Int Urogynecol J (2008) 19 (Suppl 1):S1–S166 DOI 10.1007/s00192-008-0691-y

2008 IUGA ABSTRACTS

Oral Presentations 33rd Annual IUGA Meeting, Taipei, Taiwan, 13–17 September 2008

Stress incontinence (1–7), (52–63), (109–114), (164–181) 1 Synthetic versus biological trans-obturator sling for stress urinary incontinence: a randomized study Riva D, Baccichet R, Paparella L, Cianci A, Simonazzi M, Pisapia Cioffi G U.O. Ostetricia e Ginecologia- Ospedale Canta1, Italy Industry Support: No Objective To compare results and complications of trans-obturator procedures performed with biological or synthetic sling in a multicenter randomized study at a 24 months follow-up Background Mid-urethra trans-obturator sling (TOT) is often the treatment of choice for stress urinary incontinence with urethral hypermobility. In comparison with TVT, TOT results seem to be equally positive and less complications, as haematoma or bladder perforations, are often reported: with TOT the latter is rare, while it occurs from 2 to about 9% of patients with TVT. With TOT performed with synthetic sling (polipropilene) main complications are vaginal or urethral erosions (from 3.1 to 4.8%), thigh pain, infections; the use of biological materials (porcine dermis) could reduce these complications, especially erosions, possibly without a decrease in cure rates even after a medium term follow-up. Barrington in 2002 reported similar success rates after synthetic TVT and biological TOT (85% vs. 89%); similar results were reported by Abdel Fattah in 2004 at a longer follow-up. Methods 7 Gynecological Centers recruited 168 patients from June to December 2005. Full urodynamic and quality of life assessment was performed before the operation: urethral hypermobility was confirmed with Q tip test or ultrasound. No pat. was previously submitted to surgery for genital prolapse or

incontinence. A computer generated randomisation list with closed invoices was given to each center. Sub-urethral transobturator sling operation was performed by a trained surgeon with an out-in procedure both in synthetic and in biological groups. After 6, 12 and 24 months pts. were examined with stress test, urinary diary, KHQ for quality of life and urodynamic assessment if syntomatic. Results In Table 1 most relevant data are shown regarding 151 patients followed for 24 month or more. No difference for age, parity or Ingelman-Sundberg incontinence score were observed between the 2 groups before the operation. Mean follow-up was 27.6 months for each group. Subjective and objective recurrences for SUI are 21.3% for biological sling (group A) and 10.5-9.2% for synthetic sling (group B). Rates of incontinence due to overactive bladder, erosions, reintervention for SUI are reported. Complications were 0 in group B and 4 in group A: 2 pain with infection, 1 abscess and 1 bladder perforation. Table 1 N° SUI O.B Erosions Complicat Reintervention subj/object incont Biol-Gr 75 21.3% 1.3% 0 A Synt-Gr 76 10.5/9.2% 10.5% 10.5% B

5.2%

2.6%

0

2.6%

Conclusions Cure rates for synthetic TOT group (89.5-90.8%) are comparable with results commonly reported: on the other hand in the porcine dermis group comparable results were observed after 1 year, while after that time, patients didn’t show favourable results at a longer follow-up (21.3% of recurrences). We can observe that only 2.6% patients were re-operated for SUI in both groups. Porcine dermis showed lower rates of erosions: 10.5 vs. 0%, so that pro and cons of this choice can be discussed.

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2 (E-TOT) Study: A Randomized Prospective Single- blinded Study of Two Transobturator tapes in management of Urodynamic Stress Incontinence: Objective & Patient reported Outcomes Abdel-fattah M, Ramsay I, Pringle S, Hardwick C, Tierney J, Ali H University Of Aberdeen, United Kingdom Industry Support: No Aims of study: The E-TOT study aim to provide a thorough evaluation of the Transobturator tapes (TOTs) in the management of urodynamic stress incontinence (USI) comparing the two techniques: Outside-In (TVT-O) Vs. Inside-Out (TOT-ARIS). Patients and methods; A Prospective randomized study in a regional referral Urogynaecology Centre, in the period between April 2005 and April 2007. Inclusion Criteria: & & & &

All women admitted for TOT for USI or Mixed incontinence with predominantly bothersome stress component. All would have had failed or declined PFMT. Primary or Secondary Incontinence Surgery. Ability to understand the information leaflet. Exclusion Criteria: Mixed incontinence with un-controlled OAB symptoms and/or Neurological conditions e.g. MS.

Power Analysis: showed that with 90% power, 141 women would needed in each arm to prove equivalence of the success rate at 90% in the two procedures and would enable detection of 5% difference in the complication rate between the two procedures with 80% power. With an anticipated drop out rate of 20% over three years we aim to recruit 170 women in each arm. Randomization: opaque sealed envelopes, opened by the nursing staff on the morning of the operation. Procedures were done as originally described. Preoperative Assessment: & &

Detailed history & examination & Urodynamic assessment: Uroflowmetry, Filling/Voiding Cystometry, UPP). Completion of the King’s Health Questionnaire (KHQ), Birmingham Bowel Urinary Symptom (BBUSQ-22) & Pelvic Organ Prolapse/ Incontinence Sexual Function Questionnaire (PISQ-12).

Postoperative Assessment by independent Clinician who is blinded to the type of surgery: & &

Urodynamic assessment at 6-month. International consultation on Incontinence Questionnaire (ICIQ-SF)

&

Patient Global Impression of Improvement (PGI-I) & KHQ/, PISQ-12

Main Outcome Measures at 6 month: & & & & & & &

Peri-operative complications & Postoperative Pain assessed by women on 10 point scale and also by nurses. Objective cure rates (Urodynamic (UDS) absence of USI) & Incidence of Denovo-DO Patient-reported Success rates: ICIQ-SF = Never Leak or Leak
Statistical Analysis: using SPSS (version 15) Descriptive analysis is given with in-group analysis performed using ChiSquare & Fischer Exact tests as appropriate at a significance level of 5%. Results & Interpretation: 341 women were recruited: InsideOut TVT-O n=170 Vs. Outside-In TOT n=171. Peri-operative complications: Bladder injuries 0.6% (n=2), Urethral Injuries 0.3% (n=1), Vaginal angle perforation 5.9% (n=20), Blood loss >200 mls 7.6%(n=26) Voiding Dysfunction 6%(n=21) and Severe postoperative pain 4.7%(n=14). Apart from the vaginal angles injury there was no difference between both groups. Mean operative time was comparable at 14 & 17 minutes in the TVT-O & TOT respectively. 317 women completed the 6 month follow-up however 15 patients declined postoperative UDS. Objective cure rates at 6 month: (n=302) Results of postoperative UDS are shown in Table 1 with sub-group analysis. Patient Reported Success rates: (n=317) as reported on ICIQ-SF & PGI-I are shown in tables 2 & 3 respectively with sub-group analysis. Transobturator tapes as a Secondary Incontinence Surgery or in women with pre-operative low MUCP (<30) were associated with significantly lower objective and patient reported success rates. TVT-O was more likely to be successful as a secondary surgery. 8 women had both previous incontinence surgery and low pre-operative MUCP out of which 7 (87.5%) failed both objectively and on patient reported outcomes. There was no significant difference in the objective cure of USI in women with pre-operative USI vs. Mixed group yet patient reported outcomes were significantly lower in the mixed incontinence group due to the group of women (n= 31) with cured USI & Persistent DO. Ten women (10%) with pre-operative mixed incontinence were cured of both USI & DO postoperatively and were all successful on the ICIQ-SF & PGI-I Denovo -DO occurred in 5.3% (n=16) with no difference between groups.

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Table 1 Postoperative urodynamics UDS

Whole Cohort Primary Surgery (n=260) Secondary Surg. (n=42) USI Group (n=223) Mixed Group (n=79) MUCP <30 cmH2O(n=43) MUCP>31 cmH2O (n=232)

TOTAL=302

P=

Cured (%)

Failed (%)

258 (85.4) 229 (88) 29 (69) 191 (85.6) 67 (84.8) 25 (58) 209 (90)

44 (14.6) 31(12) 13 (31) 32 (14.4) 12 (15.2) 18 (42) 23 (10)

TOT=157

0.003* 1 < 0.01*

TVT-O=160

P=

Cured

Failed

Cured

Failed

124 (83.2) 118 6 89 35 15 104

25 (16.8) 15 10 20 5 9 12

134 (87.6%) 116 23 102 32 10 113

19 (12.4%) 16 3 12 7 9 10

0.28 0.89 0.002* 0.718 0.14 0.734 0.21

Table 2 Patient reported cure rates on ICIQ-SF ICIQ-SF

Whole Cohort Primary Surgery (n=271) Secondary Surg (n=46) USI Group (n=234) Mixed Group (n=83) MUCP <30 cmH2O (n=46) MUCP >31 cmH2O(n=244)

TOTAL=317

P=

Cured (%)

Failed (%)

226 (71.3) 198 (73.1)) 27 (58.7) 177 (75.6) 48 (57.8) 20 (43.5) 182 (74)

91(28.7& 73 (26.9) 19 (41.3) 57 (24.4) 35 (42.2) 26 (56.5) 62(25.4%)

TOT=157

0.07* 0.003* < 0.001

TVT-O=160

P=

Cured

Failed

Cured

Failed

105 (67) 99 5 79 25 11 85

52 (33) 40 13 35 18 16 34

121 (75.6) 99 22 98 23 9 101

39 (24.4) 33 6 22 17 10 24

0.085 0.57 0.002* 0.56 1 0.885

Table 3 Patient reported cure rates on PGI-I PGI-I

Whole Cohort Primary Surgery (n=271) Secondary Surg (n=46) USI Group (n=234) Mixed Group (n=83) MUCP <30 cmH2O (n=46) MUCP >31 cmH2O (n=244)

TOTAL=317

P=

Cured (%)

Failed (%)

255 (80.5) 223 (82.3) 32 (69.6) 195 (83.3) 60 (72.3) 28 (61) 205 (84.1)

62 48 14 39 23 18 39

(19.5) (17.7) (30.4) (16.7) (27.7) (39) (15.9)

TOT=157

0.056 0.0072* 0.002*

Conclusion: This randomised adequately powered study has shown no difference in the peri-operative morbidity, objective and patient reported success rates between the Inside-Out & Outside-In Transobturator tapes. Transobturator tapes in women with previous incontinence surgery and/or MUCP <30 are associated with significantly lower objective and patient reported success rates.

3 TVT-Secur: The Learning Curve Vervest H1, van Dessel N2, Lammerink E1, Hinoul P3, Roovers J2, 1 St. Elisabeth Hospital Tilburg, Netherlands, 2Academic Medical Center University of Amsterdam,Netherlands, 3 Oost-Limburg Hospital, Genk Belgium

TVT-O=160

P=

Cured

Failed

Cured

Failed

121(77) 113 8 90 31 17 98

36(23) 26 10 24 12 10 21

134 (83) 110 24 105 29 11 110

26 (17) 22 4 15 11 8 15

0.138 0.779 0.008* 0.114 1 0.968 0.2

Industry Support: No Objective To determine the learning curve for TVT-Secur with regard to outcome and complications. Background TVT-Secur is a new mid-urethral sling for the treatment of Stress Urinary Incontinence (SUI). Its main advantage is that it is a vaginal incision only technique without passing the transobturator foramen and thus avoiding the peripheral branches of the obturator nerve and the adductor muscles of the upper leg. The method of fixation of the tape differs from other mid-urethral slings and this may affect the learning curve. Methods Patients were divided in 3 groups of similar size, the first group consisting of the first operated patients in each

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participating centre, the second group of the next operated patients, and the third group of patients operated thereafter. Primary outcome parameter was the report of women of any loss of urine, secondary outcome parameters were operation time, blood loss, complications, duration of catheter use and of hospital stay. A stress test was performed at 6 weeks after surgery in all patients. Results The mean age of the 131 included patients was 52 years. The numbers of women operated in each center varied from 2 to 63. Table 1 lists the functional outcome at 6 weeks after surgery. There was an ongoing statistically significant decrease demonstrable in both subjective (questionnaire) and objective (stress test) SUI symptoms (X2 test, p= 0.016). UUI symptoms decreased significantly from the first to the second group (X2 test, p=0.04). Table 2 shows that surgery time, amount of blood loss and complications did not decrease over time and were similar for all groups. Both the length of postoperative catheter use and hospitalization decreased as experience increased. Table 1 Outcome and complications after 6 weeks Group 1 (n=42)

Group 2 (n=42)

Group 3 (n=38)

total (n=122)*

any symptom 14 (33,3%) 9 (21,4%) 6 (15,8%) 29 (23,8%) of SUI (n, %) any symptom 10 (23,8%) 3 (7,1%) 3 (7,9%) 16 (13,1%) of UUI (n, %) demonstrable SUI on 10 (23,8%) 3 (7,1%) 2 (5,3%) 15 (12,3%) physical exam (n, %)

Table 2 shows that surgery time, amount of blood loss and complications did not decrease over time and were similar for all groups. Both the length of postoperative catheter use and hospitalization decreased as experience increased Group 1 (n=43) Surgical data length of surgery (minutes, mean±SD) blood loss (ml, mean SD) Surgical complications bladder injury (n, %) hematuria (n, %) Postoperative data length of catheter use (hours, mean, ± SD) length of hospital stay (hours, mean ± SD) postoperative urinary retention (>24 hours, n, %)

Group 2 (n=43)

Group 3 (n=45)

Total (n=131)

20,8±7,2 23,1±8,8 24,8±9,4 22,9±8,6 60,0±36,4 36,9±17,8 59,5±34,7 54,0±33,2 1 (2,3%) 0 (0%)

2 (4,7%) 0 (0%)

0 (0%) 1 (2,2%)

3 (2,3%) 1 (0,8%)

11,1±42,3 2,8±11,1 0,4±2,4

4,6±25,2

12,1±7,6 10,6±8,6 9,0±7,2

10,5±7,8

1 (2,3%)

3 (2,3%)

1 (2,3%)

1 (2,2%)

Conclusions TVT-Secur has a learning curve which is expressed by a lower risk on post-operative stress- and urge-incontinence in more experienced hands. As far as surgery time, blood loss and complications is concerned, there is apparently no learning curve. Studies evaluating the outcome of TVTSecur should take the learning curve into account. 4 A COMPARATIVE STUDY OF THE TVT AND IVS PROCEDURE FOR THE TREATMENT OF STRESS URINARY INCONTINENCE: LONG-TERM FOLLOW-UP OF THE MONOFILAMENT VS. THE MULTIFILAMENT POLYPROPYLENE SLING Prien-Larsen J, Hemmingsen L Nykobing Falster Hospital, Denmark Industry Support: No Objectives: Tension-free vaginal tape technique for treatment of stress urinary incontinence has become an established and widely used operation. The result of the long-term follow-up seems to be inconsistent concerning the cure rate and the bladder function. The aim of the present study was to evaluate the long-term cure rate and the changes in cure rate and bladder function over time after TVT and IVS procedures. Methods: In a prospective one-center study 316 consecutive women with urodynamically confirmed stress incontinence were enrolled. All patients underwent standardized preoperative evaluation: post void residual urine, a stress cough test in standing position with a bladder volume of 300 ml, free flowmetry and a 24-hour pad test and a 2-day bladder diary. The postoperative evaluation was done at 1 and 6 years and included post void residual urine, a stress cough test and free flowmetry. Objective cure was regarded if stress cough test was negative. Subjective cure if the reported incontinence episodes were reduced ? 90% or improved if reduction was ? 75%. One hundred and three underwent the TVT procedure (tape monofilament), hereafter the technique was changed to IVS (tape multifilament) and 213 underwent the IVS procedure. The polypropylene tape was placed under local anesthesia, and adjusted while patient coughed at a bladder volume of 300 ml. All postmenopausal women were treated with systemic or local hormone. Results: One hundred and three underwent the TVT procedure and 213 the IVS procedure. There were no significant differences between the groups concerning mean age 58 (range 27–84), BMI 27 (17–41) and parity 2 (0–9). The median follow-up time in the TVT-group was 78 months (range 47–104) and 78 were seen. In the IVS-group the median time was 56 months (range 36–79) and 148 were seen.

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The difference in cure rate between the TVT and IVS procedure was non-significant and the average subjective success rate was 92.4% (cured+improved) and the average objective cure rate was 88.9%. The changes in continence status over time for both procedures were non-significant. The change in bladder function between pre- and 1 year postoperatively was significant. Between 1 and 6 years the increase in post void residual urine was significant (p= 0.01) for both procedures. All other changes in bladder function were non-significant: Neither improvement nor deterioration was seen over time. In the IVS group were found 8.9% (19/213) vaginal tape erosions and the diagnoses were made average 34 months after operation (range 3-60) and none in the TVT group (0/103). The postoperative outcomes are listed in Table 1.

Table 1 Post-operative outcomes at 12 month and 6 years in 103 women underwent TVT and 213 women underwent IVS operation TVT IVS Preop. 12 78 Preop. 12 56 months months months months Objective cure: Subjective cure: Improved: Failed: Stress test (mean; g): Res. Urine (mean; ml): Max flow rate (ml/s): Corrected max flow:

71

95% 79% 18% 3% 0.28

94% 74% 18% 8% 1.17

60

87% 83% 13% 4% 1.93

86% 77% 15% 7% 3.07

14

34

44

8

19

31

28

16

16

28

17

17

1.66

0.95

0.96

1.63

1.07

1.04

Conclusion: Tension-free vaginal tape technique is an effective procedure for the treatment of stress urinary incontinence 6 years after operation. It shows no deterioration in cure rate and bladder function over time except for an increase in post void residual urine which apparently is without clinical relevance. Due to the high rate of vaginal erosions after the intravaginal slingplasty (IVS) we can not recommend the use of multifilament tape.

5 Prospective follow -up investigation of a specific pelvic floor rehabilitation program with focus on pre-contraction and coordination using a validated Pelvic Floor Questionnaire Junginger B, Baessler K Pelvic Floor Centre, Charite University Hospital, Germany

Industry Support: No Objective The objective of this study was to prospectively evaluate the effectiveness of a pelvic floor rehabilitation program employing pre-contraction and coordination of the pelvic floor and transverse abdominis muscles and addressing individual functional deficiencies identified at vaginal palpation and perineal ultrasound. Background Pelvic floor exercises and behavioural therapy are the mainstay of conservative pelvic floor treatment. The combination of treatment of individual pelvic floor and behavioural deficiencies on the basis of physiological continence mechanisms like pelvic floor pre-contractions and avoidance of maximal contractions has been incorporated in this rehabilitation program. Methods Fourty-one women with pure stress urinary incontinence (SUI; n=7), pure overactive bladder symptoms (OAB; n=8) and both (n=26) were included. Additionally, 27 women complained of anal incontinence. They had 0–4 children (median 2; one nullipara, vaginal birth in 38 and caesarean section only in 1). Functional assessment consisted of palpation and perineal and abdominal ultrasound to evaluate specific dysfunctions of pelvic floor and abdominal muscles. Treatment focused on these dysfunctions and the goals were to improve the quality and timing of contractions, achieve coordination between pelvic floor and abdominal muscles, maintenance of contractions during breathing, coughing, lifting, at urgency, etc. Patients were instructed how to perform correct co-contractions and advised to integrate them into their daily life, sports activities and their specific incontinence situations. A validated self-administered pelvic floor questionnaire assessing bladder, bowel, prolapse and sexual symptoms (1) was completed by all women before and 1–16 months (median 7 months, mean 7.6 months) after treatment. Improvement scales (much better, a little better, no change, a little worse, much worse) were developed for bladder, bowel, prolapse and sexuality domains. Satisfaction with treatment and care was assessed using a 10-cm visual analogue scale (VAS; 0=not at all satisfied, 100=very satisfied). Further questions regarding coordination and pre-contraction were developed to check the patient’s compliance and comprehension of the daily life integration of the specific muscle contractions. Follow-up assessment was performed by an independent health care provider. Results Treatment consisted of 1–6 sessions (median 2, mean 2,5) lasting 15-90 minutes each with a total of 75-225 minutes treatment time (median 130 min, mean 135.4 min). 63% of women were followed for more than 6 months.

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Of 33 women with stress urinary incontinence symptoms 23 (70%) denied SUI after treatment and 7 (21%) further women reported improvement (p=0.001). Overactive bladder symptoms ceased in 26 of 34 women (76%) and improved in 4 (12%) (p=0.002). Self-reported improvement rates were reported at 88% (15 of 17) for mixed incontinence, 88% (6 of 7) for pure SUI, 100% (8 of 8) for OAB, 50% (4 of 8) for faecal incontinence and 27% (7 of 26) for flatus incontinence. Bladder, bowel and sexual function domain scales improved significantly after treatment (bladder function (p<0.001), bowel function (p=0.007) and sexual function p =0.044).Of two patients with faecal incontinence as a major symptom, both reported great improvement. Patients satisfaction with treatment ranged from 15–100 (median 80) and satisfaction with care from 40–100 (median 90) on a 10 cm-VAS scale. After treatment, 36/41 (88%) women routinely contracted their pelvic floor muscles before coughing, lifting etc. (pre-contraction). Women who performed pre-contractions were more likely to report fewer SUI (p=0.008). There was a significant correlation between frequency of pre-contractions and patient satisfaction with treatment (Spearman -0.31; p=0.049). Discussion Individual dysfunction-related pelvic floor rehabilitation after evaluation of specific muscle and functional deficiencies is highly effective for SUI and OAB with improvement/dry rates of 91% and 88%, respectively. Treatment goals were achieved after approximately 2–3 sessions and persisted for more than 6 months (>50% of participants) without the need for further supervised physiotherapy. Conclusions This study confirms that an important component of pelvic floor rehabilitation is the coordination of pelvic floor precontractions. Their routine integration into daily life is an essential part in “motor learning processes”. Further studies are needed to prove the long-term efficiency of this program. References (1) Neurourol Urodyn (2004) 23; 398–399 6 The impact of TVT on sexual function Jha S1, Radley S2, Farkas A2 1 Department of Urogynaecology, Birmingham Womens Hospital, United Kingdom 2Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Trust Industry Support: No (n/a) Aims: To evaluate sexual function in women before and after a TVT. Background: Urinary incontinence affects up to 41% of the adult female population and impacts on social, psycholog-

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ical, occupational, domestic, physical and sexual well being. Numerous studies have reported on the response of incontinence to surgery but reports on the impact on sexual function are limited. Methods: In this prospective questionnaire survey, 100 women undergoing TVT between January 2006 and May 2007 for Urodynamic Stress incontinence were assessed pre-operatively & three months postoperatively using a validated pelvic floor symptoms assessment questionnaire. The incidence of orgasm incontinence, penetration incontinence, anxiety related to bladder problems during sex, avoidance of intercourse and overall impact on sex life was assessed and the impact of TVT on each of these parameters evaluated. Wilcoxan Signed Rank test was used to compare pre and post-op scores. Linear regression was used to assess the relationship between these parameters and changes in stress incontinence. Results: Incontinence during intercourse was reported in 68% of women preoperatively. Of the women who reported incontinence during sex, orgasm incontinence was present in 74% and penetration incontinence in 48%. Anxiety about the bladder & sex was reported by 69%, avoidance of sex because of bladder symptoms by 51%, partners avoiding sex with them by 24% and urinary incontinence impacting on their overall sex life by 66%(Table I).

Pre and post TVT incidence of symptoms (expressed as a percentage of the total number of women completing ePAQ) Symptom

Preoperative incidence (%)

Postoperative incidence (%)

Orgasm incontinence Penetration incontinence Anxiety related to incontinence Patient avoids intercourse Partner avoids intercourse Postcoital infections Overall impact on sex life

51% 33% 69% 51% 24% 37% 66%

12%; 6% 20% 15% 9% 16% 16%

The incidence of anxiety, avoidance, partner avoidance and overall impact of bladder problems on sex was significantly greater in those who reported incontinence during intercourse than those who did not (p<0.05). Following TVT surgery, there were significant reductions in all the following; Orgasm incontinence (51% to 12%; p<0.001), Penetration incontinence (33% to 6%; p<0.001), Anxiety regarding the bladder and sex (69% to 20%; p<0.001), Avoidance of sex because of bladder problems (51% to15%; p<0.001), Post-coital infection (37% to 16%; p< 0.001) and overall impact of lower urinary tract symptoms on sex (66% to 16%; p< 0.001). There was a non-

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significant reduction in partner avoidance of sex (24% to 9%; p=0.06) (Table II). Symptom

Z Score a

p value

Orgasm incontinence Penetration incontinence Anxiety related to incontinence Patient avoids intercourse Partner avoids intercourse Postcoital infections Overall impact on sex life

-4.747 -3.232 -4.718 -4.136 -1.906 -3.273 -4.713

<0.0001 <0.001 <0.0001 <0.0001 =0.06 <0.001 <0.0001

a: The Z score is converted from the Wilcoxon signed ranks test and is based on positive ranks

Improvements in orgasm incontinence, penetration incontinence, anxiety and overall impact on sex life were positively correlated with symptomatic improvements in stress incontinence following TVT. Conclusions: TVT significantly improves the overall sex life of women with stress urinary incontinence. Orgasm incontinence, penetration incontinence, anxiety and avoidance of sex are all reduced whereas there is no significant impact on partners avoiding sexual activity. Such information is valuable in the decision-making process relating to incontinence surgery in sexually active women. This study shows the high incidence of sexual dysfunction in women with urinary incontinence and highlights the importance of objectively measuring sexual symptoms in this context. 7 Trans-obturator suburethral tape from inside to outside (TVT-O) is associated with higher pain scores at one year follow-up when compared to tension-free vaginal tape (TVT): a multicenter randomised controlled trial Deffieux X1, Daher N2, Mansoor A3, DebodinanceP4, Salet-Lizee D5, Descamps P6 1 Hopital ANtoine Beclere, 2CHU Amiens, 3 CH Issoire,4 CH Dunkerque, 5CH Diaconnesses, 6CH Anger, France Industry Support: No Objective To compare tension-free vaginal tape (TVT) and transobturator suburethral tape from inside to outside (TVT-O) for surgical treatment of urinary stress incontinence (USI) for peroperative complications, post-operative pain and success rate. Background The mid-urethral concept, describing the biomechanical mechanisms of female USI, was developed and presented by Petros and Ulmsten. Based on this new thesis, surgical techniques recreating support and stability between the urethra and the anterior vaginal wall have continued to evolve. The TVT

procedure was the first technical offspring of this construct and has continued to be widely used for the treatment of female USI since 1995. With the aim of sparing the retropubic space and thereby reducing associated risks, the transobturator surgical approach for the placement of sub-urethral tape was developed. Clinical results as well as anatomical work using cadaveric dissection have suggested that this approach may be safer than the retropubic route. However, there are very few data concerning post-operative pain following sub-urethral tape surgery. Methods One hundred and ninety nine consecutive patients, mean age 53.7 years (33–83) affected by SUI, were included in this randomized controlled trial TVT (75 women in TVT group and 74 in TVT-O group). National Ethical Committee approval was obtained. Written informed consent was obtained from each woman. After preoperative assessment, patients were randomly allocated to the TVT (retropubic) or TVT-O (trans-obturator) procedure. The pain was prospectively assessed using visual analogue and verbal rating scales. Cure of SUI was defined as no leakage of urine during the stress test at urodynamic testing at the 12-months evaluation. The Wilcoxon test and Fisher exact test were used to verify statistical significance, set at p<0.05. Results The characteristics of patients were well balanced between groups after randomization, including pre-operative high pelvic pain score (visual analogue scale=30%): 8% and 8% for TVT-O and TVT groups, respectively (p=0.98). Patients were evaluable at the 12-months follow-up. The groups did not differ significantly in intraoperative blood loss, hospital stays, and time to return to normal activities. Success rate for SUI 12 months after the operation was 81% and 95% for TVT-O and TVT groups, respectively; p=0.2). Post-operative high pain scores (visual analogue scale=30%) were significantly more common after trans-obturator approach (TVT-O) retropubic TVT than after at the 1-week (p=0.005) and 3-weeks follow-up (p=0.009), and at 8-weeks (13% and 3% in TVT-O and TVT groups, respectively; p=0.08), 6-months (13% and 0% in TVT-O and TVT groups, respectively; p=0.01) and 12-months follow-up (20% and 2% in TVT-O and TVT groups, respectively; p=0.02). Conclusions Both techniques appear to be equally effective in the surgical treatment of SUI. However, TVT-O is associated with higher post operative pain scores at 12-months follow-up. 52 TVT-Secur: prospective data of outcome, complication risk and patients satisfaction Roovers J, van Dessel N, Vervest H, den Boon J, Milani F, Hinoul P AMC Amsterdam, Netherlands

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Industry Support: Yes (Investigator initiated, partial funding) Objective To evaluate subjective and objective outcome, complicationrate and patient satisfaction of TVT-Secur. Background TVT-Secur is a new mid-urethral sling for the treatment of Urodynamic Urinary Incontinence (SUI). As it is a vaginal incision only technique, TVT-Secur may be safer and less painful. However, large prospective data on its outcome, complication risk and patients satisfaction have not yet been published. Methods Women were recruited from an ongoing prospective randomized trial comparing TVT-Secur to TVT-O in 5 Dutch and 1 Belgium teaching hospitals with a special interest in urogynaecology. All centers participating in this trial, had to perform at least 5 TVT-Securs prior to the trial, before inclusion of the first patient was allowed. All women (in and outside this trial) who underwent a TVT-Secur procedure were included in this study. We included women with pre-dominant USI and evident loss of urine during straining at clinical and/ or urodynamic investigation. TVT-Secur was performed according to the manufacturer’s recommendations. Surgical parameters, patient satisfaction as assessed by a telephone interview (rate varying from 0 - 10) and a stress test at 6 weeks after surgery were obtained for all patients. In addition, patients participating in the trial completed a validated questionnaire to measure quality of life related to micturition and prolapse symptoms (Urogenital Distress Inventory (UDI) and Incontinence Impact Questionnaire (IIQ)) before surgery, at 6 weeks, at 6 months and at 12 months after surgery. At the same intervals patients also were assessed in the outpatient clinic for history taking and pelvic examination including a stress test. Patients were also asked to keep a diary the first six weeks postoperatively measuring pain scores and postoperative physical limitations. Results In this study 131 women were included of whom 44 participated in the RCT. The median follow-up time was 9 months (range 0-17 months). The mean age was 52 years and 8 (6%) patients had a history of previous SUI surgery. The mean operation time was 23 minutes and mean amount of blood loss 54 mL. In 3 (2%) patients a bladder perforation occurred. Catheterization had to be prolonged in 3 (2%) patients due to post-operative bladder retention. Of the 122 patients with complete 6 week follow-up data, 93 (76%) reported to be dry and 16 (13%) reported urge incontinence. A positive stress test was observed in 15 (12%) patients. UDI and IIQ scores are shown in the Table. Of the 44 trial patients, questionnaires were completed by 41 patients before surgery, 28 patients at 6 weeks after surgery and 11 patients at

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6 months after surgery. A significant improvement of the incontinence and overactive bladder domain scores at 6 weeks after surgery was observed. Although not significant, a slight detoriation in some domain scores from 6 weeks to 6 months after surgery was noted. IIQ scores were at 6 months after surgery slightly better than 6 weeks after surgery. The results of the diary showed that post-operative pain scores and reported limitations due to TVT-Secur were very low. The telephone interview was held with 94 patients after a median follow-up time of 44 weeks (range 2–76 weeks). The mean rated result of surgery was 7.0 (SD 2.9). Eighty-one (86%) patients reported to be satisfied with the result of the procedure. Table Preoperative and postoperative mean (standard deviation) UDI and IIQ domain scores Preoperative (n=41)

6 weeks postoperative (n=28)

6 months Postoperative (n=11)

UDI domain scores Overactive bladder Urinary incontinence Obstructive micturition Discomfort/Pain Genital prolapse IIQ domain scores Physical performance Mobility Social performance Emotional performance Embarrassment Social activities

UDI = Urogenital Distress Inventory 37 (26) ¶ 19 (18) 31 (21) 58 (21) ¶ 13 (20) ¶ 22 (28) 14 (25) 3 (14) 4 (11) 20 (22) 10 (19) 15 (19) 4 (9) 2 (8) 2 (6) IIQ = Incontinence Impact Questionnaire 15 (19) 9 (16) ¶ 0 (0) 25 (23) 18 (19) ¶ 1 (4) 13 (19) 6 (18) 1 (4) 25 (24) ¶ 12 (18) ¶ 4 (8) 37 (26) ¶ 16 (19) ¶ 7 (15) 19 (24) 18 (25) ¶ 0 (0)

¶ Statistically significant different as compared to preoperative

Conclusions These prospective data obtained from a large sample show that 86% of patients is satisfied about the results of TVTSecur. Morbidity and post-operative pain appear to be low. The 76% cure rate at 6 weeks after surgery is comparable to that of retropubic TVT after 2 years. However UDI domain scores at 6 months after surgery suggest that there is some decline in cure rate. Although the first results of TVT-Secur are promising, we advise to await the results of the ongoing TVT-O/TVT-S trial before selecting TVT-Secur as first choice surgical treatment in patients with SUI. 53 Multicenter prospective trial of TVTsecur for the treatment of primary stress urinary incontinence Meschia M, Barbacini P, Pifarotti P, Ambrogi V, Ricci L, Spreafico L Dept. Obstetrics and Gynecology, Magenta, Italy

