsalva with the patient confirming that the descent of the prolapse elicited was the worst they had noted. For each examination, the duration was recorded in seconds and the patient completed a discomfort score using a visual analogue scale. At visit 2, within the next 6 weeks, DPOP-Q assessments of that patient were repeated by the same clinician who undertook the DPOP-Q assessments at the first visit. These visits allowed assessment of inter and intra-observer agreement, calculated using Weighted-Kappa coefficient (κ) and Cronbach’s-alpha(). A priori power calculation at 5 % significance, 80 % power and κ=0.7 vs 0.9 stated a sample size of 88 patients was required to assess agreement between DPOP-Q and POPstixTMPOP-Q examination techniques. Randomisation was carried out using an online random number generator. The assessors had been trained in the use of this online system and would carry out the examination first or second depending on whether the generator drew an odd or even number.
S83
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Ethical approval was obtained from the National Research Ethics Service, Dulwich. Statistical analysis was performed using MedCalc Statistical Software version 12.7.8. Results: In total 109 women were recruited with a median age of 55 years (range: 25–91 years), median parity of 2 (0–6), and a median BMI of 27.1 (18.5– 44.5) years old. 23 women returned for visit 2. Comparing prolapse stage, DPOP-Q had an excellent inter-observer reliability with POPstixTMPOP-Q (κ = 0.94, 95 % CI [0.878–0.996]) (see Table 1). Intraobserver reliability was also very high (lying=0.96 and standing=0.95). DPOP-Q was significantly quicker (p= 0.02) and caused significantly less discomfort (p <0.01) than POPstixTMPOP-Q (see Table 2). Standing increased the prolapse by 1 stage in 18.7 % of cases. Table 1: Inter-observer reliability of DPOP-Q compared to POPQ using the POPstix™ method (both in modified lithotomy) Location POP-Q point
Prolapse stage
Weighted kappa (k)
95 % confidence interval
Standard error
Aa
0.943
0.907–0.980
0.019
Ba
0.925
0.867–0.983
0.030
C
0.804
0.729–0.879
0.038
GH
0.804
0.720–0.888
0.043
PB
0.741
0.627–0.854
0.058
TVL
0.669
0.573–0.764
0.049
Ap
0.920
0.873–0.968
0.024
Bp
0.697
0.599–0.795
0.050
D
0.912
0.859–0.965
0.027
Anterior wall Cervix/ Vault Posterior fornix Posterior wall Ordinal
0.966
0.929–1.000
0.019
0.722
0.588–0.857
0.069
0.803
0.710–0.896
0.048
0.907
0.847–0.967
0.031
0.937
0.878–0.996
0.030
Conclusion: DPOP-Q lying and standing is an easy to perform, acceptable, cheap and quick assessment of prolapse. These findings demonstrate its reliability and reproducibility in clinical practice. References: 1. Am J Obstet Gynecol. 1996 Jul;175(1):10–7. 2. http://www.popstix.co.nz/ 3. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Sep;19(9):1303–7 Disclosure Block: Ganesh Thiagamoorthy: Astellas: Subsidy to attend IUGA 2013, Travel Grant. Martino Zacche’: No disclosures. Linda
Cardozo: Allergan: Speaker, Honoraria. AMS: Consultant, Consulting Fee. Astellas: Board Member, Consulting Fee. Pfizer: Scientific Medical Advisor, Grant/Research Support. Madhu Naidu: No disclosures. Ilias Giarenis: No disclosures. sushma Srikrishna: Astellas: Speaker, Honoraria. Dudley Robinson: Astellas: Advisory Committee Member, Honoraria. Pfizer: Consultant, Honoraria. Allergan: Consultant, Honoraria. Ferring: Consultant, Grant/Research Support. SEP: Speaker, Honoraria.
OP 008 RATES OF COLPOPEXY AND COLPORRHAPHY AT THE TIME OF HYSTERECTOMY FOR PROLAPSE P. S. FAIRCHILD1, M. B. BERGER 2, D. M. MORGAN 2; 1 Obstetrics and Gynecology, Univ. of Michigan, Ann Arbor, MI, 2Univ. of Michigan, Ann Arbor, MI Introduction: Pelvic organ prolapse (POP) is the most common indication for hysterectomy in postmenopausal women1. Evaluating and addressing apical support at the time of hysterectomy for POP is recognized as an important aspect of care2, especially as recurrence rates are higher for women who do not have an apical suspension at the time of their surgery for POP3. Objective: The objective of this study was to determine rates of colporrhaphy and/or apical suspension when a hysterectomy was performed for POP. We also sought to identify factors that may influence the selection of concomitant procedures for POP at the time of hysterectomy. Methods: This is a case–control study of hysterectomies performed for prolapse. We used a collaborative surgical quality database containing data on a random sample of hysterectomies from 52 participating hospitals. We extracted cases from January to December 2013. Inclusion criteria were age greater than 18 years and POP as the surgical indication, identified by ICD-9 code. Route of hysterectomy and concomitant prolapse-specific procedures were identified by CPT codes. Subjects were stratified into groups based on surgical treatments: hysterectomy alone, hysterectomy with colporrhaphy, and hysterectomy with colpopexy. Preoperative and intraoperative factors along with postoperative complications and surgeon specialty were compared between groups using Chi squared tests. Factors predictive of choice of intervention were entered into a multivariable logistic regression model to identify characteristics independently predictive of surgical intervention. Results: POP was the indication for 15.7 % (946) of the hysterectomies in the collaborative. A hysterectomy with no other procedures was performed in 43.4 %, hysterectomy with colporrhaphy in 34, and 22.5 % had apical suspension with hysterectomy. Most of the apical suspensions were sacral
S84
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
colpopexies (39 %), followed by intraperitoneal colpopexies (36.6 %), and extraperitoneal colpopexies (24.4 %). The majority of the hysterectomies for POP were performed by general Ob/Gyns (91 %). Urogynecologists performed 7.2 % and other surgeons performed the remainder (1.8 %). Patient demographics are presented in Table 1. Bivariate analyses were used to identify factors significantly associated with apical suspension. Increasing age, hypertension, and laparoscopy (with or without robot-assistance) were all significantly associated with higher rates of colpopexy (Table 1). Women having surgery with a Urogynecologist were more likely to have apical suspension (73.5 % vs. 18.7 %, p<0.001). Complication rates were low overall and similar amongst women who had hysterectomy alone versus additional procedures (Table 2), although surgical times were significantly longer for concomitant hysterectomy and apical suspension. Multivariable regression was used to identify independent predictors of colpopexy at the time of hysterectomy. The final model includes age and surgery performed by a Urogynecologist (Table 3).
Table 2 - Intraoperative Factors
Urogynecologist performing procedure Type of hyst Abdominal Laparoscopic Vaginal
Hyst Only 3.6(15)
Hyst and Hyst and Colporrhaphy Colpopexy 1(3) 23.5(50)
10.2(42) 5.6(23) 4.2(172)
10.5(6/57) 24.7(18/73) 45.4(217/ 478) 45.2(38/84)
LAVH
9.2(38)
Robotic
33.1(136) 17(43/254)
p <0.001
15.8(9/57) <0.001 43.8(32/73) 18.6(89/ 478) 9.5(8/84)
Intraop Bladder Injury 2.4(1)
0
29.5(75/ 254) 9.4(2)
Intraop Bowel Injury Intraop Hemorrhage
4.9(2) 2.4(1)
3.1(1) 0
0 0
0.591 0.518
Intraop Ureter injury Intraop Vascular injury Intraop other complication Surgical Time
0 0
3.1(1) 3.1(1)
4.7(1) 0
0.429 0.379
2.4(1)
1.2(4)
4.7(1)
0.226
EBL
Table 1. Patient Factors
127.7± 121.15±57.4 168.19± 74.2 72.4 150±199 139.54± 144.63± 131.4 115.2
0.157
<0.001 0.684
Data presented as % (n/N) or mean ± S.D.
Parity
Hyst Only 52.5± 13.6 2.5±1.5
2.7±1.3
0.386
White race (%)
86.3(355) 89.4(288)
90.1(192)
0.374
COPD CAD
3.4(14) 3.9(16)
39.5(15/38) 32(16/50)
23.7(9/38) 36(18/50)
0.682 0.052
Abnormal Cr
2.4(1)
50(1/2)
0
0.735
DVT
9.7(4)
58.8(10/17)
17.7(3/17)
0.087
Dyspnea
4.1(17)
34(18/53)
34(18/53)
0.085
Functional Status Independent HTN
99.3(408) 99(319)
98.6(210)
0.446
34.8(143) 43.5(140)
41.3(88)
0.045
Normal BMI
28.3(115) 27.8(88)
28.4(60)
Overweight
32.8(133) 36.2(115)
39.6(84)
Obese <40
32(130)
31.3(99)
27.8(59)
>40
6.9(28)
4.7(15)
4.2(9)
Age (years)
Hyst and Colporrhaphy 58.61±12.3 2.6±1.5
Hyst and Colpopexy 59.4±21.1
Obese
p <0.001
0.528
Sleep Apnea No
94.4(388) 96.3(310)
93.9(200)
Without CPAP
3.4(14)
2.5(8)
3.8(8)
With CPAP Smoker
2.2(9) 20(82)
1.2(4) 16.5(53)
2.3(5) 15.5(33)
0.733
0.290
Data presented as mean ± standard deviation (S.D.), median (interquartile range), or % (n/N).
Table 3. Multivariable Analysis p value
1.2
95 % Confidence Interval 1.1–1.4
11.5
6.5–20.3
<0.001
Factor
Odds Ratio
Age (per decade) Surgeon Specialty Urogynecologist (compared to all other specialties)
0.003
Conclusions: Less than a quarter of women undergoing hysterectomy for POP receive concomitant colpopexy. As the prevalence of POP rises with increasing age, it is not surprising that older age is a significant predictor of inclusion of colpopexy. However, the differences in practice patterns noted do not appear to be related to other demographic factors, comorbidities, or socioeconomic status. There is significant variation in utilization of colporrhaphy and colpopexy depending on surgeon speciality, with Urogynecologists being more than 11 times more likely to perform a colpopexy when compared with other surgeons. Further research is needed to better understand the value and long-term consequences of these differences on patient satisfaction, anatomic outcomes and cost-effectiveness of procedures for treating POP.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
References: 1. Lancet 2007;369:1027–38. 2. Obstet Gynecol 2007;110:717–29. 3. Obstet Gynecol 2013;122:981–7. Disclosure Block: Pamela Fairchild: No disclosures. Mitchell Berger: No disclosures. Daniel Morgan: Up to Date: Author, Royalty. France Foundation: Author, Royalty.
OP 009 A MESH-RECALL IN RESPONSE TO THE FDA-REPORT; A SINGLE CENTER REPORT C. R. KOWALIK, M. M. LAKEMAN, J. E. ORYSZCZYN, J. W. ROOVERS; Obstetrics and Gynecology, Academic Med. Ctr., Amsterdam, Netherlands Introduction: The use of synthetic mesh implants for vaginal prolapse surgery is subject of debate. After the FDA announcement the use of vaginal mesh has been criticized, physicians have stopped to propose mesh surgery to their patients, and patients who were offered mesh surgery asked for safer alternatives. There is a discrepancy between the reported outcomes of many trials evaluating mesh surgery and the perceived efficacy and safety of mesh surgery. This discrepancy might be explained by the differences in patient characteristics of a population included in a clinical study, where patients with an increased risk on adverse outcome are excluded, and the characteristics of those that we operate in daily clinical practice. As a large tertiary referral center, we felt that after the commotion of the FDA report, we could no longer offer mesh surgery, without being informed about our own results. We decided to perform a “mesh-recall” of all patients operated between 2007 and 2012, and planned to evaluate whether such “recall” would be feasible. In the Netherlands patients do not routinely visit a gynecologist on a regular basis, so it is not a given that an invitation to visit the hospital for a checkup is positively responded to. Objective: We intended to review all patients who underwent mesh surgery in our tertiary center in order to objectify the outcome in daily clinical practice and to improve counseling to our patients. Methods: All patients who had undergone a vaginal synthetic mesh implant for POP in our tertiary centre, between 2007 and 2012, were included. This results in a long follow up and gives a good estimate of mesh surgery in daily practice in our center. “Mesh kits” used were Perigee™, Apogee™, Elevate® Anterior and Elevate® Posterior.
S85
In 2013 all patients were invited to visit the clinic to have a clinical examination and to fill out validated quality of life questionnaires. Patients were physically examined to assess POP-Q stage and exposure or folding of the implanted mesh. Anatomical recurrence of prolapse was defined as absence of prolapse beyond the hymen in the operated compartment. Subjective quality of life was assessed using the following validated questionnaires: the UDI-6, DDI, IIQ and the PISQ12. Results: In total 189 women were contacted by our investigators. Most women (63 %) were operated with mesh because of recurrence of prolapse. All patients who underwent surgery for primary prolapse participated in a previous study. The standardized questionnaires were completed by 127 women (67 %) and 103 women (54 %) visited the clinic for a physical examination. Median follow up was 40 months (range 12–76 months). During follow up 7 (7 %) women confirmed to have had a re-operation because of prolapse, 5 (5 %) women underwent an incontinence procedure and 5 (5 %) women were operated because of mesh-related adverse events. 86 % of the responders were satisfied with their treatment and 78 % would recommend vaginal mesh surgery to a friend. In women with a recurrence this was 91 and 74 % respectively. Total recurrence rate was 14 % (14 women) defined as absence of prolapse beyond the hymen. Overall subjective outcomes were good: IIQ median 15 (range 0–74), UDI-6 median 22 (range 0–89), DDI median 11 (range 0–74), PISQ median 13 (range 7–30). No statistical significant differences were noted in UDI, DDI, IIQ and PISQ scores between women with and without recurrence of prolapse. In 11 patients (11 %) an exposure of the mesh was diagnosed at pelvic examination. Seven women were asymptomatic and didn’t require any further treatment. Two women were managed surgically without anesthesia in the outpatient clinic, 1 required surgery due to a combination of exposure and pain when palpating the mesh and in 1 woman exposure was managed during surgery for recurrence of prolapse. Conclusions: This study pictures the outcome of mesh surgery in a tertiary center. Since it concerns a “total recall” it gives excellent insight in the surgical results of daily practice. Although we found a high anatomical recurrence rate of 14 % we can inform patients that quality of life scores did not differ between women with and without an anatomical recurrence and that overall satisfaction rates were high after mesh surgery. Most mesh related complications were solved without remaining symptoms. We recommend our colleagues world-wide to also perform a “total recall” of patients treated with vaginal mesh, to enable counselling future patients based on realistic data rather than on study results gathered in a different setting.
S86
References: N/A Disclosure Block: Claudia Kowalik: Astellas Pharma BV: Input meeting, Consulting Fee. Urogyn BV: Advisory Committee Member, Consulting Fee. Marielle Lakeman: No disclosures. Josephine Oryszczyn: No disclosures. Jan-Paul Roovers: AMS: Scientific Medical Advisor, Grant/Research Support.
OP 010 GETTING THE SIZE RIGHT ARE GYNAECOLOGISTS READY FOR IT M. NAIDU, A. H. SULTAN, R. THAKAR; Department of Urogynaecology and Pelvic Floor Dysfunction, Croydon Univ. Hosp., Croydon, United Kingdom Introduction: Digital evaluation is the most common assessment tool in obstetrics and gynecology. Its uses include cervical dilatation assessment in labor, predicting anal sphincter defects (1,2), evaluation of size of pessaries, and Objective: grading of prolapse. The current recommended assessment method for uterovaginal prolapse is POPQ using speculum and POPstix. However this assessment is found to be technically difficult and time consuming (3) and therefore in clinical practice, many clinicians use digital assessment to stage of prolapse. Objectives: Firstly we aimed to evaluate the accuracy of clinicians’ perceived length of their index finger, anal sphincter length and cervical dilatation assessment. Secondly our aim was to define the average length of index finger and evaluate if there was any difference in the accuracy according to seniority. Methodology: As part of the hands-on perineal traumatraining course, delegates were asked to participate to get their index finger measured. This was a feedback exercise to make them aware of their length of index finger. During this self-evaluation, the delegate’s index finger was measured against a measuring scale and was fed back after training. Using a disposable tape, three markings were made on the back of a paper tape measure corresponding to the 1st, 2nd and 3rd crease of the index finger and the clinician was asked to state the length of these markings. The markings were then measured against a measuring tape to obtain the actual measurement. Each delegate was asked to examine a model simulating the anal sphincter and measure the length of anal sphincter using the index finger. The length of the anal sphincter model was 3.5cms. These delegates were also asked to assess cervical dilatation using the midwives-training model. The dilatation was standardized to 7 and 9 cms. The data was analysed using SPSS v21. Intraclass correlation test was used to assess actual agreement between the
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
measured and actual values. One-way ANOVA was used to compare between the different groups. Results: A total of 180 delegates participated (99 junior trainees, 43 senior trainees, 19 midwives, 10 consultants and 9 level of training undisclosed). The normal length of the index finger ranged from 6 to 8.6 cms (mean 7.2 cms, SD 0.597). Overall there was poor agreement in the measurements for anal sphincter length, length of finger (1st crease, 2nd crease and 3rd crease) and cervical dilatation assessment (Table 1). The accuracy (with allowance of 20 % error) is shown in Figure 1. The accuracy improved with increasing length. There was no significant difference in the self-assessment amongst consultants, midwives, senior and junior trainees as shown in Table 1. Conclusion: This clinical observation shows the normal range of length of index finger. It also demonstrates poor personal perception of the length of index finger and poor correlation against the length of anal sphincter and cervical dilatation. This highlights that gynaecologists need to be aware of the length of their index finger to provide accurate assessment of gynecological examinations. This would help to provide accurate measurements that can be reproducible and provide good intra and inter observer reliability in applied in clinical practice and research. Reference: 1. Am J Obstet Gynecol 2004; 191:1797–1799 2. Int Urogynecol J. Jun;23(6):755–63 3. Int Urogynecol J. Jun;22(6):645–50. Table 1: Results of accuracy and comparison between the groups.
Perceived length of anal sphincter Perceived distance up to 1st crease Measured distance up to 1st crease Perceived distance up to 2nd crease Measured distance up to 2nd crease Perceived distance up to 3rd crease (Observed) Measured distance up to 3rd crease Perceived dilatation at 7 cms Perceived dilatation at 9 cms
Mean
SD
Accuracy
3.19
0.94
15(8.3 %)
Accuracy (20 % error) 71 %
Intraclass correlationa 0.000
2.06
0.51
(19.4 %)
44 %
0.191
2.42
0.23
4.17
0.99
4.63
0.39
18 (10 %)
39(21.7 %)
57 %
65 %
0.143
6.56
1.59
7.22
0.51
0.215
5.84
1.22
39 (21.7 %)
64 %
0.000
8.48
1.18
58 (32.2 %)
80 %
0.000
CIa
Fb
Sigb
−0.146– 0.146 0.047– 0.328
0.106
0.957
−0.003– 0.283
0.071– 0.350
−0.146– 0.146 −0.146– 0.146
1.298
0.277
3.513
0.17
0.701
0.553
1.337
0.264
1.916
0.129
1.234
0.299
1.270
0.286
0.868
0.459
a - Intraclass correlation test b - oneway ANOVA Disclosure Block: Madhu Naidu: No disclosures. ABDUL SULTAN: No disclosures. RANEE THAKAR: No disclosures.
S87
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
OP 011 DO PATIENT CHARACTERISTICS IMPACT THE RELATIONSHIP BETWEEN VAGINAL BULGE SYMPTOMS AND ANATOMIC PROLAPSE? J. T. KOWALSKI1, G. HEREDIA MELERO 1, A. MAHAL 1 , R. GENADRY 1, C. S. BRADLEY 2; 1 Obstetrics and Gynecology, Univ. of Iowa, Iowa City, IA, 2 Univ. of Iowa, Iowa City, IA Objective: Our objectives were to identify patient characteristics associated with the symptom of a vaginal bulge and to determine if those characteristics impact the relationship between symptoms and anatomic prolapse. Background: Past research has found that seeing or feeling a vaginal bulge is the most specific symptom for identifying pelvic organ prolapse (POP). The absence of bulge symptoms has been associated with subjective improvement after POP surgery to a greater extent than anatomic results alone (1). Thus, self-reported bulge symptoms are used for diagnosis and to assess treatment response. However, it is unclear if patient characteristics are associated with vaginal bulge symptoms and whether these modify the relationship between symptoms and exam findings. Methods: A cross-sectional analysis was performed using data from patients presenting to a Urogynecology clinic. Clinical data captured in the electronic medical record from all new patient visits over a 2 year period (2005–6) were previously stored in a database and analyzed for the current study. Patients were evaluated using standardized history and examination forms. Data collected included demographics, symptoms assessed by Pelvic Floor Distress Inventory Short Form 20, medical history and exam findings. Chart review verified key data points. The bulge symptom was identified using the PFDI-20 item, “Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?” Anatomic prolapse was assessed in 2 ways: 1. Dichotomous: prolapse present if beyond the hymen with straining and 2. Ordinal: maximum point of vaginal descent (maximum of C, D, Ba or Bp). Patient characteristics were compared in those who did and did not report a vaginal bulge using chi-squared, Wilcoxon rank-sum and t tests. Characteristics associated with vaginal bulge at p<=0.10 were entered in logistic regression models (predicting bulge (yes/ no)). Interactions between patient characteristics and prolapse were tested to determine if patient factors modified the association between anatomic prolapse and symptoms. Receiver operator characteristic (ROC) curves were created to test whether patient factors modified the association between maximum vaginal descent and bulge symptoms. Results: 685 patients were included with mean age 58.5 years (range 19–97). Mean (SD) BMI was 30.2 kg/m2 (7.5) and median (range) vaginal parity 2 (0–10). 298 (43.5 %) and 157
(22.9 %) had prior hysterectomy and prolapse surgery, respectively. Patients reporting a vaginal bulge were slightly older, more likely postmenopausal, had greater parity and BMI. They were more likely to report prior prolapse surgery (p<0.05 for all) and more often s/p hysterectomy (p=0.10). In multivariable analysis, prolapse (descent beyond hymen; OR (95 % CI) 23.8 (14.3, 39.7)), age group (older women less likely to report bulge (>=70 vs. <55 years; OR (95 % CI) 0.45 (0.26, 0.77)) and vaginal parity (>=3 and 1–2 vs. 0, OR (95 % CI) 4.5 (2.1, 9.5) and 3.0 (1.4, 6.4), respectively) were associated with the bulge symptom. The ROC area under the curve (AUC) was 0.87 (95 % CI 0.84, 0.90), suggesting good predictive value of maximal vaginal descent for the vaginal bulge symptom. The AUC for the youngest women (<55 years) was lower than for middle and older age groups (p<0.01) (Figure). Conclusions: Age and vaginal parity were independently associated with the vaginal bulge symptom. In this population, the level of vaginal descent did not predict the bulge symptom as accurately in younger compared to older patients. Vaginal bulge symptoms are increasingly used as important outcomes, and more research is needed to better understand relationships between patient characteristics, bulge symptoms and exam findings. References Obstetrics & Gynecology. 2009. 114(3), 600–609. Disclosure Block: Joseph Kowalski: No disclosures. Gerardo Heredia Melero: No disclosures. Amandeep Mahal: No disclosures. Rene Genadry: No disclosures. Catherine Bradley: No disclosures.
OP 012 FUNCTIONAL CHARACTERISTICS OF VAGINAL FIBROBLASTS FROM PREMENOPAUSAL WOMEN WITH PELVIC ORGAN PROLAPSE A. M. RUIZ-ZAPATA1, M. H. KERKHOF 2, B. ZANDIEHDOULABI 3, H. BROLMANN 2, T. H. SMIT 1, M. N. HELDER 1; 1 Orthopedic Surgery, VU Univ. Med. Ctr. Amsterdam, Amsterdam, Netherlands, 2Obstetrics & Gynecology, VU Univ. Med. Ctr. Amsterdam, Amsterdam, Netherlands, 3 Oral Cell Biology, ACTA - Univ. of Amsterdam and VU Univ., Amsterdam, Netherlands Introduction: Pelvic organ prolapse (POP) affects the quality of life of women world-wide, and remains a great therapeutic challenge with no optimal treatment. Risk factors are well defined, but the exact pathophysiology is still unclear. New therapies like autologous cell-based tissue engineering may provide
S88
promising alternatives to current treatments. However, it is important to discriminate between acquired and intrinsic defects because for genetic diseases treatments with autologous cells would not be an appropriate therapy. Within POP, cystocele has the least successful clinical management. In the connective tissue layer from the anterior vaginal wall, fibroblasts are the cells in charge of tissue remodeling and extracellular matrix maintenance. Altered cellular functionality may influence tissue quality. Nevertheless the role of fibroblasts in the context of pathogenesis and current treatments for POP is poorly understood. The present study was designed to rule out normal aging tissue degeneration and to identify between intrinsic and acquired cellular defects by evaluating functional characteristics of cells isolated from the prolapsed and non-prolapsed anterior vaginal wall tissues of premenopausal women with and without POP. Objective: To test the hypothesis that fibroblasts derived from prolapsed tissues of patients with cystocele, display altered in vitro functional characteristics compared to non-prolapsed site or healthy controls. Methods: Biopsies were collected from the precervical region (non-POP site) after hysterectomy of eight healthy controls and 10 cystocele cases (POP-Q stage ≥ II). Extra tissues from the prolapsed site were taken in the POP cases. Twenty eight primary fibroblast cultures were studied in vitro. A contractility assay was used to test fibroblast-mediated collagen contraction. Cellular mechanoresponses on collagen-coated or uncoated substrates were evaluated by measuring matrix remodeling factors at protein or gene expression levels. Proliferation was evaluated at different time points. Results: There were no differences between fibroblasts from the controls and the non-POP site of the case group. Fibroblasts from the POP site showed delayed fibroblastmediated collagen contraction (Fig. 1) and lower production of matrix metalloproteinase-2 (MMP-2) on collagencoated plates (Fig. 2B). Mechanoresponses to cyclic mechanical loading on uncoated plates were also different: activation of MMP-2 was more pronounced in cells from non-prolapsed tissues (Fig. 2A and C), whereas upregulation of the genes MMP-2 and its inhibitor (TIMP2) were only seen in POP site fibroblasts. No differences were found in proliferation rates suggesting that the quality and not the quantity of the cells is responsible for the results. Conclusions: Fibroblasts derived from prolapsed tissues of patients with cystocele, display altered in vitro functional characteristics depending on the matrix substrate and compared to non-prolapsed site. This implies an acquired rather than an intrinsic defect and should be
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
taken into account when improving treatments for prolapse. References: N/A
Disclosure Block: Alejandra Ruiz-Zapata: No disclosures. Manon Kerkhof: American Medical Systems: Teaching salesmanagers about urogynaecology, Honoraria. Astellas: Advisory Committee Member, Honoraria. Behrouz Zandieh-Doulabi: No disclosures. Hans Brolmann: No disclosures. Theodoor Smit: No disclosures. Marco Helder: No disclosures.
OP 013 ESTRADIOL AND PROGESTERONE MODULATE TOLL-LIKE RECEPTOR 4 IN CULTURED HUMAN BLADDER EPITHELIAL CELLS R. L. POSTHUMA, S. J. PULLIAM, T. K. BERK, C. E. F O U S T- W R I G H T, M . M . W E I N S T E I N , M . M . WAKAMATSU, M. PHILLIPPE; Massachusetts Gen. Hosp., Boston, MA Introduction: Urinary tract infections (UTI) are the most common bacterial infection in the United States. The innate immune response is the initial defense to bacterial pathogens. Bacterial pathogens such as E coli stimulate the innate immune response by binding to highly conserved pattern recognition receptors (PRR). A large family of PRRs is the Toll-like receptor (TLR). Of these, TLR4 is particularly responsive to gram negative bacteria [1]. Clinical studies show that UTIs are more common in the follicular phase of the menstrual cycle (estradiol dominant) than the luteal phase (estradiol and progesterone dominant) with the lowest rate during menses (low estradiol and progesterone) [2]. Similarly, attachment of E coli
S89
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
to uroepithelial cells is highest in the follicular phase, moderate in the luteal phase, and lowest in menses [3]. Objective: We hypothesized that steroid hormones modulate innate immunity of the urinary bladder through alterations in TLR4 expression and function. We aim to evaluate the interaction of steroids on TLR4 expression directly and functionally by measuring its cytokine product (IL-6) in cultured human bladder epithelial cells. Methods: Human urinary bladder (HUB) cell culture was prepared from a transitional cell carcinoma derived T24 cell line. Cells were incubated in hormone free (HF) media, estradiol (E2) media (at physiologic concentrations), progesterone (P4) media (at physiologic concentration), or combined estradiol-progesterone (E-P) media for 72 h. Lipopolysaccharide (LPS) was added for 0, 6, 24 h. TLR4 expression and stimulated IL-6 production were analyzed with ELISA. BSA protein assays normalized results. Cell cultures under each condition were performed in duplicate; data for replicates are being generated for statistical analysis. Results: Cultured T24 HUB cells expressed TLR4 in HF media at a mean level of 1.2 ng/mg protein. There was a 5fold increase in TLR4 in the presence of E2 (5.9 ng/mg protein at LPS 0 h, 7.1 ng/mg protein at LPS 6 h, 5.1 ng/mg protein at LPS 24 h). There was only a slight increase in TLR4 expression in the presence of P4 (1.4 ng/mg protein at LPS 0 h, 0.9 ng/mg protein at LPS 6 h, 1.9 ng/mg protein at LPS 24 h; mean 1.4 ng/mg protein). In contrast, there was a 2.8-fold increase in TLR4 in E-P (3.8 ng/mg protein at LPS 0 h, 3.4 ng/ mg protein at LPS 6 h, 2.9 ng/mg protein at LPS 24 h; mean 3.4 ng/mg protein) [figure]. The pattern of IL-6 production in cells was similar. With LPS 100 ng/ml × 6 h, IL-6 in HF media was 1519 pg/mg protein. IL-6 increased 63 % in E2 (2479 pg/mg protein) and decreased 25 % from HF in P4 (1142 pg/mg protein). In E-P, IL-6 response was similar to HF (1434 pg/mg protein) [figure]. Conclusions: Our study demonstrated that TLR4 expression and its functional activity (IL-6) appear to be responsive to estradiol and progesterone. Mimicking the follicular phase, the estradiol-only experiments show a 5-fold increase in TLR4 and an increase in IL-6 production. The progesterone-only experiments appear to have little effect on TLR4 and a slight decrease in IL-6 production. In the combined estradiol-progesterone experiments, which mimic the luteal phase, progesterone suppresses estradiol effect, showing only a 2.8 fold increase from baseline in TLR4 and similar effect on IL-6 production. TLR4 presence signals up-regulation of the innate immune response in the presence of bacterial pathogens. High concentration of TLR4 may allow for a robust cytokine response, which may play a role in increasing the rate of symptomatic UTI. Likewise, low TLR4 may dampen the response of the innate immune system thereby lessening the likelihood of a symptomatic UTI. These findings are consistent with clinical
studies [2,3] which show increase risk of symptomatic UTI and increased E coli binding in the follicular phase, moderate prevalence of UTI and E coli binding in the luteal phase, and lower prevalence of UTI and E coli binding during menses. References: 1. Eur J Clin Invest 2008;38(2):21–28 2. Clin Infect Dis 1996;23:635–6 3.J Infec Dis 1983;148(3):412–21
Disclosure Block: Rebecca Posthuma: No disclosures. Samantha Pulliam: No disclosures. Tucker Berk: No disclosures. Caroline FoustWright: No disclosures. Milena Weinstein: No disclosures. May Wakamatsu: No disclosures. Mark Phillippe: No disclosures. OP 014 HOXA 11 AND 13 EXPRESSION IN WOMEN WITH PELVIC FLOOR DISORDER S. KIM, S. PARK, Y. MOON, S. KIM, S. BAI; Obstetrics and gynecology, Yonsei Med. Ctr., Seoul, Korea, Republic of Introduction: Pelvic floor dysfunction (PFD), including stress urinary incontinence (SUI) and pelvic organ prolapse (POP), is a major health problem for elderly women. Although PFD is a highly prevalent disease, the underlying mechanism and basic pathophysiology are poorly understood. Uterosacral ligaments (USLs) are the key structures of the uterus and vagina and are fragile in patients with PFD. Endopelvic fascias in the vagina compose the supportive tissue of the pelvic floor and often are diminished in PFD. The HOXA11 gene controls the development of the lower uterine cervix and vagina. The HOXA13 gene is also responsible for the development of the vagina and regulates extracellular matrix constituents.
S90
Objective: We hypothesized that expressions of HOXA11 in USLs and HOXA13 in the vagina might be decreased in women with PFD. In addition, we investigated quantitative mRNA expression of matrix metalloproteinases (MMPs), collagen І, and collage lll, from PFD and non-PFD patients. Methods: 68 subjects were enrolled for the experimental procedure. Biopsy specimens were obtained from the anterior and posterior apex of the vagina and bilateral USLs from women with no PFD, SUI combined with POP, and POP; from patients with SUI, we took only anterior vaginal specimens by biopsies. Specimens were divided in half. One section was prepared for RT-PCR, and the other half was saved for western blot analysis. RT-PCR and western blots were used to determine HOXA11 and HOXA13 expression and the protein levels. In addition, we performed RT-PCR to compare the expression of MMP2, MMP9, collagen І, and collage lll genes in the vaginal wall and USLs of all enrolled patients. Quantitative data are expressed as mean + SEM and as percentages. The results of relative mRNA expression analysis were compared using the Kruskal-Wallis test for independent ‘k’ samples, complemented when necessary by Dunnett’s multiple comparisons test, to evaluate possible differences between patient groups, for both vaginal wall and USL samples. Statistical analyses were performed with SPSS 19 (SPSS Inc. Chicago, IL, USA) and Graph-Pad Prism 5.0 (GraphPad Software Inc., San Diego, CA, USA). A P value less than 0.05 was considered statistically significant for all data analyzed. Results: We found that the relative HOXA13 mRNA expression in the anterior vaginal wall of SUI patients was 4.3-fold lower compared with that of controls (P= 0.006). In addition, the anterior vaginal wall specimens from patients in the SUI combined POP and POP groups had lower expression of HOXA13 compared with the controls (4.3-fold, P=0.007; 6.3-fold, P<0.001, respectively). In the posterior vaginal wall, the relative mRNA expression of HOXA13 of SUI combined POP and POP patients was lower (3.1-fold, P<0.001; 2.7fold, P < 0.001, respectively) than that of control patients. There were no differences in vaginal expression of HOXA13 between SUI and POP specimens or between specimens obtained from patients with SUI combined POP and patients with only POP. Expression of HOXA11 was 2.3-fold lower in women with POP compared with controls (P=0.004). HOXA 11 expression in USLs was also 2.7-fold lower in SUI combined POP patients compared with controls (P = 0.004); however, there was no statistically significant difference between POP patients and women with SUI combined POP (P= 0.08). Western blot analysis demonstrated the presence of HOXA11 and 13 in the USLs and vagina, although the levels were lower in the POP and/or SUI group compared with controls (P < 0.001). Collagen І and
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
collagen lll expressions were lower in groups of PFD patients than controls. The expression of MMP 2 mRNA in USLs was elevated in POP patients with/without SUI compared to controls, although this alteration was not statistically significant for women with POP. In addition, the change in expression detected for both MMP2 and MMP9 was not statistically significant in samples from the anterior and posterior vaginal wall. Conclusions: Expression of HOXA13 and both collagens in the vagina was reduced in women with SUI, SUI combined POP, and POP compared with control women. Expression of HOXA11 and both collagens in USLs was also reduced in all PFD patients. These reduced levels may contribute to alterations in the biomechanical strength of the pelvic supportive tissue, leading to prolapse or incontinence. A better understanding of the influence of these genes may prove beneficial in defining the underlying etiologies of PFD development and aid in the development of new treatment options. References: 1. Connell KA, Guess MK, Chen H, Andikyan V, Bercik R, Taylor HS. HOXA11 is critical for development and maintenance of uterosacral ligaments and deficient in pelvic prolapse. J Clin Invest 2008;118:1050–5. 2. Connell KA, Guess MK, Tate A, Andikyan V, Bercik R, Taylor HS. Diminished vaginal HOXA13 expression in women with pelvic organ prolapse. Menopause 2009;16:529–33 Disclosure Block: Soo RIm Kim: No disclosures. Su Yeon Park: No disclosures. Yeo Jung Moon: No disclosures. Sei Kwang Kim: No disclosures. Sang Wook Bai: No disclosures.
OP 015 BACTERIAL FILAMENTS ARE MORE COMMON IN DETRUSOR OVERACTIVITY THAN CONTROLS: EVIDENCE FOR INTRACELLULAR BACTERIAL INVASION OF UROTHELIAL CELLS Y. CHENG 1, Z. CHEN 1, W. ALLEN 1, C. MUKERJEE 2, K. VARETTAS 2, K. J. MANSFIELD 3, M. A. SCHEMBRI 4, K. H. MOORE1; 1 Urogynaecology, St George Hosp., Sydney, Australia, 2 Microbiology, St George Hosp., Sydney, Australia, 3 Graduate School of Medicine, Univ. of Wollongong, Wollongong, NSW, Australia, 4 Australian Infectious Diseases Research Centre, School of Chemistry and Molecular Biosciences, The Univ. of Queensland, Brisbane, QLD, Australia Introduction: The aetiology of refractory detrusor overactivity (DO) remains poorly understood. Recently, it has been observed that 30–50 % of DO patients have low count
S91
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
bacterial cystitis [1]. Animal studies and one human study [2] have shown that uropathogenic Escherichia coli can invade, multiply and form intracellular bacterial communities within urothelial cells in the bladder [2]. The end-point of this invasion is characterised by E. coli fluxing out of the urothelial cells as long filamentous chains of bacteria [3]. There have been no studies demonstrating the presence of intracellular bacteria in patients with DO or overactive bladder (OAB). Objective: The aim was to examine urothelial cells isolated from patients undergoing investigation for incontinence for (i) the presence of bacteria associated with urothelial cells and (ii) evidence for the formation of intracellular bacterial communities via the detection of filamentous bacteria. The likelihood of finding filamentous bacteria was compared in patients with urodynamically proven DO, OAB versus stable controls (patients with urodynamic stress incontinence (USI)). In patients where filamentous bacteria were demonstrated, bacteria were also detected with an E. coli-specific antibody. Methods: Urine was collected from a series of 130 women who were undergoing management for incontinence at our tertiary centre, who were able to provide an MSU. The majority had a previous history of UTI. Each urine sample was split, half sent for immediate routine microbiology testing (107 Colony Forming Units (CFU)/L) as cut-off), remainder was centrifuged at 190 g for 10 min and concentrated urothelial cells were fixed (1 % formalin) on microscope slides (cytospin). Cells were then stained with Wright stain to identify bacteria and white blood cells (WBC). Some urothelial cells were also stained by immunocytochemistry using an E. coli antibody (US biological, E3500-06). Comparison of the presence/absence of bacterial filaments in patient groups was undertaken by χ2 analysis. Results: Wright stain of urothelial cells concentrated from urine demonstrated bacteria associated with urothelial cells in 75/130 (57.8 %) women. Bacterial filaments (indicative of intracellular bacterial communities) were observed in 37/85 (43.5 %) of patients (Figure 1A). The filamentous bacteria visualised with Wright stain also reacted positively with E. coli antibody, indicating infection with E. coli (Figure 1B). Bacteria were identified in 57 women with a urodynamic diagnosis, of whom 41 had DO and 16 had USI. Bacterial filaments were significantly more common in women with DO (24/41; 58.5 %) vs those with USI (4/16; 25 %) (P= 0.0229, χ2). A similar comparison was made between women with a clinical diagnosis of OAB (32/59) versus USI (4/16, P=0.0379, χ2). Conclusions: This is the first report to demonstrate the presence of filamentous bacteria (indicative of intracellular bacterial community formation) associated with urothelial cells from patients under investigation for incontinence. The study suggests an increased
prevalence of intracellular bacteria in patients with DO/OAB compared to women with no urgency and a stable bladder. References: [1] Int Urogynecol J. 2011; 22(10):1267–72. [2] PLoS Med. 2007; 4(12):e329. [3] Proc Natl Acad Sci U S A. 2006. 103(52):19884–9.
Disclosure Block: Ying Cheng: No disclosures. ZHUORAN CHEN: No disclosures. Wendy Allen: No disclosures. Chinmoy Mukerjee: No disclosures. Kerry Varettas: No disclosures. Kylie Mansfield: No disclosures. Mark Schembri: No disclosures. Kate Moore: Astellas: Advisory Committee Member, Travel Grant.
OP 016 MULTIPLE DOSES OF MESENCHYMAL STEM CELLS MAINTAIN URETHRAL FUNCTION AFTER SIMULATED CHILDBIRTH INJURY K. JANSSEN 1 , D. L. LIN 2 , B. M. BALOG 3 , B. HANZLICEK 4, C. VAN DER VAART 5, M. S. DAMASER 3; 1 Cleveland Clinic; UMCU, Utrecht, Netherlands; Advanced Platform Technology Ctr., Louis Stokes Cleveland VA Med. Ctr., Cleveland, OH, 2Louis Stock Cleveland VA Med. Ctr., Cleveland, OH, 3 Cleveland Clinic, Cleveland, OH, 4 Cleveland Clinic; Advanced Platform Technology Ctr., Louis Stokes Cleveland VA Med. Ctr., Cleveland, OH, 5 UMCU, Utrecht, Netherlands Introduction: Dual simulated childbirth injury in female rats, consisting of pudendal nerve crush & vaginal distension (PNC + VD), causes a significant decrease in continence as measured with leak point pressure (LPP), mimicking symptoms of stress urinary incontinence (SUI). Mesenchymal stem cells (MSCs), when delivered intravenously (iv), will home to injured tissues and have a systemic nonlocal effect. They have been shown to protect urethral function after pudendal nerve transection[1] and VD[2] in rats, suggesting their therapeutic effects on the urethra after injury to prevent SUI. However, the
S92
dual injury model demonstrates greater injury and a longer recovery time than either injury model alone. Therefore, we hypothesized that increasing the number of doses of MSCs would increase their therapeutic effect in the dual injury model. Objective: The aim of this study was to investigate the effects of increasing the number of doses of MSCs on urethral & pudendal nerve function after dual childbirth injury in female rats. Methods: Twenty-two virgin female Sprague–Dawley rats (225–250 g) underwent PNC + VD. Rats received either 2 million MSCs (passage 8–10) in 1 mL saline via tail vein iv injection 1 h after PNC + VD and iv saline injections 7 days & 14 after injury (n=6), the same dosage of MSCs iv 1 h & 7 days after PNC + VD and saline iv 14 days after injury (n=5), the same dosage of MSCs iv 1 h, 7 days & 14 days after injury (n= 4), or 1 mL saline iv 1 h, 7 days & 14 days after injury (n=7). An additional six age-matched rats underwent sham PNC + VD and received 1 mL saline iv 1 h, 7 days & 14 days after sham injury. Three weeks after injury, rats underwent LPP testing with concomitant measurement of external urethral sphincter (EUS) electromyography (EMG). Peak bladder pressure during LPP testing was used as a measure of urethral resistance to leakage. EUS EMG amplitude & firing rate were analyzed at baseline and peak pressure during LPP testing. Immediately after LPP & EMG testing, activity of the sensory branch of the pudendal nerve was recorded using electroneurography (ENG) at baseline and during stimulation of skin in the clitoral region. Firing rate at baseline was subtracted from firing rate during stimulation to indicate nervous response to stimulation, a functional measure of nerve regeneration. Data analysis was performed by an investigator blinded to the experimental groups. One-way ANOVA and Dunnet’s post-hoc tests were used to determine statistically significant differences between groups with significance set at P<0.05. Data is presented as mean ± standard error. Results: Peak bladder pressure during LPP testing in rats that underwent PNC + VD and received saline alone (31.5±4.5 cmH2O) was significantly reduced compared to rats that underwent sham PNC + VD (51.4±7.1 cmH2O), demonstrating reduced urethral resistance to leakage and symptoms of SUI. Peak bladder pressure after PNC + VD and a single dose of MSCs (38.0±4.2 cmH2O) was not significantly different from that of rats that underwent either sham PNC + VD or PNC + VD and were treated with saline alone. In contrast, peak bladder pressure was significantly increased with two (57.2±5.2 cmH2O) or three doses (59.0±5.9 cmH2O) of MSCs compared to saline treatment alone after PNC + VD, suggesting that multiple doses have a greater effect than a single dose. There were no significant differences between the groups in EUS EMG firing rate or amplitude. Pudendal nerve function, as demonstrated by the difference in ENG firing rate between baseline and stimulation, followed the same trend as peak bladder pressure during LPP testing, although with reduced significance levels. PNC + VD and treatment with saline alone significantly reduced ENG firing rate (279.0±67.4 Hz) compared to sham
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
PNC + VD (637.6±64.1 Hz), indicating incomplete nerve recovery after injury. Difference in ENG firing rate in rats that underwent PNC + VD and received one (285.1±94.3 Hz), two (405.7±61.6 Hz) or three doses of MSCs (414.1±82.4 Hz) was not significantly different from either rats that underwent sham PNC + VD or rats that underwent PNC + VD and received saline alone, suggesting that MSC treatment facilitated partial recovery of nerve function. Conclusions: Peak bladder pressure during LPP testing was significantly increased with multiple doses of MSCs, suggesting that two doses of MSCs restores urethral function after PNC + VD in this model. Pudendal ENG demonstrated a similar trend with firing rate increased after 2 or 3 doses of MSCs; but this trend did not reach statistical significance. Multiple MSC doses had a protective effect on pudendal nerve and urethral function after dual simulated childbirth injury and suggest that MSCs could represent a novel therapeutic option to treat postpartum SUI and prevent later development of SUI after delivery. References: 1. Urol Int. 2011;86(1):110–6. PMID: 20689260 2. Cell Transplant. 2013 Jul 17. PMID: 23866688 Disclosure Block: Kristine Janssen: No disclosures. Dan Lin: No disclosures. Brian Balog: No disclosures. Brett Hanzlicek: No disclosures. Carl van der vaart: BARD: Consultant, Consulting Fee. BARD: Contract research, Grant/ Research Support. Margot Damaser: Astellas Medical: Advisory Committee Member, consulting fee and reimbursement for travel. Eli Lilly: PI on Research Grant from Eli Lilly to Cleveland Clinic, Grant/Research Support. Beechtree Laboratories: PI on Research Grant from Beechtree Laboratories to Cleveland Clinic, Grant/ Research Support. Fate Therapeutics: Consultant, Grant/ Research Support.
OP 017 URINARY BRAIN DERIVED NEUROTROPHIC FACTOR-WILL IT EVER BE A USEFUL BIOMARKER? A. A. BHIDE 1 , L. TOLTON 2 , L. FRANKLIN 3 , R. CARTWRIGHT 1, A. DIGESU 4, V. KHULLAR 2; 1 Department of Urogynaecology, Imperial Coll. London, London, United Kingdom, 2 Imperial Coll. London, London, United Kingdom, 3 Imperial Coll., London, United Kingdom, 4Imperial Coll. NHS Trust, London, United Kingdom OBJECTIVE: To assess whether there is any relationship between urinary BDNF, symptom severity, and urodynamic diagnosis in women with lower urinary tract symptoms (LUTS).
S93
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
BACKGROUND: Brain derived neurotrophic factor (BDNF) is part of a group of endogenous soluble proteins regulating survival, growth, morphological plasticity, and synthesis of proteins for differentiated functions of neurons. Recently it has been shown that urinary BDNF levels are higher in patients with OAB (Overactive bladder) compared either to healthy controls or to women with stress urinary incontinence. Urinary BDNF could have the potential to be used as a biomarker of the OAB symptom complex, helping with treatment monitoring or identification of pathophysiological subtypes. Existing studies have failed however to systematically measure the variation in urinary BDNF either with individual lower urinary tract symptoms or with urodynamic diagnoses. METHOD: Women with LUTS were recruited from a tertiary referral urodynamics clinic. Women attending general gynaecology clinics with no bothersome LUTS served as controls. The exclusion criteria were history of moderate or severe pelvic organ prolapse, neurological conditions, renal or bladder calculi, voiding dysfunction, history of recurrent urinary tract infection (UTI) and systemic inflammatory conditions. All symptomatic women completed a 3 day frequency-volume chart, the ICIQ-FLUTS questionnaire and underwent saline urodynamics using a standardised protocol according to ICS guidelines. A midstream specimen of urine was collected prior to urodynamics. Urinanalysis was done and those with blood, leucocytes or nitrites were not included. All urine samples were sent for microscopy, culture and sensitivity (MCS). The urine was immediately centrifuged at 3000 rpm at 4 °C for 10 min. About 3 ml of urine was also sent to measure urine creatinine. The centrifuged supernatant urine was then frozen at −80 °C and used to measure the urinary BDNF levels by ELISA using the BDNF E max Immuno assay system (Promega Madison WI). The total urinary BDNF levels were further normalized to the concentration of urinary creatinine (BDNF/Cr level). Samples from women who had a positive UTI on MSU where excluded from analysis. Creatinine normalised BDNF levels were log transformed for analysis. RESULTS:113 women were recruited, of whom 26 were controls who reported no bothersome lower urinary tract symptoms. The women were aged 22 to 82 with a mean age of 50 years. Mean BMI was 24.9 and mean parity was 1. Those with lower urinary tract symptoms had non-significantly higher BDNF levels than controls (0.40 Log [pg/ml] vs. 0.34 Log [pg/ml], p 0.699). Women with OAB had higher levels of urinary BDNF compared to others but this was not significant (0.46 Log [pg/ml] vs. 0.37 Log [pg/ml], p 0.551). Women with urgency incontinence (OAB wet) again had non-significantly higher BDNF levels than women with urgency alone (OAB dry) (0.48 Log [pg/ml] vs. 0.28 Log [pg/ml], p 0.160). When comparing BDNF levels across formal urodynamic diagnoses (summarised in the table below), one way ANOVA did not show any significant difference between each diagnosis (p 1.00).
DIAGNOSIS
n
Mean BDNF Log [pg/ml]
Std. Deviation
DO USI
44 24
0.40 0.40
0.66 0.67
MIXED CONTROL
19 26
0.44 0.37
0.60 0.95
CONCLUSION: Our findings indicate that BDNF cannot be considered as a tool to discriminate between women with different lower urinary tract symptoms nor does it discriminate between different urodynamic diagnoses. We were unable to replicate previous reports suggesting that BDNF could be a useful biomarker in LUTS. Earlier studies may have suffered from spectrum bias, or measurement bias with a lack of validated outcomes. Its role as a useful biomarker should be approached with caution. Disclosure Block: Alka Bhide: No disclosures. Louise Tolton: No disclosures. Larissa Franklin: No disclosures. Rufus Cartwright: Astellas Pharma: Speaker, Honoraria. alex digesu: No disclosures. Vik Khullar: Allergan, Astellas, Pfizer: Scientific Medical Advisor, Consulting Fee. Allergan, Astellas, Pfizer: Speaker, Consulting Fee. Allergan, Astellas, Pfizer: Consultant, Consulting Fee. Allergan, Astellas, Pfizer: Advisory Committee Member, Consulting Fee.
OP 018 IMPACT OF AGING ON ARCHITECTURE AND FUNCTION OF PELVIC FLOOR MUSCLES M. ALPERIN1, L. J. TUTTLE 2, M. S. COOK 3, D. M. DIXON 4, R. L. LIEBER 5; 1 Reproductive Medicine, Division of FPMRS, Univ. of California, San Diego, San Diego, CA, 2Doctor of Physical Therapy Program, Exercise and Nutritional Sciences, San Diego State Univ., San Diego, CA, 3 3Department of Integrative Biology and Physiology, Univ. of Minnesota, Minneapolis, MN, 4 School of Engineering, Univ. of California, San Diego, San Diego, CA, 5Department of Orthopeadic Surgery and Bioengineering, Univ. of California San Diego and VA San Diego Hlth.care System, San Diego, CA Objectives: The purpose of this study was to determine the impact of aging on the pelvic floor muscles’ (PFM) structure and function. Background: Based on the imaging studies, there is a strong association between PFM defects and pelvic floor disorders (PFD) [1]. Increasing age is another well-known risk factor for development of PFD, the prevalence of which is expected to dramatically increase due to the aging of the U.S. population [2]. Despite these associations, structural and functional changes in the PFM due to aging remain unknown. Skeletal muscle
S94
architecture is the strongest predictor of a muscle’s functional capacity [3]. To mechanistically link aging and associated PFM dysfunction as one of the causes of symptomatic PFD, changes in muscle architecture and function with age must be established. Methods: Coccygeus (C), iliococcygeus (IC), and pubovisceralis (PV) muscles were harvested en bloc from five fixed cadavers aged ≤53 years with no history of PFD. Architectural parameters were determined using validated methods Physiological cross sectional area (PCSA), a predictor of force generation, and normalized fiber length (Lfn), an indicator of muscle’s active range of contraction, were calculated and compared to our previously determined data from older (mean age 85) specimens using two-tailed t-tests with significance set at 0.05. Results are presented as means ± standard errors of the mean (SEM), except where noted. Results: The average age of donors was 39.8y (range 26-53y). Muscle mass (in grams) of C and PV was not significantly different between the groups. Mass of IC was significantly greater in the younger cadavers relative to the older group: 7.43±0.83 vs 4.79±0.21 (P<0.0012). PCSA was significantly higher in all three PFM muscles in the younger specimens: C: 1.42±0.23 cm2 vs. 0.87±0.08 cm2 (P=0.014); IC: 1.43± 0.13 cm2 vs. 0.83±0.07 cm2 (P=0.0006); PV: 1.50±1.19 cm2 vs. 0.79±0.08 cm2 (P=0.0012) (see Figure). Lfn was shorter in all three muscles in the younger specimens; however the difference did not reach statistical significance. Average sarcomere length was not significantly different between the groups. Conclusions: One mechanism of the PFM dysfunction in older women is due to the decline in the force generating capacity of these muscles with age, which contributes to the increased risk of PFD in this population. References: 1. JAMA 2008; 300:1311–6 2. Obstet Gynecol 2009;114:1278–83 3. Muscle & Nerve 2000, 23: 1647–66
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Disclosure Block: Marianna Alperin: No disclosures. Lori Tuttle: No disclosures. Mark Cook: No disclosures. Danielle Dixon: No disclosures. Richard Lieber: Allergan, Inc.: Consultant, Consulting Fee. Halozyme, Inc.: Consultant, Consulting Fee. Lippincott, Williams & Wlkins: Textbook Author, Royalty.
OP 019 1H-NUCLEAR MAGNETIC RESONANCE URINARY METABOLOMICS IN OVERACTIVE BLADDER: DO NOCTURIA AND URGENCY HAVE SIMILAR METABOLIC PROFILES? R. BRAY1, B. JIMENEZ 2, D. A. MACINTYRE 3, R. CARTWRIGHT 4, L. FRANKLIN 1, E. HOLMES 2, P. R. BENNETT 5, V. KHULLAR 1; 1 Department of Urogynaecology, St Marys Hosp., london, United Kingdom, 2Computational and Systems Medicine, Department of Surgery and Cancer, Faculty of Medicine, Imperial Coll., london, United Kingdom, 3Department of Surgery and Cancer, Parturition Research Group, Institute of Reproduction and Devel, Imperial Coll., london, United Kingdom, 4Department of Epidemiology & Biostatistics, Imperial Coll. London, london, United Kingdom, 5 3. Department of Surgery and Cancer, Parturition Research Group, Institute of Reproduction and Devel, Imperial Coll., london, United Kingdom Introduction: Nocturia and urgency are prevalent lower urinary tract symptoms grouped together in the Overactive Bladder syndrome [1]. Both symptoms may have different causes including metabolic problems, which can make selection of appropriate treatments challenging. Metabolomics is a high-throughput technology that quantitatively measures metabolites within a biological sample. Metabolites in urine represent end products of normal and pathological cellular processes that are closely linked to disease states. Urine metabolic profiles may thus be regarded as functional signatures of the physiological state and can be exploited for diagnosis and for better understanding of the biochemical changes associated with bladder function pathophysiology [2]. In this study we use high field proton nuclear magnetic resonance spectroscopy (1H-NMR) to investigate urinary metabolic changes associated with nocturia and urgency. Objective: To compare the urinary metabolic profile of symptomatic and asymptomatic patients with nocturia or urgency using 1H-NMR-based metabolomics. Methods: Women attending urogynaecology and general gynaecology secondary clinics were recruited and provided urine samples, and completed the International Consultation on Incontinence - Female Lower Urinary Tract Symptoms Questionnaire [3]. Urine metabolic profiling was performed by 1H-NMR followed by multivariate modeling to compare
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
metabonomic patterns between patients reporting nocturia as “none” vs. “four or more” when asked “During the night, how many times do you have to get up to urinate, on average?” Samples were also collected from patients who reported urgency as “occasionally” vs. “all of the time” in response to the question, “Do you have a sudden need to rush to the toilet to urinate”. Principal components analysis (PCA) was used to examine data structure and identify outliers, followed by orthogonal partial least squares discriminant analysis (OPLS-DA) to model class-related variability between patient groups. Statistical models were examined using the goodness of fit parameter (R2Y) and the predictive ability (Q2Y) was calculated by a seven-round internal cross-validation of R2Y. ROC curves were prepared using cross-validated predictors to determine specificity and sensitivity of the models. Results: We recruited 288 women of mean age 46, and median parity 2. OPLS-DA modeling of the urine metabolic data enabled clear discrimination between patients with (n=28) and without nocturia (n=67) (R2Y =0.87, Q2Y =0.29; AUC=82 %, See Figure 1A). Discrimination was also observed between the urinary metabolic profile of patients reporting urgency ‘occasionally’ (n=63) or ‘all the time’ (n = 22) (R2Y = 0.88, Q2Y = 0.08; AUC = 68 %, See Figure 1B). Despite normalisation of the spectra to account for osmolarity, nocturia was associated with increased urine concentrations of creatine and decreased creatinine. However, this pattern was not observed in patients reporting urgency. Results were independent of age or BMI.
Figure 1. OPLS-DA models of urinary metabolic profiles determine by 1H-NMR showing clear discrimination between patients with and without nocturia (A) and urgency (B). Conclusions: We demonstrate that urine metabolic profiling by 1H-NMR offers an approach for identifying and characterizing underlying metabolic differences between patients with and without nocturia or urgency. Nocturia is associated with a
S95
differing urinary metabolic biomarker profile compared to urgency indicating differences in pathophysiology between the two symptoms, even though they are grouped together in the overactive bladder syndrome. 1H-NMR-based metabolomics offers an alternative approach for identification of patient subgroups based on pathophysiology and may lead to improved and individualised treatments. References: 1. Eur Urol 2014 http://dx.doi.org/10.1016/j.eururo.2014.01. 019 2. Nat Rev Drug Discov, 2003. 2(8): p. 668–76. 3. Am J Obstet Gynecol. 2004 Jul;191(1):73–82 Disclosure Block: Rhiannon Bray: No disclosures. Beatriz Jimenez: No disclosures. David MacIntyre: No disclosures. Rufus Cartwright: Astellas Pharma: Speaker, Honoraria. Larissa Franklin: No disclosures. Elaine Holmes: No disclosures. Phillip Bennett: Glaxo Smith Klein: Consultant, Grant/Research Support. ObsEva: Advisory Committee Member, Consulting Fee. Vik Khullar: Allergan, Astellas, Pfizer: Scientific Medical Advisor, Consulting Fee. Allergan, Astellas, Pfizer: Speaker, Consulting Fee. Allergan, Astellas, Pfizer: Consultant, Consulting Fee. Allergan, Astellas, Pfizer: Advisory Committee Member, Consulting Fee.
OP 020 SUPERIOR EFFICACY OF COMBINATION PHARMACOTHERAPY FOR TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY M. O. FRASER1, J. C. LLOYD 2, N. LE 2, J. S. WIENER 2, P. C. DOLBER 3; 1 Surgery, Duke Univ. Med. Ctr., Inst. for Med. Res., Durham VAMC, Durham, NC, 2Surgery, Duke Univ. Med. Ctr., Durham, NC, 3Surgery, Duke Univ. Med. Ctr., Durham VAMC, Durham, NC Introduction: Antimuscarinics are the mainstay of pharmacotherapy for neurogenic detrusor overactivity (NDO); however, bothersome side effects are common, including dry mouth, constipation, and even cognitive impairment. The use of pharmacological combination approaches to treat symptoms of NDO may afford the opportunity to utilize lower doses of each individual drug, allowing achievement of the same or better clinical benefit with fewer side effects. Objective: We sought to determine whether combination therapy would improve indices of detrusor hyperreflexia in a female rat model of NDO. This study is a follow-up of our previous report on the effects of a β3-adrenergic agonist on NDO in the same model.
S96
Methods: After ~60 min of control open cystometry and three vehicle administrations, dose–response relationships were constructed in awake, restrained chronic suprasacral (T9-10) spinal cord injured (SCI) rats (n=8– 9/group, ≥4 weeks post-SCI) using ½ log increments of fesoterodine (antimuscarinic; F), doxazosin (α1adrenergic antagonist; D), CL-316,243 (β3-adrenergic agonist; CL) and pregablin (α2δ subunit modulator of N-type Ca2+ channels; P) as either monotherapies or in paired combinations (10 groups total). Vehicles and drugs were given at ~30 min intervals. Bladder capacity (BC), filling compliance (FC), non-voiding contraction (NVC) count (#) and maximum amplitudes (MA) were captured and measured using PowerLab 16SP. Data were analyzed by Friedman test and 2-way ANOVA, P < 0.05 was significant. All results are reported as means of data normalized to last vehicle. Results: All monotherapies resulted in significant increases in BC relative to control cystometry (22– 69 %), but were not different than each other. All combinations, except D + F, resulted in significant increases in BC (39–126 %), with the greatest increment seen with CL + P (116 %, p=0.0004) and CL + F (126 %, p=0.0064). Only CL + P resulted in a significant increase in FC (115 %, p =0.0181). NVC Max Amp was significantly decreased by all treatments (38–68 %) except D, P, P + D, and P + F, with the greatest effect being seen in CL + F (68 %, p=0.0005) and CL + D (54 %, p=0.0043). NVC # was significantly decreased by D (52 %, p = 0.0045) and CL (47 %, p=0.0067). Conclusions: Monotherapies were effective against hallmark characteristics of neurogenic bladder, including BC (all), NVC Max Amp (CL, F) and NVC # (CL, D). Combination therapies provided superior efficacy for BC (CL + F, CL + P), FC (CL + P), and NVC Max Amp (CL + F, CL + D). These results suggest that combination pharmacotherapy may provide similar or superior efficacy with reduced side-effect profiles for the treatment of neurogenic bladder. References: N/A Disclosure Block: Matthew Fraser: Pfizer: Grantee, Grant/Research Support. Medtronic: Grantee, Grant/Research Support. Amphora Medical: Board Member, Consulting Fee. Circuit Therapeutics: Consultant, Consulting Fee. Lipella: Patent License, Royalty. Jessica Lloyd: No disclosures. Ngoc-Bich Le: No disclosures. John Wiener: Eli Lilly & Company: Consultant, Consulting Fee. Centers For Disease Control and Prevention: Contractee for research project, Grant/ Research Support. Paul Dolber: No disclosures.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
OP 021 EFFECTS OF SELECTIVE ESTROGEN RECEPTOR MODULATORS ON PELVIC FLOOR SUPPORTIVE TISSUE R. LIANG 1 , K. KNIGHT 2 , A. L. NOLFI 1 , S. ABRAMOWITCH 1, P. MOALLI 3; 1 Univ. of Pittsburgh, Pittsburgh, PA, 2 Univ. of Pittsburgh, PITTSBURGH, PA, 3Magee-Womens Hosp., Pittsburgh, PA Introduction: SERMs have been widely used in the management of menopausal symptoms and treatment of breast cancer. While some have successfully treated osteoporosis and increased the survival of cancer patients, others have failed to reach the market citing an adverse impact on pelvic floor function with increased incidence of urinary incontinence and pelvic organ prolapse [1], indicating SERMs may exert distinct effects on the pelvic supportive tissues. In previous studies, we demonstrated that the synthesis and degradation of vaginal and pelvic supportive connective tissues (PSCT) are highly regulated by estrogen [2]. Objective: This study aimed to define the impact of Selective Estrogen Receptor Modulators (SERMs) on the mechanical function and matrix remodeling of PSCT. Methods: 88 four month Long-Evans parous rats were administered the following SERMs by oral gavage over a period of 8 weeks (n = 8 each): idoxifene (IDX, 10 mg/kg/day), raloxifene (RLX, 5 mg/kg/day), tamoxifen (TMX, 5 mg/kg/day), bazedoxifene acetate (BZA, 3 mg/kg/day) and BZA with conjugated estrogen (BZA 3 mg/kg/day + CE 2.5 mg/kg/day). Control groups included sham-operated, ovariectomized (OVX) without gavage, OVX with placebo gavage, and 17β-estradiol (EST, 0.1 mg/kg/day, subcutaneous). The PSCT complexes were excised en bloc and tested in an established uniaxial tensile testing protocol [3]. Following the tests, collagen (hydroxyporline) and GAG content (Blyscan sulfated glycosaminoglycan assay) were measured. One way ANOVA and posthoc tests were used for statistics. Results: Animals in the groups had similar age, weight and parity. OVX significantly decreased the mechanical integrity of the tissue with a decrease in ultimate load and stiffness (p = 0.043, p < 0.001). EST supplementation restored the mechanical properties of PSCT to that of sham-operated (p = 0.039, p < 0.001) while none of the SERMs effectively restored ultimate load or stiffness (Figure 1). Although not significantly different from OVX controls, supplementation with IDX, BZA and BZA + CE significantly lowered the ultimate load and stiffness of PSCT when compared
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
S97
to EST (p < 0.05). Total collagen content did not change significantly after OVX and with EST treatment. However, mirroring the mechanical test results, supplementation with IDX (p = 0.031) and BZA (p = 0.035) induced higher collagen content compared to EST (Figure 2). GAG content did not change signifantly after OVX or with/without SERM and EST supplementation. Conclusion: Vaginal and pelvic supportive connective tissue is directly impacted by SERM treatment. Supplementation with IDX and BZA did not correct the decline in mechanical properties of the PSCT after OVX. The increase in collagen content that occurred in these groups may reflect an accelerated remodeling response with the deposition of immature collagen. Future studies will investigate the mechanisms of differential regulation by SERMs and estrogen. References: 1. AJOG, 2002, 187: p521-7; 2. AJOG, 2008, 199: p161-8. 3. AJOG, 2005, 192: p80-8
Disclosure Block: RUI LIANG: No disclosures. Katrina Knight: No disclosures. Alexis Nolfi: No disclosures. STEVEN ABRAMOWITCH: Pfizer: Investigator Initiated Research Support, Grant/ Research Support. Pamela Moalli: ACell: We received supplementary funding to support the cost of animals to complete the 3rd aim of our R01, Grant/Research Support.
OP 022 INFLAMMATORY CYTOKINE EXPRESSION IN PATIENTS WITH OVERACTIVE BLADDER VERSUS NORMAL CONTROLS N. PILLALAMARRI1, D. F. SHALOM 1, X. XUE 2, L. R. LIND 1, H. A. WINKLER 1, C. N. METZ 2; 1 Division of Female Pelvic Medicine and Reconstructive Surgery, North Shore - Long Island Jewish Hlth. System, Great Neck, NY, 2Center for Immunology and Inflammation, The Feinstein Inst. for Med. Res., Manhasset, NY. Introduction: The study of urinary biomarkers in the clinical assessment and management of patients with overactive bladder (OAB) has gained recent interest (Int Urogynecol J. 2013; 24: 1065–1072). Cytokines are proteins that act as regulators of infection, inflammation, and trauma (Eur J. Immunology. 2007; 37(Suppl 1): S34-S45), and are relevant to study because of their potential to objectivly evaluate the course of a pathological process as well as the response to therapeutic intervention. Objective: To detect differentially expressed cytokines in the urine of patients with overactive bladder compared to agematched controls. Methods: This was a prospective, controlled, singleblinded analysis. Twenty-three women with OAB and
S98
22 age-matched controls were consented to participate. OAB subjects were enrolled if they had symptoms of urinary frequency, urgency or urge incontinence for >3 months and urodynamic findings of detrusor overactivity. Each control was age-matched within±5 years to the OAB subjects and denied symptoms of urinary frequency, urgency, or incontinence. Subjects and controls were excluded if they had known inflammatory bladder or systemic conditions, acute or recurrent cystitis, bladder stones, or had used an anticholinergic within the past 21 days. Midstream clean-catch urine samples were collected in sterile containers from each subject and control; cell-free urine was stored at −80 °C until analysis. Cytokine and chemokine levels were determined using the multiplexed Meso Scale Discovery Platform. Analyte levels were corrected for urinary creatinine concentrations (determined using an enzymebased method). Statistical analysis comparing urinary cytokines/chemokines between OAB subjects and controls was performed using the Mann–Whitney test (p<0.05 was considered significant). Results: The level of each inflammatory cytokine was measured in the urine of OAB subjects and normal controls. The majority of the cytokines showed similar levels in both groups. Results are outlined in Table 1. OAB subjects had significantly lower urinary IL-10, IL-12-p70, and IL-13 levels compared to normal controls. Conclusions: This study was performed with the intent to identify specific cytokines related to OAB. To our knowledge, this is presently the largest study evaluating urinary cytokine and chemokine levels in women with OAB versus normal controls. In our study population, IL-10, IL-12p70, and IL-13 were the only cytokines found at different levels in the urine of patients with OAB compared to controls. There were no significant differences in the urinary levels of inflammatory cytokines Eotaxin-3, TARC, and MCP-1 in OAB subjects versus controls, as described in previous studies (Int Urogynecol J. 2011; 22(8): 953–961). Our findings support a larger study evaluating differential expression of urinary cytokines in patients with overactive bladder. References: Bhide, Alka et al. Biomarkers in Overactive Bladder. Int Urogynecol J. 2013; 24: 1065–1072. Dinarello, Charles. Historical Insights into Cytokines. Eur J. Immunology. 2007; 37(Suppl 1): S34-S45. Ghoniem G, Faruqui N, Elmissiry M et al. Differential Profile Analysis of Urinary Cytokines in Patients with Overactive Bladder. Int Urogynecol J. 2011; 22(8): 953–961. Table 1: Inflammatory cytokines in patients with DO versus normal controls. Data are shown as chemokine/cytokine (pg)/ Cr(g).
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Factor
DO Subjects Mean (SD)
Controls Mean (SD)
p-value
Eotaxin-3 TARC
2.03 (3.73) 27.2 (45.8)
5.45 (8.69) 25.7 (48.1)
0.25 0.95
IP-10 IL-8
36.3 (33.5) 81.2 (111.6)
32.9 (31.1) 40.6 (41.5)
0.67 0.16
MCP-1
268.7(146.3)
194.5 (80.1)
0.16
MDC MCP-4
211.0 (613.4) 32.3 (54.5)
175.2 (262.1) 20.5 (24.8)
0.35 0.30
IFN-γ IL-1β IL-2
0.02 (0.07) 4.39 (4.45) 0.25 (0.36)
0.99 (2.88) 2.47 (3.90) 0.46 (0.65)
0.10 0.86 0.62
IL-4 IL-5
0.02 (0.07) 0.03 (0.06)
0.13 (0.57) 0.74 (1.75)
1.00 0.42
IL-8 IL-10
81.2 (111.6) 27.0 (42.9)
40.6 (41.5) 167.5 (292.9)
0.16 0.02
IL-12p70
0.34 (0.67)
1.55 (2.94)
0.01
IL-13
0.18 (0.60)
4.10 (8.97)
0.03
TNF-α
0.25 (0.39)
1.04 (3.00)
0.78
Disclosure Block: NIRMALA PILLALAMARRI: No disclosures. DARA SHALOM: No disclosures. XIANGYING XUE: No disclosures. LAWRENCE LIND: Boston Scientific: Consultant, Consulting Fee. HARVEY WINKLER: Caldara: Consultant, Consulting Fee. CHRISTINE METZ: Medtronics: We received a grant from Medtronics to perform the research (approx $75,000 over 2 years to pay for research technician salary coverage, sample collection, sample processing, sample storage, and laboratory supplies), Grant/Research Support.
OP 023 PROLAPSE AND CONTINENCE SURGERY IN OECD COUNTRIES N. HAYA1, K. BAESSLER 2, C. CHRISTMANN-SCHMID 3 , R. DE TAYRAC 4, V. DIETZ 5, R. GULDBERG 6, T. MASCARENHAS 7, E. NUSSLER 8, E. BALLARD 9, M. ANKARDAL 10, T. BOUDEMAGHE 4, C. MAHER 1; 1 Obstetric and gynaecology, The Royal Brisbane and Women’s Hosp., Brisbane, Australia, 2Beckenbodenzentrum Charité, Charité Univ. Hosp., Berlin, Germany, 3Obstetric and gynaecology, Hosp. of Lucerne, Lucerne, Switzerland, 4 Obstetric and gynaecology, Carémeau Univ. Hosp., Nimes, France, 5 Obstetrics and Gynecology, Catharina Hosp. Eindhoven, Eindhoven, Netherlands, 6Center for Clinical Epidemiology, Odense Univ. Hosp., Odense, Denmark, 7 Obstetric and gynaecology, Hosp. de S. João, Porto, Portugal, 8Obstetric and gynaecology, Umeå universitet, Umea, Sweden, 9QIMR Berghofer RBWH Statistics Unit, The Royal Brisbane and Women’s Hosp., Brisbane, Australia, 10Hallands Sjukhus, Kungsbacka, Sweden.
S99
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Introduction: Surgical interventions for pelvic organ prolapse (POP) and/or continence are undertaken in nearly one in nine women during their lifetime (1). However the actual rates of surgical interventions are poorly reported. The OECD facilitates international comparisons of health interventions in member countries but they do not report on prolapse or continence procedures. Objective: We aim to measure the rates of POP and continence procedures performed in OECD countries. Methods: We contacted 30 OECD member countries contact points (2) for assistance with data extraction in writing and by electronic mail. We also contacted colleagues in many countries. We received, meaningful responses with data available from 16 countries including Australia, Canada, Denmark, England, France, Germany, Hong Kong, Ireland, Israel, Netherlands, New Zealand, Portugal, Spain, Sweden, Switzerland and United States of America however Hong Kong was excluded as we could not confirm the data represented at least 80 % of the procedures performed. To ensure consistency with data recoding we developed an International Classification of Diseases (ICD-10) compliant spreadsheet that was utilised by the authors when extracting data from local sources. Results: We report on 693,897 prolapse and 407,024 continence procedures performed in fifteen OECD countries in the most recent reported year. Generally POP procedures were performed more frequently than continence procedures with the median ratio of POP/ continence procedures being 2.43. Figure 1 provides data on rates of POP and continence procedures per 1000 women and found the median rate of POP procedures was 1.47. The median rate of continence procedures/1000 women was 0.59. The rates of POP and continence procedures were able to be stratified by age in most countries with the exception of Three. Prolapse procedures were performed more commonly in women older than 60 years and continence surgery was performed more frequently in those younger than 60 years of age. The incidence of POP procedures was highest in the 7th decade of life at a median rate of 4.25 procedures per 1000 women. Posterior/Anterior compartment repairs were performed in 51.4 % of prolapse procedures as compared to posterior repairs in 42.8 % and apical repairs in 20.5 % (Table 1). Grafts were employed at a mean rate of 12.1 % of anterior and 8.1 % of posterior vaginal repairs (Table 2). Midurethral slings represented over 90 % of continence interventions. Conclusions: Prolapse procedures are performed twice as frequently as continence surgery however wide variation
exists in the rates of interventions. Prolapse surgery is performed most commonly in women over 60 years of age and continence surgery more frequently in women under 60 years of age. Anterior compartment surgery remains the most commonly performed POP surgery and grafts are utilised in anterior compartment surgery in 12.1 % cases. Sub-urethral slings represent over 90 % of female continence procedures. The median rate of combined POP and continence procedures was 2.25/1000 women however the rate varies more than five-fold between the lowest and highest countries in t h e O E C D a n d t h i s v a r i a t i o n r e q u i r e s fu r t h e r evaluation. Table 2. Pelvic organ prolapse procedures by vaginal compartment
Australia
Anterior Compartment/ prolapse procedures % 55.2
Canada
–
–
23.3
Denmark
49.0
33.7
18.4
England
55.7
43.5
21.4
France
40.4
40.7
49.1
Germany
42.4
33.2
24.5
Ireland
65.3
52.2
10.0
Israel
33.6
46.7
13.7
Portugal
64.0
48.4
13.5
Spain
53.5
31.0
12.5
Sweden
47.4
38.1
12.2
Switzerland 59.3
46.5
18.5
42.8(8.6)
20.5 (10.4)
Country
Posterior compartment/ prolapse procedures % 56.8
25.0
Holland
Mean (SD)
Apical compartment/ prolapse procedures % 25.2
51.4 (8.5)
Table 2. Graft utilisation at Prolapse surgery. Country
Anterior compartment surgery utilising grafts (%)
Posterior compartment surgery utilising grafts (%)
Canada
6.5
6.5
Denmark England
4.1 3.3
4.1 3.4
Germany
25.6
16.8
Israel
18.4
10.2
Portugal
10.4
7.4
Spain
13.1
10.1
Sweden
12.2
8.4
Switzerland 15.7
6.5
Mean
8.1
12.1
S100
Reference: 1. Obstet Gynecol, 89(4)501–6.2. http://www.oecd.org/ health-systems
Disclosure Block: Nir Haya: No disclosures. Kaven Baessler: No disclosures. Corina Christmann-Schmid: No disclosures. Renaud de Tayrac: Boston Scientific: Consultant, Consulting Fee. Aspide Medical: Consultant, Consulting Fee. Viviane Dietz: Bard: honoraria for 4 h in 2013 for training session for FIXT., Honoraria. Rikke Guldberg: Astellas Pharma: Speaker, Salary. Teresa Mascarenhas: No disclosures. Emil Nussler: No disclosures. Emma Ballard: No disclosures. Maud Ankardal: No disclosures. Thierry Boudemaghe: No disclosures. Christopher Maher: No disclosures.
OP 024 HEALTH RESOURCE UTILIZATION AND BURDEN IN OVERACTIVE BLADDER PATIENTS TREATED WITH ANTICHOLINERGICS M. CHANCELLOR 1, A. YEHOSHUA 2, C. CORBELL 2, D. GLOBE 2, I. CHENG 3, R. PULICHARAM 3, M. JOSHI 2, K. CAMPBELL 2, S. VASAVADA4; 1 Beaumont Hosp., Royal Oak, MI, 2Allergan Inc., Irvine, CA, 3 Hlth.care Partners, Torrance, CA, 4Cleveland Clinic Main Campus, Cleveland, OH. Introduction: Overactive bladder (OAB) is a common medical condition with significant economic and humanistic burden. Inadequately managed OAB may exacerbate or result in comorbidities such as depression, urinary tract infections (UTIs), and falls; all of which increase the burden to the healthcare system. Anticholinergics (ACHs) are the most commonly prescribed first-line pharmacotherapy (following behavioral therapy) in the treatment of OAB. While there has been a fair amount of research on the economic burden of
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
OAB, the impact of ACHs on health resource utilization (HRU) and costs has not been well studied. Objective: The aim of this study was to compare comorbidities and HRU in a cohort of OAB patients with UI treated with ACH compared to matched controls. Methods: Retrospective claims data for patients seen through a California-based managed care organization were linked to a cross-sectional patient survey and used to compare HRU in a cohort of OAB cases and controls. Cases were patients with an ICD-9 code for OAB; ≥1 UI episodes/day based on self-report and who initiated anticholinergic therapy between January 2008 and May 2012. Controls were patients without an ICD-9 code for OAB who never received anticholinergic therapy and were matched to cases in a 3:1 ratio based on gender, age and observation time. The index date for cases was the date of anticholinergic initiation; for controls, the index date was the date of the medical claim that resulted in the same observation time as a matched case. Medical and pharmacy claims data were used to analyze patient comorbidities as well as track HRU (including outpatient visits, emergency room (ER) visits, hospitalizations and medication use) from the index date until the end of follow-up (May 2013). Results:A total of 655 patients with OAB and 1,965 controls were enrolled into the study. Mean age of the study population was 73.2 years; 79.2 % were female. The average follow up time was 3.1 years. OAB patients had an average of 3.56 UI episodes per day. Descriptive statistics showed that compared to controls, this cohort of OAB cases who had initiated ACH therapy had a higher prevalence of falls and fractures (55.1 % vs. 47.3 %; p<0.001), UTIs (49.6 % vs. 27.4 %; p<0.0001), diabetes (40.2 % vs. 34.6 %; p=0.01), and depression and/or anxiety (35.4 % vs. 23.1 %; p<0.0001), during the follow-up period (Table 1). OAB cases also experienced higher HRU than controls (Table 2). The mean outpatient visits per year were 17.0 and 11.2 (p<0.0001); mean ER visits per year were 2.0 and 1.4 (p=0.0008), and mean inpatient admissions per year were 0.30 and 0.24 (p=0.0011) in cases and controls respectively. Furthermore, OAB cases received more prescription fills per year than controls (7.8 vs. 4.6; p<0.0001). There were no statistically significant differences observed in the mean skilled nursing facility admissions per year. Conclusion: Our analysis indicates that this cohort of OAB patients with UI, exposed to ACHs experienced more cases of depression, falls and fractures and UTIs than patients of similar age and gender without OAB. In addition, OAB cases had higher ER visits, outpatient visits and overall medication use than controls. A higher prevalence of comorbidities and resource utilization in OAB cases than controls appeared to occur despite the fact that OAB patients had all been initiated on ACH therapy. A higher burden in OAB patients despite ACH treatment suggests an unmet need for alternative therapies that have a greater impact on reducing total HRU.
S101
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Table 1: Comorbid Conditions
Depression and/or Anxiety, n (%) Urinary tract infection, n (%) Falls and fractures, n (%) Diabetes, n (%)
p-value
OAB Cases (N=655) 232 (35.42)
Controls (N=1965) 455 (23.12)
<0.0001
325 (49.62)
538 (27.38)
<0.0001
361 (55.11) 263 (40.15)
929 (47.28) 680 (34.61)
0.0005 0.0104
OAB Case (N=655) 16.96 (11.09)
Controls (N=1965) 11.19 (8.81)
p-value <0.0001
0.30 (0.45)
0.24 (0.44)
0.0011
1.95 (4.64)
1.38 (3.38)
0.0008
7.78 (4.51)
4.63 (3.80)
<0.0001
Table 2: Resource Utilization
Mean outpatient visits per year (SD) Mean inpatient admission per year (SD) Mean ER visits per year (SD) Mean prescription drug fill per year (SD)
Character count=3,477 (2977+2 tables) [Character limit= 4,200] Disclosure Block: Michael Chancellor: Allergan: Consultant, Consulting Fee. Alon Yehoshua: Allergan: Allergan sponsored fellowship with the University of Arizona, Allergan sponsored fellowship with the University of Arizona. Catherine Corbell: Allergan, Inc: Employee, Salary. Denise Globe: Allergan, Inc: Employee, Salary. I-Ning Cheng: HealthCare Partners: Employee, Salary. Gilead Sciences: Employee, Salary. Riya Pulicharam: No disclosures. Manher Joshi: Allergan, Inc.: Employee, Salary. Allergan, Inc.: Stock Shareholder, Ownership Interest. Karen Campbell: Allergan: Employee, Salary. Sandip Vasavada: Allergan: Advisory Committee Member, Consulting Fee. Medtronic: Advisory Committee Member, Consulting Fee. Boston Scientific: Consultant, Consulting Fee.
OP 025 UTILITY SCORE RESPONSIVENESS TO TREATMENT OF URGE URINARY INCONTINENCE WITH ANTI-CHOLINERGIC MEDICATION H. S. HARVIE1, U. U. ANDY 1, L. ARYA 2; 1 Univ. of Pennsylvania, Philadelphia, PA, 2Univ. of pennsylvania, philadelphia, PA. Introduction: Utility scores are general quality of life scores that range from 0 (death) to 1 (perfect health). Utility scores are used to quantify the severity of a patient’s condition and burden of illness and are used to calculate quality adjusted life years,
essential for cost-effectiveness research. Responsiveness of utility scores to treatment of urge urinary incontinence (UUI) with anticholinergic medication is not known. Objectives: Our aim was to evaluate the responsiveness of utility scores, as measured by three multi-attribute health-status classification system instruments, Health Utilities Index Mark 3 (HUI3), EuroQol (EQ5D), and Short Form 6D (SF6D), to treatment of UUI with anticholinergic medication. Methods: This is a prospective study of consecutive women presenting with symptoms of UUI recruited from a tertiary care clinic. Women were treated with fesoterdine 4 mg and increased to 8 mg as needed. Response to treatment at 8 weeks was measured using the Patient Global Impression of Improvement (PGI). Responders were defined as women who responded “a little better”, “much better” or “very much better” to the question: “..best describes how your urinary tract condition is now, compared with how it was before you began taking medication in this study”. Utility scores were measured using HUI3, EQ5D, and SF6D. Urinary symptoms and condition-specific quality of life was assessed using the Incontinence Severity Index (ISI), Pelvic Floor Distress Inventory-20 (PFDI) and Pelvic Floor Impact Questionnaire7 (PFIQ). Comorbid medical condition was measured using the Charlson Comorbidity Index (CCI). We compared the change in symptom scores from baseline to 8 weeks and between responders and non-responders to treatment using non-parametric tests. Results: Of 129 women enrolled, mean age, BMI, and CCI were 60±14, 32±8 and 0.8±1.4 respectively. Previous treatments for urinary incontinence included 43 % anticholinergic medications, 43 % pelvic floor exercises, 16 % biofeedback, 25 % surgery, 3 % sacral neuromodulation, 2 % tibial nerve stimulation. The mean UDI, UIQ and ISI scores decreased (improved) from baseline to 8 weeks (52±23 vs 38±26, p=.001, 31±28 vs 20±25, p=.0007, and 6±3 vs 4±4, p=.01, respectively). The mean utility scores increased (improved) from baseline to 8 weeks, the increase was significant for the SF6D (.70± .14 vs .73± .15, p=.009) but not for the HUI3 (.71±.28 vs .72±.26, p=.59) or EQ5D (.71±.27 vs .73±.25, p=.41). Based on the PGI, 82 % of women were responders to treatment. Non-responders were significantly more likely to have undergone prior treatment for UUI than responders, including ≥4 treatment modalities (19 % vs 3 % p=.01) and ≥2 anticholinergic medications (24 % vs 9 % p=.003). There were no differences in baseline mean age, CCI, UDI, UIQ or ISI scores between responders and non-responders. Non-responders had lower utility scores at baseline though this difference did not reach significant levels. Mean utility scores and measures of UUI severity for responders and non-responders are summarized in table 1.
S102
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Table 1: Utility preference scores and condition-specific measures of UUI symptoms and quality of life by response to anticholinergic medication treatment of urge urinary incontinence Responders1 82 % (n=106)
Non-responders1 18 % (n=23)
P-value
60.1±13.4 0.78±1.3
58.9±17.9 0.91±1.3
0.712 0.452
0.73±0.26 0.74±0.22 0.70±0.14
0.65±0.36 0.59±0.39 0.69±0.15
0.632 0.232 0.972
UDI 52.0±21.9 UIQ 31.8±27.1 ISI 6.6±3.9 8 Week scores
56.6±29.9 45.2±33.5 8.2±3.6
0.532 0.182 0.142
HUI-3 0.74±0.24 EQ-5D 0.75±0.21 SF-6D 0.73±0.15 UDI 34.6±24.7 UIQ 20.1±25.2 ISI 3.2±2.3 Change from Baseline to 8 weeks
0.61±0.30 0.63±0.36 0.68±0.16 50.9±24.9 22.6±21.3 8.0±3.3
0.042 0.032 0.242 0.062 0.482 0.022
−0.04±0.23 0.04±0.26 −0.01±0.13 −4.6±18.4 −9.5±16.8 0.67±1.2
0.073 0.473 0.093 0.183 0.693 0.113
Age CCI Baseline scores HUI-3 EQ-5D SF-6D
HUI-3 EQ-5D SF-6D UDI UIQ ISI
0.02±0.19 0.02±0.21 0.03±0.10 −15.7±27.9 −10.9±22.8 −2.7±3.1
UDI = Urinary Distress Inventory, UIQ = Urinary Impact Questionnaire, ISI = Incontinence Severity Index Score Lower scores on the HUI-3, EQ-5D and SF-6D represent worse utility values while higher scores on the UDI, UIQ, and ISI represent worse symptom severity and quality of life values. 1 Responders based on PGI 2 Two-sample Wilcoxon rank-sum (Mann–Whitney) test 3 Logistic regression controlling for baseline scores At 8 weeks, responders had significantly lower (better) UDI and ISI scores than non-responders. Responders also had significantly higher (better) utility scores for both the HUI3 and EQ5D than non-responders. For all utility and condition specific instruments, the changes in scores at 8 weeks were not significantly different between responders and nonresponders (Table 1). Among responders, change in utility scores significantly correlated with change in symptom severity and conditionspecific quality of life measures (Table 2). Utility scores from all instruments were significantly correlated with the UDI, UIQ and ISI scores at 8 weeks. All correlations were negative,
indicating that improved (higher) utility scores correlated with improved (lower) UUI symptom severity and conditionspecific quality of life scores. Utility scores from all instruments were highly correlated with each other (r=0.68 to 0.80, p<0.0001). Table 2: Correlations of change in utility score with change in symptom severity and change in conditionspecific quality of life measures among responders to treatment of urge urinary incontinence with anticholinergic medication HUI-3 (r-value*)
EQ-5D (r-value1)
SF-6D (r-value1)
Symptom severity UDI −0.11
−0.21
−0.21
−0.74
−0.50
−0.58
−0.21
−0.44
−0.36
ISI Quality of life UIQ
UDI = Urinary Distress Inventory, UIQ = Urinary Impact Questionnaire, ISI = Incontinence Severity Index Negative correlation values are expected since higer scores on the HUI-3, EQ-5D and SF-6D represent better utility values while lower scores on the UDI, UIQ, and ISI represent better UUI condition-specific symptom severity and quality of life. 1 Spearman correlation Conclusion: The multi-attribute health-status classification system instruments provide valid utility scores in women with UUI and are responsive to treatment with anticholinergic medication. Further studies are needed to identify the most useful generic instrument(s) for measuring utility scores in women with UUI. Disclosure Block: Heidi Harvie: No disclosures. Uduak Andy: No disclosures. Lily Arya: No disclosures.