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Industry Support: No Aim: to evaluate the efficacy and morbidity of the new minimally invasive TVT-secur procedure in the treatment of primary stress urinary incontinence. Methods: The study design was a prospective multicenter trial involving four different hospitals. All patients with primary urodynamic stress urinary incontinence (SUI) and urethral hypermobility were prospectively selected to receive the TVT-secur procedure. Each center was allowed to perform the procedure either in the “hammock” or “U” shape approach. The ICI-SF, W-IPSS, PGI-S questionnaires were used to evaluate the impact of incontinence and voiding dysfunction on QoL and to measure patient’s perception of incontinence severity. The post-operative evaluation included collection of data regarding intra- and postoperative complications and analysis of outcomes. The outcome of surgical treatment was estimated both subjectively and objectively and the PGI-I questionnaire was added to assess the subjective perception of improvement. Objective cure was defined as no leakage of urine while coughing during the post-operative stress test. Subjective cure was defined as no urine loss during exertion and failure as any reported leakage of urine during ‘stress’. All patients were informed about the study and procedure and gave their informed consent. Follow-up visits were scheduled after 3, 6, and 12, months from surgery. The Statistical Package fo Social Sciences was used for data analysis. Continuos data were reported as means + standard deviation (SD)and analysed with Student’s t test. Categoric relationship were analysed by the c2 test with Yates’ correction or Fisher exact test, as appropriate. Probability values of <0.05 were considered statiscally significant. Results: From November 2006 and September 2007, 95 consecutive patients with primary stress urinary incontinence and urethral hypermobility were enrolled in the study. After enrolment 55 patients received the procedure with insertion of the tape in the “hammock” shape and 40 subjects in the “U” shape”. There were no differences between these two groups with respect to pre-operative demographic and clinical characteristics, total score in the different questionnaires used, and urodynamic parameters. Most (68%) of the procedures were performed under general anaesthesia and cystoscopy was performed in all the patients who underwent the procedure in the “U” shape approach while only 14 out of 55 patiens (25%) in the “hammock” shape group underwent cystoscopy. The intraoperative cough stress test was performed in only 6 patients. No bladder perforation occurred. There was an excessive bleeding, greater than 500 ml. in 2 patients both receiving the “hammock” shape approach and some difficulties with the detachment of the device were reported in two subjects. Four women (4.2%) had voiding difficulty

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that resolved spontaneously within the first five days from surgery and no one had urinary retention. The average hospital stay was 1.4+0.9 days and post-operative pain was reported by only one women. The mean follow-up time was 9±3.1 months (median 12). Ninety one patients were available for the analysis. Subjectively 71 (78%) women were cured by the procedure and objectively the cough stress test was negative in 74 (81%) patients. The ICI-SF questionnare symptoms score showed an higly statistical decrease from a mean of 15+3.8 before surgery to a mean of 4,4+5.7 at the last follow-up visit forwarded (p= 0.000), the W-IPSS decreased from 7.7+6.6 to 5.1+4.6 (p= 0.002). Most of the women were satisfied of their postoperative condition with a mean score of 0.8 ± 1.1at the PGII questionnaire (scale 0–5). Postoperative complications included: voiding difficulty in 7 women (8%), recurrent UTI in 9 (10%) and dyspareunia for a defect healing, with vaginal protrusion of the mesh, in two patients. Eight out of 20 failures received a new surgery for stress incontinence within the first year of follow-up, four women were treated with duloxetin and two patients underwent pelvic floor muscle training. Seven women with distressing OAB symptoms were given a trial with antimuscarinic drugs. Conclusions: Our data show that the TVT-s procedure is effective for the treatment of primary stress urinary incontinence with 78% and 81% subjective and objective cure rates associated with an highly significant improvement in incontinence related QoL. Nevertheless a comparison with our own previously published data on TVT and TVT-O, shows that TVT secur is associated, at the same follow-up time, with a 10% less success rate. References: Int Urogyn J 2007; 18:1257–61 54 Outcome assessment of the TVT Secur System for the treatment of the Stress Urinary Incontinence and its impact on urge urinary symptoms Mota R, Mascarenhas T, Costa F, Rasteiro C, Duarte S, melo A Unit of Urogynaecology; Service of Obstetrics and Gynaecology. H. S. Joao, Portugal Industry Support: No OBJECTIVE: The purpose of this study was to assess the efficacy of the TVT Secur System for the treatment of stress urinary incontinence and its impact on urge urinary symptoms. BACKGROUND: The TVT Secur System (TVT-S) is a recent minimally invasive tension-free mid urethral tape used for the treatment of stress urinary incontinence (SUI) METHODS: One hundred and twenty nine women (mean age 55.2 years, with a range 31–81) underwent an anti-incontinence surgical procedure using TVT-S. Hammock placement was used under general and spinal anesthesia. A retrospective

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review was performed. All women underwent evaluation before and post surgery with a symptoms questionnaire, the King’s Health quality of life questionnaire, and an objective assessment including physical examination, stress test, pad test (1 hour) and urodynamic testing. RESULTS: The mean age of the 129 women included was 55.2 years (31–81 years). The mean follow-up was 6 months. The SUI subjective cure rate was 88,6% (cured - 72,4% and improved - 16,2%) and the objective cure rate (pad test and stress test) was 75%. Eighty nine patients (68,9%) presented pre-operatively urge urinary symptoms: 74 (57,3%) had mixed urinary incontinence and 15 (11,6%) had urinary urge. Of the 40 patients (31,1%) that did not present urge symptoms, 9 developed urinary urge and of these 3 developed urge urinary incontinence as well. Only 1 from this group of 9 patients presented objectively and subjectively SUI worsening, whereas the remaining 8 were cured for the SUI. In the group of 15 patients with urinary urge, 3 improved and 4 worsened to develop urge urinary incontinence (in this patient group, only 1 was cured of stress urinary incontinence). In the patient group with mixed urinary incontinence (MUI), 33 (44.6%) improved their urge symptoms: 25 (33.8%) were cured of the urge incontinence and 18 (13,9%) became urge symptoms free. Complete SUI cure was obtained in 90% of the patients with pure SUI, in 66.7% of the patients with MUI and in 63.5% of those with SUI and urge symptoms. No major complications occurred.

Before Surgery (n)

De novo De novo Pure Urge UUI (%) (%)

SUI (40) SUI + UUI (74)

6 (15%)

Urge Symptoms Improvement (%)

3 (7.5%) 33 (44.6%) (25/33 with UUI cure) (18/33 urge symptoms free)

SUI + U (15)

4 (26.7%)

Table 2 Stress Urinary Incontinence Outcomes

SUI SUI + UUI SUI + Urge Total

Cure

Improve

Equal

Worst

Total

36 (90%) 47 (63.5%) 10 (66.7%) 93

2 (5%) 17 (23%) 2 (13.2%) 21

1 (2.5%) 8 (10.8%) 3 (20%) 12

1 (2.5%) 2 (2.7%) 0 3

40 74 15

CONCLUSIONS: Our results suggest that the TVT Secur System is a safe and effective treatment for women with SUI and may also improve the urge symptoms; although de novo urge symptoms may occur in a smaller number of cases. Women with pure SUI have better outcomes than those with urge symptoms.

55 Initial experience with TVT-SECUR* System procedure Martan A1, Svabik K1, Masata J1, El-Haddad R1, Koleska T1, Pavlikova M2 1 Dept Ob/Gyn, 1st Faculty of Medicine, Charles University, General Teaching Hospital, Czech Republic 2 EuroMISE Centre, Institute of Computer Science of the Academy of Science of the Czech Republic, Czech Republic Industry Support: No Objective The objective of this study is to present the TVT-S System (tension-free vaginal tape secure system) and to evaluate the safety and efficacy of this new, minimally invasive sling procedure for the treatment of stress urinary incontinence in women and to determine the most frequent peri- and postoperative complications. Background Eighty-five women with previously untreated stress urinary incontinence were recruited to participate in a clinical study. Their mean age was 55.5 years, mean body mass index (BMI) was 28.2, and mean parity was 2.0. The tape was placed 46 times in a “hammock” position and 39 times in a “U” position. The determination of the position of the tape was assessed by random ballot. The efficacy of this surgical procedure was evaluated perioperatively and three months (±1 week) after operation - objectively by cough test (n= 85) and subjectively (n=81) by questionnaires Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ12) and the International Consultation on Incontinence Questionnaire - Short form (ICIQ-UI SF). Methods TVT-Secur* System Device - the mesh consists of a 1.1× 8 cm PROLENE laser cut mesh tape - which is coated at both ends with an absorbable fleece material. The sandwiched fleece is a composite of Vicryl and PDS which provides strong fixation without the use of sutures (Fig. 1).

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Fig. 1 The GYNECARE TVT-SECUR* System

This material is usually absorbable within 90 days, with PROLENE* remaining intact to provide long-term fixation. The prosthetic implant is placed under the midurethra, runs along it and is fixed in the “hammock” position into the obturator internus muscle. In the “U” tape position it is attached behind the pubic bone to the connective tissue of the urogenital diaphragm. All data were processed and statistical analyses preformed in statistical environment R, version 2.5.1. Results From our results we can conclude that there were no perioperative complications (bladder perforation or larger bleeding), and objectively 62% of these patients were completely dry (absence of urine leakage) and 25% of patients improved; some leakage persisted in 38% of patients. When the tape was placed in the “hammock” position leakage of urine were found in 35% of patients; when it was in the “U” position stress urinary incontinence persisted in 41%. This difference is not statistically significant. Results from ICIQ-UI SF showed that 48% of patients were completely dry, 30% improved and 22% of patients still suffered from frequent leakage of urine - their condition was the same as before the operation. The operation improved leakage of urine during sexual intercourse, while other parameters were not changed. In seven cases we found vaginal erosion caused by the tape, and six patients suffered from de novo urgency. Conclusions Our first experience with TVT-S procedure, including possible complications, post-operative care and curative

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rate, is generally positive. But from our results we conclude that in our study group the cure rate was slightly lower than with the TVT-O procedure. The reason for a lower cure effect may be that the tape is slightly pulled back when extracting the inserters, and this can provide insufficient support of the urethra which then causes persisting SI. The placement of the tape with a fleece, and gentle removal of the inserter and possibly fixation of the fleece by forceps or with small tampon in the forceps, may prevent run-out of the tape. The tape used in the TVT-S procedure is less elastic than that used in the TVT or TVT-O procedure, so this tape must be slightly over-tightened, which means the tape is not tensionfree. These steps are crucial for the curative effect. Acknowledgement This work was supported by the Grant Agency of the Ministry of Health of the Czech Republic, grant NR/9216–3

56 TVT SECUR™: PROSPECTIVE STUDY AND FOLLOW UP TO 1 YEAR ABOUT 150 PATIENTS DEBODINANCE P1, LAGRANGE E2, AMBLARD J2, YAHI H, LUCOT J, COSSON M3, VILLET R4, JACQUETIN B5 1 CH Dunkerque, France, France, 2CHU Clermont Ferrand, France, 3Gynecology Obstetrics Dept - CHU Lille, France, 4 Gynecology Obstetrics Dept - Hopital Diaconnesses Paris, France, 5Gynecology Obstetrics Dept - CHU Clermont Ferrand, France, Industry Support: No Objective: To evaluate the efficacy and complications of this new sub uretral tape procedure with a follow up of 12 mois. Materials and methods: Prospective, observational study of our 150 patients operated for stress urinary incontinence with the TVT Secur™, a polypropylene sling similar to that of the TVT but shorter, that remains perineal, avoiding dangerous spaces, necessitating less dissection and less anaesthesia. Patients were operated between 24/8/06 and 18/12/07 in 4centers, and were all controlled at 2 months and 64 at 1 year. Mean age was 56.2 years with an average BMI of 28.1 and a rate of menopause rate of 64.1%. One hundred four patients had pure stress incontinence with 12 of them presenting a sphincter deficient (SD). Forty five

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had a mixed urinary incontinence (MUI) with 11 of them having SD. Preoperatively, 63 patients complained of urgency and 11 of dysuria. No associated surgical procedure was performed with the TVT Secur™and the “hammock” procedure was chosen by the authors. Twelve patients had previous incontinence surgery (1 Stamey, 5Burch, 2 Marshall Marchetti Krantz 1 TOT, 1 Peyrera and 2 Zuidex bulking agent), 10 had previous prolapse surgery (5 sacrocolpopexy, 2 Prolift, 1 Ore Loye and 2 anterior colporrhaphy) and 12 had previous hysterectomy. Anaesthesia was local for 96 patients (64%) (centre 1=89.3%, centre 2=50%), centre 3=0%, centre 4=44%), Local anaesthesia with sedation for 12 Pts (8%), epidural for 17 (11.3%) and general for 25pts (16.7%). Postoperative pain was evaluated using a visual analogical scale (VAS) quoted from 0 to 100. Results: Mean operative time (incision - closure) was 8.7 minutes [3 -30]. Seventeen per operative and 26 post operative urinary catheter were used during 24 h. Mean length of stay in hospital was 23.6 h (6 to 96 h. Per operative complications were: 5 haemorrhage more than 100 ml, 1 bladder injury, 1 vaginal wound and the device could not be placed successfully in a patient necessitating the use of a TVT - O. In the immediate postoperative phase, 21 patients had residual post micturition (100 to200 ml) and 1 groin pain. At the 2 months follow up we noted 2 tape exposed and 7 lateral vaginal cords. One of the 52 sexually active patients complained of dyspareunia. For 108 patients having had local anaesthesia with or without sedation, the mean peroperative VAS score for pain was 33/100 and 4.7/100 at the end of the procedure. Postoperatively and considering all the patients, VAS scores were 1/100 at 6 and 12 hours. At 2 months, 17 patients reported painful postoperative course lasting from 4 up to 30 days (mean=16): 4 in the vagina, 2 on the route of the tape, 1 in right iliac fossa 1 in the labia majora, 2 in groin, 1 in the buttock and 6 without precise locations. Results are summarized in the Table 1 and 2. Table 1 results at 2 months

Pure SUI without SD Pure SUI with SD Mixed UI TOTAL

n=92 n=12 n=45 n=149

Cured

Improved

Failed

73 (79.4%) 9 (75%) 21 (46.7%) 103 (69.2%)

13 (14.1%) 6 (6.5%) 3 (25%) 20 (44.4%) 4 (8.9,%) 36 (24.1%) 10 (6.7%)

Cured

Improved

Failed

28 (71.8%) 2 (40%) 14 (70.4%) 49 (69%)

2 1 1 4

9 (23.1%) 2 (40%) 3 (25.9%) 18 (25.4%)

Table 2 results at 1 year

Pure SUI without SD Pure SUI with SD Mixed UI TOTAL

n=39 n=5 n=27 n=71

(5.1%) (20%) (3.7%) (5.6%)

Among the patients with urge at baseline, 60.9% were cured at 2 months and 70.6% at 1 year. De novo urge appeared in 12.8% at 2 months and 18.9% at 1 year. De novo voiding dysfunction (max flow <15 ml/s) was found in 12.8% at 2 months and 6% at 1 year. The overall rate of satisfaction was 8.6/10 [2 to10]. All patients recommended local anaesthesia. Conclusion: TVT Secur™is a tension-free mini invasive procedure placed under the middle part of the urethra with no skin incision. This procedure is easy, fast and safe with minimum vaginal dissection. The result are less good than TVT or obturator route procedure.

57 Long-term outcome of the midurethal sling operation for women with mixed urinary Incontinence Bae J, Oh M, Lee J Korea University Medical Center, Korea Industry Support: No (n/a) Objective: The aims of our study were to investigate subjective and objective outcomes after midurethral sling (MUS) operations in women with mixed urinary incontinence (MUI), and to identify factors for favorable outcome. Methods: A retrospective data were collected from 279 women with MUI who underwent MUS operation with at least 2 years follow up. Before and after MUS, following measures were recorded; a disease-specific validated questionnaire, 24-hr pad test, standardized stress test, residual urine, and maximum urinary flow. Preoperative variables to be compared with surgical outcomes were as followed; predominance of bother (stress-predominance, urgencypredominance, or equally bothered); presence or absence of detrusor overactivity (DO); high pressure DO (detrusor pressure at which involuntary contraction occur during filling cystometry >15 cmH2O, HPDO) or low pressure DO (detrusor pressure at which involuntary contraction occur during filling cystometry <15 cmH2O, LPDO). Cure was defined as a condition where the women were very satisfied with the MUS operation and had negative stress test and 24 hr pad tests. Resolution of urgency incontinence was defined as total absence of symptoms without pharmacological therapy. Results: Overall long term success rates for SUI were 96.4% (cured at 82.4% and improved at 14%). The predominance of bothering symptoms or the presence of DO did not influence the over all success rates. In a subgroup of women with DO, those with LPDO showed significantly higher cure rate than those with HPDO. Urgency incontinence resolved in 176 (63%), improved in 60 (21.5%), while aggravated or

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persisted in 43 (15.4%). Women with stress-predominant MUI, absence of DO, or LPDO experienced better resolution urgency incontinence, improvement quality of life (QOL) and global impression of improvement (Table). Predominance Sx

SUI Sx. (%) Cured (%) Improved (%) Failed UUI Sx. (%) Resolved Improved Unchanged

Detrusor overactivity

In subgroup positive DO

SMUI UMUI Positive (n=129) (n=150) DO (n=88)

Negative DO (n=191)

LPDO (n=58)

HPDO (n=30)

111 (86.0) 15 (11.6) 3 (2.3)

119 (79.3) 24 (16.0) 7 (4.7)

67 (76.1) 16 (18.2) 5 (5.7)

8 (85.3) 23 (12.0) 5 (2.6)

49 (84.5)* 7 (12.1) 2 (3.4)

18 (60.0) 9 (30.0) 3 (10.0)

100 (77.5)** 19 (14.7) 10 (7.8)

76 (50.7) 41 (27.3) 33 (22.0)

46 (52.3) 28 (32.8) 14 (15.9)

130* (68.1) 32 (16.8) 29 (15.2)

34 (58.6) 19 (32.8) 5 (8.6)

12 (40.0) 9 (30.0) 9 (30.0)

97 (64.7) 32 (21.3) 21 (14.0)

53 (60.2) 20 (27.7) 15 (17.0)

148 (77.5)** 27 (14.1) 16 (8.4)

40 (69.0)** 15 (25.9) 3 (5.2)

13 (43.3) 5 (16.7) 12 (40.0)

PGI (%) Very Satisfied 104 (80.6)* Satisfied 15 (11.6) Dissatisfied 10 (7.8)

DO: detrusor overactivity SMUI: stress predominant mixed urinary incontinence UMUI: urgency predominant mixed urinary incontinence LPDO; low pressure detrusor overactivity (Pdetmax<15 cmH2O) HPDO; high pressure detrusor overactivity (Pdetmax≥15 cmH2O) MUCP: maximal urethral closing pressure PGI: patient global impression of improvement *: P<0.05 **: P<0.01

Conclusions: Our results suggest that women with stresspredominant MUI, without DO, or with LDO more likely to be cured of their urgency urinary incontinence after the MUS operations for mixed urinary incontinence.

58 Foreign body reaction in vaginally eroded and non eroded polypropylene tension free sub-urethral tapes in the human female: a case series Kavvadias T1, Kaemmer D2, Klinge U2, Kuschel S1, Schuessler B1 1 New Clinic of Gynaecology and Obstetrics, Cantonal Hospital of Lucerne, Switzerland 2 Departement of Surgery, University Hospital Aachen, Germany, Germany

Industry Support: No Objective: The aim of this study was to establish the pattern of tissue reaction induced by MPPM at the vaginal wall and to compare this pattern in eroded and non eroded material. Background: Tension free sub-urethral tapes are today the most frequently used surgical treatment for stress urinary incontinence (SUI) in women. Macroporous polypropylene mesh (MPPM) is the material of choice. In hernia repair use MPPM initiates a distinctive pattern of foreign body reaction. To our knowledge there are yet no published data regarding to this reaction at the vaginal wall. Methods: Ten women (mean age:57 years, min. 43 max. 73) who were primarily treated for SUI with sub-urethral tapes (7 TOT-Safyre, 2 TVTs and 1 TOT-Monarc), were seen in our outpatient clinic between May 2004 and December 2006 with the following diagnoses: tape-erosion in five patients; voiding disorders with residual urine volume in three patients; dislocation of the tape with recurrent SUI in two patients. In all patients the tapes were removed. Mean time between surgical treatment and revision was 20 months (min. 1 max. 30). Explanted tissue and tape material was stained with 1% Hematoxylin/Eosin solution and foreign body reaction was tested by immunohistochemistry aiming at accumulation of macrophages (CD-68), expression of matrix metalloproteinase (MMP) 2 and 13, cellular proliferation (Ki-67) and apoptosis (TUNEL) using a standard avidin-biotin complex and counterstaining with diaminobenzidine. Two investigators, blinded to the clinical data, scored the findings with a visual semi-quantitative scoring system (1); discrepancies were resolved under discussion. The collagen I/III quotient was also evaluated using cross-polarization microscopy after staining in picrosirius solution. Results: The inflammatory reaction consisted of fibrotic ingrowth between the pores following the length of the tape; eight out of ten explanted tapes were ‘rolled up’. The collagen I/III quotient was 7,05, Conclusions: Microscopic rolling up of the material, fibrotic ingrowth between the pores following the length of the mesh and foreign body reaction evaluated by immunohistochemistry resemble results found in abdominal wall surgery and meshes explanted from animal models (2,3). The collagen I/III quotient was typical of fibrotic tissue. There were no major differences between the five eroded and the five non eroded tapes. This study showed that foreign body reaction of MPPM in sub vaginal tissue is similar to the reaction found in hernia mesh surgery. The fact that eroded and non eroded material showed no difference in foreign body reaction may indicate that the

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origin of erosion is not based on a different pattern of tissue reaction in the individual patient. Limitation of this study is the small sample size. However this is to our knowledge the first study which examines tissue reaction of the vaginal wall initiated by explanted MPPM in the human female. Although the results are derived from tension-free vaginal tapes, in which erosion is rare and easy to control, future focus of this study may be in prolapse meshes, in which erosion of MPPM is a major problem, not yet resolved. References: (1) J Pathol 2006;208:607–614 (2) Chirurg 2000;71:43–51 (3) BJU 2005;95:833–83

59 Redefining surgical cure: Role of composite endpoints Renganathan A, Cartwright R, Cardozo L, Srikrishna S, Robinson D, Vella M King’s College Hospital, United Kingdom Industry Support: No Objective: To assess the role of composite endpoints by comparing it with objective cure, subjective cure and quality of life scores. Background: The use of composite endpoints in interventional studies has the potential to provide standardised patient-centred comparison between outcomes in different trials (1). In this study we defined a composite endpoint for the Gynecare TVT procedure based on multiple measures of objective cure (2). We compared this composite measure with pre and post-treatment change in the King’s Health Questionnaire (KHQ), for a series of women undergoing TVT in our institution (3). Methods: Women undergoing Gynecare TVT procedure between January 2005 and September 2007 in our tertiary referral hospital were eligible for inclusion in this retrospective cohort. Assessments were made at presentation and 6 months after the procedure, including completion of the KHQ, cystometry, videocystourethrography (VCU), and pressure flow studies. The ‘composite endpoint’ of objective cure required the absence of urodynamic stress incontinence (USI), de novo detrusor overactivity (DO),

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and voiding difficulties. USI was assessed with a fluoroscopic cough test at maximum cystometric capacity or 500 mls. Voiding difficulties were defined as peak flow<=15 ml/s and/ or urinary residual >=100 mls. Pre and post-treatment differences were compared using the Wilcoxon signed rank test, and the Mann-Whitney U test using SPPS version 14.0. Results: A total of 161 women were eligible for inclusion. Complete data including pre and postoperative urodynamics and quality of life evaluation were available in 80 women who were included in the analysis. The mean age at the time of surgery was 55.3 years (range 33–85 years). TVT was performed as a primary procedure in 76 women and after failed previous continence procedures in 4 women. Objective cure of stress incontinence was observed in 92.5% (74/80) of women undergoing TVT for urodynamic stress incontinence and subjective cure in 86.3% (69/80). There was a 5.0% (4/80) incidence of de novo detrusor overactivity and 8.8% (7/80) incidence of voiding difficulties at 6 months. Quality of life (QoL) scores significantly improved in the individual domains as well as the total scores of the KHQ (all domains p<0.0001) (Figure 1).

Figure 1 Difference in QoL scores before and after TVT 100 80 60 40 Before After

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Difference

0 GHP

II

RL

PL

SL

PR

EM

SE

SM

-20 -40 -60

Using the composite endpoint 64 (80%) women were treatment ‘successes’ and 16 (20%) who had USI, DO or voiding difficulties were treatment ‘failures’. Overall there was a greater improvement in QoL scores in those with composite success group when compared to those with composite failure. This achieved statistical significance only for the physical limitations domain.

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However in all domains the criteria for minimally important difference were met (Figure 2).

Figure 2 Mean changes in KHQ scores from baseline

GHP

urodynamic diagnoses of USI, DO and voiding difficulties is a valid method of defining success of TVT. Ultimately subjective cure rates and quality of life scores are more important than objective and composite scores in defining ‘cure’. References 1. Am J Obstet Gynecol. 2007 Dec;197(6):647 2. BJOG. 2004 Jun;111(6):605–12 3. BJU Int. 2007 Jan;99(1):101–6

0 II

SM

-50 SE

RL

-100 EM

PL

PR

SL

Failure Success

Key:

SM

GHP General health Perception II Incontinence Impact RL Role Limitations PL Physical Limitations SL Social Limitations PR Personal Relationships EM Emotions SE Sleep/Energy Severity Measures

There is no significant difference between the objective and subjective cure rates. The use of a composite endpoint may help to more accurately define cure as it defines objective cure whilst at the same time excludes de novo complications. Quality of life improved in all patients and this did not differ in those groups where success was measured objectively, subjectively or using the composite endpoint. Conclusion: Establishing the most appropriate treatment endpoint to assess success of treatment for stress incontinence requires further investigation. Therefore it is unclear from this study whether composite clinical endpoints, based on absence of the

60 Does levator trauma increase the risk of urodynamic stress incontinence? Bedwell P, Shek K, Dietz H University of Sydney, Australia Industry Support: No Objective: This study was designed to define the association between levator trauma and symptoms of bladder dysfunction as well as urodynamic findings. Background: Vaginal childbirth is linked to stress urinary incontinence (SUI) in epidemiological studies. Deliveryrelated levator trauma may be responsible for this association, in particular since pelvic floor muscle training is effective in mitigating SUI. Methods: In a retrospective observational study we reviewed the records of 425 women who had attended a urogynaecological unit for independent flowmetry, multichannel urodynamic testing using fluid- filled catheters and 4D pelvic floor imaging. Results: Mean age was 55 (17–87) years. Patients presented with SUI (80%), urge incontinence (75%), frequency (37%), nocturia (51%), symptoms of voiding dysfunction (such as hesitancy, a poor stream and straining to void, 27%) and symptoms of prolapse (35%). In 5 cases an assessment for levator trauma was impossible due to refusal, stenosis or scarring. Of the remaining 420 women, 104 were found to have suffered an avulsion of the puborectalis muscle (25%). These women were less likely to suffer from SUI (P<0.001) and urodynamic stress incontinence (USI, P=0.065), and more likely to show signs of voiding dysfunction (P=0.005), see tables 1 and 2. This was true even when we excluded women with significant pelvic organ prolapse (Grade 2+) and patients

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with symptoms of prolapse, although relationships no longer reached significance. Table 1 Associations between symptoms and avulsion injury Symptom

Avulsion (n=104)

No avulsion (n=316)

X2- test

Stress Incontinence Urge incontinence Frequency Nocturia Voiding dysfunction Prolapse

68% 69% 31% 46% 26% 52%

85% 77% 39% 52% 28% 30%

P<0.001 n.s. n.s. n.s. n.s. P<0.001

Table 2 Associations between urodynamic diagnoses and avulsion injury Diagnosis

USI Sensory Urgency DO Voiding dysfunction

Avulsion (n=104)

No avulsion (n=316)

X2- test

62% 15% 23% 48%

71% 18% 25% 33%

P=0.065 n.s. n.s. P=0.005

unrelated to puborectalis muscle trauma. Further research should focus on the contribution of muscular reflex activity, the integrity of urethral fixation, and the role of the urethral rhabdosphincter, all of which may be negatively affected by pregnancy and childbirth.

61 Comparison of the effect of transobturator tension free vaginal tape (TVT-o) and tension free vaginal tape (TVT) on the lower urinary tract - an ultrasound study Masata J1, Martan A1, Svabik K1, Svabik K2 1 Obstet. Gynecol. Dept., Charles University in Prague, 1st Faculty of Medicine, Czech Republic, 2Euromise, Charles University, Prague, Industry Support: No

There were no associations with numerical parameters except for maximum flow rate (MFR) centiles calculated according to the Liverpool nomogram, and detrusor pressure at maximum flow (see Table 3). Table 3 Associations between urodynamic parameters and major levator trauma as diagnosed by 4D pelvic floor ultrasound. * Mann- Whitney u test. Numbers are given as mean (standard deviation) unless marked otherwise Parameter

Avulsion (n=104)

No avulsion (n=316)

t- test

MFR Centile (n=339) Residual (ml) First Desire to void (ml) Maximum capacity (ml) pDet at max. flow (cm H2O) MUCP (cm H2O, n=159)

22.1 (22.4) median 15 211 (102) 349 (95) 29.9 (10.8) 35.9 (13.8)

30.7 (28.3) median 0 216 (102) 327 (102) 25.7 (11.4) 36.9 (14.5)

P=0.005 P=0.11* n.s. n.s. P=0.002 n.s.