OP 026 THE INTERACTION OF STRESS AND URGENCY URINARY INCONTINENCE ON QUALITY OF LIFE V. A. MINASSIAN1, H. SUN 2, X. YAN 2, D. N. CLARKE 3, J. M. PITCAVAGE 2, J. M. RUNGE 2, W. F. STEWART 4; 1 Brigham and Women’s Hosp., Boston, MA, 2Geisinger Ctr. for Hlth. Res., Danville, PA, 3Geisinger Hlth. System, Danville, PA, 4Sutter Hlth., Walnut Creek, CA. Introduction: The effect of mixed UI may be particularly important when looking at the impact of UI subtypes on quality of life, given that mixed UI is the most prevalent subtype in older women. Previous studies focused on the relation of QoL to either urgency UI or stress UI alone.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Some studies have shown that mixed UI, as opposed to stress UI or urgency UI alone, has a greater impact on QoL, but findings are not consistent. Differences across published studies may be explained, in part, by the fact that urgency and stress UI may co-occur with different levels of severity, or interact with each other in diverse ways. No study has specifically examined whether there is an interaction between stress and urgency UI that potentiates the effect on QoL Objective: 1) To determine if there is an interaction between stress and urgency urinary incontinence (UI) in relation to impact on quality of life (QoL), and 2) to better understand the heterogeneity of burden on women with UI. Methods: We used data from the General Longitudinal Overactive Bladder Evaluation - Urinary Incontinence (GLOBE-UI), a longitudinal study of women ≥40 years of age. Primary care patients from a health system in Pennsylvania where randomly sampled and recruited by mail. The Bladder Health Survey (BHS) was designed to assess lifetime, 6 months, and 4 weeks bladder UI symptoms including stress UI and urgency UI. The BHS was based on previously validated questionnaires, including the incontinence impact questionnaire (IIQ-7). Stress and urgency UI subtypes were categorized based on a severity score ranging from 0 to 8. We examined the independent and interacting effects of stress UI and urgency UI on QoL using baseline, 6-month and 12month survey data on four-recall of symptoms. A series of logistic regression models with generalized estimation equation (GEE) method were used to compare individuals with an IIQ-7 score that fell in the lower two quintiles (0–40 percentile) (i.e., those with an IIQ-7 score of 0) to the third and fourth quintiles (41–80 percentile, IIQ-7 4.76–28.57) and to the fifth quintile (81–100 percentile, IIQ-7 >28.57). All statistical tests were two-sided with a p-value of less than 0.05 as a statistical significance. Results: The odds ratios (ORs) in Table 1 represent the odds of an association between urgency UI, stress UI, and their interaction with IIQ-7, controlled for baseline demographic characteristics. In Model I (IIQ-7: 0–40 % versus 41–80%ile), urgency UI and stress UI scores were significantly associated with IIQ-7. The ORs were substantially greater for urgency UI scores 2–4 versus 0: OR=3.52 (95 % CI=3.06–4.04); 5–6 versus 0: OR= 4.99 (95 % CI = 4.02–6.19) and 7–8 versus 0: OR = 6.93 (95 % CI=4.81–9.99) than they were for stress UI scores (2–4 versus 0–1: OR=1.62 (95 % CI=1.43– 1.83); 5–6 versus 0–1: OR=3.02 (95 % CI=2.44–3.72); and 7–8 versus 0–1: OR=2.89 (95 % CI=2.17–3.84). Model II was the same as Model I, only two interaction terms were marginally significant, and there was no significant change in the individual urgency or stress
S103
UI ORs when compared to model I. In model III (IIQ-7: 0–40 % versus 81–100%ile), the individual ORs for urgency and stress UI were higher than in model I, with urgency UI being much higher than stress UI. Finally, in model IV, adding the interaction terms to model III resulted in a reduction in all ORs, and especially for stress UI where only 7–8 versus 0–1 remained significant with an OR = 2.78 (95 % CI = 1.45–5.34). Furthermore, all interaction terms were now significant, indicating that -the impact on QoL for an IIQ-7 score over the 80th percentile is mainly due to the interaction between urgency and stress UI. Conclusions: A significant share of the impact of the joint occurrence of stress and urgency UI on those with more severe IIQ-7 is explained by the interaction between these two conditions. Findings from this study raise new questions about the pathophysiology of mixed UI, namely whether stress UI, at higher severity levels, potentiates the effect of urgency UI on QoL.
References: N/A Disclosure Block: Vatche Minassian: No disclosures. Haiyan Sun: No disclosures. Xiaowei Yan: No disclosures. Deserae Clarke: No disclosures. James Pitcavage: No disclosures. Jessica Runge: No disclosures. Walter Stewart: Allergan: Consultant, Consulting Fee. Genentech: Consultant, Consulting Fee. Pfizer: Funding for a research project on low back pain, Grant/Research Support. Roche: Funding for a research project on Rheumatoid arthritis, Grant/Research Support.
S104
OP 027 ATTRIBUTABLE RISK OF PARITY AND BMI ON STRESS URINARY INCONTINENCE V. A. MINASSIAN1, X. YAN 2, R. PLATTE 3, H. SUN 2, D. N. CLARKE 4, J. M. PITCAVAGE 2, J. M. RUNGE 2, W. F. STEWART 5; 1 Brigham and Women’s Hosp., Boston, MA, 2Geisinger Ctr. for Hlth. Res., Danville, PA, 3Female Pelvic Med. and Urogynecology Inst., Grand rapids, MI, 4Geisinger Hlth. System, Danville, PA, 5Sutter Hlth., Walnut Creek, CA. Introduction: Urinary incontinence (UI) is highly prevalent and expressed as either stress (SUI), urgency (UUI), or mixed UI (MUI). Childbirth is a well established risk factor where the relationship appears to be specific to SUI. There is little information on what share of SUI is attributable to parity and whether its effect is generalizable across the spectrum of SUI symptom severity. The fact that SUI also occurs among nulliparous women suggests that parity explains only a share of SUI, and that there are etiologic variants of SUI associated with other risk factors (e.g., BMI, diabetes). Knowing the attributable risk (AR) of SUI explained by childbirth, BMI, and other risk factors would help address questions about SUI etiologic subtypes. Objective: We used data from the Generalized Longitudinal Overactive Bladder Evaluation-Urinary Incontinence (GLOBE-UI) to estimate the AR of SUI from different levels of parity and BMI. Methods: GLOBE-UI is a longitudinal study of women ≥40 years of age. Primary care patients from a large integrated health system were randomly recruited by mail. Women received the Bladder Health Survey (BHS) at baseline and every 6 months thereafter. The BHS, a validated questionnaire, was designed to assess lifetime, 6 months, and 4-week UI symptoms. We used 4-week recall questions on UI symptoms from four different surveys. The SUI score was expressed as an ordinal variable ranging from 0 to 8. We estimated the effect of various levels of parity (1, 2, 3, and 4+) on each SUI severity level, and severity levels were combined if the effects were similar. The final SUI severity groups were SUI=1, 2, 3–4, and 5+. A series of logistic regression analyses were performed adjusting for potential risk factors (age, BMI, marital status, education, alcohol, smoking, diabetes, hysterectomy, and others). We then estimated AR by parity and BMI. All statistical tests were two-sided with a p-value of less than 0.05 considered as a cut-off for statistical significance. Results: Of the 6,960 female respondents, 6,058 had valid SUI responses and were used for the study. Among them, 2,482 (41 %) had an SUI score of 1+. Women with SUI severity score of 3+ were 4 years younger compared to SUI score of 0–2 (mean age=58 versus 62), more likely to smoke, overweight (or obese) and have more births. Asthma and COPD were more prevalent among women who had SUI
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
score of 5+. Table 1 represents the odds ratios (OR) of parity and BMI on different SUI severity score levels. Except for an SUI score of 3–4, parity was consistently associated with SUI, with its effect being strongest for SUI=5+ versus 0. Being overweight or obese was significantly associated with SUI, across all SUI severity levels. In addition, BMI (versus parity) was more strongly associated with SUI. Adjusting for confounders did not result in any significant change in the OR of the association between parity, BMI, and SUI. Table 2 represents the proportion of SUI symptoms by level of severity that are explained (AR) by parity and BMI in our cohort of 6,058 women. For example, the AR of SUI=2 from parity=2 is 5.9 %; the AR of SUI=2 from a BMI=30–35 kg/m2 in the same woman is an additional 11 %. Conclusions: Both BMI and parity are significantly associated with SUI, with BMI having a stronger impact. The AR of SUI by parity level does not vary much. However it does increase significantly with increasing BMI. Knowing the AR of SUI by parity, BMI, and other risk factors will help better understand pathophysiology and etiologic subtypes of SUI.
References: N/A Disclosure Block: Vatche Minassian: No disclosures. Xiaowei Yan: No disclosures. Raisa Platte: No disclosures. Haiyan Sun: No disclosures. Deserae Clarke: No disclosures. James Pitcavage: No disclosures. Jessica Runge: No disclosures. Walter Stewart: Allergan: Consultant, Consulting Fee. Genentech: Consultant, Consulting Fee. Pfizer: Funding for a research project on low back pain, Grant/Research Support. Roche: Funding for a research project on Rheumatoid arthritis, Grant/Research Support.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
OP 028 TRIATHLETE RISK OF PELVIC FLOOR DISORDERS, PELVIC GIRDLE PAIN AND THE FEMALE ATHLETE TRIAD J. YI1, S. TENFELDE 1, D. TELL 2, C. BRINCAT 1, C. FITZGERALD 1; 1 Obstetrics and Gynecology, Loyola Univ. Med. Ctr., Maywood, IL, 2Loyola Univ. Med. Ctr., Maywood, IL. Introduction: There has been a recent surge in the popularity of triathlon events for women that encompass endurance cardiovascular training in swimming, cycling and running. High impact sports, like triathlons, have been linked to a risk of pelvic floor disorders (PFD).1 Due to the impact on the pelvic floor and pelvic girdle, there may be a significant prevalence of pelvic girdle pain (PGP). Female endurance sports have also been linked to decreased energy availability, menstrual irregularities and abnormal bone mineral density, known as the Female Athlete Triad (triad).2 An endocrinologic consequence of the triad is a hypoestrogenic state similar to menopause. Little is known about the pelvic floor consequences of coupling high impact pelvic floor activity and the potential for a hypoestrogenic state in young, otherwise healthy women. Objective: To estimate the prevalence of PFD among female triathletes and to determine if an association exits between PGP, PFD and the female athlete triad. Methods: We invited female members of triathlon interest groups around the USA to participate in this IRB-exempt study. Participants were contacted by using the USA Triathlon database of nationwide triathlon interest groups and by posting on a triathlete specific Internet forum. An email invitation was sent including a link to an online survey that included demographic, physical activity and reproductive history questions, the Epidemiology of Prolapse and Incontinence Questionnaire (EPIQ), the Pelvic Girdle Pain Questionnaire (PGPQ), and the Female Athlete Triad Screening Questionnaire. Percentage and continuous variables were analyzed using a Chi-square and Student’s T-test while correlations were analyzed with the Spearman Correlation using SPSS version 20.0 (Chicago, Illinois). Results: Two hundred fifty-nine triathletes with a median age range of 35–44 responded to the survey. Participants were white/Caucasian (88.4 %), nonsmokers (99.4 %) premenopausal (80 %) and had a mean BMI of 22.41 (14–40). Forty-six percent were parous and 95 % had vaginal deliveries. Most (82 %) were currently training for a triathlon (9.5 % Sprint, 26 % Olympic, 35 % Half-Ironman, 26.5 % Ironman, 3 % other). Mean weekly training was as follows: running: 3.7±1.2 days, biking 2.9 ± 1.1 days and swimming 2.5 ± 1.2 days.
S105
Respondents with PFD symptoms by EPIQ were 15 % Urgency Urinary Incontinence (UUI), 39 % Stress Urinary Incontinence (SUI), 10 % Mixed Urinary Incontinence and 5 % with pelvic organ prolapse (POP). Twenty-eight percent reported symptoms of anal incontinence (AI). Training mileage and intensity were not associated with PFD symptoms. Eighteen percent of respondents had PGP though it was not disabling per the PGPQ with a mean score of 26.7. Sacroiliac joint (SI) pain (Right 7 %, Left 7 %) occurred more frequently than pubic symphysis pain (4 %). Participants with SUI symptoms had a greater level of PGP (SUI p=0.05). AI frequency was not correlated to PGP. Eighty percent of respondents completed the triad questionnaire and 21 % screened positive for disordered eating, 24 % screened positive for menstrual irregularities, and 32 % screened positive for abnormal bone strength. Twenty-four percent screened positive for at least one arm of the triad. There was no significant associations found between EPIQ and the triad questionnaire. Conclusions: Forty-three percent of triathlete respondents reported either UUI or SUI symptoms by EPIQ. SUI respondents had higher levels of PGP than their asymptomatic counterparts. Twenty-four per cent of the triathletes reported at least one of the following: disordered eating, menstrual irregularities and abnormal bone strength. Triathletes who present for treatment of PFD should be examined for concurrent PGP and screened for the Female Athletic Triad. References: 1. Med Sci Sports Exerc. 2001 Nov;33(11):1797–802. 2. Med Sci Sports Exerc. 2007 Oct;39(10):1867–82. Disclosure Block: Johnny Yi: No disclosures. Sandi Tenfelde: No disclosures. Dina Tell: No disclosures. Cynthia Brincat: No disclosures. Colleen Fitzgerald: No disclosures.
OP 029 DISPARITIES IN AREAS OF KNOWLEDGE OF PELVIC FLOOR DISORDERS IN AFRICAN-AMERICAN AND OTHER WOMEN OF COLOR COMPARED TO CAUC ASIAN WOMEN D. T. MILLER1, C. L. MANDIMIKA 1, W. MURK 2, A. MCPENCOW 3, A. LAKE 1, L. YU 3, M. K. GUESS 3; 1 Yale Sch. of Med., New Haven, CT, 2Yale Sch. of Publ. Hlth., New Haven, CT, 3Yale Sch. of Med., New Haven, CT. Introduction: Knowledge about pelvic floor disorders (PFD) is lacking among women, with more pronounced knowledge deficiencies seen among women of color (1,
S106
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
2). This study aims to identify deficiencies in specific areas of knowledge of PFD amongst racial and ethnic groups. Objective: To assess areas of disproportionate knowledge about urinary incontinence (UI) and pelvic organ prolapse (POP) amongst women of color as compared to Caucasian women in an effort to identify areas for targeted education in specific populations. Methods: We conducted a cross-sectional, written survey of women’s knowledge of UI and POP in New Haven County, Connecticut from February 2010 to August 2011 using the validated Prolapse and Incontinence Knowledge Questionnaire (PIKQ). Women were stratified as White, African-American or Other Women of Color (OWOC, combined group of Hispanic, Asian or ‘Other’ women), based on self-designation. Each question had three possible responses: “yes”, “no”, and “I don’t know.” Wrong and “I don’t know” responses were considered incorrect. A passing score was defined as UI scale scores >60 % and POP scale scores >50 %. Logistic regression analysis was used to evaluate associations between lack of proficiency and race/ethnicity based on the type of knowledge reflected (etiology, diagnosis and treatments), as well as associations between race/ethnicity and incorrect responses to individual PIKQ questions. Associations were adjusted for age, household income, education, medical field employment, marital status and a reported history of urine leakage or POP. P value < 0.05 was considered statistically significant. Results: Four-hundred and thirty-one women were recruited to participate. The mean age of the respondents was 49.2± 17.9 years (range 19–98). The majority of respondents were White (63.9 %), with 22.4 % African-American, 6.3 % Hispanic, 3.1 % Asian, and 4.3 % other. Compared to White women, African-American and OWOC were more likely to incorrectly answer questions about UI etiology, POP etiology and POP treatments (Table 1). OWOC were also more likely to lack knowledge about UI treatments (Table 1). Table 1. Adjusted associations between lack of knowledge proficiency and race/ethnicity, by question type Question Race/ type Ethnicity UI Etiology AfricanAmerican OWOC
UI diagnosis
% Subjects not passing 57.0
Adjusted OR 2.99
54.4
3.49
95 % CI 1.67, 5.36 * 1.74, 7.01 *
White
30.1
Ref
AfricanAmerican
28.0
0.98
0.52, 1.88
OWOC
29.8
1.78
0.82, 3.83
Question type UI treatment
POP Etiology
POP diagnosis
POP treatment
Race/ Ethnicity White AfricanAmerican
% Subjects not passing 27.1 46.2
Adjusted OR Ref 1.17
OWOC
54.4
2.33
White AfricanAmerican
37.2 54.8
Ref 2.16
OWOC
59.7
2.94
White
41.4
Ref
AfricanAmerican OWOC
29.0
1.13
28.1
1.17
95 % CI
0.65, 2.10 1.17, 4.64 * 1.20, 3.89 * 1.43, 6.04 * 0.60, 2.14 0.54, 2.51
White
28.6
Ref
AfricanAmerican
60.2
2.55
1.40, 4.65 *
OWOC
61.4
3.02
1.47, 6.22 *
White
39.1
Ref
*: P<0.05. Compared to White women, African-American and OWOC were significantly less likely to know that urine leakage has many etiologies, to recognize female gender and childbirth as risk factors for UI or to know that exercises can be done to help control leakage. OWOC were also less likely to know that curative treatments are available for most women who leak and more women from this group thought that surgery was the only treatment for urine leakage compared to White women (OR 2.69, CI 1.32–5.50). Additionally, African-American and OWOC were significantly less likely than White women to know that POP can occur at any age, to know that childbirth is a risk factor for POP, to recognize pessaries as a treatment option for POP and to know that help is available once a patient has POP. Compared to White women, OWOC were also less likely to know that increasing age and daily heavy lifting are risk factors for POP, to recognize pelvic heaviness or pressure as symptoms of POP, to know that exercises can be done to prevent progression of POP or that surgery is a treatment option for POP. Conclusions: Our findings suggests that there are significant disparities in baseline knowledge levels of risk factors, symptoms and treatment options of UI and POP between AfricanAmerican women and OWOC compared to White women. There is a strong need for targeted, culturally-sensitive educational programs to improve patient knowledge about UI and POP. Such interventions should focus on risk factors and preventative strategies, as well as early interventions to help reduce the personal and economic burden of PFD, which have proven negative effects on women’s quality of life.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
References: 1. Am J Obstet Gynecol. 2014 Feb;210(2):165.e1-9. 2. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Oct;19(10):1371–8. Disclosure Block: Devin Miller: No disclosures. Charisse Mandimika: No disclosures. William Murk: No disclosures. Alexandra McPencow: No disclosures. AeuMuro Lake: No disclosures. Lissa Yu: No disclosures. Marsha Guess: No disclosures.
OP 030 VALIDATION OF SPANISH VERSION OF THE PROLAPSE QUALITY OF LIFE QUESTIONNAIRE (PQOL) FOR CHILEAN WOMEN C. FLORES ESPINOZA1, A. X. ARAYA 2, M. FERRER 3, O. GARIN 4, J. PIZARRO-BERDICHEVSKY 5, A. PONT 6; 1 Nursing School, Pontificia Univ. Católica of Chile, Santiago, Chile, 2Pontificia Univ. Católica of Chile, Santiago, Chile, 3 IMIM Inst. Hosp. del Mar d’l Investigacions Mèdiques, Barcelona, Spain, 4 IMIMHosp. del Mar Med. Res. Inst., Barcelona, Spain, 5H. Dr. Sotero del Rio; Univ. Catolica; Clev, Cleveland, OH, 6IMIM - Inst. Hosp. del Mar d’Investigacions, Barcelona, Spain. Introduction: The prevalence of Pelvic Organ Prolapse (POP) is estimated at 2.04 per 1000 women/year (1). Prolapse symptom severity and quality of life impact are key factors for treatment decision (2). P-QOL (3) is a specific Health Related Quality of Life instrument for POP, with 38 items covering 9 domains (general health perception, prolapse impact, physical limitation, role limitations, social limitations, emotions, sleep/energy and severity measures). There are no instruments specifically designed to evaluate symptoms or quality of life for Chilean POP patients. Objective: Our aim was to adapt the P-QOL into Chilean Spanish, to prove its conceptual equivalence with the original version, as well as, to assess its feasibility, reliability and validity. Methods: For the adaptation into Spanish we used the forward and back-translation method, with expert panels and cognitive debriefing patient interviews. A cross-sectional study was performed with women over 18 years old and without prior POP surgery, recruited in an outpatient urogynecology clinic. Socio-demographic and clinical data were registered and the P-QOL questionnaire was selfadministered. Reliability was evaluated in terms of internal consistency with Cronbach’s alpha coefficient (considered adequate if higher than 0.7 for group comparisons). Construct validity of the P-QOL was assessed by applying
S107
known groups strategy based on the severity of both, urogenital and bowel symptoms. ANOVA was used to test differences among groups. Results: One hundred and twenty-eight women met inclusion criteria. Mean age of women was 53.1 years; median of the time period from first symptoms was 24 months (IQR 12–48 months) and 93.2 % of women presented a POP-Q stage > II. P-QOL items were fully answered by women. Mean scores were: 53.5 (SD = 22.3) for general health perception, 75.5 (SD = 28.5) for prolapse impact, 55.3 (SD = 38) for role limitations, 55.5 (SD = 37.1) for physical limitations, 32.6 (SD = 33.6) for social limitations, 51.2 (SD = 37) for personal relationship, 56.9 (SD = 34.3) for emotions, 51.4 (SD = 32.6) for sleep/energy and 47.1 (SD = 25.9) for severity measures. Cronbach’s alpha reliability coefficient ranged from 0,626 to 0,866 across domains. Score means were significantly different among severity groups, both for urogenital and bowel symptoms (p < 0.001), for most P-QOL dimensions. Conclusions: These results support the use of this crossculturally adapted version of the P-QOL in Chilean women with symptomatic POP, as a reliable, consistent and valid instrument to assess symptoms severity and quality of life impact of this condition in clinical practice and research. References: 1. Mant J, Painter R, Vessey M. Br J Obstet Gynaecol. 1997 May;104(5):579–85. 2. Barber M, Brubarker L, Nygaard I, Wheeler T, Schaffer J, Chen Z, et al. Obs Gynecol. 2010;114(3):600–9. 3. Digesu GA, Khullar V, Cardozo L, Robinson D, Salvatore S. Int Urogynecol J Pelvic Floor Dysfunct. 2005:16(3):176–81. Disclosure Block: CLAUDIA FLORES ESPINOZA: No disclosures. Alejandra Araya: No disclosures. MONTSERRAT FERRER: No disclosures. Olatz Garin: No disclosures. Javier Pizarro-Berdichevsky: No disclosures. Angels Pont: No disclosures.
OP 031 CREATING A PELVIC ORGAN PROLAPSE UTILITY SCALE D. PATTERSON1, K. LEUNG 1, J. E. WARE 2; 1 OB/GYN, Univ. of Massachusetts, Worcester, MA, 2 Quanitative Health Sciences, Univ. of Massachusetts, Worcester, MA. Introduction: Health state utility values are important for accurate cost-utility analysis, decision analysis and
S108
health related quality of life studies. Utility values range from 0 representing the worst possible health state (death) to 1 representing the best possible health state (perfect health). To date, studies that have estimated the utility of pelvic organ prolapse in women have relied on expert opinion and have considered all degrees and types of pelvic organ prolapse together. Validated questionnaires that address symptom bother and impact on daily activities related to pelvic floor disorders are available, but none have been converted into a utility value. Precisely defining utility values for pelvic organ prolapse will allow better cost utility analyses and decision analyses regarding treatment options. Objective: To create a pelvic organ prolapse health utility index and to determine its relationship with overall prolapse stage. Methods: A ten item questionnaire was created incorporating general quality of life (QOL) and prolapse specific questions. Prolapse-specific questions covering seven domains were adapted from existing validated symptom and bother questionnaires. Each domain had a 4-level Likerttype response scale. In order to achieve content validity, items described a range of domains of QOL that can be affected by prolapse including symptoms, household activities, physical functioning, travel, social functioning, emotional health, and sexual activity. Three general QOL questions were adapted from existing validated questionnaires. One of the general QOL questions was a visual analog scale (VAS); the other two used a 5-level Likert response scale. The questionnaire was given to 150 women who presented for care of prolapse at the urogynecology clinic of a US academic medical center. Information on demographics and past medical history was obtained prospectively. Prolapse was graded using the pelvic organ prolapse quantification (POP-Q) system by a faculty member. Factor analysis was performed and Cronbach’s alpha was estimated for multi-item scales. A standardized score was created and scored from 0 to 1 to estimate utility values. A linear regression was then performed to determine the relationship between the utility score and overall prolapse stage. Results: Of the 150 women who participated in the study, none had stage 0 or 1 prolapse. There were 65 subjects with stage 2 prolapse, 79 with stage 3 prolapse and 6 with stage 4 prolapse. A 9-item overall QOL scale, omitting the VAS which did not correlate well with the other items, achieved a satisfactory Cronbach’s alpha of 0.861. Factor analysis showed a single factor with high loadings for the 9 items and accounting for 95.2 % of the item variances. The mean utility score was not significantly different among the three prolapse stages (p = 0.877). The mean for stage 2 was 0.67
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
(0.24), stage 3 was 0.66 (0.23) and stage 4 was 0.62 (0.30) (see Table 1). Conclusions: The results show that we have a reliable scale with good content validity. To achieve the content validity we used a range of questions that covered multiple domains to create a single overall utility score. These results suggest that the utility of prolapse can be represented as 0.66, but on average it is not related to prolapse stage. A utility score of 0.66 is consistent with other medical conditions such as asthma, hypertension and irritable bowel syndrome with typical values for most conditions in the 0.6 to 0.8 range. The lack of correlation between stage and utility score may represent the varied individual experience of prolapse. This variability observed within each stage warrants further study to understand the relationship between utility value and prolapse stage. References: Utility Score by Prolapse Stage Prolapse Stage
Mean
Standard Deviation
Minimum Value
Maximum Value
Stage 2 (n=65)
0.67
0.24
0.12
1.00
Stage 3 (n=78)
0.66
0.23
0
1.00
Stage 4 (n=6)
0.62
0.30
0.23
0.92
Total (n=149)
0.66
0.24
0
1.00
Disclosure Block: Danielle Patterson: No disclosures. Katherine Leung: No disclosures. John Ware: No disclosures.
OP 032 EFFECT OF HORMONAL CONTRACEPTION ON PELVIC FLOOR FUNCTION: A SYSTEMATIC REVIEW P. M. LATTHE1, R. CHAMPANERIA 2, R. F. MAMPRIN D’ANDREA 3; 1 Dept. of urogynaecology, Birmingham Women’s NHS Fndn. Trust, Birmingham, United Kingdom, 2Univ. of Birmingham, Birmingham, United Kingdom, 3Dept. of urogynaecology, Univ. of Birmingham, Birmingham, United Kingdom. Introduction: Pelvic floor muscles provide support to the organs that lie on it. These organs include the uterus, intestines, bladder and rectum. As well as this, the urinary and anal sphincters give conscious control over the bladder and bowel, respectively, so that there is control over the release of urine, faeces and flatus allowing us to delay emptying until it is convenient.
S109
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
When the pelvic floor muscles are contracted, the internal organs are lifted and the sphincters tighten the openings of the vagina, anus and urethra. Relaxing the pelvic floor allows passage of urine and faeces. Pelvic floor muscles are also intricately related to sexual function. Pelvic floor functioning is closely linked to a healthy female sexual cycle with female sexual disorders often being associated with concomitant pelvic floor disorders. Oral contraceptive use has been investigated in most if not all the organs lying on the pelvic floor. However, only its use for treating menstrual disorders has been widely recognised. Here we look at the effect of hormonal contraception on bladder, urinary and vaginal symptoms as well as sexual function. Objective: We undertook a systematic review and metaanalysis to evaluate the effect of hormonal contraception on pelvic floor function, in women of reproductive age. Methods: Electronic literature database searches were conducted from database inception until September 2013. Search strategies consisted of keywords and medical subject headings for the key concept terms of ‘contraception’, ‘bowel’, ‘urinary’, ‘vaginal’ symptoms and ‘sexual function’. Eligible studies evaluated bowel, urinary, or vaginal symptoms or sexual function in women taking oral contraception. Two reviewers independently screened the citations for inclusion and extracted data on study characteristics, results and quality. Data on similar outcomes were meta-analysed whenever possible. Results: Of the 381 citations identified, 12 were included in our review. Due to the variation in study designs included, different quality scales were used. Overall quality was good although validated questionnaires were not used even in the large cohort studies. Data were meta-analysed wherever possible and presented as incidence. Results indicate statistically significant links between interstitial cystitis and oral contraception use either current or in the past (2.31 [1.03, 5.16] p=0.04). The studies included in the systematic review suggest that current or past contraceptive use might be inversely associated with dyspareunia but have no effect on any type of urinary incontinence. Conclusions: Results of our review suggest that oral contraception may play a role in some conditions affecting pelvic floor function. A systematic review and meta-analysis can only be as robust as the studies included. Most of the studies were of retrospective or case control design, which are associated with their own drawbacks. Hence a temporal relationship and causal association cannot be established definitively. Few studies did not provide any data (other than P values) for meaningful conclusions.
Robustly conducted randomised trials would be ideal but not feasible. Adequately large prospective cohort studies using valid instruments (eg PFDI 20) for studying the effect of contraceptive hormones on pelvic floor function is being designed by our group. References: 1. Fertility & Sterility 2009;92(2):428–33. 2. Menopause 2013;19(4):155–62. Figure 1: Meta-analysis of studies showing risk of interstitial cystitis is higher with history of oral contraceptive use ever Contraceptive use Study or Subgroup
Non-contraceptive use
Events
Total
Events
Gardella 2011
37
131
10
Warren 2011
275
532
37
Total (95% CI) Total events
663 312
Odds Ratio
M-H, Random, 95% CI
104
43.0%
93
57.0%
1.62 [1.03, 2.54]
197 100.0%
2.31 [1.03, 5.16]
M-H, Random, 95% CI
3.70 [1.74, 7.87]
47
Heterogeneity: Tau² = 0.24; Chi² = 3.41, df = 1 (P = 0.06); I² = 71% Test for overall effect: Z = 2.04 (P = 0.04)
Odds Ratio
Total Weight
0.1
0.2
0.5
1
2
5
10
Favours [contraception] Favours [no-contraceptio]
Disclosure Block: Pallavi Latthe: Astellas: Speaker, Honoraria. Pfizer: Speaker, Honoraria. June Medical: Consultant, trip to Berlin to see the mesh implantation by Prof Tunn. Rita Champaneria: No disclosures. Ruben MAMPRIN D’ANDREA: No disclosures.
OP 033 AGE-SPECIFIC INCIDENCE FOR URINARY INCONTINENCE AND SUBTYPES X. YAN1, W. F. STEWART 2, H. SUN 1, S. KORUKONDA 1, J. M. PITCAVAGE 1, J. M. RUNGE 1, V. A. MINASSIAN 3; 1 Geisinger Ctr. for Hlth. Res., Danville, PA, 2Sutter Hlth., Walnut Creek, CA, 3Brigham and Women's Hosp., Boston, MA. Introduction: Age specific incidences of Urinary Incontinence (UI) offer important etiological clues. Previous estimates varied substantially due to variation in case definition, and to a lesser degree, incidence UI episodes are common, especially in female older than 50 years, it may be difficult to distinguish such episodes from clinical meaningful UI, thus the measurement error is large, and estimates usually didn’t consider those measurement error. Besides, in order to get agespecific UI subtypes, such as stress UI, urgency UI, and mixed UI, it required to have well-established definitions for SUI subtypes, and accurate recall the subtype at UI onset, which was usually not available in survey study. Established Methods: exist for other chronic conditions that accurately estimate age-specific incidence from cross-sectional data without the need for longitudinal follow-up.
S110
Objective: We will use cross-sectional survey data to estimate age-specific incidence of urinary incontinence (UI) for women. Moreover, subtypes of UI, urgency UI (UUI), stress UI (SUI) and mixed UI (MUI), were determined by the survey questionnaires, which allows us to estimate age-specific incidence for subtypes of UI. methods We used baseline survey questionnaire from the General Longitudinal Overactive Bladder Evaluation-UI (GLOBE-UI) study in women ≥40 years of age. UI screening questions were used to determine UI status (incident, active, not active, not a case), and age onset of UI was self-reported if individual meets UI definition. Four-weeks recall questions were used to derive 0–8 point severity scores for stress UI and urgency UI, which were used to determine subtype of UI. A semi-parametric Bayesian bivariate smoothing approach is used to estimate age-specific incidence rates from this cross-sectional survey data, where the incidence rate is modeled by a smooth function of age and lag (difference between current age and onset age), and smaller weights are given to large lag as they are subject to larger measurement error. The method is used to estimate age-specific incidence for any UI and for subtypes of UI. Sensitivity test was performed to test how UI subtype severity score affects age-specific incidence. Results: 6,993 subjects answered the baseline survey with mean age of 61.8 (sd= 12.7), and UI screening status were limit to incident and active cases. 22 subjects with “Unknown and uncertain” case status were excluded. Figure 1 shows for any UI, the age-specific incident rates gradually increases with age from age of 40 until reaches a plateau between age of 53–60 years, where the incidence rates is about 1.7 %, and rapid increases after age of 65 years. At age of 80, incidence rate is about 5.0 %. For urgency UI subtype, the agespecific incidence pattern is similar to any UI, but with smaller incidence rate: incidence rate for age of 80 years is 3.0 %. For stress UI subtype, incidence rate almost linearly increases with age, and at age of 80 the incidence rate is about 1.2 %. Incidence rate for mixed UI is very low (<1 %) across all age groups, the incidence of co-occurrence of SUI and UUI is higher after age 75 years. Conclusions: Age-specific incidence rates estimated from cross-sectional survey data are consistent with published results from different studies. The incidence rate of UI rapid increases after age 65, and is about 5.0 % at 80 years of age. Before age of 70 years, incidence rate for urgency UI and stress UI are almost even, while urgency UI overrides stress UI after age 70. SUI and UUI are likely to co-occur after age of 75 years. References: N/A
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Disclosure Block: Xiaowei Yan: No disclosures. Walter Stewart: Allergan: Consultant, Consulting Fee. Genentech: Consultant, Consulting Fee. Pfizer: Funding for a research project on low back pain, Grant/Research Support. Roche: Funding for a research project on Rheumatoid arthritis, Grant/Research Support. Haiyan Sun: No disclosures. Saritha Korukonda: No disclosures. James Pitcavage: No disclosures. Jessica Runge: No disclosures. Vatche Minassian: No disclosures.
OP 034 DO LEVATOR ANI MUSCLE HIATAL DIMENSIONS CHANGE OVER TIME IN WOMEN WITH PELVIC ORGAN PROLAPSE? I. M. VAN GRUTING, R. THAKAR, A. H. SULTAN; Obstetrics and Gynaecology, Croydon Univ. Hosp., London, United Kingdom. Objective: (1) To study changes in levator ani muscle (LAM) hiatal dimensions in women with symptomatic pelvic organ prolapse (POP) with and without surgical intervention using 3D endovaginal ultrasound (EVUS). (2) To correlate hiatal changes with signs and symptoms of prolapse. Background: LAM avulsion is associated with POP [1]. Diagnosis of LAM avulsion and hiatal biometry using EVUS has shown an excellent intra- and inter-rater reliability in parous women [2]. Increased LAM hiatal size is associated with increasing POP severity [3]. Long-term changes in hiatal biometry in women with symptomatic POP with and without surgery are not known.
S111
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Methods: In this prospective longitudinal study women with symptoms of POP were seen over a 4 years’ time period; at the initial visit, 3 months after the operation, after 1 and 4 years. At each visit, POP symptoms were assessed using the electronic Personal Assessment Questionnaire (ePAQ). Stage of POP was assessed using POP-Q and 3D EVUS was performed using the high frequency (9–16 MHz) 360° rotational probe (Type 2052, B-K Medical). Hiatal biometry and assessment of LAM avulsion were performed in the plane of the minimal hiatal dimensions. The hiatal dimensions measured were anterior-posterior (AP), left-to-right (LR) and area. Women were divided into two groups; with and without LAM avulsion. All scans were analysed by an independent investigator, blinded to clinical findings. Analyses were performed using SAS 9.2 and SPSS 20. A linear mixed model was used, with a compound symmetry covariance structure for the repeated measures of the same woman. All analyses were adjusted for age, ethnicity and parity. Results: 93 women with symptoms of POP were recruited. 48 women underwent surgical intervention and 45 women chose for conservative management. There was no significant difference between the groups in age, parity, ethnicity and number of avulsions (14 and 13 respectively). Follow-up rate was 88 % (n=82) at 1 year and 84 % (n=78) at 4 years. In the operation group (Table 1), there was no significant change in measurements in all visits, except for hiatus LR diameter which decreased 3 months after operation. Women with a LAM avulsion showed significantly bigger LR diameters at all visits compared to women with no LAM avulsion. However in both groups there was no significant change of all dimensions over time. Twenty (49 %) of the women attending the fourth visit had POP stage 2 or higher (12 asymptomatic, 8 symptomatic). Ten women had a recurrence of POP in the same compartment (9 anterior, 1 middle). Thirteen women developed a new POP in a different compartment (8 posterior, 5 anterior). Women with a LAM avulsion had a significantly higher chance of recurrence of prolapse (39 %, P=0.001) or a new prolapse (39 %, P=0.019) compared to women with an intact LAM (19 % and 26 % respectively). In the women without operation, only the hiatus AP diameter increased significantly after 4 years. Only women with avulsion showed a significant increase in hiatal dimensions at the fourth visit. Nine women (20 %) had a prolapse repair operation more than 1 year after the initial visit. However the prolapse symptoms in the rest of the group did not get significantly worse after 4 years in women with and without LAM avulsion. POP-Q stage on the other hand became significantly worse over time, from mean stage 1.64 to 2.06 p=0.008, with no difference between the intact and avulsion group. 36 % had worsening of the existing prolapse, 8 developed an additional
prolapse in another compartment (5 anterior, 2 posterior, 1 middle). There was no difference in any of the LAM hiatal measurements between the conservative and the surgical group. Conclusions: Although a prolapse operation does not influence hiatal biometry in women with or without LAM avulsion, conservative management is associated with significant worsening of hiatal dimensions in women with avulsion. Women with LAM avulsion have an increased risk of developing a recurrent or new prolapse. This information could be useful to counsel patients but also to surgeons in choosing the appropriate surgical technique. References: [1] BJOG 2008 8:979–84 [2] Ultrasound Obstet Gynecol 2013 doi:10.1002/uog.13193 [3] Obstet Gynecol. 1998 3:364–8 Figure 1 LAM biometry in women with POP Operation LAM
Conservative management Total LAM LAM
Total LAM Intact
Avulsion
Hiatus LR (mm) Hiatus AP (mm) Hiatus Area (mm2) Visit 2
40.1
38.4
45.0†
39.9
38.6
44.5†
56.7
56.3
58.5
56.2
55.9
57.6
18.8
17.8
21.4†
18.4
17.7
20.8†
Hiatus LR (mm) Hiatus AP (mm) Hiatus Area (mm2) Visit 3
38.7^ 37.8
41.7^/†
N/A
N/A
N/A
56.6
56.4
58.1
17.9
17.2
20.1†
Hiatus LR (mm) Hiatus AP (mm) Hiatus Area (mm2) Visit 4
39.6
38.6
42.8†
39.6
37.9
45.0†
56.3
56.5
56.4
56.6
56.0
59.0
17.9
17.6
19.1
18.3
17.2
21.6†
Hiatus LR (mm) Hiatus AP (mm) Hiatus Area (mm2)
39.4
37.8
44.1†
40.2
38.3
45.7†
56.8
57.0
57.1
57.7
60.3^
18.1
17.5
19.9
58.4^/ ^^^ 19.4
18.2
22.7^
Intact Avulsion
Visit 1
^= Significant difference compared to the 1st visit ^^^= Significant difference compared to the 3rd visit † = Significant difference compared to the intact group
S112
Disclosure Block: Isabelle van Gruting: No disclosures. Ranee Thakar: No disclosures. Abdul Sultan: No disclosures.
OP 035 DECREASED URETHRAL VOLUME ON 3-D ENDOVAGINAL ULTRASOUND IS COMPARABLE TO BLADDER NECK FUNNELING ON FLUOROSCOPY AS A PREDICTOR OF INTRINSIC SPHINCTER DEFICIENCY A. C. SANTIAGO1, D. E. WHITE 2, L. H. QUIROZ 3, S. SHOBEIRI 4; 1 IUGA International Research Fellow, Univ. of Oklahoma Hlth.and Sci. Ctr., Oklahoma City, OK, 2Univ of Oklahoma HSC, Oklahoma City, OK, 3Univ. of Oklahoma Hlth. Sci., Oklahoma City, OK, 4 The Univ. of Oklahoma HSC, Oklahoma City, OK. INTRODUCTION: One main goal of imaging studies in stress urinary incontinence is to detect the presence of intrinsic sphincter deficiency (ISD). Bladder neck funneling on fluoroscopy has been utilized for this purpose.1 Most studies 2 have shown a correlation between funneling and a lower maximal urethral closure pressure but it is unclear if funneling is associated with morphologic changes of the urethral sphincter complex. OBJECTIVES: The aims of this study were 1) to determine whether there is an association between presence of funneling on fluoroscopy and urethral sphincter comple x measurements o n three- dimensional endovaginal ultrasound (3-D EVUS) and 2) to determine and compare the reliability of funneling versus urethral volume measurement in the detection of ISD. METHODS: This was a retrospective analysis which included stress incontinent women seen at our institution between January 2011 and August 2013 who had undergone 3-D EVUS. Patients were dichotomized into those: 1) with ISD (Valsalva leak point pressure <60 cm H2O) and 2) with no ISD. The presence of bladder neck funneling was diagnosed by fluoroscopic images obtained at the time of urodynamics. Funneling was diagnosed when the opening of the proximal urethra was seen with two sharp lines representing the internal limits of the diverging urethral wall (without contrast medium) or when the contrast medium entered the proximal urethra.3 Measurements of the length, horizontal diameter, cross-sectional area, volume of the urethra, and the length, width, and area of the rhabdomyosphincter (RMS) and smooth muscle (SM) were obtained from 3-D EVUS images. Summary statistics were calculated for the patient population. Means were compared using t-tests. Proportions were compared using Pearson’s chi-square test. A p-value of <0.05 was
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
considered significant for analyses. Sensitivity, specificity, positive and negative predictive values, and likelihood ratios were obtained for both funneling and urethral volume measurement of <35 cm3 as predictors for ISD. RESULTS: 54 patients with stress urinary incontinence were identified. 21/54 (38.9 %) had ISD and 33/54 (61.1 %) had no ISD. The average age was 57.3 years (SD±11.9), the median parity was 1.6 (range 0, 4), and the mean body mass index was 28.9 kg/m2 (SD±5.7). Of these, 25/54 (46.3 %) had evidence of funneling. The urethral volume was significantly smaller in the ISD (25.27 cm3) versus no ISD (39.28 cm3) group (p= 0.0002). For those who had funneling, the ISD group had a lower urethral volume measurement compared to the no-ISD group (27.79 cm3 versus 40.72 cm3; p=0.0019). For those who did not have funneling, the ISD group still had a lower urethral volume compared to the no-ISD group (17.21 cm3 versus 38.73 cm3; p=0.0054). A urethral volume of <35 cm3 had a sensitivity of 81 % and a specificity of 64 % for the presence of ISD and did not significantly differ from funneling as predictor for ISD. The RMS and SM measurements were not significantly different in both groups. The reliability measurements of funneling and urethral volume are reflected in Tables 1A and 1B. CONCLUSIONS: Decreased urethral volume on 3-D EVUS is associated with ISD. A urethral volume of 35 cm3 as a cutoff provides the same reliability as fluoroscopic funneling for diagnosis of Valsalva leak point pressure <60 cm H2O. REFERENCES: A) Funneling on Fluoroscopy
B) Urethral Volume on 3-D EVUS
(+) ISD
(−) ISD
TOTAL
(+) ISD
(−) ISD
TOTAL
(+) Funneling
16
9
25
<35 cm3 Volume
17
12
25
(−) Funneling
5
24
29
>35 cm3 Volume
4
21
29
TOTAL
21
33
54
TOTAL
21
33
54
95 % Confidence Interval Estimated Value
Lower Limit
Upper Limit
Sensitivity
0.762
0.525
0.909
Specificity
0.727
0.542
0.861
Positive Predictive Value Negative Predictive Value Positive Likelihood Ratio Negative Likelihood Ratio
0.640
0.426
0.813
0.828
0.635
0.935
2.793
1.524
5.122
0.327
0.149
0.719
1
95 % Confidence Interval Estimated Value
Lower Limit
Upper Limit
Sensitivity
0.810
0.574
0.937
Specificity
0.636
0.451
0.790
Positive Predictive Value Negative Predictive Value Positive Likelihood Ratio Negative Likelihood Ratio
0.586
0.391
0.759
0.840
0.631
0.947
2.226
1.354
3.658
0.299
0.120
0.748
Urology 2003; 61: 936–941. Utrasound Obstet Gynecol 2005; 26: 287–292. 3 Urology 1996; 47: 452–453. Table 1 A and B. Disclosure Block: Andrea Santiago: No disclosures. Dena White: No disclosures. Lieschen Quiroz: No disclosures. S. Abbas Shobeiri: POP Medical: Consultant, Consulting Fee. Lifecell: Consultant, Consulting Fee. 2
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
S113
OP 036 THE RELATIVE CONTRIBUTION OF VAGINAL ATTA CHMENT AND VAGINAL WALL FAILURE IN DETERMINING CYSTOCELE SIZE: STATISTICAL ANALYSIS USING 3D STRESS MRI DATA L. L. CHEN1, S. LISSE 2, K. LARSON 3, J. A. ASHTONMILLER 1, J. O. DELANCEY 2; 1 Biomedical Engineering, Univ. of Michigan, Ann Arbor, MI, 2 Obstetrics and Gynecology, Univ. of Michigan, Ann Arbor, MI, 3 Eastern Virginia Med. Sch., Norfolk, VA. Introduction: Cystocele is, by far, the most common form of pelvic organ prolapse. Competing hypotheses exist concerning the factors responsible for cystocele formation. These include two “vaginal wall factors” (vaginal width and length) and two “attachment factors” (apical descent and paravaginal defect) related to its connection to the pelvic sidewalls. An enlarged hiatus associated with levator ani injury have also been implicated. Limited objective data exist to determine if these factors are equally important or if they are independent of one another. Objective: This study seeks to assess the relative contributions of the vaginal wall factors, attachment factors, and hiatus size to cystocele size and to test the null hypothesis that these factors each contribute equally and independently to predict cystocele size. Methods: Thirty women with a uterus and anterior predominant prolapse underwent 3D Stress MR imaging. 1 Subjects performed a maximal Valsalva maneuver for 17 s to obtain images with the prolapse protruding maximally. Bony landmarks including the pubic symphysis (PS), sacrococcygeal joint (SCJ) and the left and right Ischial Spines (IS_L and IS_R) were marked, allowing us to establish a consistent coordinate system using the Pelvic Inclination Coordinate System (PICS).2 Four equally spaced points along the anterior vaginal wall were marked as well as the posterior fornix, external cervical os, and anterior fornix on the all the slices where they were visible using 3DSlicer v4 (Fig. 1). Prolapse size was defined as the most inferior point on the vaginal wall. The paravaginal defect were quantified as the shortest distance from the lateral vaginal edge to the ipsilateral line drawn from pubis to ischial spine (P_IS) representing the expected location of the levator arch. The apical descent measured as external cervical os location and the hiatus size from PS to the perineal body was measured. Correlations and linear regression were used to examine the contribution of the various factors to the cystocele size.
Results: We reject our null hypotheses. The 2 vaginal factors, 2 attachment factors and hiatus size were neither independent nor equal in their contributions to cystocele size. The two attachment factors were strongly correlated with cystocele size (maximal paravaginal gap r=0.77, and cervix location r=0.63, p<0.05). The association of vaginal wall factors to the cystocele size is weaker; vaginal length is correlated with cystocele size (r=0.44, p<0.05) and the maximal vaginal width is not significantly correlated to the size of the prolapse. Hiatus size is strongly associated with cystocele size (r=0.79, p<0.05). The two attachment factors, apical location and maximum paravaginal gap, were correlated (r=0.66, p<0.05). Hiatus size is also highly correlated with the attachment factors (apical descent r=0.56 and paravaginal gap r=0.86, p<0.05). They were however not significantly correlated with vaginal wall factors. Linear regression shows that the combination of apical location and vaginal length explains 67 % of variation in cystocele size. Conclusions: The vaginal attachment factors (apical descent and paravaginal gap) and hiatus size predicted cystocele size better than the vaginal wall factors. Because attachment factors were strongly correlated they may be part of the same phenomenon. References: 1. 3D analysis of cystoceles using magnetic resonance imaging assessing midline, paravaginal, and apical defects. Int Urogynecol J. 2012;23:285–93 2. On pelvic reference lines and the MR evaluation of genital prolapse: a proposal for standardization using the Pelvic Inclination Correction System. Int Urogynecol J. 2013;24:1421–8. Disclosure Block: Luyun Chen: No disclosures. Sean Lisse: No disclosures. Kindra Larson: No disclosures. James Ashton-Miller: Johnson & Johnson: Speaker, Consulting Fee. Proctor & Gamble: Research grant to institution, Grant/Research Support. Boston Scientific: Research grant to institution, Grant/Research Support. John Delancey: Proctor and Gamble: Consultant, Consulting Fee.
S114
OP 037 THE ‘BOTHER’ OF OBSTRUCTED DEFECATION P. ALAM, I. KAMISAN ATAN, R. GUZMAN ROJAS, K. MANN, H. DIETZ; Urogynecology, Sydney Med. Sch. Nepean, Penrith NSW, Australia. Objective: To explore the relationship between visual analog scale (VAS) bother scores for obstructive defecation (OD) and demographic factors, symptoms and clinical findings. Background Patient-reported measures are increasingly used to assess urogynecological symptoms and monitor therapies. Questionnaires play an important role in clinical research, but are cumbersome to use in routine clinical settings. Physician administered VAS may be a practical alternative to assess bother related to urogynecologic disorders (1). Previous studies have shown that VAS bother scores are highly repeatable (2). There is little data, however, on how VAS bother scales correlate with symptoms and objective clinical findings of OD. Methods: All patients attending a tertiary urogynecological unit for pelvic floor disorders between January and October 2013 were included in this study. In addition to a standardized interview, a VAS was used to assess the bother of OD on a continuous scale, with 0 meaning “no bother at all” and 10 meaning “the worst bother”. Symptoms of OD included constipation; incomplete emptying; straining with bowel movements; and vaginal digitation to assist with emptying. Physical examination was performed to assess pelvic organ prolapse according to ICS POPQ. All patients underwent 4D translabial ultrasound (USN) in the supine position after voiding (3). USN volumes were analyzed at a later date blinded to all clinical data. Images were evaluated for position of the rectal ampula, depth of rectocele (if present), presence and descent of enterocele, and presence of intussusception using methods previously described. Linear regression and multiple regression statistical analysis were performed. Variables significant at p=0.1 were considered for the multivariate model, and backwards selection was used to produce a reduced model. A p value <0.05 was considered statistically significant. Results: During the inclusion period 292 patients were seen, however, 25 were excluded because imaging equipment was unavailable and 2 were excluded due to incomplete bother scores. Thus, 265 patients were included in analysis. In women reporting no symptoms the bother was assumed to be 0. A total of 61 % (n=161) of patients reported symptoms of OD and among these, 55 % reported bother from OD with a mean score of 5.6 (±2.7). On univariate analysis, the bother of OD was significantly associated with previous prolapse surgery and previous hysterectomy, Bp, pb and gh + pb and all USN parameters tested. On multivariate modelling, only previous prolapse surgery, previous hysterectomy, gh + pb and intussusception remained significant predictors of bother. Interestingly, the presence of intussusception was still
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
associated with a 4.3 times increase in bother (95 % CI: 2.3– 5.8, p<0.0001) after adjustment. Other variables’ effect on OD bother also remained similar to that found on univariate modelling. On multivariate modelling for anatomical abnormalities of the posterior compartment the presence of true rectocele (p=0.03), enterocele (p=0.02) and Intussusception (p=<0.0001) remained significant. Table 1: Bother and demographic variables: Data given as mean (SD) or number (%). Linear regression, ß gives the mean (95 % CI) increase in VAS bother (0–10), for every one unit increase of explanatory variable (n=265).
Demography
Mean
Age
56
SD or % 14
BMI
29.0
6.5
Menopausal status
161/ 49 % 265 246/ 93 % 265 21/265 8 %
Previous deliveries Prev. Incontinence surgery Prev. prolapse surgery Prev. hysterectomy
Bother of OD (VAS 0–10) ß (95 % CI) pvalue 0.007(−0.02– 0.63 0.04) −0.002(−0.07– 0.96 0.06) 0.8(−0.1–1.6) 0.08 0.99 (−0.63–2.61) 0.23 1.1(−0.5–2.6)
0.17
49/265 19 %
1.64(0.81–2.46)
0.0001
87/267 33 %
1.53(0.66–2.41)
0.0006
Table 2: Association of bother of OD and ICS POPQ findings. Bother of OD (VAS 0–10) Clinical findings
Avg (cm)
SD
ß (95 % CI) - bother per 1 cm increase
pvalue
Ba
−0.8
1.91 −0.02(−0.24–0.21)
0.9
C
−4.15
2.78 0.06(−0.09–0.2)
0.43
Bp
−1.02
1.46 0.42(0.13–0.70)
0.004
gh
3.76
0.89 0.45(−0.02–0.92)
0.06
pb
3.90
0.71 0.82(0.23–1.41)
0.006
gh + pb
7.67
1.25 0.5(0.16–0.83)
0.004
Table 3: Association of bother of OD and USN findings (n= 265) Sonographic
Bother of OD (VAS 0–10)
Findings
ß (95 % CI)
True rectocele (y/n)
147/ 265 True rectocele depth(mm) 17.1
Rectal ampula position (mm) Enterocele (y/n) Intussusception (y/n)
55 % 1.05(0.21–1.90)
p-value 0.01
9.3
0.07(0.00–0.13)
0.04
17.2
0.02
18/265 7 %
−0.03(−0.05– 0.01) 1.80(0.02–3.46)
13/265 5 %
4.25(2.37–6.12)
<0.0001
−9.4
0.03
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Conclusions: In this group of patients seen in a urogynecology tertiary unit, symptoms of OD were very common at 61 %. The bother of such symptoms was surprisingly high at a mean of 5.6. VAS bother scores for OD were associated with a history of previous prolapse surgery and previous hysterectomy. With regards to clinical exam findings, OD bother was associated with descent of the posterior compartment (Bp) and hiatal dimensions (gh and pb). With regards to USN findings, OD bother was associated with all tested parameters. Interestingly, the strongest association of OD bother was with intussusception (odds ratio of 4.3). Physician administered VAS bother scores are a practical, reliable and valid tool to assess symptoms of OD. They are associated with both clinical and USN measures of posterior compartment descent. References: 1. Am J Obstet Gynecol.2004. Jul;191(1):165–70 2. Neurourol Urodyn.2013.(32):864–865 3. Ultrasound in Ob&Gyn.2004. 23:615–25 Disclosure Block: Pakeeza Alam: No disclosures. Ixora Kamisan Atan: No disclosures. Rodrigo Guzman Rojas: No disclosures. Kristy Mann: No disclosures. Hans Peter Dietz: GE Medical: unrestricted educational grant, Grant/Research Support.
OP 038 THE RELATIONSHIP OF TRANSLABIAL ULTRASOUND ANAL SPHINCTER MEASUREMENTS TO ANAL INCONTINENCE AND FECAL INCONTINENCE SYMPTOMS K. V. MERIWETHER1, R. J. HALL 2, L. LEEMAN 3, L. MIGLIACCIO 4, C. QUALLS 5, R. G. ROGERS 1; 1 Univ. of New Mexico, Albuquerque, NM, 2Department of Obstetrics & Gynecology, Univ. of New Mexico, Albuquerque, NM, 3Department of Family Practice, Univ. of New Mexico, Albuquerque, NM, 4University of New Mexico, Univ. of New Mexico, Albuquerque, NM, 5 Clinical Translational Sciences Center, Univ. of New Mexico, Albuquerque, NM. Introduction: Changes of anal sphincter complex (ASC) anatomy following childbirth may affect anal (AI) and fecal incontinence (FI) symptoms. Translabial (TL-US) ultrasound is a common method of pelvic floor evaluation of postpartum women, but there are few data that evaluate the relationship of ASC measurements to AI and FI symptoms. We have previously published that TL-US is a reliable method of evaluating ASC muscle thickness.1,2 Objective: We aimed to determine whether or not anal sphincter muscle thickness on TL-US was associated with
S115
AI and/or FI symptoms as measured on a validated questionnaire at 6 months postpartum. We hypothesized that AI and FI symptoms would be associated with thinner anal sphincter muscle thicknesses at the 12 o’clock position. Methods: A large, prospective cohort of primiparous women underwent TL-US 6 months after their first delivery. Women who gave VB were low risk women attended by midwives; 90 % of women who underwent CD did not enter the second stage of labor. TL-US measurements at 6 months postpartum included the sphincter thickness at the 3, 6, 9, and 12 o’clock positions of the external anal sphincter (EAS) and the internal anal sphincter (IAS) at proximal, mid, and distal levels.3 Women also completed the Wexner Fecal Incontinence Scale (W). Logistical regression was performed to assess the correlation of AI and FI symptoms as measured by the W scale to anal sphincter measurements. We also performed sub-analyses for women who had a vaginal birth (VB) or a Cesarean delivery (CD). Results: 423 women (299 VB and 124 CD) out of 694 eligible for ultrasound (61 %) had TL-US imaging of the ASC 6 months postpartum. Few women underwent operative delivery (n=26) or episiotomy (n=8), 22 women sustained either a third or fourth degree laceration. At 6 months postpartum on TL-US, 4 had separation of the EAS and 34 had separation of the IAS at the proximal, mid or distal levels. Within the entire cohort of women having TL-US imaging, AI was significantly related to the 6 o’clock (p=0.03, OR 0.74, 95 % CI 0.58 to 0.96) and 9 o’clock (p=0.03, OR 0.71, 95 % 0.53 to 0.96) position of the proximal IAS, and smaller measurements were associated with a higher risk of AI. When sub-analysis was performed by delivery mode, TL-US measurements of the 9 o’clock proximal IAS (p=0.03, OR 0.56, 95 % 0.33 to 0.94) were significantly related to AI for women who had a CD, with thinner TL-US measurements again associated with increased AI. For women who had a VB, no sphincter measurements were significantly related to AI. For the entire TL-US imaging cohort, thinner distal IAS measurements at 6 o’clock was significantly related to FI (p=0.04, OR 0.37, 95 % CI 0.34 to 0.96). Conclusions: The majority of ASC measurements on TL-US did not correlate with incontinence symptoms at 6 months postpartum, and we did not find that thinner measurements at the 12 o’clock position of the EAS or IAS were associated with increased AI or FI symptoms. While sphincter measurements among women who gave VB were not associated with increased AI or FI symptoms, we did find that thinner measurements were associated with FI symptoms among CD women. This may indicate that the lateral anatomy may be as important as the midline or anterior sphincter anatomy in predicting symptoms. Since most women in the CD cohort did not enter the second stage of labor, the relation of thinner ASC measurements to incontinence symptoms among these women may be
S116
indicative of baseline differences in continence mechanisms. Future ASC imaging protocols should focus on maintaining full imaging of all sphincter quadrants, and not neglect determination of lateral sphincter anatomy. References: 1. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Aug;18(8):881–8 2. Int Urogynecol J. 2013 Oct 9. [Epub ahead of print.] 3. Obstet Gynecol. 1997 Dec;90(6):924–7. Disclosure Block: Kate Meriwether: SekiSui Diagnostics: SekiSui has provided OSOM BVBLUE tests at a discounted price to my institution solely for use in a research study that I am the primary investigator on. The tests are not being used outside the research study and the randomized trial Rebecca Hall: No disclosures. Lawrence Leeman: No disclosures. Laura Migliaccio: No disclosures. Clifford Qualls: No disclosures. Rebecca Rogers: American Medical Systems: DSMB chair for TRANSFORM trial, Honoraria. McGraw-Hill: Editor for textbook, Royalty. UptoDate: Author for prolapse chapter, Royalty.
OP 039 FEASIBILITY OF FULLY AUTOMATED MEASUREMENTS OF HIATAL DIMENSIONS N. SINDHWANI1, D. BARBOSA 2, M. ALESSANDRINI 2, I. URBANKOVA 3, A. TURRI 1, G. CALLEWAERT 4, J. D’HOOGE 2, J. A. DEPREST 4; 1 Department of Development and Regeneration, Univ. of Leuven, Leuven, Belgium, 2Cardiovascular Imaging and Dynamics, Univ. of Leuven, Leuven, Belgium, 3Univ. of Leuven, Leuven, Belgium, 4UZ Leuven, Leuven, Belgium. Introduction: Hiatal area at valsalva is clinically used as a predictor for prolapse and prolapse recurrence after surgery. In practice, the measurement is done by tracing the hiatus outline in the axial plane slices at the plane of minimal hiatal dimensions. Objective: Our objective is to create an automated tool for measuring urogenital hiatal dimensions on ultrasound images. Such tool will enable high-throughput, automated processing of large datasets from multicenter studies looking at correlations of hiatal dimensions with pelvic floor muscle strength. Methods: 4D translabial ultrasound image blocks were obtained in patients with symptomatic prolapse performing pelvic floor contraction and at valsalva (GE Voluson E8). These images were exported as DICOMs from 4DView (v6.2, GE). The axial plane of minimum hiatal dimensions is obtained by selecting the hyperechogenic posterior aspect of the Symphysis Pubis (SP point) and the hyperechogenic anterior border of the Pubo Visceral Muscle or PVM point posterior to the anorectal muscularis in the mid-sagittal plane [1].
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
The Automated Hiatal Segmentation (AHS) algorithm uses the SP and PVM points as input and has two main steps: 1) Hiatal shape approximation: Two shape templates (ellipse and pear parametric shape) are matched to intensity invariant edge map [2] of the ultrasound image and the best fit shape is selected. 2) Hiatal shape refinement: Using the best matching template, the hiatal shape is further refined locally towards positions of higher contrast using a real-time segmentation framework [3]. The AHS was developed in MATLAB (v2012a, Mathworks Inc.). Four operators (NS, IU, GC, and AT) blinded to the clinical outcome outlined the hiatus 3 times each on 7 axial ultrasound images using manual tracing and the AHS. Thus, a total of 84 measurements were obtained each for manual and AHS method. In one image, the hiatus outline was not completely visible due to extreme ballooning, Fig. (C). This image was excluded from statistical analysis. Measurements from the two methods were tested for similarity using paired t-test and the Bland-Altman analysis. Inter observer variability was assessed by calculating paired differences in area measurements between observers for each trial. A total of 108 difference values (6 pairs for 4 observers X 6 observations X 3 trials) were tested for significant differences in variability using a students’ t-test. Similarly, intra-observer variability was assessed using paired differences between each trial for each observer, a total of 72 values (3 difference pairs for three trials X 6 observations each X 4 observers), and tested for significant differences using a t-test. Results: Visual assessment of the segmented hiatus was good in all images where the complete hiatus outline was visible, Fig. (A) & (B). On Bland Altman analysis, the measurements from the two methods had non-statistically significant, and probably clinically irrelevant, mean bias of −0.034 cm2 (95 % CI={4.53, 4.60}), Fig (D). The automatic method had lower intra and inter observer variability (p=0.030 and p=0.0028 respectively), Fig. (E) & (F). Conclusions: We demonstrate for the first time, an automated approach to outline the hiatus and obtain its dimensions using novel image processing methodologies. The only manual input needed is the selection of the plane of minimal hiatal dimensions. The method is reproducible, robust and significantly lowers intra/inter-observer variability. Understandably, the method does not work properly if the hiatus outline is not present in the image. Further improvements may be done by automatically detecting the SP and PVM points in 3D ultrasound block and adding tools for manual adjustment. We will then validate this on a large dataset. References: [1] US Obstet. Gynecol. v25-6 p 580–85 2005 [2] IEEE Trans. Sig. Process. v49-12 p 3136–44 2001 [3] IEEE Trans. image Process. v21-1 p 241–51 2012
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
S117
Disclosure Block: Nikhil Sindhwani: No disclosures. Daniel Barbosa: No disclosures. Martino Alessandrini: No disclosures. Iva Urbankova: No disclosures. Alice Turri: No disclosures. Geertje Callewaert: No disclosures. Jan D’hooge: Siemens: Grant/Research Support, Grant/Research Support. Philips: Grant/Research Support, Grant/Research Support. Philips: Speaker, Honoraria. Jan Deprest: Medri: Unconditional grant; company is not designer of the study, owner or results or have any say in publication of results. Grant/Research Support. Ethicon: Speaker, Honoraria. AMS: Consultant, Honoraria. coloplast: Framework 7 programme of the European Commission for novel material development, Grant/ Research Support.
S118
OP 040 APPEARANCE OF LEVATOR ANI ABNORMALITIES AND CONNECTIVE TISSUE DISRUPTION IN MAGNETIC RESONANCE IMAGING IN SYMPTOMATIC PRIMIPARAS AFTER THEIR FIRST DELIVERY M. KRCMAR, L. KROFTA, K. GROHREGIN, J. FEYEREISL; urogynecology, Inst. for the care of mother and child, Prague 4, Czech Republic. Introduction: Levator ani muscle injury has already been identified as one of the factors seriously contributing to the development of female pelvic organ prolapse (POP). Fascial defects are minimally of same importance, however much less identified. Magnetic resonance imaging (MRI) is currently leading method in research of mechanisms of pelvic floor trauma as a cause of prolapse, so we decided to perform a study for description of musculo-fascial defects appearance and their mutual relationship. Objective: To describe the appearance of abnormalities in the levator ani muscle and lateral “spill ” of the vagina seen on magnetic resonance imaging in symptomatic women after their first delivery. Methods: This is a retrospective observational study of primiparas in fertile age suffering from pelvic floor dysfunction following first vaginal delivery. A total number of 110 women with signed informed consent were included in the study. All the patients were first examined according to POP-Q system. In all patients we performed dynamic MRI scan (supine position, slice thickness 4 mm, gap 1 mm) in axial, coronal and sagittal projections. All scans have been evaluated independently by two researchers. We observed the severity of musculus levator ani injury (MLAI) according to classification system of deLancey. The defect of lateral vaginal attachment to the pelvic sidewall (architectural distortion- AD) has been marked as present or not present without knowing the severity of prolapse by the examiner. Biometrical parameters of bony pelvis were also assessed: sacrococcygeal-interpubic distance (SCIPP), interspinal (BSD) and intertuberal (BTD) distance, interpubic angle (IPA), levator plate angle (LPA) at rest and during Valsalva manoeuvre. The obtained values were evaluated with parametric and non-parametric test using SPSS program, Version 19. Results: The mean age at delivery was 32,2 years (range 20– 41), mean age at examination 34,9 years (range 23–50), mean BMI 23,6 (range 17–36) kg/m2 and mean neonatal birth weight was 3524 gr (range 2440–4750). Most of (81,8 %) the patients delivered spontaneously, 17,3 % instrumentally. Only one woman (0,9 %) delivered with acute Caesarean section. Most common symptom was pelvic organ descent (57,3 %) of stage II and more (69 %), predominantly in anterior (55,5 %) and/or central (32,7 %) compartment, but not in posterior compartment. Further bothering symptoms were dyspareunia (14,8 %) and stress urinary incontinence (13,6 %). MLAI was present in 92,7 %
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
patients, of whose 70,9 % had a major defect (MRI score 4–6), 21,8 % patients minor defect (MRI score 1–3). Architectural distorsion was diagnosed in 78,2 % patients. In majority of patients (96 %) with severe MLAI (MRI score 4–6) we have simultaneously observed an AD, except of 4 % women. Neither age nor birth weight have been proved as risk factors for MLAI and AD occurrence. The only significant biometrical parameter differing in patients with more severe pelvic injury was levator plate angle LPA within Valsalva manoeuvre. Patients with MLAI and AD had mostly anterior vaginal wall (p .002, p .015) and central compartment defect (p .000, p .079). Conclusions: The MRI shows overall excellent sensitivity for detection of MLAI and AD (interobserver variability Pearson Correlation .994). In our group of symptomatic primiparas we had 70,9 % incidence of major MLAI and the incidence of AD was 78,2 %. Presence of both types of defects is joint with worse values of POP-Q (grade II and more) in anterior and middle compartment. Quantitative MRI scoring system (minor/major trauma) is more sensitive in comparison to qualitative evaluation (MLAI presence/absence). References: none Disclosure Block: Michal Krcmar: No disclosures. Ladislav Krofta: No disclosures. Klara Grohregin: No disclosures. Jaroslav FEYEREISL: No disclosures.
OP 041 MINIMAL LEVATOR HIATUS AREA IN NORMAL WOMEN AND ITS CORRELATION TO SURROUNDING BONY AND SOFT TISSUE LANDMARKS G. ROSTAMI NIA1, M. MACHIORLATTI 1, L. H. QUIROZ 2 , S. SHOBEIRI 3; 1 OUHSC, Oklahoma city, OK, 2Universith of Oklahoma Hlth. Sci., Oklahoma City, OK, 3The Univ. of Oklahoma HSC, Oklahoma City, OK. Minimal levator hiatus area in normal women and its correlation to surrounding bony and soft tissue land marks Introduction: One of the more recent applications of crosssectional imaging of women with pelvic floor disorders is the assessment of the minimal levator hiatus (MLH). In childbirth, the hiatus distends substantially. Injuries to the levator ani identified by MRI, transperineal and endovaginal ultrasonography are related to permanent enlargement of the hiatus after vaginal childbirth. The mean of MLH area in women with normal/mild levator ani deficiency and women with severe levator ani deficiency had been 14.25 and 18.42 cm2, respectively). Also, the mean MLH area at rest in women with and without pelvic organ prolapse had been 14.98 cm2 and 17.49 cm2 respectively (2). However, normal MLH area
S119
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
ranges between 9 and 17.7 cm2 in normal nulliparous women). With such great overlap in normal and abnormal measurements, it is essential to clarify the determining factors for variation of the MLH area before using it as an indicator of levator muscle injury and subsequent pelvic organ prolapse. Objective: The aim of our study was to investigate the correlation of MLH area to its surroundings soft tissue and bony structures in nulliparous asymptomatic women with normal levator ani muscles. Methods: This was a cross-sectional study of the appearance of the levator muscle in asymptomatic nulliparous women. All the women underwent complete physical examination including POP-Q and 3D 360° pelvic floor ultrasound. Levator ani muscles were evaluated and only women with normal muscles were included in the study. Ultrasound volumes were reviewed and measurements of the MLH area, pubic arch angle (PAA), levator arch angle (LAA), levator plate descent angle (LPDA), and length of pubic ramus from pubic symphysis to the levator muscle attachment point on each side were made. All the measurements were done on the MLH plane. We added the free pubic ramus length on left and right to calculate the free pubic arch length (PAL). SAS v 9.2 was used for all analyses. Summary statistics were created for categorical and continuous variables. Correlations coefficients on continuous covariates were explored using PROC CORR and significance of the correlation coefficients were examined using Pearson’s test. Results: 56 women were included in this analysis. The mean age, height and BMI were 43 (SD±13.3), 65.5 (SD±2.5) and 27.6 (SD±7.0), respectively. 83.1 % were Caucasian and 25 % were menopausal. The distribution of ultrasound measurements are summarized in Table 1. Patient’s height and pubic arch length had a positive correlation with MLH area, with Pearson correlation coefficients of 0.26 and 0.50 respectively, Table 2. Conclusions: Our study showed that there is a wide range of MLH sizes in nulliparous women with normal levator ani muscles. This range was positively correlated with patient’s height and pubic arch length. Therefore, we should practice caution in interpretation of the MLH area independent of patients’ pelvic bone characteristics as an indicator of levator muscle defect or a predictor of future pelvic organ prolapse. References: Table 1: Descriptive and Inferential Statistics Continuous Variables Variable
n
Min
Age
56 22.00
Weight Height BMI
Max
70.00
Mean
43.02
Median Standard 95 % Deviation CI LB
95 % CI UB
43.00
46.60
13.39
39.43
56 105.00 305.00 167.68 160.00
41.31
156.62 178.75
56 60.00
72.00
65.47
66.00
2.56
64.79
66.16
56 18.71
51.39
27.57
26.96
7.06
25.68
29.46
Variable
n
Min
Max
MLH
56 9.00
17.30
13.12
13.35
1.78
12.64
13.59
LPDA
56 −10.00 39.30
16.81
16.60
9.63
14.23
19.39
PAA
56 142.00 167.00 159.05 160.00
5.17
157.67 160.44
Ramus L
55 14.90
25.80
19.65
19.30
2.60
18.95
Ramus R 55 14.40
26.60
20.52
20.70
2.77
19.77
21.27
55 30.50
51.60
40.17
40.00
4.62
38.92
41.42
10.10
127.33 133.32
Free pubic Arch length Levator arch angle
Mean
Median Standard 95 % 95 % Deviation CI CI LB UB
46 106.00 154.00 130.33 130.00
20.36
Table 2 - Pearson’s Correlation Coefficients for Continuous Covariates and MLH area MLH
Height
BMI
LPDA
PAA
Ramus
Ramus
Free
R
L
PAL
LAA
MLH 1.00000 0.26078 −0.09808 −0.03793 0.13519 0.47088 0.39626 0.50480 0.05198 area
56
0.0522
0.4721
0.7813
0.3205
0.0003
0.0027
<.0001
0.7316
56
56
56
56
55
55
55
46
Disclosure Block: Ghazaleh rostami nia: No disclosures. Michael Machiorlatti: No disclosures. Lieschen Quiroz: No disclosures. S. Abbas Shobeiri: POP Medical: Consultant, Consulting Fee. Lifecell: Consultant, Consulting Fee.
OP 042 IS THERE A CORRELATION BETWEEN LEVATOR ANI DEFICIENCY AND URETHRAL SPHINCTER COMPLEX MEASUREMENTS ON 3-D ENDOVAGINAL ULTRASOUND? A. C. SANTIAGO1, D. E. WHITE 2, L. H. QUIROZ 3, S. SHOBEIRI 4; 1 IUGA International Research Fellow, Univ. of Oklahoma Hlth.and Sci. Ctr., Oklahoma City, OK, 2Univ of Oklahoma HSC, Oklahoma City, OK, 3Univ. of Oklahoma Hlth. Sci., Oklahoma City, OK, 4The Univ. of Oklahoma HSC, Oklahoma City, OK. Introduction: The critical role of skeletal muscles in pelvic floor support and urinary continence is well studied.1 Demonstrating the relationship between levator ani deficiency (LAD) and urethral sphincter complex measurements may help us understand if the skeletal muscle architectural changes are a global phenomenon or the
S120
muscles in different pelvic compartments undergo architectural change independently. Objectives: The aims of this study were 1) to determine whether there is correlation between levator ani and urethral sphincter status as visualized by 3-D endovaginal ultrasound (3D EVUS) and 2) to compare the levator ani status between patients with stress urinary incontinence (SUI) and those who are continent. Methods: This is a retrospective analysis which included patients seen at our institution between January 2011 and August 2013 who had undergone 3D EVUS. Patients were dichotomized into those: 1) with SUI (documented on urodynamics) and 2) with no SUI. LAD was evaluated by individually scoring each levator ani muscle subdivision according to published studies 2–3: 0 = no muscle defect, 1 = 50 % or less muscle defect, 2 = more than 50 % muscle defect, 3 = total absence of muscle. A cumulative score was then obtained and patients were categorized as having mild (cumulative score 0–6), moderate (cumulative score 7–12), or severe (cumulative score more than 13) LAD. The horizontal diameter, length and crosssectional area of the urethra, and the length, width, and area of the rhabdomyosphincter (RMS) and smooth muscle (SM) were measured. Summary statistics were calculated for the patient population. Twoway ANOVA, Spearman’s rank and Kendall’s tau-b correlations were used to determine the relationship between LAD score and urethral sphincter complex measurements. Chi-square or Fisher’s exact tests were used to compare LAD score with continence status. A p-value of <0.05 was considered significant for all analyses. Results: 80 patients were identified for inclusion. 54/80 (67.5 %) had SUI and 26/80 (32.5 %) were continent (no SUI). The mean age was 53.9 years (SD ±14.5), mean body mass index was 28.4 kg/m2 (SD±5.6), and median parity was 2 (range 0, 5). 18/80 (22.5 %) had evidence of mild LAD; 54/80 (67.5 %) had moderate LAD; and 8/80 (10.0 %) had severe LAD. Using nonparametric testing, there was no significant correlation found between LAD and urethral sphincter complex measurements in the study group as a whole (n=80). When comparing the means of the urethral complex measurements among incontinent patients, there was greater urethral smooth muscle width in the mild LAD group compared to those with moderate or severe LAD (p=0.0238) (Table 1). A greater proportion of patients with SUI had moderate to severe LAD compared to continent patients (p = 0.0177, OR = 3.59, 95 % CI 1.21,10.65). No difference in LAD distribution was found by type of stress incontinence (ie. with and
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
without the presence of intrinsic sphincter deficiency) (p=0.2377) (Table 2). Conlusions: Levator ani and urethral sphincter complex status as visualized by 3-D endovaginal ultrasound are independent factors. Levator ani deficiency however, is m o r e c o m m o n i n pa t i e n t s w i t h s t r e s s u r i n a r y incontinence. References: 1 Obstet Gynecol 2013;121(5):1017–24. 2 Int Urogynecol J 2013; doi:10.1007/s00192-013-2286-5. 3 Ultrasound Obstet Gynecol 2013; doi:10.1002/uog.13193. Table 1. LAD SCORE VS URETHRAL COMPLEX MEASUREMENTS AMONG PATIENTS W/SUI (n=50)
Mild LAD (n=4)
Moderate LAD (n=42)
Severe LAD (n=4)
p Value
Horizontal diameter, mm Length, mm
11.75 (2.77)
12.68 (2.45)
11.58 (2.54)
0.5702
25.18 (7.76)
26.85 (3.17)
23.95 (3.86)
0.2542
Area, cm2
0.94 (0.49)
0.93 (0.23)
0.83 (0.15)
0.7428
Measurement (mean, ±SD) Urethra
RMS Length, mm
14.70 (1.30)
12.91 (3.93)
9.93 (6.76)
0.2438
Width, mm
11.30 (1.05)
9.65 (2.93)
6.48 (4.45)
0.0673
Area, cm2
1.33 (0.21)
1.02 (0.41)
0.75 (0.52)
0.1439
Length, mm
11.48 (4.51)
13.20 (2.75)
12.03 (0.90)
0.4053
Width, mm
9.28 (2.03)
6.57 (1.90)
7.73 (2.08)
0.0238
Area, cm2
0.91 (0.36)
0.72 (0.27)
0.75 (0.18)
0.3963
SM
Table 2. LAD SCORE VERSUS CONTINENCE STATUS Continence Status
p Value
LAD Score Mild
Moderate- Severe
8 (14.81) 10 (38.46)
46 (85.19) 16 (61.54)
0.0177
5 (23.81) 3 (9.09)
16 (76.19) 30 (90.19)
0.2377
SUI (n,%) Yes No SUI Yes (n, %) ISD No ISD
Disclosure Block: Andrea Santiago: No disclosures. Dena White: No disclosures. Lieschen Quiroz: No disclosures. S. Abbas Shobeiri: POP Medical: Consultant, Consulting Fee. Lifecell: Consultant, Consulting Fee.
S121
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
OP 043 CHARACTRISTICS ASSOCIATED WITH PELVIC ORGAN PROLAPSE IN WOMEN WITH SIGNIFICANT LEVATOR MUSCLE DEFICIENCY G. ROSTAMI NIA1, J. PECK 1, L. H. QUIROZ 2, S. SHOBEIRI 3; 1 OUHSC, Oklahoma city, OK, 2Universith of Oklahoma Hlth. Sci., Oklahoma City, OK, 3The Univ. of Oklahoma HSC, Oklahoma City, OK. Characteristics associated with pelvic organ prolapse in women with significant levator ani muscle deficiency Introduction: It has been established that levator ani muscle injury increases the risk of pelvic organ prolapse (POP). The odds of worsening POP stage increases with increasing severity of levator ani deficiency). Observational studies have shown a direct correlation between the size of the levator ani muscle defect and symptoms or signs (or both) of prolapse (2). However, many patients with significant levator ani muscle deficiency do not have symptomatic POP. Two women with identical levator ani defect may have different POP presentation. Objective: The aim of our study was to identify characteristics associated with pelvic organ prolapse among women with significant levator ani deficiency (LAD). Methods: This was a cross-sectional study. Women who were referred to our Urogynecology clinic with varied pelvic floor symptoms and had 3D Endovaginal 360° ultrasound as part of their evaluation were included into the study. Women with prior POP surgery were excluded. The levator muscle subgroups were scored (0 = no defect, 1 = minimal defect with≤ 50 % muscle loss, 2 = major defect with >50 % muscle loss, 3 = total absence of the muscle) on each side based on thickness and detachment from the pubic bone. Scores were summed and categorized as 0–6 = mild, 7–12 = moderate, and >13 = severe defect. Moderate and severe levator ani defects were assigned as significant muscle deficiency. Minimal levator hiatus area (MLH), levator plate descent angle (LPDA), anorectal angle (ARA) and levator muscle thickness on each side were measured for each patient. Based on their POP-Q examination, patients were categorized as no POP (stage 0 and 1), or symptomatic prolapse (stage 2–4). Patient characteristics were compared between those with and without POP using t-tests or Wilcoxon rank sum tests as appropriate according to the distribution of the data or chi- square tests for categorical data. Modified Poisson regression models were estimated to calculate prevalence portion ratios (PPR) and 95 % confidence intervals controlling for covariates. Results: Seventy-six women were available for analysis, including 51 with symptomatic POP and 25 without POP. Table 1 displays patient characteristics by POP status. Patients with symptomatic POP had a greater mean age [66 (SD±11.8) vs 48 (SD±17.3) years, p<0.0001], greater mean MLH area [19.7 cm2 (SD±4.6) vs 17.5 cm2 (SD±3.5), p=0.048] and were
more likely to be menopausal (91.3 % vs 54.5 %, p<0.001) compared to those with no POP. Parity distributions differed slightly (p=0.02) but a median parity of two was observed for both groups (POP range 0–6 vs no POP range 0–4). Because age and menopause were strongly correlated (e.g., 94 % of women ≥age 50 were menopausal), only age was entered in the final multivariable model to avoid collinearity. In modified Poisson regression analysis omitting nulliparous women, age and smoking remained associated with symptomatic POP after controlling for one another and MLH area (Table 2). Conclusions: Our study showed that among women with significant levator ani deficiency, older women and smokers had an increased prevalence of symptomatic POP. Women with prolapse had a larger MLH area, but POP prevalence did not differ significantly across MLH area groupings. On average, normal women with significant levator ani deficiency were 18 years younger than women with POP and significant muscle deficiency. References: Table 1: Patient Characteristics by POP Status
Age(years)
POP (n=51) Mean (SD) 66.0 (11.8)
No POP (n=25) Mean (SD) 48.0 (17.3)
*p
BMI(kg/m2)
27.8 (4.6)
27.9 (4.0)
0.91
MLH Area (cm2)
19.7 (4.6)
17.5 (3.5)
0.048
Median (min, max) 2 (0,4)
**p
Parity
Median (min, max) 2 (0,6)
0.02
<0.0001
MLH Muscle Thickness 2.0 (0,6.0) Right MLH Muscle Thickness - Left 3.5 (0, 9.0)
3.7 (0,6.9)
0.08
2.3 (0, 6.9)
0.89
Anal Rectal Angle
180 (150, 180)
171 (145,180)
0.17
Levator Plate Descent Angle
0 (−20.0,20.0)
0 (−17.1,20.9)
0.36
* T-test; ** Wilcoxon rank sum test Table 2: Modified Poisson Regression Models Estimating Prevalence Portion Ratios for Associations with POP* Crude PPR (95 % CI)
Adjusted PPR (95 % CI)**
Age≥50
2.55 (1.22–5.34)
2.39 (1.03–5.55)
Smoking
1.55 (1.29–1.85)
1.34 (1.08–1.67)
MLH area ≥17 cm2
1.40 (0.90–2.17)
1.36 (0.87–2.13)
* Analyses excludes 3 nulliparous subjects; ** Adjusted for other factors in table 1 Disclosure Block: Ghazaleh rostami nia: No disclosures. Jennifer Peck: No disclosures. Lieschen Quiroz: No disclosures. S. Abbas Shobeiri: POP Medical: Consultant, Consulting Fee. Lifecell: Consultant, Consulting Fee.
S122
OP 044 CHANGES IN THE MEAN ECHOGENICITY OF THE PUBORECTALIS MUSCLE DURING PREGNANCY AND AFTER CHILD-BIRTH A. T. GROB, K. J. SCHWEITZER, M. I. WITHAGEN, C. H. VAN DER VAART; Gynaecology, Univ. Med. Ctr. Utrecht, Utrecht, Netherlands.
Introduction: The ability of three-dimensional (3D) and fourdimensional (4D) volume transperineal ultrasound imaging to assess the axial plane of the pelvic floor, has made the technology increasingly popular in gynaecology. This technique makes it possible to visualize the puborectalis muscle. Changes in functionality and dimensions of the pelvic floor are described to occur during pregnancy and after delivery [1]. Although measuring dimensions of the pelvic floor is well developed, identifying structural changes in the puborectalis muscle, is still in its infancy [2]. One of the parameters that can be assessed by ultrasound is the echogenicity of the muscle. Measuring echogenicity is increasingly used in orthopedics and neuromuscular disease but is not applied in pelvic floor research [3]. Measuring echogenicity of the puborectalis muscle could provide additional information about the structure and structural changes over time. Objective: To evaluate the effect of pregnancy and childdelivery on the Mean Echogenicity of the Puborectalis muscle (MEP). Methods: Over a period of 2 years, 280 nulliparous pregnant women were seen for 3D/4D transperineal ultrasound assessment. For our particular research the MEP of 105 women during first pregnancy was measured at 12 and 36 weeks gestation, and 6 months postpartum. The images were obtained with the puborectalis muscle at rest, during maximum pelvic floor muscle contraction (PFMC) and during maximum Valsalva. Tomographic Ultrasound Images (TUI) were constructed according to the guidelines of minimal hiatal dimensions. The puborectalis muscle structure was delineated by hand from the image using programming software (Matlab®). Echogenicity is based on the greyscale image in which the value for each pixel can vary between 0 (black) and 255 (white). The mean of all individual pixel echogenicity values of the puborectalis muscle was calculated automatically, resulting in the Mean Echogenicity of Puborectalis (MEP). To determine the effect of child-birth on MEP, the results at 6 months postpartum were split-up into vaginal deliveries and caesarean-section deliveries. In order to assess mean differences between MEP at the three measurement moments ANOVA analysis was used. The project was approved by the Institutional Human Research Ethics Committee and all women gave informed consent. Results: The MEP at 6 months postpartum (Table 1) was, manoeuvre independent, significantly (p < 0.01)
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
lower then MEP values during pregnancy. All datasets at 6 months after childbirth indicated darker puborectalis musculatures on ultrasound images. The 6 months postpartum difference in MEP between the two types of delivery was only statistical significant during Valsalva (p=0.02). Conclusions: Our study shows that MEP is a new parameter that appears to be related to pregnancy and delivery induced changes in the puborectalis muscle. It may be a helpful tool in our further understanding of changes in pelvic floor structure. References: [1] Ultrasound Obstet Gynecol 2005; 25 : 580–585. [2] Int Urogynecol J 2012; 23 : 1561–1567. [3] J Med Ultrasonics, 2013 (online)
Descriptive of MEP during pregnancy and postpartum. MEP 12 weeks gestation
MEP 36 weeks gestation
Manoeuvre Rest
MEP 6 months postpartum
MEP 6 months postpartum
Vaginal delivery Caesareansection 145
150
125*
129*
Contraction 138
140
120*
117*
Valsalva
138
113*/**
124*/**
139
*MEP values at 6 months postpartum are significant lower (p<0.01), compared to 12 and 36 weeks gestation. **MEP values at 6 months postpartum (Valsalva) are significantly (p= 0.02) different between groups (Vaginal/C-section). $$MISSING OR BAD IMAGE SPECIFICATION {CB84E66B-8C79-402C-889F-42FDFFFEC984}$$
S123
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Disclosure Block: Anique Grob: No disclosures. Karlijn Schweitzer: C.R BARD Netherlands B.V.: Consultant, Honoraria. Mariella Withagen: Bard: Consultant, Consulting Fee. Carl van der Vaart: BARD: Consultant, Consulting Fee. BARD: Contract research, Grant/ Research Support.