Conclusions: Women with avulsion of the puborectalis muscle are less likely to present with SUI and to be diagnosed with USI. Conversely, they are more likely to present with prolapse, to have signs of voiding dysfunction, to show lower MFR centiles and elevated detrusor pressures at maximum flow. The negative association between avulsion and SUI/ USI persisted even when we excluded patients with symptoms and signs of prolapse, although numbers no longer reached significance. Our findings suggest that the epidemiological link between stress incontinence and childbirth is likely due to factors

Objective The aim of our study was to evaluate and compare changes of the lower urinary tract after successful TVT and TVT-o operation (especially changes in the mobility of the whole urethra), changes of the proximal urethra (funnelling) and of the thickness of the urinary bladder wall, and to evaluate the relationship between the position and mobility of the tape and the mobility of the urethra. Background Tension free vaginal tape (TVT) is a widely-used method for the treatment of stress urinary incontinence. Although this method is simple and relatively safe, serious complications of this procedure have been described, such as the injury to the major vessels or bowel perforation. That was one of the reasons why transobturator approach was introduced. Randomised studies comparing transobturator tape to TVT found no statistical difference in terms of continence outcomes. To date, there are no relevant data comparing the complex changes of the lower urinary tract after those procedures. The question of whether both procedures are suitable for all patients is still under discussion. Methods This prospective study included 154 women with urodynamically proved stress urinary incontinence. The patients were included consecutively, 101 women underwent TVT, and afterwards 53 TVT-o. Their mean age was 56.9 years (SD=10.9), mean BMI was 27.7 (SD=4.8), and mean parity was 1.9 (SD=0.74), while there were no differences between both groups. An ultrasound examination was performed before TVT procedure and approximately 3–6 months after the surgery. The measurements were taken in supine position at rest and during maximal Valsalva. Because the anatomical length of the urethra varies, measurements of the urethra were taken at 4 defined points:

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at urethrovesical junction (UVJ), 17 mm below UVJ (middle of the urethra) and one centimeter above and below this point (upper and lower third). After the surgery, the position and mobility of the tape was also assessed. For evaluation of the proximal urethra the distance between the inner edges and depth of visible opening was measured at rest and at maximal Valsalva. Thickness of the bladder wall was measured after emptying at three points (anterior, trigone and dome). For all women, we examined the changes in position and mobility of the whole urethra during maximal Valsalva maneuver and changes induced by the surgery. Position and mobility of the urethra in both groups were compared before and after surgery. To achieve better understanding of the changes after the surgery, the women were subdivided according to their preoperative urethral mobility (division according to quartiles). For free mobility groups (low, intermediate and high) before surgery we compared the changes induced by different operation and typical position and mobility of the tape after surgery. Results Mobility of the urethra before surgery is the same in both groups and does not differ from values common in incontinent patients as published in previous studies. The position of the urethra at rest is not influenced by the surgery (it is in the same position as before). Changes in the urethral mobility induced by surgery are the same in both groups. Both operations significantly decreased the mobility of all parts of the urethra during Valsalva. The rest position of the tape with respect to the lower urethral segment is the same for both procedures, but after TVT-o the tape is approximately for 1.5 mm narrower (this is likely to be due to the different passage and higher deformation during the procedures). At maximal Valsalva the position of the tapes is different, after TVT-o the tape is slightly higher and has the same inclination to the lower urethral segment as at rest, while after TVT the inclination of tape hanges. Neither operation influenced the proximal urethra at rest and they both significantly decreased funnelling during maximal Valsalva (width and depth), but TVT - o did so to a greater extent. After the surgery there was no difference in the thickness of the bladder wall in both groups. Conclusion Transobturator tape (TVT-o) has a similar effect on the lower urogenital tract as TVT. Neither operation influenced the urethra at rest and they both significantly decreased the mobility of the urethra during Valsalva in the same manner. TVT-o caused a significantly greater decrease to the opening of the proximal urethra during Valsalva and may be more effective as suggested for patient with ISD with low urethral mobility. Different tape movement after TVT during Valsalva may explaine the higher incidence of some complications, such as voiding difficulties. This work was supported by NR 8815–3/2006, GIGH0651–00–3–223

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62 TORP - Comparing the efficacy, execution and early complications of TVT and TVT-O Valentim- Lourenço A1, Benoun M2, Mascarenhas T3, Cruz F4, Moniz L5 1 Dep. of Obstetrics, Gynecology and Reproductive Medicine, Urogynacology Division, Sta Maria Hospital, Portugal, 2Serv of Obstetrics Gynecology, Urogynacology Division, Hospital de Faro, Portugal, 3Dep. of Obstetrics Gynecology, Urogynacology Division, Hospital São João, Portugal, 4Serv. Urology, Hospital São João, Portugal, 5 Serv Gynecology, Maternidade Alfredo da Costa, Portugal Industry Support: Yes (Investigator initiated, partial funding) Objective To compare two minimally invasive techniques: TVT and TVT-O during and immediately after surgery using a global score specifically developed for this study. Material and methods Randomized, prospective, blinded (patient and 3rd observer) study of patients with mixed or stress urinary incontinence. From September 2005 to June 2007, patients were randomized to TVT or TVT-O surgery. All patients were assessed before surgery and, at 3, 6 and 12 months followup: clinical urogynecological evaluation, urodynamic evaluation and rating the quality of life through King’s Health questionnaire (range between 21 and 84 points). The global score for efficacy evaluation was determined by weighting the efficacy, execution and complications, according to the following formula: Global Score = (efficacy)-(execution)(complications). Efficacy was measured from 500 points when patient was cured to 0 points in the absence of response. Technique execution was calculated from the following formula execution = difficulty (5 to 1) * time (minutes). Different complications were measured from 50 to 200 points. The results were transformed to percentages. We analysed the results immediately after surgery. Results 149 patients were enrolled; the mean age was 54.5 years (range 45.5–63.5). 79 patients (53%) were randomized to TVT-O surgery and 70 patients (47%) were randomized to TVT. The two patients groups were similar in demographic and obstetric history data. 57% of the patients in TVT-O arm had rachis or epidural anaesthesia and 43% of the patients had general anaesthesia; whereas in TVT arm 17.1% had general anaesthesia; 64.3% rachis/epidural and 18.6% local anaesthesia. Mean time of surgery was inferior in the TVT-O group (7.2 min versus 13.5 min). 81% of TVT-O and 67.1% of TVT surgical interventions were rated with score 1 in execution technique (very easy, quick and without complications). Surgical complications in the TVT group were bladder perforation (4.2%), excessive bleeding (6.3%), vaginal lacer-

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ation (2.1%) and anaesthesical complications (8.3%). Complications among patients in the TVT-O group were: excessive bleeding (3.6%), vaginal laceration (5.5%) and anaesthesical complications (1.8%). The differences between the two groups in what concerns surgical complications were not statistically significant. The global score was significantly higher in the TVT-O group at surgery (98.1% versus 94.0%, p=0.035). Conclusion The present study confirms that TVT and TVT-O are two effective techniques for the correction of mixed and stress urinary incontinence. TVT-O showed superiority in terms of technique’s execution, surgery duration and efficacy surgery outcomes. Due to the different anatomical approaches, the complications were different between the surgeries, namely TVT-O group did not suffer bladder perforation. When a global score was used, composed by efficacy data, technique procedures execution and surgery and immediate post-operative complications, TVT-O showed better results than TVT. 63 TORP- Comparing the efficacy of TVT and TVT-O – 3 months follow-up analysis Valentim-Lourenço A1, Benoun M2, Mascarenhas M3, Cruz F3, Moniz L4 1 Dep. of Obstetrics, Gynecology and Reproductive Medicine, Urogynacology Division, Sta Maria Hospital, Lisboa, Portugal, 2Serv of Obstetrics Gynecology, Urogynacology Division, Hospital de Faro, Portugal, 3Dep. of Obstetrics Gynecology, Urogynacology Division, Hospital São João, Porto, Portugal, 4Serv Gynecology, Maternidade Alfredo da Costa, Lisboa, Portugal Industry Support: Yes (Investigator-initiated, partial funding) Study design, materials and methods Randomized, prospective, blinded (patients and 3rd observer) study, that included patients with mixed or stress urinary incontinence. From September 2005 to June 2007, patients were randomized for TVT or TVT-O surgery. All patients were assessed before surgery and, at 3, 6 and 12 months follow-up by a symptoms scale, by clinical urogynecological evaluation, by urodynamic evaluation and by rating the quality of life through a King’s Health questionnaire (range between 21 and 84 points). The global score for efficacy evaluation was determined by weighting the efficacy, execution and complications, according to the following formula: Global Score = (efficacy)-(execution)-(complications). Efficacy was measured from 500 points when patient was cured to 0 points in the absence of response. Technique execution was calculated from the following formula execution = difficulty (5 to 1) * time (minutes). Complications were measured from 50 to 200 points. The results were transformed to percentages.

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Results 149 patients were enrolled; the mean age was 54.5 years (range 45.5–63.5). The two patients groups were similar in demographic and obstetric history data. The global score was significantly higher in the TVT-O group at surgery (98.1% vs. 94.0%, p=0.035) and at 3 months follow-up (89.9% vs. 78.5%, p=0.027). In what concerns quality of life there was a significant difference between baseline and follow-up in the total study population (53.4 vs. 22.2, p<0.001), TVT-O (51.2 vs., 20.2 p<0.001) and TVT (55.9 vs. 24.4, p<0.001). Both groups demonstrated significant improvement in the symptoms scale (13.4 vs. 3.8 p<0.001) at 3 months follow-up. There were no differences between the two treatment groups. Interpretation of results Both groups improved from the urinary incontinence after surgery and at 3 months follow-up. When considering the global score, that included data on efficacy, technique’s execution and surgery and post-operative complications, TVT-O showed better performance with statistically and clinically differences between the 2 groups immediately after surgery and after a 3 months follow-up period. Concluding message TVT and TVT-O are two effective techniques for the correction of mixed and stress urinary incontinence. TVT-O seems to bring better results when all influencing factors are weighted. 109 Altered a2-Macroglobulin Expression in Relaxin-Stimulated Vaginal Fibroblasts from Women with Stress Urinary Incontinence May Affect Cell Apoptosis Wen Y, Ho Y, Man W, Polan M, Chen B Stanford University School of Medicine, Department of OB/ GYN, United States Industry Support: No OBJECTIVE: To compare relaxin’s effect on a2-macroglobulin expression in cultured vaginal fibroblasts from women with stress urinary incontinence (SUI) and continent controls, and evaluate the effect of a2-macroglobulin on apoptosis in fibroblasts. BACKGROUND: Stress urinary incontinence has been associated with increased proteolytic activity in pelvic connective tissues. This is due, in part to a relative decrease in expression of the protease inhibitors, a1-antitrypsin and a2-macroglobulin. Expression of a2-macroglobulin (a2-M) was found to be decreased in vaginal tissues from premenopausal women with SUI compared to controls during both the proliferative and secretory phases of the menstrual cycle (Wen et al. 2008). Relaxin is a peptide hormone that increases proteolysis in extracellular matrix and is produced by the corpus luteum

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during the secretory phase and the placenta. To further understand the effects of endogenous ovarian hormones on connective tissue proteolysis, we investigated expression of a2-M in relaxin-stimulated vaginal fibroblasts. In addition to its anti-protease effects, a2-M can also inhibit apoptosis. Given the observed decrease in a2-M expression in tissues from women with SUI, we sought to investigate whether a2-M can inhibit fibroblast apoptosis. METHODS: Full-thickness peri-urethral vaginal wall biopsies were obtained from premenopausal women. Vaginal fibroblasts from controls and women with SUI were isolated and cultured to confluence. After priming with17 ß-estradiol to induce relaxin receptors, the cells were stimulated with human relaxin (0–100 ng/ml) for 48 hours and the supernatant collected. Expression of a2-M in the supernatant was determined by Western-blot. Apoptotis was induced in fibroblasts by serum starvation and H2O2. a2-M (0–10 μg/ ml) was added into the culture at the beginning of induction of apoptosis. Apoptosis rate was determined by trypan blue exclusion assay and TUNEL staining. ANOVA was used for comparisons between groups. RESULTS: a2-M level in the supernatant of control fibroblasts (from both proliverative and secretory phases) increased with increasing relaxin concentration (P<0.05). However, a2-M level in the supernatant of fibroblasts from women with SUI in the proliferative phase was not affected by relaxin, and it was decreased in the supernatant of fibroblasts from women with SUI in the secretory phase, at a concentration of 10 ng/ml(P<0.007). a2-M inhibited starvation and H2O2 induced fibroblast apoptosis. CONCLUSION: Vaginal fibroblasts from women with SUI in the secretory phase demonstrated a decrease in a2-M expression when stimulated with relaxin. This is contrary to the increase in a2-M expression observed in fibroblasts from continent controls. This increase in a2-M expression, may protect fibroblast from apoptosis in continent controls. This study was supported by National Institutes of Aging R01 AG01790 and Mary lake Polan transition fund. References: Wen Y, Man WC, Sokol ER, Polan ML, Chen BH. 2008. Is alpha2-macroglobulin important in female stress urinary incontinence? Hum Reprod 23(2):387–393. 110 ARISTM TRANS-OBTURATOR TAPE: THREE YEARS FOLLOW UP Juma S1, Brito G2 1 Incontinence Research Institute, Encinitas, CA United States, 2Urology Associates, Scottsdale, AR United States Industry Support: Yes (Investigator initiated, partial funding) Objective & Background: The lack of long term outcome data of the Trans-Obturator tape (TOT) procedure in the literature

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reflects the novelty of the technique. We report the results of three years follow up of the outcome and adverse events associated with the TOT procedure in the treatment of female patients with stress urinary incontinence (SUI). Methods: Two hundred and thirty four consecutive patients were prospectively evaluated with history, pads/day (PPD), physical exam, Incontinence Impact Questionnaire (IIQ), Urogenital Distress Inventory (UDI), analog global satisfaction scale (GSS), and urodynamics studies. All patients had the TOT procedure using the ARISTM Polypropylene mesh (Coloplast A/S). Pelvic prolapse repair was done as indicated by the preoperative findings. Postoperatively patients were evaluated with history, PPD, physical exam, IIQ, UDI, and GSS. The paired t-test was used for statistical analysis. Results: Two hundred and thirty four patients (mean age 59.59 years) who have completed a minimum follow up of 12 months are the subjects of this report. Preoperatively, SUI was reported by 93.8%, and 66.2% reported urge incontinence (UI). PPD use was 2.22 (0–10). The mean scores on the IIQ were 11.05 (range 0–35), UDI 10.46 (range 0–18), and GSS 2.78 (range 0–10). Urodynamics demonstrated detrusor overactivity in 25.8%, mean valsalva leak point pressure of 74.21 cm H20 (range 3– 157). Detrusor pressure at maximum flow rate (Pdet max) was 25.82 cm H20, and the maximum flow rate (Qmax) was 16.26 ml/sec. All patients underwent the TOT procedure using the ARISTM tape (Coloplast A/S). Cystocele repair was done in 57.75% (N=134), enterocele repair in 4.31% (N=10), rectocele repair in 21.98% (N=51), hysterectomy in 12.93% (N=30), and vaginal vault suspension in 9.05% (N=21). The mean hospital stay was 0.46 days (rage 0–4 days) and 65.51% (N=152) were done as an outpatient procedure. The mean duration of catheter was 0.53 days (range 0–6 days), and 64.65% (N=150) did not require a catheter postoperatively. The mean follow up is 23.34 months (range 12–36 months), and 41% (N=98) of patients has follow up more than 24 months. SUI resolution was reported in 90.61% (P<0.0001), 61.18% reported resolution of UI (P< 0.0001), and 2 (2.5%) reported de novo urge symptoms. PPD use declined to 0.30 (P<0.0001). The mean scores on the IIQ declined to 1.64 (P<0.0001), UDI 3.80 (P<0.0001), and GSS increased to 8.0 (P<0.0001). Three (1.3%) patients had vaginal extrusion of the tape, 2 (0.9%) had urinary tract infection, and 2 (0.9%) developed urinary obstruction which required tape release. No patient sustained bladder injury, bowel injury, vascular injury, or nerve injury. Conclusions: This prospective series of patients with SUI demonstrates the success of the TOT in resolving the symptoms of incontinence. The safety, functional efficacy and patient satisfaction with the procedure are sustained at intermediate follow up. The rate of vaginal extrusion of the ARISTM tape is low. The procedure can be done as an outpatient procedure in the majority of patients, and the majority of patients do not require catheterization post-operatively. The lower incidence of de novo urge symptoms in this series is consistent with other

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series reported in the literature, and is an important advantage for the TOT over existing techniques.

111 A Danish National survey on subjective cure and satisfaction 4 years after Tension-free Vaginal Tape (TVT) Ammendrup A, Sander P, Lose G Department of Gynecology and Obstetrics, Glostrup Hospital, Denmark Industry Support: No Objective: To evaluate subjective cure-rate and satisfaction in all Danish women, who had a Tension-free Vaginal Tape (TVT) operation in 2001. Methods: From the Danish National Patient Register, all Danish women who had an op-eration code for a TVT or a TVT-like operation in 2001 were extracted. The women received a tested postal questionnaire in 2005. The questionnaire included questions about subjective cure, satisfaction, complications and a Danish version of International Consulta-tion on Incontinence Questionnaire - short form (ICIQSF). A test-retest analysis of the questionnaire was made. The study was carried out in cooperation with the Danish National Board of Health. Results: The total number of TVT operations in 2001 was 410. 386 questionnaires were mailed, 92% responded. Median missing answers were 4.1% (range 0.8–10.7%). Test-retest results were median crude agreement of 85% (range 70–96%) and median kappa value was 0.66 (range 0.4–0.88). Mean age was 60.4±21.5 (2SD) and self-reported serious co-morbidity developed after surgery was 7% (diabetes, thrombosis or cancer). 33% felt subjectively cured, 52% im-proved, 12% unchanged and 3% worse. ICIQ-SF total mean score was 6.9, 35% answered they were never incontinent, 39% was incontinent = once a week, 25% was incontinent = once a day and 1% was incontinent all the time. Incontinence impact on daily living measured by an 11-point scale (0=no impact; 10=great impact): mean 2.9. From this scale 66% answered incontinence had little or no impact on their life (answered 0–3). Satisfaction with the operation procedure measured by an 11-point scale (0=dissatisfied; 10=very satisfied): mean 8.9. 80% of TVT operated women would choose the same treatment again, where 5% would not. 87% would choose the same department again and 3% would not. Self-reported complications: 42% answered they had not had any complications. 33% said they had difficulty in emptying the bladder. Eight percent had used catheter at any stage postoperatively and 56% of these used self-catherization >1 month. Nobody was still using catheters. Two percent reported they had had

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a vaginal wound. Four percent reported they had had a new sling procedure and 1.5% had had a reoperation due to complications. Conclusion: Four years after TVT 81% of Danish women were satisfied. Nevertheless only 33% felt subjectively completely cured and 52% improved.

112 TVT vs. TVT-O for Primary Stress Incontinence: A Randomized Clinical Trial Tamussino K1, Tammaa A2, Hanzal E3, Umek W3, Bjelic V1, Koelle D4 1 Medical University of Graz, Austria, 2Wilhelminenspital Vienna, Austria, 3Medical University of VIenna, Austria, 4 Medical University of Innsbruck, Austria Industry Support: No Objective We compared objective and subjective outcomes and perioperative factors (complications) of TVT with those of TVT-O as treatment for primary stress urinary incontinence in a prospective randomized noninferiority trial. Background Transobturator approaches to placing midurethral tapes were introduced without randomized comparisons vs. retropubic placement. Methods We conducted a randomized, controlled, multicenter noninferiority trial of patients undergoing a midurethral tape procedure for primary stress urinary incontinence. All patients gave informed written consent. Patients undergoing concomitant hysterectomy or procedures to correct prolapse were excluded; minor concomitant procedures were allowed. Patients were randomized to retropubic or transobturator TVT (TVT vs. TVT-O; Gynecare, Ethicon Women’s Health and Urology). The primary outcome measure was objective cure of stress incontinence (negative cough stress test at bladder filling of 300 ml). Secondary outcome measures were overall and condition-specific quality of life data (King’s Incontinence Questionnaire; Short Form 12 (SF-12); EuroQoL5; Patient Global Impression of Severity and Improvement, PGI-S, PGI-I). Perioperative complications were recorded and data were obtained for cost and cost utility analyses. We assumed an 80% cure rate with TVT and that a 10% difference in cure between procedures would be clinically important. The hypothesis is that there is no more than a 10% difference in cure rate between the methods. To detect this level of difference with 80% power required 198 patients in each arm. Results A total of 564 patients were randomized at 25 participating centers (both general and regional hospitals and university departments). At 3 months a negative cough stress test was

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documented in 148/171 (87%) of patients after TVT compared with 143/178 (80%) after TVT-O (p=0.06, Fisher’s exact test). The rate of patients not using pads was 124/168 (74%) after TVT vs. 101/160 (63%) after TVT-0 (P<0.05). There were 9 bladder perforations (3.3%) and 1 bowel perforation with TVT. The bladder perforations healed without sequelae; the bowel (transverse colon) perforation was repaired by laparotomy 48 hours after the TVT procedure and the patient subsequently did well. There were no bladder or bowel perforations with the TVT-O operation. There were 4 cases of increased bleeding with the TVT operation compared with 2 for TVT-O. Quality of life and health economic data are being analyzed. Conclusions At 3 months continence rates after TVT were not significantly inferior to those after TVT. Fewer women continued to use pads after TVT than after TVT-O. Bladder perforations were more common with the retropubic approach. (ClinicalTrials.gov number ????)

113 Is Objective failure after Stress urinary incontinence surgery a true failure? Fiadjoe P1, Kannan K2, Corstiaans A1, Rane A1 1 Townsville Health Service District, Australia, 2James Cook University, Australia Industry Support: No Objective: To determine whether objective failure for treatment of stress urinary incontinence demonstrated by postoperative urodynamics is a “real” failure. This is done by analyzing patients’ perception and satisfaction. Background: Numerous outcome studies exist for surgical procedures to treat stress urinary incontinence. In many reports an emphasis was placed on objective cure rates using measures such as stress test, pad test and voiding diaries. More recently, the importance of subjective outcomes postsurgery, using validated patient completed questionnaires addressing symptom severity, quality of life and satisfaction with surgery has been recognized and used to complement objective outcomes. Methods: This retrospective study, reviewed the clinical notes of all women who had positive postoperative urodynamic stress incontinence after incontinence surgery between June 2005 and June 2007. The modified Bristol Female Lower Urinary Tract Symptoms questionnaires which were used pre and postoperatively were collected using a proforma and analyzed. A telephone interview was also performed between 12 months and 24 months postsurgery by the research fellow no involved previously with surgery and analysis. Results: A total of 26 women were identified for the study. The ages were between 40–77 years. All women had stress urinary incontinence (SUI), pre and postoperatively con-

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firmed by urodynamics. All women had Transobturator tape operation but 22 had other procedures including anterior and/ or posterior repair. Postoperative assessment was done at 11 weeks and again between 7 and 28 months (mean 17.5 months). Patients were subjectively better with 57.7% and 73% reporting complete dryness respectively. Preoperatively the SUI affected the quality of life in 53.8% and was reduced to 3.9% postoperatively. 14 women’s quality of life regarding sexual activity was impacted preoperatively; this was reduced to 3 and 1 at initial postoperative review and the interim interview respectively. Conclusions: Since stress urinary incontinence is a quality of life issue, we may need to put more emphasis on appropriate subjective outcome assessment and reserve routine postoperative urodynamics as a research tool or for patient with failed subjective outcome. We accept the fact that larger numbers will be required to give a definitive answer

114 Stress analysis on pelvic floor induced by the passage of a fetus Parente M1, Jorge R1, Mascarenhas T2, Duarte S3, Costa F3, Martins J4 1 IDMEC, Faculty of Engineering, University of Porto, Portugal, 2Faculty of Medicine, University of Porto, Portugal, 3S. Joao Hospital, Portugal, 4Instituto Superior Tecnico, Portugal Industry Support: No Objective: Pelvic floor dysfunction is a hidden problem with a magnitude unknown to many. Statistics show that 1 in every 10 women will have pelvic floor dysfunction so severe that it will require surgery [1]. Several studies have shown that pelvic floor injuries during a vaginal delivery can be considered a significant factor in the development of urinary incontinence, fecal incontinence and pelvic organ prolapse. The objective of the present work is to contribute to the clarification of the mechanisms behind pelvic floor disorders related to a vaginal delivery. For this purpose a numerical simulation based on the Finite Element Method was carried out. Background: Pelvic floor dysfunctions represent an extensive problem with unknown dimensions. A study by Olsen et al., showed that 11% of women had surgery for urinary incontinence or pelvic organ prolapse during their lifetime [1]. Using a finite element model which simulates the pelvic bones, pelvic floor muscles and fetus, we measured the stresses on the pelvic floor induced by the passage of the fetus, during a vaginal delivery.

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Methods: The Finite Element Model used in this work was constructed using the geometrical point data obtained from cadaver measurements. More details on the model and simulation can be consulted on reference [2]. The simulation was performed using the implicit version of the commercial software ABAQUS. The movements of the fetus during birth, in the vertex position were simulated, namely, the engagement, descent, flexion, internal rotation and extension of the fetal head. To evaluate the maximum muscular stresses, several levels along the pelvic floor muscles were defined, as shown in Figure 1. Results: The maximum stress obtained was 1.26 MPa for a vertical displacement of the fetal head of approximately 60 mm. On Figure 2 the evolution of the stresses along the different levels (normalized lengths), for a vertical displacements of the fetal head of 60 mm is shown. The stresses are calculated, along the different levels. Proceeding in this fashion, we can show the location along the different curves where the stresses are higher. Figure 2 shows that we obtain high values of stress on the edges of level 1 which correspond to the points of attachment of levator ani muscle and the pubococcygeus muscle to the pelvic bones. The maximum values for the stresses appear in an area that corresponds to the middle length of the levator ani muscle and the pubococcygeus muscle.

Fig. 1 Pelvic floor model and levels

Int Urogynecol J (2008) 19 (Suppl 1):S1–S166 Fig. 2 Tensions obtained

Conclusions: During a vaginal delivery, the elevator ani muscle and the pubococcygeus muscle are the muscles that are subjected to the largest values of stress. These muscles are the ones at greater risk for a stretch related injury. A multitude of variables such as variations in maternal pelvic shape, fetal head shape, the degree of moulding during delivery, symphyseal diastasis, types of episiotomies, and presenting orientation may affect the maximum muscle stresses, thus affecting the final results. The present work showed a non-invasive procedure which can be used in the future to estimate the damage that a vaginal delivery can induce on a specific pelvic floor. References: [1] - Obstet Gynecol (1997) 89; 501–506. [2] - Int Urogynecol J (2007) 19; 65–71.

164 EFFICACY OF PERINEAL EDUCATION AND PHYSIOKINESITHERAPY ON STRESS URINARY INCONTINENCE DURING AND AFTER PREGNANCY V. Leanza, M. Accardi. OBSTETRIC AND GYNECOLOGIC DEPARTMENT CATANIA UNIVERSITY (ITALY) Objective: to evaluate efficacy of Perineal Education (PE) and Physiokinesitherapy (PKT) on the urinary incontinence during pregnancy.

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Materials and Methods: 450 pregnant women with similar antepartum, intrapartum and socioeconomic conditions participated in a randomised controlled trial between 2004 and 2007. The sample was divided into two groups: A-group consisting of 225 patients treated with PE and PKT and B-group (control group) of 225 patients. Drop-out were 12, among them 7 (225–7=218) in the former group and 5 (225–5=220) in the latter. Inclusion criteria were as following: nulliparity, age ≥18 years old, no urinary incontinence (UI) before pregnancy, monofoetal pregnancy. Exclusion criteria were as follows: multiparity, previous caesarean section and/or myomectomy, foetal malformations, chronic urinary tract infections (UTI). A-group patients were educated with explanations regarding pelvic floor consisting on accurated anatomic and functional knowledge of perineum. Each pregnant woman of A-group received at least a total of eight treatment sessions between 14th and 36th gestational week. It consisted of two sessions of education programme including as well respiratory relaxing exercises to face birth contractions followed by pelvic-floor muscle exercise plan. Each session lasted 15–20 minutes. Patients also practiced daily pelvic-floor exercises during pregnancy. The patient was advised to continue the perineal practice following the healing from the birth. The treatment intervention was measured using three separate variables. Maximum muscle contractions (pretraining, during training, and post-training) were measured indirectly as pressure, using perineometry. Urine loss pretraining and post-training was measured by means of either urofluxometry or Pad test. Self-reported frequency of incontinence was recorded daily throughout the period of the study using a diary. Delivery modalities (instrumental deliveries, episiotomy rate and tears), UI were analyzed in both groups. An investigation was carried out late to evaluate the patient satisfaction (questionnaires ISP, QIP), the improvement of UI and the effect of this therapeutic approach on sexual function and pelvic floor stability. Comparisons of group means were performed with “t student” test for independent samples and proportions were evaluated with chi-square test (χ2). A logistic regression analysis was performed to control for covariates that differed in our two groups despite randomization.

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Results: results are indicated on the table one. PARAMETERS

A-GROUP B-GROUP CHI SQUARE (218 PZ) (220 PZ) (χ2) e t STUDENT

SUI AT TERM OF PREGNANCY PELVIC MUSCOLAR STRENGHT AT TERM OF PREGNANCY (PC- test=2–3) SUI IN POST-PARTUM, 9 WEEK SPONTANEOUS VAGINAL DELIVERY CAESAREAN SECTION

15 (6.88%) 174 (79.81%)

31 (14.09%) 57 (25.90%)

χ2 =5.31 p=0.021 χ2 =125.51 p<0.001

44 (20.18%) 155 (72.85%) 63 (27.15%) 44/155 (28.38%) 8/155 (5.16%) 19/155 (12.25%) 20±12

88 (40%) 130 (61.43%) 90 (37.58%) 84/130 (64.76%) 38/130 (29.23%) 47/130 (36.15%) 32±17

χ2 =19.49 p<0.001 χ2 =6.43 p=0.011 χ2 =6.43 p=0.011 χ2 =36.06 p<0.001 χ2 =28.51 p<0.001 χ2 =21.36 p<0.001 t Student=6.96 p<0.001

EPISIOTOMY PERINEAL TEARS MEDICAL TREATMENT DURING LABOUR TIME OF THE EXPULSIVE PHASE OF BIRTH (minutes)

Table 1 Comparison between the results of two groups

Satisfaction in A-Group was very high and nobody complained about the teaching and the practice of the pelvic floor exercises, considering this sort of physiologic method useful and agreeable. Conclusions: perineal education and physiokinesitherapy during and after pregnancy appear to be effective in decreasing episiotomy (χ2 = 36.06 p < 0.001), perineal tears (χ2 = 28.51 p < 0.001), medical treatment during labour (χ2 =21.36 p<0.001), time of expulsive phase (t Student=6.96 p<0.001), caesarean section (χ2 =6.43 p=B0.011), UI of pregnant women at term (χ2 =5.31 p= 0.021) and after birth (χ2 =19.49 p<0.001); besides pelvic floor exercises and perineal control increase the muscular strength before delivery (χ2 =125.51 p<0.001) and facilitate the course of delivery. Enhancement of physiologic resources has always represented the most suitable and safe therapy.

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165 Short-Term Assessment of MiniArc™ Sling for the Treatment of Female Stress Urinary Incontinence Kennelly M1, Moore R2, Keil K3, Nguyen J4, Lukban J5 1 McKay Urology Research, United States, 2Atlanta Medical Research Institution, United States 3 Keil Urogynecology, United States, 4Southern california Permanente Medical Group Female Pelvic Medicine & Reconstructive Surgery, United States, 5Eastern Virigina Medical School, United States Industry Support: Yes (Industry-initiated, full sponsorship) Objective: The MiniArc™Sling Study is designed to evaluate long-term safety and efficacy for a single-incision sling in female subjects with Stress Urinary Incontinence (SUI). This report includes data on intra-operative parameters for 123 subjects at procedure, 114 subjects at 7 days post-procedure and 81 subjects at 6 weeks follow-up. Methods: This is a prospective, multi-center, single-arm study. One hundred and twenty-three subjects were implanted with the MiniArc™sling to date. To place the sling, a single vaginal incision (1.5 cm) is made at the mid-urethral level, and the sling (polypropylene monofilament) is placed along the transobturator trajectory into the obturator internus muscles. Intra-operative parameters collected included type of anesthesia, Estimated Blood Loss (EBL), concomitant procedures, pain scores at discharge, length of stay (LOS), and complications. Pain level and voiding function were collected at 7 days post-procedure. Pain score, pelvic exam result, and an assessment of a subjects’ incontinence state after study treatment were collected at six weeks. Results: A total of 123 subjects were implanted in the study. Concomitant procedures were performed in 22% (27/ 123) subjects. The mean age is 51 years old (±11.1) with a BMI of 28.1 (±4.9) and parity of 2 (±1.1). Out of 123 subjects implanted, 63% (77/123) of the MiniArc procedures were performed under local anesthesia (Oral or IV sedation/local injection) and 37% under general anesthesia. The overall mean EBL was 29.45 (± 29.39) ml. The Mean LOS (defined as time from first procedure medication to discharge) was 10.2±17.6 hours. At discharge, subjects reported a mean pain score of 1.3±2.0 per Wong-Baker Faces Pain Scale (range 1–10). At 7 days post-procedure, 114 subjects were questioned on use of oral pain medication and 31% (35/114) reported no pain medication use in this period. 97.4% (111/114) of subjects returned to normal voiding within the first day post-procedure and the remaining 3 subjects resumed normal voiding within 21th day post-procedure. These 3 subjects had concomitant procedures performed in conjunction with the MiniArc. The concomitant procedures were posterior repair with

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mesh graft, LAVH/BSO, and laparoscopic sacral colopexy. No intra-operative complications were reported. A perioperative complication of a broncho spasm with bradycardia occurred after general anesthesia and resolved on the day of the procedure. The investigator deemed this event not related to the MiniArc device. At 6 weeks questionnaire data were collected on 81 subjects. Subjects reported a mean pain score of 0.2±0.6 per the Wong-Baker Faces Pain Scale. 99% of subjects reported no pain associated with the MiniArc on pelvic exam. One subject reported some minor discomfort during sexual intercourse. On the 6 weeks questionnaires, subjects were asked to compare their current incontinence to preprocedure. 93% (75/81) commented they felt cured, greatly improved, or improved; 80% (65/81) commented that their degree of urinary control was either dry all the time or dry except during vigorous activity. There have been no mesh erosions and no bladder, bowel, urethral, or major vessel perforations reported as of the 6 week visit. Conclusion: Preliminary results of the MiniArc™procedure showed limited length of stay, a low complication rate, and minimal post-operative pain. Early data suggest potential clinical advantages over more invasive procedures both intra- and peri-operatively. Subjects continue to be followed for twenty-four months in this ongoing MiniArc™Study. 166 Preliminary results of peri-operative and 3-month outcomes from a world-wide observational registry of tension-free vaginal tapes in women with stress urinary incontinence Khandwala S1, Lucente V2, Kalbfleisch R3, Lee K, Tincello D, Botha T 1 Advanced Urogynecology of Michigan, PA, United States, 2 The Institute for Female Pelvic Medicine & Reconstructive Surgery, United States, 3, Canada, 4Samsung Medical Center, Korea 5 Leicester General Hospital, United Kingdom, 6 Kempton, South Africa Industry Support: Yes (Industry-initiated, full sponsorship) Objective: TVT-WORLD is a worldwide prospective observational registry established in 2007 for GYNECARE TVT*, TVT*-Obturator and TVT-SECUR* Systems. It’s objective is to obtain long-term clinical and patient reported outcomes on the use of these devices. Here we report preliminary peri-operative and short-term outcome results. Background: Since the introduction of tension-free vaginal tapes (TVT) for the treatment of stress urinary incontinence (SUI) over a decade ago, there have been further modifications to the technology, including the trans-obturator

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approach (TVT-O) and, more recently, the introduction of single-incision tapes. Whilst there is a wealth of long-term effectiveness data for TVT, there is a need to generate longterm evaluation for newer modifications. Methods: This registry is currently being conducted in 24 sites across 7 countries. Prior to initiation of enrolment at each site, ethics committee approval was obtained. Written informed consent was obtained from all patients prior to their participation. Women diagnosed with SUI who are suitable candidates for a TVT system, as according to the relevant Instructions for Use can be invited to participate in this evaluation. Diagnosis of SUI is to be confirmed by a positive cough stress test and/or urodynamic assessment prior to surgery. Patients are evaluated at baseline, peri-operatively, and at up to 3, 6 & 12 months and then annually to 5 years. Perioperative data are collected, including pain, as assessed by a verbal pain score (0=low pain to 10=high pain) at time of discharge or 24 hours post-procedure, whichever occurred first. Effectiveness evaluations include objective assessment by standing stress test at 12 months, subjective assessment using the internationally validated Incontinence Quality of Life instrument (I-QOL). All device and procedure-related adverse events are collected. Results: Here we report interim results from the first 563 women included from 19 sites (12 US, 1 Canada, 1 South Korea, 1 Singapore, 1 Austria, 1 UK and 2 South Africa) by 13 February 2008. 352 (62.5%) were TVT SECUR patients; 90 (16.0%) TVT-O and 121 (21.5%) TVT. In TVT SECUR patients, “Hammock” placement was used in 247 women (70.2%), and “U” placement in 105 women (29.8%). Three patients withdrew consent following the TVT SECUR procedure, and 1 patient following TVT-O. One TVT and 3 TVT-O patients have been considered lost to follow up. Demographics and medical history of patients in the 3 groups appeared to be well balanced for age, weight, menopausal status, and previous gynecological surgeries. There were similar proportions of SUI (66.8%, 65.3%) to mixed incontinence (33.2%, 34.7%) in the TVT SECUR and TVT groups, respectively; in the TVT-O, the proportion was 55.6% with SUI and 44.4% with mixed. The proportion of patients with intrinsic sphincter deficiency was 4.0%, 3.3% and 13.2% in the TVT SECUR, TVT-O and TVT groups, respectively. As the proportion of patients with concurrent surgery was higher in the TVT-O group (44.4%) compared to TVT SECUR (17.9%) and TVT (21.5%), the peri-operative data to time of discharge have been analysed two ways, the second of which is reported here: 1) for all patients and 2) for patients without any concurrent surgery. The median surgical duration was 15.5, 27 and 22 minutes for TVT SECUR, TVT and TVT-O, respectively. Use of local anaesthesia with sedation was higher in TVT SECUR

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group (73.5%) compared to 41.8% TVT and 45.5% TVT-O. Discharge from hospital on the day of surgery occurred in 85.5% TVT SECUR patients compared with 74.2% for TVT and 72.0% for TVT-O. Normal voiding at discharge was reported in 92.4% for TVT SECUR, 89.0% TVT and 96.0% TVT-O. Median post-operative pain was 1 for TVT SECUR, 2 for TVT and 0 following TVT-O. Improvements in I-QOL mean changes from baseline were reported in all 3 groups. The proportion of patients with improvement greater than the minimal clinically important difference for within treatment group comparison of 6.3 points at the 3 month visit were 86.3% TVT SECUR, 85.7% TVT-O and 90.0% TVT. Complications included: 1 bladder perforation (0.8%) during a TVT procedure; 1 vaginal laceration during a TVT SECUR procedure (0.3%); bleeding in excess of 200 ml was reported in 1 (0.3%) TVT SECUR patient; mesh exposure in 4 TVT SECUR (1.1%) and 3 TVT patients (2.5%); voiding dysfunction in 3 TVT SECUR (0.9%) and 1 TVT patients (0.8%); haematoma in 3 TVT SECUR (0.9%) and 1 TVT-O (1.1%); de novo urgency in 2 (0.6%) TVT SECUR patients; worsening urge incontinence in 1 (0.8%) TVT patient. Conclusion: These early results suggest that TVT SECUR is well tolerated and safe to use. Follow up continues to assess the long-term effectiveness of this novel singleincision sling.

167 The Development of an Incontinence Treatment Motivation Questionnaire for patients undergoing Pelvic Floor Physiotherapy in the treatment of Stress Incontinence Sarma S 1 , Thakkar K 1, Hayes W 1, Karantanis E 1 , Hawthorn G2, Moore K1 1 St George Hospital, Australia, 2University of Melbourne, Australia Industry Support: No Objective: Our purpose was to design and validate a Motivation Questionnaire for use in patients undergoing pelvic floor muscle training, to enable researchers to test the hypothesis that improving motivation would improve the cure rate for this treatment. Background: Pelvic floor muscle training (PFMT) has been first line therapy in the treatment of stress incontinence for decades. At least 65% of those with mild incontinence and 35% of those with moderate leakage can obtain objective cure via this method (1), thus severity is an important prognostic indicator. Several authors have noted that motivation to comply with PFMT is also an important predictor of success (2), but to date in the literature there is

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no validated questionnaire that measures patients’ motivation. Thus no research has been conducted to assess the role of motivation as a prognostic indicator, nor whether motivation could be improved by an education program. Methods: This abstract reports the initial development of the Test Instrument, in collaboration with the Department of Psychiatry. Five broad domains, or theoretical constructs relating to motivation to persist with PFMT, were assembled by personal interview with 2 experienced continence physiotherapists, 5 experienced nurse continence advisors and 2 senior urogynaecologists (“the advisors”). In depth interviews (30–40 minutes) were conducted with 16 women with pure stress incontinence symptoms, who had undertaken PFMT previously. After tabulating the resultant responses into 15 common themes that had emerged, an item bank of 117 items was constructed. The item bank was reviewed by the Advisors, to yield a pilot questionnaire of 73 items. Each question contained a 5point Likert scale [strongly agree, agree, don’t know, disagree, strongly disagree]. This initial questionnaire was administered to 105 women (with Ethical Committee approval) attending a tertiary urogynaecology unit, who complained of stress incontinence and had had at least one episode of PFMT. Data analysis was performed using the Factor Analysis Model (3). This identifies items which are correlated with each other, to be grouped together as individual Factors, then categorises the range of questions into mutually exclusive domains. An Eigen value is calculated which explains the percentage of variance observed from each domain, internal reliability is assessed by Cronbach’s alpha. Redundant items are culled to yield a more concise questionnaire. Results: Of the 105 pilot questionnaires given, 101 respondents completed all but <5 items. The median age of the group was 64.5 years (IQR 51–75), median parity was 2 (IQR 2–3). High school education was completed to year 10 by 53%, to year 12 by 28%, university degree by 19%. Stress incontinence was the sole complaint in 55%, mixed complaints in the remainder. At the study point, 86% were under current treatment with a mean reduction of leakage of 44%. After factor analysis, the final version comprised 21 items within the 5 domain scales: Domain 1) positive attitude toward treatment, 74% variance; a=0.88, Domain 2) various excuses for not doing PFMT 52% variance; a=0.77, Domain 3) living with urinary incontinence, 57% variance; a=0.75, Domain 4) treatment participation, 60% variance; a=0.77, and Domain 5) motivation to maintain PFMT, 52% variance; a=0.69.

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Conclusion: The resulting 21 item questionnaire yields adequate internal consistency, each domain scale accounts for a fair proportion of variance thus the final version gives a good representation of the clinically important factors that affect motivation in PFMT. A prospective observational study using the final questionnaire to correlate with PFMT success is underway. (1) Brit J Obstet Gynaecol, 2003, 110:649–657 (2) Balliere Tindall Clinics in Obstetrics and Gynaecology, 2000, 14:251–289 (3) Health Measurement Scales: A practical guide to their development and use. 3rd Ed. Oxford; Oxford Medical Publications; 2006

168 2 year follow up of prospective cohort study of single incision, short segment, transvaginal tape inserted under local anaesthesia Smith A, Hilton P, North C, Ali-Ross N The Warrell Unit, United Kingdom Industry Support: Yes (Investigator initiated, partial funding) Objectives: To determine the safety and efficacy of a short segment, tension free transvaginal tape inserted through a single vaginal incision under local anaesthesia without sedation. Background: The insertion of a mid-urethral mesh tape, such as TVT (tension-free vaginal tape, Johnson and Johnson, Somerville, USA), has become standard practice for the surgical treatment of urodynamic stress incontinence (USI) in women. Although associated with high rates of cure and less morbidity than other surgical procedures described for this condition, intra-operative visceral and vascular injury has been reported and few are performed under local anaesthesia without sedation. Miniaturisation of a sub-urethral tape, such that it may be inserted via a single, small vaginal incision with no additional incisions, may reduce the risk of intra-operative injury and reduce anaesthetic and analgesic requirements. This study was designed to determine the safety and efficacy of one such tape. Interest in the development of such a procedure is increasing, particularly since the launch of TVT-Secur (Johnson and Johnson, Somerville, USA) in 2006 which has sold 100,000 devices worldwide. However, there is little published data with regard to the safety or efficacy of single incision mesh slings for USI. 11 abstracts were presented at the 32nd Annual International Urogynaecology Association Meeting in June 2007, of these 9 reported series of TVT-Secur which included a total of almost 500 patients. The cure rate for the procedure was reported as 67–96% at a maximum follow up period of five months,

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although definitions of cure were varied. Intra-operative bladder injury was described by two groups and use of additional sedation and regional or general anaesthesia was widely reported Methods: 42 patients with urodynamic stress incontinence were recruited to the study, having surgery between November 2002 and March 2006. All patients had found initial treatment with pelvic floor muscle training ineffective. The study had approval from the NHS Research Ethics Committee and the hospital department of research and development. Data was collected prospectively and all visits were conducted by one of two researchers. Local anaesthesia was infiltrated under the vaginal epithelium suburethrally and paraurethrally on both sides. A small vaginal incision approximately 2 cm in length was made in the midline to allow introduction of the polypropylene tape with no abdominal or groin exit incisions. The needle introducer is 2.5 mm diameter and fixes the tape in the retropubic space. Patients attended for post-operative assessment at intervals of one month, six months, one year and two years. Multichannel urodynamics were performed at the six month visit. A standardised one hour pad test was performed at each visit. Cure was defined by a negative pad test (gain of less than 1 g). Patients requiring further treatment for SUI exited the study and were included in the ‘fail’ group. Results: Patients were of mean age of 53 years (range 34–75) and a mean body mass index (BMI) of 28.5 (range 18–40). All procedures were completed with local anaesthesia only. No additional sedation was required. The mean duration of the procedure was 24 minutes (range 14 -60 minutes). One third of patients required no post-operative analgesia with the remaining two thirds requiring simple oral analgesia only. There were no immediate post-operative complications and mean length of hospital stay was one day (range 0–5). Only one patient required hospitalisation for five days to receive routine post-operative treatment for Von Willebrands disease. Two patients declined to attend any follow up visits. Of the 40 patients attending at one month post-operatively early complications were identified as urinary tract infection in three patients and vaginal exposure of tape in three patients. At 2 year follow up only 5 of the patients were dry and 16 had had further surgery.

Figure 1 One Hour Pad Test Results Follow up Visit (months) 1 Patients attending Mean weight gain (range) Number defined as cured (% of total recruited)

6

12

24

40 33 26 TBA 11.5 g 20.3 g 14.2 g TBA (0–103.1) (0–90.3) (0–147) 15 (36) 9 (21) 8 (19) 5 (12)

Conclusions: 1. The short segment, single incision transvaginal tape is safe and feasible to perform under local anaesthesia without sedation. 2. The short segment tape has a substantially lower cure rate than reported for full length tapes such as the TVT and the cure rate rapidly declined over the two year follow up period, especially during the first six months. References: IUGA abstracts 2007

169 Unmasking occult incontinence in advanced vaginal prolapse: which reducing tool works best? Lefevre R1, Pollak J2, Apostolis C1, Aguilar V1, Davila G1 1 Cleveland Clinic Florida, United States, 2Winthrop University Hospital, United States Industry Support: No Objective: To compare three separate prolapse-reducing tools in unmasking occult incontinence in women with advanced vaginal prolapse. Background: Occult incontinence, although not officially recognized by the International Continence Society, has been adopted in urogynecologic practice as a marker for an increased risk of developing post-operative stress urinary incontinence. Various tools including vaginal pessary, lower blade of a speculum, tampon, Colpexin device and vaginal packing may be utilized to reduce advanced vaginal prolapse during urodynamics testing. Standardization of a single most effective method may increase the detection rate of occult incontinence. Methods: 36 patients with >Grade 3 prolapse and no complaints of incontinence were recruited at two clinical sites. They were separated into two groups and randomized as to the order of prolapse-reducing tools used during urodynamics testing. Group 1: 18 patients using speculum/ pessary/vaginal packing and Group 2: 18 patients using unreduced/pessary/speculum. Demographic information, prolapse severity and urodynamic parameters (cystometric capacity, maximal urethral closure pressure, functional urethral length and leak point pressure) were measured with each prolapse-reducing tool. A 30% change in MUCP, LPP or FUL was considered to be clinically significant. 24 patients in each group were needed for a power of 80% that was statistically significant to a p=0.05. A comparison of the means was made with one-way NOVA using SPSS program version 15.0 and p-values were generated. Results: The patients were subdivided based on the detection of occult incontinence and urodynamic parameters (Table). The overall average MUCP (cm H2O)/LPP (cm H2O)/FUL (cm) were calculated for each tool respectively. Speculum: 42.25/52.59/2.81, Pessary: 41.06/

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50.69/2.83, Packing: 48.72/40.33/3.02 and Unreduced: 50.67/76.47/2.96 LPP Leak/ No Leak

FUL Leak/ No Leak

p-value

Leak

MUCP Leak/ No Leak

p-value

N

Occult Inc Detection %

p-value

Tool Unreduced Speculum Pessary Packing

18 36 36 18

2 17 18 5

11.11% 47.20% 50% 27.70%

35/52.63 31.95/53.13 27.36/53.23 27.8/56.77

0.214 <.05 <.05 <.05

62.5/78.3 50.69/52.61 45.48/56.57 51.4/36.1

0.824 0.887 0.373 0.188

2.55/3.01 2.69/2.81 2.53/3.02 3.0/3.02

0.084 0.309 <.05 0.942

Conclusion: All devices increased the unmasking of occult incontinence, with a pessary and speculum having the highest rate. A pessary affected urodynamic parameters most significantly. More patients will be recruited in order to improve on the power of this study.

170 Efficacy and safety of Aris midurethral tape in the treatment of female stress urinary incontinence in a large patient population Delorme E1, Saussine C2, Costa P3, Roumèguère T4, Grise P5, Serment G6 1 Clinique Sainte-Marie, France, 2 Hôpital Civil de Strasbourg, France, 3 Hôpital Carémeau, France, 4Hôpital Erasme, Belgium, 5CHU de Rouen Charles Nicole, France, 6 Hôpital Salvator, France Industry Support: Yes (Industry-initiated, full sponsorship) Objective: The aim of this ongoing observational study is to investigate the efficacy and safety of the Aris transobturator tape, a monofilament macroporous, knitted polypropylene tape for the surgical treatment of female stress urinary incontinence (SUI). Background: Patients who underwent the transobturator outside-in procedure with the Aris tape (Coloplast A/S, Denmark) were prospectively followed at 16 centres in France, Belgium and Germany starting in July 2004. Inclusion criteria were: SUI, urethral hypermobility with or without previous surgery, and with or without associated prolapse. Methods: Pre-operative, operative and peri-operative data was recorded. The pre-operative evaluation included: history, physical examination, urodynamic testing, residual urine. Peri- and post-operative complications were recorded. Post-operative evaluations were performed according to the follow-up schedule at each individual centre and included: physical examination, uroflowmetry, residual urine. Cure was defined as the absence of

subjective complaint of urine leakage, and the absence of leakage on cough stress test. Results: 585 women underwent transobturator tape surgery. Patient characteristics were: Mean age 57.7 y (range 29– 89 y), mean parity 2.4 (0–11), 360/564 (63.8%) menopausal patients, 129/578 (22.3%) had a prior hysterectomy, and 61/572 (10.7%) were previously operated for genital prolapse. Of 572 patients, 61 (10.7%) had recurrent SUI. 267/574 (46.5%) patients had pure stress urinary incontinence, 218/574 (37.9%) had mixed incontinence, 89/574 (15.5%) had SUI with urgency. Peri-operative complications were: bleeding > 300 mL (n=7), bladder perforation (n=4), urethral perforation (n=1), vaginal perforation (n= 19). 107 patients had at least one year of follow-up. Efficacy of the midurethral tape procedure is shown in Table 1. Post-operatively, 341/499 (68.3%) had no urgency, urgency was reduced in 60/499 (12.0%), unchanged in 43/ 499 (8.6%), worse in 16/499 (3.2%) and de novo urgency was found in 39/499 (7.8%). There were 4/524 (0.8%) defects of vaginal healing, 2/524 (0.4%) vaginal extrusions, and no urethral or bladder erosions.

Table 1 Efficacy of Aris midurethral tape in the treatment of female stress urinary incontinence

Cured Improved Failed

0–2 months n=401

2–6 months n=224

6–12 months n=180

12–18 months n=71

>18 months n=36

86.0% 10.7% 3.2%

86.6% 9.4% 4.0%

85.6% 10.0% 4.4%

80.3% 14.1% 5.6%

83.3% 8.3% 8.3%

Conclusions: The results to date of this large multicentre study show that the Aris transobturator tape is a safe and effective treatment for female stress urinary incontinence. Efficacy is maintained over time, with cured and improved rates after one year comparable to the early post-operative results. In addition, there are low occurrences of de novo urgency and extrusions.

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171 Study on estrogen receptors in tissues around levator ani muscles of SUI Zhu L, Lang J Peking Union Medical College Hospital, China Industry Support: No (Industry-initiated, full sponsorship) Objective: To study the estrogen receptor α and β ERα and ERβ status around levator ani muscles(LAM) of patients with stress urinary incontinence(SUI) and to explore its relation with SUI. Background: Stress urinary incontinence (SUI) is a common Pelvic floor disorder. Studies have shown that occurrences of SUI have relation with pelvic floor tissue relaxation. The incidence and degree of SUI increase with age, which suggests that estrogen deficiency might be responsible for this condition. From our previous study, estrogen receptor (ER) can be divided into ERα̣ and ERβ.̃ ERα̣ and ERβ can be found in uterine ligaments and the tissue around levator ani muscle of women. How to play the role of ERα̣ and ERβ in the occurrence of stress urinary incontinence with menopause or postmenopause? Is it useful to use estrogen to treat the female stress urinary incontinence? Pelvic floor muscles and fascia are responsible for support of pelvic organs. It is then important to investigate the estrogen and its receptor (ERα̣ and ERβ) in levator ani muscle and fascia. The aim of our study is to investigate the serum estradiol and estrogen receptors (ERα̣ and ERβ) in tissues around levator ani muscles of patients with stress urinary incontinence and to explore the etiology of stress urinary incontinence. Methods: The biopsy specimens of LAM were obtained from 26 subjects of SUI undergoing hysterectomy and tension-free vaginal type procedures. Twenty-one control specimens were obtained also. The histological structures around LAM were examined with routine HE staining. The ERα and ERβ in pelvic floor structure were detected by immunohistochemical staining and western blotting. Results: (1) Positive biopsy rate of tissue around of LAM in SUI group was less than that in controls, and positive biopsy rate of postmenopausal SUI group was significant less than the premenopausals (P<0.01). There was no significant difference in positive biopsy rate between premenopausal and postmenopausal control women (P> 0.05). (2) Serum estradiol level of premenopausal SUI group is significantly less than the controls (p<0.05). (3) There was no ERα and ERβ expression in the LAM of specimens. (4) ERα stained positively in the tissue around LAM. Positive expression rate of ERβ in the tissue around LAM was lower in SUI group and postmenopausal groups (p<0.05). (5) The expression of ERα in the tissue around LAM was significantly less in SUI group, compared to control groups (p<0.05). There was no significant differ-

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ence in ERα expression in the tissue around LAM between premenopausal and postmenopausal control group (P>0.05). There was no significant difference in ERβ expression in the tissue around LAM among the premenopausal SUI, postmenopausal SUI and control groups (P>0.05). (6) Western botting demonstrateḍ thaṭ ERβ expressed lower than ERα in tissues around LAM. ERα and ERβ expression in SUI group was lower than the control group. Conclusions: Pathogenesis of premenopausal SUI had relation with lower serum estradiol level. There was significant correlation between the expressions of ERα and SUI. There was also significant correlation between the positive expression rate of ERβ. ERα and ERβ may play different functions in occurrence of SUI. Table 1 Comparison of two premenopausal sub-groups Group

Case Age Gravity Parity BMI Menstrual period (years) (kg/m2) (follicular/luteal)

Control 20 SUI

9

P-value /

43.3± 1.6± 6.88 1.11 45.29± 3± 3.30 1.91 0.134 0.074

0.8± 23.70± 0.41 2.14 1.71± 25.68± 1.25 2.79 0.104 0.063

45%/55% 71%/29% /

Table 2 Comparison of two postmenopausal sub-groups Group

Case Age (years)

Control 8 SUI

12

P值

/

Postmenopausal Gravity Parity BMI (kg/m2) (Years)

61.8± 3.67± 12.6 1.21 60.22± 3.11± 9.58 1.36 0.782 0.435

2.2± 0.89 2.0± 1.0 0.996

24.94± 4.63 24.91± 2.67 0.988

13.38±10.01 11.3±6.98 0.646

Table 3 Positive biopsy rate of levator ani muscle in gynecology procedure Group premenopausal

Control

SUI

Positive case Positive Positive case Positive case(n) rate (%) case(n) rate (%) postmenopausal 7 Group 2

20 6

35 33

1 0

9 12

11 0

Table 4 ERα and ERβ expression in pelvic fascia tissue Group

E2 (pg/ml)

ERα̣ (%)

ERβ̣ (%)

Pre-control Pre-SUI Post-control Post-SUI

105.48±69.88 47.79±15.31* 4.84±3.81 4.92±4.48

9.61±5.48 4.43±2.64* 10.88±2.90 5.14±1.79*

2.75±2.89 0.79±1.52 1.75±1.37 1.47±2.18

* stand for p<0.05

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172 A NOVEL MAGNETIC DEVICE TO PREVENT URINARY INCONTINENCE Bortolotti M1, Vignoli G2, Grandis A3, Mazzero G1, Cervigni M4 1 Dept. of Internal Medicine and Gastroenterology, University of Bologna, Italy, 2Dept. of Surgical Sub-specialties & Anestesiology, Section of Urology, Policlinico S.Orsola-Malpighi, Italy, 3Dept. of Veterinary Morphophysiology and Animal Productions, University of Bologna, Italy, 4S.Carlo di Nancy Hospital Industry Support: No Objective The aim of the present study was to evaluate the effectiveness of an implantable magnetic device designed to prevent stress urinary incontinence by strengthening an hypo/atonic urethral sphincter. Backgroumd. Stress urinary incontinence is due to an urethral hypermobility and/or intrinsic sphincter deficiency. Current surgical procedures, including mid-urethral slings, are more likely to cure the defects in urethral support than intrinsic sphincteric deficiency. Moreover,the presence of intrinsic sphincter deficiency is usually associated with a higher failure rate. Conversely, several reports indicates that the improvement of sphincteric mechanism can cure incontinence due to urethral hypermobility and since the injection of bulking agents has a minimal morbidity, the procedure has been highly recommended in fraily elderly patients as a primary treatment. The efficacy of both bulking agents and slings rely on a” more or less” obstructive mechanism that may prevent incontinence, but, at certain degree, may impair the micturition with subsequent detrusor overactivity (Curr Opin Urol 2003;13:301; Eur Urol 2005;48:552). Methods The magnetic prosthesis consists in a pair of small magnetic plaques to be inserted, with a minimally invasive procedure, on the left and right side of the urethral conduit with their opposite polarities face to face, so that, attracting themselves, close the urethral lumen. The effectiveness of the magnets was tested in three suine anatomical preparations. Magnets of different magnetic force, such as ferrite and plastoferrite (the first with a higher magnetic force than the other) were tested. Bladder was filled through an incannulated ureter by a constant infusion of saline at a flow-rate of 50 ml/min. Bladder pressure was recorded through a second catheter inserted into the bladder through the controlateral ureter. The effectiveness of the magnetic closure was tested by determining vesical leak pressure point. The mean values obtained before and after magnet

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implantation were statistically compared with the Student t test. Results The vesical leak point pressure after the insertion of ferrite magnets was 37.2±5.2 cmH2O and after plastoferrite magnets was 15.1±3.7 cmH2O, all of them significantly (p<0.05) higher than the pressure recorded without the magnets (6.9±1.4 cmH2O). Conclusions The implant of a pair of magnets on both sides of the urethral wall is able to increase the vesical leak point pressure at a value dependent on the force of the magnets. By choosing magnets of different force, even more potent than those used in this experiment, such as those of neodymium, it is possible to obtain an urethral closure pressure that meets the desired requirements, performing a “tailored correction” of the urinary incontinence. The main advantage of this system lies in the fact that the magnets create a “dynamic closure”, the mechanism of which has been previously demonstrated (J Biomechanics 2006; 39:564).When the magnets are completely detached and averted by an urethral pressure above the magnet strength, they do not exert anymore a significant pressure between themselves, being far one from the other, and allow an easy transit of contents. Conversely, other systems, such as bulking agents or obstructive slings, create a rigid narrowing that may hinder the passage of urine. Once verified “in vivo” (experimental animal) the effectiveness and tolerability of magnets covered by a biocompatible sheath, this device could represent a simple and effective solution of the urinary incontinence.

173 A comparative study of pelvic floor functional electrical stimulation and vaginal cone in the treatment of women with stress urinary incontinence Santos P, Rodrigues A, Girao M, Sartori M, Oliveira L, Castro R Federal University of Sao Paulo, Brazil Industry Support: No Objective: To evaluate and compare the effects of pelvic floor functional electrical stimulation (FES) and vaginal cone therapy in the treatment of women stress urinary incontinence (SUI). Materials and Methods: All patients were submitted to a clinical history, gynecological evaluation, 1 hour pad-test, seven day voiding diary and to the “Incontinence Quality of Life Questionnaire (I-QoL)” before and after the treatment. The patients were submitted to an urodynamic study before the beginning of the study to confirm the diagnosis of SUI

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and to eliminate the women with sphincter deficiency (Valsalva leak point pressure=60 cm H2O).The patients were in postmenopausal period and had been receiving topical hormonal therapy for at least three months. The 45 selected patients were randomized into two groups, using random numbers generated by computer. 1) FES Group - composed of 24 patients who underwent functional electrical stimulation of the pelvic floor under supervision of a physiotherapist 2) Cone Group - consisting of 21 patients who used the cone therapy under supervision of a physiotherapist The electrical stimulation was done using an electrode, localized at the median of vagina. The electrical stimulus parameters included a biphasic symmetric current, pulsed with a 50-Hz frequency. The patients had sessions lasting up to 20 minutes, twice a week, during four months, conducted by the physiotherapist. The cone group used devices (Quark ®) ranging from 20 to 100 grams. The cones were used in passive and active phases. In the passive phase, there is no voluntary contraction of the pelvic floor muscles, but it is necessary to identify the cone of greatest weight that the patient can retain in the vagina for one minute while they are directed in efforts such as walking, and climbing and descending stairs, for a period of 15 minutes. In the active phase, the patient, in the orthostatic position, holds the heaviest cone that she can secure in the vagina, using voluntary contraction of the vaginal muscles. The program included 30 voluntary contractions. The ratio of contraction: rest was 5:5 (seconds). These contractions were performed under verbal guidance of a physiotherapist, in two sessions per week, with duration of 45 minutes for a period of four months. The primary outcome measurement was the objective cure based on a negative pad test. Secondary outcome measures included changes in the quality of life questionnaire (IQoL) and the frequency of leakages in the voiding diary. Subjective cure of SUI was measure by a simple question as to how the patient felt about her incontinence problem after the treatment. The only two answer options were “satisfied” and “dissatisfied”. “Satisfied”, as an answer, meant that the patient did not want a different treatment. “Dissatisfied” as an answer meant that the patient wanted some other treatment different from the initial one. Statistical analysis was performed using the SAS program version 8.2. The Kruskal-Wallis test was adopted to verify the homogeneity between the groups regarding the continuous variables such as age, duration of symptoms, parity, number of normal births, number of cesarean deliveries body mass index and data from I-QoL, pad-test and voiding diary. The Mann-Whitney test was used to verify the homogeneity and possible differences in the medians of continuous variables measuring therapeutic success between the groups. The Wilcoxon paired test for signs was

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used to analyze the variables that measured the therapeutic success for each studied group. We used the Chi-square test to verify the homogeneity between categorical variables (race, hormonal status, prior surgery for stress urinary incontinence). The level of rejection of the null hypothesis was set up at 0.05 or 5% (alpha less than or equal to 0.05). Results: The median pad weight, frequencies of urinary leakage and the scores in the I-QoL did not differ between the groups before the treatment. We observed a significant improvement in patients’ quality of life(p<0.0001), a decrease in the median weight of the absorbent(p<0.0001) and a decrease in the number of urinary incontinence episodes measured in the voiding diary(p<0.0001) after the treatments, in both groups. The good results were statistically similar in both groups. The patients self-assessment demonstrated that in the FES group, 58.3% women were satisfied and 41.7% were unsatisfied with the treatment. In the cone group, 61.9% were satisfied and only 38.1% were dissatisfied. Conclusion: Electrical stimulation and vaginal cone therapy were equally effective in the treatment of women with SUI. 174 Does the degree of bladder neck coaptation matter? Cystoscopic study in females with stress urinary incontinence (SUI) secondary to intrinsic sphincteric deficiency (ISD) Faruqui N, Ghoniem G Cleveland Clinic Florida, United States Industry Support: No Objectives: To correlate the degree of bladder neck coaptation in SUI patients with ISD before, and after urethral bulking agent injection (UBA) Background: Urethral bulking agents for female sphincteric incontinence have been used for decades. Outcome results of these procedures are usually reported as cure, improvement or failure. However, to date there are no standard definitions of these terms and no standard, widely accepted clinical tool for assessing outcome after anti-incontinence therapy. Although UBA injection is monitored cystoscopically, there is no study to elucidate the value of visual urethral/bladder neck coaptation measuring the surface area pre operatively, post operatively and on a long term basis. Methods: Thirty females were involved in this study with one year follow up after the last injection. Twelve patients had Macroplastique® Implants (Uroplasty, Inc, Minnetonka, MN, USA) and 18 underwent a bovine-collagen (Contigen) injection. Evaluation of the surface area of the opened bladder neck was made in all the cases before and after injection, and at 12 months of last injection. This evaluation is made by computer analysis of a cystoscopic picture taken 1 cm distal to bladder neck by using ImageJ (image processing and analysis in Java) free software from national

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institute of health (NIH). The reduction in the surface area was then correlated with the Stamey’s grade, pad weight reduction, number of pads change and incontinence episodes number on voiding diary and urodynamic evaluation done before and at 12 month interval after last UBA. Paired sample student’s t- test and Spearman’s correlation was used to evaluate the relationships between variables. Results: The mean age was 67 +/- 9.7 years with average incontinence duration of 10 years, 81% had prior treatment, 19% had prior incontinence surgery. Seventy two percent had history of hysterectomy. At 12 months all the patients had significant surface area reduction post operatively 0.23 inches (6 percent) as compared to the preoperative measurement 0.85 inches (24 percent) (p value<0.001). Patients improving > one Stamey grade were 93% (28/30). The one hour pad decrease was 10 g from base line 18 g (p<0.001). The QoL score improved significantly from 68 to 82 (p<0.001). Ninety percent of the patients leaked urine pre injection according to the voiding diary which improved significantly post injection and more then 53 percent were dry (p<0.001). There was a positive correlation found between the post injection surface area with the Stamey’s grade (p=0.068) and the number of episodes in the voiding diary (p=0.039). The VLPP showed inverse relation with the post operative surface area (figure 1)

Figure 1 Relation between the surface area at 12 months and VLPP

Percentage surface area 12mo

30.00

s_area_12m = 13.00 + -0.07 * VLPPpost R-Square = 0.20

20.00

10.00

0.00 40.00

80.00

120.00

160.00

valsalva leak point pressure at 12 month

175 Outpatient mid-urethral TFS sling operation for urodynamic SUI Sekiguchi Y1, Kinjyo M1, Inoue H2, Sakata H3, Kubota Y4 1 Yokohama Motomachi Women’s clinic LUNA, Japan, 2Urogynaecology Center, Shonan Kamakura General Hospital, 3 Nihon University Graduate School of Business, 4Urology, Yokohama City University Graduate School of Medicine Industry Support: No Aim: Aim to test the feasibility of using the TFS (Tissue Fixation System) to perform a mid-urethral sling for urodynamic SUI (stress urinary incontinence) in a freestanding outpatient facility. The TFS is a new “minisling” device with a one-way tightening system. Method: We performed 37 mid-urethral TFS sling operations between December 2006 and December 2007 at a Women’s Clinic. All patients had “Genuine stress Incontinence” (GSI) proven by pre-operative urodynamic testing. Results: Mean age was 58.1 (37–87). The operations were performed on a day-surgery basis under local anesthesia (LA). Post-operative pain was minimal. All patients were discharged the same day. Mean operating time including administration of LA was 22.9 minutes (15–43). Mean blood loss was 14.6 ml. Four patients who could not pass urine within 8 hours were discharged with an indwelling Foley catheter, but passed urine normally within 48 hours. Cure rate at 6 months was 91% (34 /37). The 3 failed cases were cured with another TFS midurethral sling- inserted at 3 months. Conclusions Our initial results indicate that the TFS midurethral sling operation is a simple effective procedure, and can be done without difficulty in a free standing clinic as an outpatient. 176 Perioperative pain in patients who underwent TVT-O (inside-out) suburethral sling for stress urinary incontinence: a prospective study of 50 patients Fatton B 1 , Monrigal E 1 , Bonnefoy C 2 , Kirche J 1 , Accoceberry M1, Velemir L1 1 Urogynecology Unit - University Hospital of Clermontferrand, France, 2Anaesthesiology Department - University Hospital of Clermont-Ferrand, France Industry Support: No

Conclusions: The degree of bladder neck (BN) coaptation is correlated with the degree of SUI in women with ISD. A high degree of coaptation of BN after BUA injection is essential for favorable outcome. By calculating the surface area of the bladder neck, the need for UBA re-injection can be determined. This can be an added tool for ISD assessment and outcome after UBA.