OP 045 DISCREPANCY OF IMPACTS OF INTRAVESICAL HYALURONIC ACID ON PAIN AND URINARY SYMPTOMS OF REFRACTORY INTERSTITIAL CYSTITIS/BLADDER PAIN SYNDROME AFFECTS TREATMENT OUTCOME: RESULTS FROM A PROSPECTIVE MULTICENTER STUDY ON 103 PATIENTS M. HUNG; Department of OB/GYN, Taichung Veterans Gen. Hosp., Taichung, Taiwan. Introduction: Interstitial cystitis (IC)/bladder pain syndrome (BPS) is the complaint of pelvic pain, accompanied by urinary symptoms such as urgency, frequency and nocturia [1, 2]. Intravesical therapy with a hyaluronic acid (HA) solution is an effective treatment for IC/BPS, however, with varying degrees of responses [3]. Objective: This study aims to test the hypothesis that a discrepancy of impacts of intravesical HA on pain and urinary symptoms of IC/BPS affects treatment outcome. Methods: A total of 103 women with refractory IC/BPS were enrolled in this prospective multicenter study and underwent a standard 6-month intravesical HA therapy. Symptoms, bother and sexual function were assessed using the Interstitial Cystitis Symptom and Problem Index (ICSI&ICPI), pain Visual Analog Scale (VAS), and a short-form sexual function questionnaire (PISQ-9). A 7-point Scaled Global Response Assessment (GRA) also provided patients’ perception of overall changes in pain and urinary symptoms, respectively. Data were analyzed with univariate methods or multivariate logistic regression analysis accordingly. Results: Demographic data was presented in Table 1. Mean age and duration of symptoms was 43.6±11.8 and 5.1± 5.0 years, respectively. No severe adverse events from the instillation were noted. ICSI, ICPI, pain VAS and PISQ-9 were significantly (P < 0.001) improved after treatment (Table 2). On the other hand, 73.3 % and only 47.2 % of patients reported a moderate/marked (≧ +2) improvement in pain and urinary symptoms on GRA, respectively (Figure 1). The discrepancy between the two outcome measures was statistically significant (McNemar test, P<0.001). Further multivariate logistic regression analysis showed baseline pain VAS score (P=0.026) and functional bladder capacity (P= 0.003) were correlated positively with treatment response of pain and urinary symptoms, respectively.
Conclusions: Intravesical HA is perceived to be more effective in reducing pain compared to urinary symptoms by women suffering from refractory IC/BPS. In addition, a small functional bladder capacity might predict a sub-response of urinary symptoms to the treatment. References: 1. Neurourol Urodyn 2002;21:167–178. 2. Eur Urol 2008;53:60–67. 3. Nat Rev Urol. 2012;9:707–20. Table 1. Demographic data (n=103).
Patient characteristics
Value
Range
Mean age (years)
44.3±11.5
(22–69)
% with menopause
32.0
(33/103)
Mean symptomatic years
5.1±5.0
(0.5–30)
Mean functional bladder capacity (ml)
228.6±70.8
(80–400)
Mean volume at first sensation to void (ml)
134.7±53.0
(53–296)
Mean maximum cystometric capacity (ml)
258.6±93.0
General data
*Urodynamic (filling & voiding cystometry) results
Mean bladder compliance at urgency (ml/cmH2O) 89.2±107.7 Mean voided volume (ml)
(87–615) (1–464)
259.2±116.0 (73–663)
Mean maximum flow rate (ml/sec)
15.3±6.2
(5–30)
Mean average flow rate (ml/s)
6.6±3.5
(2–19)
30.2±19.3
(2–108)
Mean voiding pressure (cmH2O) Mean residual urine amount (ml)
24.6±26.6
(0–148)
% with bladder oversensitivity
49.4
(38/77)
% with detrusor overactivity
11.7
(9/77)
% with dysfunctional voiding
32.5
(25/77)
Cystoscopic findings with hydrodistention Mean anesthetic bladder capacity (ml)
506.3±198.2 (200–1000)
% with advanced (grade II & III) glomerulations
93.2
(96/103)
% with Hunner”s ulcers
13.6
(14/103)
*: Urodynamic study was performed in 77 (74.8 %) of the 103 patients. Table 2. Changes of symptoms, bother, and sexual function (n=103). Baseline
1 month
6 months
Pain VAS
6.3±2.7
4.3±2.5
3.3±2.2
*P-value <0.001
ICSI
14.2±3.8
10.3±3.9
7.8±4.0
<0.001
Urgency
3.5±1.4
2.6±1.3
1.9±1.3
<0.001
Frequency
4.3±1.1
3.1±1.2
2.3±1.3
<0.001
Nocturia
3.5±1.3
2.7±1.2
2.2±1.3
<0.001
Bladder Pain
2.9±1.7
1.9±1.4
1.3±1.2
<0.001
ICPI
13.0±3.3
9.9±3.3
8.4±4.3
<0.001
Frequency
3.2±0.9
2.7±1.0
2.2±1.2
<0.001
Nocturia
3.4±0.9
2.7±1.0
2.3±1.4
<0.001
S124
Urgency
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240 Baseline 3.1±1.0
1 month 2.4±1.1
2.0±1.3
<0.001
Bladder pain
3.1±1.2
2.3±1.2
1.6±1.2
<0.001
PISQ-9
18.9±6.4
20.4±5.8
21.5±5.6
<0.001
Behavioral/emotive Factors
6.9±4.0
7.0±3.7
7.3±4.0
0.260
Physical Factors
4.8±2.2
5.5±1.9
5.9±1.9
<0.001
Partner-related Factors
7.6±2.6
8.2±2.4
8.5±2.3
<0.001
VAS: visual analog score (range 0–10); ICSI: interstitial cystitis symptom index (range 0–20); ICPI: interstitial cystitis problem index (range 0–16); PISQ: pelvic organ prolapse/ urinary incontinence sexual function questionnaire (PISQ-9 range 0–36); *: Friedman Test. Figure 1. Distribution of responses of pain and urinary symptoms to intravesical therapy with a HA solution on the 7-point GRA (n=103). Disclosure Block: Man-Jung Hung: No disclosures.
OP 046 THE PELVIC FLOOR MUSCLE HYPERALGESIA (PFMH) SCORING SYSTEM: A NEW CLASSIFICATION TOOL TO ASSESS WOMEN WITH CHRONIC PELVIC PAIN: MULTI CENTRE PILOT STUDY OF VALIDITY AND RELIABILITY R. BRAY1, A. BHIDE 1, V. KHULLAR 1, P. GALLO 2, F. PUCCINI 3, G. BAUDINO 2, A. SINGH 1, R. FERNANDO 1, A. DIGESU 1; 1 Department of Urogynaecology, St Marys Hosp., London, United Kingdom, 2Department of O&G, Maggiore Hosp., Crema, Italy, 3Urology Dept, St Andrea Hosp., Rome, Italy. Introduction: The contribution of pelvic floor muscle tenderness to chronic pelvic pain (CPP) is well established in the literature. Several terms are used to describe this pathology (levator myalgia, piriformis syndrome, levator ani syndrome, PFMH). It has been estimated that 24 % of women attending urogynecological clinics in US, 16 per 100000 person/year in Minnesota and 60 % of women with CPP have PFMH. However PFMH is often missed during vaginal examination of women with CPP. Examination of the pelvic floor can identify the source of pain that may be dramatically improved by targeted treatment and spare the patient extensive further investigation. To our knowledge criteria for diagnosing PFMH has not been established or validated so far. Objective: To assess the validity and reliability of the pelvic floor muscle hyperalgesia (PFMH) scoring system. Methods: Women with and without (controls) symptoms of pelvic pain attending general gynaecology outpatient clinics in 2 different countries were recruited prospectively. Patients were instructed how to report pain on digital palpation on a
visual analogue scale (VAS). Women then underwent digital pelvic examination to determine levator ani (LA) muscle hyperalgesia. The right and left levator ani muscles including pubococcygeus, iliococcygeus, ischiococcygeus, obturator, bulbospongiosus, ischiocavernosus and deep/superficial transverse perineal muscles were palpated. All women were asked to report if any discomfort was evoked by digital palpation of the pelvic muscles and to rate severity of pain using a VAS. Following examination, a PFMH score was assigned from 0 to 4. Grade 0 PFMH when the patient does not report pain/discomfort during the palpation of LA muscles. Grade I PFMH when the patient reports in one or more sites mild pain/discomfort during the bilateral palpation of LA muscles. Grade II PFMH when the patient reports in one or more sites moderate pain/discomfort during the bilateral palpation of LA muscles. Grade III PFMH when the patient reports in one or more sites severe pain/discomfort during the bilateral palpation of LA muscles. For the intra-observer reliability the examination was repeated twice on all women by the same clinician 2 weeks apart. For the inter-observer reliability the examination was repeated on all women by a second clinician within 2 weeks. The interclass correlation coefficient (ICC) was also calculated to assess limits of agreements. The validity was assessed comparing the PFMH scores with VAS using the Spearman’s rho correlation coefficient (construct validity) and by comparing the PFMH scores between symptomatic and asymptomatic women using the Mann–Whitney U test, p value <0.01 (content validity). Local ethical approval was obtained in each centre and all women were consented to participate in this study. Results: 111 (44 symptomatic and 67 controls) were recruited. The mean age was 52 years (range 19 to 86). Intraobserver reliability had ICCs between 0.426 and 0.804. Interobserver reliability had ICCs between 0.724 and 0.917 there was a good correlation between PFMH scores and VAS scores (rho 0.994, p<0.01) total scores between symptomatic and controls were significantly different (p<0.001 Mann–Whitney U test). Conclusions: The PFMH scoring system is a simple, reliable, valid and easy screening tool for in the assessment of women with CPP. References: Disclosure Block: Rhiannon Bray: No disclosures. Alka Bhide: No disclosures. Vik Khullar: Allergan, Astellas, Pfizer: Scientific Medical Advisor, Consulting Fee. Allergan, Astellas, Pfizer: Speaker, Consulting Fee. Allergan, Astellas, Pfizer: Consultant, Consulting Fee. Allergan, Astellas, Pfizer: Advisory Committee Member, Consulting Fee. Pasquale Gallo: No disclosures. Federica Puccini: No disclosures. Gianni Baudino: No disclosures. Anand Singh: No disclosures. Ruwan Fernando: Astellas: Speaker, Honoraria. AMS: Speaker, Honoraria. Alex Digesu: No disclosures.
S125
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
OP 047 ANALYSIS OF SCREENING TOOLS USED TO DETERMINE THE DIAGNOSIS OF SELF-REPORTED FEMALE SEXUAL DYSFUNCTION R. RINKO, L. THOMAS; OBGYN, York Hosp. Wellspan, York, PA. Introduction: The prevalence of female sexual dysfunction is between 19 and 45 %, depending on which screening tool is used, though this value is believed to be under reported. Objective: The purpose of this study is to analyze the ability of two different screening tools to diagnose female sexual dysfunction: The Brief Sexual Symptom Checklist (BSSC) questionnaire, as recommended by the American College of Obstetrics and Gynecology (ACOG), and The Female Sexual Function Index (FSFI-6), which has had good psychometric evaluation. We hypothesize that the recommended BCCS questionnaire will be equal to or more sensitive compared to the FSFI-6 index in screening for female sexual dysfunction. Methods: In this cross sectional study, 152 English speaking women 18 years of age and older completed the FSFI-6, BSSC, and a general demographic questionnaire containing personal data. All questionnaires that were filled out completely were included. Additional variables were recorded including age, ethnicity, religion, number of people living in the home, gestation and parity, type of deliveries, menopausal status, sexual preference, medications, medical history, frequency of intercourse, marital status and length of relationship. The data was analyzed using the Chi square and Fisher’s exact tests. Results: One hundred and fifty-two women filled out questionnaires. Of those, 141 surveys were considered complete and used in the study. The average age is 33 years old (SD 13.1). Fifty one percent of the women in the study identified as white, 24.3 % as African American, and 22.3 % as Hispanic. The majority of the study population identified their religion as Christian (62.2 %), 89.9 % have between 1 and 5 people living in their home, and 11.6 % had experienced menopause. For sexual preference, 89.8 % said they are interested in men, 4.8 % in women, and 5.4 % said both men and women. Eighty six percent have been pregnant 1–5 times. The BSSC questionnaire identified 21 (15.1 %) women with sexual dysfunction based on their answer of “no” to the question “Are you satisfied with your sexual function?.” The FSFI-6 questionnaire identified 90 (64.7 %) women with sexual dysfunction based on a score of 19 or less. This difference was not statistically significant (p=0.323). The tests were concordant in 16 women identified on both tests as having sexual dysfunction, and 44 identified by both tests as not having sexual dysfunction. They were discordant in 5 women who have sexual dysfunction according to the BSSC questionnaire but not the FSFI-6, and in 74 women who are shown to have sexual dysfunction from the FSFI-6 test, but not according to the BSSC.
Those that had scored 19 or less on the FSFI-6 were similar in age, ethnicity, religion, number of people living in the home, gestation and parity, type of deliveries, menopausal status, sexual preference, medications, and medical history when being compared to those that scored 20 or greater. However, women who scored 19 or less were more likely to report frequency of intercourse as once a month or less (p=0.025). They were also more likely to report they are married or not in a relationship currently (p=0.028), as well as in relationships for longer periods of time (p=0.028). Those identified as having sexual dysfunction by the BSSC questionnaire were similar in age, ethnicity, religion, number of people living in the home, gestation and parity, type of deliveries, sexual preference, medications, frequency of intercourse, marital status and length of relationship. However, those who did not have a sexual dysfunction according to the BSSC were more likely to be premenopausal (p=0.01), not have osteoporosis (p=0.001), not suffer from migraines (p=0.017), had regular menses (p= 0.002), had never had a stroke (p=0.016), had normal cholesterol (p=0.010) and did not report anxiety (p=0.001). Conclusions: This study found that there is not a statistically significant difference in the number of women who would be diagnosed with sexual dysfunction by using either the BSSC or the FSFI-6 questionnaire. Although ACOG recommends using the BSSC questionnaire to screen for sexual dysfunction, the FSFI-6 was able to identify 69 (30 %) more women with a sexual dysfunction that the BSSC. This difference is clinically significant, and suggests that the FSFI-6 questionnaire is a better clinical tool to screen for female sexual dysfunction. References: N/A Disclosure Block: Rebecca Rinko: No disclosures. L Martha Thomas: No disclosures.
OP 048 SELF-REPORTED PHYSICAL ACTIVITY IN PATIENTS WITH PAINFUL BLADDER SYNDROME: EFFECT ON FEMALE SEXUAL DYSFUNCTION S. ZASLAU1, D. RIGGS 1, B. JACKSON 1, R. SHAPIRO 2, D. POINT 1, R. BRYNER 3; 1 Urology/Surgery, West Virginia Univ., Morgantown, WV, 2 Obstetrics & Gynecology, West Virginia Univ., Morgantown, WV, 3West Virginia Univ., Morgantown, WV.
Introduction: The presence of Female Sexual Dysfunction (FSD) in patients with Painful Bladder Syndrome (PBS) is significant and well documented. Exercise and increased physical activity in general have been reported to exhibit beneficial effects in a wide array of medical disorders. The
S126
authors report herein the data on 337 subjects with PBS who have completed a self-reported physical activity in addition to the Female Sexual Function Index (FSFI). Objective: To evaluate the effect of physical activity on FSD in subjects with PBS. Methods: The survey was administered to patients with PBS online at the Interstitial Cystitis Network web page at: www. ic-network.com. Domain values were obtained by using the FSFI. This 19-item questionnaire evaluated FSD in the following six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Each question in the survey was targeted to a specific indicator of FSD and the answers were rated on a Lickert scale. Data were analyzed on an item-for-item basis and by the six domains of FSD for these subjects. Additionally, self-reported leisure time physical activity was measured by the Godin Leisure-Time Physical Activity Questionnaire and those scores grouped into 3 domains (Low: <14 units [less than 7 kcal/kg/week], Moderate: 14 to 23 units [between 7 and 13.9 kcal/kg/week] and High: > 24 Units [14 kcal/kg/week or more]. Statistical significance was determined with one-way ANOVA testing (P<0.05). Results: No difference was observed in the FSFI domains of Arousal, Lubrication or Satisfaction across the three levels of selfreported activity. Subjects self-reporting High levels of physical activity showed significant improvement in Desire when compared to those with self-reported Low activity (P=0.007). Moderate levels of activity showed no difference in Desire when compared to both Low and High Godin activity domains. Both Moderate and High activity levels exhibited significant improvement in Orgasm when compared to Low activity levels (P=0.050 and P=0.0020). High activity levels provided significant protection against Pain when compared to those in the low activity domain according to the Godin survey (P=0.030). No difference in age was noted between the Low (39.02±12.67 years), Moderate (35.37±11.64 years) and the High (37.65±12.3 years) Godin self-reported activity levels. Body Mass Index (BMI) was 26.15±6.66, in the Low activity subjects, 25.96±5.47 in the Moderate activity, and 23.77±4.34 in the High activity subjects. The difference in BMI between the Low and High Godin activity levels proved to be significant (P 0.006). No difference in BMI was observed between the subjects reporting Moderate activity when compared to both the Low and High levels. Conclusions: Safe and effective treatments for the sexual dysfunction experienced by patients with Painful Bladder Syndrome is needed. The ability of exercise or increased physical activity to provide relief of these symptoms would be significant to these patients. Subjects who self-reported high levels of activity as measured by the Godin LeisureTime Physical Activity Questionnaire exhibited significant improvement in the FSFI domains of Desire, Orgasm and Pain when compared to those with low activity levels. Further investigation into the effects of exercise and increased physical activity in PBS is a source of ongoing investigation.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Moderate Godin Score N=54 2.06+1.01
High Godin Score N=89 2.39+1.19
ANOVA P Value
Desire
Low Godin Score N=194 1.98+0.98
Arousal
1.81+1.54
2.19+1.49
2.13+1.54
N.S.
Lubrication
1.98+1.80
2.25+1.66
2.31+1.77
N.S.
FSFI DOMAIN
P=0.009
Orgasm
1.88+1.73
2.48+1.74
2.49+1.77
P=0.007
Satisfaction
2.26+1.53
2.39+1.43
2.49+1.63
N.S.
Pain
1.39+1.37
1.76+1.38
1.86+1.54
P=0.021
Disclosure Block: Stanley Zaslau: Medtronics: Speaker’s Bureau, Honoraria. Dale Riggs: No disclosures. Barbara Jackson: No disclosures. Robert Shapiro: No disclosures. Dana Point: No disclosures. Randy Bryner: No disclosures.
OP 049 OBESTITY, BARIATRIC SURGERY & SEXUAL FUNCTION: A SYSTEMATIC REVIEW K. RAMALINGAM1, L. VINCENT 1, A. K. MONGA 2; 1 Gynaecology, Kingston Hosp. NHS Trust, Kingston upon Thames, United Kingdom, 2Univ. Hosp. Southampton, Southampton, United Kingdom. Abstract Introduction: Obesity is a major public health issue, associated with significant medical and psychosocial co-morbidities. Patients undergoing bariatric surgery report a decline in sexual function1,2; in a recent study female sexual dysfunction (FSD) was reported in 51 % of female bariatric patients3. Objectives: To review and summarise published literature on the effects of bariatric surgery on female sexual dysfunction. Method: Search strategy - Articles were identified using a search of the National Centre for Biotechnology Information (NCBI) PubMed from January 1996 to December 2013. Selection criteria - Original studies on adult female obese patients undergoing bariatric surgery were identified, which reported changes in sexual function (SF) validated by the Female Sexual Function Index4 (FSFI) pre- and postprocedure. The FSFI evaluates SF using 6 domains: − desire, arousal, lubrication, orgasm, satisfaction and pain. Exclusions included studies with non-surgical weight loss methods and mixed populations (female and male). Main outcome measures were post-operative changes in FSFI and body mass index (BMI). Results: Six studies were included in the final review. The total number of patients was 360. Statistical analysis using a forest plot revealed a significant reduction in BMI (p<0.001) and improvement in FSFI overall score (p=0.003) and five specific domains (desire p=0.005,
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
arousal p=0.001, lubrication p=0.003, satisfaction p=0.012, and orgasm p=0.003) following bariatric surgery. There was a decrease in the levels of pain during intercourse (p=0.014) postoperatively. Conclusion: This review showed that bariatric surgery improves sexual function across all domains of FSFI in obese female patients. One study showed no SF improvement in patients reporting pelvic floor dysfunction5. Further studies are therefore required to assess effect of bariatric surgery on SF in patients with pelvic floor dysfunction undergoing bariatric surgery. As bariatric surgery appears to improve sexual function in female obese patients, this should be included as an outcome benefit associated with bariatric surgery. Keywords: Obesity, bariatric surgery, sexual function References: 1. Obes Surg. 2012;22(4):668–676. 2. Obesity (Silver Spring). 2013;21(10):1966–1974 3. J Sex Marital Ther. 2000;26:191–208. 4. Surg Obes Relat Dis. 2013 Nov-Dec;9(6):997–1007. 5. Am J Obstet Gynecol. 2012;207:431.e1-4 Disclosure Block: Kalaivani Ramalingam: No disclosures. Laura Vincent: No disclosures. Ash Monga: Pfizer: Speaker, Honoraria. Astellas: Speaker, Honoraria. Shire: Speaker, Honoraria. Allergan: Advisory Committee Member, Honoraria.
OP 050 USEFULL OF INTRAVESICAL INSTILLATION OF HYALURONIC ACID AND CHONDROITIN SULPHATE IN PREVENTING RECURRENT BACTERIAL CYSTITIS G. CALAGNA 1, G. GUGLIOTTA 2, G. ADILE 3, S. POLITO 4, R. GRANESE 5, P. SPECIALE 2, B. ADILE2; 1 OBSTETRICS AND GYNECOLOGY, Univ. Hosp. - “P. GIACCONE”, PALERMO, Italy, 2UROGYNECOLOGY, VILLA SOFIA-CERVELLO Hosp., PALERMO, Italy, 3OBSTETRICS AND GYNECOLOGY, Univ. Hosp. -, PALERMO, Italy, 4OBSTETRICS AND GYNECOLOGY UNIT, CASA DI CURE, PALERMO, Italy, 5OBSTETRICS AND GYNECOLOGY, Univ. Hosp. -, MESSINA, Italy.
Introduction: Urinary tract infections (UTI) are very common in the female population. There is also a high incidence of recurrence, at least 25–35 % and, generally, within 3 to 6 months. Acute UTI are traditionally treated by intermittent or prolonged antibiotic therapy, but this management does not appear to give satisfactory results. Hyaluronic acid (HA) is a
S127
major mucopolysaccharide component of the extracellular matrix of most tissues and constitutes an important proportion of bladder surface GAGs. Chondroitin sulphate (CS) is also a proteoglycan present in the GAG layer and is an important component for bladder mucosal integrity. Both substances (HA and CS) have been administered orally and/or intravesically in patients with interstitial cystitis to restore integrity of the vesical mucosa. Objective: This retrospective analysis aiming to evaluate efficacy and tolerability of intravesical therapy with HA-CS compared with antibiotic prophylaxis in reducing the rate of recurrent bacterial cystitis and associated symptoms. Methods: Two different series of patients treated for recurrent bacterial cystitis in our urogynecological referral centre, with two different therapeutic approaches in relation to the period considered. In Group A, we included patients who received traditional therapy for recurrent cystitis based on a long-term antibiotic prophylaxis; the Group B received a new treatment based on intravesical instillations of a sterile solution of high concentration of sodium hyaluronate and sodium chondroitin sulfate in 50 mL water with calcium chloride (IALURIL®, IBSA Farmaceutici, Lodi, Italy). As is our practice for recurrent cystitis, follow-up outpatient visits were performed at 1, 3, 6 and 12 months after the end of treatment; patients underwent outcome assessment addressing UTI status, urinary symptoms and any adverse effects associated to the performed therapy. Results: Ninety-nine patients in Group A and 112 patients in Group B were recruited for the study. Among them, only 76 (Group A) and 98 (Group B) completed the follow-up at 12 months and were included in the analysis. During the 12 months of follow-up, 109 and 69 episodes of UTI were detected in the A and B group respectively. During follow-up, moderate/severe symptoms of UTI (acute dysuria, frequency, urgency, pelvic pain) were referred in 65.2 % of cases and in 39.6 % of cases, in group A and B respectively (p=0.001). At the end of the follow-up period (12 months), 16 patients in group A (21.0 %) and 36 patients in group B (36.7 %) were free from urinary infection episode (P=0.03) Conclusions: Our data, although preliminary, show the validity of this new therapeutic option, which could be a true alternative to traditional antibiotic prophylaxis in the treatment of recurrent UTI. Further assessment will be necessary with prospective randomized blinded studies on a larger sample population. References: 1.2. Damiano R, Quarto G, Bava I et al. (2011). Prevention of recurrent urinary tract infections by intravesical administration of haluronic acid and chondroitin sulphate: a placebo-controlled randomised trial. Eur Urol 59(4):645–651
S128
2. 13. Constantinides C, Manousakas T, Nikolopoulos P, Stanitsas A, Haritopoulos K, Giannopoulos A (2004). Prevention of recurrent bacterial cystitis by intravesical administration of hyaluronic acid: a pilot study. BJU Int 93(9):1262–1266 3. 16. Lipovac M, Kurz C, Reithmayr F, Verhoeven HC, Huber JC, Imhof M (2007). Prevention of recurrent bacterial urinary tract infections by intravesical instillation of hyaluronic acid. Int J Gynaecol Obstet 96(3):192–195 Figure 1. Flow Diagram
Disclosure Block: GLORIA CALAGNA: No disclosures. GIORGIO GUGLIOTTA: No disclosures. GIORGIO ADILE: No disclosures. Salvatore POLITO: No disclosures. ROBERTA GRANESE: No disclosures. PATRIZIA SPECIALE: No disclosures. BIAGIO ADILE: No disclosures. OP 051 IMPROVED QUALITY OF LIFE AND SEXUAL FUNCTION FOLLOWING BULKAMID TREATMENT: PATIENT SUBJECTIVE OUTCOME DATA FROM A SINGLE-MASKED, RANDOMIZED, MULTI-CENTER, COMPARATIVE STUDY E. R. SOKOL1, M. KARRAM 2, R. DMOCHOWSKI 3; 1 Urogynecology and Pelvic Reconstructive Surgery, Stanford Univ., Stanford, CA, 2The Christ Hosp., Cincinnati, OH, 3 Vanderbilt, Nashville, TN. Objective: This study summarizes the changes in quality of life and sexual function from baseline to endpoint at 12months follow-up after Bulkamid versus Contigen injections for the treatment of female stress urinary incontinence (SUI).
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Background: Bulkamid is a new hydrogel bulking agent for the treatment of SUI, which is injected into the urethral submucosa using a specifically designed administration device. Safety and efficacy of Bulkamid vs. Contigen in the treatment of SUI or stress predominant mixed UI has previously been described (1). This was a randomized, prospective, 33-center (28 in the US and 5 in Canada), 2-arm parallel study of Bulkamid vs. Contigen with 12-month follow up. The FDA approved an Investigational Device Exemption for this randomized controlled trial. The study population consisted of adult female subjects with SUI due to intrinsic sphincter deficiency who had SUI or stress predominant mixed incontinence and fulfilled the inclusion/exclusion criteria. Methods: 345 subjects enrolled in the study using a 2:1 ratio (229 Bulkamid® and 116 Control.). They could receive up to 3 injections at 1-month intervals. Patients were assessed at 3, 6, 9 and 12 months after bulking and completed bladder diaries, QoL questionnaires, pad weight testing and VLPP. Subjective and Objective incontinence outcomes and adverse events were compared. Apart from testing for degree and type of incontinence and effect/adverse effects following treatments the following questionnaires on quality of life and sexual function were completed at baseline and at 12 months follow-up: International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence (ICIQ-UI) Short Form (4 questions), the Incontinence Quality of Life (IQoL) questionnaire (22 questions), and the Pelvic Organ ProlapseUrinary Incontinence Sexual function questionnaire (PISQ) (31 questions). ICIQ-UI is a brief and robust measure to assess the impact of leakage on quality of life (when, how often, how much, interference with everyday life), IQoL is a quality of life measure of the impact of urinary incontinence and urinary problems (such as overactive bladder without incontinence), and PISQ evaluates sexual functioning in women with urinary incontinence and/or pelvic organ prolapse. Results: 345 women were randomized: 229 to Bulkamid and 116 to Contigen. All measurements showed substantial improvement in both treatment groups. Changes in continence status and adverse events have been previously reported (1). There were no unanticipated adverse device events. The change from baseline to 12 months follow-up in the ICIQ-UI score showed a similar success rate for both treatment groups with 15 % completely continent and an overall 45 % reduction in stress-induced incontinence (p<.0001). Although not statistically significant at 12-months follow-up (p= 0.1206), the reduction from baseline in the mean ICIQUI score was numerically greater in the Bulkamid group than in the control group at each follow-up visit (Table 1). For both treatment groups, the average IQoL score improved after the bulking treatment and the improvement in IQoL score was maintained throughout the study (mean increase values of 31.4 points in the
S129
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Bulkamid group vs. 26.3 points in the control group at 12-month follow-up, p<.0001) (Table 2). Although approximately 30 % of women were not sexually active, a slight improvement with respect to PISQ score was seen in both the Bulkamid and Contigen groups at 12-months follow-up (2.1 and 2.3 %, respectively). Conclusion: Urethral Bulkamid treatment has a beneficial long-term effect on not only SUI but also quality of life and sexual function with a low risk of serious adverse events. ClinicalTrials.gov Identifier: NCT00629083 References: 1. International Continence Society 2013 Abstract 192. Table 1: Change from Baseline in ICIQ-UI Score at 12 Month Follow-up Visit Interval
Bulkamid®
Control
N
188
97
Mean (SD)
−6.9 (5.2)
−5.9 (5.5)
Median
−7.0
−5.0
Min. Max.
−19.0, 4.0
−20.0, 6.0
P-value
0.1206
Table 2: Change from Baseline in IQoL Score at 12 Month Follow-up Visit Interval
Bulkamid®
Control
N
197
101
Mean (SD)
31.4 (23.5)
26.3 (23.2)
Median
29.5
25.0
Min. Max.
−26.1, 92.9
−34.1, 78.4
P-value
0.0757
Disclosure Block: Eric Sokol: Pelvilon: Scientific Medical Advisor, Ownership Interest. American Medical Systems: Consultant, Consulting Fee. mickey karram: Medtronic: Speaker, Honoraria. Astellas: Speaker, Honoraria. AMS: Speaker, Honoraria. Ethicon: Consultant, Consulting Fee. Roger Dmochowski: allergan: Consultant, Consulting Fee. Medtronic: Consultant, Consulting Fee.
OP 052 STRESS URINARY INCONTINENCE IS ASSOCIATED WITH LOSS OF SENSATION IN THE GENITAL AREA S. MUSTAFA 1, I. GRUENWALD 2, I. G. GARTMAN 2 , L. LOWENSTEIN3; 1 Rambam Med. center, Haifa, Israel, 2Rambam Med. Ctr., Haifa, Israel, 3Rambam Hlth. Care Campus, Haifa, Israel.
Objectives: To compare thermal and vibratory thresholds in the vaginal and clitoral regional, between women with and without stress urinary incontinence symptoms. Methods: Women who complained of symptoms of stress urinary incontinence (SUI) underwent a full urodynamic investigation, and those with recorded pure Urodynamic stress incontinence (USI) were included in this study. After signing an informed consent they underwent genital sensory testing, performed with a thermal and vibratory Genito-Sensory Analyzer (GSA; Medoc Ltd., Israel), at the distal third of the anterior and posterior vaginal wall and at the clitoral area. Warm stimuli were used to evaluate the integrity of C- fibers, cold for A-beta and C fibers, and vibratory for A-delta fibers. Threshold values for women with SUI were compared to those from an age matched group (1:3) of women without any lower urinary tract symptoms. The paired t-test was used for statistical analysis. Results: Participants were 15 women with USI and 45 without (mean age 53 years). Parity was higher among women with SUI (median 3 (0–8) vs. 2 (0–5), P<0.0001). Women with USI had significantly higher threshold levels to warm stimuli in both the anterior and posterior vagina and at the clitoral region. Similarly women with USI were significantly less sensitive to cold and vibratory stimuli in these anatomical areas (table 1). Conclusion: Sensory deficit at the external genitalia (i.e. clitoris and distal vagina) in women with SUI (external sphincter deficiency) may be due to peripheral pudendal nerve damage in both afferent and efferent pathways. The clinical significance of such needs further exploration, as does the possible effects of surgical intervention on sensation. Table 1: Comparison between women with and without stress urinary incontinence (SUI) in thresholds for thermal, cold, and vibratory stimuli Sensory modality
Anatomical site
SUI (n=22)
No SUI (n=45)
p-Value
Warm (Celsius)
Anterior vagina
41.1±1.5
39.7±0.9
<0.000
Posterior vagina
40.5±1.3
39.3±0.7
<0.000
Clitoris
39.0±0.6
38.0±0.5
<0.000
Cold
Anterior vagina
29.8±2.1
32.1±1.8
<0.000
(Celsius)
Posterior vagina
30.4±2.1
32.4±1.9
<0.000
Clitoris
33.5±0.9
35.5±1.2
0.001
Vibration
Vagina
5.0±3.0
2.1±0.7
<0.000
(Hz)
Clitoris
2.4±0.7
1.1±1.9
0.005
Data are described by sensory modality and anatomical site combination. Thresholds are given as mean ± S.D.
S130
Disclosure Block: Susana mustafa: No disclosures. Ilan Gruenwald: No disclosures. Irena Gartman: No disclosures. Lior Lowenstein: No disclosures. OP 053 HYSTERECTOMY COSTS BY ROUTE AND IMPLICATIONS V. DANDOLU; Univ. of Nevada Sch. of Med., Las Vegas, NV. Introduction: The Health care reform calls for curtailment of costs of the health system while maintaining the quality of care. Hysterectomy being the most common elective surgical procedure lends itself to be a great topic of interest for cost analysis. Cost related to the hysterectomy is significantly affected by the route chosen. None of the published studies on hysterectomy costs have analyzed physician reimbursement by route as a factor in their cost bundle analysis. Objective: To estimate the provider, hospital and overall costs associated with different routes of hysterectomies by payor type (capitated vs. fee for service) among commercially insured population in United States from 2006 to 2010. Methods: The data for this study were obtained from Medstat MarketScan Commercial Claims database. It contains comprehensive de-identified claims records from Health Maintenance Organizations and preferred providers. Hysterectomies were classified by the route - abdominal AH, vaginal VH, and laparoscopic supracervical LASH, laparoscopic vaginal assisted LAVH and total laparoscopic TLH. Hysterectomies in each category were also grouped according to the reimbursement structure (capitated vs. fee for service FFS). The cost for physician reimbursement, hospital cost and overall cost were estimated by route. SAS® statistical software was used for analysis. Results: Over a period of 5 years, 336,838 benign hysterectomies were performed among women 18–65 years (rate= 7.16 %). The length of stay was longest in AH (2.49d), followed by1.57d in VH, and 1.47d in LH. Mean Physician reimbursement was highest for TLH ($2019.88) and lowest for AH ($1708.48) while VH had reimbursement of ($1885.03). Cost incurred by the Hospital was lowest for VH ($8378.91) and highest for TLH ($10,411.19). Total costs were also lowest with VH ($11,697.20) and highest with TLH ($14,168.52). About 16 % of hysterectomies were in the capitated group and costs were generally lower in the capitated group vs. fee for service. Due to the large sample size all results were statistically significant @ p-value <0.05. Conclusions: Route of hysterectomy is a significant determinant of cost associated with hysterectomy. Provider reimbursement for VH is lowest and ironically VH incurs lowest overall cost. TLH was the most expensive route followed closely by LASH.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Provider reimbursement for laparoscopic hysterectomy is substantially higher than for VH and may be a driver of hysterectomy cost. Despite of shorter length of stay laparoscopic hysterectomy incurred substantially higher total costs. Costs were lower in the capitated group vs. fee for service. References 1. Turner LC, Shepherd JP, Wang L, Bunker CH, Lowder JL. Hysterectomy surgical trends: a more accurate depiction of the last decade? Am J Obstet Gynecol. 2013 Apr;208(4):277 2. Wright KN, Jonsdottir GM, Jorgensen S, Shah N, Einarsson JI. Costs and outcomes of abdominal, vaginal, laparoscopic and robotic hysterectomies. JSLS. 2012 Oct-Dec;16(4):519–24 3. Dayaratna S, Goldberg J, Harrington C, Leiby BE, McNeil JM. Hospital costs of total vaginal hysterectomy compared with other minimally invasive hysterectomy.Am J Obstet Gynecol. 2013 Sep 20 Disclosure Block: Vani Dandolu: No disclosures.
OP 054 THE SECOND STAGE OF LABOR DOES NOT AFFECT PELVIC FLOOR FUNCTION ONE TO TWO YEARS AFTER DELIVERY R. G. ROGERS1, L. LEEMAN 2, N. BORDERS 3, L. MIGLIACCIO 3, C. QUALLS 4, D. TEAF 3, R. J. HALL 5, E. HERVEY 3, L. ALBERS 6; 1 Supported by NICHD R01HD049819 and UL1TR000041, Univ. of New Mexico, Albuquerque, NM, 2Univ. of New Mexico, Albuquerque, NM, 3Obstetrics and Gynecology, Univ. of New Mexico, Albuquerque, NM, 4Univ of New Mexico Hlth. Sci. Ctr., Albuquerque, NM, 5UNM HSC, Albuquerque, NM, 6School of Nursing, Univ. of New Mexico, Albuquerque, NM. Introduction: The second stage of labor is thought to damage the pelvic floor. We previously published 6 month follow-up of a prospective cohort of nulliparous women who gave birth vaginally (VB) or by cesarean (CD) to determine if the second stage of labor contributed to postpartum pelvic floor changes. In this cohort, all CD women delivered prior to entry into the second stage of labor. At 6 months postpartum, VB women were more likely to have demonstrable urinary incontinence (UI) and small changes in vaginal support of the anterior vaginal wall, but did not differ in symptom severity or quality of life measures for UI, anal incontinence (AI) or pelvic organ prolapse (POP) when compared to CD women.1 Objective: To compare pelvic floor function between primiparous women who delivered vaginally and those who delivered by cesarean but did not enter the second stage of labor at 1 to 2 years following birth.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Methods: We recruited nulliparous women during pregnancy from an academic midwifery practice and women who delivered by CD but did not enter the second stage of labor immediately postpartum and followed all women to 1 and 2 years postpartum. Women completed the Incontinence Severity Index(ISI), Pelvic Floor Impact Questionnaire(PFIQ-7 including the IIQ-7, POPIQ-7 and CRAIQ-7), Wexner Fecal Incontinence Scale(W) and Female Sexual Function Index(FSFI), as well as Present Pain Intensity Scales (PPI) at baseline and again at 1–2 years postpartum. Results: Six hundred and seventy two women delivered by either VB or CD; 331/448(70 %) VB and 144/224(64 %) CD followed up at one and/or 2 years postpartum. For women who gave both one and two data (n=206), 2 year data were used. The VB group was slightly younger (23.9+/−4.9 vs 26.6+/−6.1 years, p<.001) and less overweight/obese (38 vs 56 %, p<.001) than the CD group; baseline pelvic floor functional measures were similar between groups (all p≥.05). Women who followed-up at 1 to 2 years were older, had more years of education, and were more likely to be of non-Hispanic white race/ethnicity (all p<0.05) but did not differ in BMI, weight gain in pregnancy, fetal birth weight, epidural or oxytocin use in labor, or CD rates, (all p>0.05). Episiotomy (n=8) and operative delivery (n=26) were rarely performed. At follow-up, any urinary incontinence (UI) was common, (64 % VB vs 55 % CD ISI >0, p=0.09), but few women reported moderate to severe UI (11 % VB vs 6 % CD, ISI >/=3, p=0.1). Likewise, any AI was common (44 % VB vs 50 % CD, W >0, p=0.22) but fewer women reported FI (11 % VB vs 17 % CD, FI on W, P=0.10). Most women reported sexual activity (89 % vs 89 %, p=.12) and mean FSFI scores (28.6 +/− 5.7 VB vs 27.7 +/− 6.1 CD, p=0.15) did not differ between groups. Similarly, most women did not report any perineal pain (90 % vs 94 % no pain on PPI, p=0.08). We also analyzed the impact of pelvic floor function on QOL as measured by the PFIQ-7; median IIQ-7 scores [interquartile range Q1, Q3] among women with IIQ-7 scores >0 were not different (14.3[4.8, 19.0] vs 9.5[4.8,33.3] p=0.88); median CRAIQ-7 scores among women with W scores >0 were also not different (9.5[4.8,19.0] vs 14.3[7.1, 25.4], p=0.45) Similarly, median POPQI scores did not vary between delivery groups (14.3[7.5, 26.1] vs 19.0[9.5, 19.0], p=0.43). Conclusions: In a low risk healthy cohort of women with low exposures to episiotomy and operative delivery, entry into the second stage of labor and VB did not result in more UI, AI, FI or sexual dysfunction symptoms at 1 to 2 years postpartum. Regardless of delivery mode, most women report mild symptoms that had limited QOL impact. In this cohort, entry into the second stage of labor did not impact postpartum pelvic floor function. References: BJOG 2014, in press.
S131
Disclosure Block: Rebecca Rogers: American Medical Systems: DSMB chair for TRANSFORM trial, Honoraria. McGraw-Hill: Editor for textbook, Royalty. UptoDate: Author for prolapse chapter, Royalty. Lawrence Leeman: No disclosures. Noelle Borders: No disclosures. Laura Migliaccio: No disclosures. Clifford Qualls: No disclosures. Dusty Teaf: No disclosures. Rebecca Hall: No disclosures. Elizabeth Hervey: No disclosures. Leah Albers: No disclosures.
OP 055 CAN LEVATOR ANI TRAUMA BE PREDICTED ANTENATALLY? G. ROSTAMI NIA1, M. MACHIORLATTI 1, S. SHOBEIRI 2 , L. H. QUIROZ 3; 1 OUHSC, Oklahoma city, OK, 2The Univ. of Oklahoma HSC, Oklahoma City, OK, 3Universith of Oklahoma Hlth. Sci., Oklahoma City, OK. Introduction: While the pathogenesis of pelvic organ prolapse (POP) is likely to be multifactorial, childbirth has been identified as an important risk factor. Trauma to levator ani muscle may partly explain the link between vaginal birth and POP. Recent magnetic resonance imaging (MRI) and ultrasound studies have shown major levator defects in 25–30 % of vaginally parous women (1, 2). To develop preventive strategies, we need to identify risk factors for levator ani trauma. Identification of variables that are associated with an increased risk of levator ani trauma might enable modifi cat ion of obstetric practi ce and appropri at e counseling. Objectives: The aim of current study was to show the association between obstetric and maternal variables and severity of levator ani muscle trauma Methods: This was a prospective study and included primigravid women who were recruited through campus-wide e-mails and community advertisements. 3D Endovaginal ultrasound was performed in the third semester (24–37 weeks of gestation) and 6–12 weeks after vaginal delivery. Only women who delivered vaginally entered the study. Our obstetric variables were newborn weight, head circumference and length of second stage. We did not have any operative vaginal delivery using forceps. Ultra so unds were reviewed and levator ani deficiency (LAD) was scored based on prior published works. Change in LAD (LADΔ) was measured as a subtraction of postpartum LAD from antenatal LAD, and the change was reported as an indicator for severity of levator muscle
S132
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
trauma. The presence of levator avulsion was documented separately. Minimal levator hiatus (MLH) area was measured. Since the infant’s head should pass through the minimal levator hiatus and this is the location for the most amount of distention, we calculated MLH distention (MLH-D) as the ratio of head circumference to MLH circumference (MLH-D = HC/ MLHC). SAS v 9.2 was used for all analyses. Summary statistics were created for categorical and continuous variables. Correlations coefficients on continuous covariates were explored using PROC CORR and significance of the correlation coefficients were examined using Pearson’s test Results: 34 women were included in analysis. Demographic data is summarized in (Table 1). MLH-D ranged from 1.08 to 3.30 with a mean of 2.73 SD ± 0.39. LADΔ as an indicator for levator trauma severity ranged from 0 to 12 with a mean of 3.51 SD ± 2.91 (Table 2). There was a positive correlation of 0.4 between MLH-D and LADΔ with p-value =0.0375 (Table 3). There were two levator ani avulsions with MLHD of 2.92 and 2.90 respectively. On multivariate linear regression, stratified by length of second stage and infant weight, LADΔ continued to be associated with MLH-D, p value=0.04. Conclusions: Greater discrepancy between fetal head circumference and minimal levator hiatus circumference is associated with severity of levator muscle trauma after first vaginal delivery. While fetal head circumference and fetal weight solely cannot predict the amount of trauma, minimal levator hiatus distention ratio (MLH-D) is useful for this purpose.
References: Table 1, Demographic summary Vaginal Delivery (n=34) Age, years (mean, ±SD)
26.77 (4.72)
Race (n, %) White
31 (91.18)
Black
1 (2.94)
Hispanic
0 (0.00)
Native American
0 (0.00)
Asian
2 (5.88) 2
BMI, kg/m (mean, ±SD)
28.22 (4.98)
Comorbidities (n, %) Asthma
9 (27.27)
Diabetes
1 (3.03)
Hypertension
1 (3.03)
Connective tissue disease
1 (3.03)
Table 2: Descriptive Stats
Variable
N
Std Dev
Minimum Maximum
HC/MLHC
34 2.73345
Mean
0.39196
1.08892
3.30716
LADΔ
29 3.51724
2.91083
0
12.00000
Length of second stage(min) Baby Wt(gr)
34 82.38235 73.53664
10.00000
298.00000
35 3263
707.96725 2651
4479
Table 3, Pearson’s Correlation Pearson Correlation Coefficients Prob >|r| under H0: Rho=0 Number of Observations LAD Δ
Length of second stage
Baby Wt
0.39491
0.04562
0.00447
1.00000
0.0375
0.8009
0.9800
34
28
33
34
MLH-D MLH-D MLH-D
1 Disclosure Block: Ghazaleh rostami nia: No disclosures. Michael Machiorlatti: No disclosures. S. Abbas Shobeiri: POP Medical: Consultant, Consulting Fee. Lifecell: Consultant, Consulting Fee. Lieschen Quiroz: No disclosures.
OP 056 PERINEAL BODY LENGTH AND PERINEAL LACERATIONS DURING DELIVERY IN PRIMIGRAVID PATIENTS T. L. LANE, W. LARSEN, P. M. YANDELL, C. P. CHUNG, T. KUEHL; OB/GYN, Scott & White Mem., Temple, TX. Introduction: Severe obstetrical lacerations place patients at increased risk for pelvic organ prolapse, genuine stress urinary incontinence, sexual dysfunction, and fecal and/or flatal incontinence. We wanted to identify the risk factors for severe lacerations associated with vaginal delivery to better counsel patients and to minimize risk of such quality of life altering outcomes. Objective: To assess the relationship between perineal body length and other characteristics to the risk of perineal lacerations extending to the anal sphincter during delivery in primigravid patients. Methods: Primigravid women with singleton pregnancies who were in the first stage of labor at 37 weeks gestation or greater were recruited. The admitting physician measured the length of the perineal body and recorded
S133
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
other characteristics including age, body mass index, ethnic origin, and gestational age. Following delivery, the degree of vaginal laceration and other delivery characteristics were also recorded. Data were analyzed using univariant analyses to identify factors to include in logistic regression. Receiver operator curve (ROC) analyses were performed to set thresholds for quantitative variables and multiple logistic regressions was used to establish a model for factors associated with third or fourth degree vaginal lacerations. Results: Three parametric variables (perineal body length <3.6 cm, duration of second stage >99 min, and patient age >26 years) were associated (p<0.048) with third and fourth degree (severe) lacerations using ROC in 127 primigravid women. One nonparametric variable (delivery type as spontaneous vaginal versus vacuum or forcep assisted deliveries) was also associated (p=0.009) with severe lacerations. Using logistic regression, only the duration of second stage and length of the perineal body were significant (p<0.036) predictors of third and fourth degree lacerations with odds ratios of 32 (1.3 to 807 as 95 % CI) and 24 (1.3 to 456), respectively. Conclusions: Both perineal body length and duration of second stage of labor were associated with an increased risk of third and fourth degree lacerations in primigravid patients.
Factor
Criterion1
Coefficient POdds 95 % CI Value ratio for odds ratio
Duration of second stage in minutes Perineal body length in cm Patient age in years
Greater than 99
3.47
0.035 32
1.3 to807
Less than 3.5
3.19
0.033 24
1.3 to 456
Less than 26
2.41
0.15
11
0.43 to 293
Spontaneous Vaginal Delivery
Non-operative −0.29 delivery=1, Operative delivery=0
0.86
0.75
0.03 to 17.9
Logistic regression model for relationship of factors to development of third and fourth degree lacerations in nulliparous patients (Overall model P=0.0004 with 98 % of 127 cases correctly classified) 1 Criteria developed for quantitative variables using receiver-operator curve analyses Perineal body length: AUC of 071 P = 0.047, sensitivity 80 %, specificity 66 % Age: AUC of 0.75 P=0.005, sensitivity 80 %, specificity 75 % Second stage duration: AUC of 0.82 P<0.0001, sensitivity 80 %
Disclosure Block: Thomas lane: No disclosures. Wilma Larsen: No disclosures. PAUL YANDELL: No disclosures. CHRISTOPHER CHUNG: No disclosures. THOMAS KUEHL: No disclosures.
OP 057 DO SYMPTOMS OF PELVIC FLOOR DISORDERS BIAS MATERNAL RECALL OF OBSTETRICAL EVENTS? C. CHEN1, L. J. MCELRATH 2, C. B. PIERCE 2, J. L. BLOMQUIST 3, V. L. HANDA 1; 1 Department of Gynecology and Obstetrics, Johns Hopkins Sch. of Med., Baltimore, MD, 2Department of Epidemology, Johns Hopkins Bloomberg Sch. of Publ. Hlth., Baltimore, MD, 3Department of Obstetrics and Gynecology, Greater Baltimore Med. Ctr., Baltimore, MD. Introduction: Patient recall of medical diagnoses and interventions is greater for childbirth events than for other types of hospitalizations.1 Nevertheless, several studies have demonstrated limited concordance between patient recall and the obstetrical medical record. An important question is whether maternal recall is biased by subsequent health outcomes, such as the development of pelvic floor disorders. Objective: This study describes the agreement between maternal recall of obstetrical events and the medical record 5– 10 years after delivery. Specifically, we investigated whether maternal recall of obstetrical events is biased by symptoms of incontinence and prolapse. Methods: In a cohort of parous women, we compared obstetrical medical records with maternal recall of delivery events (median 6 years postpartum). These delivery characteristics were considered: macrosomia, labor induction, prolonged second stage, spontaneous perineal laceration, anal sphincter laceration, forceps delivery and vacuum delivery. For each of these variables, we calculated the agreement between maternal recall and the medical record using the kappa statistic.2 We then identified women with “bothersome” symptomatic pelvic floor disorders, using published thresholds for responses to the Epidemiology of Prolapse and Incontinence Questionnaire (EPIQ).3 We investigated whether agreement between maternal recall and the medical record differed for those with or without symptomatic pelvic floor disorders. Results: Across 1821 deliveries among 1011 participants, agreement between maternal recall and the medical record was best for macrosomia (0.8). Recall was fair for episiotomy (=0.61; 95 % confidence interval (CI) 0.54, 0.67) and poor for spontaneous perineal
S134
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
laceration (=0.41; 95 % CI 0.34, 0.48). Recall for anal sphincter lacerations was also fair to poor (=0.57; 95 % CI 0.46, 0.68).
Agreement between maternal recall and the obstetrical record for women with versus those without pelvic floor disorders*. Estimated kappa for women with pelvic floor disorders†
Estimated kappa for women without pelvic floor disorders†
P value for difference of % agreement
Macrosomia 0.97 (0.93, 1.00)
0.93 (0.89, 0.97)
0.37
Prolonged 0.45 (0.29, 0.60) second stage Episiotomy 0.57 (0.40, 0.74)
0.46 (0.38, 0.54)
0.79
0.60 (0.51, 0.69)
0.82
Spontaneous 0.31 (0.12, 0.50) laceration 0.43 (0.24, 0.63) Anal sphincter laceration Vacuum 0.67 (0.45, 0.88)
0.47 (0.37, 0.57)
0.14
0.40 (0.25, 0.54)
0.04
0.81 (0.70, 0.92)
0.06
Forceps
0.86 (0.78, 0.95)
0.69
0.89 (0.78, 0.99)
* For multiparous women, only the first birth is considered. † Estimated kappa (and 95 % confidence interval) Of 1011 participants, 190 had at least one symptomatic pelvic floor disorder, defined as an EPIQ score above the threshold for “bothersome” symptoms. This included 90 women with stress urinary incontinence symptoms, 56 with overactive bladder symptoms, 21 with prolapse symptoms, and 104 with symptoms of anal incontinence. The presence of a symptomatic pelvic floor disorder did not modify maternal recall with respect to macrosomia, labor induction, prolonged second stage of labor, episiotomy, spontaneous laceration or forceps delivery However, agreement differed between these groups for anal sphincter laceration. The sensitivity of maternal recall for anal sphincter laceration was higher among those with symptomatic pelvic floor disorders than others (47 % (15/32) versus 34 % (18/53)). Conversely, the specificity of maternal recall for anal sphincter laceration was somewhat lower among those with symptomatic pelvic floor disorders than others (93 % (51/55) versus 97 % (225/231)). In other words, while anal sphincter lacerations were underreported among women in both groups, symptomatic women were significantly more likely to report a history of anal sphincter laceration, regardless of whether a sphincter laceration was documented. Conclusions: Maternal recall of anal sphincter laceration may be biased by symptomatic pelvic floor
disorders. In research based on maternal recall of obstetrical events, this would have the effect of strengthening the apparent association between sphincter laceration and pelvic floor disorders. Therefore, maternal recall may not reliable enough for research or for subsequent obstetrical care; providers and researchers should continue to review medical records, rather than rely on patient recall for this outcome. References: 1. Authors. Article Title. Journal. Jun 1973(57):1–58 2. Authors. Article Title. Journal. 1977;33(1): 159–174. 3. Authors. Article Title. Journal. 2005;16(4):272–284. Disclosure Block: Crystal Chen: No disclosures. LaPortia McElrath: No disclosures. Christopher Pierce: No disclosures. Joan Blomquist: No disclosures. Victoria Handa: Up to Date: Chapter author, Royalty.
OP 058 SYSTEMATIC OVERVIEW OF OUTCOMES OF THIRD AND FOURTH DEGREE PERINEAL TEARS IN EPISIOTOMIES VERSUS NO EPISIOTOMIES P. M. LATTHE1, T. VERGHESE 2, R. CHAMPANERIA 3; 1 Urogynaecology, Birmingham Women’s NHS Fndn. Trust, Birmingham, United Kingdom, 2Obstetrics and Gynaecology, Birmingham Women’s NHS Fndn. Trust, Birmingham, United Kingdom, 3Birmingham Clinical Trials Unit, Univ. of Birmingham, Birmingham, United Kingdom. Introduction: Obstetric anal sphincter injury (OASI) complicates 1 % of all vaginal deliveries. This has the potential to cause long term physical and psychological morbidity. Nearly 60 % of all vaginal deliveries are believed to be complicated by either an episiotomy or a spontaneous perineal tear that required suturing. In Europe and the United kingdom, a mediolateral episiotomy is favoured by some obstetricians at the time of crowning resulting in widening of the introitus. A mediolateral episiotomy should be directed at an angle of 60° from the midline towards the ischial tuberosity to reduce the risk of severe perineal tear. Revicky et al. reported that women who delivered without the help of an episiotomy were 1.4 times more likely to sustain an obstetric anal sphincter injury1. In contrast, other studies have failed to demonstrate a benefit of the routine use of episiotomy. As studies have reported conflicting results, this has led to divided opinions amongst obstetricians in their clinical practice.
S135
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Objective: To undertake a systematic overview of current literature to determine the role of mediolateral episiotomies in the prevention of obstetric anal sphincter injury. Methods: Citations were retrieved using a comprehensive database search from inception to the present day (CINAHL, Cochrane, EMBASE, Medline and MIDIRS). Two independent reviewers selected studies that met the inclusion criteria. The inclusion criteria consisted of: women having spontaneous vaginal delivery, an intervention of a mediolateral episiotomy, a comparative control of spontaneous tears, outcomes of OASI reported. Data from selected studies was extracted using a pre-designed pro-forma. Information was collated based on study characteristics, methods of recruitment, patient characteristics, details of primary outcomes. The Jadad scale and Newcastle-Ottawa scale was used to assess the quality of randomized and non-randomised controlled trials respectively. A meta-analysis was conducted on retrospective studies with complete data using Review Manager (version5). Results: A total of 1114 citations were identified through the electronic literature database search. Of these 1054 were excluded with 21 studies fulfilling the inclusion criteria (1 prospective study and 20 retrospective studies). As all the studies did not give the actual numbers, they could not all be included in the meta-analysis. A meta-analysis of 10 retrospective studies suggested harm to the anal sphincter from performing routine episiotomy in women having spontaneous vaginal deliveries. The odds ratio was 3.48 (95 % CI 3.13–3.86). A prospective study reported by Andrews et al. (2006) observed no benefit from episiotomy. The rates of OASI was 41.8 % in the episiotomy group (N = 98) and 12.5 % in the control group (N = 143). Mediolateral episiotomy was found to be an independent risk factor for sphincter injury, which could be attributed to inappropriate technique.2 The more acutely angled the episiotomy or closer to anal sphincter significantly increased chance of sphincter injury. Conclusion: The findings from this systematic overview suggests that there is no benefit from routine mediolateral episiotomy in the prevention of OASI. There are a limited number of prospective studies in this field. However, only one study measured the angle of episiotomy to ascertain whether it was accurately performed. Andrew et al., found that the risk of sphincter injury may be attributed to inappropriate technique2. Focus must be placed on educating trainees in appropriate technique and identification of anal sphincter injuries. References: 1. European Journal of Obstetrics & Gynecology and Reproductive Biology. 2010;150:142–146
2. Birth. 2006;33;117–122 Disclosure Block: PALLAVI LATTHE: Astellas: Speaker, Honoraria. Pfizer: Speaker, Honoraria. June Medical: Consultant, trip to Berlin to see the mesh implantation by Prof Tunn. TINAVERGHESE: No disclosures. RITA CHAMPANERIA: No disclosures.
OP 059 IS BMI ASSOCIATED WITH INCREASED INTRA ABDOMINAL PRESSURE AND LOWER BLADDER NECK POSITION AND GREATER GENITAL HIATUS ON ULTRASOUND? K. BAESSLER1, H. VOLLHABER 1, M. RUEHL 2, B. JUNGINGER 1; 1 Pelvic Floor Unit, Charite Univ. Hosp., Berlin, Germany, 2 Charite Univ.etsmedizin Berlin, Berlin, Germany. Introduction: Obesity is an established risk factor for urinary incontinence and pelvic organ prolapse and a correlation of body mass index (BMI) and intraabdominal pressure (IAP) has been demonstrated (1). Objective: The aim of this study was to assess the association between BMI, IAP and bladder neck (BN) and puborectalis (PR) position supine and standing in women with urinary incontinence and healthy controls. Methods: We recruited 70 women with urinary incontinence from urogynaecological clinics and 17 healthy continent controls via public advertisements. All completed a validated Pelvic Floor Questionnaire and underwent POPQ-staging. Women with previous pelvic floor surgery and those with prolapse beyond the hymen were excluded. A microtip transducer was used to measure the intrabdominal pressure. Perineal ultrasound (curved abdominal probe, Voluson E8, GE) was performed to assess BN and puborectalis muscle position. Analysis was performed on-screen applying a validated measuring system. Position (height) of the BN was measured from a horizontal line at the dorsal edge of the pubic symphysis as the reference. The sagittal genital hiatus was evaluated by determining the distance between the symphysis
S136
and the most anterior part of the puborectalis muscle behind the rectum. For supine measurements, women were placed in a half-sitting position with legs supported in stirrups. Afterwards women were asked to stand relaxed with legs slightly apart to be able to place the perineal ultrasound probe. Supine measurements were taken at rest with increasing bladder volumes from 50 ml until the first desire to void between 100 and 200 ml. When the first desire to void had subsided, women were asked to get up and IAP, BN and PR position measurements were again taken. Based on data from (1), our power calculation showed that 37 women were necessary to demonstrate a correlation of 0.4 between IAP and BMI with a power of 80 % and α=0.05. Results: Healthy controls were significantly younger (mean 32 years vs 50 year; p<0.001) and had a lower BMI (mean 23 kg/m2 vs 25; p=0.033) but vaginal parity was similar in both groups ranging from 0 to 8 (median 1.5; p=0.649). The differences between IAP supine and IAP standing ranged from 0 to 12 cm H2O in healthy and from 0 to 23 cmH2O in incontinent women (p=0.045). Mean IAPs supine were 17 and 18 cmH2O in healthy and incontinent women, respectively (p=0.52) and IAP standing 24 and 25 cmH2O, respectively (p=0.237). In incontinent women, BMI correlated with &
IAP standing 0.25 (p=0.026)
&
BN position standing −0.28 (p=0.045)
&
PR distance symphysis 0.42 (p<0.001)
&
Age 0.25 (P=0.011).
A linear regression model was developed to evaluate dependent variables: Twelve percent of the variations in PR-symphysis-distance can be explained by BMI with age, vaginal parity and IAP as covariates (R2 0.17; p=0.002). In contrast, in healthy women, BMI did not correlate with IAP or BN position. IAP correlated with PR-symphysis distance 0.78 (p=0.005). In a linear regression model, 32 % of variation depended on IAP (R2 0.32; p=0.036). Conclusions: A higher BMI is associated with a larger hiatus in healthy and incontinent women, independent of parity and age. In incontinent women, a higher BMI is accompanied by an increased IAP and it also impacts on BN position. The results of this study help to understand the pathophysiology of pelvic floor dysfunction. Furthermore, obesity is a modifiable risk factor which should be discussed when counselling women.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
References: 1 Baseline abdominal pressure and valsalva leak point pressures-correlation with clinical and urodynamic data. Neurourol Urodyn. 2003;22(1):2–6. Disclosure Block: Kaven Baessler: No disclosures. Hanna Vollhaber: No disclosures. Mira Sophie Ruehl: No disclosures. Baerbel Junginger: No disclosures.
OP 060 TIMING OF EPISIOTOMY AND DELIVERY OUTCOME Z. RUSAVY, J. KARBANOVA, L. BETINCOVA, V. KALIS; Department of Obstetrics and Gynecology, Med. Faculty in Pilsen, Charles Univ. in Prague, Plzen, Czech Republic. Objective: To compare the effect of episiotomy performed before and at time of crowning in primiparous women. We were interested in immediate delivery outcome, as well as a short-term and long-term follow-up regarding healing, pain, anal incontinence and sexuality. Background While ample evidence has been published about episiotomy indications, technique, repair and consequences, there is a dearth of evidence regarding the timing of episiotomy. The optimal time for performing an episiotomy is unclear, practice varies significantly and depends largely on the indication. It is recommended to perform episiotomy when the head is visible during a contraction to a diameter of 3–4 cm. However, when employing restrictive approach of episiotomy, the indication of episiotomy often arises during crowning, i.e. when the biparietal diameter has already passed though the bony pelvis and there is no recession of the fetal head between contractions. Apart from expert opinions, no higher quality scientific evidence regarding timing of episiotomy and delivery outcome exists. Methods: A secondary analysis of data from a prospective randomized study comparing outcome of mediolateral (MLE) and lateral episiotomy (LE) was performed. The study included term primiparous women who delivered at our hospital from 4/2010 till 3/2012. It was approved by local ethics committee and all participants signed an informed consent. Patients, where MLE or LE was performed before crowning (BC) were compared to those with episiotomy at crowning (AC). All data from the trial were analyzed, i.e. immediate delivery outcome and responses to the questionnaires obtained from the patients 1, 3, and 10 days, 3 and 6 months postpartum. The following variables were observed; obstetric anal sphincter injuries (OASIS) rate, additional perineal or vaginal trauma, 5-minute Apgar score, umbilical cord pH, episiotomy length, duration of the 2nd stage of labor, blood loss, infection, hematoma, dehiscence, secondary suture, pain (VAS, VRS and ADL scores 24 h, 72 h, 10 days, 3 months and 6 months after delivery), painful
S137
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
defecation, sexual intercourse, regular sexual intercourse, dyspareunia, anal incontinence (St. Mark’s score) and constipation 3 and 6 months postpartum. Basic statistical values were calculated for study groups and subgroups. The comparison of variables in given groups with respect to their distribution was performed using non-parametric ANOVA (2sample Wilcoxon test). Categorical variables were analyzed using the χ2 test and described by contingency tables. Results: In total, 517 patients with complete follow-up data were available for the secondary analysis (110 BC, 407 AC). The groups did not differ in age, BMI, neonatal weight, occipito-posterior presentation, shoulder dystocia and type of episiotomy performed. Episiotomy before crowning was significantly more frequent in operative delivery, owing to the practice at our institution to execute prophylactic episiotomy in operative delivery. Consequently, worse neonatal outcome measures were recorded in BC. Furthermore, BC was more common among doctors, while AC was equally frequent between midwives and doctors. No significant differences in OASIS rate and additional perineal trauma were found, however, significant differences in the incidence of additional vaginal trauma, length of episiotomy and estimated blood loss were observed even in multivariate analyses. Interestingly, there was no difference in the duration of the 2nd stage of labor. Timing of episiotomy and postpartum trauma
Obstetric anal sphincter injury [N] (%) Additional perineal trauma [N] (%) Additional vaginal trauma [N] (%) Length of episiotomy [mm] mean (SD) Estimated blood loss excluding uterine atony mean (SD) Duration of repair [min] mean (SD) Legend
Before crowning (n= 110) 1 (0.9)
At crowning (n=404) 7 (1.7)
p-value
2 (1.8)
13 (3.2)
0.75c
35 (31.8)
68 (16.7)
0.0004b
43 (10.7)
36 (8.5)
<0.0001a
368 (63.8)
368 (63.8)
<.0001a
14 (5.7)
13 (5.2)
0.07a
a - non-parametric ANOVA (2-sample Wilcoxon test)
b - χ2 test and contingency tables
c - Fisher’s exact test
0.54b
The groups did not differ in pain, healing complications, evaluated sexual functions or anal incontinence in short-term or long-term follow-up. The rate of painful defecation 10 days after delivery was significantly increased in BC (47.6 vs. 27.9 %, p=0.0001), the difference was significant also in the multivariate analysis. This trend was not seen 3 months (17.4 vs. 15.2 %, p=0.57), nor 6 months postpartum (5.5 vs 7.1 %, p=0.55).
Conclusions: To our knowledge this is the first study concerning timing of episiotomy and its immediate, shortterm and long-term outcome. The results suggest that MLE or LE performed at crowning is associated with less additional vaginal trauma, shorter length, lower estimated blood loss and lower incidence of painful defecation 10 days after delivery. No statistically significant differences in functional outcome, i.e. incidence of complications, pain, sexuality and anal incontinence, were observed in short-term and long-term follow-up. The effect of episiotomy timing on pelvic organ prolapse development remains yet to be determined. References: N/A Disclosure Block: Zdenek Rusavy: No disclosures. Jaroslava Karbanova: No disclosures. Lucie Betincova: No disclosures. Vladimir Kalis: No disclosures.
OP 061 POSTPARTUM CHANGES IN PELVIC FLOOR ANATOMY AND PELVIC FLOOR DYSFUNCTION SYMPTOMS AMONG PRIMIPAROUS WOMEN G. ROSTAMI NIA1, S. D. PICKETT 2, S. SHOBEIRI 3, L. H. QUIROZ 4; 1 OUHSC, Oklahoma city, OK, 2Univ. of Oklahoma Hlth. Sci. Ctr., Oklahoma City, OK, 3The Univ. of Oklahoma HSC, Oklahoma City, OK, 4Universith of Oklahoma Hlth. Sci., Oklahoma City, OK. Postpartum changes in pelvic floor anatomy and pelvic floor dysfunction symptoms among primiparous women Introduction: The association between vaginal parity and pelvic organ prolapse (POP) has been known to have a non-linear effect, with the first vaginal delivery having its greatest impact as a risk factor for POP. The role of imaging, specifically ultrasonography, is taking an increasingly central role in defining birth related changes in the pelvic floor support system. Physical examination, even in very experienced hands is not precise enough for detection of defects such as levator avulsion. Objectives: The aim of our study is to investigate postpartum changes in pelvic floor anatomy consequent to the first vaginal delivery and the association between obstetric trauma and post-partum pelvic floor dysfunction symptoms Methods: This was a prospective study and included primigravid women who were planning a vaginal delivery. Subjects were recruited through campus-wide e-mails and community advertisements. 3D Endovaginal Ultrasound (EVUS) was performed in the third semester (24–37 weeks of gestation) and 6–12 weeks after delivery. At the study visits, all subjects also underwent an examination (POP-Q), and pelvic floor and sexual function symptoms were assessed by validated questionnaires
S138
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
A total of four ultrasound volumes were reviewed per subject. Levator muscle scored based on previously published literature. Scores could range between 0 and 18, with higher scores corresponding to worse levator muscle deficiency (LAD). Minimal levator hiatus (MLH) area was measured in the minimal levator hiatus plane. The levator plate descent angle (LPDA) and anorectal angle (ARA) were measured in the midsagittal plane. Pelvic floor questionnaires included the PFDI-20, PFIQ-7, and PISQ-12. All questionnaires were scored according to published methods SAS v9.3 was used for all analyses. Summary statistics were calculated for the patient population. Student’s t-tests and Pearson’s chi-square or Fisher’s exact tests were used where appropriate. Results: A total of 56 subjects were included for this analysis. Our cohort included 34 vaginal deliveries and 22 cesareans after trial of labor. Demographic information is summarized in Table 1. There was a significant increase in mean LAD score after delivery (4.84±4.39 v. 7.31±4.29, p=0.0032). ARA increased by a mean of 4.55° (SD±16.76) but it was not statistically significant. Other postpartum changes are listed in Table 2. Interestingly, there was no significant change in ultrasound measurements by mode of delivery. There was a significant association between worsening bother in bowel symptoms as measured by the PFIQ-7 and worsening LAD score on univariate linear regression (β=1.46, p=0.0102). Additionally, a worsening in Aa and Ba scores were associated with worsening in LAD scores [r=0.41 (0.17), p=0.0046]. Conclusion: Levator ani muscle status worsens after the first delivery and this change is associated with worsening of bowel symptoms and anterior compartment descent early postpartum. Table 1, summary of demographic Total (n= Vaginal Delivery 56) (n=34)
Cesarean Delivery (n=22)
p Value
27.95 (5.14)
26.77 (4.72)
29.87 (5.35)
0.0281
31 (91.18)
14 (63.64)
0.0408
Black
53 (75.71) 6 (8.57)
1 (2.94)
2 (9.09)
Hispanic
5 (7.14)
0 (0.00)
3 (13.64)
Native American
3 (4.29)
0 (0.00)
2 (9.09)
Asian
3 (4.29)
2 (5.88)
1 (4.55)
28.22 (4.98)
29.72 (6.59)
0.3374
9 (27.27)
4 (18.18)
0.4369
1 (3.03)
0 (0.00)
1.000
Age, yrs (mean, ±SD) Race (n, %) White
29.34 BMI, kg/m2 (mean, ±SD) (6.19) Comorbidities (n, %) Asthma Diabetes
13 (22.03) 1 (1.69)
Hypertension
3 (5.08)
1 (3.03)
1 (4.55)
1.000
Connective tissue 1 (1.69) disease
1 (3.03)
0 (0.00)
1.000
Table 2, 3D US Measurements and POP-Q Antepartum and postpartum Antepartum
Postpartum
Change
MLH area (mean, ±SD)
12.14 (2.00)
11.49 (2.35)
0.70 (2.18)
LPDA (mean, ±SD)
12.89 (7.98)
14.34 (9.18)
−1.14 (8.16)
LAD (mean, ±SD)
4.84 (4.39)
7.31 (4.29)
−3.09 (3.02)
ARA (mean, ±SD)
157.94 (14.64)
160.91 (4.70)
−4.55 (16.76)
POP-Q (median, range) Aa
2.5 (−3, 0)
2 (−3, −1)
−0.5 (−1, 2)
Ba
−2.5 (−3, 0)
−2 (−3, −1)
−0.5 (−1, 2)
C
−3 (−3, 0)
−2.5 (−3, −2)
0 (−1, 2.5)
D
−3 (−3, 0)
−2.5 (−3, −2)
0 (−1, 2.5)
TVL
−6 (−8, −3)
−5.5 (−9, −4)
0 (−2.5, 3)
Ap
−8.5 (−10, −6.5)
−8 (−10, −5.5)
−1 (−3, 2)
Bp
9 (7, 11)
8.5 (6.5, 10)
0.5 (−2.5, 3)
GH
2.5 (1, 3)
3 (1, 4)
−0.5 (−2, 1.5)
PB
3.5 (2, 6
3 (1.5, 4.5)
−5.5 (−7.5, −2)
1 Disclosure Block: Ghazaleh rostami nia: No disclosures. Stephanie Pickett: No disclosures. S. Abbas Shobeiri: POP Medical: Consultant, Consulting Fee. Lifecell: Consultant, Consulting Fee. Lieschen Quiroz: No disclosures.
OP 062 EFFECT OF MODE OF CHILDBIRTH ON THE PREVALENCE OF SYMPTOMATIC PELVIC FLOOR DISORDERS - LONGITUDINAL STUDY K. GROHREGIN, L. KROFTA, M. KRCMAR, J. FEYEREISL; Urogynecology, Inst. for the Care of the Mother and Child, Prague, Czech Republic. Introduction: Childbirth is one of the main risk factors for developing pelvic floor disorders immediately postpartum or later in life. It still remains unclear which risk factors contribute to this process and whether delivery by Caesarean Section could have a protective effect. We present a longitudinal study focused on assessment of pelvic floor disorders before and after the first delivery. Objective: The aim of this study is to report prevalence of pelvic floor disorders in early pregnancy and 6 weeks, 6 months and 1 year after the first delivery. Our secondary hypothesis was that women who delivered by Caesarean Section (CS) will be less likely to develop symptomatic pelvic floor disorders Methods: This is a single center, prospective, observational study. All check-ups include clinical and ultrasound
S139
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
examination. Women are examined in supine position after voiding, POP-Q is noted and ultrasound volumes are taken at rest, upon maximal Valsalva and during the maximum pelvic floor contraction. Parameters of urogenital hiatus are assessed offline using 4DView© software and examiners are blinded to the results of clinical examination. Questionnaires (ICIQ-SF and PISQ 12) are gathered as a part of our protocol and these provide additional information on pelvic floor function. During the period of 05/2011 and 07/2013 we obtained complete datasets from 1926 women. In this study we include only primiparous women with singleton pregnancies, we also excluded all breech presenations. Obstetric data are collected postpartum such as duration of 1st and 2nd stages of labour, use of epidural analgesia, occiput posterior position (verified by ultrasound at the beginning of the 1st stage), fetal birth weight and also maternal age and BMI. Results: Mean age was 30,55 (range 16–43), mean BMI 27,36 (range 15,8–42,6) and mean fetal birth weight was 3371,54 (range 1870–4870). Of the 1926 women 1477 (76,6 %) delivered vaginally (VD) including 47 (2,4 %) who had forceps delivery and 449 (23,3 %) underwent CS, out of which 19,8 % were acute and 3,5 % elective surgeries. Questionnaire analysis showed that during pregnancy 27,3 % of women reported SUI and 5,2 % reported symptoms of OAB, prevalence of symptoms was the same in both VD and SC group, not dependent of later mode of delivery. 6 weeks after delivery symptoms of stress urinary incontinence (SUI) had 35,2 % of women who had a VD and 14 % of women after CS. 6 months after delivery it was 30,1 % and 18,8 % respectively and 1 year after delivery it was 34 % and 18 % respectively. Symptoms of OAB were present in 5,1 % of women after VD and 1,3 % after CS. Both 6 months and 1 year after delivery it was 5 and 3 % respectively. According to the severity mild SUI (ICIQ score ≤10) was present in 24 % of women after VD and 10,5 % after CS, severe SUI (ICIQ score ≥10) in 10,7 % of the VD group and 3,6 % of the CS group. Clinical examination showed levator ani avulsion in 21 % of patients (only in vaginally parous women) whereas ultrasound evaluation revealed avulsion in 26,4 % of the cases. We found no avulsion in the CS group, both upon palpation and on ultrasound. Risk factors for avulsion in our group of patients include maternal age (p=0,025), BMI (p=0,036) and fetal birth weight (p=0,019). Parameters of urogenital hiatus showed no difference whether CS was elective or acute. Women after VD also showed significantly worsened POP-Q scores, especially in points Ba and C. 6 weeks after delivery point Ba was −1 in 30 % after VD and only in 4,6 % after CS, in 7,9 % women after VD point Ba was ≥0 which we didn’t see in any of the women after CS. Conclusions: Vaginal delivery can have a detrimental effect on pelvic floor. Vaginally parous women report higher prevalence of bothersome pelvic floor disorders than women who undergo Caesarean Section. They also show significantly worse values in the POP-Q scoring system. Caesarean
Section shows protective effect against levator ani muscle avulsion 12 months after delivery. References: N/A Disclosure Block: Klara Grohregin: No disclosures. Ladislav Krofta: No disclosures. Michal Krcmar: No disclosures. Jaroslav Feyereisl: No disclosures.
OP 063 MESH REMOVAL FOLLOWING SLING/MESH PLACEMENT: A MULTICENTER STUDY O. CHINTHAKANAN1, J. R. MIKLOS 1, R. D. MOORE 1, G. MITCHELL 1, S. FAVORS 1, D. R. KARP 2, G. M. NORTHINGTON 2, G. NOGUEIRAS 3, G. DAVILA 3; 1 Intl. Urogynecology Associates of Atlanta, Alpharetta (Atlanta), GA, 2Emory Univ., Atlanta, GA, 3Cleveland Clinic Florida, Weston, FL. Introduction: Synthetic mesh utillzed in the treatment of stress urine incontinence (SUI) and pelvic organ prolapse (POP) can often result in patients with postoperative mesh complications. Complications most often cited include: pain, mesh erosion into viscus organs, mesh extrusion into the vaginal epithelium, and infections. Patients are often treated with surgery for mesh and scar revision as well as mesh removal in an attempt to address complications. Patients who have surgery to remove the mesh are subjected to the risk of a new surgery as well as the potential complications of removing the mesh. At our institutions, we have a high volume of patients with mesh related complications who have undergone surgical mesh removal. Objective: The objective of this study is: 1) to determine the most common indications for mesh removal 2) to determine the most common complications attributed to the surgical mesh and 3) evaluate the incidence of surgical complications associated with the removal of a specific type of mesh sling and POP mesh. Methods: This was a retrospective chart review of all patients who underwent surgical removal of synthetic materials from previous suburethral sling, transvaginal mesh, and sacrocolpopexy for mesh related complications from 2011 to 2013 at three tertiary referral centers in the Southeast United States. We included all women who underwent mesh/sling removal. The database was queried to identify potential subjects. Data was analyzed by using chi-square test for categorical data, and Student’s t-test and Wilcoxon Rank Sum test for continuous data. Results: A total of 445 patients with complications underwent mesh removal either laparoscopically, via groin dissection and/or transvaginally during the study
S140
period. There were a total of 506 mesh products removed. The mean patient age was 53.8±11.2 year and parity 2.5±1.2. The majority of patients were caucasian (82.0 %), postmenopausal (72.8 %), sexually active (52.1 %), and and insured (76.4 %). 82.9 % had previous hysterectomy and 92.6 % had previously been seen by a different physician(s). 28 % had previous surgery for sling/mesh revision or removal. Of the 445 patients, 373 (83.3 %) had a synthetic midurethral sling for SUI, 178 (40 %) had transvaginal mesh and 38 (8.5 %) had a sacral colpopexy (SC) inserted for treatment of POP. These slings can be categorized into retropubic slings (RP), transobturator (TOT) slings and single incision slings (SIS). The transvaginal mesh (TVM) are categorized into anterior vaginal wall mesh and posterior vaginal wall mesh. The most common indications for sling and mesh revision/removal were pain, dyspareunia, pressure symptoms, erosion/extrusion, and vaginal discharge. Of the 506 mesh products removed, 56.5 % were slings (RP 20.9 %, TOT 22.3 %, and SIS 15.4 %) and 43.5 % were mesh for POP (TVM 37.4 % and SC 5.7 %). Among the 3 types of synthetic slings, TOT was the most common type of sling removed. TOT group was 60 % more likely to have pain than RP (OR 1.6, 95 % CI 0.9–2.7). Patients with sling who complained of vaginal pain with or without intercourse were subjected only to a vaginal approach to surgical removal of the sling (86.6 %). Patients with lower abdominal/ suprapubic pain and vaginal pain that had a RP underwent a vaginal and laparoscopic approach to sling removal (18.4 %). Patients who complained of vaginal and groin pain that had a TOT sling underwent a vaginal and inguinal approach to sling removal (4.3 %). For patients requiring vaginal wall mesh removal, 42.3 % of the patients had mesh removal from the anterior vaginal wall only, 30.6 % posterior vaginal wall only and 14.0 % both anterior and posterior mesh. Finally 13.1 % of patients had sacral colpopexy mesh removed. Complications encountered during the removal are as follow: the median intraoperative estimated blood loss was 50 cc. (range 0–800). 2 (0.5 %) of patients required blood transfusions both were the result of laparoscopic TVT sling removal. Three patients had urethral injury all occurred during TOT sling removal, 2 ureteral injury both occurred during anterior vaginal wall mesh removal and 2 rectal injuries both during posterior vaginal wall mesh removal. Conclusion: In our study, the most common indication for mesh removal was pain; however, the indication of mesh removal did not influence the mesh removal complication rate. Transvaginal sling revisions had the least amount of postoperative or intraoperative complications. Laparoscopoic RP removal had the highest incidence of blood transfusion,
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
anterior vaginal wall mesh removal had the highest incidence of ureter injury rate, and posterior vaginal mesh removal had the highest incidence of rectal injury rate. Overall sling, transvaginal mesh and laparoscopic sacral colpopexy mesh removal are safe procedures in experienced hands. Disclosure Block: Orawee Chinthakanan: No disclosures. John Miklos: Coloplast: Consultant, Consulting Fee. Coloplast: Speaker, Travel Grant. Coloplast: Advisory Committee Member, Grant/Research Support. Gyrus/Olympus: Preceptor: received compensation when visitors obserbed the surgery, Preceptor: received compensation when visitors obserbed the surgery. AMS: Consultant, Grant/Research Support. Robert Moore: American Medical Systems: Consultant, Consulting Fee. American Medical Systems: Speaker, Honoraria. American Medical Systems: Consultant, Grant/ Research Support. Gretchen Mitchell: No disclosures. Sheena Favors: No disclosures. Deborah Karp: No disclosures. Gina Northington: Allmed Healthcare Management, Inc.: Consultant, Consulting Fee. G. Mayte Nogueiras: No disclosures. G. Willy Davila: Astellas: Speaker, Honoraria. Warner-Chilcott: Speaker, Honoraria. AMS: Speaker, Honoraria. AMS: Scientific Medical Advisor, Intellectual Property Rights. Pfizer: Investigator-initiated research grant, Grant/Research Support.
OP 064 THE IUGA/ICS CLASSIFICATION OF SYNTHETIC MESH COMPLICATIONS IN FEMALE PELVIC FLOOR RECONSTRUCTIVE SURGERY: A MULTICENTER STUDY J. R. MIKLOS1, O. CHINTHAKANAN 1, R. D. MOORE 1, G. MITCHELL 1, S. FAVORS 1, D. R. KARP 2, G. M. NORTHINGTON 2, G. NOGUEIRAS 3, G. DAVILA 3; 1 Intl. Urogynecology Associates of Atlanta, Alpharetta (Atlanta), GA, 2Emory Univ., Atlanta, GA, 3Cleveland Clinic Florida, Weston, FL. Introduction: Reports of prostheses related complications are increasing in the field of female pelvic floor reconstructive surgery. The IUGA/ICS (International Urogynecological Association/International Continence Society) created the uniform classification system in order to systematically report mesh complications in a standardized manner1. Objective: Our objective was to analyze the utility of the IUGA/ICS prosthesis related complications classification and to report on sling and transvaginal mesh related complications. Methods: This was a retrospective chart review of all patients who underwent surgical removal of sling, transvaginal synthetic mesh and sacrocolpepexy for mesh related complications from 2011 to 2013 at three tertiary referral centers in the
S141
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Southeast United States. The IUGA/ICS classification system for prostheses complications was used to report complications. We included all women who underwent reconstructive pelvic surgery using synthetic mesh for prolapse or urine incontinence and subsequent synthetic mesh removal due to complications. The database was queried to identify potential subjects. Data was analyzed by using chi-square test for categorical data, and Student’s t-test and Wilcoxon Rank Sum test for continuous data. The measure of effect was determined by logistic regression analysis. Results: We identified 445 patients with mesh complications who subsequently underwent mesh removal laparoscopicaly, via groin dissection and/or transvaginally. Of those identified, 178 (40 %) had transvaginal mesh inserted for treating pelvic organ prolapsed (POP), 373 (83.8 %) had a midurethral sling, and 38 (8.5 %) had sacrocolpopexy. There were 506 pieces of synthetic mesh removed and 587 prostheses related complications classified. The mean age was 53.8±11.2 year and parity 2.5±1.2. The majority of patients were Caucasian (82.0 %), postmenopausal (72.8 %), sexually active (52.1 %), and insured (76.4 %). 82.9 % had previous hysterectomy and 92.6 % had previously been seen by a different physician(s). Twenty-five percent were current smokes. Twenty-eight percent had a previous mesh revision or removal. The most common presenting chief complaint was pain (68.6 %) with or without intercourse. Only 3.7 % of patients had viscus organ erosion or vaginal extrusion as their presenting chief complaint. According to the IUGA/ICS classification, 59.7 % were classified into category 1 (no vaginal epithelial separation). The most common category was pain related (1Be –32.5 %) followed by dyspareunia (1Bc –14.7 %). Most patients presented with mesh related complications over a year after insertion (T4). The most common affected site (S2) was away from the suture line (49 %) (Table 1). Sling group was 20 % more likely to have pain than POP group (OR 1.2, 95 % 0.8- 1.6). Comparing sling and mesh for POP complications classification, mesh for POP group had higher erosion/extrusion (less than 1 cm exposure 17.6%vs. 11.1 %, p = 0.024, more than 1 cm exposure25.6 % vs. 6.9 %, p<0.001) and more likely to occur at the area of the suture line (36.1 % vs. 15.0 %, p<0.001) than the sling group. However, the sling group had more complications in category 1 (vaginal no separation 68.0 % vs. 48.4 %, p<0.001) and category 6 (skin and musculoskeletal 7.5 % vs. 3.6 %, p=0.047). Conclusion: Based on these results surgeons should be aware that patients with mesh complications are routinely presenting more than 1 year after the initial surgery. Surgeons should note that while vaginal extrusion is a common complication of slings and transvaginal POP mesh it is more common in the latter. However most of the time the patient’s chief complaint is not an objective find (i.e.–erosion or extrusion) but more commonly a patient’s subjective complaint (i.e.pain). If the
patient had a sling and is complaining of pain it might be beneficial to focus ones exam away from the suture line (i.e. paraurethrally) and not necessarily suburethrally. The IUGA/ICS classification of mesh complication is a pragmatic system to report and analyze mesh complications. References: 1. Int Urogynecol J. 2011 Nov;22(11):1429–35. Table 1- IUGA/ICS classification of complications related directly to the insertion of prosthesis in female pelvic reconstructive surgery (506 mesh removed, 587 complication classified), n (%) Classification
Overall Comparing sling and (n=587) mesh for POP Sling (n= 337)
POP (n= 250)
Pvalue
227 (67.96) 37 (11.08) 23 (6.89) 19 (5.69)
121 (48.40) 44 (17.60) 64 (25.60) 8 (3.20)
<0.001
Category 1. Vaginal: no epithelial separation
349 (59.66) 2. Vaginal: smaller ≤1 cm exposure 81 (13.82) 3. Vaginal: larger >1 cm exposure, or any 87 extrusion (14.86) 27 4. Urinary tract: compromise or perforation including prosthesis (graft) (4.61) perforation and fistula 5. Rectal or bowel: compromise or 6 (1.03) perforation including prosthesis (graft) perforation and fistula 6. Skin or musculoskeletal: 34 complications including discharge (5.81) pain lump or sinus tract formation 7. Patient: compromise including 1 (0.17) hematoma or systemic compromise Time (Clinical diagnosed)
0.024 <0.001 0.157
2 (0.60) 4 (1.60)
0.235
25 (7.49)
0.047
9 (3.60)
1 (0.30) 0 (0)
0.387
1.000*
T1: Intraoperative to 48 h
1 (0.17)
1 (0.30) 0 (0)
T2: 48 h to 2 months
14 (2.39) 61 (10.43) 509 (87.01)
8 (2.40) 6 0.997 (2.40) 31 30 0.288 (9.28) (12.00) 294 214 0.389 (88.02) (85.60)
140 (23.97) 286 (48.97) 34 (5.82) 82 (14.04) 42 (7.19)
50 (14.97) 176 (52.69) 20 (5.99) 60 (17.96) 28 (8.38)
T3: 2 months to 12 months T4: over 12 months Site S1: vaginal: area of suture line S2: vaginal: away from suture line S3: Trocar passage S4: other skin or musculoskeletal site S5: Intra-abdominal
90 (36.14) 109 (43.78) 14 (5.62) 22 (8.84) 14 (5.62)
<0.001 0.033 0.852 0.002 0.202
*Fisher’s exact test Disclosure Block: John Miklos: Coloplast: Consultant, Consulting Fee. Coloplast: Speaker, Travel Grant. Coloplast: Advisory
S142
Committee Member, Grant/Research Support. Gyrus/ Olympus: Preceptor: received compensation when visitors obserbed the surgery, Preceptor: received compensation when visitors obserbed the surgery. AMS: Consultant, Grant/ Research Support. Orawee Chinthakanan: No disclosures. Robert Moore: American Medical Systems: Consultant, Consulting Fee. American Medical Systems: Speaker, Honoraria. American Medical Systems: Consultant, Grant/Research Support. Gretchen Mitchell: No disclosures. Sheena Favors: No disclosures. Deborah Karp: No disclosures. Gina Northington: Allmed Healthcare Management, Inc.: Consultant, Consulting Fee. G. Mayte Nogueiras: No disclosures. G. Willy Davila: Astellas: Speaker, Honoraria. Warner-Chilcott: Speaker, Honoraria. AMS: Speaker, Honoraria. AMS: Scientific Medical Advisor, Intellectual Property Rights. Pfizer: Investigator-initiated research grant, Grant/Research Support.
OP 065 INDICATION AND SURGICAL TREATMENT OF MIDURETHRAL SLING COMPLICATIONS: A MULTICENTER STUDY O. CHINTHAKANAN1, J. R. MIKLOS 1, R. D. MOORE 1, G. MITCHELL 1, S. FAVORS 1, D. R. KARP 2, G. M. NORTHINGTON 2, G. NOGUEIRAS 3, G. DAVILA 3; 1 Intl. Urogynecology Associates of Atlanta, Alpharetta (Atlanta), GA, 2Emory Univ., Atlanta, GA, 3Cleveland Clinic Florida, Weston, FL. Introduction: Although midurethral sling can be performed on an outpatient basis and is minimally invasive, it can be associated with postoperative complications such as new onset vaginal pain, dyspareunia, lower abdominal pain and even leg or thigh pain depending on the type of synthetic mesh sling procedure utilized: 1) retropubic (RP) sling 2) transobturator (TOT) or 3) single incision sling (SIS). Objective: 1) To evaluate the most common indication for sling removal in patients with synthetic mesh slings. 2) Discuss the location of pain and the incidence of the location for each of the three types of synthetic sling procedure. 3) Compare the indications for surgery for mesh removal between the three different types of synthetic mesh slings. Methods: A retrospective chart review of all patients who underwent surgical removal of sling related complications from 2011 to 2013 at three tertiary referral centers in the Southeast United States. We included all women who underwent sling removal. The database was queried to identify potential subjects, the types of procedure performed, types of mid-urethral sling and their demographic data. Data was
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
analyzed by using chi-square test for categorical data, and Student’s t-test and Wilcoxon Rank Sum test for continuous data. The measure of effect was determined by logistic regression analysis. Results: There were 337 sling complications followed the IUGA/ICS mesh complication classification. Retropubic sling (RP) was more likely to have urinary tract complications (category 4) and intra-abdominal site complications (S5) than other slings (Table 1). Main indications for RP revision/ removal were pain (53.9 %), dyspareunia (14.6 %), and urinary retention (6.9 %) respectively. Main indications for transobturator tape (TOT) sling removal were pain (66.0 %), dyspareunia (10.7 %), and urinary retention (5.3 %). Main indications for single incision sling (SIS) removal were were pain (57.5 %), dyspareunia (14.6 %), and erosion/extrusion (6.4 %). Urinary retention was more likely to be an indication for removal in RP group (p=0.049). Of those 286 sling/mesh removed, 106 (37.1 %) accounted for RP, 131 (45.8 %) TOT, and 44 (15.4 %) SIS. Table 2 shows pain location among patients who underwent surgical treatment due to pain. Vaginal pain was the most common site across sling types. 21 % of TOT group had groin pain which was 5 times higher risk than RP group (OR 5.3, 95 % CI 1.5–18.7). RP group was 3 times more likely to have suprapubic pain than TOT group (OR 2.97, 95 % CI 1.3–7.0). Fifty percent of RP was removed laparoscopically. Fifteen percent of TOT had either unilateral or bilateral groin mesh removal. Among 11 slings were removed transurethrally, 8 of them were SIS. Six slings were removed from bladder and 5 of them were RP. The median estimated blood loss was 50 cc. (range 0–800). For RP sling removal, laparoscopic combined with vaginal approach had more blood loss compared to vaginal approach alone (mean 87.2 vs. 55.0 cc, p<0.001). For TOT removal, groin removal combined with vaginal approach had more blood loss compared with vaginal approach alone (mean 79.7 vs. 59.1 cc, p= 0.008). Two patients who underwent laparoscopic RP sling removal received blood transfusion and one patient had retroperitoneal hematoma required reoperation. Among TOT removal, three patients had intraoperative urethral injury and 2 patients had excessive blood loss. Conclusion: The most common indication for sling removal was vaginal pain. RP sling has higher risk of suprapubic pain and TOT sling has higher risk of groin pain. Patients suffering from only vaginal pain underwent only vaginal removal of the sling. Patients suffering from groin pain were more often subjected to groin dissection to remove the TOT sling and patients suffering from suprapubic pain were subjected to laparoscopy to remove the arms of the RP sling. Patients with a history of SIS may have a higher incidence of urethral erosion compared to TOT or RP slings. TOT removal has higher intraoperative compications. Total sling removal for RP slings may increase the risk of blood transfusion.
S143
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Table 1- IUGA/ICS classification of complications related directly to the midurethral sling in female pelvic reconstructive surgery (286 sling removed, 337 complication classified) sling (n=337) RP (n= 133)
TOT (150)
SIS P(n=47) value
101 (67.79) 15 (10.07) 14 (9.40) 4 (2.68)
33 (70.21) 10 (21.28) 1 (2.13) 2 (4.26)
0 (0)
0 (0)
Category 1. Vaginal: no epithelial separation
85 (65.38) 2. Vaginal: smaller ≤1 cm exposure 12 (9.23) 3. Vaginal: larger >1 cm exposure, or any 8 extrusion (6.15) 4. Urinary tract: compromis or perforation 13 including prosthesis (graft) perforation (10.00) and fistula 5. Rectal or bowel: compromis or 2 perforation including prosthesis (graft) (1.54) perforation and fistula 6. Skin or musculoskeletal: complications 9 including discharge pain lump or sinus (6.92) tract formation 7. Patient: compromise including 1 hematoma or systemic compromise (0.77) Time (Clinical diagnosed) T1: Intraoperative to 48 h T2: 48 h to 2 months T3: 2 months to 12 months T4: over 12 months
0.814 0.067 0.207 0.030
0.219
15 1 (10.07) (2.13)
0.187
0 (0)
0 (0)
0.470
1 (0.77) 4 (3.08) 15 (11.54) 110 (84.62)
0 (0)
0 (0)
0.470
4 (2.68) 12 (8.05) 133 (89.26)
0 (0)
0.490
19 (14.62) 59 (45.38) 7 (5.38) 19 (14.62) 26 (20.00)
18 (12.08) 86 (57.72) 11 (7.38) 33 (22.15) 1 (0.67)
10 (21.28) 28 (59.57) 2 (4.26) 7 (14.89) 0 (0)
4 0.594 (8.51) 43 0.348 (91.49)
Site S1: vaginal: area of suture line S2: vaginal: away from suture line S3: Trocar passage S4: other skin or musculoskeletal site S5: Intra-abdominal
0.293 0.075 0.664 0.219 <0.001
Table 2- Type of sling removed due to pain, n (%) Pain location
sling (n=179) RP (n=63)
TOT (91)
SIS (n=25)
P-value
vagina
29 (46.03)
48 (52.75)
14 (56.00)
0.580
paraurethra
3 (4.76)
5 (5.49)
3 (12.00)
0.403
thigh
0 (0)
2 (2.20)
0 (0)
0.376
groin
3 (4.76)
19 (20.88)
2 (8.00)
0.012
suprapubic/lower abdomen
17 (26.98)
10 (10.99)
4 (16.00)
0.037
abdomen
11 (17.46)
7 (7.69)
2 (8.00)
0.150
Disclosure Block: Orawee Chinthakanan: No disclosures. John Miklos: Coloplast: Consultant, Consulting Fee. Coloplast: Speaker, Travel Grant. Coloplast: Advisory Committee Member, Grant/Research Support. Gyrus/Olympus: Preceptor: received compensation when visitors obserbed the surgery, Preceptor: received compensation when visitors obserbed the surgery. AMS: Consultant, Grant/Research Support. Robert Moore: American Medical Systems: Consultant, Consulting Fee. American Medical Systems: Speaker, Honoraria. American Medical Systems: Consultant, Grant/Research Support. Gretchen Mitchell: No disclosures. Sheena Favors: No disclosures. Deborah Karp: No disclosures. Gina Northington: Allmed Healthcare Management, Inc.: Consultant, Consulting Fee. G. Mayte Nogueiras: No disclosures. G. Willy Davila: Astellas: Speaker, Honoraria. Warner-Chilcott: Speaker, Honoraria. AMS: Speaker, Honoraria. AMS: Scientific Medical Advisor, Intellectual Property Rights. Pfizer: Investigatorinitiated research grant, Grant/Research Support.
OP 066 THE RISK OF URETERIC INJURY AFTER HYSTERECTOMY PERFORMED IN THE ENGLISH NATIONAL HEALTH SERVICE - A RETROSPECTIVE COHORT STUDY EXAMINING PATTERNS OF CARE BETWEEN 1998 AND 2010. A. KIRAN 1, P. HILTON2, D. CROMWELL 1; 1 Department of Health Services Research and Policy, London Sch. of Hygiene and Tropical Med., London, United Kingdom, 2Newcastle upon Tyne Hosp. NHS Fndn. Trust, Newcastle upon Tyne, United Kingdom. Introduction: Lower urinary tract fistulae in the developed world are most commonly iatrogenic in aetiology, and approximately 50 % of vesicovaginal fistulae in the UK are associated with hysterectomy. Whilst the number of hysterectomies undertaken in UK has fallen over the last decade, the risks of vesicovaginal and urethrovaginal fistulae following hysterectomy have been reported to have increased by 50 % between 2000–‘02 and 2006–’08.(1) Iatrogenic trauma is also the commonest cause of ureteric injury. Whilst there are few recent or high quality data on which to base recommendations, systematic reviews report that gynaecological, urological and colorectal surgery may be associated with injury to the ureter in up to 6 % of cases, the diagnosis typically being delayed.(2–3) Objective: To estimate the risks of operative ureteric injury at hysterectomy and of the later consequences of injury i.e. ureterovaginal fistula or ureteric stricture, diagnosed in English NHS Trusts within a year of the index procedure; to
S144
assess differences in risk between procedure types and indications, and trends in risk over time. Methods: A retrospective cohort study using Hospital Episode Statistics data for women undergoing hysterectomy in English NHS Trusts between 1998 and 2010. Unadjusted rates of ‘ureteric injury’ (ureteric injury, ureterovaginal fistula or ureteric stricture) were identified by diagnosis (ICD-10) and operative codes (OPCS-4) and were calculated by type of procedure and benign or malignant indication. Multivariable logistic regression was used to assess whether the risk of ureteric injury was associated with type of procedure, indication, or patient age (<40, 40–44, 45–49, ≤50) and whether the risks have changed during the study period (1998–200, 2001– 2003, 2004–2006, 2007–2010). Results: Women coded as having radical hysterectomy for benign indications, or having hysterectomy for menstrual problems >55 years of age were excluded; we also excluded procedure-indication pairings where <500 cases were recorded. After these exclusions 517,914 women underwent hysterectomy during the 13-year study period, of whom 1838 (0.35 %) had a diagnosis of ureteric injury. The highest rates (95 % CI) by procedure were observed with total abdominal (1.97 (1.78, 2.18)) or radical hysterectomy (3.87 (2.66, 5.43)) for invasive cancers. By indication, the risk (adjusted odds ratio (aOR) (95 % CI)) was higher in women with fibroids (3.07 (2.52, 3.74)) than those with menstrual problems and highest in women with a diagnosis of endometriosis (6.91 (5.65, 8.47)) (Table 1). Of the malignant indications, compared with cervical cancer in situ, women with ovarian cancer had the highest risk of ureteric injury (7.96 (4.62, 13.71)) (Table 2). The risk was significantly higher in the later years of the study period both in benign (3.48 (2.88, 4.21); p<0.001) and malignant indications (3.36 (2.66, 4.23); p<0.001). Conclusions: The risk of ureteric injury within 1 year of hysterectomy varied by type of hysterectomy and indication. The risk was highest in women undergoing hysterectomy for cancer; amongst women having hysterectomy for benign indications, those with endometriosis had a higher risk of ureteric injury; this is in contrast to a prior report on the risk of vesicovaginal fistula following hysterectomy.(1) The risk of ureteric injury at hysterectomy increased 3-fold during the 13-year study period. It is possible that this trend is due to a relative increase in the number of more difficult procedures being undertaken as the total number of hysterectomies declines. The finding of a similar increase in risk of ureteric injury over time with both benign and malignant indications however gives credance other explantions, such as trends in surgical technique (e.g. an increase in laparoscopic procedures) or in surgical skills. Whilst urogenital fistula remains overall an uncommon complication of hysterectomy, the trend of increasing surgical morbidity within the NHS, is
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
something of which all concerned in the provision of service and training should be aware. References: 1. BJOG. 2012;119(12):1447–54. 2. Incontinence - ICUD-EAU 5th International Consultation on Incontinence. Geneva, Switzerland: EAU Publications; 2013. p. 1527–79. 3. Eur Urol. 2012;62(4):628–39. Table 1: Association between ureteric injury and benign indications No. of procedures Benign indications Menstrual
124,230
No. of ureteric injuries
Rate (%)
OR (95 % CI)*
137
0.11
1
p-value
Endometriosis37,2342970.806.91 (5.65, 8.47)p<0.001 Prolapse130,046112 0.090.68 (0.51, 0.89) Fibroids141,6715120.363.07 (2.52, 3.74)
Table 2: Association between ureteric injury and malignant indication No. of procedures
No. of ureteric injuries
Rate (%)
OR (95 % CI)
Cervical 6,261 cancer in situ Cervical 7,992 cancer Uterine cancer 49,736
14
0.22
1
123
1.54
244
0.49
Ovarian cancer 20,744
399
1.92
6.39 (3.67, 11.13) 1.93 (1.11, 3.36) 7.96 (4.62, 13.71)
pvalue
Malignant indication
<0.001
Disclosure Block: Amit Kiran: No disclosures. Paul Hilton: No disclosures. David Cromwell: No disclosures.
OP 067 PROSPECTIVE EVALUATION OF THE ASSOCIATION BETWEEN BODY MASS INDEX AND PAIN FOLLOWING TRANSOBTURATOR MIDURETHRAL SLING L. A. CADISH1, M. R. HACKER 1, A. MERPORT MODEST 1 , K. J. ROGERS 2, S. DESSIE 2, E. A. ELKADRY 2; 1 Obstetrics and Gynecology, Beth Israel Deaconess Med. Ctr., Boston, MA, 2Obstetrics and Gynecology, Mount Auburn Hosp., Cambridge, MA. Introduction: Several factors may be considered when choosing between retropubic and transobturator approaches
S145
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
in patients planning midurethral sling for treatment of stress urinary incontinence. Given that a meta-analysis of randomized trials demonstrates comparable efficacy between approaches, the decision is often based on differing complication rates and surgeon preference.1 While the transobturator approach is notable for decreased rates of urinary tract injury, voiding dysfunction, and blood loss, the presence of postoperative pain in 16 % of patients is of concern.2 We previously reported obesity may have a protective effect against postoperative hip and lower extremity pain in women undergoing transobturator sling. In a retrospective review of 226 women, the risk of postoperative pain was 2.5 times higher in women of normal body mass index (BMI: 18.5_24.9) as compared to their obese counterparts (≥30).3 This prospective cohort study sought to confirm or refute those findings. Objective: To prospectively evaluate the association between BMI and pain following inside-out transobturator midurethral sling. Methods: We enrolled patients who underwent inside-out transobturator sling (TVT-O, Ethicon, Inc; Somerville, NJ) from March 2011 through February 2013. Preoperative BMI and self-reported activity level were recorded. Presence of pelvic girdle pain, its severity, and location were documented preoperatively and at two- and six-week postoperative visits. Pain severity was measured on a scale of one to ten, with ten being the “worst imaginable” pain. Clinicians indicated the location of the patient’s pain at each visit on a standardized diagram with views of a woman anteriorly, posteriorly, and in lithotomy. Postoperative-onset pain was defined as any pain documented postoperatively that was not documented in that location and laterality preoperatively. We used Poisson regression with robust error variance to estimate risk ratios (RR) and 95 % confidence intervals (CI) for postoperative-onset pain. Results: Of the 130 women who enrolled and met eligibility criteria, one was underweight and was excluded from the analysis. Of the 129 analyzed, the median age was 50.0 years (interquartile range: 44.0–62.0). Participants were evenly divided among the normal (47, 36.4 %), overweight (41, 31.8 %), and obese (41, 31.8 %) groups. Few women reported a low activity level (12, 9.3 %), whereas many considered themselves to have a moderate (60, 46.5 %) or high (56, 43.4 %) level of activity. The vast majority had symptomatic stress urinary incontinence (114, 88.4 %) rather than occult stress incontinence (12, 9.3 %). The most common sites of postoperative-onset pain were the lateral leg, medial leg, groin, and low back. When adjusting for age, activity level, and concomitant procedures, elevated BMI was associated with a decreased risk of developing postoperative pain. Overweight and obese women each had a 22 % lower risk of developing postoperative-onset pain than their counterparts of normal BMI (RR: 0.78, 95 % CI: 0.61–0.995, see table). For each one-unit increase in BMI, the risk of postoperative-onset pain was found to decrease by 3 %.
Neither success nor satisfaction with the procedure was associated with BMI (both P>0.35). In the study population, 98 (76.0 %) were cured, 21 (16.3 %) improved, 6 (4.7 %) failed, and 4 (3.1 %) had missing data. Overweight and obese women had similar chances as those of normal BMI of being cured or improved (RR: 0.91, 95 % CI: 0.42_1.9). Defining success as only those cured yielded a similar result (1.05, 0.95_1.17). The vast majority (113, 87.6 %) of participants reported satisfaction with the procedure, with overweight and obese women reporting virtually identical satisfaction as normal BMI counterparts (RR: 0.97, 95 % CI: 0.90_1.04). Conclusions: These findings support previous evidence that leaner women experience greater pain following transobturator midurethral sling. Such findings may inform surgical planning and preoperative counseling. References: 1. N Engl J Med 2010;362(22):2066. 2. Obstet Gynecol 2007;109(1):4. 3. Am J Obstet Gynecol 2010; 203(5):508e1-5. Table: Relative risk of postoperative pain, sling satisfaction, and success by BMI category Body mass index category
N (%) Risk Ratio Crude (95 % CI)
Risk Ratio Adjusted* (95 % CI)
Postoperative-onset pain Normal
16 (34.0) Overweight 21 (51.2) Obese 21 (51.2) Postoperative-onset pain
Reference
Reference
0.82 (0.65–1.04)
0.78 (0.61–0.995)
0.82 (0.65–1.04)
0.78 (0.61–0.995)
BMI (continuous) 58 (45.0) Sling success†
0.97 (0.95–0.995)
0.97 (0.94–0.99)
44 (97.8) 36 (90.0) 39 (97.5)
Reference
Reference
0.94 (0.48–1.9)
0.91 (0.42–1.9)
0.94 (0.48–1.9)
0.91 (0.42–1.9)
40 (85.1) 36 (76.6) 37 (78.7)
Reference
Reference
0.98 (0.92–1.05)
0.97 (0.90–1.04)
0.98 (0.92–1.05)
0.97 (0.90–1.04)
Normal Overweight Obese Satisfaction Normal Overweight Obese
*Adjusted for age at surgery, activity level and concurrent surgery †Success is defined as either cured or improved incontinence symptoms after surgery
S146
Disclosure Block: Lauren Cadish: Medtronic, Inc: I was a recipient of the 2012 AUGS Benson Grant in Neuromodulation, which is funded by Medtronic and granted by AUGS., Grant/Research Support. Michele Hacker: No disclosures. Anna Merport Modest: No disclosures. Kathleen Rogers: No disclosures. Sybil Dessie: No disclosures. Eman Elkadry: Merck: Consultant, Consulting Fee. allergan: Advisory Committee Member, Consulting Fee. Allergan: unrestricted research grant, Grant/ Research Support.
OP 068 PREDICTORS OF POSITIVE PREOPERATIVE URINE CULTURES IN ASYMPTOMATIC WOMEN UNDERGOING UROGYNECOLOGIC SURGERY. M. R. POLIN, A. L. EDENFIELD, A. A. DIETER, C. L. AMUNDSEN, A. G. VISCO, A. C. WEIDNER; Duke Univ., Durham, NC. Introduction: Impending standards of value based reimbursement will increase the importance of risk-based screening to prevent postoperative infections, including urinary tract infections (UTI). The risk of postoperative UTI in women undergoing surgery for pelvic floor disorders (PFD) is high. We want to identify those at risk for positive preoperative urine cultures because we recognize that almost one-third of these women will go on to develop a postoperative UTI.1 Contaminated preoperative urine cultures are common, viewed as inconclusive, and thus limit the utility of preoperative screening. The ability to identify women at risk for contaminated preoperative culture results will allow us to consider alternative methods of sample collection in such women. Objective: The primary objective of this study was to identify risk factors for positive preoperative urine cultures in asymptomatic women undergoing surgery for PFD. We also sought to identify risk factors for having contaminated clean catch urine cultures. Methods: Preoperative clean catch urine cultures are routinely obtained within 30 days of surgery on all women undergoing surgery for pelvic organ prolapse (POP) or urinary incontinence (UI). After IRB approval, we extracted demographic data, medical and surgical history, pelvic organ prolapse quantification (POP-Q) measurements, and preoperative urine culture results on all women who underwent surgery between 9/2011 and 9/2013. A negative urine culture was defined as no growth. A positive urine culture was defined as ≥100 K organisms. A contaminated urine culture was defined as mixed flora. Women with <100 K colony forming units of a single organism were excluded. To identify risk factors for positive urine cultures, women
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
with positive preoperative culture results were compared to those with negative results. To identify risk factors for contamination, women with contaminated preoperative culture results were compared to those with negative results. Demographic data were compared using chi-squared and Student t tests for categorical and continuous measures, respectively. Logistic regression models were constructed to evaluate for differences between groups. Results: Of the 490 women evaluated with preoperative urine cultures, 132 (27 %) were negative, 69 (14 %) were positive, and the majority, 289 (59 %), were contaminated. The study population was predominately postmenopausal with a mean age of 59 (±12) years old, Caucasian, and overweight with a mean BMI of 28.7 (±5.4). 52 % had a prior hysterectomy, 20 % had previous surgery for POP, and 24 % had undergone surgery for UI. 8 % of the women smoked, 14 % had diabetes mellitus, and 9 % had a history of recurrent UTI. When comparing positive to negative culture results, the positive culture group was more likely to have a history of recurrent UTI (20 % vs. 5 %, p=0.001). There were no differences in other baseline characteristics. In a logistic regression model controlling for age, vaginal parity, menopausal status, vaginal estrogen usage, sexual activity, diagnosis of diabetes mellitus, history of recurrent UTI, and most distal POP-Q measurement, a history of recurrent UTI (OR 6.9, 95 % CI 2.3–20.8) remained a risk factor for positive preoperative urine cultures. In the same model, higher vaginal parity (OR 1.3, 95 % CI 1.0–1.8) was associated with more positive preoperative urine cultures, while vaginal estrogen usage (OR 0.3, 95 % CI 0.1– 0.9) was associated with fewer positive preoperative cultures. When comparing contaminated to negative cultures, the contaminated culture group was more likely to be obese, as defined by BMI ≥30 (45 % vs. 28 %, p=0.001). There were no differences in other baseline characteristics. In a logistic regression model controlling for age, vaginal parity, BMI, menopausal status, vaginal estrogen usage, and most distal POP-Q measurement, obesity (OR 2.0, 95 % CI 1.3–3.2) remained a risk factor for contaminated preoperative urine cultures. Conclusions: In asymptomatic women undergoing surgery for PFD, a history of recurrent urinary tract infections and higher vaginal parity are risk factors for positive preoperative urine cultures. Preoperative vaginal estrogen therapy is associated with fewer positive urine cultures. Obesity is an independent risk factor for contaminated clean catch urine culture results. Future screening strategies may be focused on these at risk populations. Alternative urine culture collection methods may be appropriate in obese women. References: 1. J Urol. 2013;189:1721–4
S147
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Disclosure Block: Michael Polin: No disclosures. Autumn Edenfield: No disclosures. Alexis Dieter: No disclosures. Cindy Amundsen: No disclosures. Anthony Visco: No disclosures. Alison Weidner: GenProbe: spouse, Grant/Research Support. GlaxoSmithKline: spouse, Grant/Research Support. Merck: Consultant, Consulting Fee. College of American Pathologists: Consultant, Consulting Fee.
OP 069 SURGEONS’ VERSUS PATIENTS’ PERCEPTIONS OF PERIOPERATIVE EVENTS M. F. SCHMIDT1, K. JACOBS 2, O. RAMM 3, K. KENTON 4; 1 Loyola Univ. Chicago Stritch Sch. of Med., Maywood, IL, 2 OB/GYN, Loyola Univ. Med. Ctr., Maywood, IL, 3OB/ GYN, Kaiser Permanente East Bay, Oakland, CA, 4OB/GYN, Northwestern Univ., Prentice Women’s Hosp., Chicago, IL. Objective: To compare patients’ and gynecologic surgeons’ perceptions of perioperative events Background: Patient preparedness and expectations surrounding the surgical experience are often the primary determinants of patient satisfaction after surgery.1 However, despite a thorough preoperative informed consent discussion, patients often perceive perioperative medical events thought of as routine by surgeons to be bothersome complications.1 Methods: A group of expert surgeons created 66 perioperative scenarios associated with gynecologic (GYN) surgery, which were modified after receiving patient focus group input. Consenting patient participants completed a written survey prior to undergoing surgery. Participants rated whether they thought each perioperative scenario was a complication and then rated the severity of complications on a scale of 1–100. Respondents were divided into two groups based on whether they underwent elective (FPMRS or benign GYN) or nonelective gynecologic oncologic (GYN-ONC) surgery. A similar survey was also distributed electronically to gynecologic surgeons who were divided into elective (FPMRS and benign GYN) and non-elective (GYN ONC) groups. Participating surgeons classified each scenario as either a complication or a routine perioperative event. For events classified as complications, surgeons rated the severity of the event on a numeric rating scale ranging from 1 to 100 and rated the event from I to V using the Clavien -Dindo scale 2. SPSS version 20 was used to calculate means, standard deviations, intraclass correlation coefficients (ICC), and coefficients of variability (Cv) for severity rankings of each scenario within the patient and the physician groups. Results: 63/82 surgeons (77 %) responded: 29 % FPMRS, 29 % GYN ONC, 42 % benign GYN. 108 patients completed the survey: 55 women had elective surgery (37 FPMRS, 18
benign GYN) and 53 underwent GYN ONC surgery. The percentage of surgeons and patients who perceived certain events to be complications differed significantly. Surgeons tended to interpret intraoperative events as complications more frequently that patients. For example, surgeons viewed change of access from hysteroscopy to laparoscopy (81 % of surgeons vs. 44 % of patients, p<0.001) and hysteroscopy to laparotomy (89 % vs. 62 %, p<0.001) as complications more frequently than patients. Similarly, surgeons were more likely than patients to rate intraoperative injury to urinary, bowel, or vascular systems to be complications (table 1). Surgeons also tended to view suture/mesh erosion managed as an outpatient to be complications more frequently than patients (96 vs. 57, p=p<0.001). However, patients viewed quality of life postoperative events to be complications more commonly than surgeons. Patients rated certain perioperative events thought of as routine by surgeons to be complications such as post-operative constipation (27 %) and post operative fatigue (18 %). Other events include diarrhea (19 %) and bloating/gas (21 %). Patients were more likely to view postoperative urinary symptoms to be complications compared to gynecologic surgeons, both as a whole and FPMRS surgeons as sub-group (table 2). Indication for surgery (elective vs non-elective) influenced both patient and surgeons perception of certain perioperative events. Elective surgical patients classified scenarios involving suture/mesh erosion and post-operative pain as complications more frequently than those having ‘non-elective’ surgery (65 % vs.47 %, p=0.03; 22 % vs 13 %, p=0.02). GYN oncologists classified conversion from laparoscopy to laparotomy and delayed return of bowel function as complications less frequently than elective surgeons (36 % vs 12 % P=.02, 85 % vs 57 %, P=.002). Conclusions: Surgeons and patient’s perceptions of complications differs suggesting surgeons and patients may value intra and peri-operative events differently. Indication for surgery influenced both patient and surgeons perceptions of certain perioperative events. Better understanding of patient’s values may improve expectations, counseling and satisfaction after gynecologic surgery. References 1. Am J Obstet Gynecol. 2007;197:654.e1-654.e6 2. Ann Surg 2004;240;205 Scenario
% Complication All All Patients Surgeons
Bladder/ureter injury, repaired without 67 additional incisions Bowel injury requiring resection but no change 81 in access Vascular injury, no change in access 68
P value
94
<0.001
98
0.004
85
0.021
S148
Scenario
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
All All P FPMRS FPMRS P pts Surgeons pts surgeons 79 35 <0.001 83 43 0.004
Persistent SUI after antiincontinence procedure De novo SUI after sx for 82 prolapse Urgency/frequency after 83 sx Postop UUI, self-limited 50
44
<0.001 86
36
<0.001
17
<0.001 89
21
<0.001
9
<0.001 47
14
0.031
Disclosure Block: Megan Schmidt: No disclosures. Kristin Jacobs: No disclosures. Olga Ramm: No disclosures. Kimberly Kenton: No disclosures.
OP 070 MESH ANCHOR FAILURE: IN VIVO VALIDATION OF MATHEMATICAL PELVIC FLOOR MODELLING? K. SHEK1, V. L. WONG 2, A. RANE 3, H. KRAUSE 4, J. GOH 4, H. DIETZ 2; 1 O&G, Univ. of Western Sydney, Liverpool, Australia, 2Sydney Med. Sch. Nepean, Penrith, Australia, 3O&G, James Cook Univ., Townsville, Australia, 4Greenslope Hosp., Brisbane, Australia.
Introduction: Mathematical modelling is increasingly used to help understand pelvic floor biomechanics including implant mechanical behaviour. Clinical observations may act as an vivo test for model performance. Objective: To determine prevalence of mesh arm dislodgment, test association with hiatal area and avulsion, to estimate forces required for dislodgment, and to compare these forces with those predicted by two published models (1,2). Methods: This is a retrospective study on patients after Perigee or Prolift cystocele repair. Translabial 4D ultrasound (US) was performed supine after voiding. Offline analysis of US volumes was performed blinded to all clinical data. Clinical recurrence was defined as ICS POP-Q ≥stage 2. Mesh failure was diagnosed on US if the bladder descended ≥10 mm below and/or the uterus descended to the level of the pubis on Valsalva, and if there was excessive mobility of the mesh. The latter was classified as either ‘Apical’ or ‘Global’ failure (Fig. 1), appearances likely due to mesh arm dislodgement. Levator integrity was assessed on PFMC using tomographic US imaging (TUI). Hiatal area at rest and on Valsalva were determined in the axial plane. ROC statistics were used to determine optimal cutoffs for the detection of mesh arm dislodgment.
Figure 1: Midsagittal plane on Valsalva. Apical failure (left) suggesting dislodgement of cranial arms. Global failure (right) suggesting pull through of all arms. Results: Mean age was 64.5 years (32.3–85.9). Mean BMI was 28.1 (range 18–48.7). 138 (68 %) had a Perigee and 66 (32 %) an anterior Prolift. At a mean follow up of 2.3 years (0.3–5.6 years), 47 women complained of recurrent prolapse symptoms (23 %). Mean Ba was −1.8 (range 2 to −3). Clinically recurrent anterior (67) and central compartment prolapse (25) was noted in 87 (42 %). On US mean bladder position was −1.9 (21.8 to −34.8) mm. Recurrent cystocele was identified in 55 (27 %) and central compartment prolapse in 6 (3 %). Mesh arm dislodgment was identified in 54 (26 %), affecting apical arms in 20 and all four arms in 34. Mean hiatal area at rest and on Valsalva was 22.2 cm2 (11.4–42.6) and 33.3 cm2 (14.1–60); avulsion was diagnosed in 77 (38 %). On multivariate analysis only hiatal area on Valsalva remained a significant predictor of dislodgment. AUC was 0.696 for area at rest and 0.805 on Valsalva (Fig. 2).
Figure 2: ROC curves for association between mesh arm dislodgment and hiatal area at rest (left) and on Valsalva (right). Conclusions: Mesh arm dislodgment can be used as an in vivo test for biomechanical pelvic floor modelling. It seems to occur in over 1/4 of patients and is strongly associated with hiatal area on Valsalva; hence this is likely to be a crucial input variable for pelvic floor modelling. As the minimal force required for dislodgment is >5 N per arm (3), any model should predict forces up to 20–30 N. We are aware of two mathematical pelvic floor models using hiatal area on Valsalva as input variable. One (1) predicts maximal forces of
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
2.9 N, the second (2) up to 50 N, suggesting that the latter may be more realistic. References: 1) IUGJ 2013; doi:10.1007/s00192-013-2253-1 2) UOG 2012;40:495–503 3) EJOGRB 2006;124: 240–245 Disclosure Block: Ka Lai Shek: GE: Speaker, unrestricted educational grants. Vivien Wong: No disclosures. Ajay Rane: AMERICAN MEDICAL SYSTEMS: Consultant, Honoraria. Hannah Krause: No disclosures. Judith Goh: No disclosures. Hans Peter Dietz: GE Medical: unrestricted educational grant, Grant/Research Support.
OP 071 A UNIQUE METHOD UTILIZING DIGITAL IMAGING FOR MEASURING NERVE STRETCH DUE TO THE LITHOTOMY POSITION N. E. DEVENEAU1, C. F. MORALES 1, L. LIPETSKAIA 2, A. AGRAWAL 1, A. AZADI 1, N. HERRING 3, S. L. FRANCIS 1; 1 Obstetrics and Gynecology, Univ. of Louisville, Louisville, KY, 2Univ. of rochester, Rochester, NY, 3Anatomical Sciences & Neurobiology, Univ. of Louisville, Louisville, KY. Introduction: Lithotomy position is frequently used in gynecologic surgery. Case studies have documented sciatic, femoral, and common peroneal nerve injury during surgeries using the lithotomy position. It is theorized that compression and stretch may play a role in nerve injury. Many studies suggest it is important to avoid over flexion and external rotation at the hip. To our knowledge, no studies have shown to what degree the hip can be flexed before resulting in undue stretch. With the rise of robotics in gynecologic surgery, hips are left in an over extended position for long durations to accommodate robot placement. It is unknown to what extent extension can affect the femoral nerve, which is relatively fixed at the inguinal ligament. Others have shown there is disruption of conduction amplitude when peripheral nerves were stretched beyond 5 %. Objective: To design a method to measure nerve stretch in cadaveric subjects and using that method assess the degree to which the femoral nerve is stretched with varying degrees of flexion and extension in the lithotomy position. Methods: Two lightly enbalmed cadaveric subjects were obtained. In the first cadaver, dissection of the femoral nerve at the femoral triangle was completed and measurement technique was refined. In the second body, the femoral nerve was dissected at the femoral
S149
triangle and just above the inguinal ligament with the ligament intact. The nerve was marked with india ink on either side of the ligament, and the ligament was marked (Fig. 1). Measuring tape was placed next to the nerve as a reference for image capture. Baseline images of the nerve were obtained in the supine position. Then, images were obtained in the lithotomy position with the hip extended 15° below the level of the table. This procedure was repeated with the hip flexed at 155° and 90° between the calf and thigh, with minimal abduction, and with exaggerated abduction. The nerve was also examined with external rotation in lithotomy and supine positions. Five images for each position were obtained using a Nikon D5200 camera and processed in Adobe Illustrator CS3. The distance between the india ink markings, the 1 mm markings on the measuring tape, and the cranial and the caudal aspect of the nerve to the ligament were measured in pixels. Distances were calculated using a ratio of pixels to mm specific for each image, allowing for slight variation in camera location. The average distance from the five images was used to calculate the percent change from baseline for each position. Results: We found it was best practice to keep the location of the two marked points near the ligament so that the camera was able to focus on both locations and the measuring tape. It was possible to visualize and photograph the nerve on both sides of the ligament. Movement of the nerve was noted as the body changed position. With our established technique, we measured a baseline distance of 20.87 mm (SD 0.30) on the femoral nerve. In lithotomy, with hip extended, we observed a 11.40 % increase from baseline. The nerve moved 23.46 % from its original location. In the flex position, the nerve relaxed 4.60 % and movement was noted both above and below the ligament. Abduction of 45° while in lithotomy caused relaxation of 11.04 %. External rotation showed an 11.02 % stretch while supine and 13.65 % relaxation while in lithotomy. Conclusion: Some flexion of the hip relaxes the femoral nerve. A large amount of external rotation causes significant nerve stretch. The extension of the hip below the level of the operating table in lithotomy results in stretch of the femoral nerve in an amount that has been shown to cause disruption of nerve conduction. It should be considered whether hip extension is necessary when positioning for robotic surgery. To confirm these findings, further testing should be done on multiple cadaveric subjects. Using this technique, we additionally plan to examine the degree of flexion that causes excessive stretch of the sciatic nerve.
S150
References: N/A Disclosure Block: Nicolette Deveneau: No disclosures. Courtney Morales: No disclosures. Lioudmila Lipetskaia: No disclosures. Anubhav Agrawal: No disclosures. ali azadi: No disclosures. Nicole Herring: No disclosures. Sean Francis: Astellas: Speaker’s Bureau, Honoraria. IMET: Speaker, Honoraria.
OP 072 PELVIC FLOOR MUSCLE TRAINING VERSUS RETROPUBIC MIDURETHRAL SLING AS THE INITIAL TREATMENT FOR STRESS URINARY INCONTINENCE: A DECISION ANALYSIS R. POSTHUMA, S. J. PULLIAM, C. E. FOUST-WRIGHT, M. M. WEINSTEIN, M. M. WAKAMATSU, A. J. KAIMAL; Massachusetts Gen. Hosp., Boston, MA. Introduction: Stress urinary incontinence (SUI) is a common condition affecting up to 30 % of women that has significant economic impact on the individual and on the healthcare system [1]. The direct out-of-pocket cost of SUI is estimated at $750 per woman per year and the total directs costs associated with urinary incontinence exceed $16 billion. In general, SUI can be managed conservatively, with pelvic floor muscle training (PFMT), or surgically. The most common surgical treatment for SUI is minimally invasive midurethral sling (MUS). Objective: To determine the cost-effectiveness of PFMT with a physical therapist versus MUS for initial treatment of SUI. We used decision analysis to compare the strategies of an initial course of PFMT followed by MUS if PFMT was ineffective, versus proceeding directly with MUS for the diagnosis of SUI. Methods: A decision-analytic model was developed to compare outcomes (cure of incontinence, surgical complications, need for second procedure, and development of
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
urgency urinary incontinence) as well as cost-effectiveness of the two proposed strategies for the initial treatment of SUI. All women whose symptoms did not resolve with PFMT with a physical therapist were assumed to proceed with MUS. Baseline assumptions were derived from the literature and included an average age of presentation for treatment of 55 years, a 40 % cure rate with PFMT, a 78 % cure rate with midurethral sling, and an 80 % likelihood of proceeding with a second sling procedure if the first was not effective [1,2,3]. Assumptions were based on retropubic midurethral sling data. Success rates, complication rates, costs, and the utility associated with incontinence outcomes were also derived from the literature [1,2,3]. Sensitivity analyses were performed to test the robustness of our findings. Results: A strategy of initial course of PFMT was dominant, meaning that it was more effective and less costly than proceeding directly with MUS at the time of presentation for treatment of SUI (table). An initial course of PFMT also resulted in the highest cure rate and the lowest complication rate. This result was robust to variation in all inputs, including the cost and effectiveness of PFMT as well as MUS. Outcomes and cost-effectiveness of PFMT vs. MUS for a theoretical cohort of 100 women with SUI PFMT, then MUS if ineffective
Direct to MUS
Cost ($/100 women)
$738,762
$982,545
Effectiveness (QALYs/100 women)
1,808
1,791
Cure of incontinence (n/100)
91
85
Surgical complications (n/100)
21
35
Need for second procedure (n/100)
12
20
Development of urgency urinary incontinence (n/100)
4
7
Conclusions: An initial course of PFMT prior to proceeding with MUS optimizes outcomes and decreases costs of cure in women with SUI. Along with patient preference, this information should be considered when contemplating the optimal initial strategy for treatment of women with stress urinary incontinence. References: 1. Cochrane Database Syst Rev 2009;4:CD006375. 2. Neurourol Urodyn 2013;32:215–223. 3. BJU Int 2013;112(2):E151-E158. Disclosure Block: Rebecca Posthuma: No disclosures. Samantha Pulliam: No disclosures. Caroline Foust-Wright: No disclosures. Milena Weinstein: No disclosures. May Wakamatsu: No disclosures. Anjali Kaimal: No disclosures.
S151
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
OP 073 IS SLING LOCATION AT REST CORRELATED WITH DENOVO AND PERSISTENT OVERACTIVE BLADDER SYMPTOMS FOLLOWING TRANSOBTURA TOR AND RETROPUBIC MIDURETHRAL SLING SURGERY? A. HEGDE, R. HUREZEANU, G. NOGUEIRAS, V. AGUILAR, G. DAVILA; Cleveland Clinic Florida, Weston, FL. Objective: To correlate sling location at rest, as determined by 3 dimensional endovaginal ultrasound, with denovo and persistent overactive bladder (OAB) symptoms following sling surgery for stress urinary incontinence. Background: A significant proportion of patients will report persistent, worsening or denovo OAB after sling surgery (1). The diagnosis and management of idiopathic postoperative OAB can be complicated and hence understanding the causes is crucial. Using transvaginal ultrasound, slings positioned more distally were found to be more likely to be associated with postoperative urgency urinary incontinence and frequency than those placed at the midurethra (2). Methods: This is a prospective cohort study of 104 patients with urodynamic stress or mixed urinary incontinence who underwent sling surgery at our center between August 2009 and June 2012. Group A consisted of 64 patients who underwent transobturator slings (Monarc™, American Medical Systems, Minnetonka MN) and group B consisted of 40 patients who underwent retropubic midurethral slings (TVT, Ethicon, Bridgewater, NJ). All patients answered the UDI-6 and the OAB-sf validated questionnaires at the 1 year follow up visit. 3 dimensional endovaginal ultrasound of the anterior pelvic compartment was also performed (BK Medical Profocus Ultraview, Peabody, MA) at the 1 year follow-up visit by a fellow who was blinded to the patients’ history. The 3D volumes obtained were analyzed to determine the location of the sling along the urethral length in the midsagittal view and characterized as proximal to the urethrovesical junction (UVJ), proximal, midurethral and distal. The patients, in whom the sling was placed in the proximal-mid location, were included in the proximal sling location group. The location of the sling was correlated with development of denovo urgency incontinence, persistence and resolution of urgency symptoms following sling surgery. Results: Median (interquartile range) weeks of follow up were 75 (13) and 82 (20) in groups A and B respectively. In group A, the sling was placed proximal to the UVJ in 7 (10.9 %) patients, beneath proximal urethra in 27 (42.2 %) patients, midurethrally in 26 (40.6 %) patients and distally in 4 (6.3 %) patients. In group B, the sling was placed proximal to the UVJ in 5 (12.5 %) patients, beneath proximal urethra in 25 (62.5 %) patients, midurethrally in 8 (20 %) patients and distally in 2 (5 %) patients. The location of the sling was not associated with development of denovo urgency incontinence, persistence or
resolution of urgency symptoms in group A (table 1). However, in group B, though the location of the sling had no association with the development of denovo urgency incontinence, persistence of urgency symptoms was significantly more in those patients in whom the sling was not placed midurethrally (p= 0.005; table 1). Similarly, resolution of urgency symptoms in group B was significantly more in those patients in whom the sling was placed midurethrally as opposed to altered locations (p=0.034; table 1). The transformed symptom severity score and the transformed HRQL subscale scores of OAB-sf were not associated with development of denovo urgency incontinence, persistence or resolution of urgency symptoms in group A (p>0.05; table 2). However, in group B, the transformed symptom severity score was significantly lower and the quality of life subscales were significantly better when the sling was placed midurethrally (p<0.05; table 2). Conclusion: Midurethral location of the retropubic sling, as opposed to transobturator sling, is associated with reduced persistence of urgency symptoms, higher rates of resolution of urgency symptoms, lower severity of urgency symptoms and better quality of life. References: 1. Int Urogynecol J Pelvic Floor Dysfunct 2005; 16: 230–5. 2. Acta Obstet Gyneco Scand 2004; 83: 904–8. Table 1: Correlation of location of the sling relative to urethra with urgency symptoms following sling surgery Group A: Transobturator sling surgery Location relative to the urethra
Proximal to Proximal Midurethra Distal p UVJ n (%) n (%) n (%) n (%) value*
2 (28.6) 7 (25.9) 6 (23.1) Denovo urgency incontinence n=15 1 (14.3) 6 (22.2) 6 (23.1) Persistence of urgency symptoms n=14 2 (28.6) 7 (25.9) 7 (26.9) Resolution of urgency symptoms n=17 Group B: Retropubic midurethral sling surgery
0
0.70
1 (25)
0.963
1 (25)
0.999
Location relative to the urethra
Proximal to Proximal Midurethra Distal p UVJ n (%) n (%) n (%) n (%) value*
Denovo urgency incontinence n=4 Persistence of urgency symptoms n=16 Resolution of urgency symptoms n=10
0
4 (16)
0
0
0.446
5 (100)
7 (28)
2 (25)
2 (100)
0.005
0
5 (20)
5 (62.5)
0
0.034
*p value: Fisher Exact test
S152
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Table 2: Correlation of location of the sling relative to urethra with severity of symptoms and quality of life scales as determined by UDI - 6 and OAB-sf validated questionnaires Group A: Transobturator sling surgery Location relative to the urethra
Proximal to UVJ n (%) 7 (100)
Proximal Midurethra Distal p n (%) n (%) n (%) value
Positive answer to 15 (55.6) 11 (42.3) question 2 of UDI-6 n (%) Transformed 13 (7) 10 (40) 13 (26) Symptom Severity Score of OAB-sf* 95 (89) 94.5 (16) Transformed HRQL 98 (6) subscales of OABsf* Group B: Retropubic midurethral sling surgery Location relative to the urethra
Proximal to UVJ n (%) 3 (60)
Positive answer to question 2 of UDI-6 n (%) Transformed 93 (33) Symptom Severity Score of OAB-sf* Transformed HRQL 12 (10) subscales of OABsf*
1 (25) 0.13#
0 (30) 0.254
100 (21)
0.294
Proximal Midurethra Distal p n (%) n (%) n (%) value 12 (48)
3 (37.5)
2 (100)
0.433#
17 (64)
0 (56)
100
0.005
98 (48)
100 (52)
9
0.003
*Median (Interquartile range) p value: Mann Whitney U test. # chi square test Disclosure Block: Aparna Hegde: No disclosures. Razvan Hurezeanu: No disclosures. G. Mayte Nogueiras: No disclosures. Vivian Aguilar: No disclosures. G. Willy Davila: Astellas: Speaker, Honoraria. Warner-Chilcott: Speaker, Honoraria. AMS: Speaker, Honoraria. AMS: Scientific Medical Advisor, Intellectual Property Rights. Pfizer: Investigator-initiated research grant, Grant/Research Support.
OP 074 TRANSOBTURATOR SLING SURGERY WITH CONCOMITANT ANTERIOR VAGINAL WALL REPAIR PERFORMED THROUGH THE SAME INCISION:IS THERE AN IMPACT ON THE LOCATION OF THE SLING ONE YEAR FOLLOWING SLING SURGERY? A. HEGDE, G. NOGUEIRAS, V. AGUILAR, G. DAVILA; Cleveland Clinic Florida, Weston, FL. Objective: To compare the location of the transobturator sling at rest, as seen on 3 dimensional endovaginal ultrasound (3D
EVUS) 1 year following transobturator sling surgery, in patients who underwent concomitant anterior repair through a single incision versus those who underwent transobuturator sling surgery alone. Background: Transobturator slings have been found to be located more proximally in patients with failed transobturator sling surgery when compared with patients with successful outcomes (1). Patients with pelvic organ prolapse and SUI frequently undergo sling placement with concomitant anterior vaginal wall repair. It is unknown whether the placement of the transobturator sling through the same incision used for the anterior vaginal wall repair has an impact on the location of the transobturator sling. Method: This is a prospective cohort study of 100 patients who underwent transobturator sling surgery (Monarc™, American Medical Systems, Minnetonka MN) at our center between August 2009 and June 2012. Patients with prior anti-incontinence surgery and mixed incontinence with a predominance of urgency incontinence were excluded. The patients constituted two groups: group A (n=58) who underwent concomitant anterior vaginal wall repair through the same incision and group B (n=42) who underwent transobturator sling surgery alone. Treatment outcome was determined based on a composite measure of “failure”: presence of urine leakage on a standardized cough stress test (CST) at 250 ml and a ‘yes’ answer to question 3 of the UDI6 validated questionnaire. All enrolled patients underwent 3 dimensional endovaginal ultrasound of the anterior pelvic compartment with the 8848 transducer (BK Medical Profocus Ultraview, Peabody, MA) by a fellow who was blinded to the treatment outcomes. The 3D volumes obtained were analyzed to determine location of the sling in midsagittal view. Urethral length was determined from the urethrovesical junction until the external urethral meatus and the location of the sling with respect to the urethral length was characterized as proximal to the urethrovesical junction (UVJ), proximal, proximal-mid, midurethral, mid-distal and distal. The tape percentile (distance of the midpoint of the sling from the urethrovesical junction divided by the urethral length) was calculated. Results: The two groups matched with respect to their demographic data, severity of SUI and urodynamic parameters (p> 0.05). The two groups were comparable with respect to their median weeks of follow up [median (interquartile range) of 74 (21) in group A vs 65 (11) in group B; p>0.05]. 46 (79.3 %) patients in group A had a successful outcome as compared to 36 (85.7 %) patients in group B (p=0.291). The two groups matched with respect to the sling location at rest overall (table 1; p=0.089). However, a significantly higher proportion of
S153
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
patients in group A had the sling located proximally when compared with group B [29 (50 %) vs 10 (23.8); p= 0.007]. Out of these, 11 (19 %) patients had the sling located proximal to the urethrovesical junction as compared to 2 (4.8 %) patients in group B (p=0.03). All the patients, who had the sling located proximal to the UVJ, had poor treatment outcomes 1 year following surgery. The distance of the midpoint of the sling from the urethrovesical junction and tape percentile were also significantly lower in group A when compared with group B (table 2; p<0.05). Conclusion: Patients who undergo transobturator sling surgery, with concomitant anterior vaginal wall repair performed through the same incision, are more likely to have the sling located more proximally when compared with patients who undergo transobturator sling surgery alone. References: 1. Int Urogynecol J 24 (suppl 1): s112 - s113 Table 1: Tape position at rest Variable
Group A (n=62) n (%)
Group B (n=38) n (%)
p value
Proximal to the urethrovesical junction Proximal urethra
11 (19)
2 (4.8)
0.065
18 (31)
8 (19)
Proximal-mid urethra
8 (13.8)
11 (26.2)
Mid urethra
17 (29.3)
15 (35.7)
Mid-distal urethra
4 (6.9)
4 (9.5)
Distal urethra
0
2 (4.8)
p value calculated using Fisher Exact test Table 2: Location of the sling Variable
Distance of the midpoint of the sling from the urethrovesical junction (mm) Tape percentile
Group A Median (Interquartile range) 9.5 (9)
Group B Median p (Interquartile value range) 13.5 (8)
0.001
0.26 (0.21)
0.34 (0.23)
0.001
p value calculated with Mann Whitney U test Disclosure Block: Aparna Hegde: No disclosures. G. Mayte Nogueiras: No disclosures. Vivian Aguilar: No disclosures. G. Willy Davila: Astellas: Speaker, Honoraria. Warner-Chilcott: Speaker, Honoraria. AMS: Speaker, Honoraria. AMS: Scientific Medical Advisor, Intellectual Property Rights. Pfizer: Investigator-initiated research grant, Grant/ Research Support.
OP 075 THE ROLE OF INTRINSIC SPHINCTER DEFICIENCY AND URETHRAL MOBILITY ON THE OUTCOME OF TAPE INSERTIONS G. SURKONT1, V. VIERECK 2, E. WLAZLAK 1, A. KUSZKA 3, O. RAUTENBERG 2, I. ZIVANOVIC 2, R. HILGERS 4, J. KOCISZEWSKI 3; 1 Med. Univ. of Lodz, Lodz, Poland, 2Cantonal Hosp. Frauenfeld, Frauenfeld, Switzerland, 3Lutheran Hosp. Hagen-Haspe, Hagen, Germany, 4Georg August Univ., Goettingen, Germany. Introduction: Data about the influence of intrinsic sphincter deficiency (ISD) and urethra mobility on postoperative outcomes after tape insertion procedures are discussed controversially. The latest publications suggest that cure rates are the worst for incontinent women with urodynamically detected ISD and an immobile urethra. Objective: The aim of this study was to evaluate the influence of urethral mobility and tape position on the medical outcome for woman with stress urinary incontinence and ISD. Methods: Patients included in the study had a maximal urethral closure pressure (MUCP) of <20 cmH 2 O in urodynamics. TVT insertion and pelvic floor ultrasound were performed according to standard procedures. Urethral length, linear urethral dorsocaudal movement (LUDM) and distance between the tape, the longitudinal smooth muscle (LSM)complex of the urethra (DTU) and relative tape position (TP) were measured. Outcome measurements included subjective and objective parameters which were collected preoperatively and 6 months postoperatively during urogynecologic exams. For the purposes of this analysis, patients were divided into two groups: cured and not cured. Results: Of the 117 woman included in the study, 95 were cured (81.2 %). In this group of cured patients, a median MUCP of 16 cmH2O (P25 =12.5; P75 =20), a median LUDM of 12.4 mm (P25 =7; P75 =17.7), a median DTU of 3.6 mm (P25 =3; P75 = 4.4) and a median relative TP of 64.1 % (P25 =60.2; P75 =67.6) were measured. In the group of patients with persistent incontinence, a median MUCP of 16.5 cmH2O (P25 =13; P75 =20), a median LUDM of 5.6 mm (P25 =4.5; P75 =9.4), a median DTU of 5.5 mm (P25 =4; P75 =6.2) and a median relative TP of 70.7 % (P25 =66; P75 =72.8) were measured. Statistical significant differences were found between cured and not cured patients for LUDM (p<0.001), tape-urethra distance (p<0.001) and relative tape position (p<0.001), while no statistically significant differences in MUCP values were detected between cured and not cured women (p=0.677). Conclusions: The results suggest that urethral mobility (LUDM), tape-urethra distance (DTU) and relative tape position (TP), but not MUCP in the range of 5–20 cm H2O, have an influence on the likelihood of being cured following a tape insertion procedure. The women with the most challenging circumstances are those with an immobile urethra. In these
S154
cases, the tape must be placed in midurethral position. For women with hypermobile urethra, they may be cured of incontinence even if tape location is suboptimally placed. Carefully planned operations based on each individual patient’s preoperative evaluation of the length of the urethra and the mobility using pelvic floor ultrasound would be helpful in obtaining the most desirable tape placement. References: N/A Disclosure Block: Grzegorz Surkont: No disclosures. Volker Viereck: No disclosures. Edyta Wlazlak: No disclosures. Andrzej Kuszka: No disclosures. Oliver Rautenberg: No disclosures. Irena Zivanovic: No disclosures. Reinhard Hilgers: No disclosures. Jacek Kociszewski: No disclosures.
OP 076 LONG TERM OUTCOMES OF SLINGS IN VARIOUS AGE GROUPS A. ALAS1, O. CHINTHAKANAN 2, L. ESPAILLAT 1, L. PLOWRIGHT 1, G. DAVILA 3; 1 Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Cleveland Clinic Florida, Weston, FL, 2 Atlanta Urogynecology Associates, Atlanta, GA, 3Cleveland Clinic Florida, Weston, FL. Introduction: Conflicting data exists on the effect age has on the success of anti-incontinence slings.1,2 Objective: To evaluate the long term success of midurethral slings (MUS), pubovaginal slings (PVS), and transobturator slings (TOTs) in three age groups. Methods: This was a retrospective review of patients with a diagnosis of stress urinary incontinence (SUI) who underwent either a MUS (Gynecare TVT Ethicon, Somerville, NJ), PVS (IStop CL Medical, Winchester, MA), or TOT sling (Monarc AMS, Minnetonka, MN) from January 2005 to March 2013 using a comprehensive urogynecologic database. Patients were separated into three groups: ≤50 years of age (group one), 51 to 69 years of age (group two), and ≥70 years of age (group three). Primary Objective: was to evaluate success at ≥6 weeks as defined by cured, greatly improved, or improved on a validated patient improvement satisfaction score (ISS) and a negative postoperative standardized stress test (SST). Secondary Objective: was to evaluate success as defined by the primary objective and 0 incontinent episodes per day. Results: Of the 1464 patients who underwent a sling, there were 126 MUS, 876 TOTs, and 347 PVS. Mean age for group one was 44.51±4.25 (n=296), for group two 60.5±5.28 (n=680), and for group three 77.68±5.41 (n=488) with a median follow up of 26 weeks (6–498), 45 weeks (6–498), 42 weeks (6–543), respectively. Group three had statistically significant higher rates of intrinsic sphincter deficiency (ISD) and detrusor overactivity (DO), number of vaginal deliveries, years affected by urinary
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
urge incontinence (UUI) (Table 1). With all slings combined, group three had significantly lower success 79.95 % versus 89.88 % and 83.10 % in group one and two, respectively but no difference among specific slings (Table 2). Secondary success analysis for all slings combined had significantly lower success in group three and for the MUS. Previous sling placement was a negative predictive factor for both the MUS (OR 0.12, CI 0.03– 0.53) and PVS (OR 0.22, CI 0.09–0.54), but not the TOTs (OR 0.51, CI 0.16–1.65). The TOTs were significantly better in group one (OR 1.88, 95 % CI 1.02–3.48), but were significantly worse in those menopausal (OR 0.26 CI 0.09–0.81), >2 incontinence events per day (OR 0.49, CI 0.28–0.85), and positive SST (OR 0.3, CI 0.13–0.72). The PVS was significantly worse for those with >2 incontinence events per day (OR 0.47, CI 0.25–0.86) and DO (OR 0.49, CI 0.26–0.93). Among age groups there was no difference in voiding dysfunction postoperatively but there was a significant improvement in UUI. Survival analysis showed the success of all slings did decrease over time, but there was no significant difference between sling types (Table 3). Conclusions: Though sling placement had an initial success of 79.95 % for patients ≥70 years of age there was rapid decline of efficacy overtime when compared to a younger population. This may be due to more severe degrees of SUI and concomitant DO. References: 1. Kim J, Lucioni, Govier F, Kobashi K. Worse long-term surgical outcomes in elderly patients undergoing SPARC retropubic midurethral sling placement. BJU Int. 2011;108(5);708–12 2. Nilsson CG, Palva K, Aarnio R, Morcos E, Folconer C. Seventeen years’ follow-up of the tension-free vaginal tape procedure for female stress urinary incontinence. Int Urogynecol J. 2013;24:1265–69 Table 1 Preoperative Demographics and Urodynamic Testing (n=1,464), n (%) Age group Demographics Age* BMI* Vaginal delivery** Menopausal Years stress urinary incontinence** Years urge urinary incontinence** Previous sling procedure Previous hysterectomy
≤50 (n= 296) 44.51 (4.25) 27.88 (6.43) 2 (0–9)
Pvalue 51–69 (n=680) 60.49 (5.28) 28.06 (5.66) 2 (0–7)
≥70 (n= 488) 77.68 (5.41) 27.28 (5.38) 2 (0–11)
26 (11.87) 482 (90.77) 4 (0.1– 5 (0–41) 50) 3 (0.2– 4 (0–71) 40) 5 (1.69) 52 (7.65)
400 (99.75) 4.5 (0.2– 44) 2 (0.1– 44) 26 (5.33)
36 (12.16)
233 (47.75)
279 (41.03)
<0.001 0.102 <0.001 <0.001 0.835 0.025 0.001 <0.001
S155
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240 Age group DM
6 (2.41)
Pvalue 60 (10.42) 43 (6.47)
52 (13.07) 7 (1.54)
Hazard Ratio 0.76
0.296
51–69 (n=680)
<0.001
≥70 Ref. (n=488)
Current smoker
28 (9.69)
Follow-up period (weeks)**
26 (6–498) 45 (6–498) 42 (6–543) <0.001
95 % CI 1 year
3 year
5 year
0.57– 86.98 % 1.01 (n=320)
70.65 % (n=162)
62.88 % (n=127)
28.33 % (n=103)
86.49 % (n=230)
69.12 % (n=121)
43.15 % (n=97)
13.24 % (n=89)
Urodynamic Evaluation Positive stress test
23 (7.96)
47 (7.21)
29 (6.33)
0.689
Volume at first leak*
199.27 (150.66) 93.00 (37.15) 190 (64.19) 36 (12.16)
220.08 (168.51) 82.39 (40.87) 480 (70.59) 87 (12.79)
229.68 (162.78) 70.22 (33.88) 370 (75.82) 138 (28.28)
0.062
Leak point pressure at 150 cc* Intrinsic sphincter deficiency (MUCP <20 or LPP <60)* Detrusor overactivity
<0.001 0.002 <0.001
*mean (S.D.), normal distributed, ANOVA p-value **median (range), nonparametric, Kruskal-Wallis test p-value ***Fischer exact test Otherwise n (%), Chi-square test Table 2: Success by Age and Sling Type Age Overall (n=1,464)
P-value
<50 (n=296)
51–69 (n=714)
70+ (n=488)
Primary success*
231 (89.88)
509 (83.17)
355 (79.95)
0.003
Secondary success*
180 (63.38)
347 (53.14)
229 (48.21)
<0.001
MUS (n=126)
<50 (n=41)
51–69 (n=60)
70+ (n=30)
Primary success*
32 (86.49)
43 (82.69)
22 (78.57)
0.702
Secondary success*
25 (67.57)
29 (53.70)
10 (34.48)
0.028
TOT (n=876)
<50 (n=216)
51–69 (n=425)
70+ (n=252)
Primary success*
171 (90.96)
312 (85.01)
187 (84.23)
0.094
Secondary success*
136 (65.07)
228 (58.46)
113 (54.29)
0.065
PVS (n=347)
<50 (n=39)
51–69 (n=143)
70+ (n=173)
Primary success*
28 (87.50)
98 (83.05)
126 (78.26)
0.394
Secondary success*
19 (50.00)
62 (47.33)
73 (43.45)
0.682
*N, (%)
Table 3: Survival Rate by Age and Sling Type Hazard Ratio All Slings Combined
95 % 1 year CI 87.82 % (n=655)
3 year
5 year
10 year
69.50 % (n=329)
56.58 % (n=259)
24.01 % (n=218)
Sling MUS
Ref.
88.53 % (n=51)
56.37 % (n=25)
45.09 % (n=23)
30.06 % (n=20)
TOT
0.68
0.42– 88.48 % 1.09 (n=365)
74.51 % (n=179)
69.81 % (n=136)
29.50 % (n=107)
PVS
1.03
0.62– 87.46 % 1.71 (n=159)
68.40 % (n=82)
33.59 % (n=62)
no data
0.56
0.36– 93.11 % 0.87 (n=104)
66.58 % (n=46)
66.58 % (n=44)
29.96 % (n=46)
Age ≤50 (n= 296)
Disclosure Block: Alexandriah Alas: Pfizer: Recieved grant funding through Pfizer to investigate Toviaz medication with and without premarin cream., Grant/Research Support. Orawee Chinthakanan: No disclosures. Luis Espaillat: No disclosures. Leon Plowright: No disclosures. G. Willy Davila: Astellas: Speaker, Honoraria. Warner-Chilcott: Speaker, Honoraria. AMS: Speaker, Honoraria. AMS: Scientific Medical Advisor, Intellectual Property Rights. Pfizer: Investigator-initiated research grant, Grant/Research Support.
OP 077 FACTORS ASSOCIATED WITH FAILURE OF A REPEAT MID-URETHRAL SLING PROCEDURE R. C. CHAN 1, J. SCOVELL 2, J. TAN 2, A. BILGUTAY2, A. GOMELSKY 3; 1 Houston Methodist Hosp., Houston, TX, 2Baylor Coll. of Med., Houston, TX, 3LSU Hlth. Sci. Ctr., Shreveport, LA. Introduction: Initial failure of a mid-urethral sling procedure defined as either a response of yes to the questions of leaking during physical activity, coughing, or sneezing, or requiring another incontinence procedure, occurs in approximately 14 % of patients. Failure after a repeat mid-urethral sling procedure occurs in approximately 28 % of patients. Factors including larger body mass index (BMI), intrinsic sphincter deficiency, previous continence surgery, mixed incontinence, increased age, concomitant surgery, diabetes, increased pad weight, fixed urethra, MESA score for urge >10, are predictive of initial sling failure1. However, little is known about the factors that place women at a higher risk of failure of repeat mid-urethral sling after previously failing initial sling placement. Objective: We sought to determine predictive factors that are associated with failure of a repeat mid-urethral sling procedure. Methods: Data was collected prospectively for 152 consecutive women undergoing a repeat mid-urethral sling using a retropubic approach (SPARC) after prior sling failure. Patients were accrued between September 2009 and June 2012, and surgeries were performed by a single surgeon at a single institution. Cure was defined as both an absence of objective (negative cough stress-test) and subjective (zero on SEAPI stress subset) stress urinary incontinence. Patient characteristics including age, body mass index, gravidity and parity, previous pelvic/vaginal surgeries, pre-operative urethral hypermobility, Baden-Walker grade of cystocele, rectocele, and
S156
vaginal or cervical prolapse, and valsalva leak point pressure (VLPP). Pre-operative questionnaires including the SEAPI, IIQ, UDI-6, and VAS were also recorded. Means and frequencies reported, and statistical analysis included student t-test and chi-square where appropriate. Results: 152 women underwent a repeat mid-urethral sling procedure for previous sub-urethral sling failure. 60.0 % (n= 91) of women were continent and 40.0 % (n=61) continued to remain symptomatic with a mean follow-up of 27.3 months vs. 32.5 (p=0.11). Patients who remained incontinent had a greater number of pre-operative pads per day (4.2 vs. 3.0, p=0.02), and reported greater scores on SEAPI sub-scores of protection (2.6 vs. 2.1, p<0.01) and inhibition (1.9 vs. 1.5, p=0.01) as well as a greater overall total SEAPI score (7.8 vs. 6.7, p<0.01). Surprisingly, there was no difference in the prevalence of urethral hypermobility between patients who failed and succeeded a repeat mid-urethral sling procedure (48.0 % vs. 58.2 %, p= 0.232). The pre-operative IIQ scores trended towards significance (13.9 vs. 12.0, p=0.052). There was no difference between patient BMI (30.7 vs. 29.5, p=0.233), gravidity (3.0 vs. 2.9, p= 0.233), parity (2.6 vs. 2.6, p=0.99), Baden-Walker grades of cystocele (1.2 vs. 1.3, p=0.72), rectocele (0.7 vs. 0.5, p=0.15), vaginal or cervical prolapse (0.7 vs. 0.8, p=0.51), unstable detrusor contractions during UDS (10.0 % vs. 6.6 %, p=0.46), VLPP (74.6 cm H2O vs. 81.4, p=0.19). There was no difference between pre-operative UDI (10.1 vs. 9.9, p=0.68) or VAS (2.1 vs. 2.3, p=0.38) scores. Conclusions: Understanding the factors associated with the failure of a repeat mid-urethral sling procedure is important in patient counseling and management. Our subjective cure rate (60.0 %) was similar to other published rates in repeat midurethral slings (62.0 %)1. We found that women who were using a greater number of pads per day were more likely to fail a repeat mid-urethral sling. Furthermore, the SEAPI and IIQ questionnaires may also be useful in identifying the appropriate patients for a mid-urethral sling. Although there was no difference in pre-operative hypermobility, we hypothesize that a larger series may be valuable in determining if this anatomic finding plays a role in pre-operative evaluation. By determining what factors predict failure of repeat mid-urethral sling with the use of a retropubic approach, management may be altered by considering other sling modalities such as a fascial sling, which allows for greater tension. References: 1. Stav, K., Dwyer, P. L., Rosamilia, A. et al.: Repeat synthetic mid urethral sling procedure for women with recurrent stress urinary incontinence. J Urol, 183: 241, 2010 Disclosure Block: Robert Chan: No disclosures. Jason Scovell: No disclosures. James Tan: No disclosures. Aylin Bilgutay: No disclosures. Alex Gomelsky: AMS: Consultant, Honoraria.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
OP 078 MANAGEMENT OF STRESS URINARY INCONTINENCE AFTER FAILED MIDURETHRAL SLING: A SURVEY OF MEMBERS OF THE INTERNATIONAL UROGYNECOLOGICAL ASSOCIATION (IUGA) I. GIARENIS, G. THIAGAMOORTHY, M. ZACCHE’, D. ROBINSON, L. CARDOZO; King’s Coll. Hosp., London, United Kingdom. Objective: To evaluate the management of persistent or recurrent stress urinary incontinence following a failed midurethral sling among IUGA members. Background: Synthetic midurethral slings (MUS) have gained popularity in the surgical management of stress urinary incontinence (SUI), due to their minimally invasive nature and high long-term success rates [1]. However, a proportion of treated patients experience surgical failure. The management of persistent or recurrent SUI after failed MUS presents a new challenge as currently there are no robust data to recommend or refute any of the different management strategies [2]. Methods: This web-based anonymous survey consisted of 29 questions. Permission was granted by IUGA’s Research and Development committee. A brief introductory e-mail was sent to IUGA members by the IUGA office containing a link to the SurveyMonkey® website. Further information about the survey was included in IUGA’s weekly bulletin for 3 consecutive weeks. The survey included questions on demographics, training, current workload and methods of assessment. Participants were also asked to state their preferred surgical option in various clinical scenarios and comment on future research on the subject. Categorical variables were reported as frequencies using percentages and compared with the chi-square or Fisher’s exact test, as appropriate. Results: Three hundred and thirty-one responses were obtained. Respondent’s characteristics are described in table 1. Table 1 N (%) Specialty
Geographic area of practice
Practice type*
Urogynaecology
199 (60.1)
Gynaecology/Obstetrics
106 (32.0)
Urology
19 (5.7)
Other
7 (2.2)
Europe
161 (48.6)
North America
71 (21.4)
South America
43 (13.0)
Asia
28 (8.5)
Oceania
22 (6.7)
Africa
6 (1.8)
University Teaching Hospital
163 (49.2)
District General Hospital
114 (34.4)
Private
85 (25.7)
S157
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240 N (%) Age
Fellowship training
<40
70 (21.2)
40–50
119 (35.9)
50–60
93 (28.1)
>60
49 (14.8)
Yes
180 (54.4)
No
151 (45.6)
*Total may be >100 % as more than one response could be selected More than two thirds of the responders reported that they saw less than 10 cases of recurrent SUI after failed MUS per year and only 14.5 % had more than 20 cases per year. However, only 7.6 % were referring these cases to a tertiary centre. A range of tests were performed for the assessment of women presenting with recurrent SUI (table 2). The type of previous surgery, urodynamic findings and surgeon’s preference/ experience were considered as the most important factors in choosing the type of surgical management (table 2). Table 2
Retropubic sling (RPS) was the preferred surgical option in most of the clinical scenarios, especially in the presence of urethral hypermobility and after a failed transobturator sling (TOS) or a single -incision sling (SIS). The role of urethral bulking agents (UBA) was important in the absence of urethral hypermobility. There was significant variation in the responses from different geographic areas and specialties but not from different age groups. The responses to the clinical scenarios are summarised in table 3. Table 3 Failed RPS
Failed TOS
Failed SIS
RPS 39.3 %
RPS 83.1 %
RPS 71.2 %
TOS 26.0 %
Colpo 4.6 %
TOS 21.0 %
Colpo 11.4 %
ST 3.2 %
Colpo 1.8 %
RPS 36.1 %
RPS 52.1 %
RPS 69.9 %
UBA 19.2 %
UBA 15.5 %
TOS 9.6 %
AFS 14.2 %
Colpo 10.1 %
UBA 8.7 %
No urethral hypermobility & normal urethral UBA closure function 44.8 %
RPS 42.5 %
RPS 43.4 %
RPS 14.2 %
UBA 32.9 %
UBA 26.9 %
AFS 11.4 %
AFS 7.3 %
TOS 8.7 %
UBA 53.0 %
RPS 37.4 %
RPS 39.7 %
RPS 13.2 %
UBA 37.4 %
UBA 33.3 %
AFS 9.6 %
AFS 7.8 %
Colpo 7.8 %
RPS 56.6 %
RPS 74.9 %
RPS 65.8 %
TOS 22.8 %
TOS 10.5 %
TOS 21.0 %
Colpo 5.0 %
Colpo 3.7 %
Colpo 4.1 %
Urethral hypermobility & normal urethral closure function
Urethral hypermobility & low pressure urethra (ISD)
N (%) Assessment+
Factors influencing management++
+
Laboratory conventional urodynamics
241 (72.8)
Urethral pressure profilometry
133 (40.2)
Leak point pressure
132 (39.8)
Q-tip test
81 (24.5)
Pelvic floor ultrasound
77 (23.3)
Pad test
57 (17.2)
Ambulatory urodynamics
57 (17.2)
Videourodynamics
53 (16.0)
Type of previous continence surgery 237 (71.6) Urodynamic findings
207 (62.5)
Surgeon’s preference/experience
126 (38.1)
Age
97 (29.3)
Symptoms of overactive bladder
90 (27.2)
Pelvic Organ Prolapse
81 (24.5)
Body Mass Index
65 (19.6)
Previous abdominal surgery
35 (10.6)
Menopausal status
28 (8.5)
Vaginal length/elasticity
23 (6.9)
Percentages refer to positive responses (total may be >100 %) ++ Factors ranked as the three most important in a list of ten (total may be >100 %)
No urethral hypermobility & low pressure urethra (ISD)
MUS not in midurethral position
RPS: retropubic MUS, TOS: transobturator MUS, SIS: single-incision MUS, Colpo: colposuspension, ST: sling tightening, UBA: urethral bulking agents, AFS: autologous fascial sling The vast majority of the responders (93.0 %) recognised the urgent need for good quality research for management of recurrent SUI after failed MUS. However, only 57.7 % would participate in a randomised controlled trial (RCT) comparing repeat
S158
MUS with AFS and 50.7 % in a RCT comparing repeat MUS with Colpo. Conclusions: Our survey highlights the current trends in the management of recurrent SUI among IUGA members. The type of previous surgery, the urodynamic findings and the surgeon’s preference guide decision making for the management of these challenging cases. RPS and UBA are the most common procedures performed after a failed MUS. Despite the lack of consensus in diagnosing urethral hypermobility and ISD, these factors influence significantly the choice of surgery for recurrent SUI. References 1. Int Urogynecol J. 2012; 23: 1117–22 2. Cochrane Database Syst Rev. 2013; 2: CD009407 Disclosure Block: Ilias Giarenis: No disclosures. Ganesh Thiagamoorthy: Astellas: Subsidy to attend IUGA 2013, Travel Grant. Martino Zacche’: No disclosures. Dudley Robinson: Astellas: Advisory Committee Member, Honoraria. Pfizer: Consultant, Honoraria. Allergan: Consultant, Honoraria. Ferring: Consultant, Grant/Research Support. SEP: Speaker, Honoraria. Linda Cardozo: Allergan: Speaker, Honoraria. AMS: Consultant, Consulting Fee. Astellas: Board Member, Consulting Fee. Pfizer: Scientific Medical Advisor, Grant/Research Support. OP 079 A RANDOMIZED COMPARISON OF SINGLE INCISION MID-URETHRAL SLING (MINIARC™) AND TRAN SOBTURATOR MID-URETHRAL SLING (MONARC™) FOR TREATMENT OF STRESS URINARY INCONTINENCE: 2-YEAR CLINICAL OUTCOMES. R. P. SCHELLART1, M. G. DIJKGRAAF 2, F. VAN DER AA 3, J. LUCOT 4, B. KIMPE 5, D. DE RIDDER 3, K. OUDE RENGERINK 2, J. ROOVERS 2; 1 Obstetrics and gynecology, Kennemer Gasthuis, Haarlem, Netherlands, 2Obstetrics and gynecology, Academic Med. Ctr., Amsterdam, Netherlands, 3Urology, Univ. Hosp. KU Leuven, Leuven, Belgium, 4Obstetrics and gynecology, Hôpital Jeanne de Flandre, Lille, France, 5Urology, AZ SintLucas, Bruges, Belgium. Objective: To compare subjective and objective cure, morbidity and discomfort following MiniArc™ and Monarc™ sub-urethral sling in women with stress urinary incontinence. Background: Standard midurethral slings (SMUS), such as Monarc™, have become the surgical treatment of choice for women with stress urinary incontinence (SUI). Single-incision mini-slings (SIMS), such as MiniArc™, have been introduced
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
to reduce postoperative pain and improve recovery with comparable effectiveness. However, this has never been investigated in a well-powered randomized trial. At the IUGA in 2013 we reported MiniArc™ to be superior to Monarc™ with respect to pain immediately following the operation and non-inferior to Monarc™ with respect to efficacy at 12 months. Methods: We performed a randomized controlled trial (NTR3783) in two Dutch, two Belgian and one French teaching hospitals. Women with symptomatic stress urinary incontinence were eligible. Women with prior stress urinary incontinence surgery and/or a pelvic prolapse stage ≥2 (ICS) were excluded. Women were randomly allocated to a SIMS (MiniArc™) or transobturator SMUS (Monarc™). Surgeons had performed at least ten of each prior to start of inclusion. The 2-year outcome was subjective cure defined as responding with ‘mild’ or ‘not serious’ to the question: ‘You are having urinary and/or prolapse complaints. Select the answer from the list below that best reflects the severity of your condition now.” (PGIS). Additionally, we assessed Objective: cure (defined as a negative cough stress test with at least 300 ml bladder filling), UDI-6 score and reinterventions during recovery. At present 2-year data on urinary incontinence are available for about 75 % of the planned inclusion; complete follow-up will be presented at the IUGA meeting (last 24-months follow-up visit is planned at February 24, 2014). We hypothesized that the cure rate with MiniArc™ was non-inferior to the cure rate with Monarc™. Results:We randomized 193 women: 97 were allocated to MiniArc™ and 96 to Monarc™. The groups were comparable for the baseline characteristics age, body mass index, parity and the proportions of postmenopausal women and women with previous POP surgery. Both groups were similar for UDI domain scores as well. During the 2 years of follow-up most complaints in both groups related to urinary tract infections and bladder retention. In addition, stress incontinence was more frequently observed in the MiniArc™ group, whereas urge incontinence was more frequently observed in the Monarc™ group. The table shows that at 12 and 24 months of follow-up, subjective cure was 87 % and 82 % respectively in the MiniArc™ group and twice 91 % in the Monarc™ group. Objective cure was 89 % and 92 % respectively in the MiniArc™ group and 92 % and 94 % in the Monarc™ group. The UDI domain scores at 24 months for irritation and stress were slightly increased for the MiniArc™. Three re-operations had to be performed in the Monarc™ group; one to correct a tape exposure, one to release the tape unilateral because of obstructive micturition and one retropubic TVT was performed because of failure. In the MiniArc™ group two retropubic TVT’s were performed because of failure.
S159
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Conclusions:At 2 years of follow-up, subjective and objective cure rates of MiniArc™ are still within the predefined noninferiority limit when compared with Monarc™. These are preliminary observations at face value. Statistical testing will be performed upon completion of the follow-up data early March 2014 and presented at the conference. Table: Subjective and objective outcomes Figures are: (1) number (percentage); (2) mean (standard deviation) Urinary incontinence (1)
MiniArc™ 12 M FU (N=86)
Monarc™ 24 M FU (N=66)
12 M FU (N=87)
24 M FU (N=66)
Subjective cure
75 (87 %)
54 (82 %)
79 (91 %)
60 (91 %)
Objective: cure
77 (89 %)
57 (92 %)
81 (92 %)
60 (94 %)
UDI domains (2)
12 M FU (N=85)
24 M FU (N=66)
12 M FU (N=84)
24 M FU (N=65)
Irritative
24 (23)
31 (28)
23 (25)
21 (23)
Stress
16 (21)
21 (24)
13 (18)
14 (18)
Obstructive/ discomfort
16 (22)
13 (19)
9 (14)
11 (16)
Disclosure Block: Rene Schellart: American Medical Systems, Inc.: Consultant, Grant/Research Support. Astellas Pharma B.V.: Advisory Committee Member, Consulting Fee. Marcel Dijkgraaf: Echo Pharmaceuticals: Advisory Committee Member, Consulting Fee. Frank van der Aa: gsk: Speaker, Honoraria. Ipsen: Advisory Committee Member, Consulting Fee. Ipsen: Consultant, Consulting Fee. Astellas: Speaker, Honoraria. Astellas: Advisory Committee Member, Grant/Research Support. Medtronic: Consultant, Grant/Research Support. Jean-Philippe Lucot: boston scientific: surgical teaching sessions, Honoraria. american medical systems: surgical teaching sessions, Honoraria. Bart Kimpe: No disclosures. Dirk De Ridder: American Medical Systems: Speaker, Consulting Fee. Bard: Speaker, Consulting Fee. Katrien Oude Rengerink: American Medical Systems: Research support for performing the trial was provided to the research group, not to me personally., Grant/Research Support. Jan-Paul Roovers: AMS: Scientific Medical Advisor, Grant/Research Support.
S160
OP 080 TRANS OBTURATOR TAPE FOR THE MANAGEMENT OF STRESS URINARY INCONTINENCE IN OBESE PATIENTS: RESULTS AT 7 YEAR FOLLOW-UP M. J. URZUA 1 , C. RONDINI 2 , H. BRAUN 2 , V. CASTEBLANCO 3, M. I. TAGLE 2, F. R. TRONCOSO 4; 1 hospial padre hurtado, santiago, Chile, 2Hosp. padre hurtado, santiago, Chile, 3hospital padre hurtado, Hosp. padre hurtado, santiago, Chile, 4Hosp. PADRE HURTADO, SANTIAGO, Chile. Introduction: Obesity is a pathology of high prevalence among women. For years it was associated to high risk of failure in surgical treatment for stress urinary incontinence (SUI). Recent evidence has shown equivalent TOT results in non-obese and obese patients. Objective: To compare long term subjective result of TOT in non-obese and obese patients Methods: Cohort study. Subjective result is compared in 294 obese patients vs. 65 normal weight patients with diagnosis of pure or mixed SUI submitted to TOT. Patients were classified according to WHO criteria in: normal weight (BMI 18.5–24.9), Obesity type I (BMI 30–34.9), Obesity type II (BMI 35–39.9) and Obesity type III (BMI >40). PGII validated questionnaire was used to evaluate surgery success. All patients that were better, much better or very much better than during pre-operatory with respect to their urinary incontinence symptoms, were considered successfully treated. Demographic variables among groups were compared. Cure rates are expressed as actuarial survival rates using Kaplan Meier method. p<0.05 is considered significant. Results: The average BMI for non-obese and for obese patients was 23.4±1.3 vs. 34.1±3.3 respectively with a p<0.001. There was no difference between both groups for age (59.0±9.9 vs. 60.5±9.5 p=0.3), parity (3.4±1.8 vs. 3.6 ± 1.7; p = 0.4) and history of previous urinary incontinence surgery (6.2 % vs. 5.1 %; p = 0.5). 32.3 % of non-obese patients and 39 % of obese patients had a diagnosis of MUI with stress predominance (p=0.3). Average follow-up was 82.3±16.5 months for non-obese patients and 82.3±16.5 months for obese patients (p=0.03). The rate of subjective success at 7 year follow-up in nonobese and in obese patients is similar: 67.2 % vs. 63.8 % log Rank: p=0.521. When comparing success rates at 7 years in obese patients according to different obesity degree, the result was similar: Obesity type 1: 64.2 %; Obesity type II: 62.9; Obesity type III: 63.6 %, Log Rank p=0.906. Conclusions: The rate of subjective cure of TOT at 7 year follow-up in normal weight patients and in obese patients is equivalent. Likewise, in obese patients the rate of success is similar independent from obesity degree
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
References: none Disclosure Block: Maria Urzua: No disclosures. carlos rondini: No disclosures. Hernan Braun: No disclosures. valentina casteblanco: No disclosures. maria tagle: No disclosures. FERNANDO TRONCOSO: No disclosures.