Objective: to assess perioperative pain in patients with stress urinary incontinence (SUI) treated by transobturator vaginal tape inside-out (TVT-O). Background: An isolated TVT-O procedure was carried out in 50 consecutive patients complaining of pure SUI (33 patients) or mixed incontinence (17 patients). Procedure

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was performed according to a modified De Leval technique (exit points of the helical needles were located in the thigh folds at the clitoris level). Patients were operated on under local anaesthesia with appropriate sedation. Methods: Patients were prospectively enrolled with verbal consent obtained for all patients. A verbal scale and a visual analog scale were used to record pain prior to, during and after surgery (3 hours after surgery, day after surgery and at one month follow-up). A complementary awareness scale is used to assess level of sedation during the procedure. Results: Mean age was 60.2 years [37–81]. Two patients (4%) had a previous SUI surgery, 11 (22%) a previous hysterectomy and 3 (6%) a previous pelvic organ prolapse surgery. Mean operating time was 22 min including anaesthesia. Local anaesthesia was performed with a 50 to 75 ml saline with Naropein® (Ropivacaïne) solution. Sedation was a combination of nitrous oxide/oxygen and opioid analgesic (Sufenta®). When discomfort or pain occurred during procedure, a supplementary sedation was offered with propofol (Diprivan®). According to the sedation scale, intraoperative drowsiness was moderate in 3 patients and severe in 2 patients. Intraoperative complications were one vaginal injury (2%) recognized and repaired at surgery. Pain scores registered by VAS are reported in table 1. Thirty two (64%) patients did not report any pain during procedure. Seven patients (14%) reported pain attributable to the procedure one day after surgery with none of whom reporting a pain score greater than 5. No patient required self catheterization after surgery. At one month follow-up only one patient complained of an unilateral thigh discomfort (VAS 2). No patients required medication for pain. Overall forty eight patients (96%) were cured for SUI and among the seventeen patients with mixed UI, overactive bladder symptoms were cured or significantly improved in 13 (76.5%), unchanged in 2 (11.8%) and worsened in 1 (5.9%). Table 1 pain according to the VAS scale (0=no pain and 10=the worst pain) Pain score

during 3 h after surgery procedure

Day after surgery one month follow-up

Attributable NA Attributable NA Attributable NA VAS 1–2 VAS 3–4–5 VAS 6–7 VAS 8–9–10 Overall

8

5

4

5

1

1

0

6

4

1

2

3

0

2

3

2

0

0

0

0

0

1

0

0

0

0

0

0

18

11

5

7

4

1

2

Attributable to the procedure NA = non attributable

Conclusions: Anatomical studies have suggested an increased risk of nerve damage with inside-out procedure compared to out-in. These results have supported the theory that inside-out procedure was more likely to result in postoperative thigh pain than out-in procedure. This prospective study demonstrates that modified TVT-O is a safe and effective painless procedure. Only one patient (2%) reported persistent occasional low pain. Moreover, TVT-O is easily performed under local anaesthesia with all patients but one satisfied with the procedure and reporting they would recommend it to a friend. References De Leval J. Novel surgical technique for treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol, 2003; 44: 724–730 Spinosa JP, Dubuis PY, Riederer BM. Transobturator surgery for female stress incontinence: a comparative anatomical study of outside-in vs inside-out techniques. BJU Int, 2007, 100:1097–102.

177 Colposuspension versus Anterior Repair with TVT: feasibility pilot randomised controlled trial (CARPET 1) Tincello D1, Kenyon S1, Mayne C2, Slack M3, Toozs-Hobson P4, Jones D1 1 University of Leicester, United Kingdom, 2University Hospitals of Leicester NHS Trust, United Kingdom 3 Addenbrookes’ Hospital, United Kingdom, 4Birmingham Women’s Hospital Industry Support: No Objectives: To assess the feasibility of conducting a large multicentre randomized trial to compare efficacy of colposuspension against a combined procedure of anterior repair with TVT for the treatment of stress incontinence and prolapse. Background: Although of proven efficacy as a treatment for urodynamic stress incontinence, the efficacy of suburethral tapes inserted during prolapse surgery has not been assessed by robust randomised controlled trials (RCT). The National Institute of Clinical Excellence in the UK stated in 2003 that the use of TVT in combination of other surgery required further evaluation. In response to this, we developed a protocol for a feasibility pilot study of Colposuspenion versus Anterior REpair with TVT (CARPET 1) for women with anterior prolapse and urodynamic stress incontinence (USI). The intention was to use collected data to inform development of a full protocol. Methods: The pilot study was conducted in three tertiary referral centres in the UK. All eligible women were

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approached in a 12 month recruitment window at each site. A randomised, patient preference trial was conducted (May 2006 to September 2007). Primary outcomes were: number of eligible patients, number participating, willingness to be randomized. Primary procedure outcome was disease specific quality of life (Kings’ Healthcare Questionnaire (KHQ), Prolapse Quality of Life Questionnaire (Prol-Q)). Multicentre research ethics approval was obtained and the trial was registered on Current Controlled Trials (ISRCTN34759911). The study was funded by the Medical Research Council in the UK. Data are presented as number (5), median [range]. Comparisons by Mann Whitney U test. Results: 56 women were approached to participate. 25 women already on the waiting list were sent postal information; 31 were approached in clinic. Participation was significantly greater among women approached face to face (27/31, 87%) than in those approached by letter (4/25, 16%) (risk difference 71%; 95% CI:53%, 90%). Four women (13%) agreed to randomisation (two to each arm), 21 (68%) chose TVT and anterior repair, 6 women chose colposuspension (19%). One later changed her mind. Recruitment remained low, even after relaxing the entry criteria to include posterior/apical prolapse. 30 women (97%) had stage II anterior prolapse; one had stage III. Four women (13%) had no posterior prolapse, 12 women (39%) had stage I, 15 (48%) had stage II. Median duration of surgery was 60 minutes [35–100] in the TVT arm, and 73 minutes [50–100] in the colposuspension arm (p=0.10). There was no difference in blood loss, and two intra operative complications. Patients in the TVT group were catheterized for 2 [1–4] days, and for 4 days [2–4] in the colposuspension arm (p=0.017). Hospital stay was 3 days [2–6] in the TVT arm and 4 days [3–5] in the colposuspension arm (p=0.017). At six week follow up data on 30 women were available. Seven women (23%) had no anterior prolapse, 15 women (39%) had stage I, 8 (26%) had stage II descent (above the introitus). All the women with stage II anterior descent were in the TVT/anterior repair group, a recurrence rate of 35%. 24 hour pad test results fell from 18 g [1–133] preoperatively to 3.5 g [0–133] at six weeks. There was no difference in the reduction in pad test result between the two treatment arms. Conclusion: Important logistical factors must be considered during design of surgical trials. Obtaining consent during the consultation at which decision on surgery is made provides high recruitment rates. Women expressed strong preferences when faced with markedly different alternative treatment arms, and the majority were not prepared to be randomized. Successful trials are likely to be those where treatment arms have similar interventions. The difficulties

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of excluding prolapse in other compartments will be discussed.

178 Home in 3 Hours: Contemporary Length of Stay when using a Peri-Operative Care Pathway for Mid-urethral Sling surgery McAchran S, Goldman H Cleveland Clinic,Cleveland, OH United States Industry Support: No (n/a) Objective & Background The tensionless mid-urethral sling is a well-accepted and effective treatment for stress urinary incontinence. Despite its excellent safety profile and minimal morbidity, several authors have advocated routine in-house post-operative monitoring. We sought to evaluate whether mid-urethral slings could be performed safely in the ambulatory setting and to evaluate the length of stay when a strict care pathway is followed. Methods Care Pathway: Patients receive pre-operative education about the care pathway. Unless contraindicated, the procedure is performed with deep intravenous sedation and local anesthetic. Upon completion, the bladder is left full, no urethral catheter or vaginal pack is left, and labs are only ordered to evaluate hemodynamic instability. After the patient has voided she is asked to rate her force of stream (FOS) on a scale of 0–100% compared to her pre-operative voiding. If the self-reported FOS is significantly diminished then a catheter may be replaced. A retrospective chart review of all patients presenting for surgery with a single surgeon at a single hospital from February 2005 to July 2007 was performed. Postoperative care unit records as well as hospital charts were reviewed and the following data points were extracted: date and time of admission to the recovery room, date and time of discharge, patient age, type of anesthesia, whether or not post-operative lab work was ordered, transfusion of blood products, any emergency room visits in the next 30 days, readmissions within 7 and 30 days, and whether or not the patient was discharged home with a urethral catheter. Results 112 mid-urethral slings were performed during the study period. 26 cases were excluded because of either concomitant surgical procedures by a second surgeon (22) or incomplete data (4) leaving a study population of 86 patients. The median age of patients was 52 years (range

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34–89). The mean LOS was 2:42 hours and the median was 2:15 hours. 68/86 (79%) of the procedures were performed with local and IV sedation. No post-operative labs were ordered and no transfusions were required. One patient (1%) presented to the ER within thirty days of her procedure and was admitted for evaluation of chest pain. 79/86 (92%) of patients were discharged home without a Foley catheter. Conclusions When the above care pathway is followed, the tensionless mid-urethral sling can be performed safely in the outpatient setting with a median time from arrival in the recovery room to discharge of less than 3 hours.

179 HRT- Does it improve the success rate of periurethral injection of Macroplastique? Woodman J, Jhamb B, Pitkin J Nortwick Park Hospital, United Kingdom Industry Support: No Objective: A retrospective audit of Macroplastique injections done from 2002 till 2007 with outcome assessed at 1 year to assess whether the use of HRT made any difference to outcome. Background: Periurethral injection of Macroplastique is a well-recognised treatment for stress incontinence. The overall success rate is quoted to be 60% with a cure rate of 48%. The value of HRT in the treatment of incontinence is controversial and whether it makes a difference if used with any other treatment modality is unknown. In fact, HRT has been reported to worsen stress incontinence1. Methods: Case notes and completed Visual Analogue Score (VAS) questionnaires at 12 months post operative was obtained for 78 patients. Definition of cure was being completely dry and of improvement was a substantial reduction in amount of leakage. Success was a combination of improvement and cure. The figures reported are the number (and percentage) of subjects in each group with respective cure and success rates. The difference in cure and success between the various groups was examined using Fisher’s Exact test. Results: The overall cure rate is 23% (18/78) with a success rate of 71% (56/78). Twenty- nine percent (23/78) was premenopausal while 70% (55/78) was post menopausal. 72% (40/55) of menopausal patients were either on systemic HRT, topical HRT or both with 27% (15/55) on no HRT. Menopausal patients appeared to have a higher cure rate (27%) than premenopausal patients (13%) but statistical

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analysis revealed no significant difference; success rates between the two groups were the same (70% and 73% respectively) (Table 1).

TABLE 1 COMPARISON OF PATIENT GROUPS ACCORDING TO HORMONAL STATUS AND HRT USE 1 Premenopausal, 2Postmenopausal, 3Local HRT, 4Systemic HRT, 5 Local and Systemic HRT, 6No HRT (HRT = Hormone Replacement Therapy) Status

Cure rate

Percentage

Success rate

Percentage

Pre1 Post2+LHRT3 Post2+SHRT4 Post2+BHRT5 Post2+NHRT6

3 5 6 4 1

13% 26% 30% 50% 8%

17 of 23 14 of 19 14 of 20 6 of 8 6 of 12

73% 73% 70% 75% 50%

of of of of of

23 19 20 8 12

The difference between pre-menopausal, post-menopausal with HRT and post-menopausal without HRT groups was examined for the two outcomes. The first p-value represents the overall difference between the three groups, whilst the second p-value represents the specific difference between the two post-menopausal groups (Table 2). The results indicated that there was no overall significant difference between the three groups of subjects, or evidence of a specific difference between the HRT and no HRT group, for the cure or success outcome. TABLE 2 STATISTICAL ANALYSIS OF OUTCOME MEASURES (HRT = Hormone Replacement Therapy) Outcome Group

No N (%)

Cure

20 (87) 3 (13) 32 (68) 15 (31) p=0.08 (ns) P=0.11 (ns) 11 (91) 1 (8)

Success

Pre Post + HRT Post + No HRT Pre Post + HRT Post + No HRT

Yes N (%)

Overall comparison P-value

HRT vs. No HRT P-value

6 (27) 17 (73) 13 (27) 34 (72) 6 (50) 6 (50) p=0.28 (ns) P=0.37 (ns)

Conclusions: The presence of oestrogen and prosesterone receptors in the lower urinary tract is well documented and an improvement in incontinence is expected with HRT. It is acknowledged that Peri-urethral injection of macroplastique is an effective treatment modality. Logically, one can expect, therefore that the combination of HRT and PUI should increase the success

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rate in the treatment of stress incontinence, although contrary evidence exists suggesting that HRT use can worsen stress incontinence1. Our study shows a striking observational trend in improved outcome in postmenopausal women on both systemic and topical oestrogen replacement compared with those on no oestrogen replacement. Unfortunately this is not confirmed by statistical analysis due to the relatively small sample size; a larger study is required to detect differences between the various groups of subjects and we would argue that this trend would most likely be confirmed. Furthermore, our results tends to support the view that HRT certainly does not worsen outcome. References: 1. Hendrix SL, Cochrane BB, Nygaard IE, et al. Effects of estrogen with and without progestin on urinary incontinence. JAMA. 2005; 293:935–948.

180 De novo urge symptoms after mid-urethral sling procedures - A prospective case-controlled study Wang A, Wu R, Lo T, Lin Y, Liang C, Tseng L Chang Gung University Hospital (at Linko), Taiwan Industry Support: Objectives: To determine whether bacteria-infection-elicited immune response after mid-urethral sling (MUS) may cause de novo urge symptoms (DNUS) and to evaluate the efficacy of suburethral sling excision for relieving the urgency. Background: The reported incidence of DNUS after midurethral sling MUS is various (ranged from 0 to 21.3%). DNUS was defined as elevation of the detrusor pressure with urge sensation or urge incontinence during a filling cystometry performed postoperatively. The cause of urgency is not fully understood, in particular for those women having a new onset after MUSP. However, in host-humoralimmune response which is the main protective mechanism against bacteria infection, the resulting over production of cytokins by activated TH cells activates macrophages to kill ingested pathogens more effectively but this over production may cause various lower urinary tract symptoms. Based on this concept which relates immunogenicity to the bacterial infection, a prospective study including Gram stain, histomorphology and immunohistochemistry for the subjects with refractory urgency and the control group was conducted to analyze the pathologic basis of DNUS. Methods: In a period of 40 months, 360 consecutive subjects with urodynamic stress incontinence had undergone one of three different MUS (TVT, Sparc and Monarc).

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As per the protocol, all women underwent preoperative assessment and were instructed to keep a 4-day baseline micturition diary each at the recruitment and after the completion of treatment. Follow-up examinations were scheduled each 1 month, 3 months, 6 months and annually. Urodynamic testing was each scheduled at the recruitment and 6-month or whenever the subjects complained of urge sensation after each of the three procedures. Sixty-eight women with DNUS were included as the urgency group after exclusion. At beginning, conservative treatments were given for those 68 women. Excision of the suburethral tape and excision of periurethral tissue near the tape, irrespective of three different continence procedures, were performed for those subjects whose symptoms were not abated despite they had been treated conservatively for 3 months. Additionally, another 12 of the 360 women, who had symptomatic vaginal prolapse, but without DNUS after the MUS were recruited as control and relieved their complains by vaginal repair. The suburethral sling of 24 of the 68 women needed to be excised because of refractory urgency. The excised vagina or periurethral tissue included mesh sling of the study and control groups were sent for microbiological and immunohistochemical analyses (IHC). Results: A comparison of the outcome of the change in micturition diary variables revealed that urgency and frequency were significantly mitigated (4 [0.2, 11] versus 1.6 [-1, 10], p=0.014) and (2.05 [-3.3, 10.9] versus 0.83 [-2.6, 6.0], p=0.010), respectively, whereas the differences of nocturia and UI (number/24 hr, median [min, max]) were not significant (0 [-1, 2] versus 0 [-1.8, 2.1], p=0.144) and (0 [-1, 1] versus 0 [-1, 2], p=0.431), respectively; all KruskallWallis test. Based on these findings, 19 (80.2%) of the 24 women were deemed having response to the tape excision (urgency abated), but 5 women persisted in complaining of various irritating lower urinary tract symptoms. The urodynamic diagnosis for those 5 women included 2 each with DO and IBS and 1 normal. The gram stain for the sections of excised tissue, of the 24 women in the urgency group, gram (+) bacteria was identified in 20 while only one individual in the control group had positive bacteria stain (p<0.001, chisquare test). The most striking and important finding in the IHC analysis was that a significantly larger amount of CD68 was found in the urgency group (p=0.024). In the urgency group, bacteria-infection-elicited immune response leads rejection-type response by stimulation of the surface molecules CD68 and CD4+CD25+ to reach statistical significance (p=0.024, p=0.016, respectively) and of CD25 to attain marginal statistical significance (p= 0.053). The success rate of sling excision for DNUS was 80.2%. Conclusions: Bacteria-infection-related immune hyperreactivity might explain the pathologic basis of DNUS after MUS.

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181 PELVIC FLOOR MUSCLE TRAINING IN FEMALE STRESS URINARY INCONTINENCE: A COMPARISION BETWEEN GROUP TREATMENT AND PERFECT ASSESSMENT SCHEME Camargo F, Rodrigues A, Sartori M, Girao M, Oliveira L, Castro R Federal University of Sao Paulo, Brazil Industry Support: No Purpose: the objective of this study was to compare individual physiotherapy using PERFECT assessment scheme and group physiotherapy for female stress urinary incontinence (SUI). Materials and methods: Sixty women 30 to 75 years old with SUI were eligible for this study. The patients were randomly assigned to participate in exercises according to pelvic floor muscle training in group (group 1) and individual pelvic floor exercises based on the PERFECT assessment scheme (group 2). The PERFECT assessment scheme is a standardized way of measuring the functional evaluation of the pelvic floor. The evaluation of the function of the perineal muscles by the PERFECT assessment involves the introduction of the index and middle fingers, in the distal 3 cm of the vagina. PERFECT is an acronym with P representing power (or pressure), E = endurance, R = repetitions, F = fast contractions, and finally ECT = every contraction timed. It evaluates both the fast and the slow contractions of the muscle fibres to plan the exercise program. The group 1 did the standard physiotherapy of the pelvic floor in group with two weekly sessions of 45 minutes each. The patients, in the orthostatic position, received oral instructions to perform 10 contractions of 5 seconds, with 5 seconds of recovery time; 20 contractions of 1 second with 1 second of recovery and 3 contractions of 10 seconds with 5 seconds of recovery followed by 5 repetitions of strong contractions together with stimulated cough, with one minute interval between sets. The group 2 did the individual physiotherapy based on the PERFECT assessment scheme, that is, the contractions were done in agreement with the endurance, power and time the patients could tolerate. The patients performed 10 slow contractions with 10 seconds of recovery time; 10 fast contractions with 10 second of recovery, 10 alternating fast and slow contractions, 5 fast contractions associated with cough and 5 slow contractions associated with cough. They performed two weekly sessions of 15 to 30 minutes each; the duration was established according to PERFECT evaluation under the supervision and command of the physical therapist. The patients were evaluated before and after the treatment with the Oxford grading system, pad test, voiding diary and with the validated King’s Health Questionnaire. The x2 test

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was used for the comparison of categorical data between the groups with a significance level of 5% (p<0.05). Numerical data were compared using the paired Wilcoxon test within groups or non parametric Mann-Whitney U test between groups. All statistics were performed with the software STATA (Statistical Package for Social Sciences), version 7.0. Results: The groups were similar in respect of the type, severity and duration of incontinence. After the treatment, there were statistically significant improvements in the muscle strength and quality of life. Both PERFECT assessment group and group therapy produced significant changes in urinary leakage compared to baseline as measured by the pad test (p<0.0001) and bladder diary (p <0.0001). When we compared the groups, there were no differences in the good results of the therapies between them, except for the final muscle strength that was bigger in the PERFECT group (p<0.0003) (Tables 1).

Table 1 The association of the measurement of muscle strength, pad test and bladder diary before and after the treatment and between the two groups. Variant

Initial muscle strength Final muscle strength

Initial pad test

Final pad test

Initial bladder diary Final bladder diary

Measures

Min–Max Average Average ± Min–Max Average Average ± p-value* Min–Max Average Average ± Min–Max Average Average ± p-value* Min–Max Average Average ± Min–Max Average Average ± p-value*

Groups of treatment

sd

sd

sd

sd

sd

sd

Physical therapy

Perfect

0–4 3 2,6±0,8 2–5 4 3,6±0,8 <0,0001* 0–41 2,5 7,3±10,3 0–14 0 1,9±3,5 0,0001* 0–6 2 2,6±1,4 0–3 0 0,2±0,6 <0,0001*

1–4 2 2,2±0,9 2–5 4 4,3±0,7 <0,0001* 0–69 3 9,2±15,5 0–4 0 0,6±1,4 <0,0001* 1–9 3 3,1±1,5 0–2 0 0,1±0,4 <0,0001*

p-value

0,0592**

0,0003**

0,7977**

0,0709**

0,2121**

0,2429**

*p value obtained by the Wilcoxon test **p value obtained by the Mann-Whitney test sd: standard diversion

Conclusions: our results indicated that the PERFECT assessment and group physiotherapy appear to be equally effective in improving SUI.

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OAB/Voiding dysfunction (8–14), (64–75), (121–132) 8 Efficacy of Fesoterodine on Overactive Bladder Symptoms in Subjects With Different Baseline Severity of Urgency Urinary Incontinence Cardozo L1, Sand P2, Khullar V3, Wang J4, Guan Z4, Wein A5 1 King’s College Hospital, London, United Kingdom, 2 Northwestern University, Feinberg School of Medicine, United States, 3Imperial College, St Mary’s Hospital, United Kingdom, 4Pfizer Inc, United States 5Hospital of the University of Pennsylvania, United States Industry Support: Yes (Industry-initiated, full sponsorship) Objective: The primary purpose of this pooled analysis was to evaluate the clinical efficacy of fesoterodine (FESO) at 2 therapeutic doses (4 and 8 mg) on the number of urgency urinary incontinence (UUI) episodes per 24 hours in subjects with different severity of UUI at baseline. Background: Antimuscarinics are efficacious and relatively well-tolerated agents for the management of overactive bladder (OAB). For many subjects, additional therapeutic benefits may be achieved with dose escalation, a step not widely embraced in clinical practice. In a recently published pooled analysis of 2 fixed-dose phase III studies, FESO, a new nonselective antimuscarinic, demonstrated an apparent dose response, with the 8-mg dose being statistically significantly more effective than the 4-mg dose in improving key OAB endpoints. However, it is not clear which OAB subpopulation may benefit more from the higher dose of FESO. The aim of this analysis was to assess if baseline UUI severity could be used as a clinically meaningful predictor of the usefulness of FESO dose escalation. Methods: This pooled analysis included data from 2 multicenter, double-blind, placebo (PBO)-controlled trials. Eligible subjects reported OAB, defined as urinary frequency (=8 micturitions/24 h) and either urinary urgency (=6 episodes during 3-d diary evaluation) or UUI (=3 episodes during 3-d diary evaluation), and at least moderate bladder problems on a 6-point Likert scale. Subjects were randomized to receive PBO or FESO 4 or 8 mg daily for 12 weeks. One study also used tolterodine extended release 4 mg daily as an active control. The primary endpoint was the change in the number of UUI episodes from baseline to week 12 by baseline UUI severity. Only subjects in the full analysis set with UUI>0 in a 3-day bladder diary have been included in this analysis. Subjects were stratified into 3 UUI severity groups based on the number of UUI episodes recorded in their 3-day bladder diaries at baseline: 1/3 of the subjects had >0 to <2 episodes (mild); 1/3 had 2 to <4 episodes (moderate); and 1/3 had =4 episodes (severe).

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Results: A total of 1964 subjects were enrolled and randomized in the 2 trials. Of these, 1507 reported >0 UUI episode in their 3-day bladder diaries at baseline (PBO, n=416; TER, n= 223; FESO 4 mg, n=427; FESO 8 mg, n=441). Subjects were predominately women and white. At the end of treatment, all active treatments produced significantly greater reductions in the least squares (LS) mean change and median percentage change in UUI episodes than PBO, irrespective of baseline severity (P<0.05; Table). Overall, the reductions in the FESO 8-mg group were significantly greater than those in the FESO 4-mg group. Only subjects with moderate and severe baseline UUI showed significantly greater LS mean reductions in UUI episodes with FESO 8 mg compared with FESO 4 mg (efficacy dose response). However, in subjects with mild UUI at baseline, FESO 8 mg did not show a significantly greater reduction on UUI vs FESO 4 mg. Rates of common side effects such as dry mouth and constipation were comparable in subjects with different baseline severity of UUI. UUI Severity at Baseline

PBO

FESO 4 mg

FESO 8 mg

All

3.7

3.9

3.8

Baseline mean of UUI episodes (>0 UUI episodes) LS mean change Median % change Mild (>0 to <2 UUI Baseline mean of episodes) UUI episodes LS mean change Median % change Moderate (2 to Baseline mean of <4 UUI episodes) UUI episodes LS mean change Median % change Severe (? 4 UUI Baseline mean of episodes) UUI episodes LS mean change Median % change

–1.12 –1.85* –42.9 –75.0* 1.1 1.0

–2.33*† –83.3*† 1.1

–0.06 –0.55* –0.63* –50.0 –100.0* –100.0* 2.7 2.8 2.7 –0.86 –1.43* –44.4 –68.3* 7.0 7.3

–1.92*† –85.7*† 7.0

–2.23 –3.31* –37.2 –61.5*

–4.17*† –70.7*

*P<0.05 vs PBO; †P<0.05 vs FESO 4 mg.

Conclusions: These results confirm that subjects with more severe UUI at baseline are more likely to benefit from the higher dose of FESO. 9 The time course of white cell destruction in urine samples and the necessity of immediate analysis Khan S, O’Connor D, Khasriya R, Malone-Lee J UCL, United Kingdom Industry Support: No Objective This study was designed to measure the timed decay of white cells in urine samples when stored at room temperature and

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when refrigerated at 4O°C. The study hypothesis that was tested was that there would not be a significant decay in white cell counts in response to storage over a day. Background Part of the diagnosis of overactive bladder (OAB) requires the exclusion of significant urine infection. It is now known that the routine culture of midstream urine (MSU) samples seeking culture of 3105 colony forming units (cfu) ml-1 is not sufficiently sensitive and results in 50% of genuine urine infections going undetected [1]. This implies that the screening for urinary infection in patients with OAB symptoms needs to be reassessed. There are significant difficulties with sampling and culture methods used in clinical practice, which mean that an improved culture method may be some time away. An alternative is to use a surrogate marker of infection. Since 1968 it has been known that the detection of 310 white blood cells (wbc) ml1 of a fresh, unspun, urine sample, examined by light microscopy using a haemocytometer is the best surrogate marker of urinary infection [2]. Despite this the literature is surprisingly uninformative about the sampling methods that should be achieved for optimum results. It is know that centrifuging urine causes white cells to lyse with resulting underestimate of the pyuria signal. There are no data to guide sampling method MSU or catheter specimen (CSU) and period and method of storage have not been studied. These are apposite matters since in the health services urine samples can spend many hours in the journey to the laboratory. Methods Because there were no data to guide expectations a sample size calculation could not be effected.Urine samples were obtained from women presenting with overactive bladder symptoms by the midstream clean-catch method. A disposable pipette was used to load a clean haemocytometer chamber with a sample. This preparation was examined using a x20 objective with a x10 optical (magnification x200). The leucocyte count (wbc μL-1) was enumerated by counting cells in five large squares and multiplying the result by 2.2, since the volume of the whole chamber was 0.9 μl (Fig. 1). If a cell overlapped a dividing line, it was counted if the line ran along the top or right side and ignored if the line ran along the bottom or left side. The samples were divided into two aliquots of which one was stored at room temperature (18O°C) and one refrigerated at 4O°C. These samples were then examined repeatedly in the same way every two hours for the duration of the working day (09:00 am to 17:00 pm) for the 2 days. The samples were disposed of once the WBC count reached zero, or the two-day time period had expired. Results 90 female patients with OAB provided specimens that manifest pyuria >6 wbc μl on first sampling. Their mean age was 56 (sd=18). At the room temperature samples,

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WBC count decreases to about 60% of the original in the first two hours after collection. In the samples that were refrigerated, the WBC count decreases to about 80% of the original the first two hours after collection. Conclusions Lysis of the white blood cells in urine appears to commence very shortly after sampling and is not significantly retarded by storage at 4O°C. It seems that delayed examination of the urine deposit for pyuria is associated with significant error that must lead to an underestimation of the inflammatory response. At this time the only solution seems to lie in immediate microscopic examination in the clinic at the time of collection. References 1. Am.J.Med. 75(1B), 53–58. 28–7–1983, 2. Ugeskr.Laeger 130(4), 136–139. 25–1–1968 10 Predictors of compliance with drug therapy in patients with overactive bladder Basra R1, Cortes E2, Basra H2, KhullarV3, Kelleher C2 1 Imperial College London, United Kingdom, 2St Thomas Hospital London, United Kingdom, 3St Mary’s Hospital London, United Kingdom Industry Support: No Objectives: The aim of this multicentre, prospective study of patients with overactive bladder (OAB) was to explore social and disease factors, and how they influence compliance with drug therapy. Background: Poor compliance is a challenge in the treatment of OAB. Data from clinical studies suggest adherence rates of <20% at 6 months of treatment. Poor compliance with treatment may lead to disappointment in the treatment, inappropriate drug dose escalation, medication switches and ultimately increased costs of disease management. Factors which affect compliance may be divided into social factors which include cultural beliefs about taking prescribed medication; and disease factors including disease severity, treatment efficacy and tolerability. The influence of disease factors on treatment compliance is well recognised. Social and cultural factors which may influence patients’ decision to use drug therapy for OAB have not been investigated. Methods: Women with symptoms of OAB were recruited from 2 urogynaecology tertiary referral centres. Patients were asked to complete a series of validated questionnaires at baseline, 6 and 18 weeks; the short form 36 generic health questionnaire (SF-36), the condition specific Kings health questionnaire (KHQ), the single item patient perception of bladder condition (PPBC) and patient global impression of improvement (PGII) scales, the medicines belief questionnaire (MBQ), the Hospital anxiety and depression scale (HADS) and the medication adherence

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report scale (MARS). The HADS is a 14 item screening tool for anxiety and depression. The MARS is a five item, self report adherence questionnaire. The 17 item MBQ questionnaire has 2 subscales; the general subscale assesses beliefs about overuse and harm associated with all prescribed medication, the specific subscale assesses patients’ beliefs about the necessity of and concerns associated with antimuscarinic therapy. The general subscale of the MBQ was completed by all patients at baseline. Patients who subsequently used drug therapy were asked to complete the MBQ specific subscale and MARS. Results: 250 patients (mean age 54 yrs) were approached to take part in the study. 236 patients completed the questionnaires on at least one occasion. 153 women were prescribed an antimuscarinic drug at baseline, of which 83 (55%) were using medication at 6 weeks. 79 patients were using drug therapy at 18 weeks. Results of the MBQ general subscale showed that patients with strong beliefs about harm from prescribed drugs believed that doctors overuse drug therapy. Low perceived harm from prescribed drugs was associated with better compliance at 6 weeks. High perceived harm from prescribed drugs was more commonly found in patients with high concerns about using antimuscarinic medication. Results of the MBQ specific subscale showed that high concerns about antimuscarinic therapy were associated with poor compliance. Analysis of the PGI-I scale showed that patients using drug therapy who experienced improvement of their symptoms had significantly lower concerns about using antimuscarinics than those patients who reported no change/deterioration in symptoms. Symptom improvement reported on the PGII was associated with greater perceived necessity of drug therapy. Beliefs about using drug therapy were not influenced by OAB symptom severity as reported on the PPBC and KHQ. Baseline PPBC scale scores were significantly higher at baseline in those patients who comply with drug therapy compared with patients who discontinue treatment. Results of the baseline KHQ showed that patients who comply with therapy report lower quality of life in the general health perception, incontinence impact, role limitations, emotions and sleep/energy domains of the questionnaire. Women who were not compliant with medication reported higher scores in the physical limitations, severity measures and social limitations domains. Analysis of the HADS questionnaire revealed no significant difference in anxiety and depression in women who comply with drug therapy for OAB and those who discontinue treatment. There was no difference in baseline SF36 scores of patients who use drug therapy and patients who

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discontinue treatment. Compliance with therapy was not affected by patient age, the number of concomitant medications or eligibility for free prescriptions. Conclusions: OAB symptom severity is an independent predictor of compliance with drug therapy. Personal beliefs about the harm and overuse of drug therapy are strong predictors of compliance with drug therapy. Beliefs about the necessity of antimuscarinic medication for control of OAB are dependent upon treatment efficacy.