OP 081 FLOW DISRUPTIONS IN ABDOMINAL SACROCOLPOPEXY: DOES ROBOTIC SURGERY INTRODUCE UNFORESEEN CHALLENGES FOR SURGEONS? C. E. PERKINS1, K. CATCHPOLE 2, K. S. EILBER 2, B. GROSS 3, S. JAGANNATHAN 4, N. HAKAMI-MAJD 1, J. T. ANGER 2; 1 David Geffen Sch. of Med. at UCLA, Los Angeles, CA, 2 Cedars-Sinai Med. Ctr., Beverly Hills, CA, 3Texas A&M Hlth. Sci. Ctr. Coll. of Med., College Station, TX, 4Saint Louis Univ., St. Louis, MO. Introduction: With the potential to decrease morbidity and improve patient outcomes, robotic surgery is poised to change the landscape of the surgical field. However, technologies can fundamentally change the requirements for teamwork, process, and individual skills. The introduction of surgical robots changes many elements of the work system - for example, the surgeon no longer operates at the table, the robot needs to be docked to the patient, the instrument changes need to be carefully managed - which may change the intraoperative requirements for communication, coordination, equipment use, expertise, and training. Such problems often result in flow disruptions, defined as deviations in the optimal course of care. Flow disruptions during robotic surgery may impact patient outcomes, as well as operating room efficiency. Objective: Human factors research is the study of how humans interact with and perform in complex systems. The purpose of this study is to employ a human factors research approach to identify flow disruptions in robotic abdominal sacrocolpopexy procedures, with the ultimate goal of developing system interventions to improve the safety and efficiency of robotic surgery. Methods: Fifteen robotic abdominal sacrocolpopexy procedures were evaluated, nine of which included a concomitant supracervial hysterectomy. Flow disruptions were classified using categories defined previously1(Table 1). Flow disruptions were categorized into four stages: 1) patient arrival and induction of anesthesia; 2) port placement and robot docking; 3) console time; and 4) undocking of robot, incision closure, and patient exiting operating room. Results: The average patient age was 55 years (range: 39–68) and the average patient body mass index was 27. Seven of the
S161
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
fifteen procedures were performed on the da Vinci S and eight procedures were performed on the da Vinci Si. A mean of 50 (95 % CI, 37–63) flow disruptions occurred in each robotic abdominal sacrocolpopexy case, with a mean of 10 (95 % CI, 7–13) flow disruptions per hour. The most frequent flow disruptions in this study were due to equipment issues, with an average of 13 flow disruptions per case. This was closely followed by coordination, communication, and training disruptions (Table 2). In a detailed analysis, we found that many of the communication disruptions were due to auditory difficulties between the surgeon on the console and the other team members. These communication problems may ultimately be due to the robotic equipment, making them both equipment and communication disruptions. Conclusions: Flow disruptions in robotic abdominal sacrocolpopexy surgery occur about every 6 min. They impair progress, increase team workload, operating time, and reduce efficiency and safety. The study of disruptions can be used to diagnose and suggest improvements for systems problems predisposed by new OR technology. Focusing on equipment management, coordination, and communication would be beneficial. References: 1. Parker SE, Laviana AA, Wadhera RK et al. Development and evaluation of an observational tool for assessing surgical flow disruptions and their impact on surgical performance. World J Surg, 34 (2) (2010), pp. 353–361 Table 1. Categories
Definition
Communication Any miscommunication that impacts surgery progress
Coordination
Any lapse in teamwork to prepare for/conduct surgery that affects surgery flow
Examples Examples: Surgeon on console is unable to hear bedside assistant, who has to repeat communication. Nurse does not hear surgeon suture request Example: Surgeon always uses a specific piece of equipment, but staff fails to retrieve item prior to when it is needed during the surgery Examples: Resident enters room to ask attending about another patient. Surgeon receives cell phone call or text message
External Factors
Any interruption that is not relevant to the current case or surgery
Training
Any instruction by the Example: Surgeon attending surgeon to instructing resident on fellows, residents, or where to place the ports medical students Any equipment issue that Example: Bovie pad falls affects surgery progress off of patient
Equipment
Categories
Definition
Environment
Any room conditions that Example: Music is too impact surgery progress loud, making it difficult for staff to hear surgeon requests Any patient characteristic Example: Obesity making that impedes efficient port placement difficult surgery progress
Patient Factors
Examples
Table 2. Average (95 % Confidence Interval) Number of Flow Disruptions Per Case Surgery Length (minutes) Number of Flow Disruptions Per Hour Communication Disruptions Per Case Coordination Disruptions Per Case External Factors Disruptions Per Case Training Disruptions Per Case
50 (37–63)
Equipment Disruptions Per Case
13 (9–17)
Environment Disruptions Per Case Patient Factors Disruptions Per Case
1
296 (257–335) 10 (7–13) 9 (5–13) 11 (7–15) 3 (2–4) 9 (4–14)
1
Disclosure Block: Colby Perkins: No disclosures. Ken Catchpole: No disclosures. Karyn Eilber: American Medical Systems: Consultant, Consulting Fee. Boston Scientific: Investigator; no payment received as of yet, Investigator; no payment received as of yet. Astellas: Speaker, Honoraria. Bruno Gross: No disclosures. Samantha Jagannathan: No disclosures. Niv Hakami-Majd: No disclosures. Jennifer Anger: No disclosures.
OP 082 THE EXPLICIT USE OF REPORTING GUIDELINES IN UROGYNECOLOGY ARTICLES IN 2013- A REVIEW OF 6 JOURNALS M. KOCH, W. UMEK, P. RISS, E. HANZAL; Obstetrics and Gynecology, Med. Univ. of Vienna, Vienna, Austria. Introduction: Correct reporting of research is necessary for assessment of its quality and of its potential reproducibility. Researchers have access to reporting guidelines (RG) for different study designs, and many journals require authors to edit their manuscripts according to
S162
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
these. The first RG was the CONSORT statement for randomized controlled trials (RCTs) in 1996, followed by the STROBE statement for observational studies (2004). A guideline for the reporting of systematic reviews and meta-analyses was published in 2005 (PRISMA). (1) However, we do not know to which extent RGs are used and specifically mentioned in urogynecology articles. Objective: To determine the current explicit mentioning of the 3 RGs (CONSORT, STROBE, PRISMA) in urogynecology articles of 6 journals in 2013, and to assess whether journals require authors to use RGs. Methods: Descriptive bibliometric study. All articles assigned to the field “urogynecology”, which were published between January and December 2013 in the 6 journals IUJ (International Urogynecology Journal), NAU (Neurourology and Urodynamics), AJOG (American Journal of Obstetrics & Gynecology), Obstetrics & Gynecology, BJOG (An International Journal of Obstetrics and Gynaecology) and FPMRS (Female Pelvic Medicine and Reconstructive Surgery) were included in this research. All articles from NAU were taken into consideration irrespective of the investigated gender. Journals were accessed electronically and issues were searched for reviews, RCTs, cohort studies, case–control studies and cross-sectional studies by two independent investigators. Other study designs were not included, as they are not reflected in the selected RGs. The study category was either indicated in the table of contents, in the title of the article, or assessed by the investigators. In a second step the electronic article was searched for the term PRISMA, CONSORT or STROBE according to the study design. The current “Instructions to Authors” of the 6 journals were screened for the requirement of using RGs. Results: Table 1 Frequency of explicit declaration of each reporting guideline (PRISMA, CONSORT, STROBE) out of total number of articles in the respective category (n/n)
GREEN
PRISMA (systematic review) 0 n/a
CONSORT (RCT)
STROBE (observational)
Total***
1/7
14 %
0/8
0%
1/15
AJOG
0
n/a
0
n/a
0/12
0%
0/12
BJOG
0
n/a
0/1*
0%
2/14
14 %
2/15
NAU
2/6
33 %
2/6
33 %
0/25
0%
4/37
IUJ FPMRS
5/7 0
71 % n/a
7/22 0/4
32 % 0%
1/137 0/47
0.7 % 0%
13/166 0/51
Total**
7/13
54 %
10/40
25 %
3/243
1.2 %
-
* follow- up study after RCT; ** total frequency of declaration of each reporting guideline in urogynecology articles, ***total
frequency of declaration of all reporting guidelines per journal; (GREEN) Obstetrics & Gynecology, (AJOG) American Journal of Obstetrics & Gynecology, (BJOG) An International Journal of Obstetrics and Gynaecology, (NAU) Neurourology and Urodynamics, (IUJ) International Urogynecology Journal; (FPMRS) Female Pelvic Medicine and Reconstructive Surgery (FPMRS), n/a (not applicable), (RCT) Randomized Controlled Trial Table 2 Use of reporting guidelines required in the “instructions to authors” of the respective journal; no (0), yes (1) PRISMA
CONSORT
STROBE
Impact Factor 2012
GREEN AJOG
1 1
1 1
1 1
4.798 3.877
BJOG NAU*
1 0
1 1
1 0
3.76 2.674
IUJ
0
1
0
2.169
FPMRS
0
0
0
n/a
* authors are encouraged to consult reporting guidelines relevant to their specific research design; (BJOG) An International Journal of Obstetrics and Gynaecology, (GREEN) Obstetrics & Gynecology, (AJOG) American Journal of Obstetrics & Gynecology, (NAU) Neurourology and Urodynamics, (IUJ) International Urogynecology Journal, (FPMRS) Female Pelvic Medicine and Reconstructive Surgery Conclusions: The explicit use of RGs in 2013 was generally low (overall 1–54 %), with a trend towards using PRISMA for systematic reviews. Statements in the “instructions to authors” of the investigated journals do not seem to be related to the actual number of explicitly mentioned RGs in the respective articles. Three out of 6 journals (GREEN, AJOG, BJOG) only published few urogynecology articles in 2013 (n=42). We were not able to determine if the RGs were used in the preparation of the manuscripts, as we only investigated the explicit declaration of the keywords PRISMA, CONSORT and STROBE in the published text. Overall, we found a low rate of explicit statements of RGs in 2013. We conclude that there is a need to promote their use in urogynecology articles. References: (1) http://www.equator-network.org/(accessed January 18, 2014) Disclosure Block: Marianne Koch: No disclosures. Wolfgang Umek: Astella: Speaker, Honoraria. Paul RISS: No disclosures. Engelbert
S163
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Hanzal: Astellas, Allergan: Advisory Committee Member, Consulting Fee. Johnson & Johnson Gynecare, Astellas, Pfizer,
OP 083 INDEPENDENT ASSESSMENT OF LONG TERM OUTCOME IN A PROSPECTIVE COHORT OF PATIENTS UNDERGOING LAPAROSCOPIC SACROCOLPOPEXY. S. PACQUEE1, K. NAWAPUN 1, F. CLAERHOUT 1, J. VERGUTS 1, E. WERBROUCK 1, J. VELDMAN 1, D. DE RIDDER 2, G. COREMANS 1, J. DEPREST 1; 1 Pelvic Floor Unit, UZ Leuven, Leuven, Belgium, 2Univ. Hosp. KU Leuven, Leuven, Belgium. Background: Laparoscopic sacral colpopexy (LSC) is the standard surgical procedure for level I defects but little is known about its long-term efficacy and safety. Objective: To report on a prospective consecutive cohort of 312 consecutive patients who underwent LSC at our unit. Materials and methods: This is a prospective cohort of all patients with symptomatic prolapse (≥stage 2) who underwent for LSC from the first case onwards, and who were at least 1 year postoperative. Principle outcome measures were duration of follow up, anatomical outcome, level I failure rate at the vault (=C or D ≥ −1 cm) or failure in any compartment, the occurrence of and time point of complications, reintervention, subjective measures like Patient Global Impression of Change-score, and responses to a standardized interview based on a the UDI-6, IIQ-7 and PQOL. Patients who could not be physically assessed were interviewed by telephone. Evaluations were performed by an assessor not involved in the surgery or clinical management of the patient. Data are reported as mean (SD) or median (IQR), number and %, as appropriate. Student t-test, Chi square Fisher exact and survival analysis were used to compare groups. Results: 312 patients were contacted, 180 (57 %) underwent physical re-evaluation and 72 (23 %) had a telephone interview (total n=252; 80 % follow up rate). At that point their mean age was 72.46±9.93 years and they were in follow up for a median of 104.50 months (84.25–134.75; range: 15–210). Anatomical cure at point C was 93.2 %. Recurrence at the vault presented at any time postoperatively (Figure 1). The presence of anterior (22.2 %) and/or posterior compartment (35.8 %) prolapse was common. Of those with level I anatomical cure, 8.3 % (n=15) felt worse. Of those, in only one third (n= 5) this was because of prolapse in another compartment. The other had either urinary problems (n=10) and/or obstructive defecation (n=2). Conversely, when there was Objective: recurrence at the vault (n= 11), the majority of patients (n=7) still reported to be improved.
At interview (n = 252), 50 patients (19.8 %) reported reoperations at some stage (Table 1), of whom 25 for mesh related complications and 23 for recurrent or de novo prolapse. At study closure, 85.1 % felt better, 5.6 % (n=14) were as before, 5.2 % (n=13) resp. 4.1 % (n=10) were slightly resp. frankly worse. Of those women reporting subjective worsening, 39 % (n=9) had still prolapse symptoms, 69 % (n=16) reported urinary incontinence and 35 % (n=8) had defecation problems, of whom 2 had fecal incontinence. All patients were asked about the occurrence of de novo bothering pelvic floor symptoms: those results are displayed in table 1. Conclusions: We were able to retrieve long term outcomes in 80 % of patients, of whom 75 % were operated at a median of 8.7 years before reassessment. An independent assessor found an Objective: cure rate at point C of 93.8 %. However 15 % of the clinically assessed patients reported no improvement: in one third this was because of prolapse, the majority however because of urinary or bowel problems. Of those with Objective: recurrences at level I the majority still considered their selves improved. There were many patients with Objective: prolapse in other compartments, though only in total 9.0 % were re-operated for prolapse. The leading cause for reoperation was GRC (9.9 %) followed by urinary incontinence (6.3 %). Figure 1: Kaplan Meier curve of the 180 patients clinically assessed for recurrence; 252 patients interviewed for reintervention for GRC. Table 1 : Follow up on 252 patients: reinterventions and pelvic floor dysfunction according to self reported history. De novo pelvic 68 Reinterventions N (procedures) floor function – disorders 50 patients Related to the mesh 31 Urinary problems – 25 (9.9 %) Mesh exposure 23 Stress Incontinence
% of the population
Pain
Urge Incontinence
16.1 %
Urgency
22.8 %
Frequency
21.1 % 14.6 %
8
Related to prolapse – 24 23 (9.1 %) Anterior 6 Vault
10
Obstructive voiding
Posterior
7
Defecation problems
14.1 %
Rectumprolapse
1
Constipation
17.8 %
Related to urinary incontinence – 16 (6.3 %) Persistent
16
Faecal Incontinence
2.3 %
7
Digital Support
4.4 %
De novo
9
Sexual function problems Dyspareunia
20.4 %
Related to anal 1 incontinence Others: hernia, small 2 bowel obstruction
Lump interfering with intercourse
3.5 %
S164
Disclosure Block: Stefaan Pacquee: No disclosures. Katika Nawapun: No disclosures. Filip Claerhout: No disclosures. Jasper Verguts: No disclosures. Erika Werbrouck: No disclosures. Joan Veldman: No disclosures. Dirk De Ridder: American Medical Systems: Speaker, Consulting Fee. Bard: Speaker, Consulting Fee. Georges Coremans: No disclosures. Jan Deprest: Medri: Unconditional grant; company is not designer of the study, owner or results or have any say in publication of results. Grant/Research Support. Ethicon: Speaker, Honoraria. AMS: Consultant, Honoraria. coloplast: Framework 7 programme of the European Commission for novel material development, Grant/Research Support.
OP 084 DISTANCE TO CARE AND RELATIVE SUPPLYAMONG FEMALE PELVIC MEDICINE AND RECONSTRUCTIVE SURGEONS COMPARED TO OBSTETRICS AND GYNECOLOGY SUBSPECIALISTS T. M. MUFFLY1, R. WETERINGS 2, K. M. DAVIS 3, K. A. CONNELL 1; 1 Division of Female Pelvic Medicine and Reconstruct, Univ. of Colorado, Lone Tree, CO, 2Naresuan Univ., Phitsanulok, Thailand, 3Division of Female Pelvic Medicine and Reconstructive Surgery, Univ. of Colorado, Lone Tree, CO. Introduction: In a 1980 report, the Graduate Medical Education National Advisory Committee recommended 95 % of the population have a maximum travel time of 90 min for surgical care, but provided no specific recommendation about travel times to obstetrics and gynecology services.(1) No studies have compared the geographic distribution of Female Pelvic Medicine and Reconstructive Surgery (FPMRS) to other obstetrics and gynecology subspecialists. Objective: The aim of this study is to describe geographic proximity to and quantify the distribution of Female Pelvic Medicine and Reconstructive Surgeons compared to subspecialty obstetrics and gynecology physicians in the United States.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Methods: Data from the December 2013 National Provider Index taxonomy codes were used to calculate subspecialty-specific, straight-line distances between counties and the nearest physician. These same data sources were used to calculate the percentage of adult women (greater than 20 years old) living within selected distances of providers for each of the obstetrics and gynecology subspecialties. Counties were classified as being within 10 miles, 11 to 20 miles, 21 to 40 miles, 41 to 80 miles, or 80 or more miles of a provider. The thresholds were used assuming that 20 miles corresponds to a drive time of 30 min (2). Specialtyspecific percentages of the overall older than 20 years population living within these distances of a provider were then calculated. Results: Maps depicting the provider locations for each of the obstetrics and gynecology specialties are presented in (Figure, Distribution of Board Certified Female Pelvic Medicine and Reconstructive Surgeons per State: Number of Adult Women, 2013). Across obstetrics and gynecology specialties, mean distances to the nearest provider was 82 miles for FPMRS physicians, 66 miles for Gynecologic Oncology, 56 miles for Maternal-Fetal Medicine, and 86 miles for Reproductive Endocrinology. Practice locations for all physicians paralleled the geographic distribution of women in the US, however, FPMRS surgeons had the fewest women in the population nearby compared to other subspecialists, with approximately 62 % of the adult female population living less than ten miles from a FPMRS provider (Table). Geographic access is greatest for Maternal-Fetal Medicine specialists for which 87 % of the older than 20 years female population live within 40 miles, or an approximately 1 h drive, of a high risk obstetrician. Conclusions: Although the practice locations of FPMRS physicians parallel the geographic distribution of women in the United States, large percentages of the adult female population must travel long distances to receive care from these providers. Patients have the least access to FPMRS subspecialists, and the low numbers of providers is estimated to take decades to increase to a critical mass of FPMRS surgeons in order to serve the adult population of women in the US. References: 1. Report of the Graduate Medical Education National Advisory Committee to the Secretary, Department of Health and Human Services. Vol I GMENAC Summary Report. Hyattsville, MD: Health Resources Administration, DHHS Pub. No. (HRA); September 1980. p. 105. 2. Rosenthal MB, Zaslavsky A, Newhouse JP. The geographic distribution of physicians revisited. Health Serv Res 2005;40:1931–52.
S165
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Table: Percent of adult female population within selected distances of OB/GYN subspecialists Gynecologic Maternaloncology fetal (n=1,039) medicine (n=2,030)
10 or fewer miles
Female pelvic medicine and reconstructive surgery (n=575) 62 %
64 %
71 %
64 %
11–20 miles
8%
9%
7%
8%
21–40 miles
9%
10 %
9%
9%
41–80 miles
12 %
10 %
8%
10 %
6%
3%
8%
Distance to the nearest provider
More than 80 miles 8 %
Reproductive Endocrinology and Infertility (n=1,203)
Disclosure Block: Tyler Muffly: No disclosures. Robbie Weterings: No disclosures. Karlotta Davis: No disclosures. Kathleen Connell: No disclosures.
OP 085 RETRROSPECTIVE REVIEW OF VAGINAL SALPINGECTOMIES: SUCCESS RATES AND COMPLICATIONS S. IWANICKI, D. CENAIKO, M. ROBERT; ob/gyn, Univ. of Calgary, Calgary, Canada. Objective: Calculate the success rate of performing vaginal salpingectomies on all women undergoing vaginal hysterectomy for benign conditions. Review the complications of performing bilateral vaginal salpingectomies at the time of vaginal hysterectomies Indentify risk factors that can predict inability to perform salpingectomies.
Background Recent literature (1,2) suggests that most cases of pelvic serous carcinoma (ovarian and peritoneal) may arise from the fimbrial end of the Fallopian tube. The Society of Gynecologic Oncology of Canada recommended in Sep. 2011, that due to its cancer potential, physicians discuss the risks and benefits of bilateral salpingectomy with patients undergoing hysterectomy for any indication (3). Methods: This is a retrospective chart review of all hysterectomies done between Oct 1 2011, following the Society of Gynecologic Oncology of Canada recommendations, and Aug 31 2013. All women undergoing hysterectomy (in private practices) were offered prophylactic salpingectomies. Vaginal hysterectomies were carried out with the LigaSure Vessel Sealing Reusable Instrument (Covidien Surgical Solutions, Mansfield, MA) or suture ligated (or both) once entry into the peritoneal cavity was secured. The uterus was morcellated or cored (if needed) after the urterine vessels were sealed. The mesenteries of the fallopian tubes were sealed with LigaSure and the tubes excised with scissors, carefully avoiding bowel by packing it away with a sponge. If there was difficulty accessing the tubes, they were grasped with a sponge forcep or long Kelly and removed in portions or intact. Descriptive analysis were used. Linear regression was used to identify possible predictive factors leading to inability to perform salpingectomies using STATA V9 (Statacorp, Texas, USA). P < 0.05 was considered significant. Results: During the time period, a total of 353 hysterectomies were performed of which 302 were vaginal. The preferred route was always vaginal hysterectomy first unless there was a compelling reason ex: large fibroids, endometrial cancer. Four scheduled vaginal hysterectomies were changed to abdominal due to uterine size. Sixty-seven (20 %) of vaginal hysterectomies were done for prolapse. In the vaginal hysterectomy group, bilateral salpingectomies was successful in 226 (75 %), unilateral in 29 (10 %) and not done in 47 (16 %). The reasons for only doing a unilateral salpingectomy was: could not reach; 12, adhesions; 5, previous unilateral salpingectomy; 10 and unknown; 2. Thus 17 or 19 (if consider the unknowns) were not done because of technical reasons. In those women who did not have a salpingectomy, the reasons were: not attempted; 7, no consent; 20, patient refused; 3, too difficult 11 (2 women with BMI over 50), age over 70; 2, previous bilateral salpingectomies; 4. Therefore overall, 28/302 (9 %) or 30/302 (10 %) (if include unknown reasons) of women did not have a salpingectomy for technical reasons.
S166
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
OP 086
Table 1: Complications of Vaginal Hysterecomies Complication
n total 302
Blood transfusion Small bowel laceration
4 1
Post op fever* Pulmonary embolism
10 2
Readmission† Re operation††
13 10
Complications within 6 week follow up Vaginal cuff cellulitis
n total 281 5
Urinary tract infection Hematoma
6 4
Vaginal infection Granulation tissue
5 3
Other¥
5
*urinary tract infection 3, pelvic abscess 4, unknown 3 †return to OR 10, drainage of abscess by ultrasound 2, pulmonary embolism 1††wound dehiscence 2, release of incontinence tape 2, drainage of cuff hematoma 1, drainage of abscess 2, ovarian cystectomy 1, oophorectomy 1, renal stone extraction 1¥labial cellulitits 1, vulvar abscess 1, right lower quadrant pain 1, overactive bladder symptoms 1, intravenous antibiotic treatment as outpatient Linear regression identified increase in body weight and presence of adhesions as significant factors predicting failure to achieve salpingectomy (p<0.05). Non predictive was: age, parity, degree of prolapse, uterine weight, previous pelvic surgery (including tubal ligations). Conclusions: Vaginal salpingectomy is a safe and feasible surgery. Body weight and presence of adhesions are predictive of failure to complete salpingectomy. References: 1. Crum CP, Drapkin R, Kindelberger D, Medeiros F, Miron A, Lee Y (2007) Lessons from BRCA: the tubal fimbria emerges as an origin for pelvic serous cancer. Clin Med Res 5(1):35–44 2. Kindelberger DW, Lee Y, Miron A, Hirsch MS, Feltmate C, Medeiros F, Callahan MJ, Garner EO, Gordon RW, Birch C, Berkowitz RS, Muto MG, Crum CP (2007) Intraepithelial carcinoma of the fimbria and pelvic serous carcinoma: evidence for a causal relationship. Am J Surg Pathol 31(2):161–169 3. http://www.g-o-c.org/uploads/11sept15_gocevidentiary statement_final_en.pdf Disclosure Block: Stanislaw Iwanicki: No disclosures. David Cenaiko: No disclosures. Magali Robert: cook Myosite: Advisory Committee Member, nothing financial received. cook Myosite: investigator, Grant/Research Support.
THE ERGONOMICS OF VAGINAL SURGEONS: OPPORTUNITIES TO ADVANCE THE SCIENCE FROM AWKWARD STRAINING TO OPTIMAL POSITIONING L. YURTERI-KAPLAN1, X. ZHU 2, C. B. IGLESIA 1, R. E. GUTMAN 1, A. I. SOKOL 1, V. PAQUET 2, A. J. PARK 1; 1 Obstetrics and Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Washington Hosp. Ctr./ Georgetown Univ. Sch. of Med., Washington, DC, 2Department of Industrial and Systems Engineering, Univ. at Buffalo, The State Univ. of New York, Buffalo, NY. Introduction: Awkward postures are positions held for sustained time and performed repetitively causing musculoskeletal injury. There is a paucity of data regarding awkward postures in vaginal surgeons. Objective: To determine the frequency and duration of awkward positions for primary and assistant vaginal surgeons, and correlate postural demands with surgeon musculoskeletal discomfort. Methods: This IRB-approved cross-sectional study evaluated ergonomic positions of primary and assistant surgeons performing vaginal hysterectomy +/− concomitant procedures. Surgeon and patient demographics were collected. During surgical tasks, real-time observations characterized the frequency and duration of awkward postures associated with strain using the Ergonomics Posture Assessment in Real Time (ErgoPART). Five predefined awkward postures were evaluated: trunk flexion (>20°), trunk lateral bending (>20° relative to midsagittal plane), neck deviation (>30° flexion±lateral deviation), and right and left shoulder deviation (>60° flexion ± abduction). Perioperative data included operative time, use of stools and retractors, table height, bed angle and length, task locations relation to ischial spines, and patient hip and knee angles. Pre- and postoperatively, surgeons answered validated questionnaires, Body Part Discomfort and Exertion [BORG CR-10], to quantify surgeons’ subjective discomfort. Statistical analysis was performed using independent t-test to compare postures between primary and assistants and Mann–Whitney test for non-parametric data. Results: 13 primary and 14 assistant surgeons were evaluated during 13 cases. Mean operating time was 180.3 (±58) min. The assistant spent more time and percentage of the case in trunk flexion compared to the primary (4 % (7.4 min±6.8) vs. 2 % (2.9 min± 3.6), p=0.045). Similarly, there is a trend for assistants to spend more time in trunk lateral bending, neck deviation, and left shoulder deviation. Both assistant and primary surgeon spent a similar amount of time in right shoulder deviation. (Graph 1) However, the frequency of right and left shoulder deviations were higher in
S167
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
primary compared to assistants (p<0.01 and p=0.046, respectively). When comparing pre- and postoperative muscular discomfort, all surgeons experienced significant increase in postoperative discomfort of the neck, mid and lower back, and right and left wrists, hands and fingers. Interestingly, greater than half of primary surgeons had an increase in neck and mid back discomfort postoperatively on the BORG CR-10 pain scale compared to greater than half of assistants, who experienced increased discomfort of the neck, upper back, and mid back. Right and left shoulder discomfort correlated moderately with frequency of trunk flexion (r=0.44 and r=0.55, p<0.01). Similarly, foot discomfort correlated with frequency of trunk flexion (r=0.39, p=0.046) and right shoulder deviation (r=0.44, p=0.02). Lastly, right upper leg discomfort correlated with duration of neck deviation (r=0.39, p=0.046). Conclusions: Awkward postures are highly prevalent during vaginal surgery. Assistants spent significantly more time in trunk flexion. There is a trend for assistants to spend more time in trunk lateral bending, neck deviation, and left shoulder deviation compared to primary surgeons. However, the frequency of movement from neutral to awkward postures for the primary surgeon is significantly higher for right and left shoulder deviation. Postoperative discomfort ratings increased across all body parts for all surgeons, and were significant for neck, upper extremities, and mid and lower back. There were moderate correlations between shoulder discomfort and trunk flexion as well as foot discomfort and both trunk flexion and right shoulder deviation. Future research efforts are underway to determine if reducing the frequency and duration of awkward postures during vaginal surgery improves surgeon postoperative muscular discomfort. References: n/a
OP 087 AN OBSERVATIONAL ERGONOMICS JOB ANALYSIS METHOD TO QUANTIFY POSTURAL RISK FACTORS FOR MUSCULOSKELETAL INJURY AMONG GYNECOLOGIC VAGINAL SURGEONS X. ZHU1, L. YURTERI-KAPLAN 2, A. J. PARK 3, A. SOKOL 4, C. B. IGLESIA 5, R. E. GUTMAN 4, V. PAQUET 6 ; 1 Industrial and Systems Engineering, Univ. at Buffalo, SUNY, Buffalo, NY, 2Washington Hosp. Ctr./Georgetown Univ., Washington, DC, 3Georgetown Univ. Sch. of Med., Washington, DC, 4 MedStar Washington Hosp. Ctr./ Georgetown Un, Washington, DC, 5 MedStar WHC/ Georgetown, Washington, DC, 6Univ. at Buffalo, SUNY, Buffalo, NY. Introduction: There is a high prevalence of workrelated musculoskeletal disorders (MSDs) among gynecologic surgeons, but the risk factors thought to contribute to these injuries have not been fully characterized. One barrier to investigate risk factors contributing to the development of work-related MSDs is a lack of efficient to collect operating room data, surgeons’ behavior, and surgical tasks simultaneously in real-time. Objective: The aim of this study was to develop and evaluate an observational ergonomics job analysis method to capture predefined awkward (non-neutral) postures during vaginal surgeries. Methods: A novel observational ergonomics evaluation method was developed to quantify the frequency and duration of awkward neck, shoulder, and trunk postures (Table 1) among surgeons. Table 1 Description of awkward (non-neutral) upper body postures
Posture
Description of awkward (non-neutral) posture
Neck deviation
Neck flexion and/or lateral bending relative to the sagittal plane ≥30°
Left shoulder deviation
Left shoulder flexion and/or abduction >60°
Right shoulder deviation Right shoulder flexion and/or abduction >60° Trunk flexion Trunk lateral bending
Disclosure Block: Ladin Yurteri-Kaplan: No disclosures. Xinhui Zhu: No disclosures. Cheryl Iglesia: No disclosures. Robert Gutman: No disclosures. Andrew Sokol: No disclosures. Victor Paquet: No disclosures. Amy Park: No disclosures.
Trunk flexion ≥20° Trunk lateral bending relative to the sagittal plane >20°
This research requires the use of a customized software application, the Ergonomics Posture Assessment in Real Time (ErgoPART) for tablets or laptops that allows an observer to track the surgeons’ postures, tasks, and their basic behavior during surgery in real time (Figure 1).
S168
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
epidemiologic studies of musculoskeletal injuries or ergonomic interventional trials in the operating room to assess surgical equipment and/or surgeon behavior. References: N/A
The visual feedback provided by the interface enhances reliability of coding postures during the surgery. This tool is a Microsoft Excel 2010 (Microsoft, Redmond, WA, USA) VBA Macro that provides an easy-to-use interface for data collection, automatically generating the frequency and duration of awkward postures, surgical tasks and the environmental features affecting posture during surgery. This methodology has the advantage of being minimally intrusive compared to the use of bioinstrumentation and optical motion capture systems, and is less time consuming and costly than video recording analysis. The inter-observer reliability of this methodology was tested among four observers who were trained to use the tool and who had varying expertise in ergonomics job analysis and vaginal surgery. Four observers formed six distinct pairs and these pairs were tested one by one in random order during surgery. Two observers in the tested pair with two identical tablets uploaded with ErgoPART were asked to collect postural data on one surgeon and this data was compared between observers to test the inter-observer reliability. The consistency between observers was measured in two ways: the percentage of time observers coded each of the postures identically (%Identical Time), and the difference in the measured duration of each awkward postures between observers during the surgical task (%Duration Difference). High %Identical Time and low %Duration Difference would therefore suggest high reliability. Results: The inter-observer reliability of ErgoPART was evaluated during a surgery lasting 128 min. The median % Identical Time on posture classification across all posture categories was 85.9 % (min-max: 85.2–90.3 %) and the median % Duration Difference across all posture categories between observers was 1.5 % (min-max: 0.2–5.9 %). There was less consistency for classification of left shoulder deviation: 85.2 %Identical Time and 5.9 %Duration Difference. Trunk flexion had the highest consistency with only a 0.2 %Duration Difference. Conclusions: The ErgoPART is a promising new ergonomics postural assessment tool that is capable of characterizing postural risk factors for MSDs related to vaginal surgery. Our results suggest that the ErgoPART requires minimal training and can be used during vaginal surgery to reliably code neck, shoulder, and trunk posture. It could also be used in
Table 1 Description of awkward (non-neutral) upper body postures Posture
Description of awkward (non-neutral) posture
Neck deviation
Neck flexion and/or lateral bending relative to the sagittal plane ≥30°
Left shoulder deviation
Left shoulder flexion and/or abduction >60°
Right shoulder deviation Right shoulder flexion and/or abduction >60° Trunk flexion
Trunk flexion ≥20°
Trunk lateral bending
Trunk lateral bending relative to the sagittal plane >20°
Disclosure Block: Xinhui Zhu: No disclosures. Ladin Yurteri-Kaplan: No disclosures. Amy Park: No disclosures. Andrew Sokol: No disclosures. Cheryl Iglesia: No disclosures. Robert Gutman: No disclosures. Victor Paquet: No disclosures.
OP 088 OUTCOMES OF GYNECOLOGIC SURGEONS’ KNOWLEDGE, CONFIDENCE AND PERSPECTIVE ON PERFORMING UTEROSACRAL LIGAMENT SUSPENSION AFTER STRUCTURED TRAINING MODULE F. M. LINDO1, B. L. SHULL 1, T. J. KUEHL 2, J. F. PLIEGO 3; 1 Department of Obstetrics & Gynecology Section of Female Pelvic Medicine and Reconstructive Surgery, Scott & White Hlth.care, Texas A&M Hlth. Sci. Ctr., Coll. of Med., Temple, TX, 2Scott & White Hlth.care, Temple, TX, 3Department of Obstetrics & Gynecology, Scott & White Hlth.care, Texas A&M Hlth. Sci. Ctr., Coll. of Med., Temple, TX.
S169
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Introduction: Methods for assessment of surgical skills in urogynecology have been limited. Objective: This study was performed to evaluate the effectiveness of uterosacral ligament suspension (USLS) training module on perceived technical competency, confidence level, and technical skills in gynecologic surgeons performing a USLS for pelvic organ prolapse. Methods: Study was waived by the IRB. In order to evaluate the effectiveness of the USLS training module on practicing gynecologists attending the training sessions we measured baseline anxiety, surgical confidence level, and the surgeons’ knowledge of the USLS procedure. Individuals were requested to complete evaluations of anxiety using standardized instrument, a questionnaire rating with a visual analog scale (VAS) for confidence in each of 15 steps for USLS surgery and a 12-question knowledge exam before and after the course. The training intervention was for a total of 3 days and included lecture, cadaver lab and live surgery. Before and after course scores on the three instruments were compared using ANOVA with repeated measures designs that only included those participants with complete results before and after the course. Post hoc comparisons were performed using Duncan’s test. P-values less than 0.05 were taken as significant. Results: A total of 51 subjects participated in the training programs at three venues. 19 were males and 32 were females between 27 and 68 (mean and SD of 45 and 12) years of age. For the anxiety comparisons, both S and T scales improved (p<0.001) after participating in the course for 17 individuals with complete data. Others with partial data had similar means. Participants evaluated 15 elements of the USLS procedure before and after the training course using VAS scales. Results for 29 who had complete data are shown in the Table and Figure. There was a significant improvement in confidence, but confidence did vary between the various steps. Knowledge scores for exams completed by 33 participants both before (67.7 %) and after (81.3 %) the course were significantly (p<0.001) improved. Conclusions: Participants’ perception of general anxiety improved after a 3 day training course. Confidence in performing the steps of the USLS procedure and cognitive skills also improved significantly. Assessing physicians’ surgical skills is essential for ensuring patient safety. Having a reliable training module with a specific checklist is an important tool to both assess and improve surgical skills and confidence in performing specific procedures. Having a measurable outcome on the lasting effect on educating surgeons in new skills or concept also enables instructors to evaluate improvements in content and methods for teaching. Future studies that objectively demonstrate the effectiveness of surgical training models are warranted both for urogynecology and other surgical specialties.
Table. Comparison using VAS (means with SE) of self-rated confidence for 15 elements of USLS before and after course (N=29) VAS component Identify appropriate patients for USLS Perform USLS
Test Item 1
Precourse 59±5
Postcourse 79±2
p-value*
>0.001
>0.001
2
43±5
68±4
Know procedural step sequence
3
51±5
82±2
>0.001
Dissect ant vag mucosa from bladder
4
75±4
85±2
0.011
Dissect post vag mucosa from rectum
5
68±5
85±3
>0.001
Identify enterocele sac
6
60±5
77±3
0.001
Enter enterocele sac
7
62±4
74±3
>0.001
Pack bowel out of pelvis
8
68±5
82±3
>0.001
Identify uterosacral ligament
9
55±5
74±3
>0.001
Select proper suture
10
56±5
79±3
>0.001
Place suture through uterosacral ligament
11
52±6
72±3
>0.001
Perform cystoscopy
12
72±5
80±4
0.071
Perform voiding trial
13
58±5
81±3
>0.001
Correct any ureter obstruction
14
36±5
60±4
>0.001
Identify nerve injury
15
35±4
58±4
>0.001
Overall Average
total
57±13
76±8
>0.001
*Comparison using Duncan’s post hoc test after ANOVA with repeated measures design in 29 subjects with complete data Figure. Results for the VAS evaluations of confidence are summarized in the plot below. References: British Journal of Surgery.2010;97:972–987. Am J Obstet Gynecol. 1994;171:1429–1439
Disclosure Block: Fiona Lindo: No disclosures. BOB SHULL: No disclosures. Thomas Kuehl: No disclosures. Jose Pliego: No disclosures.
S170
OP 089 URINARY NERVE GROWTH FACTOR LEVELS ARE REDUCED IN FEMALES AFTER RELIEVING ANATOMIC BLADDER OUTLET OBSTRUCTION R. KHAVARI, J. STEWART, R. C. CHAN, A. MUNOZ, T. BOONE, S. FLETCHER; Department of Urology, Houston Methodist Hosp., Houston, TX. Objective: The aim of this prospective, IRB approved, study is to evaluate NGF levels in women with anatomic bladder outlet obstruction (BOO) resulting from pelvic organ prolapse (POP) and/or previous incontinence surgery and the effect of surgery to relieve BOO on NGF levels. Background: Bladder outlet obstruction (BOO) in women can be a diagnostic challenge. The etiologies of BOO in female patients vary widely with no clear consensus on its definition. The urinary biomarker, nerve growth factor (NGF), has been previously shown to be elevated in male patients with BOO and other lower urinary tract symptoms (LUTS) [1]. No published studies have examined NGF as a potential urinary biomarker in females with BOO. Methods: From January to September 2012, all female patients referred for evaluation and management of BOO from POP or previous incontinence surgery were screened for enrollment. Inclusion criteria included: elevated post-void residual (PVR), valsalva voiding on urodynamics (UD) or urinary peak flow (Qmax) ≤12 mL/s. A control group of 10 asymptomatic age-matched female volunteers was also recruited. In all subjects, urinary NGF and creatinine (Cr) levels were measured by enzyme-linked immunosorbent assay. The total urinary NGF levels were normalized to the urinary Cr concentrations (NGF/Cr). Urinary NGF levels were measured post-operatively following surgery to relieve anatomic BOO. Results: A total of 7 female patients with anatomic BOO (mean age of 64±13 years) and 10 female control subjects (mean age of 62±7 years) were recruited. Etiologies of BOO in the study group included POP (n=1), previous incontinence surgery (n=4), and a combination of POP and previous incontinence surgery (n=2). 6/7 of the patients underwent UD, all with evidence of valsalva voiding. The mean Qmax for these 6 patients was 5.3 mL/s (SD 4.3). The one patient who did not undergo UD had frank urinary retention with a PVR of 1200 mL. The urinary NGF/Cr levels in the study patients with BOO (mean ± standard error 22.95±6.512 pg/mg) were significantly higher (p=0.0027) than the levels in the age-matched control group (5.595± 0.656 pg/mg). After treatment with release of prior antiincontinence procedure or POP repair, the urinary NGF/Cr level significantly decreased to 7.48±0.962 pg/mg (p=0.0001). Conclusions: In this study, female patients with anatomic BOO resulting from POP and/or previous incontinence surgery had significantly higher urinary NGF/Cr levels when compared to age-matched controls. After surgical correction, the urinary
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
NGF/Cr levels significantly decreased. Urinary biomarkers are attractive as a possible adjunct to the evaluation and monitoring of various LUTS and following treatment. References: (1) Urology 2008; 72(1): 104–108 Disclosure Block: Rose Khavari: No disclosures. Julie Stewart: No disclosures. Robert Chan: No disclosures. Alvaro Munoz: No disclosures. Timothy Boone: Allergan: Consultant, Consulting Fee. allergan: Speaker, Honoraria. astellas: Consultant, Consulting Fee. american medical systems: Consultant, Consulting Fee. Sophie Fletcher: No disclosures.
OP 090 EFFECT OF SURGICAL INJURY ON VAGINAL FIBULIN-5 and MMP-9 IN AN ANIMAL MODEL K. CHIN, J. F. ACEVEDO, P. KELLER, R. WORD; UT Southwestern Med. Ctr., Dallas, TX. Introduction: Fibulin-5 is an extracellular matrix elastogenic organizer expressed in various tissues, including skin, uterus, aorta, and lung (1). In the vaginal wall, fibulin-5 is crucial for pelvic organ support serving not only in the assembly of elastic fibers, but also as a matrix inhibitor protein that downregulates MMP-9 protease activity (2). Previous studies indicate that these observations in mice are relevant to human biology because fibulin-5 is downregulated and MMP-9 is upregulated in connective tissues of the pelvic floor from women with pelvic organ prolapse. Objective: Here, we sought to determine the effect of vaginal wall injury on fibulin-5 and MMP-9 as a function of time. Methods: Sprague–Dawley rats (65–75 days, n = 32) underwent either (i) injury with a single linear incision in the posterior vaginal wall (n=20) or excision of a wedge-shaped vaginal segment (n=12). Injured animals were compared with uninjured controls (24 or 48 h after anesthesia only, n=3). To normalize estrogen levels, all animals were treated with systemic estradiol prior to and following injury. Tissues were collected 12 h, 24 h, 48 h, and 7 days after injury. Fibulin-5 content was quantified by immunoblot analysis of ureaextracted matrix of the injured and uninjured vaginal muscularis (within 5 mm). Q u a n t i t a t i v e g e l a t i n zymography was used to compare vaginal MMP-9 activity among groups. Expression of Prss3, an epithelial protease that degrades fibulin-5 in vitro, and its inhibitor, elafin, was quantified and normalized to the housekeeping gene, CYPA, using qPCR in uninjured and injured epithelium. Statistical analysis was conducted using rank-based ANOVA and Dunn’s Test vs control.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Results: Surgical injury resulted in significant loss of vaginal fibulin-5 as a function of time after injury. Specifically, vaginal fibulin-5 was decreased 98 % 24 h after injury (0.04± 0.018, cut; 0.04 +/− 0.022, wedge; compared with 1.08±0.17, uninjured R.U./mg protein, P<0.01). Limited recovery occurred by 48 h (0.31 +/− 0.14, cut; 0.19 +/− 0.11 R.U./mg prot, mean +/− SEM, wedge) with variable, but partial recovery 7 days after injury (1.03 ± 0.46, cut; 0.85 ± 0.49 R.U./mg). Interestingly, although loss and recovery of fibulin-5 tended to be more profound with excisional surgery, both incisional and excisional wounds resulted in similar injury-induced patterns of fibulin-5 expression. MMP-9 activity correlated inversely with fibulin-5 content, with peak activity 24–48 h after injury (from nondetectable baseline levels to 0.50± 0.06 cut and 0.13±0.03 RU/mg protein, wedge) decreasing to low levels by 7 days (0.02±0.001, cut; 0.057±0.003, wedge). The serine protease, Prss3, was not expressed in rat vaginal epithelium. Elafin mRNA was maintained in the epithelium immediately after injury decreasing to low levels at 7 days (from baseline 20.5±9.5 RU/CPHA, n=6) to 15.92±7.9, 12 h; 4.4±0.5, 24 h, 3.1±0.7, 48 h, and 3.2±1.4, 7 days. Conclusions: Vaginal injury resulted in time-dependent activation of MMP-9 and loss of fibulin-5 in the vaginal muscularis. Fibulin-5 was reactivated 7 days after injury coincident with recovery of MMP-9 to baseline levels. This recovery occurred with both simple and complex injuries. Since fibulin-5 is not strongly regulated by transcriptional processes, injury-induced loss of fibulin-5 in the vagina is likely mediated by proteases activated and released from the epithelium or fibromuscular wall (3). We suggest that mechanisms to attenuate protease activation and preservation of fibulin-5 after surgical injury may augment surgical repair of pelvic organ prolapse by inhibiting matrix degradation and promoting matrix synthesis. References: 1. 2002 Nature 415:168–171 2. 2011 J Clin Invest 121:2048–2059 3. 2007 J Cell Biol 176:1061–1071 Disclosure Block: Kathleen Chin: No disclosures. jesus acevedo: No disclosures. Patrick Keller: No disclosures. R. Ann Word: No disclosures.
OP 091 IS THERE A ROLE FOR THE PROGESTERONE RECEPTOR IN POP? C. BETSCHART1, D. A. SCHEINER 1, A. GUAITA 1, D. FINK 1, D. PERUCCHINI 1, C. MAAKE 2; 1 Gynecology, Univ. Hosp. Zurich, Zurich, Switzerland, 2 Anatomy, Univ. Zurich, Zurich, Switzerland.
S171
Objective: The aim of this study is to compare the quantitative expression of the androgen receptor (AR), progesterone receptor (PR), and estrogen receptor alpha (ER1) and beta (ER2) in the connective tissue of the anterior wall of patients with pelvic organ prolapse (POP), and controls with a selective method of laser capture microdissection microscopy and quantitative PCR. Background: The endopelvic fascia, consisting of connective tissue and smooth muscle cells is involved in the support of the pelvic organs, including the vaginal wall. ER, PR and AR are expressed in the stroma of the vagina [1]. Methods: The study was approved by the ethics committee Zurich (StV 09/2010) and registered at Clinical Trials.gov (NCT01042470). For this case control study 74 women were screened for their blood hormone levels and age to build two homogenous groups of postmenopausal women with and without POP. Specimens of the anterior vaginal wall were collected intraoperatively between July 2009 and January 2011 of patients with cystocele (POP-Q ≥3) undergoing POP repair with colporrhaphia anterior (n=10) and controls (POP-Q ≤1) undergoing a hysterectomy for benign reasons (n=9). Samples were snap-frozen and – after cryosectioning used for laser capture microdissection of the vaginal lamina propria (2 mio μm2 from each individual). Subsequently, the specimen had been subjected to routine RNA extraction and RNA preamplification followed by a quantitative real-time polymerase chain reaction (qPCR) (Roche LightCycler 480), using primer/probe combinations for AR, PR, ER1, ER2 as well as for 18S as house keeping gene. Data analysis was performed by use of the Relative Expression Software Tool (REST-384) that includes a pairwise fixed reallocation randomization test. Only fold changes of >2 were considered. Statistical analysis (SPSS 20) was done with descriptive statistics (mean ± SD, or median and range) or number of patients. Comparisons were done with independent Student-t or Mann–Whitney test. Results: Both groups did not differ significantly in demographical and serological hormonal status. PCR methods revealed that ER2 was undetectable in vaginal stroma. However, AR and ER1 were clearly expressed, but did not change significantly between controls and POP (p= 0.65 and p=0.47, respectively) (Fig. 1). Transcription levels of PR mRNA were 2.82-fold upregulated in the POP group compared to controls, though not significantly (p=0.45). No correlation between PR and age could be found neither in the POP group (p=0.5) nor controls (p=0.24). After exclusion of patients with hormonal substitution (leaving n=5 POP, n=5 controls) for a first and exclusion of patients with no PR expression (leaving n=6 POP, n=6
S172
controls) for a second subanalysis, no statistically significant differences were found neither for demographics nor steroid receptor expression. Conclusions: Laser microdissection of the lamina propria in the vaginal wall is an adequate and selective method to investigate the steroid receptor expression in a tissue layer of structural importance in the etiology of prolapse. Our preliminary study showed a trend towards an upregulation of the PR expression in women with POP, while AR and ER1 were unchanged. This finding is partly in accordance with a previous study, where the vaginal tissue revealed an increase of the PR and a decrease of the ER expression though with a different method [2]. Our finding deserves further investigations with regard to the role of PR isoforms in a larger patient sample group. Figure 1: Box plot of the steroid receptor expression. AR, androgen receptor; PR, progesterone receptor; ER1_PL22, estrogen receptor isoforms. _P, prolapse. _C, control Vertical axis unit: crossing point counts of logarithmic PCR curves. References: 1 Br J Obstet Gynaecol 1998;105:216–222 2 Int Urogynecol J 2011;22(6):705–12
Disclosure Block: Cornelia Betschart: No disclosures. David Scheiner: No disclosures. Alessandra Guaita: No disclosures. Daniel Fink: No disclosures. Daniele Perucchini: No disclosures. Caroline Maake: No disclosures.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
OP 092 CYTOLOGICAL AND HISTOLOGICAL PARAMETERS OF THE VAGINAL WALL AND THEIR CORRELATION WITH MESH EXPOSURE RATES J. FARTHMANN1, I. MARTYNOV 2, B. GABRIEL 3, A. NIESEL 4, C. FUENFGELD 5, A. KRAUS 6, F. LENZ 1, H. AUGENSTEIN 1, D. WATERMANN 7; 1 Univ. Med. Ctr., Freiburg, Germany, 2Univ. of freiburg, Freiburg, Germany, 3St. Josefs-Hosp. Wiesbaden, Wiesbaden, Germany, 4Klinik Preetz, Preetz, Germany, 5Klinik Tettnang, Tettnang, Germany, 6Frauenklinik Fulda, Fulda, Germany, 7 Ev. Diakoniekrankenhaus, Freiburg, Germany. Introduction: Treatment of pelvic organ prolapse (POP) using native tissue repair bears a high risk of recurrence. The implantation of vaginal meshes has led to lower recurrence rates, but on the other hand specific risks such as mesh exposure have to be taken into account (1, 2). Mesh erosions can, in most cases be managed by local estrogen therapy or local excision of the mesh. Of note, many patients don’t have any complaints at all regarding the mesh exposure. Still, the risks of mesh exposure have not been completely understood (3). Objective: In this prospective study, both cytology and histology characteristics of the vaginal wall were studied, and a potential correlation of these features with mesh exposure were investigated, also with the question whether there would be a correlation with mesh exposure. Furthermore, local estrogen therapy and other clinical parameters were analyzed. Methods: This study enrolled 201 patients with a mean age of 64.3 years at time of surgery. One hundred and eighty-six (93.5 %) were postmenopausal. All patients had a cystocele ≥stage 2 and were treated using implantation of a six-armed vesicovaginal mesh. Tissue samples and vaginal wall swabs were taken for histological and cytological examination. The vaginal specimens were examined, both quantitatively (presence of the layers) and qualitatively (thickness of each layer and the total thickness of the vagina). The cytological specimens of 199 patients were taken three times (preoperatively, at three and at 12 months postoperatively). Proliferation was determined according to Schmitt’s proliferation score. Results: There was a total of 23 mesh exposures, and we observed a significant correlation between the length of the anterior colpotomy and the occurrence of erosions (p=0.024). There was no correlation between the age and Schmitt‘s proliferation score (r=0.34, p=0.6), or between local estrogen therapy and Schmitt’s proliferation score 3 and 12 months postoperatively (p=0.8). However, there was a correlation between local estrogen therapy 3 months postoperatively and the risk of mesh exposure, with a higher risk for women with estrogen treatment (p=0.037). pH-values of the vaginal wall had no influence on mesh exposure. There was no statistically significant correlation between the qualitative detection of individual
S173
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
vaginal wall layers and mesh exposure rates at 3 and 12 months postoperatively. Furthermore, measurements of pre- and postoperative proliferation of the vaginal epithelium showed no difference between patients with or without mesh exposure. Conclusions: We observed a correlation between the length of the anterior colpotomy and the risk for mesh exposure. Histology showed no correlation between qualitative and quantitative vaginal wall features and the risk of mesh exposure. The correlation of estrogen therapy and erosions may be because women with an erosion were treated more intensively with estrogen. The majority of patients in this study had a highly worn-out vaginal epithelium. This study refutes the hypothesis on the relationship between vaginal wall thickness, the maturity grade of the vaginal epithelium and other clinical parameters, and the risk of erosion. References: 1. Obstet Gynecol 2008; 111:891–898 2. Obstet Gynecol 2011; 117(2):242–250. 3. Acta Obstet Gynecol Scand. 2009;88(7):772–80. Disclosure Block: Juliane Farthmann: pfm medical, Cologne, Germany: Scientific Medical Advisor, Consulting Fee. Illya Martynov: No disclosures. Boris Gabriel: Serag-Wiessner GmbH & Co KG: Speaker, Honoraria. Achim Niesel: No disclosures. Christian Fuenfgeld: Serag-Wiessner: Speaker, Honoraria. AMS: Speaker, Honoraria. PFM: Speaker, Honoraria. AMI: Speaker, Honoraria. Bard: Speaker, Honoraria. Alfons Kraus: No disclosures. Florian Lenz: Disclosure Not Provided. Hansjoerg Augenstein: Disclosure Not Provided. Dirk Watermann: PFM: Consultant, Consulting Fee. Serag Wiessner: Consultant, Consulting Fee. AMS: Consultant, Consulting Fee.
Materials and methods: We reviewed 457 medical documents of all female patients who underwent transvaginal procedures for POP in Peking University People’s Hospital between February 2009 and January 2014. Cases of postoperative symptomatic pelvic hematoma were analyzed. Results: 457 patients underwent transvaginal procedures for POP, of whom 11 (2.40 %) presented with symptomatic pelvic hematomas postoperatively. The most common symptoms included fever, abdominal or pelvic pain, perineal ecchymosis and urinary retention, which accounted for 72.73 %(8/11), 63.64 %(7/11), 27.27 %(3/11) and 18.18 %(2/11), respectively. The hematomas were located at the vaginal cuff in 7(63.64 %), anterior-vesicle wall in 2(18.18 %) and posterior-vesicle wall in 2(18.18 %). The mean volume of the hematomas were 211.71 ± 191.85 cm3. 10(90.91 %) underwent transvaginal hysterectomy, 8(72.73 %) were performed colporrhaphies with mesh augmentation and 3(27.27 %) without mesh. Only 2 patients (18.18 %) required ultrasound-guided drainage of the hematoma, the rest were treated with conservative hemostasis therapy and traditional Chinese medicine. All patients recovered well within 8 weeks postoperatively. Conclusions: Symptomatic pelvic hematoma is rare after pelvic surgeries for POP. The most common clinical manifestations include fever, pain, perineal ecchymosis and urinary retention. It is closely related to transvaginal hysterectomy. Disclosure Block: QIANG HUANG: No disclosures. xiuli sun: No disclosures. JIANLIU WANG: No disclosures.
OP 094 OP 093 SYMPTOMATIC PELVIC HEMATOMA AFTER TRAN SVAGINAL PROCEDURES FOR PELVIC ORGAN PROLAPSE IN CHINESE WOMEN Q. HUANG1, X. SUN 2, J. WANG 3; 1 OBGYN, Peking Univ. People’s Hosp., Beijing, China, 2Peking Univ. People’s Hosp., Beijing, China, 3Peking Univ. people’s Hosp., Beijing, China. Symptomatic pelvic hematoma after transvaginal procedures for pelvic organ prolapse in Chinese women Huang Qiang, Sun Xiuli*, Wang Jianliu* Gynecology department of Peking university people’s hospital, Beijing, China Objective: To evaluate the incidence, clinical manifestations, risk factors of symptomatic pelvic hematoma after transvaginal procedures for pelvic organ prolapse(POP) in Beijing, China.
AGING, MENOPAUSE AND MULTIPARITY HAVE A NEGATIVE IMPACT ON THE EXPRESSION OF OXYTOCIN RECEPTOR IN UTEROSACRAL LIGAMENTS R. IWANAGA1, Y. CHEN 1, J. ARNETT 1, D. J. ORLICKY 2, M. K. GUESS 3, K. J. HURT 1, K. A. CONNELL 1; 1 Obstetrics & Gynecology, Univ. of colorado school of medicine, Aurora, CO, 2Pathology, Univ. of colorado school of medicine, Aurora, CO, 3Yale Sch. of Med., New Haven, CT. Introduction: Pelvic organ prolapse (POP) is a debilitating condition that negatively impacts the quality of life in more than 225,000 women in the US. Uterosacral ligaments (USLs) are the main supportive structure of the pelvic organs. The USLs are mechanically attenuated in women with POP, however the mechanism of the attenuation is not clear. Oxytocin (OXT) is an abundant neurohypophysial hormone and plays an important role during parturition and lactation by
S174
regulating smooth muscle contraction. It has been reported that oxytocin increases the cell number on smooth muscle cells in tissue culture, suggesting that OXT/oxytocin receptor (OXTR) may play a role in smooth muscle durability. More recently, OXTR has also been found in smooth muscle cells throughout the body, suggesting a more global role in smooth muscle maintenance. Previously, we have shown that the USLs in rodents are similar in composition to human USLs, consisting mainly of smooth muscle bundles and connective tissue. We have also shown that the OXTR is expressed in both human and rodent USLs. We hypothesize that the OXTR plays a role in USL tone, and that OXTR expression is affected by aging, menopause and parity, the critical risk factors of POP. Objective: Our first aim was to determine if the expression of OXTR is altered in USLs in women with POP. Our secondary aim was to determine if rat USLs respond to oxytocin stimulation. Lastly, we sought to determine if aging, hypoestrogensim and parity, important risk factors of POP, affect the expression of OXTR in mouse USLs. Methods: Human USL specimens were collected from 10 women with POP and 10 women with normal support undergoing hysterectomy for benign gynecologic indications. Real time PCR was performed to detect OXTR expression. Rat USLs were harvested from 6 nulliparous rats and organ bath was performed in pairs. The set of USLs from each rat was either exposed to oxytocin stimulation at increasing concentrations or buffer control. Area under the curve of contractions was calculated and compared between controls and OXT stimulated USLs. USLs were harvested from aged (8 months old) C57BL/6 female mice from three groups: 1) Aging with long term hypoestrogenism (premature ovarian failure model); Nulliparous mice were ovariectomized or underwent sham at 8 to 10 weeks old and USLs were harvested 6 months later; 2) Aging with short term hypoestrogenism (perimenopausal model); Nulliparous female mice and retired breeders underwent OVX or sham surgery at 8 months old and USLs were harvested 2 weeks later; 3) Advanced aging (post menopause); USLs from multiparous mice at 14 months old were harvested. Results: The POP group of women were significantly older (58.6±12.6 vs 46.1±8.9 years), menopausal and were more parous (median parity 3 vs 2) compared to women without POP (p<0.01). OXTR expression was confirmed in human USL and was decreased by 8-fold in women with POP compared to women with normal pelvic support. Rat USLs contracted to OXT stimulation in a concentration dependent manner. In nulliparous mice, short term OVX decreased OXTR expression by 25 % compared to sham group of mice (n=3 and 4 respectively). Age matched nulliparous mice between short term OVX and long term OVX mice (n=3 and 5 respectively)
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
showed that the USLs in the long term OVX mice decreased OXTR expression by 33 %. In age matched nulliparous and multiparous mice (n=4 and 3 respectively), expression of OXTR was decreased by 37 % in the multiparous mice. Additionally, comparison of multiparous mice at 8 month old with sham, 8 months old with OVX, and 14 months old postmenopausal mice (n=5, n=6 and n=2 respectively), demonstrated that the 8 months old mice with OVX had a similar OXTR expression as the14 months old postmenopausal mice. OXTR expression was decreased by 30 % in these two groups compared to 8 month old sham. One way ANOVA between all mouse groups were p<0.05, indicating that aging, longer periods of hypoestrogenism and multiparity all decrease OXTR expression in USLs. Conclusions: Women with POP may have significantly decreased OXTR expression compared to women with normal pelvic support. This may be an additive effect of aging, hypoestrogenism and vaginal delivery, which decrease OXTR expression in mouse USLs. USL smooth muscle is responsive to OXT stimulation. Our data suggests that OXTR expression in USLs may play an important role in smooth muscle tone, and that decreased OXTR expression from aging, menopause and parity leads to attenuation in women with POP. References: Lancet. 2007 Mar 24;369(9566):1027–38 Folia Biologica (Praha) 55, 159–165 (2009) Disclosure Block: ritsuko iwanaga: No disclosures. YI CHEN: No disclosures. jameson Arnett: No disclosures. David Orlicky: No disclosures. Marsha Guess: No disclosures. K Hurt: No disclosures. Kathleen Connell: No disclosures.
OP 095 EFFECT OF PREGNANCY AND PARTURITION ON PELVIC ORGAN SUPPORT IN ANIMALS WITH PARTIAL LOSS OF FIBULIN-5 IN THE VAGINAL WALL K. CHIN1, H. SHI 1, S. BALGOBIN 1, I. MONTOYA 2, H. YANAGISAWA 3, R. WORD 1; 1 UT Southwestern Med. Ctr., Dallas, TX, 2Texas Tech Univ. HSC at El Paso, El Paso, TX, 3Molecular Biology, UT Southwestern Med. Ctr., Dallas, TX. Introduction: Compromise of elastic fiber integrity in connective tissues of the pelvic floor is most likely acquired through aging, childbirth-associated injury, and genetic susceptibility. Mouse models of pelvic organ prolapse have systemic deficiencies in proteins that affect elastic fibers in various connective tissues throughout numerous organ systems. Prolapse, however, does not occur until several months after birth and is thereby acquired with age or after parturition.
S175
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Objective: The goal of this investigation was to determine the impact of compromised levels of fibulin-5 (FBLN-5) during adulthood on pelvic organ support after pregnancy and vaginal delivery. Methods: To study the impact of fibulin-5 loss after completion of elastogenesis, tissue-specific conditional knockout (cKO) mice were generated in which doxycycline treatment results in deletion of fibulin-5 in cells that utilize the smooth muscle α actin promoter (i.e., smooth muscle cells (SMCs) and myofibroblasts, i.e., Fbln5 f/f /SMA ++ /Cre +/+ ). cKOs and negative controls (Fbln5f/f/SMA++/Cre−/−) were mated and MOPQ measurements were conducted before and after the first, second, and third pregnancy by examiners blinded to genotype status. Results were analyzed by repeated measures ANOVA. Immunoblots were used to quantify fibulin-5 protein levels in urea-extracted vaginal matrix and gelatin zymography was used to analyze MMP-2 and MMP-9 activity. Results: Doxycyline treatment of cKO animals resulted in significant knockdown of FBLN-5 in the vagina compared with Dox-treated wild type or Fbln5 f/f / SMA++/Cre−/− mice (20–50 %, n=10, P<0.01). In negative controls, perineal body length (PBL) and bulge increased significantly after delivery (from 6.1±0.13 to 7.8±0.08 mm) but declined to baseline values within 6– 8 weeks (6.3±0.11 mm, Fig. 1). Although overt prolapse did not occur in cKO animals, these transient increases in PBL postpartum were amplified (to 8.3± 0.1 mm) and, unlike controls, parturition-induced increases in PBL (and bulge) did not recover to baseline (7.8±0.11 mm). Rather, perineal body length remained significantly increased in cKOs for 12 weeks. To gain insight regarding the potential molecular mechanisms of this poor recovery from parturition, vaginal tissues were collected 48 h after the first delivery and analyzed for MMP9 activity and fibulin-5 levels. Active MMP-9 was increased in postpartum cKO animals (from 5.5 +/− 1.2 to 9.1 +/− 0.8 U/mg protein, P<0.05). In contrast to negative controls in which vaginal FBLN-5 levels were recovering from pregnancy and parturition, FBLN-5 was not detectable in cKOs. Conclusions: Our model system in which FBLN-5 is conditionally knock-downed in stromal cells of the pelvic floor is likely to mimic development of POP in women. These animals undergo normal elastogenesis during development but lose fibulin-5 as adults, thereby mimicking pregnancy and parturition-induced loss of the protein in the vagina. Recovery of pelvic support after delivery was impaired and postpartum vaginal MMP-9 was increased in mice with loss of fibulin5 in the vaginal wall. These results indicate that vaginal fibulin-5 is crucial for protection and recovery
from parturition-induced compromise of pelvic organ support.
Disclosure Block: Kathleen Chin: No disclosures. Haolin Shi: No disclosures. Sunil Balgobin: No disclosures. Ignacio Montoya: No disclosures. Hiromi Yanagisawa: No disclosures. R. Ann Word: No disclosures.
OP 096 MODELING THE IMPACT OF TENSIONING OF TRAN SVAGINAL MESHES TO PREDICT MESH OUTCOMES K. KNIGHT 1 , W. R. BARONE 1 , P. MOALLI 2 , S. ABRAMOWITCH 1; 1 Univ. of Pittsburgh, Pittsburgh, PA, 2Magee-Womens Hosp., Pittsburgh, PA. Objective: The purpose of this study was to determine whether tensioning of tranvaginal mesh dictates altered mesh behavior using a sophisticated computational approach. Background: In vivo contraction/shrinkage, bunching, and collapsing of pores are all undesired outcomes associated with the use of synthetic meshes in transvaginal repairs of pelvic organ prolapse. Clinically, contraction of synthetic mesh has been associated with dyspareunia, vaginal pain with movement, and localized tenderness around the contracted portions of the mesh1. Mesh bunching and the reduction of porosity leads to areas of high mesh burden that may be linked to localized and enhanced host foreign body responses possibly resulting in complications. The exact etiology of these outcomes is currently unknown; however, we hypothesize that the manner in which synthetic mesh is tensioned in vivo may be a contributing factor. Methods: In this study, we varied the direction of tension applied to a finite element model of Restorelle DirectFix Anterior (Coloplast). The dimensions (length, width, thickness, and pore size) of this mesh were measured based on the actual product. These measurements were then utilized to create a 3D model of
S176
the mesh using SolidWorks 2013 (x64 Edition). A neo-Hookean material model was chosen to model both the fibers of the mesh and the knots with the fibers being incompressible and the knots being completely compressible. Material properties of the mesh were determined by tuning the finite element model (FEM) of the mesh to data obtained from uniaxial tensile tests along and 45° to the fiber direction. The finite element discretization of the mesh consisted of 23,735 tetrahedral elements and 11,147 nodes. Finite element analysis software FEBio (V1.7) was then used to simulate various tensioning patterns. Rigid fixations were applied between the short and long arms on each side of the mesh model. Two pounds of force was applied to each arm horizontally, vertically, or diagonally with respect to the mesh. A custom Mathematica (V9) script was used to quantify mesh burden (amount of mesh per unit area). Results: With each simulated tensioning pattern, regional increases in mesh burden due to mesh contraction and collapse of pores were observed. The location of the burden changed with the applied tension direction. With the upper arms pulled diagonally or horizontally, consistent with the way it is tensioned during surgery, increases in mesh burden were located between the upper arms, an area previously reported as problematic1 (Figure 1b-f). In addition to increased burden within the body of the mesh, increased burden was also measured in the short, lower arms for all tensioning patterns (Figure 1c-g). Conclusions: Using a sophisticated modeling approach, we show that loading conditions alter mesh behavior and contribute to adverse mesh outcomes observed clinically. In this study, minimal tension was applied along each arm (2 lbs; within the range of physiologic loading and\or tensioning during surgery). This suggests that surgical parameters including the location of fixation and applied tension very likely contribute to the degree of mesh contraction, bunching, the collapse of pores, and possibly complications. It should be noted that this model did not allow for mesh wrinkling out of the plane of the mesh and is therefore likely an underestimate of the true mesh burden for these tensioning patterns. References: Obstet Gynecol 2010;115:325–30
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Disclosure Block: Katrina Knight: No disclosures. William Barone: No disclosures. Pamela Moalli: ACell: We received supplementary funding to support the cost of animals to complete the 3rd aim of our R01, Grant/Research Support. Steven Abramowitch: Pfizer: Investigator Initiated Research Support, Grant/Research Support.
OP 097 USING BLADDER DIARIES IN THE ASSESSMENT OF WOMEN WITH URINARY INCONTINENCE I. GIARENIS, M. ZACCHE’, G. THIAGAMOORTHY, D. ROBINSON, L. CARDOZO; King’s Coll. Hosp., London, United Kingdom. Objective: To determine the clinical value of bladder diaries in separating patients with different types of urinary incontinence (UI). Background: The use of bladder diaries is widely recommended for the initial assessment of women with lower urinary tract symptoms [1]. They provide information about urinary frequency, urgency, diurnal and nocturnal micturition, functional bladder capacity, urine output and leakage episodes. Despite their general use, there is no evidence that raw data from paper bladder diaries can differentiate between types of UI [2]. Methods: This was a cross-sectional study in a tertiary referral urogynaecology unit. Consecutive women attending an outpatient clinic with UI were included in the study prospectively. We excluded women unable to read or write in the English language; with known neurological conditions and with dementia or memory disorders. All women were asked to complete a 3-day bladder diary incorporating the validated Patient’s Perception of Intensity of Urgency Scale (PPIUS) [3] and a King’s Health Questionnaire (KHQ), before attending the clinic. The five grades of the PPIUS (from 0: no urgency, to 4: urgency incontinence) were used to assess the degree of urgency associated with each void. Urgency episodes were counted as voids with PPIUS level 3 and 4 (without or with urgency incontinence respectively). Based on the symptom domain of the KHQ, the participants were divided into groups with urgency urinary incontinence (UUI), stress urinary incontinence (SUI) and mixed urinary incontinence (MUI). SPSS (V 22) was used for statistical analysis and p≤0.05 was considered as statistically significant. The Kruskall-Wallis and the Mann–Whitney U tests were used for comparison of the bladder diary variables between the different types of UI. Results: 556 consecutive incontinent women were included in the study with a mean age of 52.2 years (SD: 14.7) and a mean BMI of 27.6 (SD: 5.6). In our population 114 women (20.5 %) had UUI, 113 (20.3 %) SUI and 329 (59.2 %) MUI. There was a statistically significant difference between the groups in daytime voids, night-time voids, 24-h voids and
S177
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
maximum voided volume (p<0.01). The results of the comparison between the groups with the Kruskall-Wallis test are summarised in table 1. Table 1
Daytime voids
UUI Mean (SD) 6.6 (1.5)
SUI Mean (SD) 6.3 (1.5)
MUI Mean (SD) 8.2 (2.3)
P-value 0.008
Nocturnal voids 1.2 (1.4) 1.0 (1.1) 0.7 (0.7) 0.001 24-h voids 7.8 (2.4) 7.3 (2.2) 9.0 (2.6) 0.001 446.6 (201.1) 522.2 (229.2) 473.9 (230.7) 0.002 Maximum voided volume (ml)
Comparison of the variables provided by the urgency scale (PPIUS) revealed statistically significant differences between the groups (table 2). Table 2
Maximum urge rating
UUI Mean SUI Mean MUI Mean P-value (SD) (SD) (SD) 3.4 (0.7) 1.8 (0.7) 3.3 (0.6) <0.001
Urge rating/void
1.9 (0.5)
1.5 (0.5)
2.1 (0.7)
<0.001
24-h urgency episodes 2.6 (2.6)
0.1 (0.3)
3.3 (3.5)
<0.001
24-h urge rating (sum) 14.4 (8.2)
10 (4.2)
18.5 (10.5) <0.001
Further comparison between the groups showed that the women with UUI and MUI tended to report more voids and more urgency compared to the group with SUI (table 3). There were no recorded differences of the bladder habits between women with UUI and MUI. Table 3 UUI vs SUI
SUI vs MUI
P-value
P-value
UUI vs MUI P-value
Daytime voids
0.079
0.001
0.245
Nocturnal voids
<0.001
0.001
0.166
24-h voids
0.005
<0.001
0.646
Maximum voided volume
<0.001
0.003
0.110
Maximum urge rating
<0.001
<0.001
0.754
Urge rating/void
<0.001
<0.001
0.762
24-h urgency episodes
<0.001
<0.001
0.523
24-h urge rating (sum)
<0.001
<0.001
0.960
Conclusions: Our study provides evidence for the use of paper bladder diaries in everyday clinical practice. Raw data from bladder diaries can separate women with SUI from women with UUI and MUI. As the presence of urgency plays a pivotal role in the bladder function, diaries cannot distinguish UUI from MUI. Data from this large population of women with LUTS could be used as reference values for bladder diary variables in groups with different types of UI.
References: 1. Eur Urol 2012; 62:1130–42 2. JAMA 2008; 299: 1446–1456 3. BJU Int 2011; 107: 1612–7 Disclosure Block: Ilias Giarenis: No disclosures. Martino Zacche’: No disclosures. Ganesh Thiagamoorthy: Astellas: Subsidy to attend IUGA 2013, Travel Grant. Dudley Robinson: Astellas: Advisory Committee Member, Honoraria. Pfizer: Consultant, Honoraria. Allergan: Consultant, Honoraria. Ferring: Consultant, Grant/Research Support. SEP: Speaker, Honoraria. Linda Cardozo: Allergan: Speaker, Honoraria. AMS: Consultant, Consulting Fee. Astellas: Board Member, Consulting Fee. Pfizer: Scientific Medical Advisor, Grant/Research Support.
OP 098 PELVIC FLOOR MUSCLE TRAINING ADDED TO ANOTHER ACTIVE TREATMENT VERSUS THE SAME ACTIVE TREATMENT ALONE FOR URINARY INCONTINENCE IN WOMEN: COCHRANE SYSTEMATIC REVIEW R. AYELEKE 1, J. HAY-SMITH 2, M. OMAR1; 1 Cochrane Incontinence Review Group, Univ. of Aberdeen, Aberdeen, United Kingdom, 2Univ. of Otago, Dunedin, New Zealand. Introduction: Pelvic floor muscle training (PFMT) is a firstline conservative treatment for urinary incontinence in women. Other active treatments include: physical therapies (e.g. vaginal cones); behavioural therapies (e.g. bladder training); electrical or magnetic stimulation; mechanical devices (e.g. continence pessaries); drug therapies (e.g. anticholinergics and duloxetine); and surgical interventions including sling procedures and colposuspension. This systematic review evaluated the effectiveness of adding PFMT to any other active treatment for urinary incontinence in women. Objective: To compare the effectiveness of PFMT combined with another active treatment versus the same active treatment alone in the management of women with urinary incontinence (UI). Methods: We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE in process, and hand-searching of journals and conference proceedings (searched 28 February 2013), EMBASE (January 1947 to 2013 Week 9), CINAHL (January 1982 to 5 March 2013), ClinicalTrials.gov (searched 30 May 2013), WHO ICTRP (searched 3 June 2013) and the reference lists of relevant articles. We included randomised or quasi-randomised trials with two or more arms in women with clinical or urodynamic evidence of
S178
stress urinary incontinence, urgency urinary incontinence or mixed urinary incontinence. One arm of the trial included PFMT added to another active treatment; the other arm included the same active treatment alone. Two review authors independently assessed trials for eligibility and methodological quality and resolved any disagreement by discussion or consultation with a third party. We extracted and processed data in accordance with the Cochrane Handbook for Systematic Reviews of Interventions (1). Quality of evidence was assessed by adopting the Grading of Recommendations Assessment, Development and Evaluation (short GRADE) approach (2). Results: Eleven trials met the eligibility criteria, comprising women with stress urinary incontinence (SUI), urgency urinary incontinence (UUI) or mixed urinary incontinence (MUI), and they compared PFMT added to another active treatment (494 women) with the same active treatment alone (490 women). The majority of the trials did not report the primary outcomes specified in the review (cure/improvement, quality of life) or measured the outcomes in different ways. There was moderate-quality evidence from a single trial investigating women with SUI, UUI or MUI that a higher proportion of women who received a combination of PFMT and heat and steam generating sheet reported cure compared to those who received the sheet alone: 19/37 (51 %) versus 8/37 (22 %) with a risk ratio (RR) of 2.38, 95 % confidence interval (CI) 1.19 to 4.73). More women reported cure or improvement of incontinence in another trial comparing PFMT added to vaginal cones to vaginal cones alone: 14/15 (93 %) versus 14/19 (75 %), but this was not statistically significant (RR 1.27, 95 % CI 0.94 to 1.71). We judged the quality of the evidence to be very low. Only one trial evaluating PFMT when added to drug therapy provided information about adverse events (RR 0.84, 95 % CI 0.45 to 1.60; very low-quality evidence). With regard to condition-specific quality of life, there were no statistically significant differences between women (with SUI, UUI or MUI) who received PFMT added to bladder training and those who received bladder training alone at 3 months after treatment either on the Incontinence Impact QuestionnaireRevised scale (mean difference (MD) −5.90, 95 % CI −35.53 to 23.73) or on the Urogenital Distress Inventory scale (MD −18.90, 95 % CI −37.92 to 0.12). Conclusions: This systematic review found insufficient evidence to state whether or not there were additional effects of adding PFMT to other active treatment when compared with the same active treatment alone for urinary incontinence (SUI, UUI or MUI) in women. These results should be interpreted with caution as most of the comparisons were investigated in small, single trials. None of the trials in this review were large enough to provide reliable evidence. Also, none of the included trials reported data on adverse events associated with the PFMT regimen, thereby making it very difficult to evaluate the safety of PFMT.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
References: 1. Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org. 2. Guyatt GH, Oxman AD, Schünemann HJ, Tugwell P, Knotterus A. GRADE guidelines: A new series of articles in the Journal of Clinical Epidemiology. J Clin Epidemiol. 2010 Disclosure Block: Reuben Ayeleke: No disclosures. Jean Hay-Smith: No disclosures. Muhammad Imran Omar: No disclosures.
OP 099 PELVIC FLOOR MUSCLE TRAINING FOR FEMALE URINARY INCONTINENCE: NEW EVIDENCE FROM THE UPDATED COCHRANE SYSTEMATIC REVIEW AND META-ANALYSIS C. DUMOULIN1, J. C. HAY-SMITH 2, G. MAC HABEESEGUIN 3; 1 Rehabilitation, Faculty of Medicine, Univ. of Montreal, Montreal, Canada, 2Rehabilitation Teaching and Research Unit, faculty of Medicine, Otago Univ., Wellington, New Zealand, 3Rehabilitation, Faculty of Medicine, universite de montreal, Montreal, Canada. Introduction: PFMT is the most commonly used physical therapy treatment for women with stress urinary incontinence (SUI). It is sometimes also recommended for mixed urinary incontinence (MUI) and, less commonly in isolation, for urgency urinary incontinence (UUI). New trials are eligible for inclusion in the systematic review (last updated 20101) and evidence grading standards have changed; an update of current best evidence is needed. Objective: To determine the effectiveness of pelvic floor muscle training (PFMT) in the management of female urinary incontinence. The following hypothesis was tested: that PFMT is better than no treatment, placebo, sham, or any other form of inactive control treatment. Methods: We searched (15 April 2013) the Cochrane Incontinence Group Specialised Register, containing trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and MEDLINE in process, and hand searched journals, conference proceedings, and the reference lists of relevant articles. We included randomised or quasi-randomised trials in women with SUI, UUI or MUI (based on symptoms, signs, or urodynamics). One arm of the trial included PFMT. The comparator arm was no treatment, placebo, sham, or other inactive control treatment. Trials were sub-grouped by diagnosis. Outcomes of interest were patient reported measures, clinician reported measures, quality of life and side effects. Two reviewers independently assessed eligibility and methodological quality of
S179
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
trials. Any disagreement was resolved by discussion or arbitration with a third party. Two reviewers independently extracted data for the pre-defined outcomes. Meta-analysis was conducted when appropriate. For categorical outcomes we used risk ratio (RR) and for continuous outcomes we determined a mean difference, both with 95 % confidence intervals (CI). A fixed effect model was used except if there was statistically significant heterogeneity in which case a random-effects model was considered. Risk of bias assessment was carried out as described in the Cochrane Handbook.2 Quality of evidence of the critical outcomes was assessed by adopting the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach 3; a methodological advance on previous versions of this review. Results: Twenty one trials involving 1281 women (665 PFMT, 616 controls) were included; 18 trials (1051 women) contributed data to the meta-analysis. The trials were generally of small or moderate size and many were at moderate risk of bias, based on the trial reports. There was considerable variation in interventions used, study populations, and outcome measures. There were no trials of women with UUI or MUI alone. In women with SUI, there was high quality evidence from 4 trials that PFMT is associated with cure in comparison with inactive control: with a RR of 8.38 (95 % CI 3.68 to 19.07), p value <0.00001. There was moderate quality evidence from 2 trials that PFMT is associated with cure or improvement in comparison with inactive control: with a RR of 17.33 (95 % CI 4.31 to 69.64), p value <0.0001. In trials with women with any type of UI, there was also moderate quality evidence that PFMT is associated with cure or cure and improvement in comparison with inactive control. The RRs were 5.5 (95 % CI 2.87 to 10.52) and 2.39 (95 % CI 1.64 to 3.47) respectively. Women with either SUI or with any type of UI were also more satisfied with the active treatment, while women in the control groups were more likely to seek further treatment. Women treated with PFMT leaked urine less often, lost smaller amounts on short office-based pad test, and emptied their bladders less often during the day. Their sexual outcomes were also better. Information about persistence of benefit in the medium and long term was supported by two small to moderate sized trials. Of the few adverse effects reported, none were serious. Conclusions: We found moderate to high level of evidence that PFMT is better than no treatment, placebo, sham, or other inactive control treatment for women with SUI or urinary incontinence. The addition of seven new trials did not change the essential findings of the prior review; although, the wider range of secondary outcome and GRADE quality criteria emphasised the strength of recommendation for women with SUI. Notwithstanding that long-term effectiveness of PFMT needs to be further researched, the review provides support for the widespread recommendation that PFMT be included as first-line conservative management programs for women with stress, and urinary incontinence.
References: 1. Cochrane Database of Systematic Reviews 2010, Issue 1. Art. No.: CD005654 doi 10.1002/14651858.CD005654.pub2. 2. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0, March, 2011. 3. Journal of Clinical Epidemiology 2013;66(2):173–83. Disclosure Block: Chantal Dumoulin: No disclosures. Jean Hay-Smith: No disclosures. Gabrielle Mac Habee-Seguin: No disclosures.
OP 100 PELVIC FLOOR MUSCLE ELECTROMYOGRAPHY DURING THREE DIFFERENT RUNNING SPEEDS - AN EXPLORATORY AND RELIABILITY STUDY H. LUGINBUEHL1, J. BAEYENS 2, R. L. NAEFF 1, A. ZAHND 1, A. KUHN 3, L. RADLINGER 1; 1 Bern Univ. of Applied Sci. Hlth., Bern, Switzerland, 2Vrije Univ.it Brussel, Faculty of Physical Ed. and Physiotherapy, Belgium, Brussel, Belgium, 3Women Hosp., Urogynaecology, Bern Univ. Hosp. and Univ. of Bern, Switzerland, Bern, Switzerland. Introduction: Stress urinary incontinence (SUI) affects women of all ages including young athletes, especially those involved in high-impact sports. High impact physical activities involve abrupt repeated increase of the abdominal pressure and the impact loading on the pelvic floor muscles (PFM), suggesting involuntary and therefore PFM reflex activity to guarantee continence (1). PFM function has to be clarified for functional movements with short impacts typically provoking SUI (e.g. running, jumping, coughing) and not only for nonfunctional isolated test situations like maximal voluntary contraction in supine (2). To date, few studies investigated PFM activity during high impact loads and hardly any of those concern functional whole body movement situations as typically occurring during sports activities. Objective: The aim of this study was the description and reliability test of nine PFM EMG (electromyography) variables and one time variable during three different running speeds. The secondary objective was the evaluation of a speed dependent difference between the PFM activity variables. Methods: This trial was designed as an exploratory and intrasession retest reliability study including ten young healthy nulliparous female subjects to characterize PFM activity during running at three different speeds derived from EMG. Ten previously defined variables for each running speed, averaged over ten steps of each subject, were tested regarding their reliability (ICC 2.1). The variables of pre-activity and variables of slow, mid and long latency and long latency succeeding responses as a characterization of reflex activity during an eccentric-concentric stretch-shortening cycle (3)
S180
followed study protocols of former investigations (1,3). The study was conducted in accordance with the Declaration of Helsinki and all subjects gave written informed consent. Results: PFM EMG variables showed ICC values of 0.79–0.92 for running at 7 km/h, 0.70–0.90 at 9 km/h and 0.64–0.88 at 11 km/h. ICC values for the time of maximal EMG activity were 0.07–0.45. PFM EMG values rose significantly with increasing running speed (p≤0.008) (figure). Conclusions: PFM EMG variables of running at 7 km/h showed excellent reliability. As to running at 9 km/h six PFM EMG variables showed excellent and three fair to good reliability and as to 11 km/h, five PFM EMG variables showed excellent and four fair to good reliability. All time variables showed fair to poor reliability. The decrease of PFM EMG reliability with higher running speed could be due to an increased exposure of the vaginal probe to minimal shifts related to speed increase, as ground reaction force and PFM impacts rose. The higher values of all EMG variables with faster running speed could be the response to the higher ground reaction forces and therefore higher impacts causing higher PFM pre-activity and reflexivity during faster running speeds. After an activity increase during pre-activity compared to rest condition the mean PFM EMG activity first decreased till the beginning of the short latency response and then increased to maximal activity for all running speeds, suggesting PFM reactivity acting in a stretch-shortening cycle muscle action form (3). This study contributed to the understanding of PFM pre-activation and reflexive function during whole body movements, specifically during running. Further studies should first investigate PFM reactivity patterns of SUI patients and secondly the responsiveness of the PFM EMG variables of the current study to a physical therapy intervention for SUI patients. References: 1. Int Urogynecol J 2013 24:1515–22 2. Phys Ther 2005 85:269–82 3) Eur J Physiol 2010 110:177– 187 Means of EMG variables of three running speeds in %EMG
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Variables EMG activity at: T0=initial contact, T-50=T0 minus 50milliseconds (ms); Mean EMG activity between: T-50-0=T0 and minus 50 ms, T0-30=T0 and 30 ms, T30–60=30 ms and 60 ms, T60–90=60 ms and 90 ms, T90–120=90 ms and 120 ms, T120–150=120 ms and 150 ms; EMGmax: Maximal EMG activity Disclosure Block: Helena Luginbuehl: No disclosures. Jean-Pierre Baeyens: No disclosures. Rebecca Naeff: No disclosures. Anna Zahnd: No disclosures. Annette Kuhn: Astellas: Speaker, Travel Grant. Lorenz Radlinger: No disclosures.
OP 101 PELVIC FLOOR MUSCLE ACTIVATION AND STRENGTH COMPONENTS INFLUENCING FEMALE URINARY CONTINENCE AND STRESS INCONTINENCE: A SYSTEMATIC REVIEW H. LUGINBUEHL1, J. BAEYENS 2, J. TAEYMANS 1, I. MAEDER 3, A. KUHN 4, L. RADLINGER 1; 1 Bern Univ. of Applied Sci. Hlth., Bern, Switzerland, 2Vrije Univ.it Brussel, Faculty of Physical Ed. and Physiotherapy, Brussel, Belgium, 3Univ. of Bern, Univ. Library of Bern, Switzerland, Bern, Switzerland, 4 Women Hosp., Urogynaecology, Bern Univ. Hosp. and Univ. of Bern, Switzerland, Bern, Switzerland. Introduction: Pelvic Floor Muscle (PFM) training is effective and therefore recommended as a first-line treatment for female stress urinary incontinence (SUI) (1). However, complex standardized PFM training protocols - aiming at the improvement of specific PFM components such as maximal strength, power (starting strength, explosive strength, short and fast stretchshortening cycle), hypertrophy, strength-endurance and related muscle action forms (concentric, eccentric, isometric, eccentric-concentric) - are still lacking, although the specific training principles and methods are well described (2). A better understanding of PFM activation and strength components is a prerequisite to get better insight into PFM contraction characteristics and develop more specific PFM training regimens for SUI patients. Objective: The aim of this systematic review was to evaluate and summarize existing studies investigating PFM activation and strength components influencing female continence and SUI. Methods: This systematic review was conducted following the PRISMA guidelines (3). PubMed, EMBASE and Cochrane databases were systematically searched for literature from January 1980 to November 2013. Selection Criteria were crosssectional observational studies comparing female SUI patients with healthy controls and pre-post designed intervention studies, including SUI patients, reporting on the association
S181
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
between PFM activation and strength components and continence or SUI respectively. Two investigators independently screened titles and abstracts, reaching consensus through discussion in case of disagreement. The same researchers independently assessed the full-text articles for eligibility based on the a priori defined inclusion criteria, again finding consensus through discussion in case of disagreement. Trial characteristics, evaluated PFM components, their definitions, measurement methods, study outcomes, as well as quality measures based on the Cochrane risk of bias tool were independently extracted always by the same two researchers. The high heterogeneity of the retrieved data made pooling of results impossible and therefore restricted the analysis to a systematic review. The study protocol was registered at PROSPERO. Results: The literature search identified 2630 abstracts for consideration. After removal of duplicates and application of inclusion/exclusion criteria 121 studies entered the full-text review. From those, 107 were excluded mainly because of not fulfilling inclusion/exclusion criteria and hence 14 studies - nine cross-sectional and five pre-post designed - were selected for further analysis. As to cross-sectional studies, measurement methods varied: In six studies strength measurements were performed (used terminology: Strength, force or pressure; measured units: Newton or mmH2O) while in three studies surface EMG amplitude was assessed. The measurements were performed with various probes. All cross-sectional studies except one showed group differences of PFM components in favor of the continent women. In all pre-post designed studies exercise based PFM training programs were performed. Two studies were secondary data analyses while another study additionally performed inferential current therapy. The described PFM training protocols and the measurement methods varied among studies, all performing strength (used terminology: strength, force, pressure) measurements. The probes varied among studies. Changes in SUI were assessed by pad-tests among other methods. All intervention studies showed an improvement of PFM strength and decrease in urine loss in patients with SUI after physical therapy. Conclusions: In summary, higher maximal, mean, endured and increase of PFM strength and earlier onset of PFM activation had a beneficial effect on female urinary continence. However, a high variation of testing procedures, measurement methods and terminology as well as definitions of the evaluated PFM activation and strength components and their characteristics were found among the selected studies. The heterogeneity of the measured PFM activation and strength components, the lack of information on the exact intervention given to the study participants and the intervention’s standardization limit the comparison of the outcomes across the studies. This systematic review underscores the need for a standardized PFM components’ terminology related to muscle function, similar to the commonly used terminology in training science (2). Together with the use of standardized instructions of patients’ test behavior provoking the respective PFM component this would enable
the development of well matched diagnostic instruments and specific PFM training protocols for SUI patients. References: 1) World J Urol 2012 30:437–43 2) Med Sci Sports Exerc 2009 41:687–708 3) J Clin Epidemiol 2009 62:e1-34 Disclosure Block: Helena Luginbuehl: No disclosures. Jean-Pierre Baeyens: No disclosures. Jan Taeymans: No disclosures. Ida-Maria Maeder: No disclosures. Annette Kuhn: Astellas: Speaker, Travel Grant. Lorenz Radlinger: No disclosures.