11 The progression of overactive bladder symptoms in women: A prospective longitudinal population based study Anna-Lena Wennberg1, Ulla Molander 2, Magnus Fall3, Christer Edlund3 Ralph Peeker3, Ian Milsom1 Departments of 1Obstetrics and Gynaecology, 2Geriatric Medicine and 3Urology, Sahlgrenska Academy at Göteborg University and Sahlgrenska University Hospital, Göteborg Industry Support: Yes (Investigator initiated, partial funding) Objective: The aim of this study was to describe the progression of OAB symptoms in the same women studied prospectively over time. Background: Cross sectional prevalence studies have demonstrated that overactive bladder (OAB) is common in both women and men and prevalence increases with increasing age (1). There are however few studies describing the progression of symptoms in the same individuals over time. Methods: In 1991, 2911 women, aged >20 years, were selected at random from the National Population Register. The women received a self-administered postal questionnaire on OAB, urinary incontinence (UI), other lower urinary tract symptoms (LUTS) as well as questions on social, medical and demographic data. The response rate was 74% (n=2,239). The women who responded in 1991 and who were still alive and available in the National Population Register (n=1,376) were re-assessed 16 years later in 2007 regarding OAB, UI and other LUTS using the same questionnaire technique. On both occasions OAB and LUTS were assessed according to the current ICS definition (2). The presence or absence of OAB symptoms were classified as follows: No OAB symptoms=No OAB; OAB without UI=OAB dry; and OAB with UI=OAB wet. Results: In 2007, 1,081 of the 1,376 women who were still available in 2007 responded (79%) to the questionnaire Complete data regarding OAB was available for 949 women from both 1991 and 2007. The table and figure

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below shows the percentage numbers of women reporting OAB symptoms in 1991 and 2007.

No OAB (1991) OAB dry (1991) OAB wet (1991) Total 2007 N (%)

No OAB (2007) n

OAB Dry OAB Wet (2007) n (2007) n

Total (1991) n (%)

634 52 14 700 (74%)

64 24 191 99 (10%)

791 (83%) 106 (11%) 53 (6%) 949 (100%)

93 29 28 150 (16%)

During the course of this 16-year observation period the overall prevalence of OAB in the same women increased from 17% to 26% (p<0.001). The most marked increase was in the proportion of women with OAB wet which increased from 6% to 16% (p<0.001). Conclusions: There was a marked increase in the prevalence of OAB in the same women assessed longitudinally over this 16-year period. The biggest increase was in the number of women who developed OAB wet. References: 1. Irwin DE, Milsom I, Hunskaar S et al. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol 2006; 50: 1306–15. 2. Abrams P, Cardozo L, Fall M et al. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn 2002; 21: 167–78. 12 Effects of Fesoterodine on Symptom Relief and Patient Satisfaction in Patients With Overactive Bladder Wyndaele, J,1 Goldfischer, E,2 Morrow, J,3 Gong J,3 Tseng, L,3 Choo, M4 1 Department of Urology, Universitiet en Universitair Ziekenhuis Antwerpen, Antwerp, Belgium; 2Hudson Valley Urology, P.C., Poughkeepsie, NY, US; 3Pfizer Inc, New York, NY, US; 4Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

Industry Support: Yes (Industry-initiated, full sponsorship) Objective: To evaluate the efficacy and tolerability of fesoterodine in subjects with overactive bladder (OAB) who were dissatisfied with previous treatment with tolterodine or tolterodine extended release (ER). Background: Antimuscarinics are a mainstay of OAB treatment, but efficacy and tolerability vary among agents

and between patients. Furthermore, some agents lack dosing options to allow individualized treatment. Tolterodine and fesoterodine are structurally related and have the same active metabolite, but tolterodine does not offer flexible dosing. This study examined whether a flexibledose fesoterodine regimen can improve OAB symptoms, treatment satisfaction, and health-related quality of life (HRQL) in patients who reported dissatisfaction with tolterodine or tolterodine ER. Methods: This was a 12-week, multicenter, open-label, single-arm, flexible-dose study of adult subjects with OAB reporting =8 micturitions and =3 urgency episodes per 24 hours in 5-day bladder diaries, and dissatisfaction with tolterodine or tolterodine ER treatment received within 2 y of study enrollment. Subjects received fesoterodine 4 mg once daily for 4 weeks; thereafter, daily dosage was either maintained at 4 mg or increased to 8 mg based on a subjective assessment of efficacy and tolerability by the subject and investigator. Subjects recorded micturitions and urgency urinary incontinence (UUI) episodes in 5-day diaries at baseline and weeks 1, 4, and 12. Subjects rated the sensation of urgency associated with each micturition episode using the 5-point Urinary Sensation Scale (USS; 1=no urgency, 2=mild urgency, 3=moderate urgency, 4= severe urgency, 5=UUI). Urgency episodes and severe urgency episodes were defined as micturitions with a USS rating =3 and =4, respectively. Subjects assessed treatment satisfaction at 12 weeks on a 5-point Likert scale using the validated Treatment Satisfaction Question (TSQ). Subjects also completed other validated OAB-specific questionnaires, including the Patient Perception of Bladder Condition (PPBC) and the Overactive Bladder Questionnaire (OAB-q) at baseline and week 12. The PPBC is a singleitem, 6-point instrument used by subjects to rate the severity of their bladder-related problems. The OAB-q comprises an 8-item Symptom Bother scale and a 25-item HRQL scale with 4 domains. For efficacy analyses, all mean changes from baseline were tested using a pairwise ttest. Safety and tolerability were assessed based on treatment-emergent adverse events (AEs) and study withdrawals due to AEs. Results: Among 516 subjects treated, approximately 90% completed the study, and about 50% opted for dose escalation to 8 mg at week 4. Significant improvements at week 12 were observed in micturitions (mean change, -3.0), UUI episodes (-1.7), urgency episodes (-5.0) and severe urgency episodes (-3.5) per 24 hours (P<0.0001 for all vs baseline; Table). Approximately 80% of subjects who responded to the TSQ at week 12 (n=474) reported being satisfied with treatment, with approximately half of these being “very satisfied.” Significant improvement was observed in mean PPBC scores (-1.8;

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P<0.0001); 83% of subjects reported improvement at week 12, with 59% reporting a major improvement (=2 points). Significant improvements (P<0.0001) were observed in the OAB-q Symptom Bother and HRQL scales, as well as in all 4 HRQL domains; all improvements exceeded the minimally important difference of 10 points. Dry mouth (23%) and constipation (5%) were the most frequently observed AEs, with nearly all AEs (94%) being mild to moderate in severity. Serious AEs were reported by 9 subjects, but none was deemed to be treatment related. Table Improvements in OAB symptoms associated with fesoterodine n

Micturitions, mean (SD)/24 h UUI episodes, mean (SD)/24 h* Urgency episodes, mean (SD)/24 h Severe urgency episodes, mean (SD)/24 *

Baseline

Week 12† Median % change

514 12.7 (3.9) 9.7 (3.4)‡ -22% 256 2.3 (2.8) 0.6 (1.3)‡ -100% 514 10.0 (4.5) 5.0 (4.7)‡ -57% 442 5.0 (4.4)

1.5 (2.7)‡ -94%

*Includes only those subjects reporting this symptom at baseline. Last observation carried forward. ‡P<0.0001 vs baseline.

†

Conclusions: In this open-label study using flexible dosing, fesoterodine treatment resulted in significant improvements from baseline in OAB symptoms and HRQL in subjects with OAB who were dissatisfied with prior tolterodine or tolterodine ER therapy. Approximately 80% of subjects reported satisfaction with fesoterodine treatment. Half of subjects opted to receive the 8-mg dosage. Fesoterodine was well tolerated.

13 Urinary Interleukin-6 and pyuria in patients with symptoms of OAB Khasriya R, Bhome R, Khan S, Ali V, Malone-Lee J UCL, United Kingdom Industry Support: No Objective We tested the hypotheses that urinary IL-6 expression in the urine of patients with OAB would be increased in association with pyuria.

Background The study of OAB has started to focus on the pathophysiology of the urothelium, particularly in relation to ATP signalling through the puringergic system. In the human lower urinary tract, ATP has not been found to play the major role that has been described in other animals. However, it is known that if an inflammatory response affects the human urothelium, then ATP is produced in large amounts [1]. Recently an inflammatory response in the urine of patients with OAB symptoms has been described. However, the method necessary to detect the offending white cells requires light microscopy of a fresh, unspun urine sample in a haemocytometer. This is not an easily applied method and would struggle to achieve widespread acceptance. In addition, the detection of pyuria on its own may not be clinically relevant and corroborating data is necessary before significance be accepted. Interleukin-6 is an immune protein in the hematopoietins family. IL-6 stimulates the acute-phase reaction, which enhances the innate immune system and protects against tissue damage. It is released very early in the inflammatory response and has a short half-life so its detection reflects on recent events. IL-6 is expressed by the urothelium in response to infection, in addition to IL8 and platelet derived growth factor (PDGF). IL-6 has been studied in urinary infection and interstitial cystitis but not OAB [2]. The detection of IL-6 expression in urine in association with OAB symptoms would support the hypothesis of a urothelial inflammatory response as part of the pathophysiology. Methods This was a blinded, observational cohort study. Women with symptoms of the OAB were asked to give consent to participate and provide catheter specimens of urine for the study. Their symptoms were recorded using a validated questionnaire. A CSU was obtained by inserting a Lofric (in and out) size 12 Fr catheter into the urinary bladder under aseptic conditions. Urine specimens were collected into a sterile container and a 4 ml aliquot was taken immediately. The aliquot was centrifuged at 2000 revolutions per minute for five minutes and frozen at -80°C. A sample of 0.9 μl was taken in order to effect a count of white blood cells using a light microscope and a haemocytometer. The samples were thawed and analysed in batches, blinded, once weekly. Human urinary IL-6 concentrations were determined using a commercial high sensitivity ELISA with

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a limit of detection of 0.09 pg/ml with an inter and intra assay coefficient of variation of less than 10% (R&D Systems, Oxon, UK). T The study was powered at 87% to detect a clinical significant difference in IL-6 of 1 pg/ml given a standard deviation of 1.5 with 40 patients in each group. The between group differences in IL-6 were tested by use of the t-test for independent samples. Correlations between IL-6 and log pyuria were examined by means of Pearson’s R. Results Because of the exponential nature of increasing pyuria the log of the urinary white cell count was calculated. There was a significant difference in IL-6 levels between those with pyuria and those without (95% CI of difference -2.9 to -0.11, p=0.34, t=-2.1) It was found that there was a correlation between the log white cell count and IL-6, Pearson R=0.5, p=0.001. There was no relationship between IL-6 and symptoms of urgency, frequency and incontinence. Conclusions The pyuria found in these patients with OAB was associated with an alternative marker of inflammation, namely IL-6. This provides some additional independent verification of the significance of pyuria detected by microscopy of fresh unspun specimens of urine. Whilst there was a correlation between the pyuria and IL-6, this was not sufficiently strong to encourage the view that IL-6 might prove to be a useful surrogate marker of pyuria. Pyuria in patients with OAB symptoms is associated with urinary expression of the acute phase cytokine IL-6. This finding is supportive of the view that OAB symptoms in some patients are associated with a urothelial inflammatory reaction. References 1. J Urol. 166(5), 1951–1956. 2001 2. Urology 68(4), 702–706. 2006 14 A prospective analysis of the effect of TVT retropubic and Monarc trans-obturator sling on lower urinary tract symptoms (LUTS) in women with urodynamic stress incontinence (USI) and intrinsic sphincter deficiency (ISD) Schierlitz L1, Dwyer P1, Rosamilia A2, Hiscock R1, Lim Y1, De Souza A1 1 Mercy Hospital for Women, Australia, 2Monash Medical Centre, Australia

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Industry Support: No Objective: To prospectively compare the effect of TVT retropubic and Monarc trans-obturator sling on lower urinary tract symptoms (LUTS) in women with urodynamic stress incontinence (USI) and intrinsic sphincter deficiency (ISD). Background: The natural history of overactive bladder (OAB) symptoms in the context of anti incontinence sling procedures is still not well understood. The development of de novo symptoms as well as the resolution of pre-existing symptoms is important as it has a significant effect on patient satisfaction. Methods: An explorative analysis of LUTS such as urinary urgency, frequency, nocturia and urge incontinence (UI) was conducted in the setting of a prospective, randomized controlled trial of women with USI and ISD undergoing TVT or Monarc sling. The pre- and postoperative protocol at 6 months included: complete urogynaecological history, physical examination and multichannel urodynamics testing. The Urogenital Distress Inventory (UDI) 6 SF was assessed both as a total score and as the individual domains. Statistical analysis was performed using Wilcoxon sign rank test, McNemar’s test, Fisher’s exact test and Bonferroni correction for multiple comparisons. Results: From February 2004 until 2007, 181 women were eligible and 164 were enrolled with 82 randomized to each group. No differences in demographic or clinical data were detected. The incidence of bothersome urinary frequency (>7 voids/day) and nocturia (>2 voids /night) did not change between pre- and postoperative assessments and showed no difference between the two slings. Urgency (any) did not differ pre- and postoperatively or between TVT and Monarc sling and resolved in 50% and 36% respectively. Bothersome urgency (>1/week) improved significantly with 100% resolution in both groups. De novo urgency occurred in 21% of the TVT group and 10% of the Monarc group. Urge incontinence (any) increased in both sling groups after surgery, but did not reach statistical significance. Bothersome UI (>1/week) did not change pre- to postoperatively within the groups and was similar in both slings. The resolution of UI (any) was 40% in the TVT and 36% in the Monarc compared to 80% and 63% respectively with bothersome UI. The incidence of de novo urge incontinence (any or bothersome) was similar in both groups. The total and relevant individual domains of the UDI 6 SF showed an improvement in median score

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(p <0.001) after surgery but no difference between TVT and Monarc (p=0.43). Table 1 Subjective outcome at pre-operative and at six month follow-up Symptoms

Frequency (>7 voids/day) Nocturia (>2 voids/night) Urgency (any) Urgency (>1/week) De novo Urgency (any) De novo Urgency (>1/week) Urge Incontinence (any) Urge Incontinence (>1/week) De novo Urge Incontinence (any) De novo Urge Incontinence (>1/week)

n^ TVT (n=82)

27 17 51 51 51 51 51 51 51 51

n^ Monarc (n=82)

Pre-operative

Post-operative

p value*

16 4 28 17 10 10 -

14 2 25 (49) 0 (0) 11 (21) 0 (0) 22 (43.1) 9 (17.6) 16 (31.4) 7 (13.7)

0.75 0.62 0.69 <0.0001

(54.9) (33.3)

(19.6%) (19.6%)

0.008 0.80

32 20 52 52 52 52 53 53 53 53

p value**

Pre-operative

Post-operative

p value*

17 7 34 (65) 30 (57.7) 11 (20.7) 11 (20.7) -

13 3 24 (46.1) 0 (0) 5 (9.6) 0 (0) 20 (37.7) 11 (20.7) 13 (24.5) 7 (13.2)

0.21 0.12 0.04 <0.0001 0.21 0.99 0.03 0.99 0.49 0.99

data presented as number(%), ^ number with all data present, * McNemar’s test – within treatment groups, ** Fisher’s exact test - between treatment groups

Conclusion: The results of our study show at 6 months that, the resolution and new development of OAB symptoms overall do not significantly differ following a TVT or Monarc sling in women with intrinsic sphincter deficiency. The number of women with any degree of urgency did not change after either sling (as a result of resolution in some and de novo symptoms occurring in others), but the subgroup with bothersome urgency (>1/week) did improve significantly in both sling groups. 64 The effect of anterior repair on voiding and the overactive bladder Basu M, Duckett J Medway NHS Foundation Trust, United Kingdom Industry Support: No Objective To identify whether anterior compartment vaginal prolapse repair has any effect on voiding function and whether this has any effect on overactive bladder symptoms (OAB) and detrusor overactivity (DO). Background There is limited information regarding the co-existence of urinary symptoms and prolapse. One study reported that 68% of women with prolapse also complain of urgency, with 50% suffering from urge incontinence. 41% of a cohort of women with severe prolapse were reported to have DO. The link between OAB and prolapse may be due

to the prolapse causing dysfunctional voiding. Our previous work has implied a place for obstruction in the pathophysiology of DO in women. There have been few studies examining the effect of a prolapse repair on OAB. A recent study of the effect of anterior repair on urinary symptoms showed resolution of urinary frequency, urgency and urge incontinence in 60, 70 and 82% of women following an anterior repair, as well as significant improvements in quality of life. There are no studies in the literature examining changes in urodynamic parameters in women with DO/OAB undergoing anterior repair. The aim of this study was to identify any changes in these parameters and to equate these with symptom improvement or persistence. Methods 49 women with DO and OAB with symptomatic anterior wall prolapse of Grade 2 or above who underwent an anterior repair between 2003 and 2007 were included. Of these 40 agreed to repeat urodynamic evaluation. 9 provided qualitative data only. Each woman was assessed pre-operatively with a urogynaecological history and examination and pressure-flow studies. Women were followed up post-operatively using a King’s Health Questionnaire, urogynaecological examination and repeat cystometry. Patients were divided into those with resolution of OAB symptoms (Group 1, defined as absence of urgency/ urge incontinence in relevant domains of King’s Health Questionnaire and denial on direct questioning) and those with persistent OAB symptoms (Group 2). Significance testing was used to evaluate any differences in urodynamic parameters between these groups pre- and post-operatively.

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Results DO was objectively cured in 24.4% of participants. 53.3% were subjectively cured of OAB. Resolution of OAB was associated with a significant increase (p=0.049) in the maximum flow rate (12.8 ml/s pre-operatively to 17.3 ml/s). There was a significant association between persistent OAB symptoms and persistent DO (17 of 18 patients with persisting symptoms had DO on cystometry, p=0.0003). Two of the 49 women (2%) women had symptomatic recurrent Grade 2 cystoceles and were offered surgical management. These women were both in group 1. Two women in group1 developed USI. Each was offered a TVT after conservative measures had failed to control their symptoms. Conclusions These results have shown that over half of women with OAB undergoing a prolapse repair are cured of their symptoms. Resolution of overactive symptoms is associated with a significant improvement in maximum flow rates. This is despite no change in detrusor pressure at maximum flow. The underlying reason that the detrusor becomes overactive may be mechanical, i.e. increased contractility to overcome the obstructive element. Bladder wall thickness has been described as a marker for DO; this may represent hypertrophy in response to enhanced activity of the muscle. The relationship between obstruction and OAB is supported by evidence looking at men with bladder outlet obstruction caused by prostatic enlargement. Cucchi et al. have shown that men with prostatic obstruction have a DO-related facilitation of bladder contractility. This may be to overcome the outflow obstruction, or could also be explained by urethral relaxation caused by the DO. There are certain limitations relating to the above study. This is a very select population and it is possible that the results are not generalisable to all women with OAB and DO. The retrospective nature of the study may lead to bias. The time to follow up varied between patients, although none had undergone subsequent continence or prolapse procedures in the interval between the anterior repair and follow up. The study is also limited by the fact that anterior repair was carried out in conjunction with other prolapse procedures; this may be a potential source of bias. The strength of the study is the use of pressure-flow data after prolapse repair, which, to the best of our knowledge, has not been previously documented. Our findings suggest that improvement in urinary flow rates caused by prolapse repair is of importance in symptom resolution in women with anterior compartment prolapse and overactive bladder symptoms.

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65 Repeated courses of intradetrusor Botulinum Toxin (Dysport®) injections for the treatment of overactive bladder. Are they effective? Doumouchtsis S, Jeffery S, Abboudi H, Wang K, Fynes M, Department of Urogynaecology, St George’s Hospital, St George’s University of London, United Kingdom Industry Support: No Objective At present the long term efficacy of repeated courses of intradetrusor botulinum toxin injections for the treatment of refractory OAB is not known. Our study evaluated quality of life parameters using the King’s Health Questionnaire in a cohort of patients with refractory OAB who required more than one course of Dysport® injections. Methods We prospectively studied the efficacy of repeated doses of intradetrusor injection of Dysport® using the Kings Health Questionnaire (KHQ). Preoperatively, all patients had detrusor overactivity confirmed by urodynamic investigations and underwent bladder retraining. Patients were only included if they had failed more than one anticholinergic agent for at least 6 months, or if anticholinergic therapy was contraindicated or if they were unable to comply with anticholinergic drugs due to severe side-effects. The procedure was performed in the operating theatre as a day case. Dysport® 500–1000iu was diluted in 20 ml of normal saline and 1 ml aliquots were injected into the detrusor muscle at 20 sites above the interureteric ridge sparing the trigone and the dome using a grid pattern of 5×4 sites spaced evenly. Response to treatment was assessed at 1 week, 6 weeks, 3 months, 6 months and 9 months postoperatively for each injection procedure. Assessment also included the use of 24 hour pad tests and voiding diaries. Urodynamic assessment was repeated at 3 months Results For the purposes of this study we present outcomes based on the KHQ domain scores. Fifty seven female patients underwent intradetrusor Dysport® injections, over a 3 year period. Of them, 35 women had at least one repeat course of this treatment. The mean and median time interval between the first and the second injection was 9 months. Data for long term follow up (at least 9 months from the second course) were available for 14 patients.The mean age of this cohort was 63 years. There were no significant perioperative complications apart from voiding difficulty. Improvements in quality

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of life parameters are demostrated in Table 1 and Fig. 1. Those improvements were maintained for 6 to 9 months. The improvements of the quality of life domains were significant for the first and second course but not for the third probably due to the small numbers of women requiring a third injection. The incidence of voiding difficulty defined by symptoms on KHQ domains and/or requirement for catheterisation by any route (IDC, SPC, or CISC) was not increased on subsequent courses.

Conclusions Repeated courses of Intradetrusor Dysport® appear effective in the treatment of refractory OAB for up to 9 months post treatment. The necessity for repeated courses of intradetrusor botulinum toxin injections appears to be more common in older patients. In our cohort patients requring repeat courses tend to be older. On review, these patients have reduced PDetMax compared to younger subjects which may predispose them to higher rate of postoperative voiding difficulty. In such patients CISC should be taught

Table 1 Mean scores for Various Domains on the King’s Health Questionnaire Pre/op

Urgency Perception of Bladder Condition Role Limitations Physical Limitations Social Limitations Emotions Sleep/Energy Severity Measures

1st Course (14 women)

2nd Course (14 women)

3rd Course (9 women)

6 wks

3 mo

6 mo

9 mo

6 wks

3 mo

6 mo

9 mo

6 wks

3 mo

6 mo

9 mo

2.54 74

2.36 55

2.21 52

1.62 56

2 78

2.16 75

1.77 51

1.77 50

2.4 38

2 57

0.8 72

2.67 67

1.67 55

72 69 62 64 68 82

59 74 62 57 63 66

50 63 50 54 53 61

58 58 47 52 63 57

72 68 66 66 59 60

60 58 42 57 65 61

61 61 46 63 68 63

50 55 34 54 50 57

50 50 44 40 53 52

43 71 47 63 62 74

56 72 48 55 53 73

73 67 59 51 61 80

49 50 33 77 38 75

Figure 1 Various domains on the King’s Health Questionnaire

Figure 2 Mean urgency values on the King’s Health Questionnaire

preoperatively or consideration given to insertion of an SPC if CISC is not possible because of body habitus or lack of manual dexterity. These represent a difficult group of patients to treat as they have a combination of refractory OAB possibly due to age related detrusor degeneration and associated voiding difficulty. Botulinum toxin in this small cohort appears to improve both quality of life and urge frequency symptoms in those with refractory OAB where other conservative treatments have failed. Currently available alternative surgical interventions such as sacroneuromodulation or augmentation cystoplasty are more invasive, costly and associated with higher morbidity. Further consideration should be given to the role of repeat intravesical botulinum toxin injections in women with refractory OAB. Ongoing research is required to determine appropriate patient selection and optimal dosage. However we feel that intravesical botulinum toxin is a valuable effective and minimally invasive option for this difficult group. 66 Use of antimuscarinic drugs for overactive bladder in a Danish population Brostrom S1, Hallas J2 1 Department of Obstetrics and Gynecology, Glostrup Hospital, Copenhagen, Denmark, 2Research Unit of Clinical Pharmacology, University of Southern Denmark

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Industry Support: No Objective The use of antimuscarinic drugs for the overactive bladder syndrome (OAB) is supported by evidence from mostly 12weeks industry-sponsored RCTs showing statistically significant improvements in symptoms, though recent trials suggest that this is associated with only modest improvement in quality of life. Withdrawals in the 12-weeks RCT registration studies were few, and the results of industrysponsored long-term or open-label extension studies have also shown very good long-term persistence. However, the external validity of the findings of these industry-sponsored studies has been questioned. As the studies on OAB drugs persistence in the literature represent selected populations, and there is a lack of data on OAB drug use in other care settings, we wanted to see if we could replicate these findings in a Danish population characterized by socialized medicine with universal health care coverage. We also wanted to extend our analysis beyond the 6-month or 1year follow-up employed in other studies, and we wanted to compare differences in persistence between older and newer OAB drugs. Methods We used the Odense University Pharmacoepidemiological Database, which has complete capture of all reimbursed prescriptions. The study was retrospective by design. We retrieved all prescriptions on drugs belonging to ATC-code G04BD for the period 1999 through 2006. We generated measures are therapeutic intensity, i.e., the amount measured in DDD per 1000 inhabitants per day, the incidence rate, the average age of users and the gender distribution. The duration of a treatment episode was set to the interval between the first and last prescription of that episode plus a period assigned to the last prescription. We generated Kaplan-Meyer curves for each of the substances, and analyzed determinants of termination of OAB drug treatment; Independent variables were age, gender, a history of prior use of another OAB drug, use of antidiabetics, the estimated dose and the choice of drug. Results With the data for 2006, we found 11,081 prescriptions dispensed to 2477 persons, of which 1641 were women (66.2%) and 836 men (33.8%). Their average age was 69.0 for men and 68.0 for women. With the exception of trospium chloride, all OAB drugs had continuation rates of less than 50% at 6 months, less than 25% at 1 year and less than 10% at 2 years and longer. Trospium chloride, however, exhibited continuation rates of around 50% at 6 months, around 35% at 1 year, around 20% at 2 years and around 15% at 3 years.

S47 Figure 1 Kaplan-Meyer graphs of persistence with antimuscarinic drugs for overactive bladder. Data from Funen County, Denmark 1999–2006

Conclusions Surprisingly, we found much higher persistence rates than previously reported in the literature, with our 1-year persistence rates comparable to the 30-days persistence rates found by others (1–3). Several factors might explain this. The health-care setting with easy access and generous reimbursements might certainly be a contributing factor. Due to national regulations, the dispensing of free drugs samples by doctors is severely restricted in Denmark; thus, almost all patients entered in our study had probably paid for their first prescription themselves, and probably excluding those reluctant to pay anything at all. Other studies have shown better continuation rates with once-daily dosing. We fail to replicate this finding in the present study, as trospium chloride, prescribed as twice-daily dosings to be taken on an empty stomach, had much better continuation rates than e.g. tolterodine or solifenacin, substances that are prescribed without these caveats. Interestingly, we found that one of the older drugs on the market, trospium chloride, performed better than other drugs. Tolterodine, darifenacin, solifenacin, and oxybutynin all undergo extensive hepatic metabolization. Trospium does not, and is eliminated as an unchanged drug, thus having a lower potential for drug-drug interactions and being a safer treatment option for OAB in the context of polypharmacy, a significant concern in older patients. In a setting of socialized medicine with universal health care coverage we found higher continuation rates of OAB drugs than previously published for US Medicaid managed care settings. Interestingly, we found that one of the older drugs on the market, trospium chloride, performed much better than the other drugs for OAB. References 1/ Value Health. 2005; 8: 495–505. 2/ Value in Health 2001; 4: 161. 3/ Am J Manag Care 2005; 11: S121–9.

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67 THE EFFECT OF TOPICAL ESTROGEN ON THE PULSATILITY INDEX IN URINARY BLADDER ARTERIAL VESSELS Milart P1, Wozniakowska E1, Paszkowski T1, Klepacz R2, Palacz T1 1 3rd Department of Gynecology, Medical University in Lublin, Poland, 2Department of Clinical Pathomorphology, Medical University in Lublin, Poland Industry Support: No Objective: The incidence of urinary urge incontinence in women increases after menopause. The depletion of estrogens during the menopause period seems to be the cause of the improper metabolism of collagen thus influencing the anatomy and function of the urinary bladder. Moreover, it may affect the estrogen-dependent tissues within the blood vessels wall, which may cause poor blood supply for the detrusor muscle and the urothelium. The lesser vascularization of the urinary bladder may intensify its malfunction. Doppler velocimetry of urinary bladder arteries evaluated by means of transvaginal ultrasound seems to be the promising diagnostic tool. The aim of the study was to evaluate the influence of the topically administered estrogens on pulsatility index (PI) changes in urinary bladder arteries in women suffering from urinary urge incontinence. Material and method: The studied group consisted of 25 menopausal women suffering from urinary urge incontinence. The values of pulsatility index (PI) in urinary bladder arterial vessels were measured 3 times by means of Doppler velocimetry assessment using a 7.5 MHz transvaginal probe (Medison SONOACE 9900 Prime) in the coronal plane and the mean value was calculated. The variables were measured before, after 3, and after 6 months of treatment with vaginal 17ß-oestradiol, initially 25µg pro die for two weeks, followed by 25 µg twice a week. Results: The median values (ranges) of pulsatility indices before, after 3, and after 6 months of topical administration of estrogens were 2.8 (2.4-3.2), 2.8 (2.3-3.3) and 2.7 (1.93.1) respectively. The decrease of bladder arteries PI was observed in 14/25 patients and no change in 11/25 patients. (Friedman ANOVA, ?2=16.42, p=0.0025). No significant change in the PI values after 3 months of treatment were found (Wilcoxon Signed-Rank Test, Z=1.96, p=0.07). No correlations between PI and the clinical variables of studied patients were found. Conclusion: 6-month-long estrogen therapy results in significant decrease of PI values in urinary bladder arterial vessels thus giving the evidence of improved blood supply to the urinary tract structures treated with topical oestradiol.

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68 Routine MSU culture in patients with symptoms of OAB may be missing many genuine infections Khasriya R, Bignall J, Khan S, Malone-Lee J UCL, United Kingdom Industry Support: No Objective This study tested the hypothesis that more meticulous culture methods and a diagnostic threshold of 102 cfu ml-1 would demonstrate more infections than routine clinical laboratory methods applying the 105 cfu ml-1 criterion. Only if a difference were evident from this experiment would a comparison using MSU sampling be merited. Background Since 1957 the diagnosis of urinary tract infection (UTI) from culture of a mid-stream urinary specimen (MSU) has relied on a culture threshold of 105 colony forming units (cfu) ml-1 of a known urinary pathogen. This was based on an experiment using asymptomatic women [1]. The author never claimed to define a threshold applicable in the presence of symptoms. Nevertheless 105 cfu/ml has been widely adopted in clinical practice. More recent studies conducted on acutely dysuric women have shown that in the presence of the classical symptoms of acute cystitis; frequency and urethral pain on micturition, a culture result of 102 cfu/ml was the appropriate diagnostic threshold. This has been validated in several ensuing studies. There are no data on a threshold applicable to patients with urgency ± incontinence, frequency or nocturia. Additionally, the transport and processing delays that affect clinical samples have not been addressed. This is important because the diagnosis of overactive bladder (OAB) presupposes the exclusion of urinary infection. If the diagnostic threshold is set too high significant errors will incur. Whilst the 105 cfu ml-1 criteria were designed for MSU sampling, the first step in examining this matter is best achieved by use of catheter specimens (CSU). Bacteria isolated from CSU have such a high probability of urinary tract origin that it has been established that a 102 cfu ml-1 threshold can be applied to all CSUs. It is also advisable to avoid a priori restrictions on sampling, so a study should be powered to include patients on or off antibiotics. Methods Because we wished to include patients taking antibiotics, we estimated a clinically significant difference as a diagnostic bacterial culture in 10% of routinely processed samples and 20% of those using the study method. It was calculated that a sample size giving 400 pairs would have a power of 97.8% to yield a statistically significant result. Female patients with symptoms of OAB, gave their consent to participate. Their symptoms were recorded using a validated

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questionnaire and their antibiotic consumption noted. A CSU was obtained by Inserting a Lofric (in and out) size 12 Fr catheter into the urinary bladder under aseptic conditions. The urine was collected into a sterile container and used immediately. One pre dried ChromID CPS (Biomerieux) culture plate and two pre dried blood agar culture plates (horse) were immediately inoculated with 200 μL of fresh unspun urine and incubated. The Chrome plates were incubated aerobically for 24 hours at 35–37°C and the blood plates were incubated anaerobically at 35–37°C for five days. The lower threshold of 102 cfu/ml-1 was used to identify a positive culture. An aliquot of each CSU also underwent routine analysis at the threshold of 105 cfu/ml-1. Results 194 women with OAB symptoms were recruited. Their mean age was 57 (sd=18). They provide 378 urine samples collected by CSU. The routine laboratory cultures reported positive results in 46 (12%) of samples whereas the study culture methods isolated bacteria in 114 (30%) of samples (?2=100, df=1, p<0.001, 95% CI of difference 17% to 26%). The study method identified bacteria in 43 (94%) of samples positive on routine culture. However 71 (21%) of those positive on special culture were negative on the routine method. The concomitant consumption of antibiotics had no effect on these differences. Conclusions These data demonstrate more than doubling of the bacterial isolation rate when a more meticulous culture method is deployed. This experiment used CSU sampling so there can be some confidence about the isolates coming from the bladder. These data imply that the misgivings about the validity of routine culture methods apply to patients with symptoms of OAB. They indicate that genuine bacterial infection may be frequently missed during the usual assessment of a patient with OAB symptoms. References 1. Arch.Intern.Med. 100, 709–714. 1957 69 The Safety and Tolerability of Antimuscarinic Treatments in Overactive Bladder: Results From an Update of a Systematic Review and Meta-analysis Chapple C 1 , Khullar V 2 , Gabriel Z 3 , Muston D 4 , Ebel Bitoun C5, Weinstein D5 1 Sheffield Teaching Hospital NHS Trust, Royal Hallamshire Hospital, United Kingdom 2Imperial College, St. Mary’s Hospital, United Kingdom, 3Pfizer Ltd., United Kingdom,

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Heron Evidence Development Ltd, United Kingdom, Pfizer, France

Industry Support: Yes (Industry-initiated, full sponsorship) Objective: To systematically review the evidence from randomized controlled trials on safety and tolerability of antimuscarinic treatments in overactive bladder (OAB). Background: Antimuscarinics, first-line pharmacotherapy for OAB, are proven to be efficacious compared with placebo; however, the relative efficacy is less clear. Safety profiles are highly variable between interventions. Constipation, possibly the most bothersome adverse event (AE), is common, particularly in elderly patients. Therefore, constipation rates associated with agents used to treat urinary symptoms should be considered when selecting a treatment. Methods: A systematic review of the tolerability, safety, and efficacy of licensed antimuscarinic treatments in OAB was published in October 2005 (56 trials). To update the review, a comprehensive search of the major literature databases and conferences was rerun from 2005 to October 2007. This updated review now includes 83 trials and the new agent fesoterodine, which received EMEA approval in April 2007. Meta-analysis was conducted when possible to pool results for each safety outcome and for each combination of treatment by daily dose category and formulation. Results: The following AEs were reported at statistically significant higher levels in active treatments than in placebo: constipation (darifenacin, propiverine ER, solifenacin, tolterodine, and trospium) and blurred vision (oxybutynin, propiverine, and solifenacin) (Table 1; *P=0.05; † P=0.01). Fesoterodine, oxybutynin, propiverine IR, propiverine ER 30 mg/d, and tolterodine IR 2 mg/d were not associated with a statistically significant increased risk of constipation compared with placebo. Relative risks (RRs) for constipation appeared greater with propiverine and solifenacin than with other agents. RRs for safety outcomes generally increased with dose. All antimuscarinics, except oxybutynin IR 5 mg/d and oxybutynin TDS had an increased risk of dry mouth that was statistically significant compared with placebo. Oxybutynin IR 7.5–10 and 15 mg/d, propiverine IR 30 mg/d and ER 20 mg/d, and solifenacin 10 mg/d had a statistically significant higher risk of withdrawals due to AEs than placebo. Interestingly, tolterodine ER had a significantly lower risk of withdrawals due to AEs than placebo.