OP 102 TEMPORARY VAGINAL PESSARY CAN RESTORE THE DETRUSOR CONTRACTILITY PATTERN OF PELVIC PRGAN PROLAPSE PATIENTS T. KITTA, T. MITSUI, Y. KANNO, H. CHIBA, K. MORIYA, K. NONOMURA; Department of Renal and Genitourinary surgery, Hokkaido Univ. Graduate Sch. of Med., Sapporo, Japan. Objective: Pressure flow studies (PFS) have long been regarded as the gold standard for evaluating the bladder function not only outlet obstruction, but also contractility. We previously reported that PFS using a temporary vaginal pessary can predict the lower urinary tract function after pelvic organ prolapsed (POP) surgery (2012 IUGA). In this study, we focused on the detrusor contractility pattern of POP patients with and without temporary vaginal pessary. Background: POP may cause bladder outlet obstruction and decrease detrusor contractility [1]. Bladder contractility consists of contractile strength and contractile duration. However, the method for evaluating the contraction duration is not well validated. The contractility of the bladder was quantified by a parameter of approximated power per bladder wall area based on the Hill equation. The most widely used measure of bladder contractility is the Watts factor (W), which calculates the detrusor pressure in relation to the volume and flow rate. W was calculated throughout bladder emptying and plotted as a function of the volume in the bladder at each moment in time. Again, it does not provide a measure of contraction sustainability. Impaird contraction represent not only decreased the peak of W, but also poorly sustained micturition contractions. From this point of view, the maximum height of the resulting curve (Wmax) and its pattern should be discussed separately. Methods: Sixteen women with advanced anterior vaginal wall prolapsed were urodynamically evaluated. The first time, PFS were performed with POP left as is, then second time procedure were performed with reduction of POP using a temporary vaginal pessary. Detrusor pressure (Pdet) was calculated by
S182
subtracting intraabdominal pressure from bladder pressure. Maximal urinary flow rate (Qmax), Detrusor pressure at maximal flow (Pdet at Qmax), voided volume, residual volume, bladder contractility index (BCI = Pdet at Qmax+5 Qmax) and Wmax were measured. In this study, we defined Wmax (%) as the percentage of maximum W during micturition (Fig. 1). A normal detrusor contractility pattern show a sharp increase at the initiation of micturition, and slight increasing to the end of micturition. However, patients with impaired detrusor contractility show a fading contraction pattern (decreasing to the end of micturition). Mastrigt et al. reported [2] that the most patients a preoperative fading contraction was restored to normal pattern after transurethral resection of the prostate surgery. Wmax (%) could represent the pattern of detrusor contractility. The urodynamic data were compared via Student’s t test and P<0.05 was considered statistically significant. Results: The mean age (range) of patients was 68.5±10.9 (40–81). Qmax were increased significantly after insert the temporary vaginal pessary. The mean Pdet at Qmax, voided volume and residual volume was not significantly changed with and without temporary vaginal pessary. Not only BCI and Wmax, but also Wmax (%) were increased significantly after insert the temporary vaginal pessary (Table 1). Conclusions: PFS using a temporary vaginal pessary improved lower urinary tract dysfunction, and restore the detrusor contractility pattern of POP patients. The measurement of detrusor contractility pattern could provide some insight into the patients with impaired detrusor contractility, but we need further study. References: 1. Neurourol Urodyn. 2007;26:1030–5 2. J Urol. 1992;148:1856–60
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Table 1 Qmax (cmH2O)
pessary (−) 10.0±6.0
pessary (+) 18.9±9.6
p 0.017
Pdet at Qmax (cmH2O) Voided volume (ml)
23.0±21.4 249±187
18.4±10.7 331±141
0.36 0.081
Residual volume (ml) BCI
146±136 71.9±30.7
61±145 111.5±47.5
0.063 0.015
Wmax (μW/mm2) Wmax (%)
5.1±3.4 64.6±24.7
10.5±8.6 81.5±23.9
0.046 0.012
Disclosure Block: Takeya kitta: No disclosures. Takahiko mitsui: No disclosures. Yukiko kanno: No disclosures. Hiroki chiba: No disclosures. Kimihiko moriya: No disclosures. Katsuya nonomura: No disclosures.
OP 103 A MIXED METHODS STUDY TO ASSESS THE FEASIBILITY OF A FUTURE RANDOMISED CONTROLLED TRIAL OF INVASIVE URODYNAMIC TESTING PRIOR TO SURGERY FOR STRESS URINARY INCONTINENCE IN WOMEN P. HILTON1, N. ARMSTRONG 2, C. BRENNAND 3, D. HOWEL 4, J. SHEN 4, A. BRYANT 4, D. G. TINCELLO 5, M. G. LUCAS 6, B. S. BUCKLEY 7, C. R. CHAPPLE 8, T. HOMER 4, E. MCCOLL 3; 1 Directorate of Women’s Services, Newcastle upon Tyne Hosp. NHS Fndn. Trust, Newcastle upon Tyne, United Kingdom, 2 Health Sciences, Univ. of Leicester, Leicester, United Kingdom, 3 Newcastle Clinical Trials Unit, Newcastle Univ., Newcastle upon Tyne, United Kingdom, 4Institute of Health & Society, Newcastle Univ., Newcastle upon Tyne, United Kingdom, 5Reproductive Science Section, Cancer Studies & Molecular, Univ. of Leicester, Leicester, United Kingdom, 6Urology, Swanseas NHS Trust, Swansea, United Kingdom, 7School of Medicine, Natl. Univ. of Ireland, Galway, Ireland, 8Urology, Royal Hallamshire Hosp., Sheffield, United Kingdom. Introduction: The current position of invasive urodynamic testing (IUT) in the diagnostic pathway for urinary incontinence (UI) is not agreed. Current guidance from NICE, based on limited evidence, suggests that invasive urodynamic testing (IUT) is not required prior to surgery where the diagnosis of stress urinary incontinence (SUI) is clear on clinical grounds. Systematic reviews have called for high quality primary research on the clinical utility of urodynamics. Objective: To investigate the feasibility of a definitive randomised controlled trial of IUT, compared to clinical assessment, in women potentially suitable for surgery for SUI or stress predominant mixed urinary incontinence (MUI); to
S183
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
determine whether refinements to the design or conduct of a future definitive trial are warranted. Methods: A mixed methods feasibility study: a pragmatic multicentre randomised pilot trial was conducted, incorporating an exploratory economic evaluation; a survey of clinicians’ views about their use of IUT and willingness to enter patients into a trial; qualitative interviews with clinicians and trial participants. Results: In the randomised pilot trial, 78 % (222) eligible women identified were recruited. Questionnaires were completed by 75 % at baseline, and 53 % 6 months after treatment. 95 % in the control arm underwent surgery, compared to 80 % in the ‘IUT’ arm, reflecting changes in the management plan following IUT. Baseline questionnaires were completed by 75 % participants, although only 53 % returned the follow-up questionnaires at 6 months after start of treatment; missing data within the returned booklets were few. The results of the economic evaluation are not sufficient to recommend changes in practice due to trial data limitations; they do however suggest that further research would be valuable. Among the 34 % (176/517) who responded to the initial clinician survey (Aug 2011), 70 % rated the research question ‘very’ or ‘extremely important’. Given the time between circulation of the initial survey (August 2011) and our final report, a further brief update survey was undertaken (June 2013). There was no obvious shift in surgeons’ opinions despite other recently published studies.(1,2) Eighteen clinicians were interviewed. The majority of those using IUT routinely were convinced of its clinical utility, although a small number reported that their practice was influenced more by local norms than any personal commitment to IUT on their part. In contrast, those who used IUT less often saw little benefit from its use but recognised significant costs (e.g. in time, financial implications, and infection risk). While some clinicians’ views on the importance of a future definitive trial were shaped by genuine uncertainty about the value of IUT, commonly the research question was regarded as important because clinicians believed they personally knew the answer and wanted research in order to bring others’ practices in line with their own. A purposive sample of 36 trial participants agreed to interview, of whom 29 were interviewed. The specific nature of the study and the intervention being assessed was an important factor for some women; some subsequently randomised to the ‘no further testing’ arm reported being very pleased with this allocation; others randomised to the intervention arm subsequently withdrew. Reactions to the written study information were mostly positive – it was regarded as clear and informative with enough information for women to make a decision about taking part. Participants’ understanding of the study was good, and the principle of random allocation to one of two possible groups was generally well understood. While some viewed completing the follow-up questionnaires positively (as it underlined how successful the
treatment had been), others reported finding them burdensome and irrelevant now they had few or no symptoms to report. Conclusions: We have shown that a definitive trial is feasible. Despite evidence emerging during the course of these studies,(1,2) the most recent meta-analysis,(3) and recently surveyed UK clinical opinion (June 2013) indicates that a large definitive trial is still required. We have identified several modifications to patient screening, recruitment, retention, and staff engagement across multiple sites, as well as economic evaluation that would be desirable in designing and conducting a future definitive trial. Whilst such a trial would be challenging, requiring between 500 and 1100 recruits across 15–30 sites (depending upon the outcome and target difference sought), we have found evidence that a sufficient number of UK clinicians and patients would take part. References: 1. N Engl J Med. 2012;366(21):1987–97. 2. Neurourol Urodyn. 2012;31(7):1118–23. 3. Cochrane Database Syst Rev. 2013(10): Art. No.: CD003195. Disclosure Block: Paul Hilton: No disclosures. Natalie Armstrong: No disclosures. Catherine Brennand: No disclosures. Denise Howel: No disclosures. Jing Shen: No disclosures. Andrew Bryant: No disclosures. Douglas Tincello: Allergan: Speaker, Honoraria. Malcolm Lucas: Allergan: Trial participant, Grant/Research Support. Brian Buckley: Calmoseptine Inc: Consultant, Consulting Fee. Christopher Chapple: Allergan, AMS, Astellas, Lilly, ONO, Pfizer and Recordati.: Advisory Committee Member, Honoraria, Travel Grant. Allergan, AMS, Astellas, Lilly, ONO, Pfizer and Recordati.: Consultant, Consulting Fee. Allergan, AMS, Astellas, Pfizer and Recordati.: Scientific Medical Advisor, Grant/Research Support. Allergan, Astellas, Pfizer, Ranbaxy and Recordati.: Speaker, Honoraria, Travel Grant. Tara Homer: No disclosures. Elaine McColl: No disclosures.
OP 104 COMPARISON OF A BLADDER NECK EFFECTIVE PELVIC FLOOR REHABILITATION PROGRAM AND EMG-BIOFEEDBACK AUGMENTED PELVIC FLOOR MUSCLE TRAINING: A RANDOMIZED CONTROLLED TRIAL B. JUNGINGER1, M. METZ 2, K. BAESSLER 3; 1 Pelvic floor centre Charite, Charite Univ.etsmedizin Berlin, Berlin, Germany, 2Charite, Berlin, Germany, 3Charite Univ. Hosp., Berlin, Germany. Objective: Efficacy of pelvic floor muscle training (PFMT) programs for women with stress and/or urge incontinence vary with regards to patient centred outcomes, long-term
S184
efficacy, adherence and effect on pelvic floor muscle (PFM) changes. The aim of this prospective randomized controlled trial was to compare subjective improvement and cure rates of a specific bladder neck (BN) effective PFM rehabilitation program with PFMT augmented with biofeedback (BF). Methods: Sixty four women with stress urinary incontinence symptoms with or without overactive bladder symptoms were randomly allocated to undergo a bladder neck effective PFM rehabilitation program (group 1) or biofeedback-augmented PFMT (group 2). Women with previous pelvic floor (PF) surgery, neurological diseases, dementia or those currently in treatment for PF disorders were excluded. Primary outcome measure was subjective improvement or cure outlined in a self-administered validated PF questionnaire that includes a posttherapeutic module with improvement and satisfaction scales. Based on a systematic review that calculated a 50 % improvement/cure rate of PFMT and Biofeedback (1), 29 women were required in each group to demonstrate a clinically significant difference of 25 % with a power of 80 % and alpha=0.05. Secondary outcomes included changes in PF questionnaire scores and ability of BNeffective PFM contraction. Randomization was PC-generated. Allocation was concealed in opaque envelopes that were stored by a secretary who was not involved in the study. Allocation blinding was not possible during the study but post- treatment data collection and analysis was performed by a third party. All women completed a validated PF questionnaire that included bladder, bowel, prolapse and sexual symptoms. After PF rehabilitation, an additional posttreatment module was applied. This module assesses improvement by scales as well as bothersomeness and satisfaction with treatment success and with care. Perineal ultrasound was performed before and after treatment to assess BN position and movements during pelvic floor muscle contractions (PFMC). In group 1 perineal ultrasound also belonged to the rehabilitation program to evaluate, teach and practice BN-supporting or BN-elevating PFMC. In three sessions 1–4 weeks apart, women were taught to maintain submaximal PFMC during increases in IAP and to integrate PFMC before coughing e.g. (“Knack”) into daily life. Women in group 2 received an EMG-Biofeedback device with a vaginal probe (Periform). Parameters of the strength training program: 80 % of a maximal contraction with 8 s contraction time and 10 s rest between the contractions for 10 min. Women were .asked to practice for 3 months and adherence and handling were also checked three times. Women were offered to switch groups after 3 months if they were not satisfied with treatment success. Follow-up was scheduled at 4 weeks, 3, 6 and 12 months. This report contains data on 3-months-follow up.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Results: Eighty eight women were invited to participate, 8 declined, 80 were randomized (group 1; n=36; group 2; n= 31), 6 women in group 1 and 7 in group 2 were lost to follow. Baseline characteristics did not differ significantly between groups (age, parity, BMI, bladder function score; Table 1). Both groups reported significant improvement without significant differences in bladder function scores and satisfaction with treatment success and with care (Table 1). However, only group 1 demonstrated improvement in OAB symptoms. In group 2, 14 women preferred to switch to group 1 after 3 months of biofeedback training. Group 1 N=30
Group 2 N=24
P*
Age (years)
46 (27–84)
45 (29–75)
0.886
BMI
24 (19–32)
23 (19–37)
0.424
Vaginal parity
0.5 (0–3)
1 (0–2)
0.822
Bladder Score BEFORE treatment
2.9(1.1–6)
3.0 (1.6–6)
0.353
Bladder Score AFTER treatment
1.9 (0–5.6)
2.4 (0.2–4.9)
0.197
Satisfaction with treatment success
60 (20–100)
57 (10–100)
0.421
Satisfaction with care
100 (60–100)
97 (30–100)
0.866
Some improvement Great improvement
10 (28 %) 15 (42 %)
12 (46 %) 8 (31 %)
0.365
Table 1: Baseline characteristics and outcome measures * Mann–Whitney- test Conclusions: The bladder neck effective PF rehabilitation program yields similar short term results as an established PFMT with EMG-Biofeedback. However, only women in the biofeedback group desired to switch after 3 months. Further follow up is necessary to assess long-term efficacy. References: Feedback or biofeedback to augment pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2011 Disclosure Block: Baerbel Junginger: No disclosures. Melanie Metz: No disclosures. Kaven Baessler: No disclosures.
OP 105 A NOVEL, CONVENIENT AND SAFE NONSURGICAL APPROACH TO THE MANAGEMENT OF ACCIDENTAL BOWEL LEAKAGE E. S. LUKACZ1, M. M. SEGALL 2, S. D. WEXNER 3; 1 UC San Diego Hlth. Systems, La Jolla, CA, 2Segall Med. Corp., Los Gatos, CA, 3Colorectal Surgery, Cleveland Clinic Florida, Weston, FL. Introduction: Accidental bowel leakage (ABL) has a profound, negative impact on quality of life and occurs in approximately 20 % of women.1,2 Unfortunately, the majority of people with
S185
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
ABL fail to receive care likely due to embarrassment in discussing the condition and poor understanding of treatment options. Objectives: We aimed to assess the efficacy, tolerability and safety of a new, single-use, disposable device for the management of ABL. Methods: This multi-center, prospective, open label, single-arm study included subjects with moderate to severe ABL. Participants ≥18 years of age, with a Wexner score3 ≥12, and at least weekly leakage of solid and/or liquid type stool were included. Individuals with anal pathology (3rd degree hemorrhoids, rectal prolapse, anal fissure, anismus or stricture), inflammatory bowel disease, immune suppression or other major medical illnesses were excluded. Eligible participants underwent a 4-week baseline evaluation including daily bowel diaries to confirm eligibility, followed by a 12-week treatment period of continuous device use. The device is a soft silicone, single use, self-administered anal insert, designed to prevent leakage of solid and liquid stool (Fig. 1). It is expelled and a new one is replaced with each bowel movement. The two definitions of success were: 1) ≥20 % reduction in average daily leakage and 2) ≥10 % reduction in Wexner score at 12 weeks. Overall subject satisfaction and experience were measured on 10-point scale and adverse events assessed by subject report, digital and anoscopic examination. Sample size calculations determined that 76 subjects were needed to achieve statistical significance with at least a 10 % Percent Reduction in ABL at 90 % power. A modified intent to treat analysis was performed on all subjects who entered treatment and completed at least 1 week of device use. Paired T-test and Wilcoxon tests were used as appropriate. Results: 91 of the 97 subjects remained eligible after baseline; 85 completed at least 1 week of treatment and 73 completed all 12 weeks. 90 % of subjects were female and 91 % were Caucasian with a mean age of 68.6±12.1 year. Only 7 of the 18 who withdrew were dissatisfied with the device (8 % of treated subjects). In those 85 who received at least 1 week of treatment, ABL frequency was reduced by 82 % from 8 per week (mean 1.13±0.85, median 0.89 per day) at baseline to 1– 2 per week (mean 0.29±0.38, median 0.17 per day) by 12 weeks (p<0.001). Overall, 92 % had ≥20 % reduction in ABL frequency and 8/85 (9 %) achieved total continence. Mean Wexner scores improved by 32.4 % after treatment (16.2±2.1 vs 10.9±4.4, p=<0.001) with 81 % (62/77) achieving ≥10 % reduction in score. Success in both daily ABL and Wexner score reduction occurred in 75 %. The majority of subjects who completed 12 weeks of treatment (78 %, 57/73) were very or extremely satisfied with the device and 91 % rated the overall experience and ease of insertion above 8 on the 10-point scale (median 9.5). There were no serious adverse events and only 3 moderate adverse events (fecal urgency, soreness and bleeding hemorrhoids) related to insert use in 2 subjects during the 12-week treatment. Displacement of the device upward into the anal canal occurred in 24 %, but resolved with natural expulsion during bowel movements.
Conclusions: This novel device provides a non-surgical, convenient, safe and effective management strategy for individuals with ABL, with high satisfaction and low adverse event rates. This innovative insert provides a new alternative to invasive therapy for patients with ABL who fail conservative measures. References: 1. Int J Clin Pract 2012;66:1109–16. 2. Int J Clin Pract 2012;66:1101–8. 3. Dis Colon Rectum 1993;36:77–97.
Disclosure Block: Emily Lukacz: Pfizer, Inc, Renew Medical: Consultant, Consulting Fee. Med Edicus: Scientific Medical Advisor, Honoraria. AMS: Advisory Committee Member, Honoraria. Boston Scientific, Pfizer, Inc: Investigator, Grant/Research Support. National Institutes of Health: Scientific Medical Advisor, Honoraria. Mark Segall: Renew Medical Inc.: ‘ownership interest’ (stock options) as a medical advisor (since Dec 2013) and a company consultant, but both engagements occurred after Study 210 was completed for “A NOVEL, CONVENIENT AND SAFE NONSURGICAL APPROACH TO THE MANAGEMENT O Steven Wexner: Century Medical, Cubist, Incontinence Devices Inc, Karl Storz Endoscopy America, LifeBond, Mederi Therapeutics, Medtronic, Novadaq, Pacira Pharmaceutical, Precision Therapeutics, Renew Medical: Consultant, Consulting Fee. Covidien, Karl Storz Endoscopy America, novoGI: Speaker, Royalty. LifeBond, CRH Medical, EZ Surgical, NeatStitch, novoGI: Stock Shareholder, Royalty. CRH Medical, EZ Surgical, Intuitive Surgical, NeatStitch, novoGI: former consultant, Consulting Fee. Salix Therapeutics: Scientific Medical Advisor, Ownership Interest. Premier Research: Advisory Committee Member, Honoraria.
S186
OP 106 RISK FACTORS FOR FECAL INCONTINENCE IN A NATIONALLY REPRESENTED SAMPLE OF DIABETIC WOMEN. M. L. NIETO1, J. M. WU 2, W. E. WHITEHEAD 3, A. D. MARKLAND 4; 1 Division of Urogynecology and Reconstructive Pelvic Surgery, UNC, Chapel Hill, NC, 2UNC-Chapel Hill, Chapel Hill, NC, 3Dept of Medicine/Division of Gastroenterology and Hepatology, UNC, Chapel Hill, NC, 4UAB Comprehensive Center for Healthy Aging, UAB, Birmingham, AL. Introduction: Diabetic patients appear to be at an increased risk of fecal incontinence (FI); however, specific factors associated with FI in diabetic women are not well characterized.1–2 Objective: The goal of this study was to assess the prevalence of FI among women with diabetes and to evaluate factors associated with FI in this patient population. Methods: Using the U.S. National Health and Nutrition Examination Survey from 2005–2006, 2007–2008, to 2009–2010, we conducted a cross sectional study of adult women (age ≥20 years) with diabetes in this nationally representative sample. Subjects were considered to be diabetic if they were given the diagnosis by their physician and/or were currently taking insulin or pills for diabetes (DM). FI was defined as involuntary loss of mucus, liquid, or solid stool in the previous month. The Fecal Incontinence Severity Index (FISI) score3, ranging from 0 to 54, was used to assess FI severity with higher scores representing greater symptom severity. Potential risk factors included age, race/ethnicity, poverty income ratio, education, parity, prior hysterectomy, co-morbidities, depression and BMI (<25, 25–29, ≥30 kg/m2). We also evaluated stool characteristics including the presence of loose stool consistency (Type 6 and 7 on the Bristol Stool Form Scale) and frequency of bowel movements per week (<3, 3–20 and ≥21). Using appropriate sampling weights, weighted chi square analysis and multivariable logistic regression models with odds ratios (OR) and 95 % confidence intervals (95 % CI) were reported for variables associated with FI among diabetic women. Results: Of the 7,039 adult women, 961 (10.0 %, 95 % CI, 8.9– 11.1) were diabetic. Among diabetic women, 19.2 % reported FI (95 % CI, 14.5–25.0) compared to 8.4 % (95 % CI 7.6, 9.4) among non-diabetic women. When comparing diabetic women with and without FI, the two cohorts were similar in race/ethnicity, education, poverty status and BMI. Women with FI were more likely to be older (mean age 62.5 vs 58.6 years, p=.002), parous (96.1 % vs 89.8 %, p=.005), have a prior hysterectomy (50.2 % vs 40.7 %, p=.05), and have more comorbidities (≥3 comorbidity index 50.9 % vs 36.4 %, p=.006). Women with FI were also more likely to report moderate-severe depression (10.5 % vs 5.0 %, p=.03) and fair or poor selfreported health (61.3 % vs 41.9 %, p=.001). FI was also significantly associated with increased stool frequency (22.4 % vs
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
5.9 % with ≤21 BM/week p=<.003), having loose stools (24.6%vs 11.1 % p=<.001), and concomitant urinary incontinence (79.3 % vs 49.5 % p<.001) When controlling for other factors in a multivariable model, age (OR 1.3, 95 % CI 1.1–1.6), depression (OR 2.1 95 % CI 1.0–4.5), poorer self–reported health (OR 2.0, 95 % CI 1.2–3.4), and increased stool frequency (OR 10.5, 95 % CI 2.4–46.1), and urinary incontinence (OR 3.6, 95 % 2.1–6.0) were associated with FI among diabetic women. Conclusion: FI affects almost one in five women with diabetes, which is more than twice the rate among women without diabetes (1 in 12 women, 8.4 %). Based on other NHANES data, factors associated with FI among diabetic women are similar to those among women without diabetes, including increased stool frequency and urinary incontinence. The high prevalence of FI in diabetic women underscores the importance of FI screening. Future research should explore the effects of medications and diabetic control on FI among women with diabetes. References: 1. Nelson RL. Epidemiology of fecal incontinence. Gastroenterology 2004;126, Supplement 1:S3-S7. 2. Ditah I, Devaki P, Luma HN, et al. Prevalence, Trends, and Risk Factors for Fecal Incontinence in United States Adults, 2005–2010. Clinical Gastroenterology and Hepatology. 3. Rockwood TH. Patient and surgeon ranking of the severity of symptoms associated with fecal incontinence: the fecal incontinence severity index. Diseases of the colon & rectum 1999;42:1525–32. Disclosure Block: Maria Nieto: No disclosures. Jennifer Wu: Proctor and Gamble: Consultant, Consulting Fee. William Whitehead: Rome Foundation: Board Member, Honoraria. Salix Pharmaceuticals: Principal Investigator on grant, Grant/Research Support. Ono Pharmaceuticals: Consultant, Consulting Fee. Ironwood Pharmaceuticals: PI on grant, Grant/Research Support. Takeda Pharmaceuticals: Co-investigator on grant, Grant/Research Support. Alayne Markland: No disclosures.
OP 107 ANAL INCONTINENCE: THE IMPACT OF FLATAL INCONTINENCE IN WOMEN I. MEYER, J. M. SZYCHOWSKI, H. E. RICHTER; Univ. of Alabama at Birmingham, Birmingham, AL. Introduction: Accidental bowel leakage (ABL) negatively impacts quality of life (QOL). The differential impact on QOL that anal incontinence (AI, leakage of liquid/solid stool and gas) confers compared to women with fecal incontinence (FI, leakage of liquid/solid stool only) is unclear. Objective: To characterize differences in symptoms distress and impact on QOL as well as baseline anorectal diagnostic
S187
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
testing findings, specifically anorectal manometry (ARM) and endoanal ultrasound (EAU), among women with AI to women only with FI. We also wished to explore factors of women with only flatal incontinence presenting for evaluation. Methods: Women undergoing evaluation of ABL between 2003 and 2013 at our institution were eligible for this cohort study. Participants completed validated, symptom specific distress, impact and general QOL measures, including the Modified Manchester Questionnaire (MMHQ) which includes the Fecal Incontinence Severity Index (FISI), and the Short Form −12 including the mental and physical component summary scores (MCS and PCS). Subjects with ABL ≥ once a month were identified using MMHQ and divided into three groups; Group A, comprised of women with flatal and liquid/solid stool incontinence, group B, women with only liquid/solid stool incontinence, and group C, women with only flatal incontinence. All participants underwent ARM and EAU evaluations. Chi-square, ANOVA, and Kruskal-Wallis tests were performed. Statistical significance is indicated by p-values of ≤0.001. Results: Of the 436 eligible subjects, 381 were assigned to group A, 45 to group B, and 10 to group C. There were no significant differences in clinical and demographics variables between groups A and B. (Table 1) Significant differences were noted in symptom specific distress and impact for the MMHQ total scores and FISI scores with subjects in group A being more impacted. (Table 2) There were no differences in diagnostic test results including resting/squeeze pressures and rectal capacity on ARM, as well as the presence of external or internal sphincter defects between the two groups. (Table 3) As an exploratory aim, we characterized differences in women with liquid/solid stool incontinence vs. flatal only incontinence. Women with flatal incontinence were significantly younger (mean 46 vs. 61, p=0.001). There were no differences in the total as well as individual subscale scores of the MMHQ (data not shown). In addition, the FISI and SF12 scores were similar between groups with flatal only incontinence vs. fecal incontinence. (Table 2) Women with flatal only incontinence had significantly higher resting and squeeze pressures. (Table 3) The rates of anatomical sphincter defects (either external or internal) did not differ between the groups. Conclusions: Women with ABL comprised of liquid/solid stool and flatus have higher general impact and symptom specific distress as well as great negative impact on QOL compared to women with liquid/solid stool incontinence only. Contrary to other existing studies, the prevalence of combined flatal and fecal incontinence (AI) was much higher than either solely fecal or flatal incontinence in this study population (1, 2). Traditionally, flatal incontinence has been considered having less impact upon QOL compared to stool loss (2). Although a limited sample size, the impact of flatal only
incontinence in women appears to have both physical and psychological burdens trending toward that of women with fecal incontinence only. Further studies are needed to characterize and to develop optimal treatment approaches for women with all forms of ABL. References: 1. Am J Obstet Gynecol. 2009;201:539.e-1-3 2. Am J Obstet Gynecol. 2005;192:1637–42 TABLE 1: Patient Demographics Overall Age (yrs), 57±14 mean ± SD White Race, N(%) 378(87)
A: Flatal and B: Fecal C: Flatal Fecal Only Only 57±13 61±16 46±17
0.005
0.05
0.001
332(87)
36(80)
10(100)
0.19
0.19
0.19
0.07
0.42
0.04
8(2)
2(4)
1(10)
BMI, N(%) Underweight
11(3)
Normal
127(29)
111(29)
15(33)
1(10)
Overweight
135(31)
118(31)
16(36)
1(10)
P (Global) P (A vs B) P (B vs C)
Obese
163(37)
144(38)
12(27)
7(70)
Smoker, N(%)
63(14)
58(15)
4(9)
1(10)
0.48
0.25
>0.99
Colorectal Surgery, N(%) Hysterectomy, N(%) OB Sphincter Injury, N(%)
52(12)
49(13)
3(7)
0(0)
0.24
0.23
>0.99
307(70)
272(71)
31(69)
4(40)
0.10
0.73
0.14
136(31)
121(32)
12(27)
3(30)
0.78
0.49
>0.99
TABLE 2: Validated Questionnaires Overall
A: Flatal and Fecal 52.8±20.4
B: Fecal only 40.9±21.4
C: Flatal ONly 39.8±19.4
P (Global)
P (A vs B)
P (B vs C)
51.3±20.8
0.0002
0.0002
0.89
28.8±12.5
31.0±11.5
15.4±6.8
5.4±2.7
<0.0001
<0.0001
0.0097
PCS, mean ± SD
41.5±11.7
41.2±11.7
43.3±12.4
46.4±11.1
0.22
0.27
0.45
MCS, mean ± SD
41.6±12.3
41.2±12.4
45.7±12.3
40.9±8.7
0.08
0.03
0.26
Total MMHQ, mean ± SD FISI, mean ± SD SF-12 Score
TABLE 3: Anorectal Diagnostic Testings:
Overall
A: Flatal and Fecal
B: Fecal Only
C: Flatal Only
P (Global)
P (A vs B)
P (B vs C)
Anorectal Manometry, mean(STD) Resting Pres, mmHg
35.8 (19.2)
35.0 (18.6)
37.9 (16.3)
58.5 (35.7)
0.0004
0.33
0.002
Squeeze Pres, mmHg
71.3 (36.0)
71.5 (35.0)
78.5 (32.1)
111.7 (61.1)
0.001
0.21
0.008
Capacity, mL
117.0 (55.4)
117.5 (55.7)
110.2 (56.2)
130.0 (38.4)
0.54
0.41
0.31
External Sphincter Defect
97 (22)
86 (23)
11 (24)
0 (0)
0.005
0.41
0.009
Internal Sphincter Defect
64 (15)
58 (15)
6 (13)
0 (0)
0.39
0.74
0.58
Endoanal Ultrasound, N(%)
Disclosure Block: Isuzu Meyer: No disclosures. Jeff Szychowski: Study operated by UCSF, funded by Halt Medical: Member of DSMB for the UTLRA study., Honoraria. Holly Richter: Pelvalon: Consultant, Consulting Fee. Pelvalon: Fecal incontinence, Grant/Research Support. UpToDate: Review of UpToDate articles, Royalty.
S188
OP 108 VALIDATION OF A COMMUNITY-BASED OBSTETRIC FISTULA SCREENING TOOL IN RURAL NEPAL D. BARRY1, S. K. KHATRY 1, E. KLASEN 2, M. SINGH 3, S. C. LECLERQ 1, J. KATZ 1, J. M. TIELSCH 1, L. C. MULLANY 1, C. CHEN 4; 1 Johns Hopkins Univ., Baltimore, MD, 2International Health, Johns Hopkins Univ., Baltimore, MD, 3OB/ GYN, Inst. of Med., Kathmandu, Nepal, 4johns hopkins, baltimore, MD. Introduction: Obstetric fistula (OF) is a neglected maternal morbidity affecting up to 2 to 3.5 million women globally, with 50,000 to 100,000 annual incident cases. OF generally occurs in low-income settings among women who experience prolonged or obstructed labor without access to timely, quality obstetric care. In addition to fetal demise, women with OF often suffer from chronic leaking of urine and/or feces, resulting in physical and economic consequences, as well as severe social stigmatization and psychological trauma. The validity of global OF prevalence estimates is uncertain, as most estimates are derived from hospital-based studies in Sub-Saharan African settings or population-based studies without clinical confirmation of women’s selfreported OF status. Objective: To estimate OF prevalence and determine the validity of a symptom-based fistula questionnaire in a community-based rural setting in Nepal. Methods: A community-based cross-sectional survey of parous, reproductive age women was conducted in rural Nepal, using a screening questionnaire for current experience of vesico-vaginal fistula (VVF) and/or rectovaginal fistula (RVF) symptoms as well as stress and urge urinary incontinence (SUI, UUI), and pelvic organ prolapse. OF cases identified during the screening were selected for inclusion in a nested case–control study. Two types of controls were randomly selected among women who screened negative, in a ratio of 1:4:4 (case:control:control). The first type of control included women with reported symptoms of urinary or fecal incontinence, while the second type of control were women who did not have incontinence or fistula symptoms. All consenting cases and controls underwent a clinical exam and data collection on sociodemographics, current health and reproductive history. Overall frequencies of women’s self-reported symptoms were conducted and compared to diagnoses based on the clinical exam. As women with OF are often stigmatized, we also used a case-finding strategy using local community health care workers that lived within our study population to identify women suspected of having OF but were not part of our study.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Results: An existing demographic surveillance site database identified 18,383 parous women of reproductive age. Among these, 17,040 completed screening. Women’s self-reported OF status included: VVF only (66, 0.4 %), RVF only (1, 0.01 %), both RVF and VVF (1, 0.01 %). Clinical examination confirmed only one OF case within the study population, which the screening tool had correctly identified as both a VVF and RVF. This indicated that the tool had a sensitivity of 100 % and specificity of 94.2 % for correctly identifying VVF cases, and a sensitivity of 100 % and specificity of 99.9 % for RVF cases. Using our case-finding strategy, we identified three additional cases (all VVF only) were found outside of the study area, based on respondent referral. A total of 406 women were included in the case control study. Among women who were OF false positives, clinical assessment at the time of exam confirmed that 69.8 % had SUI, 66.0 % UUI, and 20.8 % had pelvic organ prolapse. Among these, women with UUI were significantly more likely to have screened as VVF false positives compared to women without UUI (74.5 % vs 40.0 %, p=0.001). Similarly, women with both SUI and UUI were also more likely to have screened as VVR false positives, compared to women who did not have both conditions (72.1 % vs 44.9 %, p=0.01), however this was likely driven by UUI status alone. VVF false positives rates did not vary significantly by SUI or prolapse status. Conclusions: The low OF prevalence in this study may indicate that higher prevalence estimates from SubSaharan African or hospital-based studies are not generalizable to our population in rural South Asian. Additionally, the number of false positives demonstrates the need for validated screening tools to distinguish VVF symptoms from symptoms experienced by women with UUI. The screening tool used in this study may be useful for more accurate population-based OF prevalence estimates, or to target treatment efforts. However, the low OF population prevalence in this study prohibited meaningful assessment of the tool’s positive and negative predictive value. Follow-up studies in high prevalence settings are needed to further validate the tool. References: Intl Jour Gyn Obst, 2007. 99(1 Suppl):S4-9. Intl Jour Gyn Obst, 2007. 99(1 Suppl): S1-3 Lancet, 2006. 368(9542):1201–9. Disclosure Block: Danika Barry: No disclosures. Subarna Khatry: Disclosure Not Provided. Elizabeth Klasen: No disclosures. Meeta Singh: Disclosure Not Provided. Steven LeClerq: No disclosures. Joanne Katz: No disclosures. James Tielsch: Disclosure Not Provided. Luke Mullany: No disclosures. chi chiung grace chen: No disclosures.
S189
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
OP 109 THE PREVALENCE OF ABNORMAL POSTERIOR COMPARTMENT ANATOMY IN UROGYNECOLOGICAL PATIENTS. R. A. GUZMAN ROJAS1, I. KAMISAN ATAN 1, K. SHEK 2 , H. DIETZ 1; 1 Sydney Med. Sch. Nepean, Penrith, Australia, 2Univ. of Western Sydney, Liverpool, Australia. Introduction: Symptoms of bowel dysfunction are frequently elicited in patients presenting to urogynecological services (1). Translabial pelvic floor ultrasound (PFUS) has recently be shown to demonstrate anatomical abnormalities of the posterior compartment, and it is much better tolerated than the most commonly used competing method, defecation proctography (2). This study was designed to determine the prevalence of the commonest anatomical abnormalities of the posterior vaginal compartment in our patients. Objective: To determine the overall prevalence of anatomical abnormalities of the posterior compartment in women seen in a tertiary urogynaecological clinic. Methods: This is a retrospective study of 750 women who attended a urogynecology unit for the investigation of pelvic floor disorders between 9/11 and 4/13. All women underwent a standardised interview, clinical examination and 3D/4D PFUS. Ultrasound volumes were analysed at a later date, using proprietary software, blinded against all other data. Pelvic organ descent was determined relative to the inferior margin of the symphysis pubis (SP) for each compartment including cystocele, uterine, enterocele and rectocele descent in mm. A true rectocele, ie. a diverticulum of the rectal ampulla indicative of a defect of the rectovaginal septum (RVS), was diagnosed if there was a discontinuity in the anterior contour of internal anal sphincter and anterior anorectal muscularis (3). A rectal (rectoanal) intussusception was diagnosed if there was splaying of the anal canal and inversion of the anterior wall of the rectal ampulla into the anal canal, with the tip of the intussuscipiens entering the anal canal, without there being overt rectal prolapse (Fig. 1). Univariate and multivariate logistic regression was undertaken to predict symptoms of obstructed defecation (OD).
Results: During the inclusion period 750 patients were seen. Ultrasound data was missing in 19 cases; in 8 patients the volume datasets were of poor quality; 4 patients were not examined clinically, leaving 719 for analysis. Three hundred and sixty nine (51 %) patients reported symptoms of prolapse. Ninety-seven (13 %) complained of fecal incontinence, 190 (26 %) of constipation and 461(64 %) of OD symptoms such as vaginal digitation (13 %), straining at stool (45 %), and/or incomplete bowel emptying (52 %). On clinical assessment, 405 (56 %) women were diagnosed with significant posterior compartment prolapse (POP-Q stage 2+). Posterior compartment descent was significantly associated with OD symptoms (p<.0001). On US, 326 (45 %) had a significant descent of the rectal ampulla (≥15 mm below SP) and 103(14 %) an enterocele (at or below SP). There were 382 true rectoceles (53 %). On univariate analysis all tested sonographic parameters were significantly associated with OD symptoms (Table 1). On multivariate analysis only true rectocele (p=0.003) and rectal intussusception (p=0.004) remained significant. Sonographic Parameter
n/mean
%/SD
OR for OD (95 % CI) 0.98 (0.97–0.99)
P value
Position of the rectal ampulla (mm) True rectocele (yes/no)
−10.4
15.5
382
53 %
1.8 (1.3–2.4)
0.0002
Rectocele depth (mm)
16.9
7
1.06 (1.03–1.10)
0.0008
Enterocele (yes/no)
103
14 %
2.02 (1.24–3.28)
0.005
Rectal Intussusception (yes/no)
31
4.3 %
8.6 (2.0–36.3.3)
0.003
0.0005
Table 1: Prevalence of anatomical abnormalities of the posterior compartment in urogynaecological patient (n=719) and association between OD symptoms and sonographic findings. Conclusions: Both symptoms of OD and anatomical abnormalities of the posterior compartment such as true rectocele, enterocele and rectal intussusception are common in urogynaecological patients and deserve more attention, both in clinical practice and in research. References: 1. BJOG 1994; 101: 147–152. 2. Ultrasound Obstet Gynecol 2008; 31: 567–571 3. Ultrasound Obstet Gynecol 2005; 26: 73–77.
Figure 1: A shows the depth of a True Rectocele, B a rectoenterorocele and C the typical appearance of intussusception. SP: symphysis pubis, B: bladder, PR: puborectalis muscle, AC: anal canal, SB: small bowel.
Disclosure Block: Rodrigo Guzman Rojas: No disclosures. Ixora Kamisan Atan: No disclosures. Ka Lai Shek: GE: Speaker, unrestricted educational grants. Hans Peter Dietz: GE Medical: unrestricted educational grant, Grant/Research Support.
S190
OP 110 OVERLAPPING SPHINCTEROPLASTY FOR CLOACAL DEFECT FOLLOWING OBSTETRICAL INJURY: PRESENTING CHARACTERISTICS AND SUBJECTIVE LONG-TERM OUTCOMES P. A. MALDONADO, M. M. GOOD, D. D. MCINTIRE, S. D. PATHI, S. M. ROSHANRAVAN, M. M. CORTON; Obstetrics and Gynecology, UT Southwestern Med. Ctr., Dallas, TX. Introduction: Fourth-degree obstetrical lacerations extend from the vagina into the rectal lumen and involve complete separation of the perineal body and anal sphincter complex. Breakdown of a primary repair or failure to recognize these lacerations at the time of delivery can result in “chronic” fourth-degree lacerations, also known as cloacal deformities. Women with these defects have an increased risk of developing anal incontinence and sexual dysfunction. Subjective outcomes following anal sphincteroplasty vary (1,2). Because cloacal deformities are rare occurrences, data regarding patient characteristics, perioperative management, and especially long-term outcomes are limited. Objective: To describe patient demographics, presenting symptoms, perioperative management, and subjective longterm outcomes (current anal incontinence, sexual function, and quality of life) in a cohort of women with cloacal deformities who underwent repair with overlapping sphincteroplasty over the past 17 years. Methods: Hospital records were reviewed for 57 patients who underwent an anal sphincteroplasty at our institution from 1996 to 2013. Thirty-four women underwent the procedure for a chronic fourth-degree laceration or cloacal deformity of the perineum. Information collected included: patient demographics, presenting symptoms, use of preoperative endo-anal ultrasound, perioperative management (including suture type, post-operative antibiotics, postoperative diet and bowel regimen), postoperative complications (within 1 month of surgery), readmissions, and reoperations. Patients were contacted by telephone and administered the validated Modified Manchester Health Questionnaire (MMHQ) in either English or Spanish, to assess anal continence status and anal incontinence-related quality of life (3). Patients were excluded if they did not speak either English or Spanish, as the questionnaires are validated in these two languages only. Results: Of 57 patients screened, 37 met inclusion criteria. The average age at the time of surgery was 33.0 +/− 10.6 years (range 19 to 56 years). The patient population was predominately Hispanic, 64.7 %. The average BMI was 28.3 +/− 6.3 kg/ m2 (range 20.2 to 48.4 kg/m2). The average parity was 2.7 +/− 1.49 (range 1 to 7) and approximately 26.5 % of patients reported a history of prior forceps or vacuum-assisted vaginal delivery. Presenting complaints included: fecal incontinence (61.8 %), flatal incontinence (47.1 %), sexual dysfunction (17.6 %) and poor body self-image (2.9 %). The average length
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
of time from obstetrical injury to time of surgery was 70.7 +/− 91.3 months (range 1 to 324 months). Average length of hospital stay was 2.6 +/− 1.1 days (range 1 to 5 days). Approximately 29.4 % of patients underwent a preoperative endo-anal ultrasound documenting a disrupted anal sphincter complex. Overlapping sphincteroplasty was performed using polydioxanone (either 2–0 or 3–0) suture on the external anal sphincter in 100 % of cases and extended post-operative therapeutic antibiotics was given in 73.5 % of cases for an average of 4.0 +/− 3.0 days (range 1 to 14 days). Average estimated blood loss was 299.2 +/− 242.2 cc (range 50 to 1000 cc). Intraoperative blood transfusion was given in 2 cases. Wound separation was noted in 5 patients, 2 of which required reoperation for primary closure. Postoperative wound infections occurred in 2 patients (5.9 %), one of which presented with a perirectal abscess. Of the 34 patients included, 15 patients (44.1 %) were available for administration of the validated telephone MMHQ. Based on the Fecal Incontinence Severity Index component of the MMHQ, 9 (60 %) patients queried were continent of solid stool and 6 (40 %) patients were totally continent at a median follow up time of 6.6 +/− 3.6 years (range 3 to 14 years). The remaining 9 patients reported some combination of solid, liquid, mucus, or flatal incontinence (66.7 %, 44.4 %, 11.1 %, and 33.3 % respectively). Conclusions: Perioperative morbidity following overlapping sphincteroplasty for cloacal defects following obstetrical injury is rare. Although long-term complete anal continence may be difficult to achieve in all cases, continence of solid stool may be reached in up to 60 % of cases at a median follow-up of 6.6 years. References: 1. Lancet 2000;355: 260–65. 2. Tech Coloproctol 2012;16: 153–156. 3. Dis Colon Rectum 2005;48: 323–334. Disclosure Block: Pedro Maldonado: No disclosures. Meadow Good: No disclosures. Donald McIntire: No disclosures. Sujatha Pathi: No disclosures. Shayzreen Roshanravan: No disclosures. Marlene Corton: No disclosures.
OP 111 MODE OF DELIVERY AFTER PREVIOUS OBSTETRIC ANAL SPHINCTER INJURIES (OASIS)—A PROSPECTIVE OBSERVATIONAL STUDY R. KARMARKAR1, A. A. BHIDE 2, A. DIGESU 3, V. KHULLAR 2, R. FERNANDO 1; 1 Department of Urogynaecology, Imperial Coll. Hlth.care NHS Trust, London, United Kingdom, 2Imperial Coll. London, London, United Kingdom, 3Imperial Coll. NHS Trust, London, United Kingdom.
S191
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Introduction: OASIS is one of the commonest causes for anal incontinence amongst women. The reported risk of sustaining a further OASIS after a subsequent delivery is about 7 %1. Between 17 and 24 % of women developed worsening faecal symptoms after a second vaginal delivery following previous OASIS2. There are no published systematic reviews or randomised controlled trials to suggest the best method of delivery following OASIS. In the UK, RCOG guidelines on the management of OASIS recommend that women who had a previous OASIS should be offered an elective caesarean section if they were symptomatic, had abnormal manomtery or anal sphincter defects on endoanal ultrasound3. Objective: Prospectively compare the outcome of vaginal delivery and caesarean delivery in women who sustained OASIS in their previous pregnancy. Method: All women who sustained OASIS in a tertiary university hospital and subsequently became pregnant between January 2007 and March 2013 were prospectively followed up in a dedicated one-stop pelvic floor clinic. All patients completed a validated bowel symptom questionnaire and were offered anal manometry and endoanal ultrasound scan between 8 and 12 weeks after the OASIS and during the second trimester of the subsequent pregnancy. Women who were symptomatic, those who had abnormal manomatery or anal sphincter defects on endoanal ultrasound scan were offered an elective caesarean section as recommended by the RCOG guidelines 3 . Women completed the questionnaire and were offered anal manometry and endoanal ultrasound between 8 and 12 weeks after the subsequent delivery. Symptoms, anal manometry and endoanal scan findings were compared in the vaginal and caesarean delivery groups after OASIS, during pregnancy and after the subsequent delivery. Results: Between January 2007 and March 2013, there were 16,825 vaginal deliveries and 428 (2.5 %) sustained OASIS. Three hundred and seventy three (87 %) women who sustained OASIS attended the dedicated pelvic floor clinic. Sixty five women subsequently became pregnant following previous OASIS. Based on validated symptom questionnaire, anal manometry and endoanal scan findings 38 were offered a vaginal delivery and 27 were offered an elective caesarean section. Fifty two women completed the follow-up to date. Of the elective caesarean section group one had a vaginal delivery and three had emergency caesarean section in labour. Table 1 shows the baseline characteristics of the vaginal delivery and caesarean section group.
Table 1: Baseline characteristics, Grade of OASIS, anal sphincter defects, manometry and symptoms after OASIS
Mean Age (SD)
Vaginal delivery Caesarean section P (n=29) (n=23) 31.2 (5.45) 31.8 (5.96) 0.71
Mean Gestational age seen 28.6 (6.2) in pregnancy (SD) Grade of OASIS (%) 3a 7 (13 %)
25.5 (8.5)
0.16
3 (6 %)
3b 3c
13 (25 %) 8 (15 %)
11 (21 %) 6 (12 %)
4
1 (2 %)
3 (6 %)
Prior to the subsequent delivery, there were 8 Internal Anal Sphincter (IAS) defects and 4 External Anal Sphincter (EAS) defects in the caesarean section group and no IAS or EAS defects found in the vaginal delivery group. After the second delivery there were no new IAS or EAS defects were found in either groups. There were no change in the anal incontinence symptoms, mean resting and mean squeeze pressure in the vaginal delivery or elective caesarean section groups. However there was worsening of anal incontinence symptoms, mean resting and squeeze pressure in the woman who was recommended an elective caesarean section but had a vaginal delivery and two of the women who had emergency caesarean section. Conclusions: Mode of delivery of the subsequent pregnancy after previous OASIS based on symptoms and investigations appears to be the best option available at present. Further follow-up of these patients are essential to evaluate the longterm effects of this decision. References: 1. Mode of delivery after previous obstetric anal sphincter injuries (OASIS)-a reappraisal? Int Urogynecol J Pelvic Floor Dysfunct. 2009 Sep;20(9):1095–101.) 2. Risks of anal incontinence from subsequent vaginal delivery after a complete obstetric anal sphincter tear. BJOG 1992;99:724–6. 3. Management of Third- and Fourth-Degree Perineal Tears. Green-top Guideline No. 29. London: RCOG; 2007 Disclosure Block: Roopali Karmarkar: Pfizer: I attended a day of a conference arranged and funded by the company. Travel cost of 38 BPS was paid by the company., Travel Grant. Alka Bhide: No disclosures. alex digesu: No disclosures. Vik Khullar: Allergan, Astellas, Pfizer: Scientific Medical Advisor, Consulting Fee. Allergan, Astellas, Pfizer: Speaker, Consulting Fee. Allergan, Astellas, Pfizer: Consultant, Consulting Fee. Allergan, Astellas, Pfizer: Advisory Committee Member, Consulting Fee. Ruwan Fernando: Astellas: Speaker, Honoraria. AMS: Speaker, Honoraria.
S192
OP 112 FUNCTIONAL INDEPENDENCE MEASURE AND GLASGOW COMA SCORES PREDICT URINARY AND FECAL INCONTINENCE AFTER TRAUMATIC BRAIN INJURY J. M. DANFORD1, D. J. OSBORN 2, N. C. WHITE 1, E. A. GREEN 2, O. D. GUILLAMONDEGUI 3, W. REYNOLDS 2, R. R. DMOCHOWSKI 2; 1 Obstetrics and Gynecology, Vanderbilt Univ. Med. Ctr., Nashville, TN, 2Urology, Vanderbilt Univ. Med. Ctr., Nashville, TN, 3 Surgery, Vanderbilt Univ. Med. Ctr., Nashville, TN. Objective: The incidence of urinary incontinence is high in traumatic brain injury (TBI) patients. No study has evaluated the incidence of both urinary and fecal incontinence and the association with prognostic factors in this patient population. The objective of this study is to evaluate the incidence of lower urinary tract symptoms (LUTS) and fecal incontinence in patients who have sustained traumatic brain injuries. The secondary objective is to identify prognostic factors that are associated with urinary and fecal incontinence. Methods: A retrospective review of electronic medical records of female patients who were diagnosed with traumatic brain injury (TBI) at a level one trauma center from November 2004 to December 2010 was performed. These patients were obtained from the National Trauma Registry of the American College of Surgeons (NTRA CS) database. The diagnosis of TBI was based on a head computed tomography (CT) positive for intracranial hemorrhage and a head and neck abbreviated injury score greater than 2. Patients who sustained bladder or spinal cord injuries were excluded from the study. The NTRACS database contained demographic information and emergency room Glasgow coma score (GCS), mechanism of injury, hospital length of stay, disposition and functional independence measure (FIM) score. The electronic medical record was reviewed for information regarding pre-injury urinary incontinence, fecal incontinence, over active bladder (OAB) diagnosis, and the use of an anticholinergic. Follow-up visits were reviewed for: diagnosis of urinary incontinence, fecal incontinence, OAB, urinary retention, acute cystitis and if prescription for anticholinergic was given. Patient visits were also reviewed to determine if the provider asked about lower urinary tract symptoms (LUTS). Multivariate logistic regression modeling was used to determine the association between de novo urinary incontinence (and de novo fecal incontinence) and the potential risk factors of age, GCS, trauma type and FIM score. Statistical significance was defined as p<0.05. All analyses were performed using Stata 13.1 software. Results: Of the identified 1275 patients with TBI, 1008 patients met inclusion criteria. Mean age was 46 years old.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Median hospital stay was 4 days (IQR of 8). Average follow-up was 14.9 months. Average GCS was 9.6 and 969 (96.1 %) secondary to blunt trauma. Of the 1008 patients, 20.5 % (207) died during their initial admission, 82 % (664) had more than 2 weeks of outpatient followup. The overall incidence of de novo urinary incontinence was 8.5 % (100). Providers asked 59.0 % (392) of these patients about LUTS. The incidence of de novo urinary incontinence in the 392 patients who were asked about their LUTS, was 20.4 % (80). The incidence of de novo fecal incontinence in patients in this same population was 13 % (51). The overall rate of urinary tract infection (inpatient as well as outpatient) was 12.6 % (127/1008). Severe GCS score (<9) as well as FIM score equivalent with patient requiring assistance (<5) were associated with an increased risk of de novo urinary incontinence (OR of 0.88, 95 % CI 0.83–0.93, p<0.001 and OR 0.78, 95 % CI 0.71–0.87, p<0.01, respectively). Similarly, both severe GCS score and low FIM score were associated with an increased risk of fecal incontinence (OR of 0.87, 95 % CI 0.80–0.94, p<0.01 and OR 0.83, CI 0.71–0.91, p<0.001 respectively). Conclusions: The de novo urinary incontinence incidence after TBI was 12.0 %, and de novo fecal incontinence was 7.7 %. However only 59 % of all patients with follow up were asked about incontinence symptoms. These numbers could increase with proper questioning and the use of a validated questionnaire. In addition, an association is seen with lower GCS and FIM scores and both urinary and fecal incontinence. References: N/A Disclosure Block: Jill Danford: No disclosures. David Osborn: No disclosures. Nicola White: No disclosures. Elizabeth Green: No disclosures. Oscar Guillamondegui: No disclosures. William Stuart Reynolds: Allergan: PI on multicenter clinical trial, Grant/ Research Support. Roger Dmochowski: allergan: Consultant, Consulting Fee. Medtronic: Consultant, Consulting Fee.
OP 113 TRENDS AND COSTS OF INPATIENT PELVIC ORGAN PROCEDURES IN THE UNITED STATES FROM 2000 to 2011 M. M. MAMIK1, E. L. MOSHIER 2, J. H. GODBOLD 2, C. J. ASCHER-WALSH 1; 1 Obstetrics and Gynecology, Icahn Sch. of Med. at Mount Sinai, New York, NY, 2Preventive Medicine, Icahn Sch. of Med. at Mount Sinai, New York, NY. Introduction: The lifetime risk of surgery for pelvic organ prolapse (POP) has been estimated to be as high
S193
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
as 19 %1 and in the United States, the cumulative lifetime risk of POP and urinary incontinence surgery has been estimated to be 11.8 %2. Majority of POP procedures are performed in an inpatient setting. If the United States population increases 24 % by 2030 as projected by the United States Census Bureau, the demand for care for pelvic floor disorders will increase by 35 % between 2010 and 20303. It is therefore important to understand the costs associated with this on a national level. Also the current trends may have been impacted by several factors such as the FDA warning of transvaginal mesh-related procedures which was issued in 2008 and possibly the litigious climate related to mesh use in recent times. There is no data in literature that examines these trends recently especially since the FDA notification and there is no data on inpatient pelvic organ prolapse procedures that examines the trends of costs at a national level in the United States. Objective: The objective of this study is to evaluate the trends and costs of inpatient pelvic organ prolapse procedures from 2000 to 2011. Methods: The Nationwide Inpatient Sample (NIS) is the largest all-payer inpatient health care database in the United States giving national estimates of hospital inpatient stays and is part of databases developed for the Healthcare Cost and Utilization Project (HCUP). Weighted estimates have data on approximately 40 million hospitalizations and form a sampling frame of hospitals that comprised approximately 97 % of all hospital discharges in the United States in 2011. The NIS may be reliably used to analyze national trends in health care utilization, total charges, quality and outcomes due to its large sample. ICD-9 diagnosis codes for pelvic organ prolapse and procedure codes were used and patients included if they had any combination of both the diagnosis and the procedure codes. Patient demographics, total charges per procedure, length of stay, type of institution, type of surgery and age-adjusted rates of pelvic organ prolapse procedures per 1000 women were calculated using 2000 U.S Census data in SAS Version 9.2®. Results: The mean age of women remained fairly stable over the 12 years ranging from 55.99±0.23 years to 58.94±0.25 years. The majority of women were White (77.55–84.65 %). The age-adjusted inpatient POP procedures showed a decreasing trend from 9.6 per 1000 women in 2000 to 5.067 per 1000 women in 2011. The length of stay also showed a decreasing trend from 2.44+0.02 days in 2000 to 1.69+0.03 days in 2011. Conversely the costs showed an increasing trend with the total charges ranging from $ 10,672 ± 288.93 on average per procedure in 2000 to $ 30,662±1029.46 in 2011. Conclusions: The inpatient pelvic organ prolapse procedures show a decreasing trend over the past 12 years whereas the
costs have almost tripled per procedure. References: 1. Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010 Nov;116(5):1096–100 2. Fialkow M, Newton K, Lentz G. Lifetime risk of surgical management for pelvic organ prolapse or urinary incontinence. Int Urogynecol J 2008;19:437–40. 3. Kirby AC, Luber KM, Menefee SA.An update on the current and future demand for care of pelvic floor disorders in the United States. Am J Obstet Gynecol. 2013 Dec;209(6):584.e1-5.
ICD - 9 diagnosis codes for pelvic organ prolapse ICD-9 code
Diagnosis
ICD-9 code
Diagnosis
618
Genital prolapse
618.3
Uterovaginal prolapse, complete
618.00
Unspecified prolapse of vaginal walls
618.4
Uterovaginal prolapse, unspecified
618.0
618.5
Prolapse of vaginal vault after hysterectomy
618.01
Prolapse of the vaginal walls without mention of uterine prolapse Cystocele, midline
618.6
Vaginal enterocele, congenital or acquired
618.02
Cystocele, lateral
618.8
Other specified genital prolapse
618.03
Urethrocele
618.9
Unspecified genital prolapse
618.04
Rectocele
618.81
Incompetence or weakening of pubocervical tissue
618.05
Perineocele
618.82
Incompetence or weakening of rectovaginal tissue
618.09
Other uterine prolapse without mention of uterine prolapse/ cystourethrocele Uterine prolapse without mention of vaginal wall prolapse Uterovaginal prolapse, incomplete
618.83
Pelvic muscle wasting
618.84
Cervical stump prolapse
618.89
Other specified genital prolapse
618.1
618.2
S194
Disclosure Block: Mamta Mamik: No disclosures. Erin Moshier: No disclosures. James Godbold: No disclosures. Charles Ascher-Walsh: No disclosures.
OP 114 AWARENESS OF FEMALE PELVIC MEDICINE AND RECONSTRUCTIVE SURGERY SPECIALTY BY FAMILY MEDICINE RESIDENTS: A NATIONAL SURVEY O . F. D U E N A S 1 , M . J E A N - M I C H E L 2 , G . A . MARROQUIN 3, M. MIKHAIL 1; 1 Obstetrics and Gynecology, Bronx Lebanon Hosp. Ctr., New York, NY, 2Bronx-Lebanon Hosp. Ctr., Bronx, NY, 3Bronx Lebanon Hosp., Bronx, NY. Objective: To identify the referral practice patterns of family medicine (FM) resident physicians for the evaluation of genitourinary conditions, and to determine their awareness of the Female Pelvic Medicine and Reconstructive Surgery (FPMRS) specialty as an available referral source. Background: Primary care practitioners play an important role in diagnosing, initiating treatment, and/or referring patients with pelvic floor disorders.1, 2 In a publication series endorsed by the American Academy of Family Physicians (AAFP) entitled “Problem Oriented Diagnosis”, providers have been encouraged to refer patients with urinary incontinence to urogynecologists or urologists since 1998. However in similar publications for interstitial cystitis and pelvic organ prolapse (POP), no clear referral recommendations are made. 2 Methods: This cross-sectional study evaluated all physicians enrolled in a FM residency training program within the U.S. An online survey was electronically submitted to all resident physicians and fellows who provided an email address on the AAFP provider directory between June 2013 and January 2014. The survey contained demographic questions such as level of postgraduate training, type of program, and geographic location. It also presented several genitourinary conditions and inquired which practice specialty was believed to be the most appropriate in its evaluation: gynecology, general urology, or urogynecology. Surveys were completed anonymously and voluntarily, without financial compensation. Results: Of the 454 FM residency training programs in the U.S., 422 were identified and invited to participate. A total of 910 respondents were received (92.9 %). Training programs in all US states were represented, except for Alaska, Hawaii, Idaho, Mississippi, Missouri, New Hampshire, Oregon, Utah and Washington, West Virginia. Seventy-three percent of the respondents were enrolled in a community-based program while 27 % were part of a university program. Rural programs were the most common practice setting (86 vs 4 %). By level of training, 1st-, 2nd-, 3rd-year, and fellows comprised 36, 38, 24, and 2 %,
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
respectively. When questioned regarding the differences between services provided by urology and FPMRS, the following responses were provided: 4 % same services, 61 % different services, and 35 % similar services but with substantial differences. 53 % of the respondents were aware that FPMRS was a board certified specialty and 33 % were aware that urologists are able to specialize in FPMRS. Table 1 represents the specialty referral patterns of FP resident physicians by preference. Urology was the preferred referral service for the management of 4 out of the 5 genitourinary conditions listed. Gynecology, followed by FPMRS, was most often considered for the evaluation of POP (45 vs 39 %). Condition
Urology Female Gynecologist Urogynecologist None urologist (FMPRS) 15 %* 1 %* 45 %* 39 %* 0 %*
Pelvic organ prolapse Recurrent urinary 62 %* tract infections Kidney stones 88 %*
Macroscopic 85 %* hematuria Interstitial cystitis 85 %*
8 %*
12 %*
6 %*
12 %*
0 %*
0 %*
0 %*
12 %*
0 %*
1 %*
6 %*
8 %*
1 %*
5 %*
8 %*
1 %*
*Percentages were rounded to nearest decimal Conclusion: Amongst referring FP resident physicians, FPMRS is rarely considered beyond the management of pelvic organ prolapse. Increased physician awareness of the role of FPMRS in the evaluation of genitourinary conditions is very much needed. References: 1. Milbank Q. 2011 Mar; 89(1):39–68. 2. Am Fam Physician. 2010 Sep 15; 82(6):638–43. Disclosure Block: Omar Duenas: No disclosures. Marjorie Jean-Michel: No disclosures. Guillermo Marroquin: No disclosures. Magdy Mikhail: No disclosures.
OP 115 SYMPTOM BOTHER AND CARE SEEKING FOR URINARY INCONTINENCE IN WOMEN H. REEVES1, R. CARTWRIGHT 2, F. SORRENTINO 2, L. FRANKLIN 1, V. KHULLAR 2; 1 Women’s Health Research Centre, Imperial Coll. London, London, United Kingdom, 2Imperial Coll. London, London, United Kingdom. Introduction: Urinary incontinence remains stigmatizing among women, despite its high prevalence. Approximately 40 % of all women experience significant urinary incontinence, but fewer than 5 % present to primary care providers for investigation and treatment [1]. Understanding the root causes of this underutilization of healthcare resources, and the major barriers to
S195
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
care-seeking is important as both stress and urgency incontinence are amenable to non-invasive treatment. Recent randomized trials have demonstrated that a proactive approach among women who have not presented for care, including evidence-based continence promotion, to incite women to access care, improves self-reported symptoms [2]. A recent community based study from the US, using qualitative methods has suggested that normalization of symptoms, and minimization of symptom bother, may be one factor preventing care seeking [3]. Such associations between self-reported bother and UI care-seeking may be biased by inequity in access to care, or other unmeasured confounders of care seeking in general, including self-perception of stigmatization. Objective: With limited data available from community-based studies, we conducted an in hospital cross-sectional study, aiming to compare symptom bother for women with varying severities of stress and urgency incontinence, who had either presented for care for UI, or presented for care for other conditions. Methods: Women were recruited from either urogynaecology clinics or general gynaecology clinics (including reproductive endocrinology, colposcopy, and recurrent miscarriage). They completed the validated International Consultation on Incontinence Questionnaire for Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) items reporting both the frequency of stress and urgency incontinence (Scale: never/occasionally/ sometimes/most of the time/all of the time), and the bother associated with each incontinence symptom (10 point scale). We used multivariate ordinal regression, adjusting for age, to assess the association between incontinence care seeking and bother, for each level of incontinence frequency. Analyses were conducted using SPSS v21.0. Results: We recruited 403 women, of mean age 48.6, median parity of 1.0, and mean BMI 25.8. Symptom bother was negatively associated with age (p<0.01). For both stress and urgency incontinence, across the range of symptom frequencies, women who had presented for incontinence care reported more severe symptom bother (see table). In multivariate ordinal regression we observed a similar effect size for both urgency incontinence (estimate 1.135 p=0.008) and stress incontinence (estimate 0.955, p=0.015). Table: Mean symptom bother for stress and urgency incontinence, stratified by symptom frequency.
Stress Incontinence Symptom Frequency
Urgency Incontinence Mean Bother
Symptom Frequency
Mean Bother Care Seeking
Non-Care Seeking
3.5
Occasionally
5.0
3.6
5.3
Sometimes
7.7
7.2
8.7
6.4
Most of the time
9.0
7.0
9.6
10.0
All of the time
9.7
10.0
Care Seeking
Non-Care Seeking
Occasionally
4.2
Sometimes
6.7
Most of the time All of the time
p=0.015
p=0.008
Conclusions: Women who do not present for care with incontinence self-report lower bother at the same symptom
severity compared to women who do seek incontinence care. Women with occasional symptoms, who had not sought care, rarely reported major bother. Our results are compatible with symptom bother being among the main drivers of treatment seeking. Collecting data from women with UI, who sought secondary care for other conditions, may have reduced unmeasured confounding, however our results may not be generalizable to primary care settings. Future research should explore the interaction of bother and care-seeking longitudinally. When employing a proactive approach to incontinence screening, clinicians should routinely assess the bother associated with symptoms, and target women for intervention based both on symptom severity and symptom bother. References: 1. Int Urogynecol J 2012 Aug;23(8):1087–93 2. BMJ Open 2013 Dec 10;3(12):e004135 3. Qual Health Res 2011 Sep; 21(9):1229–38 Disclosure Block: Heather Reeves: No disclosures. Rufus Cartwright: Astellas Pharma: Speaker, Honoraria. Felice Sorrentino: No disclosures. Larissa Franklin: No disclosures. Vik Khullar: Allergan, Astellas, Pfizer: Scientific Medical Advisor, Consulting Fee. Allergan, Astellas, Pfizer: Speaker, Consulting Fee. Allergan, Astellas, Pfizer: Consultant, Consulting Fee. Allergan, Astellas, Pfizer: Advisory Committee Member, Consulting Fee.
OP 116 UNDERSTANDING BARRIERS TO SEEKING CARE FOR URINARY INCONTINENCE IN AN INSURED POPULATION J. K. LEE1, S. REITER 2, S. HSIEH 3, L. WENZEL 3, K. L. NOBLETT 4; 1 Urogynecology, Kaiser Permanente Orange County, Anaheim, CA, 2Obstetrics and Gynecology, Univ. of California Irvine, Orange, CA, 3Health Policy Research Institute, Univ. of California Irvine, Irvine, CA, 4Urogynecology, Univ. of California Irvine, Orange, CA. Introduction: Projections estimate urinary incontinence to affect 41 million Americans in 2050 (1). Despite this, prior research has shown less than half of affected women with moderately bothersome urinary incontinence seek treatment (2,3). Since improvement in continence can be achieved in up to 80 % of patients, interventions addressing modifiable barriers to care seeking may provide an opportunity to improve patients’ quality of life. Objective: The aim of this study was to identify barriers to seeking treatment for urinary incontinence in insured women. Methods: This was a qualitative focus group study. Focus group participants were recruited for “treated” and “untreated”
S196
groups with 4 planned groups (2 treated and 2 untreated). Inclusion criteria for all participants: 1) adult female 2) not pregnant or not planning pregnancy 3) fluent in English 4) actively insured. For “treated” groups, participants had to have previous treatment or evaluation for urinary incontinence. For the “untreated” group, participants had to have 1) moderate to severe incontinence by Sandvik’s severity index and 2) not discussed their condition with a healthcare provider. Subjects were recruited both by passive (email research announcements, flyers) and active recruitment (from offices of urogynecology providers). The focus group qualitative interview questions were semistructured and used open-ended questions posed by a neutral, non-practitioner moderator. The focus groups were audiorecorded and transcripts were prepared by a verbatim translation of the audiotapes. Thematic analyses were conducted on focus group data. All data were managed and analyzed using QSR International’s NVivo 10 qualitative data analysis software tool. The transcriptions were inputted into the software and selected parts of the text were coded as nodes (themes). Each coded node was given a title. The theme titles were refined and connections were made between groups of themes to identify higher order and sub-themes. Results: We conducted four focus groups including 19 women. 11 women participated in the “untreated” and 8 in the “treated” focus groups. Mean age for the group was 51 years and 90 % of the group had a college education or higher. Participants were Caucasian (47 %), Hispanic (21 %), Asian (21 %) and other (2 %). Thematic saturation was reached with no additional themes identified in the fourth focus group. Five sets of barriers were identified: 1. Normative thinking with participants’ belief in the prevailing idea that urinary incontinence was a normal part of aging, childbearing, or hereditary. 2. Other health issues took priority over urinary incontinence. 3. Fear of medical or surgical treatment including medication side effects and recovery time for surgery. 4. A communication barrier was identified as subjects viewed the condition as embarrassing and therefore less likely to be mentioned, particularly when there was a time constraint in the visit. 5. Physicians themselves were identified as a barrier; doctors did not query for it and when the issue was mentioned, it was often dismissed or misinformation prevailed. Conclusions: Significant barriers to seeking care for urinary incontinence were identified in this study population of insured women. Results from this study indicate that these modifiable barriers can be targeted to facilitate more open communication
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
and change standard practices. Specifically, physicians can be educated to screen patients for this prevalent and embarrassing condition as a routine part of medical care, as well as address fears and misconceptions regarding etiology and treatment options. References: 1. Wu JM, Hundley AF, Fulton RG, Myers ER. Forecasting the prevalence of pelvic floor disorders in U.S. Women: 2010 to 2050. Obstet Gynecol. 2009 Dec;114(6):1278–83. 2. Benner JS, Becker R, Fanning K, Jumadilova Z, Bavendam T, Brubaker L. Bother related to bladder control and health care seeking behavior in adults in the United States. J Urol. 2009; 181 (6):2691–8. 3. Keller SL. Urinary incontinence: occurrence, knowledge, and attitudes among women aged 55 and older in a rural Midwestern setting. J Wound Ostomy Continence Nurs. 1999 Jan;26(1):30–8. Disclosure Block: Jennifer Lee: No disclosures. Samantha Reiter: Hospira, Inc.: Speaker’s Bureau, Consulting Fee. Cadence Pharmaceuticals: Speaker’s Bureau, Consulting Fee. Susie Hsieh: No disclosures. Lari Wenzel: Disclosure Not Provided. Karen Noblett: Medtronic: Consultant, Honoraria. Boston Scientific: Consultant, Honoraria.
OP 117 THE ACCURACY OF CURRENT PROCEDURAL TERMINOLOGY (CPT) CODES TO CAPTURE THE SURGICAL APPROACH USED FOR HYSTERECTOMY D. M. MORGAN1, N. MAHNERT 1, K. M. THOMPSON 2, G. SHELBY 3, C. W. SWENSON 2, G. KRAPOHL 1, D. E. FENNER 1, A. SAWSAN 1, D. CAMPBELL 3; 1 Department of Obstetrics & Gynecology, Univ. of Michigan, Ann Arbor, MI, 2Univ. of Michigan, Ann Arbor, MI, 3Transplant Surgery, Univ. of Michigan, Ann Arbor, MI. Introduction: Current Procedural Terminology (CPT) is the most widely accepted medical nomenclature used to report medical procedures and services in the United States. In addition to setting reimbursement, CPT codes are often used when reporting quality improvement measures and making public policy. Administrative data, including CPT codes, have the potential to significantly impact clinical and financial decision-making.1 Therefore, analyses to establish the accuracy of these data are crucial. Objective: To determine the accuracy of Current Procedure Terminology (CPT) codes in capturing surgical approach to hysterectomy. Methods: The data for this retrospective analysis is from a 52 hospital collaborative of academic and community institutions which voluntarily report perioperative outcomes of hysterectomy for quality improvement. Each hospital has a specially trained, dedicated nurse abstractor to collect patient characteristics,
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
intraoperative processes of care, and administrative data including CPT codes. Standardized data collection methodology is routinely validated through scheduled site visits, conference calls, internal audits, and inter-rater reliability audits. For this study, data from the operative note by the nurse abstractor was compared with CPT codes utilized for billing. The nurse reviewer indicated if the surgical approach was described in the operative note as abdominal, laparoscopy, robotic assisted laparoscopy, laparoscopy assisted vaginal hysterectomy or vaginal hysterectomy. Because CPT codes do not differentiate cases with and without robotic assistance, robotic cases were included in the laparoscopy group. When the surgical approach from operative note and CPT code were consistent, they were considered “concordant” and when not consistent, they were considered “discordant.” Chi square analysis was used to assess the likelihood of concordance between the surgical approach described by the nurse reviewer and the CPT code utilized. Results: Between January 1, 2013 and December 9, 2013, 50 hospitals have reported data on 7,499 hysterectomies. The rate of concordance between the surgical approach abstracted from the operative note and the CPT code was 82.7 % (6198/7499). When there was discordance between the surgical approach in the operative note and the CPT code, the CPT codes most frequently used were those for LAVH (70.9 %, 912/1301 cases) followed by abdominal (12.9 %, 169/1301), vaginal (9.6 %, 126/1301), and laparoscopy (7.2 %, 94/1301). Conclusions: This stud, analyzing the accuracy of hysterectomy CPTcodes from a large, statewide collaborative demonstrates that CPT codes do not accurately reflect surgical approach described in operative reports in 17.3 % of cases. Because of the potential clinical and financial repercussions, this discrepancy should be a target for quality improvement and warrants further study. References: 1. Validity of selected Patient Safety Indicators: opportunities and concerns. J Am Coll Surg. 2011 Jun;212(6):924–34. Disclosure Block: Daniel Morgan: Up to Date: Author, Royalty. France Foundation: Author, Royalty. Nichole Mahnert: No disclosures. Katherine Thompson: No disclosures. Gwendolyn Shelby: No disclosures. Carolyn Swenson: No disclosures. Greta Krapohl: No disclosures. Dee Fenner: American Medical Systems: Research grant, Grant/Research Support. As-Sanie Sawsan: Disclosure Not Provided. Darrell Campbell: No disclosures.
OP 118 ASSESMENT OF HEALTH AND FUNCTIONAL STATUS IN ELDERLY WOMEN WITH PELVIC ORGAN PROLAPSE: PRELIMINARY ANALYSIS T. V. SANSES1, N. SCHILTZ 2, S. MAHAJAN 3, H. JOHNSON 4, D. F. WARNER 5, S. M. KOROUKIAN 6; 1 Univ. Of Maryland Sch. of Med., Baltimore, MD, 2Department of Epidemiology, Case Western Reserve Univ.,
S197
Cleveland, OH, 3Case Western Reserve Univ., Cleveland, OH, 4Univ. Of Maryland Med. Ctr., Baltimore, MD, 5Department of Sociology, Univ. of Nebraska-Lincoln, Lincoln, NE, 6 Department of Epidemiology and Biostatistics, Case Western Reserve Univ., Cleveland, OH. Introduction: Health and functional status (HFS), frequently used in geriatric population (1,2), could serve as quality of life measures in evaluation of outcomes in elderly women with pelvic organ prolapse. If a certain surgical procedure negatively affects these measures, it will be important to know which surgical procedure is likely to lead to decline in HFS. Objective: To assess HFS using the Health Retirement Study (HRS) linked to administrative Medicare files. Methods: We obtained the linked HRS-Medicare data from the Centers for Medicare/Medicaid Services. The HRS is the largest ongoing prospective longitudinal study of older persons’ health in the U.S. beginning in 1992 (3). It is a nationally representative sample of more than 30,000 persons over 50 years of age and their spouses interviewed every 2 years. Medicare files include information on inpatient admissions, outpatient hospital encounters, and ambulatory surgeries. Using appropriate prolapse diagnoses, we determined the demographics, comorbidities, and HFS in women ≥65 years with prolpase between 1992 and 2008. HFS assessment consisted of two elements: 1) Health status was self-rated by respondents as poor, fair, good, very good, and excellent. 2) Functional status measures included evaluation of strength, upper/lower body mobility, and activities of daily living (ADLs). Functional status impairment was considered when limitations on at least 4 out of 21 items were present. Results: We identified 952 women with prolapse in linked HRS-Medicare file. The median age was 73 (interquartile range: 69, 79). The racial/ethnic distribution was 85.3 % white, 6.5 % black, 7.1 % Hispanic, and 1.1 % other. Just over 20 % were classified as obese. Comorbities were arthritis (70.3 %), hypertension (57.5 %), heart disease (27.1 %), history of stroke (11.9 %), history of cancer (14.0 %), COPD/Lung disease (10.4 %), and emotional problems (16.8 %). The mean number of comorbidities per person was 2.0 (sd: 1.26). Health status was poor or fair in 31.8 % of the population based on self-rated assessment. Half of the population had impairment in functional status with limitations on at least 4 of 21 items. Difficulties in ADLs were reported for bathing (2.5 %), getting in and out of bed (2.7 %), dressing (2.8 %), eating (1.1 %), and moving across the room (5.2 %). Additional population characteristics included low cognitive performance −31.8 %, hearing impairment −19.5 %, vision impairment 20.1 %.
S198
Conclusions: Our preliminary analysis suggests that large proportion of elderly women with prolapse have limitations in HFS. HFS could serve as quality of life measures in evaluation of outcomes in elderly women with pelvic organ prolapse. References: 1. Dennis RA, Johnson LE, Roberson PK, Heif M, Bopp MM, Garner KK, Padala KP, Padala PR, Dubbert PM, Sullivan DHJ. Changes in Activities of Daily Living, Nutrient Intake, and Systemic Inflammation in Elderly Adults Receiving Recuperative Care Am Geriatr Soc. 2012 Nov 23. doi:10.1111/ jgs.12007. 2. Lin JS, Whitlock EP, Eckstrom E, Fu R, Perdue LA, Beil TL, Leipzig RM. Challenges in Synthesizing and Interpreting the Evidence From a Systematic Review of Multifactorial Interventions to Prevent Functional Decline in Older Adults [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Oct. Report No.: 12-05169-EF-1. U.S. Preventive Services Task Force Evidence Syntheses, formerly Systematic Evidence Reviews. 3. Wallace RB, Herzog AR. Overview of the Health Measures in The Health and Retirement Study. The Journal of Human Resources. 1995 S84-S107 Disclosure Block: Tatiana Sanses: Allergan: Consultant, Consulting Fee. Nicholas Schiltz: No disclosures. Sangeeta Mahajan: Astellas, Inc: Speaker’s Bureau, Honoraria. Allergan, Inc: Investigator initiated trial research grant, Grant/Research Support. Harry Johnson: TDOC: Stock Shareholder, Ownership Interest. IMET: Stock Shareholder, Ownership Interest. David Warner: No disclosures. Siran Koroukian: Summa Care: Consultant, Not reimbursed. American Renal Associates: My spouse is Medical Director of dialysis units by American Renal Associates., Salary.
OP 119 HOW MANY WOMEN GET WHAT THEY WANT—A NONTRAUMATIC NORMAL VAGINAL DELIVERY? J. L. CAUDWELL-HALL1, I. KAMISAN ATAN 1, R. A. GUZMAN ROJAS 1, K. SHEK 2, H. DIETZ 1; 1 Sydney Med. Sch. Nepean, Penrith, Australia, 2Univ. of Western Sydney, Liverpool BC, Australia. Introduction: Clinical trauma to the perineum, external and internal anal sphincters is common, as is (usually occult) trauma to the levator ani muscle. Most of it occurs during a first vaginal delivery. In this study we aim to quantify the proportion of primiparous women after term cephalic delivery who achieve a normal vaginal birth while avoiding major trauma to pelvic floor structures.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Objective: To investigate rates of non-traumatic normal vaginal birth in primiparous women after term cephalic delivery. Methods: This is a retrospective observational study utilising data sets of primiparous women seen in the context of a perinatal trial. Between August 2008 and March 2012, 626 patients carrying an uncomplicated singleton pregnancy were seen at a tertiary unit. They all underwent an interview and 4D translabial pelvic floor ultrasound both ante- and postnatally for assessment of the levator ani (1) and anal sphincters (2). Postprocessing analysis of ultrasound volumes was performed blinded against all clinical data and analysed against obstetric data retrieved from the local maternity database.
Figure: Tomographic levator and anal sphincter imaging in a 28 year old patient who suffered both an avulsion and anal sphincter tear during a normal vaginal delivery at term. Results: A total of 474/626 women (76 %) returned for a follow-up appointment at a mean interval of 5 (2.3–24.3, SD 2.43) months. Mean age was 30.8 (18.8–45.3, SD 5.2) years, mean BMI was 24.0 (16.1–47.2, SD 5.0), and mean gestation at delivery 39.9 (36.0–42.2, SD 1.2) weeks. Mean birthweight was 3447.5 (2222–4996) grams, median length of 1st stage was 400 (IQR 250–600) minutes, of the 2nd stage 49 (IQR 16–104) minutes. In 22 patients we were unable to retrieve US data sets or imaging was unsatisfactory, delivery data was missing in 6, and a further 3 patients were pregnant at the time of follow-up. Hence a total of 443 women were analyzed. These patients are part of an ongoing perinatal trial, but the trial intervention had no effect on our main outcome measure (P=0.965). Of 443 women, 239 (54 %) had a normal vaginal delivery (NVD). Of those 239, 37 patients (15 %) were diagnosed with an avulsion, leaving 202, of whom 65 women showed evidence of irreversible overdistention, leaving 137 women. A total of 45 patients (19 %) were found to have evidence of significant external anal sphincter trauma, and for 24 of those, this was the only evidence of major trauma, leaving 113 out of 443 women (25.5 %) who could be said
S199
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
to have had a nontraumatic NVD. On univariate analysis a number of predictors were significantly associated with nontraumatic normal vaginal delivery. On multivariate analysis, only younger age (p=0.001) and a larger area on valsalva (p<0.001) remained highly significant as predictors. Table: Predictors of nontraumatic vaginal delivery (n=443). * Mann- Whitney test
Predictors (Antepartum) Age at first
Non-traumatic
P-value
NVD (yes/no) 29.4 (SD 5.14) vs
delivery (years)
31.28 (SD 5.11)
Body Mass Index
23.74 (SD 4.98) vs
Predictors (Intrapartum)
Non-traumatic
P-value
NVD (yes/no)
0.001
Epidural use
29/113 vs 170/328
<0.001
NS
Syntocinon use
31/113 vs 182/328
<0.001
0.001
1st stage of
median 375 vs 415
NS*
median 47 vs 49
NS*
Birth weight
3393 (SD 359) vs
0.076
(grams)
3466 (SD 430)
24.11 (SD 4.99) Gestation at delivery (weeks) Bladder position on Valsalva (mm) Hiatal area on Valsava (cm2)
39.5 (SD 1.2) vs 40 (SD 1.2) 8.2 (SD 11.3) vs
labour (min) 0.002
12.1 (SD 10.8) 21.2 (SD 6.3) vs 18.8 (SD 5.8)
2nd stage of labour (min)
<0.001
Conclusions: The prevalence of significant pelvic floor trauma is much higher than generally assumed. Together with the high prevalence of operative delivery in our population (over 40 %), this implies that only a small minority of primiparous women will achieve an optimal outcome. NVD without significant pelvic floor trauma occurred in only about 1/4 of 443 singleton cephalic first deliveries at term. Younger maternal age at delivery and measures of increased pelvic organ mobility and pelvic floor distensibility seem to increase the likelihood of non-traumatic NVD. References: 1.) Int Urogynecol J 2011; 22: 1221–1232. 2.) Ultrasound Obstet Gynecol 2013; 42: 461–466 Disclosure Block: Jessica Caudwell-Hall: No disclosures. Ixora Kamisan Atan: No disclosures. Rodrigo Guzman Rojas: No disclosures. Ka Lai Shek: GE: Speaker, unrestricted educational grants. Hans Peter Dietz: GE Medical: unrestricted educational grant, Grant/Research Support.
S200
OP 120 THE ASSOCIATION OF PELVIC ORGAN PROLAPSE AND JOINT HYPERMOBILITY: RESULTS FROM THE TWINSUK ADULT TWIN REGISTRY F. SORRENTINO1, R. CARTWRIGHT 2, P. GRECO 3, H. REEVES 4, V. KHULLAR 2, M. JARVELIN 2, T. SPECTOR 5; 1 Department of Urogynaecology, Imperial Coll. London, London, United Kingdom, 2Imperial Coll. London, London, United Kingdom, 3Univ. of Foggia, Foggia, Italy, 4Women’s Health Research Centre, Imperial Coll. London, London, United Kingdom, 5King’s Coll. London, London, United Kingdom Introduction: Joint hypermobility (JHM) describes increased range of movement in the joints or spine and it has been identified in up to 15 % of the general population. Collagen dysfunction plays an important role both in laxity of the joints and in inadequate support of the pelvic organs [1]. Some evidence suggests a common genetic origin for JHM and pelvic organ prolapse (POP) [2]. As JHM typically first presents in childhood, it may be an important early marker of connective tissue abnormalities and susceptibility to POP. Many previous small case control studies have tested for an association between JHM and POP, but with highly heterogeneous findings [3]. Objective: The aim of this study was to assess whether symptomatic POP is associated with JHM, using a large population representative sample. Methods: We conducted a cross-sectional study, recruiting participants in TwinsUK, a large UK population representative registry of adult twins. Women were invited to complete either an online or a postal questionnaire including validated items on symptomatic POP, and items on diagnosis and treatment of POP. We defined symptomatic prolapse using two ICIQ-Vaginal Symptoms Questionnaire (ICIQ-VS) items: 1. “Are you aware of a lump or bulge coming down in your vagina?” 2. “Do you feel a lump or bulge coming out of your vagina altogether, so that you can feel it or see it on the outside?” Response options ‘never/occasionally/sometimes/ most of the time/all of the time’. We considered women responding to either item between ‘occasionally’ to ‘all the time’ as a symptomatic case for this analysis. Previous diagnosis or treatment for prolapse was determined using the items: “Have you ever been diagnosed by a doctor or nurse with prolapse of the womb or vagina?” and “Have you ever had treatment for prolapse of the womb or vagina (including a pessary or prolapse surgery)?” (response options: yes/no). JHM was assessed using a validated self reported 5-point questionnaire, with previously demonstrated high concordance for formal clinical diagnosis of JHM. We used multivariable logistic regression adjusting for age, to assess associations. Results: 5,648 women were invited to participate. We received 3,475 usable responses (61.5 %). There was no
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
evidence of non-response bias. Women were of mean age 61, median parity 2, and mean BMI 26.6. The prevalence of significant symptomatic POP was 8.6 %, and the prevalence of symptomatic JHM was 20.8 %. Parity was the strongest predictor of POP (adjusted OR 1.30/delivery, p<0.001) but was unassociated with JHM. Age and BMI were both modestly negatively associated with JHM and positively associated with POP (each p<0.01). In logistic regression, adjusting for age (see Table), JHM was significantly associated with symptomatic POP, with a plausible biological gradient (adjusted OR 1.15/point for bulge inside the vagina; adjusted OR 1.33/point for bulge outside the vagina). We found a similar effect size for self-report of treatment of POP (adjusted OR 1.17/point), and a directionally consistent but non-significant association with self-report of diagnosis of POP (adjusted OR 1.08/point). Conclusions: This is the largest study conducted to date of an association between JHM and POP. Strengths include the population representative sample, the use of validated questionnaires for both conditions, and blinding of participants to the study hypothesis. Our results demonstrate a small positive association with narrow confidence intervals for both symptomatic prolapse and treatment for prolapse. Our results are consistent with shared genetic or environmental risk factors for these conditions, and future research should explore these interactions. Clinicians should be aware that JHM in young women may be a risk factor for POP at mid-life. Women with JHM should be targeted for primary and secondary prevention of POP. References: 1. Int Urogynecol J. 2012;23(3):313–9 2. Twin Res. 2004;7(3):254–60 3. BJOG. 2013;120(2):187–92 Logistic regression analyses of JHM as a predictor of each POP case definition Adjusted OR
95 % CI
p
1.15
1.01–1.31
0.032
1.33
1.10–1.61
0.003
1.15
1.01–1.31
0.031
1.08
0.95–1.23
0.237
1.01–1.35
0.034
Symptomatic bulge inside the vagina Symptomatic bulge outside the vagina Any symptomatic vaginal bulge Self report of POP diagnosis Self report of POP treatment
1.17
Disclosure Block: Felice Sorrentino: No disclosures. Rufus Cartwright: Astellas Pharma: Speaker, Honoraria. Pantaleo Greco: No disclosures. Heather Reeves: No disclosures. Vik Khullar: Allergan, Astellas, Pfizer: Scientific Medical Advisor, Consulting Fee. Allergan, Astellas, Pfizer: Speaker, Consulting Fee. Allergan,
S201
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Astellas, Pfizer: Consultant, Consulting Fee. Allergan, Astellas, Pfizer: Advisory Committee Member, Consulting Fee. Marjo-Riitta Jarvelin: No disclosures. Tim Spector: No disclosures.
OP 121 BODY IMAGE, REGRET, AND SATISFACTION 6 MONTHS FOLLOWING COLPOCLEISIS; A MULTICENTER STUDY C. C. CRISP1, J. A. CUNKELMAN 2, N. M. BOOK 3, A. L. SMITH 4, R. N. PAULS 5; 1 Division of Urogynecology and Reconstructive Pelvic Surgery, Good Samaritan Hosp., TriHlth., Cincinnati, OH, 2 Department Obstetrics and Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Loyola Univ., Chicago, IL, 3Deptartment Obstetrics and Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Riverside Hosp., Columbus, OH, 4Department Obstetrics and Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Cleveland Clinic Florida, Westin, FL, 5Good Samaritan Hosp., Cincinnati, OH Introduction: It has been shown that colpocleisis, a vaginal obliterative procedure for the treatment of pelvic organ prolapse, is a durable approach that leads to decreased pelvic floor symptoms. Furthermore, improvements in body image, low levels of patient regret, and high patient satisfaction have been documented at 6 weeks after surgery. Long term data, however, is less robust; therefore, our aim was to describe these parameters 6 months following repair. Objective: To evaluate the impact of colpocleisis on body image, regret, satisfaction, and pelvic floor symptoms 6 months following surgery. Methods: This was a prospective multicenter study conducted through the Fellows’ Pelvic Research Network. Data was collected from 7 sites across the United States. Women were eligible for enrollment if they selected colpocleisis as treatment for pelvic organ prolapse (POP). Outcomes assessed were body image, regret, satisfaction, and pelvic floor symptoms following colpocleisis. Data was collected at 6 and 24 weeks following surgery; this report contains analysis of the 24 week postoperative data. The Pelvic Floor Impact Questionnaire (PFIQ), Pelvic Floor Distress Inventory (PFDI), and the modified Body Image Scale (BIS) were completed pre and postoperatively. The Decision Regret Scale and the Satisfaction with Decision Scale were administered at 6 and 24 weeks postoperative visits. A sample size of 88 subjects was calculated to evaluate for a significant change in the BIS at 6 weeks. Results: Eighty-nine subjects were enrolled. Two did not undergo surgery, and 7 were deceased at the time of 24 week follow up. Of the remaining subjects, 76 % (61/80) responded
to their 6 month questionnaires. There was no difference in demographic data between responders and non-responders. Mean age was 78 years (SD 6) with a mean body mass index (BMI) of 26.8 (SD 4.25). The majority (94.8 %) was Caucasian. Significant improvements in all pelvic floor symptoms were noted 6 weeks postoperatively. When compared to baseline, 6 month data showed sustained improvement in pelvic floor symptoms in the subscales of the PFDI, including significant change in the POPDI (p<.001), CRADI (p<.001), UDI (p<.001), and PFDI summary score (p<.001). Further pelvic floor assessment using the PFIQ revealed persistent significant improvements in the bladder (p<.001), vagina (p<.001), and summary score (p<.001). Additionally, mean and total body image scores continued to show significant improvement when compared to preoperative scores (p<.001 and p<.001, respectively). Finally, patients continued to be satisfied with their decision to undergo surgery (mean 4.6, SD 0.61) and had a very low level of regret regarding this decision (mean 1.5, SD 0.68). Conclusions: Colpocleisis is a highly effective surgical treatment option for pelvic organ prolapse with improvements in both pelvic floor symptoms and body image. These improvements, in conjunction with high satisfaction and low regret seen at 6 and 24 weeks after surgery, provide reassurance that colpcleisis is an ideal alternative to reconstruction for appropriate patients. References: N/A Disclosure Block: Catrina Crisp: No disclosures. Jacqueline CUNKELMAN: No disclosures. Nicole Book: No disclosures. Aimee SMITH: No disclosures. Rachel Pauls: Trimel Inc: Research site, Grant/Research Support.
OP 122 ARE SUBJECTIVE CONTINENCE OUTCOMES SUSCEPTIBLE TO COGNITIVE DISSONANCE OR CONTEXT BIAS? Y. QUEZADA1, J. L. WHITESIDE 2, K. F. SPRATT 1; 1 Female pelvic Medicine and Reconstructive Surgery, The Christ Hosp., Cincinnati, OH, 2The Christ Hosp./Univ. of Cincinnati, Coll, Cincinnati, OH Introduction: Subjective outcomes may be vulnerable to cognitive dissonance, a type of placebo effect. Cognitive dissonance occurs when there is a conflict between an individuals beliefs and experiences of reality. Because it is desirable to match reality with our beliefs about it, subjective outcome measures are vulnerable to re-interpretation to regain consistency. The effect of such re-interpretations of reality is magnified in a setting such as surgery.[1]
S202
Among subjective incontinence severity assessments, the Incontinence Severity Index (ISI) measure is convenient and popular. Using the ISI we sought to estimate the presence and impact of cognitive dissonance on subjective incontinence severity following a mid-urethral sling procedure. Additionally, we also evaluated the effects that the ordering of survey items might have on ISI responses. Objective: To evaluate if among women who sustained no improvement or deterioration of ISI scores there was a bigger difference in recalled pre-treatment ISI score and actual pretreatment ISI score. To determine if pre-treatment and post-treatment follow-up ISI scores would be affected by survey item order. Methods: Cases were identified by CPT code of women who underwent a mid-urethral sling with or without concomitant prolapse surgery for the 4-year calendar period January 1st, 2007 to December 31st, 2010. Telephone questionnaire was conducted by trained interviewers using a script of validated surveys where question order was randomized at the time of phone call. Among the validated surveys used in the script was the Incontinence Severity Index that was administered for current incontinence severity and recalled pre-treatment incontinence severity. Survey responses were matched with demographic and clinical data extracted from the electronic medical record (EMR), including pre-treatment ISI scores. Cognitive dissonance was evaluated by comparing the likelihood of recalled ISI scores at baseline being higher than actual pre-treatment ISI scores for those whose actual post treatment follow-up ISI scores did not demonstrate real improvement compared to those whose actual post treatment ISI scores did demonstrate real improvement. Both absolute percent differences and relative risks were used to test this hypothesis. The effects of item order was determined by creating 8 distinct item orders on pre-treatment to post-treatment follow-up ISI scores that was evaluated as a 8 randomized orders x 2 Time mixed model analysis using the GLIMMIX procedure in SAS 9.4 (SAS Institude, Cary, NC). Results: Of 497 patients identified three had died since surgery leaving 494 eligible subjects of which 157 were enrolled. Mean age at the time of the procedure was 58 years (range 27–73). Mean time since the surgery was 4.5 years (range 2–6 years). Among the 157 enrolled subjects, 125 had ISI scores at pretreatment, and at phone survey follow-up that included a current ISI and a recalled estimate of ISI at pre-treatment. 74 patients (59.2 %) reported a real change in ISI score between pretreatment and current assessment indicating an ISI gain of >4. 51 patients (40.8 %) demonstrated no real change from pre-to post-treatment ISI. 58 % of the patients reporting no real improvement recalled having a worse incontinence problem than was actually recorded at pre-treatment compared to 40.5 % of the patients reporting real improvement also having recalled worse problems at pre-treatment than they historically recorded. This absolute change of an 18.3 % higher rate of over-reported pre-
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
treatment incontinence severity was significant (p<0.045). The relative risk of over-reporting recalled pre-treatment incontinence status was 1.45 with a 95 % CI of 1.02–2.07. The results of mixed model factorial design indicated that pre-treatment ISI scores were significantly higher than post-treatment ISI scores, p<.0001. These differences were in the same direction and significant for all 8 randomized patterns. The significant Order x Time interaction (p<.013) indicate that there was little variation in ISI scores across randomization levels for the follow-up ISI score but that the pre-treatment ISI scores, which were much larger, were quite volatile. Conclusions: There is a 1.45× greater risk of over-reporting baseline incontinence severity if the present incontinence severity is not reflective of a real gain from pre-treatment. This is consistent with cognitive dissonance. Further evaluation is needed to better understand factors that affected or effected the large variation in ISI scores across the 8 different order of item presentation. References: 1. Homer, J.J., C.E. Sheard, and N.S. Jones, Cognitive dissonance, the placebo effect and the evaluation of surgical results. Clin Otolaryngol Allied Sci, 2000. 25(3): p. 195–9. Disclosure Block: Yarini Quezada: No disclosures. James Whiteside: The International Academy of Pelvic Surgery: Board Member, Honoraria. Ethicon: Consultant, Consulting Fee. Kevin Spratt: No disclosures.
OP 123 TOO MUCH TOO SOON? LIFETIME PHYSICAL ACTIVITY AND STRESS URINARY INCONTINENCE I. NYGAARD1, J. SHAW 2, T. BARDSLEY 1, M. EGGER 3; 1 Obstetrics and Gynecology, Univ. of Utah, Salt Lake City, UT, 2Exercise and Sport Science, Univ. of Utah, Salt Lake City, UT, 3Family and Preventive Medicine, Univ. of Utah, Salt Lake City, UT Introduction: The effect of physical activity on SUI may vary by dose and timing. Objective: To estimate, in women ages 39 to 65 years not seeking care for UI, whether moderate to severe SUI is associated with overall lifetime physical activity (including leisure, household, outdoor, and occupational), lifetime leisure activity, lifetime strenuous activity, and strenuous activity during teenage years. Methods: Participants in this case–control study were recruited from primary care clinics. Primary exclusion criteria included current/recent pregnancy, BMI <18.5 or ≥40 kg/m2, prior pelvic organ prolapse (POP) or UI surgery, and medical problems precluding exercise for last year. Eligible women
S203
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
underwent POP-Q exams and completed the Lifetime Physical Activity Questionnaire (LPAQ) and Occupational Questionnaire (OQ), in which they detailed activities during 4 age epochs. Staff assessing POP and UI were masked to LPAQ results. Because SUI and POP may overlap but have different risk factors, we excluded women with maximal vaginal descent >−1 cm. Potential cases had moderate/severe UI (score of ≥3 on Incontinence Severity Index with predominant SUI); potential controls (no or mild UI) scored ≤2 on ISI. After excluding women whose LPAQ was not returned or had insufficient quality for analysis, 213 cases were frequencymatched 1:1 by age group to controls, randomly selected from 642 potential controls when >1 was eligible. We assigned all activities a MET value (metabolic equivalents) from the Compendium of Physical Activities and classified activities associated with repetitive impact and/or relatively higher intraabdominal pressures as strenuous. Using weighted averages, we expressed overall lifetime and leisure activity in MET-h/week and strenuous activity in h/week. We created separate multivariable logistic regression models for activity measures. Results: Participants’ mean age was 49 years. Compared to controls, SUI cases were more likely to have delivered vaginally, be overweight or obese, and to report their health status as less than excellent. The odds of SUI increased slightly with increased overall lifetime activity (OR 1.20 (1.02, 1.41), per 70 additional METh/week). [70 units is equivalent to 10 MET-h/day every day (e.g., running at 10 min/mile for 1 extra h/day or doing child care for 3.5 extra hrs/d every day]. As lifetime leisure activity demonstrated neither a linear nor polynomial pattern, we compared activity quintiles between cases and controls. Compared to the reference (quintile 2), all other quintiles incurred about half the odds of SUI (across quintiles, p=0.009) with OR for quintile 5 0.65 (95 % CI 0.36, 1.18). Results are similar when also adjusted for teen strenuous activity. The odds of SUI were not significantly associated with lifetime strenuous activity (OR 1.11; 95 % CI 0.99, 1.25). Greater strenuous activity in teen years was associated with modestly increased odds of SUI (OR 1.37 per 7 additional h/week (95 % CI 1.09, 1.71); OR 1.75 (1.15, 2.66) in sensitivity analyses adjusting for LPAQ measurement error using simulation-extrapolation. The predicted probability of SUI rose linearly in women exceeding 7.5 h of strenuous activity/week during teen years (Figure). Teen strenuous activity had a similar effect on SUI odds when adjusted for subsequent strenuous activity during ages 21–65 years, while subsequent strenuous activity adjusted for teen strenuous activity was not associated with SUI (OR 1.02; 95 % CI 0.90, 1.15). Body mass index and vaginal deliveries did not modify the effect of activity measures on SUI.
Conclusion: In middle-aged women without POP not seeking care for UI, overall lifetime physical activity is associated with modest increases in SUI odds, while lifetime leisure activity decreases and lifetime strenuous activity appears unrelated to SUI odds. Greater strenuous activity during the teen years, even accounting for subsequent strenuous activity, is associated with modest increases in SUI odds in later life.
References: NA Disclosure Block: Ingrid Nygaard: No disclosures. Janet Shaw: No disclosures. Tyler Bardsley: No disclosures. Marlene Egger: Bristol Myers Squibb: Stock Shareholder, Received $1847 in stocks as an inheritance and sold them the next month. Eli Lilly & Co: Stock Shareholder, Received $1432 in stocks as an inheritance and sold them the next month. Merck & Co Inc New: Stock Shareholder, Received $1422 in stocks as an inheritance and sold them the next month.
OP 124 TRENDS AND PATTERNS OF URODYNAMIC STUDIES IN U.S. FEMALES, 2000–2011 M. CONOVER 1, M. JONSSON FUNK 1, A. C. KINLAW 1, A. CONNOLLY 2, J. M. WU3; 1 Epidemiology, Univ. of North Carolina, Chapel Hill, NC, 2 Univ. of North Carolina, Chapel Hill, NC, 3UNC-Chapel Hill, Chapel Hill, NC. Introduction: Despite the widespread use of urodynamic studies in the United States, limited population-based data exist regarding recent patterns and trends of these procedures among adult women. Furthermore, recent studies suggest that urodynamic studies may not be necessary before surgery for women with uncomplicated, demonstrable stress urinary incontinence (1, 2).
S204
Objective: The purpose of this study is to provide utilization rates for cystometrograms (CMG) and to describe patterns and trends in urodynamic procedures in the United States, from 2000 to 2011. Methods: We used the 2000–2011 Truven Health Analytic’s Marketscan® Commercial Claims and Encounters and Medicare Supplemental Database. This includes deidentified healthcare claims for employees, dependents, and retirees with employer-based insurance. The population of interest included all enrolled females ≥18 years of age. Current procedural terminology (CPT) codes were used to identify unique service dates on which a CMG was performed, and any concurrent procedures, including uroflowmetry, voiding pressure study, urethral pressure profile, electromyography, and fluoroscopy. Covariates included age, calendar year the CMG was performed, region of the U.S., and associated ICD-9 (International Classification of Diseases, Ninth Revision) diagnosis codes. CMG utilization rates were estimated per 10,000 person-years. Poisson models were used to evaluate the independent effects of calendar year and region, after adjusting for age. Results: During 123,331,748 person-years of observation, we identified 506,984 CMGs for an overall utilization rate of 41.1 (95 % CI: 39.5, 42.8) per 10,000 person-years. CMG utilization increased with age (figure), peaking at age 76 with a rate of 88.1 per 10,000 person-years. CMG utilization increased between 2000 and 2011 (figure). This increase was most pronounced among patients over the age of 65, but was still present among women between ages 35 to 55. Compared to the baseline period of 2000–2004, age-adjusted utilization rates were significantly higher from 2005 to 2011 (p-value <0.0001 in each year). Utilization was relatively stable 2007–2010, peaking in 2009 then dropping 7.7 % (95 % CI: 4.5, 10.8) by 2011. The ageadjusted utilization rate in the West was 31.2 % (95 % CI: 28.5, 33.9) lower than the age-adjusted rate in the rest of the country. Among patients who had a CMG, uroflowmetry occurred with 72.2 % and a voiding pressure study accompanied 80.4 %. Urethral pressure profile, electromyography and fluoroscopy occurred in 53.8, 55.1 and 5.2 %, respectively. Conclusions: Utilization of cystometrograms is more common in older women. Utilization rates increased substantially among both older and younger adult females after 2005 and have remained near peak levels through 2011. Use varies widely by geographic region. References: 1. Nager CW, Brubaker L, Litman HJ, et al. A randomized trial of urodynamic testing before stress-incontinence surgery. N Engl J Med. 2012;366(21):1987–1997. 2. Van Leijsen, Sanne Adriana Lucia, Kluivers KB, Mol BWJ, et al. Value of urodynamics before stress urinary incontinence surgery: A randomized controlled trial. Obstetrics & Gynecology. 2013;121(5):999–1008.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Disclosure Block: Mitchell Conover: No disclosures. Michele Jonsson Funk: GlaxoSmithKline, Merck, UCB: MJF has received salary support in the past from the Center for Pharmacoepidemiology at UNC which is funded, in part, by an unrestricted grant from GlaxoSmithKline, Merck, and UCB., MJF has received salary support in the past Alan Kinlaw: No disclosures. AnnaMarie Connolly: No disclosures. Jennifer Wu: Proctor and Gamble: Consultant, Consulting Fee.
OP 125 IS URODYNAMIC DIAGNOSIS ASSOCIATED WITH TREATMENT RESPONSE TO MIRABEGRON? M. BASU1, A. BALACHANDRAN 1, J. DUCKETT 2; 1 Gynaecology, Medway Maritime Hosp., Gillingham, United Kingdom, 2Medway NHS Fndn. trust, Gillingham, United Kingdom Introduction: Mirabegron was the first β3-adrenoceptor selective agonist introduced into clinical practice. The detrusor muscle and urothelium contain 3 sub-types of β-adrenoreceptors with β3-adrenoreceptors forming the vast majority (97 %). β3adrenoreceptors promote relaxation of detrusor smooth muscle and urine storage during the storage phase of micturition. Mirabegron causes blockade of these receptors with consequent detrusor smooth muscle relaxation during the storage phase. Prior to the introduction of mirabegron, established pharmacological management of overactive bladder revolved around antimuscarinic drugs. Antimuscarinics inhibit involuntary bladder contractions by binding to muscarinic receptors, as well as having an established effect on bladder afferent function1. Whilst mirabegron is currently thought to act via predominantly motor pathways during filling, there is some evidence from animal studies of an effect on micromotions and afferent function2. Previous studies have found that the urodynamic finding of detrusor overactivity is not predictive of a positive response to antimuscarinic drugs3, which may indicate that the mode of action of such drugs is not predominantly motor driven.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Objective: There have been no studies evaluating whether the urodynamic diagnosis of detrusor overactivity is predictive of treatment response to mirabegron, and this was the objective of the current study. Establishing whether this is the case would provide novel insight into the in vivo mechanism of action of mirabegron. Methods: This was a secondary analysis of a prospective evaluation of mirabegron in women with refractory overactive bladder symptoms who were treated between February and October 2013. The inclusion criteria were urgency predominant symptoms which had failed to respond to at least one antimuscarinic medication. Women with stress predominant symptoms, a history of recurrent urinary tract infections, bladder pain and voiding dysfunction were excluded. All women underwent multichannel urodynamic evaluation after a clinical assessment. Women were treated for 6 weeks with mirabegron 50 mg once daily. The primary outcome measure was the subjective response to treatment assessed using the Patient Global Impression of Improvement. Patients answering “very much better”, “much better” or “a little better” were designated as responders. A Fisher’s Exact test was used for categorical variables and a student’s t-test for continuous variables. Results: A total of 67 women were included in this study. The mean age was 59.3 years, and the mean BMI was 29.8 kg/m2. 40/67 women (59.7 %) were defined as responders to mirabegron. There was a significant association between a urodynamic diagnosis of detrusor overactivity and response to mirabegron (p=0.002). There were no differences in maximum flow rate, detrusor pressure at maximum flow and opening pressure between responders and non-responders. Conclusions: In this cohort of women with refractory overactive bladder symptoms, a urodynamic diagnosis of detrusor overactivity was predictive of response to mirabegron. This novel finding is in contrast to previous studies evaluating the predictive value of urodynamics in women treated with antimuscarinics. This may indicate that the contribution of modulation of motor pathways may be more significant in the mode of action of mirabegron than antimuscarinic drugs. This finding will need to be further evaluated in prospective head to head studies. References: 1. Eur Urol 2011; 59: 377–386 2. Eur Urol 2012; 62: 1165–1173 3. BJU Int 2009; 103: 931–937 Disclosure Block: Maya Basu: Astellas: Speaker, Honoraria. Boston Scientific: Support to attend scientific meetings, Travel Grant. Aswini Balachandran: No disclosures. Jonathan Duckett: Astellas: Advisory Committee Member, Consulting Fee. Astellas: Speaker, Honoraria. Astellas: research funding, Grant/ Research Support. Astellas: Commercial research funding, Commercial research funding.
S205
OP 126 IS SELF REPORTED ADHERENCE ASSOCIATED WITH CLINICAL OUTCOMES IN WOMEN UNDERGOING TREATMENT WITH ANTICHOLINERGIC MEDICATIONS FOR OVERACTIVE BLADDER? U. U. ANDY1, L. ARYA 2, H. S. HARVIE 1; 1 Univ. of Pennsylvania, Philadelphia, PA, 2Univ. of pennsylvania, philadelphia, PA Introduction: Anticholinergic medications are the first-line treatment for Overactive Bladder(OAB) in women. Adherence to anticholinergic medication is poor. The association between adherence and clinical outcome in women with overactive bladder is not known. Objective: Our goal was to determine whether selfreported adherence is associated with clinical outcomes in women treated with anti-cholinergic medication for OAB. Methods: We conducted a prospective study in women with OAB treated with flexible-dose fesoterodine therapy 4–8 mg. Adherence to medication was measured at 8 weeks using the Medication Adherence Self-report Inventory (MASRI). The MASRI is a brief self-administered validated questionnaire used to measure adherence to medication. The MASRI provides a numeric estimate of the adherence rate ranging from 0 to 100 %. Adherence was defined as an adherence rate of ≥80 % on the MASRI. Primary clinical outcome was improvement in symptoms as measured by the Patient Global Impression of Improvement. The Patient Global Impression of Improvement is a validated 7-point scale, ranging from “very much better” to “very much worse” that compares symptoms at 8 weeks to before treatment. Women were defined as having improvement in their symptoms if they reported that their symptoms were “little better”, “much better” or “very much better” compared to baseline. Secondary clinical outcomes were Patient Global Impression of Severity and change in the Urinary Distress Inventory (UDI-6) score between baseline and 8 weeks. The Patient Global Impression of Severity is a 4-point scale that asks patients to describe their symptoms at 8 week as “normal”, “mild”, “moderate”, or severe”. We compared Patient Global Impression of Improvement scores at 8 weeks in women who were adherent (≥80 %) and nonadherent (<80 %). We also compared Patient Global Impression of Severity score at 8 weeks and change in UDI scores between baseline and 8 weeks in women who were adherent and non-adherent to treatment. Result: Of 193 women, 122(63 %) were adherent and 71(37 %) were non-adherent at 8 weeks. Mean age (62.2± 12.7 vs. 59.5±13.7 years) and BMI (31.9±8.0 v 32.0±7.8 kg/ m2) were not significantly different between the adherent and non-adherent groups. Prior treatment with anticholinergic medication (50 % v. 45 %) and pelvic floor exercises (44 % vs. 35 %) were also similar between the two groups. Mean
S206
UDI scores was not significantly different at baseline between the adherent and non-adherent groups (52.2±21.1 vs. 51.0± 29.5, p=0.75). Based on the Patient Global Impression of Improvement, adherent women were more likely to report improvement in urinary symptoms compared to nonadherent women.(84 % vs. 24 %, p<0.001). Based on the Patient Global Impression of Severity score at 8 weeks, adherent women were less likely to report their overall bladder symptoms as “moderate” or “severe” as compared to nonadherent women (44 % v. 74 %, P=0.03). There was no significant difference in the change in UDI scores in the adherent group compared to the non-adherent group (13.3± 25.8 vs. 11.1±30.4, p=0.57). Conclusions: Adherent patients are more likely to have an overall perception of improvement in OAB symptoms compared to non-adherent patients despite a lack of difference in urinary symptom scores. Disclosure Block: Uduak Andy: No disclosures. Lily Arya: No disclosures. Heidi Harvie: No disclosures.
OP 127 DETERMINATION OF LATENCY AND WASHOUT PERIODS FOR SACRAL NEUROSTIMULATION PATIENTS L. A. CADISH1, K. E. OSANN 2, K. L. NOBLETT 1; 1 Obstetrics and Gynecology, Univ. of California, Irvine Med. Ctr., Orange, CA, 2Medicine, Univ. of California, Irvine Sch. of Med., Irvine, CA Introduction: Women with urge incontinence and overactive bladder whose condition has been refractory to conservative therapies may respond well to third-line therapies, including sacral neuromodulation. Although sacral neuromodulation has been approved by the Food and Drug Administration for over 15 years, evidence to guide clinicians to optimally program the device remains sparse.1 Although pharmacologic agents undergo study to determine the time to clinical response (half-life, and washout period) no such data exists for neurostimulation. Determination of a latency and washout period for sacral neuromodulation is meaningful in both clinical and research settings, as it indicates the length of time a patient must be on a new device setting before she may be queried regarding the efficacy of the new setting. Objective: The primary aim of our study is to determine the latency and washout periods for a patient who has experienced success with sacral neurostimulation. How long after turning the device off will patients notice a return in symptoms? Once the device is reactivated, how long before patients’ symptoms return to baseline?
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Methods: We enrolled participants who had an Interstim (Medtronic Inc, Minneapolis, MN) sacral neuromodulator implanted for the indications of urgency incontinence or overactive bladder, who were satisfied with the functioning of the device. Patients completed a baseline 24 h bladder diary and the Incontinence Impact Questionnaire short form (IIQ-7). Participants’ baseline settings were recorded before the device was turned off. When a participant reached the point of symptom recurrence that allowed her to answer affirmatively to the question “Are my symptoms severe enough that, if I’d never had an Interstim device placed, I’d want one placed now?” she repeated the bladder diary and IIQ-7 before having the device reactivated. Participants were instructed to repeat the bladder diary for the final time once symptoms had remitted back to baseline, when answering affirmatively to the question “Am I back to normal today?” Descriptive statistics were used to calculate the latency and washout periods. Results: A total of 13 women enrolled in the study, with a mean age of 66 years (range 50–86) and a mean baseline stimulation amplitude of 1.59 V (standard deviation 0.87). One participant withdrew immediately after enrollment; the remaining twelve completed the study. The mean voids per day at baseline, recurrence, and resolution were 8.75, 9.75, and 9.50, respectively (see Table). The mean number of leakage episodes per day at baseline, recurrence, and resolution were 1.75, 4.25, and 1.33. The mean IIQ-7 score at baseline was 20.24. This rose to 53.57 with symptom recurrence and fell to 10.32 with symptom resolution. Washout–the time from device deactivation to symptom recurrence–was on average 11.25 days (SD 9.47, median 7.5, range 4–31) whereas latency–the time from device reactivation to symptom resolution–was an average of 6.42 days (SD 1.62, median 6.0, range 5–11). In 75 % of patients, symptoms recurred within 10 days. For those with lesser symptoms at baseline, 67 % recurred within 10 days; for those with greater symptoms at baseline, 83 % recurred within 10 days. Symptoms then resolved within 6 days in 67 % of patients and within 7 days for 92 % of patients. All of those with lesser symptoms at baseline resolved within a week, whereas 83 % of those with greater symptom severity did. When combining both latency and washout periods, the 90th percentile of a sacral neurostimulator was found to be 15 days. Conclusions: Two weeks is a conservative, appropriate length of time for sacral neuromodulation patients in a clinical or research setting to trial a new program prior to determining its efficacy. References: 1. Premarket Approval for P970004. Food and Drug Administration. September 29, 1997.
S207
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Table: Voiding characteristics at baseline, recurrence, and resolution Mean Minimum Maximum 75th percentile Baseline Voids/day Leaks/day IIQ-7 Recurred
8.75 1.75
5 0
12 7
20.24 0
57.14
Voids/day
9.75
18
Leaks/day IIQ-7
4.25 0 53.57 9.52
4
Days to recurrence 11.25 4 Resolved Voids/day Leaks/day
9.50 1.33
5 0
IIQ-7 10.32 0 Days to resolution 6.42 5
11 80.95 31
12.5
14 7 28.57 11
7
Disclosure Block: Lauren Cadish: Medtronic, Inc: I was a recipient of the 2012 AUGS Benson Grant in Neuromodulation, which is funded by Medtronic and granted by AUGS., Grant/Research Support. Kathryn Osann: No disclosures. Karen Noblett: Medtronic: Consultant, Honoraria. Boston Scientific: Consultant, Honoraria.
OP 128 COMPARISON OF CYCLING REGIMENS IN SACRAL NEUROMODULATION PATIENTS L. A. CADISH1, K. E. OSANN 2, K. L. NOBLETT 1; 1 Obstetrics and Gynecology, Univ. of California, Irvine Med. Ctr., Orange, CA, 2Medicine, Univ. of California, Irvine Sch. of Med., Irvine, CA Introduction: Although sacral neuromodulation has been approved for treatment of refractory urgency incontinence and overactive bladder for over 15 years, evidence to guide clinicians to optimally program the device remains sparse.1 Implantation of the Interstim (Medtronic Inc, Minneapolis, MN) device involves placement of a lead wire and implantable pulse generator (IPG), which provides the energy source. Previously, two IPGs were available: a first-generation battery with a 5– 10 year life weighing 42 g, and a second-generation battery with a 3–5 year life, weighing 22 g. This allowed for a strategy of placing the original IPG in those predicted to require more stimulation, or for whom the benefit of infrequent replacement surgeries outweighed the bother of a larger device.2 Unfortunately, the larger battery is no longer manufactured. Optimal programming would allow patients to experience maximum symptom relief while maximizing battery life, thus
reducing IPG replacements. Cycling is the practice of setting the device for intermittent stimulation such that battery life is conserved. While the literature acknowledges that cycling modes prolong battery life and should be considered, no specific optimal cycling mode is specified.3 Objective: To determine if symptoms may be equally controlled with energy-conserving programs in patients using an Interstim device. A secondary aim was to evaluate if patients, when reviewing their own data from distinct programs, would choose the lowest effective dose. Methods: We enrolled women who had an Interstim sacral neuromodulator for urgency incontinence or overactive bladder who were satisfied with symptom control. Patients completed a baseline 24 h bladder diary and Incontinence Impact Questionnaire (IIQ-7), and a rating on a 1–7 Likert scale of the extent to which they agreed with the statement: “I would be satisfied with this setting as my permanent setting.” Each participant then had her device programmed with the following four settings in an order determined by computerized random number generator: &
A: Continuous regimen
&
B: Cycled regimen of 16 s on, 8 s off
&
C: Cycled regimen of 1 h on, 23 h off
&
D: Cycled regimen of 1 h on, 2 h off
All other parameters were kept identical to the participant’s baseline. Participants were not informed of the four settings being trialed. The amplitude limit was adjusted to prevent increasing the amplitude. Each participant then trialed each setting for a minimum of 2 weeks, a standard time interval scientifically established during a previous study. Each program was evaluated with a bladder diary, IIQ-7, and evaluation on a Likert scale. After trialing all four settings, we disclosed each of the regimens and reviewed corresponding bladder diaries, IIQ-7, and Likert scores with the patient. The setting the patient chose at the time of study conclusion was noted. The minimum effective dose was the most energyconserving setting that the patient rated as a 5, 6, or 7 on the Likert scale. Results: We recruited 23 women with a mean age was 67 years (range 39–86). At enrollment, patients had been using an Interstim device for an average of 41.3 months and the most recent IPG placement was 22.1 months ago. Eleven (47.8 %) were on a continuous regimen at baseline, 12 (52.2 %) on a cycled regimen. At baseline, patients voided 9.52 times and leaked 1.52 times daily, had an IIQ-7 score of 19, and rated their setting as a 5.44 on the Likert scale. At study conclusion, 9 (39 %) patients chose to revert to their
S208
baseline setting, 14 (61 %) chose a more energy-conserving setting, and none chose a setting with higher energy utilization. Three (13.0 %) chose setting A, 5 (21.7 %) chose B, 4 (17.4 %) chose C, 7 (30.4 %) chose D, and 4 (17.4 %) chose to revert to a baseline that was not one of the four study settings. Fifteen (65.2 %) chose the minimum effective dose as their setting following the study. Pairwise t-tests with correction for multiple comparisons indicated IIQ-7 was significantly higher for setting C (p=0.01) compared to baseline. Likert score was not significantly different between settings. Order was not found to play a role in setting preference. Battery life was prolonged by an average of 11.5 months. In those opting for a more energy conserving setting, battery longevity increased by 18.9 months. Conclusions: In patients satisfied with Interstim device functioning, battery life may be prolonged with use of cycling settings without inferior symptoms. A 1-hour on, 2 h off cycle warrants future study. In patients willing to trial multiple settings, an effective energy-conserving setting often may be found. When given a choice, many patients opt for settings that will preserve battery longevity. References: 1. Premarket Approval for P970004. Food and Drug Administration. September 29, 1997. 2. Int Urogynecol J. 2010; 21:S453-60. 3. Curr Urol Rep. 2011;12:327–5. Disclosure Block: Lauren Cadish: Medtronic, Inc: I was a recipient of the 2012 AUGS Benson Grant in Neuromodulation, which is funded by Medtronic and granted by AUGS., Grant/Research Support. Kathryn Osann: No disclosures. Karen Noblett: Medtronic: Consultant, Honoraria. Boston Scientific: Consultant, Honoraria.
OP 129 EARLY MIRABEGRON EXPERIENCE AND PERSISTENCE: COMPARISON WITH TOLTERODINE EXTENDED RELEASE V. W. NITTI1, E. ROVNER 2, B. FRANKS 3, G. MUMA 3, T. BERNER 3; 1 Department of Urology, NYU Langone Med. Ctr., New York, NY, 2MUSC Urology, Charleston, SC, 3Health Economics Clinical Outcomes, Astellas, Northbrook, IL Introduction: Antimuscarinic therapy has been the mainstay of pharmacological treatment for symptoms of overactive bladder (OAB). Despite their proven efficacy in reducing OAB symptoms, side effects associated with antimuscarinics and patient perceptions of suboptimal therapeutic benefit may negatively affect adherence and persistence [1].
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Objectives: The objectives of the current study were to investigate the medication persistence of patients receiving mirabegron, to identify factors associated with time to discontinuation, and to compare persistence to that of patients receiving an antimuscarinic, tolterodine extended release (ER). Methods: Claims records of patients in the Optum database who had the index event, a valid prescription of mirabegron or tolterodine ER for OAB between 1/1/2010 and 9/30/2013 were analyzed retrospectively as part of an intent-to-treat analysis (ITT). Patients were included in a per-protocol analysis set (PPS) provided that they also had a minimum of 6 months insurance coverage pre- and post-index. Patients were classified into treatment-naïve or treatment-experienced cohorts for a minimum 6-month look-back period within the database. Persistence was evaluated for each drug by monthly persistence rates and also by time to drug discontinuation. Kaplan-Meier estimates were used to assess the distribution of duration of persistence. Unstratified and stratified Cox proportional hazard models (controlling for age, gender and naïve/experienced) were fitted to compare persistence between mirabegron and tolterodine. Health resource utilization of patients on mirabegron and tolterodine ER were compared at baseline and for the 6-month post-index period, as were baseline age, region, insurance and plan type, Charlson comorbidities, polypharmacy, calendar year initiating index therapy, and prior and subsequent therapies. Results: A total of 380 patients received mirabegron (195 treatment naïve, 185 treatment experienced) and 2248 patients received tolterodine ER (1859 treatment naïve, 389 treatment experienced). Median persistence was longer for mirabegron (90 days) than for tolterodine ER (30 days) in the per-protocol set (intent to treat analysis set: mirabegron [170 days] and tolterodine ER [90 days]). Similar patterns of improved persistence on mirabegron versus tolterodine ER were seen for subgroups; for instance in treatment-experienced patients, persistence was 125 days for mirabegron and 90 days for tolterodine ER, and in treatment-naïve patients, persistence was 80 days for mirabegron and 30 days for tolterodine ER. Results from the Cox model, while controlling for the modelled factors, showed mirabegron as having a statistically significant increase in persistence compared to tolterodine ER. There were also significant differences in health resource utilization at baseline and in change from baseline: patients receiving mirabegron experienced a median reduction in unique number of prescription medications as opposed to the increase in polypharmacy in those receiving tolterodine ER, and, over 6 months, outpatient visits were reduced by median of one visit per patient receiving mirabegron, with accompanying median cost reductions of $122 per patient. Conclusions: These data suggest that, after controlling for multiple factors, patients receiving mirabegron during the first
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
year post launch persisted on therapy longer than those receiving tolterodine ER, and that treatment of OAB with mirabegron was associated with reduction in overall costs and resource utilization over 6 months. References: 1. BJU Int 2008; 102:774–9. Disclosure Block: Victor Nitti: Astellas, Allergan, Medtronic: Consultant, Consulting Fee. Allergan, Pfizer, Ipsen, Uroplasty: Scientific Medical Advisor, Grant/Research Support. Eric Rovner: Astellas: Consultant, Consulting Fee. Billy Franks: Astellas: Employee, Salary. Gilbert Muma: Astellas: Employee, Salary. Todd Berner: Astellas: Employee, Salary.
OP 130 THE IMPACT OF ANTICHOLINERGIC LOAD ON BLADDER FUNCTION J. F. DE LA CRUZ, C. K. KISBY, J. M. WU, E. J. GELLER; UNC-Chapel Hill, Chapel Hill, NC Introduction: Although anticholinergic medications are commonly used to treat overactive bladder (OAB), numerous medications with anticholinergic properties are also used to treat hypertension, asthma, seasonal allergies, vertigo, depression, and psychosis.1,2 The cumulative load of medications with anticholinergic properties has been shown to increase serious adverse events. Validated scales, such as the Anticholinergic Risk Scale (ARS), have been developed to measure cumulative anticholinergic exposure.2 An important, potential adverse event of anticholinergics is urinary retention. Currently, there are limited data regarding the impact of cumulative anticholinergic load on voiding dysfunction.3 Objective: Our primary objective was to evaluate the impact of anticholinergic load on urinary retention, based on post-void residual (PVR) on micturition study. Secondary objectives were to assess the effect of anticholinergics on other aspects of bladder function, including maximum cystometric capacity (MCC), maximum flow rate on micturition study (Qmax), and detrusor pressure at maximum flow (Pdet@Qmax). Methods: This was a retrospective cohort study of women who underwent urodynamics (UDS) at one academic institution between February 2012 and September 2013. Subjects were excluded if they had POP-Q stage ≥3, any neurologic disorder that may affect bladder function, an anti-incontinence procedure ≤6 months prior to UDS, a diagnosis of uterine, cervical, or ovarian cancer, or did not undergo the micturition study during UDS. Medications used by subjects at the time of UDS were assessed and scored using the ARS. 2 This validated scale assigns rank scores to each medication based on their anticholinergic potential on a 3-point scale (e.g. 0=no or low risk potential to 3=
S209
high risk potential).2 Subjects were dichotomized into two anticholinergic cohorts: low ARS (ARS score 0–1) or high ARS (ARS score ≥2), based on a validation study which found significant differences in the number of adverse events when ARS 0 was compared to ARS 1–2. 2 Our primary outcome was post-void residual (PVR) on micturition study. We also collected socio-demographic data and urodynamic parameters. For our analysis, we also performed sensitivity analyses to assess the association of higher ARS scores and voiding dysfunction. Results: During the study period, 599 women who underwent urodynamics met inclusion criteria. Overall, ARS scores ranged from 0 to 8, with 440 (73.5 %) having a low ARS scores and 159 (26.5 %) having a high ARS score. The mean ARS score in the low and high ARS group was 0.1±.03 and 2.9±1.1, respectively. When comparing our two cohorts, mean age in low ARS vs. high ARS groups was 57.2±14.0 vs. 56.3±12.9, p=.47, respectively. There were no differences in parity, prior incontinence or prolapse surgery, diabetes, smoking status, or hormone use. While all medications with anticholinergic properties were used to assess ARS score, more subjects in the high ARS group were taking an anticholinergic for OAB at the time of UDS (21.9 % vs. 3.4 %, p<0.01). For our primary outcome of micturition PVR, there was no difference between low ARS and high ARS groups (66.8±108.6 mL vs. 78.6±121.0 mL, p=0.25). There was also no difference between ARS groups in other voiding function parameters: MCC (418.4±182.0 mL vs. 438.0± 189.4 mL, p=0.25), Pdet@Qmax (22.1±12.9 cm of water vs. 23.3±14.8 cm of water, p=0.37), Qmax (17.2±9.8 mL/s vs. 18.1±10.2 mL/s, p=0.30), uroflow capacity (246.8± 207.0 mL vs. 232.2±187.9 mL, p=0.71), or uroflow PVR (43.4±65.8 mL vs. 53.0±67.9 mL, p=0.12). For our sensitivity analyses, higher ARS scores of ≥3 or ≥4 were not associated with higher micturition PVRs. However, we did find a higher micturition PVR with ARS 0–4 (n=583) vs. ARS ≥5 (n=16): 68.3±109.1 mL vs. 127.5+185.7 (p<0.01). Conclusions: Despite the prevalence and risks associated with the use of anticholinergics, no cumulative effect on bladder function was demonstrated when comparing anticholinergic risk scale scores of 0–1 to ≥2. However, higher ARS scores of ≥5 are associated with significantly elevated PVR. 1,2,3 Additional research is needed to evaluate the impact of higher anticholinergic load on bladder function. References: 1. Kay GG, Abou-Donia MB, Messer WS, et al. Antimuscarinic Drugs for Overactive Bladder and Their Potential Effects on Cognitive Function in Older Patients. Journal of American Geriatric Society. 2005 Dec; 53(5):2195–2201. 2. Rudolph JL, Salow MJ, Angelini MC, McGlinchey RE. The anticholinergic risk scale and anticholinergic adverse effects in older persons. Arch Intern Med. 2008 Mar 10; 168(5): 508–13.
S210
3. Verhamme K, Sturkenboom M, Stricker B, et al. Drug induced urinary retention: incidence, management and prevention. Drug Safety. 2008; 31(5): 373–388. Disclosure Block: Jacquia De La Cruz: No disclosures. Cassandra Kisby: No disclosures. Jennifer Wu: Proctor and Gamble: Consultant, Consulting Fee. Elizabeth Geller: Intuitive Surgical, Inc: Speaking at postgraduate courses, Honoraria.
OP 131OP 132 PRELIMINARY RESULTS OF BUS STUDY-A MULTICENTRE STUDY OF THE ACCURACY OF BLADDER WALL THICKNESS IN DIAGNOSING DETRUSOR OVERACTIVITY IN WOMEN P. M. LATTHE1, S. RACHANENI 2, S. A. MCCOOTY 3, L. J. MIDDLETON 2, J. DANIELS 2; 1 Dept. of urogynaecology, Birmingham Women’s NHS Fndn. Trust, Birmingham, United Kingdom, 2Univ. of Birmingham, Birmingham, United Kingdom, 3Birmingham Women’s NHS Fndn. Trust, Birmingham, United Kingdom Introduction: Detrusor overactivity (DO) is the occurrence of involuntary detrusor contractions during filling phase of cystometry (1). Urodynamics [UDS] has been considered the gold standard investigation but is invasive, embarrassing, and expensive and has a risk of urinary infection (2). Increased bladder wall thickness [BWT] on transvaginal scan has been proposed as a potential diagnostic tool for DO in a few observational studies (3), although these studies were lacking in quality and size. The NICE guidance and a HTA report on urinary incontinence recommended that “further studies were required to clarify the role of ultrasound for the assessment of overactive bladder.” The primary aim of our study is to evaluate whether BWT ultrasound scan (index test) has sufficient diagnostic accuracy in the diagnosis of DO to replace UDS (reference standard). Methods: The sample size of 600 was based on the assumption that the prevalence of DO is 50 % and to enable measurement of sensitivity and specificity confidence intervals within a width <10 %. Inclusion criteria were consecutive consenting women presenting with frequency of 9 or more voids in 24 h, mild – severe urgency (cannot defer the urge to void) on at least two occasion in 3 day bladder diary and post void residual (PVR) volume <100 mls on screening. If patient had stress urinary incontinence (SUI), SUI surgery &/or Botox less than 6 months ago, stress predominant mixed UI, pregnancy, recurrent cystitis, prolapse > grade 2, UDS in the last 6 months, PVR >100 mls, mental incapacity, current use of antimuscarinics, they were excluded. We collected data on demographics, clinical history, bladder diary, and quality of life. All participants were subjected to both transvaginal BWT scan and UDS by two independent blinded operators. BWT was measured at dome, anterior wall
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
and the trigone and the mean of the three was used as the index test measurement (4) UDS was recommended per good urodynamic practice guidelines. Results: We recruited 687 women (mean age 53 years; SD 14) with overactive bladder from 24 centres in the UK. BWT was 4.8 mm in women with DO compared to 4.7 mm in women without DO (p=0.2). Measurements of test accuracy using a cut-off of 5 mm for BWT are given in Table 1. ROC curve analysis gave the area under the curve as 0.53 (Figure 1). Conclusion: BWT does not discriminate women with DO versus those without DO and hence is not an accurate test for diagnosing DO. References: 1. Neurourol Urodyn. 2010; 29(1):4–20. 2. Cochrane Database Syst Rev. 2012 Oct 17; 10: CD008224. 3. World J Urol. 2013 Oct; 31(5):1093–104. doi:10.1007/ s00345-013-1030-6. 4. Accuracy of Bladder Ultrasound Study (BUS) protocol Version 5.2(2013) URL:www.birmingham.ac.uk/research/ activity/mds/trials/bctu/trials/womens/BUS/index.asp Funding: National Institute for Health Research Health Technology Assessment Programme (09/22/122) Table 1: Accuracy measures for TV bladder wall thickness in diagnosis of detrusor Overactivity Measurement
Value
95 % CI
Sensitivity
42 %
37 to 47 %
Specificity
62 %
56 to 68 %
Positive Predictive Value
64 %
58 to 70 %
Negative Predictive Value
40 %
35 to 46 %
Positive likelihood ratio
1.11
0.91 to 1.36
Negative likelihood ratio
0.93
0.82 to 1.06
Collaborators: list will be provided
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Disclosure Block: Pallavi Latthe: Astellas: Speaker, Honoraria. Pfizer: Speaker, Honoraria. June Medical: Consultant, trip to Berlin to see the mesh implantation by Prof Tunn. Suneetha Rachaneni: No disclosures. Shanteela McCooty: No disclosures. Lee Middleton: No disclosures. Jane Daniels: No disclosures.
OP 132 TRANSCUTANEOUS TIBIAL NERVE STIMULATION TO TREAT URGE URINARY INCONTINENCE IN OLDER WOMEN: 12-MONTH FOLLOW-UP OF RANDOMIZED TRIAL L. SCHREINER1, T. DOS SANTOS 2, M. KNORST 3, I. DA SILVA FILHO 4; 1 Hosp. São Lucas - Pontificia Univ., Porto Alegre, Brazil, 2 Ginecologia, Hosp. São Lucas - Pontificia Univ., Porto Alegre, Brazil, 3Fisioterapia, Hosp. São Lucas - Pontificia Univ., Porto Alegre, Brazil, 4Instituto de Geriatria e Gerontologia, Hosp. São Lucas - Pontificia Univ., Porto Alegre, Brazil Introduction: The frequency of urge urinary incontinence increases according to aging, especially in women. It is important to develop non-invasive management strategies for urinary incontinence in elderly population. The tibial nerve electrical stimulation is peripheral, non-invasive and a lowcost therapy. Several studies have shown positive results of this therapy in the treatment of urinary symptoms, including improvement in the quality of life and urodynamic findings of patients. Most of these studies were done using percutaneous technique. Objective: The aim of this study was to examine immediate and long term efficacy of transcutaneous tibial nerve stimulation to treat urge urinary incontinence in older women. Methods: The study design was a randomized clinical trial, parallel group. 106 elderly women (>60 years) with urge urinary incontinence were selected. 101 of them completed treatment, 50 women performed 12 weeks of bladder retraining and pelvic floor muscle exercises, while 51 were randomly selected to receive electrical stimulation associated. The cases were evaluated by the 3-day bladder diary, the Kings Health Questionnaire (Incontinence Quality of Life scale), International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) and clinical data. Patients presenting global satisfaction at the end of therapy were reevaluated each 3 months during 12 months. Results: The study population had a mean age of 69 years, 54 % were single, 68 % had previous treatment, and 71 % had associated stress incontinence. These characteristics, measures of urinary loss and quality of life prior to treatment were similar between the
S211
groups. Both groups showed significant improvement in ICIQ-SF, in most areas of the Incontinence Quality of life scale, and in urge incontinence on bladder diary. There was a greater improvement in the group treated with electrical stimulation in all parameters. 66.7 % were satisfied after electrical stimulation vs 32.0 % in control group (P<0,001). All 34 patients satisfied were followed during 12 months after finished the tibial stimulation. 16 of them had recurrence of incontinence along the follow up, most of them between 9 and 12 months after finished therapy. 13 of 16 were satisfied again, after a new therapy. Conclusions: Our study showed that transcutaneous tibial nerve stimulation has a promise immediate and long term efficacy to treat urinary urge incontinence in older women. Recurrence has good response with a new therapy. This therapy should be considered a good option in the treatment of elderly incontinent women. References: 1. Schreiner L, dos Santos TG, Knorst MR, da Silva Filho IG. Randomized trial of transcutaneous tibial nerve stimulation to treat urge urinary incontinence in older women. Int Urogynecol J Pelvic Floor Dysfunct. 2010 Sep;21(9):1065– 70. Epub 2010 May 11. 2. Marchal C, Herrera B, Antuña F, Saez F, Perez J, Castillo E, et al. Percutaneous tibial nerve stimulation in treatment of overactive bladder: when should retreatment be started? Urology. 2011 Nov;78(5):1046–50. 3. Peters KM, Carrico DJ, Wooldridge LS, Miller CJ, Macdiarmid SA. Percutaneous Tibial Nerve Stimulation (PTNS) for the Long-Term Treatment of Overactive Bladder: ThreeYear Results of the STEP Study. J Urol. 2012 Dec 3. pii: S0022-5347(12)05807-7. doi:10.1016/j.juro.2012.11.175. [Epub ahead of print] Disclosure Block: Lucas Schreiner: No disclosures. Thais Guimarães dos Santos: Disclosure Not Provided. Mara Regina Knorst: Disclosure Not Provided. Irênio Gomes da Silva Filho: Disclosure Not Provided.
OP 133 PREVALENCE OF DO AND OTHER URODYNAMIC DIAGNOSES IN WOMEN WITH OVERACTIVE BLADDER SYMPTOMS P. M. LATTHE1, S. RACHANENI 2, S. A. MCCOOTY 3, L. J. MIDDLETON 2, J. DANIELS 2; 1 Dept. of urogynaecology, Birmingham Women’s NHS Fndn. Trust, Birmingham, United Kingdom, 2Univ. of Birmingham, Birmingham, United Kingdom, 3Birmingham Women’s NHS Fndn. Trust, Birmingham, United Kingdom.
S212
Introduction: Bladder has been stated to be an unreliable witness in the past. Detrusor overactivity (DO) is the occurrence of involuntary detrusor contractions during filling phase of cystometry (1). Urodynamics [UDS] has been considered the gold standard investigation for diagnosing DO. The prevalence of DO was found to be 11 to 54 % in various retrospective studies (2, 3). Aims: To prospectively study the prevalence of DO and various other urodynamic diagnoses obtained in real life clinical practice in women who present with urgency, frequency with or without urge predominant mixed incontinence. Methods: We approached consecutive women with urgency or urgency predominant mixed urinary incontinence. Inclusion criteria were: age >18 years, mild – severe urgency (cannot defer the urge to void) on at least two occasion in 3 day bladder diary, frequency of 9 or more voids in 24 h at least on one of the 3 days, post void residual (PVR) volume <100 mls on screening, informed consent. If patient had stress urinary incontinence SUI), SUI surgery &/or Botox less than 6 months ago, stress predominant mixed UI, pregnancy, recurrent cystitis, prolapse > grade 2, UDS in the last 6 months, PVR >100 mls, current use of antimuscarinics, they were excluded. We collected data on the demographics, detailed clinical history, bladder dairy, urine dipstick and Quality of Life. All women underwent urodynamics as part of a multicentre diagnostic accuracy study (BUS study) for DO. (4) Results: We attained a diagnosis from 658 women with overactive bladder from 24 centres in the UK. The demographics of the study population are in table 1 and details of the various urodynamic diagnoses are given in table 2. Of the women recruited, 61 % (95 % CI: 57 to 65 %) had a diagnosis including DO. Low compliance was the diagnosis given in 53/ 658 (8.05 %) tests either in isolation or along with other diagnoses but the thresholds of detrusor pressure at the end of filling varied in different centres. Of these women with OAB symptoms, 19 % had normal urodynamics. Conclusion: The prevalence of DO in this multicentre study was 61 % in women who complained of urgency, frequency with or without incontinence. The slightly high prevalence may be due to selection bias or there is a possibility of spectrum bias (that our sample may be of more ‘severe’ cases if they were recruited after already being suspected to have DO). The entity of Low compliance needs to be standardised. References: 1. Neurourol Urodyn. 2010; 29(1):4–20. 2. Int Urogynecol J. 2012 Nov; 23(11):1577–80. 3. Neurourol Urodyn. 2003; 22(2):105–8. 4. URL: www.birmingham.ac.uk/research/activity/mds/trials/ bctu/trials/womens/BUS/index.aspx Funding: National Institute for Health Research Health Technology Assessment Programme (09/22/122)
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Collaborators: list will be provided Table 1: Demographics of women recruited in the BUS study Age (years) Ethnicity
Parity
Post-menopausal (lmp >1 year) BMI
Mean (SD) White British/Irish/Other
53 (14) 513 (79 %)
Asian Pak/Ind/Bang/other Black Carrib/African/other
69 (11 %) 49 (8 %)
Mixed/other Not given/missing
19 (3 %) 37
0 1
67 (10 %) 88 (13 %)
2 3
240 (36 %) 151 (23 %)
4 >4
56 (8 %) 63 (9 %)
Missing
22
Yes No
372 (56 %) 287 (44 %)
Missing
28
Mean (SD) Missing
31 (12) 37
Incontinence type
Previous use of anti-muscarinics
Urgency alone
225 (34 %)
Urgency plus stress
419 (63 %)
Stress alone
4 (1 %)
Neither
19 (3 %)
Missing
20
Yes
214 (32 %)
No
453 (68 %)
Missing
20
Table 2: Summary of all diagnoses Urodynamic diagnoses
n=658 (%)
Including DO: DO only
258 (39 %)
DO/USI DO/low compliance
96 (15 %) 8 (1 %)
DO/voiding dysfunction
18 (3 %)
DO/voiding dysfunction/USI
12 (2 %)
DO/USI/low compliance
2 (<1 %)
DO/voiding dysfunction/USI/low compliance
1 (<1 %)
DO/voiding dysfunction/low compliance
1 (<1 %)
Other: USI only
77 (12 %)
Low compliance only
35 (5 %)
Voiding dysfunction only
14 (2 %)
Voiding dysfunction/USI USI/low compliance
7 (1 %) 6 (1 %)
Normal
123 (19 %)
S213
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Disclosure Block: Pallavi Latthe: Astellas: Speaker, Honoraria. Pfizer: Speaker, Honoraria. June Medical: Consultant, trip to Berlin to see the mesh implantation by Prof Tunn. Suneetha Rachaneni: No disclosures. Shanteela McCooty: No disclosures. Lee Middleton: No disclosures. Jane Daniels: No disclosures.
OP 134 IMPACT OF TREATMENT OF OVERACTIVE BLADDER WITH ANTICHOLINERGIC MEDICATIONS ON PHYSICAL ACTIVITY C. M. CHU, H. S. HARVIE, U. U. ANDY, L. ARYA; Univ. of Pennsylvania, Philadelphia, PA Objective: Our aim was to determine the effect of treatment of OAB with anticholinergic medication on physical activity. Background: Urinary symptoms, including overactive bladder (OAB) and urge urinary incontinence (UUI), have been shown to significantly impact a patient’s participation in exercise activities. The impact of treatment of OAB with anticholinergic medication on physical activity is unknown. Methods: This is a prospective study of women with OAB symptoms treated with flexible-dose fesoterodine therapy 4–8 mg. Patients were evaluated at baseline and 8 weeks post-treatment. Physical activity scores were calculated using the Short Form 12 (SF-12) question 2a and b: “Does your health now limit you” in a) “Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf?” and b) “Limit you in climbing several flights of stairs?” Possible scores ranged from 2 to 6. Subjects were categorized based on their responses into 3 levels of physical activity: no limitations (score of 5–6), moderate limitations (3–4), severe limitations (2). Response to treatment at 8 weeks was measured using the Patient Global Impression of Improvement (PGI). Responders were defined as women who responded “A little better”, “Much better” or “Very much better” to the question: “⋯best describes how your urinary tract condition is now, compared with how it was before you began taking medication in this study.” Urinary symptom severity was measured with the Incontinence Severity Index (ISI), the Pelvic Floor Distress Inventory (PFDI) and its bladder sub-scale (UDI), and the Pelvic Floor Impact Questionnaire (PFIQ) and its bladder sub-scale (UIQ). Comorbid medical conditions were measured using the Charlson Comorbidity Index (CCI). We compared the physical activity score at baseline to the score at 8 weeks, as well as the symptom scores
between subjects with and without improvement in physical activity using non-parametric tests. Results: We recruited 146 women, with mean age, BMI and CCI of 60.1±13.7 years, 32.1±8.1 kg/m2, and 0.9± 1.3, respectively; 81 % were post-menopausal. Of these, 73 (50 %) had no physical limitations, 39 (27 %) had moderate, and 34 (23 %) had severe physical limitations at baseline. At 8 weeks following treatment with anticholinergic medication, the mean UDI, UIQ, and ISI scores decreased (improved) from baseline to 8 weeks (53±23 vs 39±25, p=.0005, 31±28 vs 23±26, p=.01, and 6±2 vs 4±4, p=.05, respectively). Overall, physical activity improved in the cohort, with fewer women reporting severe restriction at 8 weeks than at baseline (Table 1). Based on the PGI, 82 % were categorized as responders to anticholinergic medication. At 8 weeks, the proportion of women with no restriction in physical activity was higher in responders than non-responders (52 % vs 33 %) while the proportion of women with severe restriction was lower in responders than nonresponders (13 % vs 17 %). When we compared women who had improvement in physical activity to those who did not (Table 2), there were no significant differences in response to treatment with anticholinergic medication, age, number of comorbidities, severity of OAB at baseline, and severity of OAB at 8 weeks (Table 2). There was no difference in urinary symptom score on the UDI, UIQ, and the ISI between women who reported improvement in physical activity and those who did not. Conclusion: Treatment of OAB with anticholinergic medication significantly improves patients’ ability to perform physical activity. Interestingly, this improvement in physical activity may not be directly associated with improvement in urinary symptoms. Further studies should include direct measurement of physical activity and explore mechanisms through which treatment of OAB improves physical activity. References: N/A Table 1: Physical activity impairment categories at baseline and after treatment with anticholinergic medication Physical Activity Impairment1
Baseline
8 Week
p-value
None Moderate
50 % 27 %
48 % 37 %
0.032
Severe
23 %
15 %
1
Physical activity impairment based on SF-12 question 2a and b Chi2
2
S214
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Table 2: Characteristics and OAB severity scores by improvement in physical activity Improvement in No Improvement Physical Activity in Physical Activity Impairment Impairment Category1 (N=28) Category1 (N=118) Responders2 78 % 83 % Age 62.8±12.1 60.1±14.3 CCI 1.2±1.6 0.8±1.2 Baseline Severity of Urinary Symptoms UDI 59.1±29.3 52.7±21.4 UIQ 37.0±27.5 33.6±28.1 ISI-index 2.7±1.3 2.5±1.0 Eight week Severity of Urinary Symptoms
p-value
0.573 0.314 0.424 0.354 0.514 0.454
39.0±26.6
0.794
UIQ 22.1±25.5 23.7±25.7 ISI-index 1.8±0.84 2.1±0.99 Change in Urinary Symptom Scores
0.874 0.614
UDI
UDI UIQ ISI-index
40.8±21.7
−12.8±30.5 −4.4±27.9 −1.0±1.0
−13.4±25.5 −9.3±23.9 −0.3±0.9
0.504 0.574 0.224
UDI = Urinary Distress Inventory, UIQ = Urinary Impact Questionnaire, ISI = Incontinence Severity Index, CCI = Charlson Comorbidity Index 1 Physical activity impairment based on SF-12 question 2a and b 2 Responders based on PGI 3 Chi2 4 Wilcoxon rank-sum test Disclosure Block: Christine Chu: No disclosures. Heidi Harvie: No disclosures. Uduak Andy: No disclosures. Lily Arya: No disclosures.
OP 135 MIRABEGRON, AN ALTERNATIVE TO BOTULINUM TOXIN A: A PROSPECTIVE COHORT STUDY IN PATIENTS WITH DRUG RESISTANT OVERACTIVE BLADDER A. BALACHANDRAN, M. BASU, J. DUCKETT; Obstetrics & Gynaecology, Medway Martime Hosp., Kent, United Kingdom Introduction: Antimuscarinic agents are currently the mainstay of treatment for Overactive Bladder Syndrome (OAB). However, the compliance rates are low [1]. Consequently, Botulinum Toxin A (BTXA) is offered as treatment in patients with refractory OAB in whom antimuscarinics have not been
effective. The application of BTXA is not without its disadvantages. It is invasive, requires repeated injections and may lead to self-catheterisation [2]. Mirabegron is a novel drug treatment for OAB that acts via β3-adrenoreceptors. β3adrenoreceptors promote relaxation of detrusor smooth muscle and improved urine storage and therefore act in a completely different manner to antimuscarinics [2]. In Phase 3 trials, it has shown to reduce the mean number of micturitions and incontinence episodes [3]. Our current clinical experience with Mirabegron is limited. We have therefore, conducted a prospective cohort study to evaluate the effectiveness of Mirabegron in patients with refractory OAB resistant to conventional antimuscarinic therapy. Objective: The aim of the study was to evaluate the efficacy and tolerability of Mirabegron in a non-trial situation and to assess its potential position in treatment algorithms when used prior to referral for Botulinum Toxin A therapy. Methods: The study was carried out between February and October 2013 in patients with urgency or urgency incontinence in whom antimuscarinic medication was ineffective. Primary outcome was measured using the Patient Global Impression of Improvement Scale (PGI-I) with patients answering “very much better”, “much better” or “a little better” being designated as responders. Patients answering “no change”, “a little worse” and “very much worse” were classified as non-responders. Secondary outcome measures included discontinuation rates and improvement in quality of life. Symptoms were assessed initially and at 6 weeks using the International Consultation of Incontinence Modular Questionnaire (ICIQ-SF) and the King’s Health Questionnaire (KHQ). Statistical analysis of improvement of quality of life and discontinuation rates between responder and non-responder groups were performed. A p-value of less than 0.05 was considered significant. Results: There were a total of 67 patients in our study. 59 % of patients described their symptoms has very much better, much better or a little better (Table 1). There were no significant baseline difference in demographics and clinical variables between responders and non-responders. The ICIQ-SF demonstrated a significant change in quality of life in responders (p≤ 0.0082) (Table 2). The KHQ showed a significant improvement in Incontinence impact (p≤0.0008), Emotion (p≤0.008), Sleep and Energy (p≤0.002), Severity Measure (p≤0.009) and Scales (p≤0.008). Mirabegron has a good synergic effect with 80 % of patients on a pre-existing antimuscarinics and mirabegron exhibiting symptom improvement. Of the patients who did not respond to Mirabegron (27), 4 (15 %) have now gone on to be treated with BTXA. Conclusions: Mirabegron is a new class of drug, which has been shown to improve clinical and quality of life outcomes in patients with OAB. Side effects seem low and the drug is well tolerated. Even patients previously treated with multiple antimuscarinics showed a response to therapy. It may therefore be a viable alternative to BTXA in patients with refractory OAB.
S215
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
References: 1. Wagg A, Compion G, Fahey A, et al. Persistence with Prescribed Antimuscarinic Therapy for Overactive Bladder: A UK Experience. BJU Int 2012; 110:1767–74 2. Andersson K. New developments in the Management of Overactive Bladder: Focus on Mirabegron and Onabotulinumtoxin A. Therapeutics and Clinical Risk Management 2013; 9:161–170 3. Khullar V, Amarenco G, Angulo JC, et al. Efficacy and Tolerability of Mirabegron, a β3-adreno-receptor Agonist, in Patients with Overactive Bladder: Results from a Radomised European-Australian Phase 3 Trial. Eur Urol 2013; 63(2):283–295 Table 1: PGI-I Scores for Cohort PGI-I
Entire Cohort n=67(%)
Very much better
6 (9)
Much better
17 (25)
A little better
17 (25)
No change
23 (35)
A little worse
4 (6)
Table 2: ICIQ-SF Scores for Responders vs Non-responders ICIQ-SF n (±SD) Responders Pre-Mirabegron
12.64 (±5.72)
Responders Post-Mirabegron
9.21 (±5.30)
Non-responders Pre-Mirabegron
12.76 (±6.56)
Non-responders Post-Mirabegron
12.8 (±5.71)
Disclosure Block: Aswini Balachandran: No disclosures. Maya Basu: Astellas: Speaker, Honoraria. Boston Scientific: Support to attend scientific meetings, Travel Grant. Jonathan Duckett: Astellas: Advisory Committee Member, Consulting Fee. Astellas: Speaker, Honoraria. Astellas: research funding, Grant/ Research Support. Astellas: Commercial research funding, Commercial research funding.
OP 136 PATIENT FACTORS INFLUENCING THE LIKELIHOOD OF CURE OR IMPROVEMENT AFTER TREATMENT WITH BOTULINUM TOXIN FOR REFRACTORY DETRUSOR OVERACTIVITY: SECONDARY ANALYSIS OF DATA FROM A RANDOMISED TRIAL D. G. TINCELLO1, R. K. OWEN 2, M. C. SLACK 3, P. M. TOOZS-HOBSON 4, C. J. MAYNE 5, K. R. ABRAMS 1; 1 Univ. of Leicester, Leicester, United Kingdom, 2Health Sciences, Univ. of Leicester, Leicester, United Kingdom,
3
Addenbrooke’s Hosp. NHS Fndn. Trust, Cambridge, United Kingdom, 4Birmingham Women’s Hosp. NHS Fndn. Trust, Birmingham, United Kingdom, 5Women’s and Childrens CBU, Univ. Hosp. of Leicester NHS Trust, Leicester, United Kingdom Introduction: Botulinum toxin (BoNT) is an established second line treatment for overactive bladder(OAB) and detrusor overactivity (DO). Several randomised studies demonstrate high efficacy with long duration of action and a good safety profile1–3 but there are little data examining patient factors influencing the likelihood of a good outcome. Not all patients report significant or lasting benefit after one treatment with BoNTA, and identification of patients who are less likely to respond is of potential benefit to allow rational prescribing and treatment, while avoiding the risk of urinary retention in patients unlikely to obtain symptom relief. Objective: We set out to investigate whether patient demographic factors, or baseline urodynamic variables had any association with patient-reported failure of improvement after a single treatment with 200 units of onabotulinum toxin A (onaBoNTA). Methods: We conducted a secondary analysis of patient data from a large randomised trial, where women with refractory DO were treated with 200 units of onaBoNTA or placebo1. Outcome data at 6 weeks after treatment for the women who received active drug only were analysed using stepwise logistic regression to identify demographic factors, or baseline clinical parameters associated which were associated with non-response to treatment. We defined non-response from the reported outcomes from each of five main outcome measures used in the trial: leakage episodes, urinary urge episodes, urinary voiding frequency, continence status (no), and an outcome on the patient global impression of improvement scale (PGI-I) of “no change” or worse. For leakage, urgency and voiding frequency, a change from baseline of 10 % or less was defined as non-response. The following factors were analysed: age; ethnicity; parity; previous continence surgery; BMI; baseline leakage episodes, urgency episodes & voiding frequency; and urodynamic variables (volumes at first sensation & capacity; maximum detrusor pressure during filling & voiding, and at maximum flow; volume at first contraction and amplitude of first contraction). Results: Data from 122 women were included. After multivariate analysis, only baseline leakage episode frequency was associated with failure to achieve continence (OR 1.16; 95 % CI 1.03, 1.30; p=0.012). For the response reported on PGI-I, both increasing age (OR 1.04, CI 1.0, 1.09) and BMI (OR 1.07, CI 1.0, 1.16) showed a weak association with non-response. Conclusions: From this analysis, few demographic factors or clinical characteristics of patients at baseline can predict non-response. Women with greater baseline leakage are less likely to achieve continence (16 % increased odds
S216
of non-response for each additional episode), which is not a surprising observation. Increasing age and BMI have increased odds of failure to report improvement, although these failed to reach statistical significance in this analysis. On the basis of these data, it is not possible to identify patients in advance who are unlikely to benefit from treatment, but those with high numbers of incontinence episodes should be counselled that full continence may not be achieved. References: 1. Eur Urol 2012;62:507–514. 2. J Urol 2013;189(6):2186–2193. 3. Eur Urol 2012;61(3):520–529. Disclosure Block: Douglas Tincello: Allergan: Speaker, Honoraria. Rhiannon Owen: No disclosures. Mark Slack: Astellas Pharma: Consultant, Consulting Fee. Johnson and Johnson: Consultant, Consulting Fee. Cambridge Medical Robotics: Board Member, Intellectual Property Rights. Philip Toozs-Hobson: Allergan: Advisory Committee Member, Consulting Fee. Allergan: Speaker, Honoraria. Astellas: I received financial support to attend IUGA last year, Travel Grant. Christopher Mayne: Astellas: Advisory Committee Member, Honoraria. American Medical Systems: Speaker, Honoraria. Johnson and Johnson (Ethicon womens health): Speaker, Honoraria. Keith Abrams: Roche: Advisory Committee Member, Honoraria. AstraZeneca: Advisory Committee Member, Honoraria. Janssen: Advisory Committee Member, Honoraria. Amaris: Consultant, Consulting Fee. OptumInsight: Consultant, Consulting Fee. Creativ-Ceutical: Consultant, Consulting Fee.
OP 137 PULSATING ELECTROMAGNETIC FIELD STIMULATION OF UROTHELIAL CELLS INDUCES APOPTOSIS AND DIMINISHES NECROSIS: NEW INSIGHT TO MAGNETIC THERAPY IN UROGYNECOLOGY K. JUSZCZAK1, P. MACIUKIEWICZ 2, P. THOR 3; 1 Dept. of Urology & Dept. of Pathophysiology, Mem. Rydygier Hosp. & Jagiellonian Univ. Med. Coll., Cracow, Poland, 2Dept. of Urology, Mem. Rydygier Hosp., Cracow, Poland, 3Dept. of Pathophysiology, Jagiellonian Univ. Med. Coll., Cracow, Poland Introduction: The potential mechanisms of electromagnetic field action on lower urinary tracts (LUT) are only partially described. It is believed that nerves are particularly sensitive to
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
the effects of PEMF (Pulsating Electromagnetic Fields)-induced eddy currents causing its depolarization, and, in a consequence, may regulate local blood flow and other factors (still unknown). PEMF stimulation activates efferent nerves and motor end plates of pelvic-floor muscle, providing better muscle strength and endurance. On the other hand, PEMF may affect the somatic nerve firing rate responsible for pelvic muscle and sphincter tone. The imbalance between apoptosis and necrosis of the urothelium affects the detrusor muscle activity. Overstimulation of afferent unmyelinated C-fibers and its local effector function (via neurogenic inflammation) by substances released from urothelium may induce detrusor overactivity leading to OAB symptoms and/or urge incontinence. Diminishing the release of the urothelial cells’ mediators to reduce afferent nerve over-stimulation seems to be crucial in urinary bladder sensory and motor activity control. Objective: The evidence of electromagnetic therapy (EMT) efficacy in stress and/or urge urinary incontinence, as well as in detrusor overactivity is generally lacking in the literature. The potential EMT action of neuromuscular tissue depolarization has been described. Because there is no data on the influence of PEMF on the urothelium, we evaluated the effect of PEMF stimulation on rat urothelial cultured cells (RUCC). Methods: 15 Wistar rats were used for RUCC preparation. RUCC were exposed to PEMF (50 Hz, 45±5 mT) three times for 4 h each with 24-h intervals. The unexposed RUCC was in the same incubator, but in a distance of 35 cm from the PEMF generator. Annexin V-APC (AnV+) labelled was used to determine the percentage of apoptotic cells and propidium iodide (PI+), as standard flow cytometric viability probe to distinguish necrotic cells from viable ones. The flow cytometric analysis was carried out on a FACS calibur flow cytometer using Cell-Quest software. Results: The density of RUCC was 0.5×10”6 cells/ml. The RUCC characterized high urothelial cells viability (about >75 % of viable urothelial cells in the culture). In PEMF-unstimulated RUCC, the percentage of AnV+, PI+, and AnV + PI + positive cells were 1.24±0.34 %, 11.03±1.55 %, and 12.43±1.96 %, respectively. The flow cytometry analysis of rat urothelial cell culture was performed after the last PEMF stimulation of the cells culture. PEMF stimulation significantly induced the apoptosis (an increase of 16.9 %, as compared to PEMFunstimulated culture), and inhibited the necrosis (a decrease of 36.3 %, as compared to PEMF-unstimulated culture) of the urothelial cells in RUCC. The percentages of apoptotic (AnV+) and necrotic (PI+) urothelial cells obtained after PEMF stimulation were 1.45±0.16 % (p= 0.027) and 7.03±1.76 % (p<0.001), respectively. Additionally, AnV + PI + positive urothelial cells measured
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
as a percentage of double stained cells - Annexin V and Propidium Iodide positive in RUCC, upon PEMF exposure, achieved lower level (9.48±3.40 %, p=0.003), as compared to control unstimulated RUCC (a decrease of 23.7 %, as compared to PEMF-unstimulated culture) (Fig. 1). The PEMF stimulation of RUCC induces apoptosis (increase of AnV + cells) and inhibits necrosis (decrease of PI + cells) of urothelial cells. Conclusions: A low-frequency PEMF induces apoptosis and diminishes necrosis of urothelial cells. The ‘pro-apoptotic’ and ‘anti-necrotic’ action of PEMF on urothelial cells may be potentially applied in the therapy of functional disorders of urinary bladder (e.g. OAB/DO, urge incontinence, etc.). Nevertheless, further experimental and clinical studies are strongly required for the evaluation of the potential role and molecular mechanisms of PEMF actions on urothelium and detrusor muscle function.
Disclosure Block: Kajetan Juszczak: No disclosures. Piotr Maciukiewicz: No disclosures. Piotr Thor: No disclosures.
OP 138 IMPACT OF AGING ON VAGINAL SMOOTH MUSCLE: A MORPHOMETRIC STUDY R. LIANG1, M. FAWCETT 1, R. M. SHAFFER 1, S. L. PALCSEY 2, P. MOALLI 3; 1 Univ. of Pittsburgh, Pittsburgh, PA, 2Magee Womens Res. Inst., Pittsburgh, PA, 3Magee-Womens Hosp., Pittsburgh, PA Introduction: Smooth muscle comprises a critical layer of vaginal wall imparting physiological functions of maintenance of vaginal tone and contractility. Abnormalities in smooth muscle fibers are present in women with POP and may contribute to the pathogenesis of this condition [1]; yet, the mechanism is not clear. Aging, concomitant with a decline
S217
in circulating estrogen, is implicated in the deterioration of smooth muscle function and structure in other organ systems. However, it is not clear how aging impacts vaginal smooth muscle and whether aging further impacts smooth muscle in patients with POP. Objective: To define the impact of aging on the morphology of the vaginal smooth muscle in women with and without pelvic organ prolapse (POP). Methods: Full thickness vaginal biopsies obtained from the anterior and apical vagina from 30 patients with similar BMI and parity were obtained at the time of surgery. For eligibility, patients had to meet strict criteria to define hormonal status. Assignments to aging groups with or without prolapse were as follows: no prolapse less than 50 years (NP 50, n=6), no prolapse 50 to 70 years (NP50-70, n=4), prolapse less than 50 years (P50, n=5), prolapse 50 to 70 years (P50-70, n=8), and prolapse older than 70 years (P70, n=7). POPQ stage of prolapse ranged from II to III, and was randomly distributed in different age groups. Tissue blocks were cryosectioned (7 μm) and labeled for smooth muscle alpha actin. Nikon Elements software was used for the morphometric measurements. Density of smooth muscle was determined by the fraction of area of positive staining divided by total measured area. Smooth muscle bundle sizes represented by miniferets were analyzed in areas where fibers were cross-sectioned, and the frequency within different ranges was calculated. One way ANOVA and posthoc tests were used for statistics. Results: The BMI and parity of the patients were not statically different between groups. The two NP and P50 groups were all premenopausal while all patients but one in the older than 50 prolapse groups were postmenopausal. In the non-prolapse groups, muscle density in the patients older than 50 decreased by 33 % as compared to patients younger than 50 (0.27± 0.05 vs. 0.18 ± 0.04, P = 0.026). The vaginal smooth muscle layer in the aging patients contained higher percentage of small bundles (less than 20 μm in miniferet, P=0.049) and a lower percentage of larger bundles than younger patients (Figure 1A). In the prolapse groups, however, the aging effects did not occur in either muscle density (0.19±0.07 for P50, 0.23±0.19 for P50-70, and 0.19 ± 0.08 for P70, respectively) or bundle sizes (Figure 1B). Large variations were observed in the P50-70 group. When comparing subjects younger than 50, muscle density was 30 % lower (P= 0.09), and the percentage of muscle bundles smaller than 20 μm was increased (P=0.018) with a significant decrease of bundles larger than 30 μm (P < 0.05, Figure 1C) in the prolapse patients. In patients older than 50, the difference between prolapse and nonprolapse was not significant due to large variations.
S218
Conclusion: In patients without prolapse, vaginal smooth muscle was less dense with increased proportion of smaller muscle fibers with aging. However, in patients with prolapse, the impact of aging was no longer apparent as inferior smooth muscle structure had already occurred before age 50. Future studies will investigate mechanisms that induce these changes in vaginal smooth muscle. References: 1. AJOG, 2002, 187: p56-63. Disclosure Block: Rui Liang: No disclosures. Megan Fawcett: No disclosures. Rebecca Shaffer: No disclosures. Stacy Palcsey: No disclosures. Pamela Moalli: ACell: We received supplementary funding to support the cost of animals to complete the 3rd aim of our R01, Grant/Research Support. OP 139 LOWER URINARY TRACT SYMPTOMS AND URINARY NEUROPEPTIDES AFTER TREATMENT WITH VAGINAL ESTROGEN: A PILOT STUDY G. M. NORTHINGTON1, J. F. PENNYCUFF 2, S. C. SCHUTTE 1, D. R. KARP 3, C. O. HUDSON 1, A. P. MALYKHINA 4; 1 Gynecology and Obstetrics, Emory Univ. Sch. of Med., Atlanta, GA, 2Emory Univ. Sch. of Med., Atlanta, GA, 3 Emory Univ., Atlanta, GA, 4Surgery, Univ. of Pennsylvania Sch. of Med., Philadelphia, PA Introduction: Vaginal estrogen has been shown to improve urinary urgency and frequency in women with overactive bladder [1]. Estrogen’s effect on neural activation is one mechanism by which vaginal estrogen may improve symptoms. Objective: The purpose of this pilot study was to determine the changes in lower urinary tract symptoms and urinary neurotrophic factors - brain-derived neurotrophic factor (BDNF) and substance P (SP) - in women with overactive bladder 6 and 12 weeks after initiation of vaginal estrogen therapy. Methods: Eight postmenopausal women over the age of 50 with symptoms of OAB were recruited to participate in this study. OAB symptoms were assessed using the symptom severity subscale of the OAB-q, a validated questionnaire which reliably discriminates between women with and without OAB. Additional lower urinary tract symptoms were also assessed using the Incontinence Impact Questionnaire (IIQ-7). Women were excluded if they had a UTI, neurologic disorder, malignancy, renal disorder, diabetes, had been treated for OAB (anticholinergics or neuromodulation), or were taking estrogen within 3 months of enrollment. All women were treated with vaginal estradiol for 12 weeks (every night for
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
the first 2 weeks followed by 2 times per week up to 12 weeks). Women received a pelvic exam and symptoms were assessed with the OAB-q and IIQ-7 at baseline, 6 and 12 weeks. Urinary neuropeptides, BDNF and Substance P were measured using enzyme-linked immunosorbent assay at each time point. Six and 12 week mean (+/− SD) questionnaire scores and mean (+/− SEM) urinary neuropeptide levels were compared using matched pairs analysis. Results: Mean (+/−SD) ages and BMI were 65.6 (+/−8) years and 29.7 (+/−10), respectively, at baseline. Five women were Caucasian and 3 were African American. Mean parity was 2.2 (+/− 1) and 75 % (n=6) had at least one prior pelvic surgery in their medical history. None of the women were current smokers. Mean questionnaire scores for OAB-q and IIQ-7 at baseline were 68.9 +/−29.7 (max 100) and 45 +/− 24.7 (max 100), respectively. Compared to baseline, all women had significantly lower scores on the OAB-q symptom severity subscale at 6 and 12 weeks (44.1 +/− 17.7 and 38.3 +/− 12.2, P=0.0035). There was a nonsignificant decrease in IIQ-7 symptoms at 6 and 12 weeks compared to baseline (25.8 +/− 29.2 and 22.9 +/− 28.2, respectively vs. 45.0 +/− 25.7, P= 0.12). Urinary BDNF, trended towards a decrease at 12 weeks compared to baseline although this did not reach statistical significance (Figure, P=0.25). There was an initial nonsignificant decrease in Substance P at 6 weeks compared to baseline (0.17 +/− 0.06 vs. 0.24 +/− 0.07 pg/mL, P=.18) which was sustained at week 12 (0.17 +/− 0.02 pg/mL). Conclusions: This pilot study of postmenopausal women suggests that one mechanism by which vaginal estrogen may exert an effect on the urinary tract is by decreasing neural activation. Larger prospective studies are required to confirm and fully elucidate the mechanisms of estrogen on bladder function in women with overactive bladder. References: 1. Cardozo L, Lose G, McClish D, Versi E. A systematic review of the effects of estrogens for symptoms suggestive of overactive bladder. Acta Obstet Gynecol Scand 2004;83:892–7.
S219
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Disclosure Block: Gina Northington: Allmed Healthcare Management, Inc.: Consultant, Consulting Fee. Jon Pennycuff: No disclosures. Stacey Schutte: No disclosures. Deborah Karp: No disclosures. Catherine Hudson: No disclosures. Anna Malykhina: No disclosures.
OP 140 IMPLANTATION OF POLYPROPYLENE PROLAPSE MESH ALTERS RATIO OF COLLAGEN SUBTYPES IN THE VAGINA 3 MONTHS AFTER SACROCOLPOPEXY K. BOCHENSKA1, D. MANI 2, J. WROBLEWSKI 2, B. BROWN 2, P. MOALLI 3; 1 Obstetrics and Gynecology, Magee-Womens Hospital, Univ. of Pittsburgh, Pittsburgh, PA, 2McGowan Institute for Regenerative Medicine, Univ. of Pittsburgh, Pittsburgh, PA, 3 Magee-Womens Hosp., Pittsburgh, PA
Introduction: Synthetic polypropylene mesh has been used to overcome mechanical failure associated with native tissue repair in the treatment of pelvic organ prolapse. However, the use of mesh has been associated with complications including pain and vaginal exposure. These complications have been suggested to be a result of abnormal tissue remodeling due to stress shielding and/or a chronic inflammatory response leading to tissue degradation. A recent study demonstrated increased deterioration of biomechanical properties of the vagina following the implantation of high-stiffness mesh materials as compared to lower stiffness mesh materials (1). Briefly, deterioration of mechanical properties was greatest following the implantation of a heavier weight, lower porosity mesh (Gynemesh PS) as compared to lower weight, higher porosity mesh materials (Ultrapro, Restorelle). The exact mechanism for these changes is unclear, but may be due, in part, to changes in tissue collagen subtypes. Objective: To determine the impact of polypropylene mesh implantation on the ratio of type III to type I collagen following abdominal sacrocolpopexy in a nonhuman primate model. Methods: In a previous study, following Institutional Animal Care Use Committee approval, 50 rhesus macaques were implanted with Gynemesh PS (n=12), UltraPro with its blue line perpendicular to the longitudinal axis of vagina (n=10, low stiffness orientation), UltraPro with its blue line parallel to the longitudinal axis of vagina (n=8, high stiffness orientation) or Restorelle (n=8) via sacrocolpopexy following hysterectomy (2). Sham-operated animals (n=12) served as controls. The mesh-vagina complex was removed after 12 weeks and tissue blocks were prepared for histological sectioning. Three representative tissue samples from each group were evaluated in this study. A modified Herovici’s polychrome stain was utilized to distinguish between type III and type I collagen as previously
described (3). Multispectral microscopy was then used to image the subepithelial, muscular and adventitial layer of each group at 40× magnification. Five 40× images were generated per layer per slide, yielding a total of 225 images. A ratio of collagen III to collagen I was then calculated. Statistical analysis was performed using the Kruskal-Wallis test with Mann–Whitney U post-hoc comparisons utilizing a Bonferroni-adjusted significance level (p=0.05). Results: Elevated type III to type I collagen ratios were observed in both the subepithelial and muscular layers in animals implanted with mesh as compared to sham operated animals, while a slight reduction in the collagen type III to I ratio was observed in the adventitia. Although not statistically significant (p=0.492), a trend of increased collagen type III to type I ratios was observed in the subepithelium layer for the stiffest mesh material (Gynemesh) as compared to all other mesh groups. The greatest collagen type III to type I ratio in the muscular layer was observed for the Ultrapro implanted animals, where significance was seen relative to Restorelle (p=0.018) and sham (p=0.018). No significant differences in collagen type III to type I ratios were observed in the adventitial layer (p=0.244). When Ultrapro was implanted in the high stiffness direction, the collagen type III to type I ratio was significantly decreased in the adventitia (p=0.047), muscle (p=0.034) and subepithelium (p=0.021) as compared to Ultrapro implanted in the low stiffness direction. Conclusions: Tissue remodeling of all layers of the vagina occur following mesh implantation. This remodeling may include the formation of new tissue with significantly altered collagen composition. In the present study, the implantation of a higher stiffness mesh material (Gynemesh, PS) had a large effect upon remodeling of the subepithelial layer resulting in the deposition of increased levels of collagen type III as compared to type I. These changes correlate with the changes in biomechanical properties as well as the lowered collagen content and increased presence of MMP9 previously reported in animals implanted with heavier weight, lower porosity mesh materials. Of note, implantation of Ultrapro in the high stiffness direction resulted in significant changes of the collagen type III to I ratio as compared to Ultrapro in the low stiffness direction. Further work is needed to determine the exact mechanism which underlies the changes in tissue remodeling associated with implanted mesh and the implications of these findings for biomechanical properties of vaginal tissues. References: 1. BJOG. 2013 Jan;120(2):224–32 2. BJOG. 2013 Jan;120(2):233–43 3. J Tissue Eng Regen Med. 2013 Feb;7(2):139–48.
S220
Disclosure Block: Katarzyna Bochenska: No disclosures. Deepa Mani: No disclosures. John Wroblewski: No disclosures. Bryan Brown: No disclosures. Pamela Moalli: ACell: We received supplementary funding to support the cost of animals to complete the 3rd aim of our R01, Grant/Research Support.