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Table 1 Relative Risk of Adverse Events with Antimuscarinic Treatments vs Placebo Treatment

Constipation Blurred Dry Withdrawals Vision Mouth Due to AEs (Any Severity)

Darifenacin 7.5 mg/d Darifenacin 7.5 mg/d titrated Darifenacin 15 mg/d Fesoterodine 4 mg/d Fesoterodine 8 mg/d Oxybutynin IR 5 mg/d Oxybutynin IR 7.5–10 mg/d Oxybutynin IR 15 mg/d Oxybutynin IR 20 mg/d Oxybutynin TDS 3.9–4.0 mg/d Propiverine IR 30 mg/d Propiverine IR 45 mg/d Propiverine ER 20 mg/d Propiverine ER 30 mg/d Solifenacin 5 mg/d Solifenacin 10 mg/d Tolterodine ER 4 mg/d Tolterodine IR 2 mg/d Tolterodine IR 4 mg/d Trospium chloride 40 mg/d

2.39†

5.05

2.57†

0.67

2.65†

ND

2.15†

2.16

3.32†

ND

4.40†

1.83

70 The Patient-Perceived Effects of Antimuscarinic Treatment: Results From an Update of a Systematic Review and Meta-analysis Khullar V 1 , Chapple C 2 , Gabriel Z 3 , Muston D 4 , Ebel Bitoun C5, Weinstein D5 1 Imperial College, St. Mary’s Hospital, United Kingdom, 2 Sheffield Teaching Hospital NHS Trust, Royal Hallamshire Hospital, United Kingdom, 3Pfizer Ltd., United Kingdom, 4 Heron Evidence Development Ltd, United Kingdom, 5 Pfizer, France

1.47

0.20

3.01†

1.40

Industry Support: Yes (Industry-initiated, full sponsorship)

2.03

0.21

3.95†

1.33

1.12

0.85

1.08

1.50

1.26

1.65*

2.96†

1.91†

1.74

2.75†

4.42†

1.89†

2.17

8.00*

2.90†

ND

0.26

1.18

1.41

ND

3.84

7.67*

3.54†

7.67*

12.21

2.38†

3.13†

ND

3.05†

2.63*

4.10†

2.39†

3.36

9.30*

3.38†

5.68

3.09† 4.70† 1.49*

1.20 2.29† 2.76

3.32† 5.90† 3.00†

1.16 1.53* 0.71*

1.48

2.44

2.41†

0.90

1.50*

0.71

3.44†

0.88

2.10†

ND

3.17†

1.27

Conclusions: This updated systematic review demonstrates the wide variation in AE risks between agents and some evidence of dose response. Considering the burdensome nature of those AEs, particularly constipation, safety profiles are clearly an important consideration in treatment selection.

Objectives: To systematically review the evidence from randomized controlled trials on the patient-perceived effect of antimuscarinic treatments in patients with overactive bladder (OAB). Background: OAB can adversely affect health-related quality of life (HRQL), and the impact of urinary symptoms can vary markedly based on patients’ priorities and lifestyles. Patient-reported outcomes (PROs) are vital to assessing disease severity and improvement with treatment. Methods: A systematic review of licensed antimuscarinic agents for OAB was published in October 2005 (56 studies). As an update, a comprehensive search of major literature databases and conferences was rerun from 2005 to October 2007. This updated review now includes 83 studies and also the new agent fesoterodine, which received EMEA approval in April 2007. We report here the prevalence of PRO instrument use in studies by antimuscarinic treatment and gender. Results: Of 83 studies included, fewer than half (n=41, 49%) presented PRO data. The most commonly used instruments were the King’s Health Questionnaire (KHQ, n=14), Visual Analog Scale (VAS, n=8), Patient Perception of Bladder Condition (PPBC, n=6), and the OAB questionnaire (OAB-q, n=4). Several other PRO instruments were used infrequently, including the Guandez Questionnaire (n=3), Incontinence Impact Questionnaire (n=3), Indevus Urgency Severity Scale (n=3), SF-36 (n=3), and Urogenital Distress Inventory (n=2). 16 instruments were used in 1 trial each, demonstrating the vast array of instruments available. Table 1 shows the number of studies presenting PROs using the most common instruments and the treatment assessed. Of the 14 studies that reported HRQL data using the KHQ, 9 (64%) reported data by domain, whereas 5 (36%) reported solely overall scores. Many studies failed to report quantitative HRQL data.

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Table 1 PRO Instruments Used in Placebo-Controlled Studies Treatment

Darifenacin ER 15 mg Fesoterodine 4 mg Fesoterodine 8 mg Oxybutynin IR 7.5 mg Oxybutynin TDS 3.9 mg Oxybutynin TDS 26 cm2, 39 cm2, 52 cm2 Oxybutynin IR 9 mg Oxybutynin IR 15 mg Oxybutynin IR 20 mg Propiverine ER 20 mg Propiverine ER 30 mg Propiverine IR 30 mg Solifenacin 5 mg Solifenacin 5 mg titrated Solifenacin 10 mg Tolterodine ER 4 mg Tolterodine IR 2 mg Tolterodine IR 4 mg Tolterodine IR 8 mg Number of treatment arms Number of studies

PRO Instrument KHQ

VAS

PPBC

OAB-q

1 1 1 1 0 1

0 0 0 0 1 0

0 1 1 0 0 0

1 0 0 0 0 0

1 0 0 1 1 1 1 0 1 5 0 1 0 17 14

0 1 1 0 0 0 0 1 0 1 1 1 1 8 8

0 0 0 0 0 0 2 0 0 3 0 0 0 7 6

0 0 0 0 0 0 0 1 0 1 0 0 0 3 4

Conclusions: The number of studies reporting patientperceived effects was found to be very low. There was large variability in the global and disease-specific HRQL instruments used, which limits meaningful comparison of relative HRQL improvements associated with different antimuscarinics. With the prevalence of OAB similar in men and women, it is noteworthy that of the 41 studies reporting PRO data, 10 (12% of total, 24% of those reporting HRQL data) presented HRQL results for a female-only patient population. Consistent use of validated PRO instruments in OAB studies would assist in effective evaluation of treatment outcomes.

71 The occurrence of childhood micturition symptoms in mothers from children with dysfunctional voiding or overactive bladder syndrome van der Vaart H, de Jong T, Labrie J, Nieuwhof A University Medical Center Utrecht, Netherlands Industry Support: No Objective To compare the presence of childhood dysfunctional elimination symptoms between mothers from children with

dysfunctional voiding or overactive bladder syndrome, and a control group. Background Recently, an association between childhood urgency and adult life dysfunctional elimination symptoms was demonstrated.[1] This finding raises the question if hereditary factors are of importance in this association. If so, mothers of children with dysfunctional voiding or overactive bladder syndrome symptoms are expected to have experienced these symptoms themselves in childhood. Methods Mothers of children with proven dysfunctional voiding and/ or overactive bladder syndrome were compared to mothers from children without these complaints, in a case-control setting. All mothers were invited to participate when they presented with their children to the Hospital or were contacted by mail. They were asked to fill out a questionnaire that includes baseline characteristics and 18 questions on childhood symptoms as published previously. [1] Results The table shows the results of our case-control population. At a p-value of <0.1 needing to quickly find toilet to pass urine, often leaving class to pass urine, taking medicine to calm bladder, passing only a few bowel motions a week and waking up in wet bed > few times each month, were all significantly associated. After correction for age in a logistic regression analyses, needing to quickly find toilet to pass urine (Odds Ratio 3.5, 1.7;7.2), often leaving class to pass urine (Odds Ratio 3.1, 1.2;8.0), passing only a few bowel motions a week (Odds Ratio 2.2, 1.0;4.9) and waking up in wet bed > few times each month (2.2, 1.0;5.0) remained significantly associated Conclusions Mothers of children with dysfunctional voiding or overactive bladder syndrome symptoms have experienced these symptoms significantly more often themselves in childhood as compared to mothers from the control group. This is especially true for symptoms related to bladder sensation (urgency), suggesting that these symptoms in childhood are (at least partly) hereditary. Reference 1. Bower WF, Yip SK and Yeung CK J Urology 2005;174: 1623–1628

72 A comparison study of two lower urinary tract symptoms screening tools in clinical practice: The B-SAQ and OAB-V8 questionnaires Basra R1, Cortes E2, Khullar V3, Kelleher C2 1 Imperial College London, United Kingdom, 2St Thomas Hospital London, United Kingdom, 3St Mary’s Hospital London, United Kingdom

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Industry Support: No Objectives The aim of this study was to compare the ability of two screening tools to identify women with bothersome LUTS in a real world setting. Background There is increasing use of screening questionnaires in the field of Urogynaecology. The NICE and ICS guidelines recommend the use of structured urinary symptom questionnaires for the evaluation of patients with LUTS. The choice of screening instrument for a trial or clinic setting should reflect the healthcare needs of the population. A large proportion of patients with urinary incontinence suffer with mixed urinary symptoms, in which case, an overactive bladder specific questionnaire may be too specific for general use. A LUTS screening questionnaire may provide a more all round assessment. The B-SAQ is a valid screening tool for the presence of bothersome LUTS. It is a 4 item self administered scale, which assesses the symptoms and bother associated with urinary frequency, urgency, nocturia and incontinence. The score interpretation table directs patients to seek help as appropriate. The OAB-V8 is a validated, self report 8 item screening questionnaire (OAB-q).The questionnaire assesses the 4 symptoms associated with overactive bladder (OAB). Patients with aggregate scores >8 for women are advised to seek help. Methods Women were recruited prospectively from 2 gynaecology outpatient clinics in two secondary care centres, and a primary care practice. Exclusion criteria for the study were women aged <18 years who were pregnant, lactating, or unable to speak or understand English. Participants were asked to complete the B-SAQ and OAB-V8 questionnaires in the waiting area prior to assessment by a clinician. The order in which patients were presented with both questionnaires was alternated. During the consultation, the doctor completed an evaluation sheet without prior knowledge of the patients’ questionnaire responses, indicating whether the patient was suffering with bothersome LUTS. Data analysis was performed using Pearson’s correlations and receiver operating characteristic curves (ROC). Results 216 women took part in the study (mean age 49yrs). 97 (46%) clinical consultations were for LUTS. Of the study population; 53 women were asymptomatic, 56 women had a clinical diagnosis of overactive bladder symptoms (OAB), 25 women suffered with stress urinary incontinence (SUI), 73 had mixed urinary symptoms (MUS) and 9 had other LUTS. All participants fully completed the B-SAQ; however 3 women (2.5%) left incomplete responses on

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the OABV8. Complete questionnaire responses were used for statistical analysis. Pearson’s correlation values between the B-SAQ and OAB -V8 were 0.74 and 0.60 for OAB symptoms, 0.82 and 0.54 for MUS, and 0.45 and 0.20 for SUI respectively. The Pearson’s correlation values between the B-SAQ questionnaire and the clinical diagnosis showed a stronger correlation than the OAB-V8 scale. Interpretation of the ROC curves shows that both the B-SAQ and the OAB-V8 perform well in detecting symptoms of OAB (ROC areas of 0.83 and 0.82 respectively) and MUS (ROC area of 0.87 and 0.85 respectively). The B-SAQ performs better in detecting symptoms of stress incontinence than the OABV8 (ROC area of 0.85 and 0.68 respectively). Conclusions The choice of screening questionnaire must be tailored to the aim of the screening exercise. In a real world setting, a LUTS screening instrument may be more useful than a condition specific instrument, for symptom detection in a diverse population. 73 Online questionnaire survey of overactive bladder in adult female patients Kato M, Inoue Y, Mita K, Usui T Department of Urology, Graduate School of Biomedical Sciences, Hiroshima University, Japan Industry Support: No Objective: This survey was performed to elucidate the symptom prevalence of overactive bladder (OAB) in adult female patients aged 20 years or older in Japan. Methods: In January 2007, we requested a research company, in which 561,631 subjects were registered and monitored, to conduct a survey through the Internet. In the initial screening, 80,367 Japanese females were randomly selected so that individual age groups in their 20s, 30s, 40s, and 50s or older would include similar numbers of participants, and the O’Leary and Sant symptom index was sent to them. Among the 32,074 participants (39.9%) who provided us with effective answers, those who had some storage symptoms were selected. Among them, 1,155 participants were randomly selected so that the individual age groups would again have a similar number of participants, and a questionnaire survey was performed for them. Questionnaire sheets including questions about their QOL and sexual function in addition to the Overactive Bladder Symptom Score (OABSS) were delivered to them. Results: As a result of the screening, when OAB patients were defined as those who exhibited 2 or more points regarding the items of urgency and 2 or more points regarding the items of frequency, the symptom prevalence

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of OAB was 5.4% (1,738/32,074). When examining individual age groups, we found that the symptom prevalence was 4.9% in the 20s, 5.2% in the 30s, 5.3% in the 40s and 6.3% in the 50s or older, suggesting that the prevalence would increase with age. As a result of the questionnaire survey, it was found that QOL would significantly decrease along with an increase in severity of OAB, but no significant effect on sexual function was confirmed. Conclusions: The symptom prevalence of OAB in female patients in their 40s was almost equivalent to the results of epidemiological investigations performed in Japan, and the symptom prevalence of OAB in patients in their 20s and 30s was also clarified in this survey.

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also has 3 items which evaluate perceived understanding and emotional impact of the disease. Results: 236 participated in the study; 75 patients completed the questionnaires on a single occasion (data not included in this analysis). 90 patients completed the study. 71 patients dropped out of the study due to poor treatment benefit (n=55) and symptom resolution (n=16). All patients who participated in the study reported improvement in all KHQ domains with the exception of the general health perception. Figure 1 shows the changes in KHQ domain score from baseline to 12 months for all patients. Figure 1 Changes in KHQ domain scores from baseline to 12 months 90

74 Do patients who seek treatment for overactive bladder get better? Results of a 12 month prospective study Basra R1, Cortes E2, Basra H2, Khullar V3, Kelleher C2 1 Imperial College London, United Kingdom, 2St Thomas Hospital London, United Kingdom, 3St Mary’s Hospital London, United Kingdom

baseline 3 months 6 months 12 months

80 70 60 mean 50 score 40 30 20 10

Industry Support: No Objectives: The aim of this study was to evaluate real world quality of life (QoL) outcomes of conventional therapy for OAB and investigate the influence of patients’ perceptions of disease on compliance with medication. Background: The natural history of OAB is unknown and it is unknown whether treatment offers short or long term control of symptoms or for some patient’s ultimate cure. Antimuscarinic and behavioural therapies are the mainstay of treatment. Outcomes of OAB treatment are derived mainly from short term clinical trials rather than clinical practice where treatments may be more diverse and followup less stringent. Beliefs about illness and understanding of disease influence satisfaction with treatment and are predictive of future healthcare use. An individual’s perception of illness provides a framework on which they make sense of their symptoms, assess the health risks and direct action and coping strategies. Methods: Women referred from primary care with symptoms of OAB participating in a 1 year prospective study of conservative treatment for OAB were recruited from two urogynaecology clinics. Patients were assessed at baseline and 4 follow-up visits over a 12 month period. Participants completed 2 validated questionnaires at each visit. QoL was evaluated using the Kings health questionnaire (KHQ). Perception of OAB was evaluated using the Brief-Illness perception questionnaire (IPQ) which evaluates the 5 domains of illness perception (identity, cause, time-line, consequences, cure/control) and

0 general health incontinence role limitations impact perception

physical limitations

emotions

sleep/energy

severity measures

social limitations

personal relationships

KHQ domains

There was no difference in baseline KHQ domain scores of women who completed the study and those patients who dropped out because of poor treatment benefit. Patients who reported symptom resolution reported better QoL scores on the KHQ at baseline than patients who dropped out of the study early and those patients who completed the study. The identity domain of the IPQ evaluates symptoms perceived to be due to disease. All patients reported a reduction in OAB symptoms over the study period; a greater score reduction was reported by compliant patients than those who stopped treatment. The cure/control domain of the IPQ evaluates overall symptom control (i.e. disease control from selfdeveloped coping strategies and medical intervention) and treatment control alone (i.e. control of disease due to medical intervention). Over 12 months all patients perceived greater treatment control scores than overall symptom control. All patients reported a reduction in the emotional impact of OAB over the study period. Compliant patients reported greater emotional impact and concerns about OAB symptoms at baseline than non-compliant patients; at 12 months there was no difference in emotion domain scores between compliant and non-compliant patients. Analysis of the IPQ consequences domain showed that all patients perceived a reduction in symptoms and disease effects from baseline to 12 months. Patients who were prescribed drug therapy at baseline reported higher scores on the consequences domain than

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patients who were only given behavioural advice. Patients perceive OAB to be a chronic disorder; this score was consistent throughout the study. At baseline all patients reported poor understanding of OAB. Subsequently, patients who were compliant with medication reported greater disease understanding than non-compliant patients. OAB symptoms were attributed to childbirth/ pregnancy, surgery, stress, anxiety and aging. Conclusions: Treatment of OAB in clinical practice is associated with continued improvement in bladder symptoms and quality of life over a 12 month period. Perceived benefit from treatment is associated with better compliance with medication, fewer symptoms and reduced emotional impact of OAB. Understanding OAB is associated with greater compliance with drug therapy. Symptom resolution is most likely in patients with mild symptoms and low QoL impact.

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who were at least “a little satisfied” with treatment at weeks 8 and 16; the proportion who were dissatisfied at week 8 and then became at least “a little satisfied” at week 16; and changes in OAB symptoms from baseline to weeks 8 and 16. Results: Among subjects dissatisfied with previous TER or other antimuscarinic therapy, 92% and 90%, respectively, were at least “a little satisfied” with TER and behavioral intervention at week 16; 70% and 59% reported being “very satisfied,” respectively (Table 1). Among subjects dissatisfied with treatment at week 8, 76% became at least “a little satisfied” at week 16. Significant improvements from baseline in total micturitions and UUI episodes per 24 hours were reported by subjects previously dissatisfied with TER and by those previously dissatisfied with other antimuscarinic therapy at weeks 8 and 16 (paired t test, all P<0.0001). Table 1 Treatment Satisfaction* and Diary Variables Reported by Subjects Receiving TER and Behavioral Intervention at week 16

75 Combined Effects of Behavioral Intervention and Tolterodine in Subjects Dissatisfied With Their Overactive Bladder Medication Klutke C1, Wyman J2, Guan Z3, Sun F3, Berriman S3, Burgio K4 1 Washington University School of Medicine, United States, 2 University of Minnesota, United States, 3Pfizer Inc, United States, 4Birmingham/Atlanta Geriatric Research, United States Industry Support: Yes (Industry-initiated, full sponsorship) Objective: To assess the effect of tolterodine extended release (TER) in conjunction with behavioral intervention on treatment satisfaction and clinical outcomes in subjects with overactive bladder (OAB) who were dissatisfied with their most recent antimuscarinic therapy. Background: Antimuscarinics are the first-line pharmacotherapy for OAB. Behavioral interventions may enhance clinical outcomes of pharmacotherapy. Methods: Eligible subjects (men and women aged=18 y) in this 16-week, multicenter, single-arm, open-label study reported dissatisfaction with prior antimuscarinic OAB medication; had a mean of=8 micturitions, including=2 urgencyrelated micturitions, per 24 hours and=1 urgency urinary incontinence (UUI) episode reported in a 5-day bladder diary at baseline; and reported having OAB symptoms for=3 months. All subjects received TER plus self-administered behavioral intervention (education handouts) for 8 weeks. Satisfied subjects continued on the same program, and dissatisfied subjects received TER and individualized therapy for an additional 8 weeks. Individualized therapy included clinic-based pelvic floor muscle training with tailored behavioral techniques. Endpoints were the proportion of subjects

Previous Antimuscarinic OAB Therapy

Treatment satisfaction at week 16, n (%) At least “A little satisfied” “Very satisfied” Change in total micturitions per 24 h from baseline to week 16, mean (SD) Change in UUI episodes per 24 h from baseline to week 16, mean (SD)

TER (n=191)†

Other (n=225)†

Total (n=416)†

167 (92) 128 (70) –3.7 (3.8)‡

190 (90) 124 (59) –3.3 (2.8)‡

357 (91) 252 (64) –3.5 (3.3)‡

–1.3 (1.6)‡

–1.3 (1.6)‡

–1.3 (1.6)‡

*Reported on the Patient Perception of Treatment Satisfaction question; †Subjects who received ≥1 dose of assigned study drug and ≥1 post-baseline efficacy assessment. ‡P<0.0001 vs baseline.

Conclusion: TER plus behavioral intervention resulted in high treatment satisfaction and improved symptoms in subjects with OAB who were previously dissatisfied with antimuscarinic therapy, even among those dissatisfied with previous TER therapy.

121 ANTICHOLINERGIC TREATMENT AFTER TRANSOBTURATOR PROCEDURES Pakiz M1, But I2 1 University Clinical Center Maribor, Slovenia, 2Health Institute Faganelj But Maribor, University Clinical Center Maribor, Slovenia Industry Support: No

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Objective: To assess whether the anticholinergic treatment has any influence on satisfaction of patients with transobturator procedures (TOT) and on Quality of Life (QoL) in patients with mixed urinary incontinence (MUI). Methods: 114 patients underwent surgical treatment in local anesthesia (Monarc, TVT-O) due to their MUI. At the postoperative visit, which was scheduled three months after the procedure all patients completed the Urogenital Distress Inventory and Incontinence Impact Questionnaire. The success of surgery was estimated by means of modified visual-analog scale (VAS) ranging from 0% to 100%. The patients were divided in two groups according to whether they were treated with anticholinergics after the procedure or not. Nonparametric tests were used to compare the two groups. Results: UDI symptoms significantly improved after the TOT procedure in all patients with MUI (Table 1). After the procedure the anticholinergic treatment was prescribed to 18 (15.8%) out of 114 patients. No sig. differences in UDI and IIQ points were observed between both groups after the procedure (Table 1). QoL (IIQ points) was significantly inversely correlated (Spearman Correlation Coefficient r=-0.56, p=0.000) to the mean satisfaction rate of the patients after TOT procedure which was estimated at 86.3% (median 93.8%). Objective cure rate three months after TOT procedure was set at 99.1%. Table 1 UDI points, QoL score and Satisfaction rate in patients with and without anticholinergic drugs after TOT procedure ANTICHOLINERGIC DRUGS AFTER TOT PROCEDURE YES NO p (18 pts) (96 pts) Irritative Symptoms (UDI points 0–100) Stress Symptoms (UDI points 0–100) Obstructive Symptoms (UDI points 0–100) Quality of Life (IIQ points 0–400)

Before Surgery After Surgery p Before Surgery After Surgery p Before Surgery After Surgery p

56.9 11.1 0.000 86.1 0.3 0.000 30.9 16.9 0.008

Before Surgery 289.6 After Surgery 99.2 p 0.002 Satisfaction of Patients 86.2% (VAS score 0%–100%)

60.1 10.4 0.000 80.2 0.3 0.000 21.4 7.6 0.000

0.39 0.55

233.8 45.7 0.000 86.4%

0.019 0.086

0.24 0.55 0.035 0.006

0.18

Conclusions: TOT significantly improves QoL in all patients with MUI. However, it seems that anticholinergic treatment after the procedure does not additionally improve

irritative symptoms in MUI patients. Also anticholinergic treatment bears no influence on QoL and satisfaction of patients three months after TOT procedure. Prospective randomized studies are needed to determine the real place of AH treatment in MUI patients after TOT procedures. 122 Effect of Age and Durations of Diabetic Mellitus on Progress of Diabetes-Associated Bladder Dysfunction in Women Chen Y, Huang J, Tsui K, Chen G School of Physical Therapy, Chung Shan Medical University, Taiwan Industry Support: No Objectives: The bladder dysfunction is a frequent complication of diabetes mellitus (DM). We evaluate factors that affect occurrence of diabetes-associated bladder dysfunction in diabetic women who were referred for urodynamics study. Materials and Methods: From January 2003 to December 2006, 202 diabetic women with lower urinary tract dysfunction were referred to our urodynamic unit because of suffering from lower urinary tract dysfunction. All patients underwent a complete urogynecological evaluation including detailed history, physical examination, urine analysis, pad test for quantification of urine leakage, and urodynamics study. DM history and control were documented from chart records and interview. Patients with detrusor overactivity, hypersensitive bladder and mixed incontinence were clustered as overactive bladder (n=97). Those who had detrusor hyperactivity and insufficient contractility as well as underactive detrusor with poor voiding efficiency were grouped as impaired voiding function (n=62). Data are presented as mean±standard deviation, median or percentage depending on the variables. A P-value of less than 0.05 was considered to be statistically significant. Results: Eighteen patients with incomplete data were excluded. Mean age of 184 patients were 61.7(±11.8) years. Median of parity was 4. One hundred and forty-seven patients (79.9%) were menopause. Comparison of variables of patients with overactive bladder (OAB) and impaired voiding function (voiding dysfunction, VD) were showed in following Table. Conclusion: Patients who had impaired voiding function with an older age, longer duration of DM history, longer menopause and more frequent recurrent urinary tract infection (UTI). [Sponsored by NSC 92-2314-B-040-025 and NSC 93-2314-B-040-014 National Science Council (NSC) of Taiwan].

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Age, years Years of DM Years of menopause Menopause Recurrent UTI, n(%)

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OAB (n=97)

VD (n=62)

P value

60.1±11.4 7.3±6.5 11.6±9.3 74 (76.3) 24 (24.7)

66.2±11.8 10.5±7.9 17.5±10.0 57(91.9) 36 (58.1)

0.002 0.009 0.000 0.01 0.000

123 Womens’ perspective of Botulinum toxin treatment for overactive bladder symptoms Digesu A, Camarata M, Lee R, Kundi N, Fernando R, Khullar V Department of Urogynecology, St. Marys Hospital, Imperial College London, United Kingdom Industry Support: No (n/a) Objective: The aim of our study was to evaluate the womens’ expectation about botulinum toxin treatment and what is an acceptable level of improvement from the patients’ perspective. Background: Botulinum toxin is a new form of treatment for detrusor overactivity and is administered via cystoscopic injections of the bladder wall. The minimal invasiveness of Botox-A toxin injection in the bladder makes it attractive as a treatment of refractory detrusor overactivity with a cure rates between 26–80%1. Although data are still lacking on dose, concentration, site, and number of injection and long term efficacy and side effects clinicians are still offering such treatment option to patients. Methods: Women with overactive bladder symptoms (OAB) referred to a tertiary referral urodynamic clinic were recruited between January and March 2008. Only women with detrusor overactivity were included in the study. All women were asked to fill out a self completed multiple choice questionnaire in the waiting area prior to their appointment. A cover letter explaining the aim of our survey (which was not an offer of a new treatment option but to understand womens’ view of botulinum toxin treatment) as well as a brief description of botulinum toxin injections including the reported cure and complication rates1 were also provided to the women. This questionnaire consisted of 14 questions, asking patients about their urinary symptoms, whether they would consider botulinum toxin treatment and what level of urinary symptoms and complications they would find acceptable if they would undergo this treatment. Results: One hundred and one women were studied. The mean age was 63 (range 39–78). There were no missing items. Fiftythree women (52.5%) answered that would accept a

botulinum toxin treatment if the clinician offered to them such therapeutical option whereas 48 women (47.5%) would prefer not to have it. In the group of women who would have a botulinum toxin treatment up to 60% would accept the risk of being unable to empty their bladder and using clean intermittent self catheterization (CISC)=15%; 64% would accept to use CISC only for one day; up to 67% would consider acceptable a beneficial effect=9 months; 79% of women will consider acceptable a cure rate=70%. 93% of these women would expect to have a daytime frequency <8 times a day; 67% of women will accept to have urgency no more than twice a week; up to 75% of women would expect to become continent after botulinum toxin treatment. Conclusion: Only 50% of woman with OAB and detrusor overactivity would consider undergoing botulinum toxin treatment. The majority of these women (64%) will accept to perform CISC only for one day. A cure rate=70% is considered as acceptable by most of women (79%). Up to 75% would expect to become dry after botulinum toxin treatment. Botulinum toxin treatment involves a complex interaction of efficacy and complications. It is important to elicit these from patients. References J Urol 2003;169 (Suppl):351. 124 Urethral Overdilation for Women with Non-neurogenic Voiding Dysfunction TSENG L, LO T, CHEN I, WANG C, Ko Y, Liang C, Dep. OBS/GYN, CGMH, Taiwan School of Electrical and Information Engineering, University of Sydney, Australia, Industry Support: No ABSTRACT Objective: We study the effect using urethral overdilaion for women with voiding dysfunction. Background: 36 patients diagnosed with voiding dysfunction were enrolled in the study. The main indications for urethral overdilation included women with bothersome voiding symptoms presently intermittent catheterization (3, 8.3%), impaired free flow rate (23, 63.8%), and high residual urine (10, 27.8%). All of our patients had the baseline evaluation including noninvasive flow study, videourodynamics, and cystoscopy. Methods: We described a method called urethral overdilation (wide caliber) which means the urethra was dilated up to 54 F with or without the aid of meatotomy for females with voiding dysfunction. Patients were re-evaluated every 3 month with serial free flow rate and ultrasound residual. Outcome measure is based on the change of flow rate, and residual urine. Voiding diary, Urogenital Distress Inventory-

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6 (UDI-6), International Prostate Symptom Score (IPSS) data were also collected. Results: All patients were available follow up and the mean period was 1.7 years (0.5–2.1). The decision between success and fail were based on residual urine, flow rate, UDI-6 and IPSS score. The mean age of the success (n=24, 66.7%) and fail (n=12, 33.3%) group were 56.8 years and 51.3, respectively. By analyzing multiple parameters we used (age, residual urine, flow rate, anesthesia bladder capacity, etiologies, videourodynamics parameters) only anesthesia bladder capacity reach statistically significant (854 vs. 611, P=0.005). Incontinence, however, is a very rare complication. It affected 5.1% of patients and most cases were transient. Conclusions: The present study provides evidence that urethral overdilation, as a minimally invasive procedure, offers a satisfactory cure rate on short term follow-up for women with voiding dysfunction.