OP 141 SINGLE NUCLEOTIDE POLYMORPHISMS OF THE PROMOTER OF MMP-3 GENE IN WOMEN DIAGNOSED WITH PELVIC ORGAN PROLAPSE: PRELIMINARY RESULTS C. KARACHALIOS1, G. KAPAROS 2, C. GRIGORIADIS 1 , E. LIAPIS 1, P. BAKAS 1, A. LIAPIS 1; 1 2nd Department of Obstetrics and Gynecology, Aretaieion Hospital, Univ. of Athens, Med. Sch., Athens, Greece, 2Department of Microbiology, Aretaieion Hospital, Univ. of Athens, Med. Sch., Athens, Greece Table of Contents &
Introduction
&
Objective
&
Methods
&
Results
&
Conclusions
&
References
Introduction: Pelvic organ prolapse (POP) is a frequent disorder with a lifetime prevalence of 30–50 %. There are several factors that can contribute to POP. However, the exact pathophysiological pathways of POP remain unclearly identified. Connective tissue metabolism disorders have also been described as a potential cause of this condition. Matrix metalloproteinases (MMPs) are enzymes which can break down collagen and other elements of the extracellular matrix. MMP-3 can play a significant role in connective tissue remodeling. Single nucleotide polymorphisms (SNPs) in regulatory areas of the MMP-3 gene might alter its expression and, thus, make the final gene product more or less active. These changes could lead to differences in the effect of MMP3 on connective tissue and, therefore, modify the development and progress of POP.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Objective: The aim of the study is the investigation of the connection between the various SNPs of the MMP-3 gene and POP. The presence of the 6A (adenosine) allele facilitates attachment of the repressor ZBP-9 which downregulates the expression of the MMP-3 gene. The 5A/5A genotype leads to the greatest transcription level of the MPP-3 gene, while women with 6A/6A SNP have the lowest level. Consequently, 5A/5A patients could have the greatest risk for POP, while 6A/6A females might face a lower risk. Methods: This was a prospective clinical and experimental study. All patients were referred from the hospital’s Urogynecology Clinic and asked to take part in the study after admission and by giving their informed consent. The study protocol was approved by the Hospital’s Ethics Committee. Group A consisted of 80 patients with symptomatic pelvic organ prolapse (Stage 2 or more according to the POP-Q Classification). The control group (Group B) consisted of 80 women without serious POP (Stage 0–1), admitted with uterine fibroids and other benign gynecologic conditions, such as dysfunctional uterine bleeding. None of the subjects suffered from connective tissue autoimmune diseases, joint and bone diseases, malignancy, chronic inflammation or other serious or life-threatening conditions. The two groups were well matched regarding their demographic and clinical characteristics. Peripheral venous blood samples were taken 16 h before the operation into tubes with EDTA as anticoagulant. Genomic DNA was extracted from wholeblood leukocytes. DNA was stored in −20 °C until analyzed. MMP-3 polymorphisms were being determined by the use of polymerase chain reaction (PCR) and restriction fragments length polymorphism (RFLP) analysis. Results: Preliminary results after analysis of the first 20 patients’ samples (10 out of each Group), showed: a. in Group A, 40 % 5A/5A, 40 % 5A/6A and 20 % 6A/6A, while b. in Group B, 20 % 5A/5A, 20 % 5A/6A and 60 % 6A/6A. According to these results, a statistically significant difference between these two groups is present. In women of group A, polymorphisms of the promoter of the MMP-3 gene associated with higher or moderate risk for POP (5A/5A and 5A/6A) were identified in 80 % of cases. In contrast, the same percentage among women of group B was 40 %, while polymorphisms associated with low risk (6A/6A) were present in the majority of patients (60 %).
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Conclusions: According to the preliminary results of our study, it seems that specific polymorphisms of the promoter of MMP-3 gene (5A/5A, 5A/6A) are involved in pathophysiological pathways of POP, as their presence was found significantly increased among Group A patients in comparison with the control Group. References: 1. Int Urogynecol J. 2013 Jun; 24(6):1033–8. 2. Arch Gynecol Obstet. 2012 Jun; 285(6):1581–6. Disclosure Block: Charalampos Karachalios: No disclosures. Georgios Kaparos: No disclosures. Charalampos Grigoriadis: No disclosures. Elias Liapis: No disclosures. Panagiotis Bakas: No disclosures. Angelos Liapis: No disclosures.
OP 142 CHANGE OF PYCR1 AFTER VAGINAL DISTENSION AND OVARIECTOMY IN MOUSE Y. MOON, S. BAI; Yonsei Univeristy, Seoul, Korea, Republic of Introduction: Defective elastic fiber synthesis with proteolytic degradation of extracellular matrix plays a critical role in the development of POP. Recently, a genetic disease caused by elastinopathy has been found to be associated with PYCR1 mutation. Previously, we confirmed that the level of PYCR1 decreased in uteroscaral ligaments of POP patients (not published). Objective: We hypothesized that changes in PYCR1 levels may have a role in POP pathophysiology. Since vaginal delivery and menopause are known to be two major risk factors of POP, we studied the effect of vaginal distension and ovariectomy on PYCR1 in the vaginal wall as well as its potential significance in POP pathogenesis. Methods: The female C57BL/6N mice were used. All animal experiments were approved by the Committee for the Care and Use of Laboratory Animals(Project license number: 2011– 0295). Mice aged 6 weeks were used. After anesthesia, they had a latex balloon inserted into the vagina. Mice underwent vaginal distention for 40 min by inflating the balloon with 450 μl of saline, while the remaining animals had an uninflated balloon for a sham procedure. Mice (n=8) were sacrificed at 0 h, 3 h, 9 h, 24 h, 48 h, 72 h and 1 week respectively after vaginal distension. Mice aged 8 weeks were used for bilateral ovariectomy or sham operation. The operation was performed by standard methods under general anesthesia. Mice (n=6)
S221
were sacrificed at 4 weeks after the operation. The vaginas were cut longitudinally into two equally sized pieces, and all tissues were frozen in liquid N2 for analysis Results: To examine the effect of vaginal distention on PYCR1, real-time PCR and immunoblotting were conducted on vaginal tissues of mice from 0-hour to 1-week after vaginal distension or sham operation. The mRNA and protein level of PYCR1 decreased significantly 3–9 h after vaginal dilatation, but returned to the sham-operated level 1-week afterwards (Figure 1A, B). To determine whether menopause affects the PYCR1 level, real-time PCR and immunoblotting were performed to quantify mRNA and protein levels of PYCR1 from the vaginal wall 4 weeks after the sham-operation and ovariectomy. The baseline expression of PYCR1 indicated that after ovariectomy, mRNA and protein levels of PYCR1 expression in the vaginal wall were increased (Figure 1C) Conclusions: PYCR1 in vaginal tissue of mice decreased right after vaginal dilatation, and recovered to the baseline after time. PYCR1 in vaginal tissue of mice increased after ovariectomy. PYCR1 changes dramatically throughout the lifetime, especially after vaginal delivery and menopause, both of which are major risk factors of POP. References:
Disclosure Block: Yeo Jung Moon: No disclosures. Sang Wook Bai: No disclosures.
S222
OP 143 GABAPENTIN SUPPRESSED VOIDING FUNCTION AND VISCERAL PAIN-RELATED VISCEROMOTOR REFLEX IN MICE WITH CYCLOPHOSPHAMIDE-INDUCED CYSTITIS H. H. CHANG1, X. ZI 2, G. GHONIEM 3; 1 Anesthesiology & Perioperative Care, UC Irvine, Irvine, CA, 2 Urology, UC Irvine, Irvine, CA, 3Univ. of California, Irvine, Orange, CA Introduction: Interstitial cystitis/painful bladder syndrome (IC/PBS) is a debilitating condition of unknown etiology characterized by pain associated with bladder that affects 3– 8 millions in the United States. It is a global disease with varying prevalence because of different diagnostic criteria. It is difficult to characterize the pain with existing diagnostic tools, such as visual analog scales. A novel prototype method integrating urodynamics, pain sensing, and electromyography (EMG) of abdominal muscles, and diagnosing functionalities at the end of the study can offer physicians a useful tool to examine the visceral pain. The visceromotor reflex (VMR) is an EMG recording of the external oblique muscle in response to the level of visceral pain induced by inflammatory bladder and graded bladder distention (non-inflammatory). Objective: A quantitative evaluation of visceral pain-related VMR in IC/PBS, would be ideal to refine its diagnosis and guide treatment. In this study, voiding function and VMR were examined in naive mice, and the mice with acute cyclophosphamide (CYP)-induced cystitis. Furthermore, pharmacological administration of gabapentin was also investigated for possible treatment since gabapentin has been clinically using for neuropathic pain. Methods: A total of 12 BDF1 mice were used. 5 mice were given 0.1 mL of saline (ip), and another 7 mice received 200 mg/kg of CYP (ip) 48 h before the urodynamic recordings. At the day of urodynamic recording session, the animals were anesthetized by urethane (1.5 g/kg, ip). A PE-50 tube was inserted into the bladder dome. Then the tube was connected to the infusion pump (1.8 mL/h) and the pressure sensor to obtain the bladder pressure. Left external oblique muscle was exposed and embedded with wires to obtain the VMR during voiding. Two wires were inserted with 27-gauge needle from the urethral
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
outlet, and embedded inside the urethral sphincter to obtain EUS EMG activity. Gabapentin (50 mg/kg, ip) was given to examine the voiding function and VMR at the end of recording sessions. Results: In the mice with acute CYP-induced cystitis, the bladders were larger, and bloody urine was found during the surgical preparation. Firing durations of VMR were significantly increased in the mice with cystitis (Figure 1). The effect of gabapentin started to affect the voiding contractions 0.5–4 h after drug administration (Figure 2). Gabapentin gradually suppressed the EUS EMG activity and VMR, and then completely eliminated the micturition reflexes and VMR in 1 h. Conclusions: Gabapentin did not significantly prolong the inter-contraction intervals, which means no effect on the overactive bladder induced by cystitis. Decreased EUS EMG activity and VMR indicated that gabapentin may ameliorate visceral pain induced by CYP as well as partially suppress the voiding function. The study showed that BDF1 female mouse is suitable for investigating altered voiding function and visceral pain associated with CYP-induced cystitis. Further studies are needed to establish a dose–response curve of gabapentin on the urodynamic recordings and VMR.
S223
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
References: None Disclosure Block: Huiyi Chang: No disclosures. Xiaolin Zi: No disclosures. Gamal Ghoniem: Astellas: Speaker, Honoraria. Uroplasty: research grant, Grant/Research Support.
OP 144 A NEW BIOENGINEERED SCAFFOLD FOR HERNIA REPAIR L. LOWENSTEIN1, L. ELDOR 1, N. ZEEVI LEVIN 2, I. JOSEPH 3; 1 Rambam Hlth. Care Campus, Haifa, Israel, 2Rambam Hlth. Care Campus, Haifa, Israel, HAIFA, Israel, 3Rambam, HAIFA, Israel
A NEW BIOENGINEERED SCAFFOLD FOR HERNIA REPAIR Objective: To evaluate the efficacy and safety of polypropylene mesh covered with mesenchymal stem cells derived extracellular matrix (ECM) for the repair of pelvic organ prolapse and abdominal hernia. Methods: Three different types of mesh implants were implanted and evaluated in a model for the repair of iatrogenic abdominal hernia in adult Sprague Dawley rats. Group I: polypropylene mesh (NET only; 6 rats); group II: (7 rats) polypropylene covered with electrospined nano- filaments (NFL) of biomaterial consisting fabricated of poly lactic-coglycolic acid (PLGA) and polycaprolactone (PCL) (NETNFL, 7 rats); group III: (9 rats) polypropylene mesh covered with NFL and acellular ECM (NET-NFL-ECM; 9 rats). The ECM was produced from adipose derived mesenchymal stem cells (aMSCs) or from mesenchymal progenitor cells which were derived from human embryonic pluripotent stem cells (hESChPSC-MPCs). After a period of 8 weeks from implantation the mesh implants were recovered and sent for histological evaluation. Two pathologists blinded to the type of the mesh implant evaluated the percentage area of the newly formed collagen around the mesh by using a computerized
S224
morphometric measurement. Connective tissue organization (fibroblastic proliferation), inflammation, and vascularization were scored in a semi quantitative manner on a scale of 0–4. Results: Surgery was well tolerated in all animals, excluding two rats from group I that were sacrificed 4 days following surgery due to dehiscence of the abdominal scar. Erosions of the mesh through the abdominal scar was observed in more than half (50–60 %) of the rats from group I and II. There were no cases of mesh erosion in rats from group III. Mesh with ECM showed significantly more widely spread collagen fibers around the mesh (40 %) compared with group I and II (25 %, 29 %, P<0.0001, respectively). There were no significant differences between the percentage of collagen fibers in the area around the mesh between group I and II (P =0.1). Inflammatory score was significantly higher in the ECM covered implants (group III) compared with the NET only (group I). The organization level, evaluated by the amount of newly formed fibrosis around the implants, showed significantly higher organization with significantly larger amount of accumulated fibrosis around the ECM covered implants compared with NET + NFL and NET. Comparison in the number of newly formed blood vessels around the scaffold, did not demonstrate significant differences between the 3 groups of rats (p>0.05). Conclusion: Mesh covered with ECM is biocompatible and seems to enhance local tissue regeneration, mainly newly formed connective tissue. This newly formed connective tissue around the ECM covered mesh might explain the lower rates of mesh extrusion seen in this group. Thus this mesh construct may be found to be suitable for different models of hernia repair including the pelvic floor. Disclosure Block: Lior Lowenstein: No disclosures. Liron Eldor: No disclosures. Naama Zeevi Levin: No disclosures. Itskovitz Joseph: No disclosures.
OP 145 ADEQUATE COMPENSATION? THE RESPONSE OF BLADDER SMOOTH MUSCLE TO BOTULINUM TOXIN TYPE A IN A RAT MODEL A. A. DIETER1, J. M. WU 2, N. Y. SIDDIQUI 1, D. J. DEGOSKI 3, J. M. BROOKS 3, P. C. DOLBER 4, M. O. FRASER 4; 1 Department of Obstetrics & Gynecology, Duke Univ. Med. Ctr., Durham, NC, 2UNC-Chapel Hill, Chapel Hill, NC, 3Institute for Medical Research, Durham VA Med. Ctr., Durham, NC, 4Department of Surgery and Department of Research & Development, Duke Univ. Med. Ctr. and Durham VA Med. Ctr., Durham, NC
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Introduction: Botulinum Toxin A (BoNT/A) is an effective treatment for urgency urinary incontinence. The effect of BoNT/A on striated skeletal muscle has been studied extensively, with recovery in rats occurring 4–6 weeks after injection.1 However, the neuromuscular organization of bladder smooth muscle is starkly different than that of striated muscle. Limited studies in rats have shown that BoNT/A: 1) decreases in vivo detrusor pressure 2 days after exposure;2 and 2) decreases in vitro detrusor contractility immediately after incubation.3 No studies have attempted to discern the time course and mechanisms of the bladder response to BoNT/A injection. Objective: We designed our experiments to characterize the responses of the rat bladder to functional cholinergic denervation from BoNT/A over a 9-weeks period using in vivo, in vitro and microanatomical methods. Methods: Chronic bladder catheters were implanted in isoflurane-anesthetized female Sprague–Dawley rats. The free ends were tunneled subcutaneously to the midscapular region. Rats received either 1) BoNT/A (10 units in 20 μl saline, n= 32) or 2) Control (20 μl saline alone, n=16) injected in 5×4 μl doses throughout the bladder wall. At 1, 3, 6 and 9 weeks post-treatment, conscious restrained cystometry (Cysto) was performed to assess bladder function. At each time point, 25 % of the rats in each group were euthanized and bladders harvested for in vitro contractility (IVC) and microanatomical analysis (MAA). Cysto – After a 60 min control period (normal saline, 0.1 ml/ min), single filling cystometrograms were performed to determine true bladder capacity (TBC), followed by ~60 min of continuous Cysto to determine functional bladder capacity (FBC). Voiding efficiency (VE) was calculated as the average FBC/TBC. Voiding bladder contraction durations (BCD) were also determined. IVC – Circumferential (Circ; equatorial) and ventral longitudinal (Long) bladder strips were mounted in a bath of oxygenated Krebs buffer at 37C with baseline tension set to 1 g. IVC was measured as the maximal tension responses to 3 successive stimulus series: 1) electric field (EFS; 0.5–32 Hz, 0.5 msec pulse duration, 10 s train, 100 V) to assess neurallymediated contractility; 2) carbachol (Carb; 10−1–103 uM) to assess direct cholinergic stimulation; and 3) potassium chloride (KCl; 60 mM) to assess inherent muscle contractility. EFS and Carb were delivered in escalating intensities and concentrations, respectively. MAA – Remaining tissues were drop-fixed in Zamboni’s fixative and banked for future MAA. Data were analyzed by 2-way ANOVA, +/− repeated measures as appropriate, with Sidak’s multiple comparison post-test. Results: This research is still in progress, we present here the preliminary results from the first 27 animals (n=18 BoNT/A and 9 Control).
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Cysto - At 1 week, there was no difference between treatment groups in TBC; however, BoNT/A animals had increased BCD (0.51 min vs. 0.34 min; P<0.01) and decreased VE (74 % vs. 89 %; P=0.01). These early differences were not maintained across subsequent weeks. IVC - All data were normalized for each strip to its 60 mM KCl response. The results thus far show no differences in the neurally-mediated responses to EFS between BoNT/A and Control, or between time points within treatment groups. However, mean response to 102 uM Carb at 3 weeks in Circ from BoNT/A treated bladders was significantly greater than that from Control (60 %, P<0.05). When comparing Long from BoNT/A animals across time, the mean response to Carb was greater at 3 weeks (~50 %), compared to all other time points, at 101–103 uM Carb (P<0.05–0.0001). Similar results were found in Circ from BoNT/A animals, with the 3 weeks responses almost double those from 6 to 9 weeks at 102–103 uM Carb (P<0.05 to 0.01). Conclusions: Following functional cholinergic denervation by BoNT/A, supraspinal control of bladder activity is the first to compensate by increasing the duration of efferent drive during voiding (i.e. increasing BCD at 1 week). At 3 weeks after BoNT/A injection, bladder smooth muscle exhibits denervation supersensitivity of cholinergic receptors as a second compensatory mechanism, allowing BCD and VE to recover. At 6 and 9 weeks, we observed no differences in either Cysto or IVC responses, suggesting either efferent sprouting as a third compensatory mechanism or loss of BoNT/A effect. Future MAA of changes in neural and muscular components of the bladder will help verify the compensatory mechanisms used to maintain bladder function following BoNT/A. References: 1. Proc Natl Acad Sci U S A. 1999;96(6):3200–3205. 2. Urology. 2005;65(3):622–626. 3. Brain Res Bull. 2003;61(2):165–171. Disclosure Block: Alexis Dieter: No disclosures. Jennifer Wu: Proctor and Gamble: Consultant, Consulting Fee. Nazema Siddiqui: Medtronic, Inc: Research grant with salary support, Grant/ Research Support. Institute for Surgical Excellence: Board Member, Intellectual Property Rights. American Urogynecologic Society: Research grant, Grant/Research Support. Intuitive Surgical, Inc.: Speaker, Honoraria. Danielle Degoski: No disclosures. Jillene Brooks: No disclosures. Paul Dolber: No disclosures. Matthew Fraser: Pfizer: Grantee, Grant/Research Support. Medtronic: Grantee, Grant/ Research Support. Amphora Medical: Board Member, Consulting Fee. Circuit Therapeutics: Consultant, Consulting Fee. Lipella: Patent License, Royalty.
S225
OP 146 FIRST VAGINAL DELIVERY AFFECTS LONG TERM ACTIVE AND PASSIVE BIOMECHANICAL PROPERTIES OF SHEEP VAGINA I. URBANKOVA1, A. FEOLA 1, G. CALLEWAERT 2, Z. LIAQUAT 1, N. SINDHWANI 3, L. KROFTA 4, C. E. GARGETT 5, J. A. DEPREST 2; 1 KU Leuven, Leuven, Belgium, 2UZ Leuven, Leuven, Belgium, 3Univ. of Leuven, Leuven, Belgium, 4Inst. for the care of mother and child, Prague, Czech Republic, 5MIMR-PHI Med. Res. Inst., Clayton, Australia Background: Pelvic floor disorders occur in up to one third of pre-menopausal and half of menopausal women. The leading causes of prolapse are pregnancy and vaginal delivery. Pregnancy induces remodeling of extracellular matrix and smooth muscles in pelvic floor, and vaginal delivery may cause local trauma. In rodents, the effect of pregnancy and delivery are reversible to some degree. While in non-human primates, vaginal birth permanently affects the biomechanical properties of the vagina. We have become interested in sheep as a model for the effects of pregnancy and vaginal surgery. Their anatomy allows vaginal surgery. Interestingly this animal develops spontaneous uterovaginal prolapse, so that it might be a suitable model to study the effects of pregnancy and vaginal delivery. Objective: To compare the effect of the first vaginal delivery on the active and passive biomechanical properties of the vaginal wall. Methods: We used 6 nulliparous and 6 primiparous Texel sheep, whose ovarian cycles were synchronized with a progesterone sponge (Veramix, Pfizer, Capelle a/d IJsse, Nederlands). Four days after sponge removal the vaginal tissue was removed en block. The specimen was opened along the urethra and the posterior vaginal wall was divided into a proximal and distal part (Figure). Full thickness specimens were prepared to test the passive (30×30 mm) and active (8×10 mm) biomechanical properties. We performed bi-axial tensiometry with a plunger test (200 N-Zwicki tensiometer, Ulm, Germany). Here, we report data from the low stress part of the load-elongation curve (comfort zone), the comfort zone stiffness and length. Active properties were determined by a contractility assay. Freshly collected samples were equilibrated in Krebs solution and then exposed to 80 mM KCl. The generated forces were normalized to the volume of the tissue. Results: In nulliparous animals, there were no regional differences in the stiffness or contractility (Table). In the primiparous group the distal vagina had a 40 % lower comfort zone stiffness compared to the proximal vagina (p = 0.014). Similar there were regional differences in
S226
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
active properties (38 % lower in the distal area (p = 0.028)). The comfort zone length showed no differences between locations. Comparing nulli- and primiparous ewes, there were differences only in the distal vagina. Primiparous animals had a 49 % lower stiffness (p = 0.05), and 26 % longer comfort zone (p=0.04) than nulliparous animals. On contractility test, distal primiparous samples generated about 64 % less force (p=0.008) than nulliparous controls. Conclusion: A single vaginal delivery significantly induces changes in the active and passive biomechanical properties of the distal vaginal wall of sheep. These can be summarized as an increase in laxity and a decrease in contractility. These changes are consistent with previous observations. In rodents pregnancy affects the active and passive biomechanical properties; however, after delivery these properties are largely recovered. In non-human primates, delivery induced similar decrease in stiffness, but the active biomechanics have not yet been reported. These results highlight the impact of delivery, its magnitude may be dependent on the animal model. We are now documenting the underlying biochemical and morphologic changes of vaginal delivery in the sheep model. Table: Biomechanical properties of the vaginal wall Median (IQR) Mean ± SD
Nulliparous
Primiparous
Distal
Proximal
Distal
Proximal
0.1670 (0.060)
0.1852 (0.0604)
0.0654 (0.0405)
0.2088 (0.2397)
Active properties Contractility Passive properties Comfort zone stiffness (N/mm) Comfort zone length (mm)
0.26±0.1 0.23±0.07 0.14±0.04 0.24±0.07 3.91± 0.61
4.81±0.71 5.28±1.27 4.32±0.37
Disclosure Block: Iva Urbankova: No disclosures. Andrew Feola: No disclosures. Geertje Callewaert: No disclosures. Zahra Liaquat: No disclosures. Nikhil Sindhwani: No disclosures. Ladislav Krofta: No disclosures. Caroline Gargett: No disclosures. Jan Deprest: Medri: Unconditional grant; company is not designer of the study, owner or results or have any say in publication of results. Grant/ Research Support. Ethicon: Speaker, Honoraria. AMS: Consultant, Honoraria. coloplast: Framework 7 programme of the European Commission for novel material development, Grant/Research Support.
OP 147 IMPACT OF PROLAPSE MESH PROPERTIES ON THE HOST INFLAMMATORY RESPONSE B. N. BROWN1, D. MANI 2, A. L. NOLFI 1, P. MOALLI 3; 1 Univ. of Pittsburgh, Pittsburgh, PA, 2McGowan Institute for Regenerative Medicine, Univ. of Pittsburgh, Pittsburgh, PA, 3 Magee-Womens Hosp., Pittsburgh, PA Introduction: Surgical mesh is increasingly used to improve anatomical outcomes over native tissue repairs in pelvic organ prolapse. While there is evidence to support the use of mesh in sacrocolpopexy, complications are observed at rates of at least 10 %. It has been suggested that erosions may be precipitated by stress shielding. That is, a mismatch in stiffness between mesh and tissue leads to degeneration of vaginal tissues and loss of mechanical integrity. Recent work has demonstrated that differences in mesh properties (weight, pore size, density) are related to the degree of degradation. Mesh materials with higher weight, lower porosity, and thus, increased stiffness, are associated with increased degradation (1,2). It has also been suggested that complications following mesh implantation are, at least in part, attributable to an inflammatory processes mounted by the host following implantation of mesh. However, a detailed investigation of the host response to mesh materials placed in the vagina has never been performed. Objective: The objectives of the present study were: (1) to determine the predominant cell type (macrophage, Tlymphocyte, B-lymphocyte, mast cell) present within the area of implantation associated with three separate mesh materials following sacrocolpopexy in rhesus macaque; and (2) to determine the phenotypic profile (M1 proinflammatory, M2 antiinflammatory) of the macrophage population participating in the host response. Methods: 43 female, middle aged, parous, BMI matched rhesus macaques underwent supracervical hysterectomy followed by sacrocolpopexy with implantation of 1 of 3 different polypropylene mesh materials. Materials included one heavier weight, lower porosity mesh (N=8, Gynemesh PS) and two lighter weight, higher porosity meshes (N=6, Restorelle and N=7
S227
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Ultrapro). Sham operated animals were used as a control (N=9). Three months post-surgery, the vagina-mesh complex was harvested and a portion was frozen in OCT for histologic sectioning with another portion reserved for ELISA assay. Histologic sections were labeled for leukocyte common antigen (CD45), macrophages (CD68), T-lymphocytes (CD3), Blymphocytes (CD20), and mast cells (CD117). Additional labeling was performed using markers specific for M1 (CD86) and M2 (CD206) macrophage phenotypes. Three representative mesh areas were imaged using a 40× objective on each slide and quantification of positively labeled cell populations was done using Cell Profiler Analysis Software (Broad Institute, Harvard University). Tissues from the same animals were assayed for both pro- (IL-12, and TNF-α) and anti-inflammatory (IL-4, IL-10) cytokines by ELISA. Statistical analysis was performed by Kruskal-Wallis test with Mann–Whitney U post-hoc comparisons utilizing a Bonferroni-adjusted significance level (p=0.05). Results: A dense cellular response was observed surrounding each individual mesh fiber with the macrophage as the predominant cell type (10–25 %) within the inflammatory response at 3 months. This response became more diffuse with increasing distance from the fiber surface. T-lymphocytes (5– 10 %) were the second most common cell type followed by Blymphocytes (<3 %) and mast cells (<1 %). This response was characteristic of the host response regardless of the type of mesh. Few positive cells were observed in surgical site of sham-operated animals. Further labeling revealed polarization of the macrophage response towards the M1 phenotype in all mesh groups as compared to sham (p<0.02 for ally mesh types), however the degree of M1 polarization was observed to be less in the groups implanted with lighter weight, higher porosity mesh materials, though not statistically significant. Analysis of cytokine levels did show a statistically significant shift towards increased expression of anti-inflammatory cytokines in groups implanted with lighter weight, higher porosity meshes as compared to heavier weight, low porosity mesh groups (p < 0.001 Gynemesh vs. Restorelle, p = 0.02 Gynemesh vs UltraPro). Conclusions: The host response to polypropylene mesh consists predominantly of macrophages polarized to a pro-inflammatory M1 phenotype at 3 months postimplantation. However, implantation of lighter weight, higher porosity mesh attenuated the pro-inflammatory M1 response. While additional work is required to establish a causal relationship, these results suggest a link between macrophage polarization profile during the host response and downstream clinical outcomes. An improved scientific understanding of the mechanisms of the host response to synthetic mesh materials placed in the vagina has the potential to significantly affect the design of next generation mesh materials, inform clinical practices and improve outcomes in pelvic floor repair.
References: 1. BJOG. 2013 Jan;120(2):224–32. 2. BJOG. 2013 Jan;120(2):233–43. Disclosure Block: Bryan Brown: No disclosures. Deepa Mani: No disclosures. Alexis Nolfi: No disclosures. Pamela Moalli: ACell: We received supplementary funding to support the cost of animals to complete the 3rd aim of our R01, Grant/Research Support.
OP 148 INFLUENCE OF REPRODUCTIVE STATUS ON TISSUE COMPOSITION AND BIOMECHANICAL PROPERTIES OF OVINE VAGINA D. ULRICH1, S. L. EDWARDS 2, K. SU 2, J. F. WHITE 2, J. A. RAMSHAW 2 , G. JENKIN 1 , J. DEPREST 3 , A. ROSAMILIA 1, J. A. WERKMEISTER 2, C. E. GARGETT 1; 1 Monash Univ., Melbourne, Australia, 2CSIRO Materials Sci. Engineering, Melbourne, Australia, 3Univ. Hosp. Leuven, Leuven, Belgium Introduction: Studies of the human vaginal wall especially in the non-prolapsed state are inconclusive due to lacking information of the exact tissue acquisition and often restricted to one type of analysis (1). Sheep have been suggested as a convenient model for assessing surgical treatments for pelvic organ prolapse. Objective: To undertake a comprehensive analysis of the biochemical tissue composition and passive biomechanical properties of ovine vagina and relate this to the histoarchitecture at different reproductive stages as part of the establishment of a large preclinical animal model for evaluating regenerative medicine approaches for surgical treatment of pelvic organ prolapse. Methods: Vaginal tissue was collected from virgin (n=3), parous (n=6) and pregnant sheep (n=6; mean gestation; 132 days; term=145 days). Tissue histology was analyzed using H + E and Masson’s Trichrome staining. Biochemical analysis of the extracellular matrix proteins used a hydroxyproline assay to quantify total collagen, SDS PAGE to measure collagen III/I + III ratios, dimethylmethylene blue to quantify glycosaminoglycans and amino acid analysis to quantify elastin. Uniaxial tensiometry was used to determine the Young’s modulus, maximum stress and strain, and permanent strain following cyclic loading. Results: Vaginal tissue of virgin sheep had the lowest total collagen content and permanent strain. Parous tissue had the highest total collagen and lowest elastin content with concomitant high maximum stress. In contrast, pregnant sheep had the highest elastin and low collagen content, and thickest smooth muscle layer, which was associated with low maximum stress and with least dimensional recovery following repetitive loading.
S228
Conclusions: Pregnant ovine vagina was the most extensible, but the weakest tissue, whereas parous and virgin tissues were strong, but not as elastic. Pregnancy had the greatest impact on tissue composition and biomechanical properties, compatible with significant tissue remodeling as demonstrated in other species. Biochemical changes in tissue protein composition coincide with these altered biomechanical properties. References: 1) Couri BM, Lenis AT, Borazjani A, Paraiso MF, Damaser MS (2012) Animal models of female pelvic organ prolapse: lessons learned. Expert Rev Obstet Gynecol 7: 249–260. Disclosure Block: Daniela Ulrich: Astellas: Speaker, Travel Grant. SHARON EDWARDS: No disclosures. KAI SU: No disclosures. JACINTA WHITE: No disclosures. JOHN RAMSHAW: No disclosures. GRAHAM JENKIN: Mesoblast Ltd: Sponsored Research Agreement, Grant/Research Support. Cell Care Ltd: Research Agreements, Grant/Research Support. JAN DEPREST: Medri: Unconditional grant; company is not designer of the study, owner or results or have any say in publication of results. Grant/Research Support. Ethicon: Speaker, Honoraria. AMS: Consultant, Honoraria. coloplast: Framework 7 programme of the European Commission for novel material development, Grant/Research Support. ANNA ROSAMILIA: AMS: Research grant, Grant/Research Support. Boston Scientific: research grant, Grant/Research Support. astellas: Speaker, Honoraria. JEROME WERKMEISTER: No disclosures. CAROLINE GARGETT: No disclosures.
OP 149 HISTOLOGICAL CHARACTERIZATION OF VAGINAL CUFF TISSUE USING DIFFERENT ENERGY SOURCES DURING ROBOTIC HYSTERECTOMY: A RANDOMIZED TRIAL. M. BILLOW 1 , M. CHENG 2 , J. CORNELLA 1 , P. MAGTIBAY 1, L. LANCEROTTO 3, D. ORGILL 4, L. CHEN 5, I. OCAL 5, R. KHO 1; 1 Gynecologic Surgery, Mayo Clinic Arizona, Phoenix, AZ, 2 Division of Health Sciences Research, Section of Biostatistics, Mayo Clinic Arizona, Phoenix, AZ, 3Pathology, Brigham and Women’s Hosp., Boston, MA, 4Pathology, Brigham and Women’s Hosp., Boston, MA, 5Pathology, Mayo Clinic Arizona, Phoenix, AZ Introduction: The use of electroenergy during colpotomy is unique to the minimally invasive approach to hysterectomy. Vaginal cuff dehiscence, occurring more frequently after laparoscopic and robotic procedures, has been postulated to result from poor wound healing with the use of energy during
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
colpotomy 2. To date, many animal studies have demonstrated that wounds made with a cold knife have greater tensile strength, less inflammation and faster re-epithelization compared with electrosurgery1. Current literature using animal models, however, provides conflicting evidence regarding lateral thermal tissue effect of electrosurgery including the CO2 laser 3. Furthermore, lateral thermal injury effect on human vaginal tissue has not been previously evaluated. Objective: Our study aims to compare the degree of LTI effect resulting from the use of monopolar energy and CO2 laser at the time of colpotomy during robotic hysterectomy. Methods: A prospective, randomized trial was conducted between May and November, 2013 on patients undergoing a robotic hysterectomy. Patients were randomized to have the colpotomy performed with monopolar energy (coagulation mode set at 40 W) or CO2 laser (Omniguide Inc, Cambridge, MA, set at 14 W). We determined a sample size of 10 patients in each group was needed to show a significant difference at a level of 0.05 for a power of 90 %. All patients over the age of 18 undergoing a hysterectomy for benign condition were included in the study. Vaginal tissue segments from the 12 and 6 o’clock positions from the specimen side were retrieved and cut into 4×3 mm sections and then further, into 5 μm sections. LTI was evaluated as follows using: 1. H&E staining, measuring gross extent of LTI from colpotomy edge (mm); 2 Masson’s Trichrome staining, microscopic extent of coagulation (microns); and 3. Masson’s Trichrome staining, extent of tissue edema (microns). Slides were evaluated by 4 blinded pathologistsThe two-sample Wilcoxon rank sum test and fisher exact test were used to compare the two groups. Interobserver variability was also measured. Results: A total of 24 patients were recruited for this study. After three patients were excluded due to inability to evaluate the tissue, a total of 11 patients were enrolled in the monopolar and 10 in the CO2 laser group. The average age of patients in the monopolar group was 51 and 48.5 in the laser group (p= 0.6316). There were no statistical difference in patients’ BMI (30.1 vs 28.8), menopausal status (27 % vs 40 %), and tobacco use (0 % vs 10 %) in the monopolar vs laser group. There were no differences in the extent of thermal injury using all three methods from the sections obtained from the 12 and 6 o’clock positions. Using the H&E stain, the mean extent of LTI in the monopolar group was significantly greater (1.1 mm) compared to the CO2 laser group (0.7 mm) (p=.0191). Using the Masson’s Trichrome stain, the mean depth of coagulation effect using monopolar cautery was greater (327.7 μm) compared to the CO2 laser (290 μm) but did not achieve statistical significance. (p=0.2698). Similarly, the mean amount of tissue edema with monopolar cautery was greater (677.3 μm) compared to the CO2 laser (505.0 μm) but also did not achieve statistical significance. (p=0.0972).
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Overall, there appears to be a 2-fold increase in gross thermal injury effect using monopolar energy compared to CO2 laser. Histologically, CO2 laser also resulted in less coagulation and tissue edema effect compared to monopolar energy. Conclusions: In conclusion, the use of CO2 laser energy during colpotomy resulted in less LTI compared with monopolar cautery. The impact of greater lateral thermal injury at the time of surgery on subsequent vaginal wound healing needs to be further evaluated. References: 1. Sinha UK, Gallager LA. Effects of Steel Scalpel, Ultrasonic Scalpel, CO2 Laser, and Monopolar and Bipolar Electrosurgery on Wound Healing in Guinea Pig Oral Mucosa. Laryngoscope 113: 228–236 Feb 2003. 2. Croak AJ, Gebhart JB, Klingele CJ, Schroeder G, Lee RA, Podratz KC. Characteristics of patients with vaginal rupture and evisceration. Obstet Gynecol 103:572–576. 2004. 3. Schoinohoriti OK, Chrysomali E, Tzerbos F, Iatrou I. Comparison of lateral thermal injury and healing of porcine skin incisions performed by CO2 laser monopolar electrosurgery and radiosurgery: a preliminary study based on histological and immunohistochemical results. International Journal of Dermatology. 51: 979–986. 2012. Disclosure Block: Megan Billow: No disclosures. Meng-Ru Cheng: No disclosures. Jeffrey Cornella: No disclosures. Paul Magtibay: No disclosures. Luca Lancerotto: No disclosures. Dennis Orgill: Kinetic Concepts Inc. (KCI): Consultant, Consulting Fee. Kinetic Concepts Inc. (KCI): PI, basic research, Grant/ Research Support. Integra LifeSciences: Consultant, Consulting Fee. Integra LifeSciences: Speaker, Honoraria. Celleration: PI, Clinical research, Grant/Research Support. Longwen Chen: No disclosures. Idris Ocal: No disclosures. Rosanne Kho: No disclosures.
OP 150 THE IMPACT OF ROBOTIC-ASSISTED SURGERY ON TRAINING GYNECOLOGY RESIDENTS D. MOOLA1, L. B. WESTERMANN 2, R. N. PAULS 3, C. C. CRISP 4; 1 Department of Obstetrics and Gynecology, TriHlth., Cincinnati, OH, 2TriHlth. Good Samaritan Hosp., Cincinnati, OH, 3 Good Samaritan Hosp., Cincinnati, OH, 4Good Samaritan Hosp., TriHlth., Cincinnati, OH Objective: To evaluate the trend in hysterectomy route for benign conditions before and after the implementation of robotic assisted surgery and to assess the impact on surgical training of residents at a large accredited Obstetrics/ Gynecology program.
S229
Background: Surgical training in Gynecology is an evolving process; producing competent physicians requires a comprehensive curriculum, adequate volume, and hands-on experience. The introduction and widespread adoption of robotic surgery has raised concerns regarding resident learning and exposure. Resultant impact on overall numbers of vaginal, open/abdominal, and rigid laparoscopic hysterectomy is currently unclear, potentially affecting program accreditation and skill of future physicians. Methods: This retrospective chart review obtained Institutional Review Board approval. Subjects undergoing hysterectomy during the 2005 and 2011 calendar years were identified by current procedural terminology (CPT) codes. Cases performed by a gynecologic oncologist or having an associated staging, debulking, and radical dissection were excluded. Of all hysterectomies performed, a stratified random sample representative of the overall number of hysterectomies, 20 per month for each year was obtained. These charts were then reviewed for route of hysterectomy and resident involvement. Chi squared analysis was used for main outcomes. Results: Four hundred eighty charts were identified. After excluding oncology cases and missing data, 193 cases were included from 2005 to 146 cases from 2011. For the sample, the average age was 48 years with an average body mass index of 29. A significant decline in vaginal hysterectomies was noted from 2005 to 2011: 62.2 % (n=120) to 27.4 % (n=40), (p<.001) (Table 1). Laparoscopic hysterectomies also declined from 30.1 to 19.9 %, over the same period (p<.026). In contrast, abdominal hysterectomies increased from 7.8 to 26 %, (p<.001). Additionally, while no robotic hysterectomies were performed in 2005, by 2011 this approach accounted for over one quarter of all such surgeries. Resident training was next analyzed. Of the cases examined, 40 in 2005 and 45 in 2011 were not attended by any resident. In 2005, most 52 % (21/40) of the uncovered cases were vaginal hysterectomies. However, in 2011, 55 % (25/45) of the uncovered cases were robotic-assisted and only 11 % (5/45) were vaginal hysterectomies. Conclusions: The introduction of robotic hysterectomy places new challenges on physicians and residents in training. The resultant decline in vaginal and laparoscopic hysterectomies coupled with the additional procedure to master places an increased burden on training programs. The decrease in the percentage of uncovered vaginal hysterectomies suggests an already recognized emphasis on this declining route of hysterectomy. The impact of the changes on surgical competency is not known. Our results identify potential areas for focus in training to ensure the graduation of surgically competent physicians.
S230
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
References: I. National Data Report: Obstetrics and Gynecology Case Logs, Accreditation Council for Graduate Medical Education Web site, 2003–2011 2. Obstet Gynecol 2008;111:69S 3. J Reprod Med 2009;54:675–677 Table 1. Route of hysterectomy 2005 % (N)
2011
P
Vaginal Abdominal
62.2 (120) 7.8 (15)
27.4 (40) 26.0 (38)
< 0.001 < 0.001
Laparoscopic Robotic
30.1 (58) 0
19.9 (29) 26.7 (39)
0.026 < 0.001
Total
100 (193)
100 (146)
Table 2. Hysterectomy coverage by residents 2005
2011
P
Route covered
% (N)
% (N)
Vaginal
82.5 (99)
87.5 (35)
0.458
Abdominal
86.7 (13)
89.5 (34)
0.771
Laparoscopic
70.7 (41)
62.1 (18)
0.417
Robotic
–
35.9 (14)
NA
Total covered
79.3 (153)
69.2 (101)
0.034
Total uncovered
20.7 (40)
30.8 (45)
0.034
Disclosure Block: Deepthi Moola: No disclosures. Lauren Westermann: No disclosures. Rachel Pauls: Trimel Inc: Research site, Grant/ Research Support. Catrina Crisp: No disclosures.
OP 151 THE EFFECT OF AGE ON POSTOPERATIVE MORBIDITY IN WOMEN UNDERGOING UROGYNECOLOGIC SURGERY C. E. BRETSCHNEIDER1, E. J. GELLER 1, B. ROBINSON 2, J. M. WU 1; 1 UNC-Chapel Hill, Chapel Hill, NC, 2Georgia Regents Univ., Augusta, GA Introduction: Conflicting information exists regarding the effect of age on postoperative morbidity. While some studies have identified older age as an independent risk factor for postoperative complications and prolonged hospital stays (1), other studies have found that comorbidities rather than age are the main determinant of postoperative morbidity (2). In order to provide effective perioperative management and counseling, further investigation is needed to delineate the association
between older age and postoperative morbidity in women undergoing elective urogynecologic surgery. Objective: To estimate the effect of older age on postoperative morbidity and to assess other factors associated with postoperative complications. Methods: We conducted a retrospective cohort study of 508 women who underwent pelvic floor reconstructive surgery between March 2011 and June 2013. Our two cohorts were based on age: younger women <65 years and older women ≥65 years. All women who underwent surgery for prolapse or stress incontinence were included. Women who underwent only sacral neuromodulation were excluded. Our primary outcome was the degree of postoperative complications based on the Dindo-Clavien Scale (3), with a score of ≥2 representing a serious postoperative complication. Data regarding patient demographics, operative procedures, estimated blood loss (EBL), intraoperative and postoperative complications, and length of hospitalization were collected. Charlson Comorbidity Index (CCI) scores and ASA class were used to classify comorbidities and health status preoperatively. For our primary analysis, we compared younger versus older women and assessed the risk of postoperative complications. Logistic regression was also used to evaluate factors associated with postoperative morbidity, while adjusting for potential confounders. Results: Of the 508 patients, 300 (59.1 %) were in the younger cohort and 208 (40.9 %) were in the older cohort. The two groups were similar in parity and history of laparoscopic or vaginal surgery. Older women were less likely to smoke (2.4 % vs 10.7 %, p<.001) and had a lower BMI (mean 27.6±5.4 vs 29.7±6.2 kg/m2, p<.001. They also had higher CCI (0.7±1.0 vs 0.4±0.7, p<.001) and ASA scores (66.8 % vs 38.0 % with ASA class 3, p<.0001). The older and younger cohorts had similar rates of intraoperative complications (4.8 % vs 5.3 %, p=0.79, respectively), EBL (123±157 vs 144±315 ml, p=0.32, respectively), and operative time (127± 75 vs 13-±80 min, p=0.63, respectively). For our primary outcome, we found that older women had a higher rate of serious postoperative complications (12.5 % vs 6.7 %, p=.02). In a multivariate logistic regression model that included smoking status, CCI, BMI, and operative time, older age remained significantly associated with postoperative morbidity (OR 2.01, 95 % CI 1.05, 3.86). Length of surgery in hours was also associated with morbidity (OR 1.45, 95 % CI 1.15, 1.84). Conclusions: Women aged 65 years and older undergoing urogynecologic surgery had a higher risk of postoperative complications based on the Dindo-Clavien score compared to women less than 65 years of age. Longer operative times were also associated with higher postoperative morbidity. References: 1) Sung VW, et al. Effect of patient age on increasing morbidity and mortality following urogynecologic surgery. Am J Obstet Gynecol. 2006 May;194(5):1411–7.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
2) Friedman WH, et al. Outcomes of octogenarians and nonagenarians in elective major gynecologic surgery. Am J Obstet Gynecol. 2006 Aug;195(2):547–52. 3) Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004; 240: 205–13.| Disclosure Block: C. Bretschneider: No disclosures. Elizabeth Geller: Intuitive Surgical, Inc: Speaking at postgraduate courses, Honoraria. Barbara Robinson: Boston Scientific: I was a subject for a research study and received a stipend for study participation., I was a subject for a research study and received a stipend for study participation. Jennifer Wu: Proctor and Gamble: Consultant, Consulting Fee. OP 152 QUALITY OF WEB-BASED HEALTH INFORMATION REGARDING PELVIC ORGAN PROLAPSE: HOW GOOD IS IT AND DOES DOMAIN SUFFIX MATTER? A. B. KAKOS1, D. A. LOVEJOY 2, J. L. WHITESIDE 3; 1 Female Pelvic Medicine & Reconstructive Surgery, The Christ Hosp./Univ. of Cincinnati, Cincinnati, OH 45219, OH, 2Obstetrics and Gynecology, Univ. of Kentucky, Lexington, KY, 3The Christ Hosp./Univ. of Cincinnati, Coll, Cincinnati, OH Introduction: By 2050, the total number of women estimated to annually undergo a surgical repair of pelvic organ prolapse (POP) is more than 240,000.1 Considering still more women pursue conservative treatment options, the impact of POP is significant establishing the need for available, high quality, patient level information regarding POP treatment options. Patient centered information available on the web concerning POP can be incomplete, limiting patient awareness to all treatment options both surgical and non-surgical .2 The DISCERN instrument is a reliable tool to estimate the quality of web-based information.3 The Health on the Net (HON) label is another external criteria to estimate web sites health information quality. These tools have not been used to estimate the quality of health information regarding POP. The purpose of our study was to estimate the overall quality of health information regarding POP using standardized measurement instruments. We also sought to determine if domain suffix (.com, .org, .edu, .gov) can guide estimates of web information quality for POP. Objective: 1. To determine if web site domain suffix correlates with the quality health information regarding POP.
S231
2. To estimate the quality of web-based health information regarding POP. 3. To determine the quality of web-based health information regarding conservative treatment (observation, pessary, physical therapy) of POP. Methods: Two independent investigators, using 3 search engines (Google, Yahoo and Bing), searched and reviewed the top 30 unique sites for four terms: “Bladder prolapse;” “dropped bladder;” “uterine prolapse;” and “dropped uterus.” Determination of identified sites was conducted on a single day at two geographic but regionally similar sites. A two stage, 6-point rating scale with score range per question 0 to 5 with 0 corresponding to “strongly disagree” and 5 corresponding to “strongly agree” was developed from the DISCERN instrument. Also recorded was if a site had HON certification. A separate search was undertaken wherein the domain suffix for the top 100 sites per search term was conducted. There were 16 questions based on the DISCERN instrument rendering a maximum score of 80. Four questions focused on information availability and quality of conservative treatments for POP (pessary, watchful waiting, physical therapy). Results: The summary of 400 sites reviewed across the 4 search terms identified 64 % “.com”, 19 % “.org”, 8 % “.edu”, 6 % other and 3 % .”gov”. A total of 210 unique web sites were reviewed across the 4 search terms and 3 search engines. Of the 210 sites search terms 1, 2, 3, 4 accounted for 53, 59, 48, and 50 unique sites. Likewise, 138 were “.com”, 32 “.org”, 12 “.edu”, 5 “.gov” and 23 other. 166 of the 210 unique sites were identified on Google, 37 on Yahoo and 7 on Bing. Only 21(10 %) sites were HON certified. The mean (Std Deviation, 95 % confidence interval) DISCERN scores by domain suffix were 26.2 (14.1, 23.8– 28.5), 33.9 (13.6, 29–38.8), 28.5 (11.6, 21.1–35.9), 33.1 (19.6, 8.7–58.5), 33.2 (13.4, 27.4–39) for “.com”, “.org”, “.edu”, “.gov”, and other respectively. Despite wide variation, mean DISCERN scores were lower for “.com” sites relative to “.org” and other sites (p=0.005 and p=0.03 respectively). HON certification was significantly associated with higher DISCERN scores (p<0.0001). While most sites described vaginal pessaries (median score 5, interquartile range 4–5), few showed images of them (median score 0, interquartile range, 0–0). While physical therapy was described as a treatment option across the survey sites (median score 4, interquartile range, 0–5), watchful waiting was not (median score 0, interquartile range, 0–0). Overall, 158 (76 %) of sites reviewed possessed a summed mean score for the 4 questions describing conservative treatments of 3 or less. Conclusions: Web-based information available to women regarding the treatment of pelvic organ prolapse, based on the modified DISCERN instrument, is incomplete, heavily represented by business and commercial enterprises and weighted against presentation of conservative treatment options.
S232
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
References: 1. Wu JM, Kawasaki A, Hundley AF, et al. Predicting the number of women who will undergo incontinence and prolapse surgery, 2010 to 2050. Am J Obstet Gynecol 2011;205:230.e1-5. 2. Minaglia S, Kaneshiro B, Soules K, Harvey S, Grzankowski K, Millet L, Oyama IA. Assessment of internet-based information regarding pelvic organ prolapse and urinary incontinence. Female Pelvic Med Reconstr Surg. 2012 Jan-Feb;18(1):50–4. 3. Khazaal Y; Chatton A; Zullino D; Khan R. HON Label and DISCERN as content quality indicators of health‐related websites. Psychiatr Q); 2012 Vol. 83, p15-27, 13p. Disclosure Block: Andrea Kakos: No disclosures. David Lovejoy: No disclosures. James Whiteside: The International Academy of Pelvic Surgery: Board Member, Honoraria. Ethicon: Consultant, Consulting Fee.
OP 153 PREDICTING LEVATOR AVULSION FROM ICS POPQ FINDINGS A. PATTILLO, R. A. GUZMAN ROJAS, H. DIETZ; Sydney Med. Sch. Nepean, Penrith, Australia Introduction: Levator avulsion is a common consequence of vaginal childbirth. Its presence is associated with symptomatic female pelvic organ prolapse (FPOP) (1) and is also a predictor of recurrence after surgical correction.(2) Skills and hardware necessary for diagnosis by imaging are not universally available. Hence, diagnosis of avulsion will frequently require an elevated index of suspicion. Objective: To examine the predictive value of ICS POPQ for the diagnosis of levator avulsion by tomographic 4D translabial ultrasound. Methods: This is an analysis of data obtained in routine clinical practice in a tertiary urogynaecological unit. Subjects underwent a standardised interview, multichannel urodynamic testing, ICS POP-Q examination and 4D translabial pelvic floor ultrasound (US), supine and after voiding. US postprocessing was performed by the first author blinded against all clinical data. Avulsion of the puborectalis muscle was diagnosed by tomographic ultrasound imaging as shown in Figure 1. We tested components of ICS POP-Q associated with symptomatic FPOP (Ba, Bp, C, Gh and Pb) and other known predictors of avulsion with uni- and multivariate logistic regression. A risk score was constructed for clinical use.
Figure 1: Full right- sided avulsion (left side of individual slices) and partial left-sided avulsion. A full avulsion is diagnosed if slices 3–5 are all abnormal on at least one side. Defects indicated by (*). Results: Between January 2012 and July 2013, 719 patients were seen. We were able to retrieve the US volume data sets of 677. As 8 women did not have a full clinical examination, the final data set comprises 669 patients. Mean age was 56±13.8 years. Mean BMI was 29±6.4 kg/m2. Patients had a mean vaginal parity of 2.4±1.4, 88.9 % of patients had vaginal delivieries, and 26.6 % a forceps delivery. 52 % presented with symptoms of FPOP. Significant FPOP (ICS stage II+) was observed in 77.1 %. Mean hiatal area on valsalva was 29.3±9.8 cm2, with 64.3 % of patients having an abnormal hiatal area >=25 cm2 (ballooning). Overall, 15.8 % of patients had a unilateral avulsion on either side, and 13.5 % a bilateral avulsion. Results for uni- and multivariate analysis of POP-Q parameters and avulsion predictors are shown in Table 1. Risk scores were obtained from OR on multivariate analysis. For categorical variables, the score was assigned if present. For continuous variables, the score was multiplied by its value. Total risk score was the sum of scores obtained from each variable. Two prediction models were constructed, one using only clinical risk factors (forceps, FPOP surgery), and another including POP-Q parameters. Likelihood ratio test showed the latter to be a better predictor for avulsion (P<0.0001). Association with avulsion and score assigned for each risk factor
Age BMI Forceps Prev. HE
Univariate
p value
Multivariate
p value
OR (95 % CI)
p value
OR (95 % CI)
p value
Risk Score
N.S. N.S. 2.3 (1.6–3.2) <0.0001 1.9 (1.3–2.8) 0.002
8
N.S.
FPOP surgery 2.4 (1.6–3.6) <0.0001 2.5 (1.6–3.8) <0.0001 11 Ba
1.3 (1.2–1.5) <0.0001 1.2 (1.0–1.3) 0.01
2
S233
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240 Association with avulsion and score assigned for each risk factor Bp 1.2 (1.0–1.3) 0.009 0.9 (0.8–1.1) N.S. C Gh
1.2 (1.2–1.3) <0.0001 1.1 (1.0–1.2) 0.04 1.8 (1.5–2.1) <0.0001 1.4 (1.1–1.8) 0.003
1 4
Pb
1.9 (1.5–2.4) <0.0001 1.6 (1.3–2.1) <0.0001 6
Table 2 shows risk score cut-off points for low, medium and high risk of avulsion and OR for avulsion in each group. OR and incidence of avulsion for each risk group Group (points) Low (<29) Medium (29- <47)
OR (95 % CI) 1 3.6 (2.0–6.5)
Avulsion/N 15/168 (8.9 %) 86/330 (26.1 %)
High (≥47)
12.8 (6.9–23.5)
95/171 (55.6 %)
Conclusions: Levator avulsion is associated with ICS POPQ findings. Values obtained from POPQ measurements, along with simple clinical data, can be used to predict avulsion. This information may be useful in clinical practice by modifying the index of suspicion for this condition, thus increasing the likelihood of correct diagnosis. References: 1. Br J Obstet Gynecol 2008;115(8):979–984. 2. Ultrasound Obstet Gynecol 2012; 40 (S1): 95–96 Disclosure Block: Alejandro Pattillo: Johnson & Johnson: Occasional funding for attending meetings, Travel Grant. Rodrigo Guzman Rojas: No disclosures. Hans Peter Dietz: GE Medical: unrestricted educational grant, Grant/Research Support.
OP 154 COMPLICATIONS DURING MESH REMOVAL AND PATIENT-BASED OUTCOMES AFTER PELVIC MESH REMOVAL S. D. PICKETT1, B. J. BARENBERG 2, L. H. QUIROZ 3, S. SHOBEIRI 4, M. A. NIHIRA 5, H. KARBOWSKI 6, B. SNYDER 6, D. E. WHITE 7; 1 Obstetrics and Gynecology, Univ. of Oklahoma Hlth. Sci. Ctr., Oklahoma City, OK, 2Univ. of Oklahoma Hlth. Sci. Ctr., Oklahoma City, OK, 3Universith of Oklahoma Hlth. Sci., Oklahoma City, OK, 4The Univ. of Oklahoma HSC, Oklahoma City, OK, 5 Univ. of Oklahoma, Oklahoma City, OK, 6College of Medicine, Univ. of Oklahoma Hlth. Sci. Ctr., Oklahoma City, OK, 7 Univ of Oklahoma HSC, Oklahoma City, OK Introduction: Surgeries for mesh revisions can be associated with risks such as blood loss, damage to adjacent organs, and lack of symptom resolution. With the increase in use of synthetic mesh
in pelvic reconstructive surgery, there has been an increase in the number of patients seeking care for mesh-related complications. Objective: The purpose of this study was to investigate the complications subsequent to mesh removal performed in the operating room and to describe the patient-based outcomes following mesh removal. Methods: A retrospective review was performed on all patients undergoing mesh removal from January 2008 to June of 2013 at a tertiary care center. Patients were identified based on the Current Procedural Terminology (CPT) for removal of vaginal mesh or removal of sling. Information on demographics, presenting symptoms, surgical procedure data, and postoperative symptoms were collected. SAS v9.3 (SAS Institute, Cary, NC) was used for all statistical analyses. Summary statistics were calculated for the patient population. Complications were also compared between single compartment mesh removal surgery (SCS) and multi-compartment mesh removal surgery (MCS). Continuous variables were compared with t-tests, ANOVA, or Kruskall-Wallis tests where appropriate; categorical variables were compared using chi-square or Fisher’s exact tests. Odds ratios were obtained using univariate logistic regression. A pvalue of <0.05 was considered significant for all analyses. Results: During a 66 month period, a total of 267 procedures were performed for the removal of vaginally-placed mesh (Figure 1). The mean age was 55.8 years (SD ±11.8), median parity was 2.0 (range 0, 8), and mean body mass index was 28.9 kg/m2 (SD ±6.8). The main indications for mesh removal included: mesh exposure (60 %), dyspareunia (51 %), pain (56 %), and voiding dysfunction (36 %). The mean length of follow-up was 9.81 months (SD ±10.69). 75 patients (28.96 %) had previously undergone a mesh revision, and 40 % were on some type of hormone replacement therapy at the time of presentation to our clinic. 96 % of mesh excisions were performed vaginally, with the remainder being performed laparoscopically or abdominally. The mean amount of mesh removed was 4.17 cm (SD±3.07) in length. 86.8 % of patients had mesh revision surgery involving a single compartment (e.g. only sling, anterior, posterior or apical), while 13.3 % had MCS. Those with MCS had two to three times higher estimated blood loss (EBL) compared to SCS (p= 0.0004). The odds of blood transfusion following MCS were 14 times higher than the odds of transfusion after a SCS (OR 14.5; 95 % CI 2.5, 82.6; p=0.003. MCS were at seven times higher odds of taking longer than 1 h is compared to SCS (OR 7.39, 95 % CI 2.51, 21.72; p=0.0003). MCS procedures also resulted in greater median days of hospital stay (p=0.0018). There was no difference in intraoperative injury to adjacent organs between MCS to SCS. Postoperatively, 16 % of patients needed additional surgery for mesh removal, 12 % needed an incontinence procedure, and 7.5 % needed additional prolapse surgery due to recurrence of the prolapse in the same compartment as the mesh was removed. Postoperatively, those who previously had dyspareunia experienced a significant
S234
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
improvement in their pain (p=0.0013). Voiding dysfunction significantly improved after mesh removal in 76 % of patients who initially complained of voiding dysfunction (p<0.0001). Conclusions: Complications are higher with concomitant removal of mesh from multiple compartments. However, removal can lead to improvements in dyspareunia, voiding dysfunction, and symptoms of exposure. References: N/A
Research, Grant/Research Support. Coloplast: Contracted Research, Grant/Research Support. Cook: Contracted Research, Grant/Research Support. POP Medical: Contracted Research, Grant/Research Support. Salix: Contracted Research, Grant/ Research Support. Ethicon: Unrestricted Educational Grant, Grant/Research Support. Hayli Karbowski: No disclosures. Brandon Snyder: No disclosures. Dena White: No disclosures.
Table 1. Outcomes by type of mesh removal/revision
OP 155 REOPERATION FOLLOWING ROBOTIC AND VAGINAL MESH RECONSTRUCTIVE SURGERY: A RETROSPECTIVE COHORT STUDY L. A. MARTIN1, R. CALIXTE 2, P. S. FINAMORE 1; 1 Urogynecology, Winthrop Univ. Hosp., Mineola, NY, 2Biostatistics, Winthrop Univ. Hosp., Mineola, NY
EBL (ml)(mean, SD) Transfused (n, %) Operative time (min) (mean, SD) Hospital time (days) (median, range) Injury (n, %)
Anterior Sling or only (n=114) posterior (n=62) 83.89 108 (159.40) (103.73) 0 (0.00) 1 (0.72)
p Value Apical Multi(n=33) compartmental (n=33) 86.03 226.25 (86.37) (280.18)
0.0003
76.13 (49.65)
96.05 (58.24)
1 4 (12.12) 0.0016 (3.45) 79.96 126.16 (55.94) <0.0001 (57.65)
0 (0, 2)
1 (0, 2)
0 (0, 2) 1 (0, 2)
0.0001
2 (6.90) 1 (3.45) 0 (0.00)
1 (3.03)
0.335
1 (3.03)
0.069
0 (0.00)
1.00
Bladder
2 (1.79) 1 (1.64)
Rectum
0 (0.00) 0 (0.00)
Urethra
1 (0.09) 0 (0.00)
Disclosure Block: Stephanie Pickett: No disclosures. Benjamin Barenberg: No disclosures. Lieschen Quiroz: No disclosures. S. Abbas Shobeiri: POP Medical: Consultant, Consulting Fee. Lifecell: Consultant, Consulting Fee. Mikio Nihira: American Medical Systems: Consultant, Consulting Fee. American Medical Systems: Contracted
Introduction: Pelvic organ prolapse (POP) is a highly prevalent condition which has a significant negative impact on a woman’s quality of life. With more than 300,000 women in the U.S. undergoing surgery for POP each year1, there is a substantial need for effective, well-tolerated and durable procedures to treat POP. Robotic sacrocolpopexy and vaginal prolapse repair procedures utilizing permanent mesh both offer a minimally invasive approach. Critics of transvaginal mesh often cite the increased risk of reoperation as a compelling reason against this application of permanent mesh. Objective: The primary aim of this study was to compare reoperations following robotic sacrocolpopexy versus transvaginal mesh surgery for apical prolapse repair. We also sought to compare intraoperative complications and postoperative adverse events. Methods: We performed an IRB-approved retrospective chart review of women who underwent either robotic sacrocolpopexy (RASC) or transvaginal apical mesh support procedures (TVM) at Winthrop University Hospital between August 2009 and August 2013. All robotic procedures utilizing the Da Vinci system (Intuitive Surgical Inc., Sunnyvale, CA) were sacrocolpopexy performed with a prefabricated polypropylene Y mesh and permanent suture. All vaginal procedures were sacrospinous ligament fixation utilizing a prefabricated polypropylene mesh either with the Uphold or Pinnacle system (Boston Scientific, Natick, MA). All procedures were performed by a single surgeon. Reoperations and perioperative events were analyzed using Chi-square and Fisher’s exact tests. Results: During the 4-year period, there were 179 robotic assisted sacrocolpopexies and 64 transvaginal mesh repairs. The mean patient age and BMI in the RASC group were 56 and 27 and in the TVM group 71 and 29, respectively. Twelve (6.70 %) patients returned to the operating room from the RASC group, and an additional 7 patients (3.91 %) underwent an office procedure following the original surgery (Table 1). In the TVM group 3 (4.69 %) patients returned to the OR and an additional 2
S235
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
(3.13 %) underwent an office procedure (P=0.7851 and P= 1.0000, respectively). There were 4 intraoperative complications in the RASC group: (3 cystotomies and 1 ureteral injury) and 2 in the TVM group (1 cystotomy and 1 proctotomy) (P=1.0000). Postoperative adverse events occurred in 74 (41.34 %) patients of the RASC group and 22 (34.38 %) in the TVM group (P= 0.4069). The most frequent of these were urinary tract infections, which occurred in 17 (9.50 %) patients of the RASC group and 12 (18.75 %) of the TVM group (P=0.082). Mesh/suture exposure occurred in 5 (2.79 %) patients of the RASC group and 2 (3.13 %) patients of the TVM group (P=1.0000). Conclusions: In our cohort we found no difference in rate of reoperation between patients undergoing RASC and TVM. There was no difference in overall intraoperative complications or postoperative adverse events between the two groups, and specifically there was no difference in mesh exposure frequency. Based on our data we conclude that RASC and TVM have similar complication rates in our study population.
References: 1. Shah AD, Kohli N, Rajan SS, et al. The age distribution, rates, and types of surgery for pelvic organ prolapse in the US. Int Urogynecol J Pelvic Floor Dysfunct 2008; 19:421–428
Table 1: Subsequent Procedures Following RASC and TVM Repairs
Introduction: Women are commonly offered the same apical suspension procedures for surgical correction of posthysterectomy vaginal vault prolapse (VVP) and repair of uterovaginal prolapse (UtVP). VVP repair may result in worse surgical outcomes than UtVP because of loss of anatomical landmarks, surgical scarring and vaginal shortening that often follows hysterectomy. Likewise, one approach may result in an increased risk of complications. Foundational work with a large patient population is required to compare surgical success in these two patient populations presenting with prolapse. Objective: We compared prolapse repair success and complication rates between women with symptomatic VVP versus UtVP in a large cohort of well characterized participants undergoing prolapse repair with apical suspension. Methods: We performed a retrospective review of women who participated in Pelvic Floor Disorders Network trials: Outcomes following Vaginal Prolapse Repair and Midurethral Sling (OPUS), Colpopexy and Urinary Reduction Efforts (CARE) or Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL). All participants underwent surgical correction of stage 2–4 prolapse with apical repair by experienced pelvic surgeons at 17 sites throughout the US; vaginal mesh procedures and participants who did not receive apical suspension were excluded. Women were followed to 1 to 2 years postoperatively depending on study. Success was defined as absence of bothersome bulge symptoms as measured by the POPDI, no prolapse beyond the hymen on POPQ examination and no subsequent treatment for prolapse. Women not meeting all three criteria were considered prolapse surgical failures. POPQ examinations and POPDI, POPIQ and PISQ-12 measures were administered at baseline and each follow-up visit. Complications and serious adverse events (SAE) were recorded on standardized forms. With baseline assumptions that 85 % of women provided
Total Number of Patients (n) Return to Operating Room – Laparoscopy for small bowel obstruction lysis of adhesions
RASC (%) 179
TVM (%) 64
12 3 (6.70) (4.69) 2 (1.12) 0
P Value 0.7851 0.9656
– Suture or mesh excision
2 (1.12) 2 (3.13)
0.6093
– Recurrent prolapse repair
5 (2.79) 0
0.4020
– Release of sling
2 (1.12) 0
0.9656
– Sling placement
1 (0.56) 1 (1.56)
1.0000
Subsequent Office Procedure
7 (3.91) 2 (3.13) 1 (0.56) 0
1.0000 1.0000
– Sling exposure excised
1 (0.56) 0
1.0000
– Suture exposure excised
3 (1.68) 0
0.7020
– Granulation tissue excised
1 (0.56) 0
1.0000
– Peri-urethral bulking
1 (0.56) 1 (1.56)
1.0000
– Trigger point injections
0
0.5904
– Cystoscopy
1 (1.56)
(RASC = robotic assisted sacrocolpopexy; TVM = transvaginal mesh)
Disclosure Block: Lindsay Martin: No disclosures. Rose Calixte: No disclosures. Peter Finamore: Boston Scientific: Consultant, Consulting Fee. Intuitive Surgical: Consultant, Consulting Fee.
OP 156 POST-HYSTERECTOMY PATIENTS ARE AS LIKELY AS PATIENTS WITH UTEROVAGINAL PROLAPSE TO HAVE SUCCESSFUL PROLAPSE SURGERY R. G. ROGERS; Submitted on behalf of NICHD’s Pelvic Floor Disorders Network, Univ. of New Mexico, Albuquerque, NM
S236
follow-up data, we estimated 90 % power to detect a difference in prolapse treatment success of 6 % or greater. Where possible, comparisons between groups were controlled for by clinical site, age, BMI, baseline POPQ stage, apical repair procedure performed, prior prolapse repair and performance of a concurrent anterior and/or posterior repair. Outcomes measured at multiple timepoints were analyzed using longitudinal models and associated hypotheses tested using contrast statements for assessing whether differences existed for the two groups across study follow-up. Results: 1022 participants met inclusion criteria; 421 underwent VVP and 601 underwent UtVP apical repair. Participants undergoing VVP repair were older (63.9 +/− 9.0 vs 57.5 +/− 10.4 years), more likely to be White (93 vs 85 %), to have undergone prior UI (10 vs 1 %) or prolapse repair (42 vs 1 %), have POPQ Stage 4 prolapse (15 vs 6 %) and reported more bother from their prolapse as measured by POPDI scores (120 +/− 71 vs 100 +/− 64) when compared to the UtVP group (all P≤ 0.03). The VVP group was more likely to undergo abdominal sacral colpopexy (54 vs 15 %) while the UtVP group was more likely to undergo sacrospinous ligament suspension or uterosacral ligament suspension (85 vs 46 %, p<0.001). Women in the VVP group were less likely to undergo anterior repair (45 vs 52 %, p<0.001), but were equally likely to undergo posterior repair (43 vs 41 %, p=0.45). Overall success was similar between groups (OR 0.81 for VVP vs. UtVP, 95 % CI 0.54–1.19, p=0.29) as were changes in POPDI scores (−79.8 vs −80.3, p=0.88) and POPIQ scores (−46.2 vs −46.0, p=0.95). Postoperative point C measurements did not vary between groups (−6.8 vs −6.9 cm, p=0.57). Change in PISQ 12 scores did not show differences between groups (+0.85 vs −0.67, p=0.06). When analyses were repeated including only women who underwent repair with a vaginal approach (VVP=193, UtVP=508), surgical success rates were still not different (OR 0.69, 95 % CI 0.46–1.06, p=.10). Specific complications including blood transfusion, cystotomy, deep vein thrombosis, pulmonary embolis, or visceral injuries did not differ between groups (all p>0.05). SAEs (25 vs 17 %, p=0.85), did not vary between VVP and UtVP groups. Conclusions: Surgical repair success rates of stage 2–4 VVP and UtP by experienced pelvic surgeons were not different as measured by standardized anatomical and patient reported outcomes. Likewise, no differences were found in complication rates. This may aid surgeons in decision making regarding prolapse repair in women who have undergone prior hysterectomy. References: None Disclosure Block: Rebecca Rogers: American Medical Systems: DSMB chair for TRANSFORM trial, Honoraria. McGraw-Hill: Editor for textbook, Royalty. UptoDate: Author for prolapse chapter, Royalty.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
OP 157 VAGINAL SUSPENSION DURING FIRST SURGERY FOR GENITAL PROLAPSE: MCCALL’S VS SHULL’S TECHNIQUE AT 5 YEAR FOLLOW UP F. SPELZINI1, C. FUMAGALLI 2, M. C. CESANA 1, S. MANODORO 3, E. NICOLI 4, M. SICURI 5, D. VERRI 6, M. FRIGERIO 1, R. MILANI 1; 1 Ospedale San Gerardo, Monza, Italy, 2Bicocca Univ., Bernareggio, Italy, 3San Gerardo Hosp., Monza MB, Italy, 4 San Gerardo Hosp., Monza, Italy, 5Italy, 6 Introduction: Pelvic organ prolapse (POP) is a common condition affecting about 50 % of parous women [1]. Restoring vaginal apical support is the cornerstone of primary surgical treatment. In this institution a modified McCall’s culdoplasty consisting in a high uterosacral plication and Shull’s utero-sacral ligaments suspensions are routinely performed. Objective: This retrospective study compares the effectiveness, complications rate and functional pelvic health between the two techniques. Methods: Between January 2008 and June 2012, 351 consecutive women underwent prolapse primary repair including a vaginal hysterectomy followed by uterosacral ligaments suspension, either through modified McCall’s (Group A) or Shull ’s technique (Group B). Additional procedures are listed in Table 1. No prosthetic materials have been used, with the exception of midurethral slings when indicated. According to IUGA-ICS guidelines, medical interview and physical evaluation were performed pre-opertively, 1, 6, 12 months after surgery and then annually [2]. Prolapse recurrence was defined as vaginal descent ≥ II stage according to POP-Q system. Logrank test has been performed to compare clinical outocomes. A p value <0.05 was considered statistically significant. Results: A total of 351 women were enrolled: 225 in group A and 126 in group B. 18 patients were lost at lost at first follow-up visit, so we analysed 210 patients in group A and 123 in group B. The mean follow up was 24±14 months in Group A and 20± 12 months in Group B. Patient characteristics were comparable except for age (mean: 70 years in group A and 60 in group B; p<0,001). Populations reflect the choice of the surgeons, who preferentially performed a modified McCall culdoplasty in older women and Shull suspension in younger ones. Outcomes are listed in table 2. By the analysis of POP-Q scores, the only parameter that significantly differs between gorups is postoperative tvl (8.4 in group A and 9.2 in group B; p<0.0001) Conclusions: McCall modified culdoplasty and Shull’s uterosacral colposuspension are equally effictive in the studied population population. Both techniques showed a low rate of perioperative complications and medium/long term functional
S237
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
outocomes are comparable. Our results demonstrate that the choice to perform either one or the other technique in relation to patient’s age can be a strategy to aim similar results in older and younger women. The difference in vaginal lenght didn’t condition patient sexuality. Table 1 Concomitant procedures Additional procedures
Group A
Group B
Anterior vaginal repair Posterior vaginal repair
204 151
101 102
Miurethral sling
37
23
Table 2 - Outcomes Outcomes
Group A
Group B
p-values
Recurrence
40 (18 %)
16 (13 %)
n.s.
Re-operation rate
1 (0,4 %)
2 (1,5 %)
n.s.
Perioperative complications - visceral injurues
6 (2,7 %) 3
5 (4 %) 1
n.s.
- haemoperitoneum
1
2
- vaginal bleeding
–
1
- chornic urinary retention
2
1
0.37
0.39
n.s.
80 (36 %) 19 (8,4 %)
45 (36 %) 8 (6 %)
n.s.
44 (19 %) 14 (6 %)
23 (18 %) 4 (3,2 %)
n.s.
84 (37 %) 57 (25 %)
59 (47 %) 38 (30 %)
n.s.
71 (31 %) 15 (6,7 %)
42 (33 %) 5 (4 %)
n.s.
77 (34 %) 25 (11 %)
69 (55 %) 22 (17 %)
n.s.
20 (26 %) 4 (16 %)
22 (32 %) 3 (14 %)
n.s.
PGI-I Stress urinary incontinence Pre op Post op Urge incontinence Pre op Post op Voiding disfunctions Pre op Post op Constipation Pre op Post op Sex active women Pre op Post op Dyspareunia Pre op Post op
References: 1. Obstet Gynecol 1997; 89(4): 501–6 2. Int Urogynecol J 2010; 21(1): 5–26 Disclosure Block: Federico Spelzini: No disclosures. Caterina Fumagalli: No disclosures. Maria Cesana: No disclosures. Stefano Manodoro: No disclosures. Elena Nicoli: No disclosures. martina sicuri: No
disclosures. Debora Verri: No disclosures. Matteo Frigerio: No disclosures. Rodolfo Milani: No disclosures.
OP 158 VAGINAL MORCELLATION AND RISK OF INCIDENTAL UTERINE MALIGNANCY FOLLOWING VAGINAL OR LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY P. A. MALDONADO, C. A. HAMID, K. CHIN, S. BALGOBIN; Univ. of Texas Southwestern Med. Ctr., Dallas, TX. Introduction: Uterine morcellation of leiomyomata during endoscopic hysterectomy has received recent attention due to the risk of intraperitoneal dissemination of unexpected leiomyosarcoma (LMS), which worsens prognosis and decreases survival rates (1–3). Morcellation and specimen extraction by the vaginal route has theoretically similar risks, yet there is scant data in the literature regarding the risk of unsuspected cancer pathology following uterine morcellation during vaginal surgery. Objective: To describe the rate of incidental leiomyosarcoma and other uterine malignancies following uterine morcellation during vaginal or laparoscopic-assisted vaginal hysterectomy for benign indications in a large academic institution. Methods: A retrospective chart review was performed from 2006 to 2013 examining all cases of vaginal hysterectomy (VH) and laparoscopic-assisted vaginal hysterectomy (LAVH) by both general and subspecialty gynecology services at the three main teaching hospitals of the primary academic institution. Baseline patient demographics and surgical indication were recorded. Operative reports and dictations were reviewed to confirm the surgical approach, and to determine if the specimen was morcellated for removal. In addition, specimen weights and diagnoses were obtained from pathology reports. The primary outcome was number of cases of incidental leiomyosarcoma and other uterine malignancies in morcellated specimens. Secondary outcomes included overall incidence of unexpected malignancy and vaginal morcellation rate. Results: The chart review spanned 7 years from July 1 2006 to March 15, 2013 and included a total of 1613 cases, including 1093 VH and 520 LAVH procedures. Cases were distributed among a total of 48 faculty surgeons, consisting of 31 academic general gynecologists, 13 general and subspecialty private gynecologists and 4 academic female pelvic medicine and reconstructive surgeons. Mean ± SD patient age was 45.9 ±11.2 years and 1469/1613 (91 %) women were parous. Abnormal uterine bleeding was among the preoperative diagnoses in at least 885/1614 (55 %) cases. Vaginal morcellation
S238
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
was performed in 315/1613 (20 %) cases, and the majority of these (80 %) were morcellated during VH. Among the 1613 cases, there were no cases of leiomyosarcoma. There was one case each of endometrial adenosarcoma and endometrial stromal tumor, and 3 cases of smooth muscle tumor of uncertain malignant potential (STUMP), all occurring during VH procedures (Table). Interestingly, there were 8 cases of incidental endometrioid adenocarcinoma (4 VH and 4 LAVH) associated with hyperplasia, but none of these specimens were morcellated. Overall mean ± SD uterine weight was 140.9±91.0 grams (g), and leiomyomata were found on pathological examination in 928 (57.5 %) cases. In the morcellated subset of patients, mean ± SD uterine weight was 219.6±117.8 g with fibroids noted in 80.3 % of pathology reports. Table. Incidental malignant and borderline sarcomas after VH Case Age Parity Morcellation Pathology Diagnosis
Uterine Lesion weight Size (g) (cm)
1
37
G4P3
No
116
2.5
2
39
G2P2
No
3
38
G4P4
4
32
G8P5
5
47
G2P2
93
4.0
No
Endometrial adenosarcoma Low grade endometrial stromal tumor STUMP
269
5.5
No
STUMP
244
2.0
Yes
STUMP
403
3.5
Conclusions: At our institution, the overall rate of uterine sarcoma after VH or LAVH is approximately 1 in 800 cases with no LMS in this review of over 1600 patients. Although incidental endometrioid adenocarcinoma occurs at a higher rate, no uterine malignancy was morcellated. Vaginal morcellation is more frequent with VH than LAVH, with larger uteri, and a higher proportion of cases with fibroids on pathology. Our findings suggest that the risk of intraperitoneal dissemination of unexpected uterine malignancy is rare during VH and LAVH. However, when there is an increased likelihood of specimen morcellation during vaginal surgery, preoperative patient counseling of the risks of incidental malignancy may be prudent. References: 1. Gynecologic Oncology 122 (2011) 255–259. 2. PLoS ONE 7(11): e50058. doi:10.1371/journal.pone. 0050058 3. http://online.wsj.com/news/articles/ SB10001424052702304020704579278600195925942
Disclosure Block: Pedro Maldonado: No disclosures. Cherine Hamid: No disclosures. Kathleen Chin: No disclosures. Sunil Balgobin: No disclosures. OP 159 TOWARDS PATIENT SPECIFIC MODELING OF PELVIC FLOOR LOADING AND PROLAPSE REPAIR W. R. BARONE1, K. KNIGHT 2, P. MOALLI 3, S. D. ABRAMOWITCH 1; 1 Bioengineering, Univ. of Pittsburgh, Pittsburgh, PA, 2Univ. of Pittsburgh, PITTSBURGH, PA, 3Magee-Womens Hosp., Pittsburgh, PA. Pelvic organ prolapse resulting from a loss of structural support for the vagina is estimated to affect 50 % of women over the age of 501. Surgical management of prolapse aims to restore the anatomical position of the pelvic organs, often through the use of synthetic mesh. While many patients undergo successful surgery, complication rates up to 20 %2 suggest that a greater understanding of these repairs is needed, especially in regards to the highly complex mechanics of the vagina and its supportive tissues. The aim of this study was to develop a computational model that simulates prolapse of the anterior vaginal wall and subsequent mesh repair, considering patient specific vaginal geometries, pressures, presence of apical support, mesh material properties, mesh attachment to the vagina, and mesh tensioning. To create a 3D vaginal geometry, interior and exterior surfaces of the vagina were segmented from an MRI scan, reconstructed and a solid geometry was defined between the two surfaces using tetrahedral elements. The mesh geometry used in this study was based on Coloplast’s Restorelle DirectFix anterior mesh, modeled as a solid with tetrahedral elements. Vaginal and mesh properties were obtained from uniaxial testing, with Restorelle tested at various loading directions. Using this model the following scenarios were examined: 1) vaginal loading with “ideal” apical support 2) vaginal loading with an anterior/apical defect 3) vaginal loading with untensioned mesh fixation 4) vaginal loading with tensioned mesh (8.9 N =2 lbs). In each case a traction force of 1.55 N (0.35 lbs) was applied to the anterior wall of the vagina in the posterior-distal direction, simulating abdominal pressure, while the distal edge of the vagina was fixed. In mesh repair scenarios, mesh was fixed at 8 discrete locations on the vagina to simulate suture attachment. Loads and boundary conditions applied to the vagina were constant for each simulation.
S239
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
In each case, the vagina underwent noticeable displacement in response to application of an anterior load. Fixing the apex to simulate ideal support minimized both displacement and stress throughout the vagina. Conversely, removal of this support led to increases of 215 and 104 % in total displacement at the apex and the leading edge of the anterior vaginal bulge respectively (Fig. 1g). Untensioned mesh repair effectively restored displacement of the leading edge, though apical displacement was found to increase 90 % relative to the ideal case (Fig. 1h). Finally, mesh repair with a tensioned mesh did not restore displacements as effectively as the untensioned case, with leading edge and apical displacements increasing 74 and 133 % compared to the ideal case. In addition, mesh repair produced highly regional variations in vaginal stress, with an overall increase in average vaginal stress by an order of magnitude (Table 1). In this study a computational method for applying vaginal loads and examining the interaction between specific mesh products and vaginal tissue was developed for patient specific geometries. These findings demonstrate that mesh repair for pelvic organ prolapse does not restore the original mechanics exhibited by ideal apical support. Further, tensioning mesh with arms positioned posteriorly is less effective and increases regional mesh burden relative to a tension-free mesh with arms aligned along the length of the vagina. While these findings were applied to a single patient geometry in response to 1 loading condition, this approach can be utilized more broadly to gain insight into mesh successes, complications and failures. It also may prove useful in developing an individualized approach to prolapse repair. 1. Int Urogynecol J. 17(S), 2006 2. Int Urogynecol J. 20(1), 2008
Summary of total displacement and effective stress throughout the vagina for each tested scenario. Max Average Leading Apex Total Edge Total Displacement Effective Effective Vaginal Vaginal Displacement (cm) Stress Stress (cm) (MPa) (MPa) Ideal Apical Support Apical Defect
3.20
2.26
17.43
0.20
6.53
7.13
175.49
0.45
Mesh Repair - No 3.22 tension Mesh Repair - 2 lb 5.57 tension
4.29
808.25
52.38
5.28
2330.97
51.91
Disclosure Block: William Barone: No disclosures. Katrina Knight: No disclosures. Pamela Moalli: ACell: We received supplementary funding to support the cost of animals to complete the 3rd aim of our R01, Grant/Research Support. Steven Abramowitch: Pfizer: Investigator Initiated Research Support, Grant/Research Support.
OP 160 PREOPERATIVE EXAM AS PREDICTOR OF FAILURE OF PELVIC ORGAN PROLAPSE SURGERY M. F. ASLAM1, B. OSMUNDSEN 2, R. EDWARDS 1, M. A. DENMAN 3, J. LIM 4, C. MATTHEWS 5, W. GREGORY 1; 1 OHSU, Portland, OR, 2Providence Hlth.and Services, Portland, OR, 34181 SW Sam Jackson Park Road, Portland, OR, 4Oregon Hlth.and Sci. Univ, Portland, OR, 5UNC, Chapel Hill, NC. Objective: We wish to determine if there is a correlation between the level of preoperative prolapse stage and postoperative recurrence of prolapse. Background: Recurrence of pelvic organ prolapse following surgical correction is common. Some studies have identified advanced prolapse as a risk factor for recurrence after native tissue vaginal repair yet little is known about risk factors for sacrocolpopexy. Recent data has also suggested that as a gold standard surgery for pelvic organ prolapse, sacrocolpopexy may not be as effective as initially thought. Therefore, to enhance our understanding of who recurs after prolapse surgery, we wish to determine if there is a correlation between the level of preoperative prolapse stage and postoperative recurrence of prolapse. Methods: This is a multicenter retrospective cohort study from three centers. We included subjects who underwent minimally invasive robotic-assisted sacrocolpopexy, with or without concomitant hysterectomy, and completed a
S240
standardized 1 year follow up from 2009 to 2013. All subjects had a complete preoperative evaluation and physical exam, including POP Q examination, and completed 12 months follow up with a POP Q examination. For the purpose of this study, we defined recurrence as any point on POP Q equal to or greater than point 0 at the 1 year examination, because mounting evidence suggests that women become symptomatic from prolapse once the leading edge goes past the hymen, and other anatomic criteria for recurrence may be too stringent. We compared those subjects who met the definition of recurrence to those who did not, analyzing the following covariates: stage of prolapse using ICS definitions; individual POP Q points; age; BMI; race; exogenous estrogen use (including oral and vaginal); menopause; smoking; vaginal parity; cesarean section; and performance of concomitant procedures. Statistical analysis was performed using SPSS (Version 22.0. Armonk, NY: IBM). Univariable analysis was done using Student t test for continuous variables and chi-square for categorical variables. We used Fisher’s exact test when assumptions for the chi square distribution were violated. This was followed by multivariable logistic regression to adjust for confounders. Results: We had 125 women from three centers who met our criteria with 23.2 % of them having recurrence at 1 year. Mean age for the women in the group without recurrence was 59.6 (12.2) years, compared to women in the recurrence group with mean age of 64 (11) years (p=0.09). Postmenopausal women had increased risk of recurrence compared to premenopausal women. Recurrence was seen in 11.1 % premenopausal women, compared to 39 % in postmenopausal (p=0.04). However, there was no difference in recurrence with estrogen use. We did not find difference in smoking status, vaginal parity, cesarean section and posterior repair between the two groups.
Int Urogynecol J (2014) 25 (Suppl 1):S1–S240
Ninety three women in our cohort underwent hysterectomy. Of these, 48 had total hysterectomy (TLH) and 45 had supracervical hysterectomy (SCH). We found that 16.6 % women with TLH met our definition of recurrence of pelvic organ prolapse compared to 28.8 % women who underwent SCH (p=0.15). If the definition of recurrence were tightened by 1 cm (greater than or equal to Stage 2 POP), 29.7 % of the TLH group and 80 % of the SCH groups recurred (p-=0.02). The preoperative genital hiatus was wider in women who had recurrence (mean 5.1 cm (1.2) compared to women who had successful repair at 1 year (mean 4.6 cm (1.1); p=0.05). We found that recurrence increased as the preoperative ICS stage of prolapse increases (p=<0.001 in the univariate model). In the multivariate model, using logistic regression, we found that that risk of recurrence of pelvic organ prolapse increases as the pre surgery clinical stage increases with an odds ratio of 4.2 (95 % CI 1.6–11) when controlling for age, menopausal status, genital hiatus and type of hysterectomy (p=0.003). Conclusions: Much like a higher stage of disease in oncology, we found that increasing stage of prolapse preoperatively increases the risk of recurrence at 1 year post sacrocolpopexy. Disclosure Block: Muhammad Aslam: No disclosures. Blake Osmundsen: No disclosures. Renee Edwards: No disclosures. Mary Denman: Depuy Spine: Spouse is a speaker, receives honorarium., Spouse is a speaker, receives honorarium. Nuvasive: Spouse is a speaker, receives honorarium., Spouse is a speaker, receives honorarium. Jeong Lim: No disclosures. Catherine Matthews: Pelvalon: Grant funds received for clinical study, Grant/Research Support. AMS: Consultant, Consulting Fee. W. Thomas Gregory: Uroplasty: Contracted Research to institution, Grant/Research Support.