125 Predicting voiding dysfunction following laparoscopic surgery to moderate and severe endometriosis VASHISHT A, GULUMSER C, PANDIS G, SARIDOGAN E, CUTNER A UCLH, United Kingdom Industry Support: No Objectives: The aim of this study was to identify the incidence of postoperative voiding dysfunction in women undergoing laparoscopic treatment for moderate to severe endometriosis Background: Surgical treatment for severe endometriosis often involves deep pelvic dissection. It is recognised that with extensive surgical dissection for gynaecological oncology disease there is a risk of developing postoperative voiding dysfunction, thought to be a result of neuronal damage. Similar problems have not been well reported in endometriosis patients. Methods: Local ethics committee approval was obtained. All women undergoing surgery from October 2006 to January 2008 were invited to participate in the study. At the time of surgery a urinary catheter was inserted. A record was made of extent of pelvic dissection and of the stage of endometriosis. The urinary catheter was removed at 6.00 am the next morning and a trial of void protocol was instituted. Results: A total of 77 women were recruited, of which 48 were included. Exclusions included 4 women who had bowel

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resections, 2 sustained bladder injury, 1 needed ureteric stenting, 1 underwent full thickness uterovesical pouch excision. Others had mild endometriosis only. 7 (15%) women failed their trial of void on the first postoperative day. The American Fertility Society (AFS) stage was not related to voiding dysfunction. The most significant factor was rectovaginal dissection (Fisher Exact Test p=0.011). Of the 19 women who had rectovaginal dissection, 6 failed their trial of void. Of the 29 women who had no rectovaginal dissection, only 1 failed her trial of void. Conclusions: This study has highlighted a significant degree of voiding problems following laparoscopic surgery for moderate and severe endometriosis. Within this group of patients, we have not seen any correlation between the grade of disease and postoperative voiding dysfunction. We suggest a hypothesis that rectovaginal dissection poses a significant risk for subsequent bladder dysfunction. Whether this is a result of surgical trauma to the bladder’s nerve supply or whether the dysfunction is due to the disease process itself, is unclear.

126 Trospium chloride once-daily extended release is effective and well tolerated in elderly patients (aged 75 years and over) with overactive bladder (OAB) Sand P1, Dmochowski R2, Rovner E3, Sandage, Jr. B4, Harnett M4, Ellsworth P5 1 Northwestern University, Feinberg School of Medicine, United States, 2Vanderbilt University School of Medicine, United States, 3Medical University of South Carolina, United States, 4Indevus Pharmaceuticals, Inc., United States, 5Brown University, United States Industry Support: Yes (Industry-initiated, full sponsorship) Objective We performed a subgroup analysis to determine the efficacy and tolerability of trospium chloride once-daily 60 mg extended release (XR) in patients aged >/=75 years. Background OAB prevalence increases with age. Pharmacotherapy of OAB in the elderly is complicated by polypharmacy, increased medication side effects and interactions, and risk of cognitive dysfunction. The molecular and metabolic properties of trospium chloride XR, a quarternary ammonium compound with a low likelihood of penetrating the blood brain barrier due to its hydrophilicity, polarity and molecular size, minimal metabolism via cytochrome P450, and low incidence of adverse events, suggest that it may be beneficial and safe in elderly patients.

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Methods Pooled data from two randomized, placebo-controlled, double-blind studies were analyzed for patients aged >/=75 years. Patients were required to have urinary frequency of >/=30 toilet voids/3 days, >/=1 “severe” urgency severity rating/ 3 days (as measured by the Indevus Urgency Severity Scale), and >/=3 urge urinary incontinence (UUI) episodes/3 days (based on a 3-day patient diary). Patients received trospium chloride XR 60 mg or placebo, once daily for 12 weeks. Safety and tolerability outcomes, voiding diary parameters and quality of life (QOL) were evaluated. Results Of the 1165 patients randomized, 143 were aged >/=75 years (85 trospium chloride XR, 58 placebo; mean age 79 years, ∼75% female) and maximum age in each treatment group was 90 years. Anticholinergic OAB therapy had previously been used by over half of the patients. At week 12, trospium chloride XR produced significantly greater mean reductions from baseline than placebo in average daily toilet voids (-2.15 vs -0.37; p< 0.001), daily UUI episodes (-1.77 vs -0.54; p<0.01) and average daily urge frequency (-2.53 vs -0.61; p<0.01), and a significantly greater mean increase in daily volume/toilet void (+30.73 vs +3.10 mL; p<0.01); median percent change in weekly UUI episodes was -69.9% vs -25.0% (p<0.05). Further, the onset of effect for these significant changes was generally within the first week of treatment with trospium chloride XR, reflecting a rapid improvement in OAB symptoms for these patients. There were no significant between-group differences in the change from baseline in average urgency severity associated with toilet voids. Trospium chloride XR was superior to placebo on the OAB Patient Global Assessment and the OAB Questionnaire Health-Related QOL subscales and symptom bother scale. The most common treatment-emergent adverse events (AEs) considered at least possibly related to study medication with trospium chloride XR versus placebo were dry mouth (10.6% vs 3.4%) and constipation (10.6% vs 0%) and were comparable to the overall patient population studied. AEs led to discontinuation in 5.9% of trospium chloride XR recipients and 5.2% of placebo recipients; there were no serious adverse events that were judged to be at least possibly related to study treatment during the 3-month double-blind treatment period. In addition, trospium chloride XR demonstrated similar efficacy and tolerability among patients who went on to receive open-label trospium chloride XR for >/=9 months. There were no reports of CNS adverse effects such as dizziness, vertigo, confusion, somnolence, or visual disturbance in any trospium-treated patient during the 12-week double-blind treatment period, and there were no clinically significant changes in laboratory parameters. This population of patients >/=75 years of age was taking numerous (approximately 5–7) concomitant medications

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during both the double-blind and open-label periods; however, there were no clinically evident metabolic drug interactions or patient dropouts due to this. Conclusions In patients with OAB aged >/=75 years, trospium chloride once daily 60 mg extended release was as effective and well tolerated as in patients aged <75 years, suggesting that it is as safe, effective and tolerable in the elderly as in the population as a whole. The low incidence of CNS effects may be due to the drug’s unique chemical and metabolic properties. 127 ARE OVERACTIVE BLADDER SYMPTOMS ALONE ACCURATE IN PREDICTING DETRUSOR OVERACTIVITY IN WOMEN AND CAN WE DO BETTER? Haylen B1, Yang V1, Logan V1, Husselbee S1, Law M2, Zhou J2 1 St Vincents Clinic, Australia, 2HIV Epidemiology, University of New South Wales, Australia Industry Support: No OBJECTIVE: To test the accuracy of the clinical diagnosis of detrusor overactivity (DO) using overactive bladder (OAB) symptoms alone and to determine whether the addition of any other significant clinical parameters might improve this accuracy. BACKGROUND: Multivariate logistic regression analysis of a wide range of clinical parameters (not just OAB symptoms) in 1140 women presenting for initial urogynecological assessment including urodynamics for symptoms of pelvic floor dysfunction, in order to determine a model of factors most accurately predicting the urodynamic diagnosis of DO. METHODS: Each woman underwent a comprehensive clinical and urodynamic assessment. Data were separated according to (i) no DO; (ii) DO. Clinical and urodynamic parameters possibly associated with DO were assessed using multiple logistic regression analysis with stepwise building of an optimal model for predicting DO. RESULTS: The prevalence of DO was 23%. In multivariate analysis, the OAB symptoms of urge incontinence, urgency and nocturia (not frequency) were significantly associated with DO (all p<0.001). Prediction of DO was not of high accuracy (sensitivity 0.64; specificity 0.67). Other significant clinical parameters (multivariate analysis) were (i) absent symptom of stress incontinence (p=0.012); (ii) women is of lower parity (0–1 vs 2 or more: p=0.003); (iii) no sign of any grade or type of prolapse (p<0.001). Figure 1 shows the receiver operator curves (ROC) for (a) OAB symptoms alone (Model 1); (b) OAB symptoms plus (i) and (ii) (Model 2); (c) OAB symptoms plus (i) to (iii) (Model 3).

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When (i) to (iii) were added to the diagnostic model, there was a marginal improvement in accuracy (area under the ROC increased from 0.70 to 0.74) though this was not deemed to be clinically useful.

Figure 1 Receiver Operator Curve (ROC) of the multivariate logistic regression models

CONCLUSIONS: The OAB symptoms of urge incontinence, urgency and nocturia alone were not found to be particularly accurate in predicting DO. Frequency was not found to be predictive of DO in multivariate analysis. The addition of other significant clinical parameters to a multivariate logistic regression model using OAB symptoms alone, only resulted in a small statistical advantage which is not clinically useful. An accurate clinical diagnosis of DO in women would appear to remain elusive. 128 Urothelial metaplasia and overactive bladder symptoms - Data supporting chronic urothelial stress Lunawat R, Whitehurst N, Khasriya R, Falzon M, Malone-Lee J UCL, United Kingdom Industry Support: No Objective This experiment was designed as a Popperian falsification “What would lead us to believe that OAB is not associated

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with chronic urothelial stress or inflammation?” One answer would be a failure to detect the ubiquitous manifestation of urothelial stress, metaplasia. Background It has been proposed that one mechanism underlying OAB could be a chronic urothelial inflammation resulting in excessive release of ATP. If correct, a number of consequences could be inferred, and these are testable. Serial bladder biopsies could be examined for inflammatory changes related to symptoms. The urinary sediment could be similarly evaluated for evidence of inflammation. The urine itself could be tested for cytokine or ATP expression in relation to symptoms. The urine could be examined for evidence of sustained urothelial stress. Many epithelia react to chronic stress by developing metaplasia. In the early stages this is manifest as greater cell turnover. Exfoliated cell deposits show increased ratios of deeper immature cells to mature surface cells. With persistence, the superficial cells become squamous forming squamous metaplasia and eventually squamous keratinisation can occur. The uroepithelium is very susceptible to metaplasia which should be expected as a manifestation of significant prolonged urothelial stress. Nevertheless, urothelial metaplasia is the focus of only 35 publications on Medline. Cystoscopists, anecdotally describe it as a frequent macroscopic finding, but sampling and recall bias may influence that claim. Methods The study had a 87% power to detect a 15% difference in transitional cell proportions between OAB patients and 20 controls. This was an a blinded observational cohort study Urine samples were obtained by catheter specimens (CSU) apart from males and control subjects who provided cleancatch midstream specimens (MSU). The urine samples were processed in a Shandon Cytospin 2. This centrifuge is used to concentrate the cells from small volumes of urine into a small area on a glass slide with the excess fluid absorbed onto a cardboard filter. Six drops of urine were placed into disposable cuvettes which fitted into a sealed, removable rotor head that was placed in the Shandon Cytospin. The centrifuge was run at 850 rpm for 5 minutes using high acceleration. The slides, prepared in this manner, were then stained by the Papanicolaou method. The stained sediments were examined under light microscopy using a x40 objective with x10 eyepiece. 100 cells were counted and individually identified as (1) superficial umbrella cells (2) deep transitional cells (3) squamous cells (4) inflammatory cells

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The data were examined for differences between patients and controls using a t-test for independent samples at the 95% level of confidence Results 95 patients with OAB were sampled and their mean age was 59 (sd=18) There were 21 controls who were significantly younger with a mean age of 31 (sd=11) with a gender difference there were 14 controls were male but only 2 patients were male. The results of the t-test analysis are shown in Table 1. Table 1 the results of the t-test for independent samples t

Umbrella cells Deep Transitional cells Squamous cells Inflammatory cells

df

Sig. Mean Std. Error 95% Confidence Difference Difference Interval of the Difference Lower

Upper

3.177 114 .002 1.94

.611

.731

3.152

4.186 114 .000 22.20

5.303

11.691

32.702

-.250 114 .803 -1.81

7.236

-16.144 12.524

2.324 114 .022 8.00

3.442

1.180

14.818

Conclusions The age and sex of the controls reflects the difficulties experienced in obtaining samples from normal asymptomatic controls. The asymptomatic tend to be younger and men are more willing than women. However, whilst disappointing these differences do not compromise the experiment, because it was an attempt at falsification. The high proportion of deep transitional cells in the sediments obtained from patients with OAB is indicative of metaplasia so the proposition survives the test. 129 The Association of Detrusor Overactivity Pressure with Overactive Bladder Symptom Severity and Urge Urinary Incontinence Gamble T1, Aschkenazi S1, Nguyen A2, Botros S1, Goldberg R1, Kuo R1, Sand P 1 Evanston Northwestern Healthcare, United States, 2Center for Outcomes Research and Education, United States Industry Support: No (n/a) Objective: To evaluate the relationship between detrusor overactivity (DO) pressure and overactive bladder (OAB) symptom severity and its impact on urge urinary incontinence (UUI). Background and Methods: All female patients attending a single tertiary uroygnecologic referral center between 6/05 – 8/05 and diagnosed with detrusor overactivity on urody-

namic testing were included. High Pressure DO (HPDO) was defined as an involuntary detrusor contraction with a maximum rise from baseline exceeding 40cmH2O (McGuire et al). Subjects with and without HPDO were compared with regards to OAB symptoms, presence of UUI severity, Urodynamic Stress Urinary Incontinence (USUI), and response to various treatments. Results: DO was diagnosed in 383/551 women (70%) with 17% having HPDO. Mean age (range) was 63 (18–89); BMI 28 (15–47) cm/m2, and parity 3 (0–4+). No significant differences were found in age, parity, or BMI between women with with HPDO versus women whose DO pressure was=40 cm H2O. UUI episodes per week were more prevalent in the HPDO group compared to=40 cm H2O (21.4 vs. 13.6, p<.064). Univariate analysis revealed that patients with DO pressures of>40 cmH2O were significantly less likely to have improvement with treatment; more likely to have more severe UUI (>21 episodes per week) and less likely to have USUI. Differences in urgency and nocturia were also noted (Table 1). After controlling for age, BMI, cystocele > Stage II, hysterectomy, post void residual=100°cc, and UTI, HPDO was directly associated with urgency, frequency, nocturia, and UUI. However, women with HPDO were significantly less likely to have USUI or improvement with antimuscarinics, behavioral therapy, and/or prolapse surgery (Table 2). Table 1 Univariate logistic regression Outcomes

DO pressure >=40 vs. <40

Odds ratio (OR)

95% Confidence Interval (CI)

p value

Urgency Frequency Nocturia USUI Improvement with treatment UUI severity

yes vs. no >2 vs. =2 vs. <2 yes vs. no yes vs. no

1.97 0.76 1.68 0.24 0.41

0.99–3.93 0.43–1.36 0.98–2.90 0.14–0.42 0.23–0.73

0.055 0.357 0.062 <0.001 0.003

>=21 vs. <21

2.51

1.39–4.52

0.002

Table 2 Multivariable analysis Outcomes

>/=40 vs. <40

Odds ratio (OR)

95% Confidence Interval (CI)

p value

Urgency Nocturia Frequency Frequency USUI

yes vs no >=2 vs <2 >2 vs. <=2 8 or more vs. <8 yes vs. no

1.61 1.39 0.78 0.74 0.29

0.78–3.31 0.77–2.53 0.42–1.44 0.40–1.37 0.16–0.53

0.192 0.276 0.425 0.341 <0.001

Improvement with any form treatment UUI severity

yes vs. no

0.47

0.25–0.89

0.020

>=21 vs. <21

2.23

1.17–4.24

0.015

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Conclusions: “High pressure” Detrusor Overactivity was significantly associated with more severe OAB symptoms and a less favorable response to treatment. DO pressure can be a useful indicator of OAB symptom severity and whether a patient responds to various treatments. Future studies are warranted to evaluate if more aggressive treatment of HPDO will lead to better control of OAB symptoms and improved quality of life.

130 Are Obstructive Voiding Symptoms in Women with Pelvic Organ Prolapse Associated with Objective Urodynamic Findings? Dain L, Abramov Y Carmel Medical Center, Israel Industry Support: No Background and Objective: The symptoms of voiding difficulty related to the emptying phase of the micturition are hesitancy, straining to void, difficulty starting, diminished stream, a feeling of incomplete bladder emptying and urinary retention. Women presenting for urogynecologic assessment have a 24–39% prevalence of voiding difficulty, and one of the most significant conditions associated with these obstructive urinary symptoms is pelvic organ prolapse. Moreover, it has been shown that there is a significant relationship between voiding difficulty and increasing grades of uterine prolapse, cystocele and rectocele. It is thought that prolapse results in distortion or kinking of the urethra, creating a bladder outflow obstruction. Women with high-grade genital prolapse were found to have increased urethral closure pressure and pressure/ transmission ratios, which decrease after the prolapse is reduced. Impaired bladder emptying is defined as a repeated maximum flow rate below 15 ml/second or a residual urine volume of 150 ml or more. The goal of our study was to determine whether women with advanced pelvic organ prolapse and obstructive urinary symptoms have an objective evidence of bladder outlet obstruction. Materials and methods: In our institution, all women scheduled for pelvic reconstructive surgeries for POP undergo a thorough preoperative urogynecologic evaluation, which includes validated Pelvic Floor Distress Inventory questionnaires, a pelvic examination and a multichannel urodynamic testing. We reviewed preoperative data of all patients who eventually underwent pelvic reconstructive surgery for advanced pelvic organ prolapse (3rd to 4th degree by the Baden Walker halfway system) in our institution between December 2005 and November 2007. Patients’ age, parity, degree of cystocele, rectocele and uterine prolapse, and urody-

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namic parameters (maximal and average urinary flow and residual bladder volume) were recorded in all patients. Results: Eighty women aged 44–80 years were identified and included in the study of whom 39 (48.8%) had obstructive voiding symptoms preoperatively. Of these women only 4 had postvoid residual volume of more than 150 cc and only 7 had obstructive uroflowmetry (maximal flow less than 15 ml/sec). Compared to women without these symptoms, these women did not differ in terms of their demographic and clinical parameters including age, parity, and degree of cystocele, rectocele and uterine prolapse. Moreover, they did not differ in terms of their urodynamic measurements, including postvoid residual bladder volume (52.8±65.8 vs. 41.6±41.2 ml), maximal (23.8±11 vs. 21.9±9.6 ml/sec) and average (10.3±6.2 vs. 9.3±4 ml/sec) urinary flow velocity. Conclusions: Almost half of all women with advanced pelvic organ prolapse complain of obstructive voiding symptoms. However, only a small proportion of these women have objective urinary retention and obstructive uroflowmetry. These findings suggest that the majority of these obstructive voiding symptoms are due to sensory and not motor dysfunction. 131 Responsiveness of the Bladder Control Self-Assessment Questionnaire (B-SAQ) in women receiving treatment for overactive bladder Basra R1, Cortes E2, Basra H2, Khullar V3, Kelleher C2 Imperial College London, United Kingdom, St Thomas Hospital London, United Kingdom, St Mary’s Hospital London, United Kingdom Industry Support: No Objectives: The aims of this study were to evaluate the responsiveness of the B-SAQ; to determine whether patients’ whose lower urinary tract symptoms (LUTS) are well controlled screen negative for lower urinary tract dysfunction (LUTD) after treatment and whether the BSAQ would be a useful clinical tool to determine when patients would benefit from further clinical intervention. Background: With increasing pressure on healthcare organisations to maximise patient health and reduce waiting times and follow-up schedules, it is important to determine when a patient has optimised their LUTS control and will not benefit from further intervention. The Bladder Control Self-assessment Questionnaire (B-SAQ) is designed for use by patients and physicians to screen and determine the need for treatment of LUTS. The scale has undergone psychometric testing for validity and reliability in 14 languages. The responsiveness of the B-SAQ to change in LUTS, and

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its utility as a clinical tool for the follow up of patients with LUTD has not been demonstrated. Methods: Patients referred to 2 urogynaecology tertiary referral centres were recruited to take part in a 12 month prospective study of conservative treatment of OAB. All patients screened B-SAQ positive at baseline (i.e. directed to seek help according to the sum of symptom/ bother scores). Participants were asked to complete the B-SAQ, Kings health questionnaire (KHQ) and patient perception of bladder condition scale (PPBC) at baseline and four follow-up visits over 12 months. The KHQ is a valid 9 domain quality of life instrument which has been used extensively in the assessment of patients with LUTD. The PPBC is a validated single item questionnaire which assesses patients’ perception of their bladder symptoms. Summed symptom and bother scores of the B-SAQ were correlated with the PPBC and KHQ using Spearman’s correlation for all study related visits. PPBC and KHQ scores of patients were compared with B-SAQ scores at the end of the study period using Chi squared to assess the proportion of patients who were screen negative for LUTS after initiating treatment. Using the PPBC scale, patients who reported no bladder problems at the end of the study were defined as asymptomatic, and the positive and negative predictive value of the B-SAQ was calculated. Results: 236 patients (mean age 54 yrs) were approached to take part in the study, 75 patients completed the B-SAQ, KHQ and PPBC at baseline only, 90 patients completed 12mth follow-up; 71 patients dropped out of the study early because of symptom resolution (n=16) or poor treatment benefit (n=55). 688 completed questionnaires were suitable for data analysis. The B-SAQ symptom and bother scores were poorly correlated with the general health perception and personal relationships domains of the KHQ, however were strongly correlated with the 7 remaining domains. B-SAQ scores were strongly correlated with urinary frequency, nocturia, urgency, urge and stress incontinence as reported on the symptom severity scale of the KHQ (Spearman’s 0.42– 0.67). The B-SAQ symptom and bother scores correlated well with change in PPBC scale scores. Following treatment for OAB, 27 patients reported symptom resolution and screened negative for LUTS according to the BSAQ and 29 patients reported no bladder problems on the PPBC scale. 16 patients who reported OAB symptom resolution continued to use drug therapy, 11 were receiving no drug therapy. The positive predictive value of the BSAQ was 98%; the negative predictive value was 63%. Improvement in B-SAQ symptom and bother scores were also associated with QoL improvement as shown by KHQ domain scores and improvement in PPBC scores. The BSAQ has a high positive and negative predictive value in the assessment of symptom resolution in patients with OAB.

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Conclusions: The B-SAQ is responsive to change in LUTS after treatment. It is a valid and reliable tool for the assessment of LUTS, and provides a useful method of evaluating change in symptoms in women receiving treatment for OAB. After initiating treatment for OAB, patients who screen negative on the B-SAQ are unlikely to require further medical intervention, and would benefit from maintenance therapy which may include continuing behavioural measures or drug therapy.

132 Randomized comparison of vaginal electric stimulation, oxybutynin and placebo in managing overactive bladder – urgency-free time interval as primary endpoint for evaluating the treatment outcomes Wang A, Kuo W, Lin Y, Lo T, Liang C, Tseng L Chang Gung University Hospital (at Linko), Taiwan Industry Support: Objective: To determine whether urgency-free time interval (UFI) was effective to evaluate the treatment outcome of overactive bladder (OAB) and the correlation of changes between UFI and urgency episodes. Background: The treatment of OAB is yet to be determined and the evaluation of treatment outcome is as well. Warning time (WT) was first proposed in 1980 by Chalifonx and was used as an efficacy endpoint for evaluating a pharmacological treatment for the symptom of urinary urgency. We have used WT and the change of urgency episodes as efficacy variables to evaluate those subjects with OAB who underwent three different treatment modalities including vaginal electric stimulation (ES), oral oxybutynin (2.5 mg TDS) and placebo. The ES was the most effective treatment among the three. However, the correlation between the changes in WT and urgency episodes was nonsignificantly correlated. Recently, Khullar has proposed UFI which is conceptually another period of time between successive episodes of urgency, as another efficacy endpoint to evaluate the treatment outcome of urinary urgency and OAB. Material & Methods: A randomized placebo-controlled trial was conducted for 73 women with OAB. The interventions for 12-week period, conducted by the physiotherapist, who was unaware of the progress and outcome, included a vaginal electric stimulation program using biphasic symmetric, pulsed current with a 10-Hz frequency, 400-μs pulse width, 10/5 duty cycle and varying intensity; and oxybutynin (2.5 mg) or placebo three times per day. Identical preintervention and postintervention assessments included the measurement of UFI, WT, voiding diaries and King’s Health Questionnaire (KHQ). Both intent to treat

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(ITT) and per protocol (PP) analyses were used to interpret the data. Results: Seventy-three women were randomly allocated into three groups with 26 in the ES, 24 in the oxybytynin, and 23 in the placebo group. The ITT population included 73 subjects (ES, 26; oxybutynin, 24; placebo, 19). Preintervention, statistically significant differences among the three groups were found in urgency and urinary incontinence (all p<0.005, and all p=0.008, respectively). The reduction rate of OAB was 65.4% for ES, 53.6% for oxybutynin and 13.1% for placebo. Further pairwise comparison of the outcome showed the ES was significantly higher as compared with the other two. In the two populations multiple comparison among groups revealed the changes in UFI were nonsignficantly different (all p= 0.518). In all groups, neither of the spearman’s correlation coefficient indicated significant correlation of the improvements between UFI and urgency episodes (all p=0.323 and all p=0.297, respectively). The data between the ES and placebo groups revealed statistically significant difference in domain 2 and total score of KHQ after treatment (p= 0.024 and 0.005, respectively).

WT/UFI WT/Frequency WT/urgency UFI/Frequency UFI/urgency

WT/UFI WT/Frequency WT/urgency UFI/Frequency UFI/urgency

WT/UFI WT/Frequency WT/urgency UFI/Frequency UFI/urgency

ES group ITT (n=26) P-value SCC† -0.152 0.488 0.328 0.127 0.084 0.703 -0.069 0.755 -0.216 0.323 Oxybutynin group ITT (n=24) P-value SCC† 0.213 0.367 -0.008 0.975 -0.551 0.012 0.462 0.04 0.059 0.806 Placebo group ITT (n=23) P-value SCC† 0.191 0.433 0.069 0.794 0.013 0.959 -0.172 0.510 -0.064 0.808

PP (n=23) SCC† -0.290 0.428 0.081 -0.031 0.160

P-value 0.214 0.060 0.736 0.897 0.502

PP (n=20) SCC† 0.352 0.001 -0.506 0.443 -0.260

P-value 0.152 0.997 0.032 0.066 0.297

PP (n=19) SCC† 0.159 0.076 0.082 -0.197 0.043

P-value 0.557 0.778 0.761 0.464 0.875

Conclusion: UFI was not an efficacy endpoint for determining the treatment outcome of conservative OAB treatment. The improvement of UFI was not significantly correlated with that of urgency episodes.

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Assessment/UDS (15–21), (34–45) 15 The Utility of the Empty Supine Stress Test as a Predictor of Intrinsic Sphincter Dysfunction Parekh M, Ginn N Geisinger Medical Center, United States Industry Support: No Objective: To assess the utility of the Empty Supine Stress Test (ESST) to predict presence of intrinsic urethral sphincter dysfunction (ISD) without performing any invasive testing. Background: The success of various treatment modality in particular surgical treatments is based on presence or absence of ISD1, 2 therefore an easy screening test such as ESST will be useful in predicting which patients should undergo multichannel urodynamic testing. In a previous study by Lobel and Sand, the empty supine stress test was found to be a useful screening test for those with intrinsic sphincter dysfunction and stress urinary incontinence.3 A positive empty supine stress test was found to have a 70% sensitivity and 90% negative predictive value for detecting very low urethral closure pressure (MUCP=20 cm H2O), and a 98% positive predictive value of genuine stress incontinence.3 Methods: The study population included all patients seen by one provider in the urogynecology clinic who had multichannel urodynamic testing. The initial evaluation included a thorough history and physical exam that included gravity, parity, menopausal status, voiding and incontinence issues as well as previous medical and surgical care as well as medications. The patient then had an exam that included a cough stress and a post void empty supine stress test as well as a post voids residual urine volume and culture and sensitivity. Standard urodynamic testing was done at a subsequent visit. The test indices were evaluated as to the result of the ESST, the presence of stress urinary incontinence and or detrusor instability, maximal urethral closure pressure, prolapse correction, and post void residual volume. Objective data collected from the exam and urodynamics were maximum straining cotton swab angle, maximum cystometric capacity, maximum urethral closure pressure, presence or absence of stress incontinence and detrusor instability, prolapse correction for testing, post void residual, and empty supine stress test results. The data were analysed using SAS version 9.1 (SAS Institute; Cary, NC). Two independent samples t-test, Chi-square test and Wilcoxon two-sample test were used to determine which variables were

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significantly associated with a positive test and maximum urethral closure pressure of =20 cm H2O. Two by two contingency tables were used to calculate indices. Results: Five hundred ninety six patients qualified to be included in the study. One hundred sixty had a positive ESST and 436 had a negative test. The data were further evaluated as to the post void residual volume and calculations were performed on the total group regardless of post void residual value and those with post void residual <100 ml. Upon analysis Diagnostic indices for using stress urinary incontinence and positive empty supine stress test as a test for maximum urethral closure pressure =20 cm H2O showed sensitivity of 31.8% of detecting intrinsic sphincter dysfunction, specificity of 73.0% of excluding it and a positive predictive value of 5.5% and a negative predictive value of 95.6%. The post void residual data show that there was little difference between the positive and negative groups as to the results even when all PVR were included. Conclusions: The empty supine stress test has been touted as a screening test for intrinsic urethral sphincter dysfunction. Given the data collected from a broad range of patients, the utility of this procedure as a screening test both for intrinsic sphincter dysfunction and stress urinary incontinence appears to be questionable. With the data presented, we cannot recommend this test as a screening test for intrinsic urethral sphincter dysfunction. Take home message: 1. ESST is a poor test for the diagnosis of intrinsic urethral sphincter dysfunction, 2. ESST if negative has good predictive value in ruling out intrinsic urethral sphincter dysfunction. References 1. Ward KL, Hilton P. A prospective multicenter randomized trial of tension-free vaginal tape and colposuspension for primary urodynamic stress incontinence: A two-year follow-up. AM J Obstet Gynec 2004; 190:324–31. 2. Sand PK, Bowen LW, Panganbian R, Ostergard DR. The low-pressure urethra as a factor in failed retropubic urethropexy. Obstet Gynec 1987; 69: 399–402. 3. Lobel, RW, MD, Sand, PK, MD. The empty supine stress test as a predictor of intrinsic urethral sphincter dysfunction. Obstet Gynec 1996; 88:128–32.

16 Predicting Persistent Detrusor Overactivity After Sling Procedures Gamble T1, Aschkenazi S1, Nguyen A1, Goldberg R1, Botros S1, Rivas V2, Sand P1 1 Evanston Northwestern Healthcare, United States, 2 Northwestern University, Evanston, IL USA

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Industry Support: No (n/a) Objective: Determine predictors of persistent postoperative detrusor overactivity (DO) and urge urinary incontinence (UUI) after sling procedures for mixed urinary incontinence (MI). Materials and Methods: From January 2000 to July 2007 a total of 728 slings were performed on women with complaints of stress or mixed urinary incontinence. Subjects underwent transvaginal midurethral slings (Tension Free Vaginal Tape [TVT] [Ethicon, Inc., Somerville, NJ] or SPARC, [American Medical Systems, Minnetonka, MN] or trans obturator tapes (TOT) Monarc, [American Medical Systems] or Obtryx [Boston Scientific, Natick, MA] or transvaginal bladder neck slings anchored to Cooper’s ligament Capio CL slings, [Capio CL, Boston Scientific, Natick, MA]. Women with persistent DO postoperatively were compared to those whose DO had resolved postoperatively on urodynamic testing. Multivariable logistic regression models were used to evaluate the possible confounding effects among predictors on the outcome of persistent postoperative detrusor overactivity. All variables that were individually statistically significantly related to persistent DO (p<0.05) were entered into the multivariable model and non-significant variables were removed one at a time. Subjects with persistent versus resolved UUI were similarly compared. SAS version 9.1 (SAS Institute, Inc., Cary, NC) was used for all analyses. Results: 305 of 432 (70.6%) women who had preoperative DO completed postoperative urodynamic testing. Age, parity, BMI, prior surgery, concurrent hysterectomy, and performance of anterior/posterior repair did not differ in women with persistent postoperative DO versus those whose DO resolved. The median age was 65 years (range: 32–91). Median (range) of follow-up was 3(1–17) months. Stress incontinence cure rate in this subset of women was 88.7% (228/257), with 29(11.3%) failures. 31.5% of women had post operative resolution of DO. Transobturator slings had the lowest rate of persistent DO (53%), followed by retropubic slings ([SPARC =66%; TVT= 64%]) and lastly bladder neck slings (86%). Significant predictors for persistent DO included age (OR=1.38, p=.001), prior hysterectomy (OR=1.95, p=.012), absence of paravaginal repair (OR= 0.46, p=.015), nocturia (OR=1.91, p=.013), maximum cystometric capacity (MCC) (OR=0.79, p<.001), DO volume (OR=0.83, p=.006), urethral closure pressure (OR=0.83, p<.001), and maximum flow rates (OR=0.77, p=.014). Persistent UUI was predicted by sling procedure (p<0.001). See Tables 1–2.

S65 Table 1 Preoperative urodynamics parameters of sling patients who had preoperative DO and returned for postoperative urodynamic) testing (N=305)

Maximum cystometric capacity DO pressure, cm H2O DO volume, cc

Patients with Patients with OR (95% Persistent DO Resolved DO CI) Mean (SD) Mean (SD)

p value

458.9 (185.6)

<0.001

22.1 (15.4)

434.5 (192.5)

Urethral 31.3 (23.6) closure pressure, cm H2O Max Flow 16.8 (10.7) Rate, cc/sec Mean Flow Rate, cc/sec

9.5 (7.6)

539.3 (175.8) per 100 cc, 0.79 (0.69– 0.91) 17.8 (10.0) per 10 cm H2O, 1.31 (1.05–1.63) 501.8 (190.1) per 100 cc, 0.83 (0.73– 0.95) 45.0 (30.0) per 10 cm H2O, 0.83 (0.74–0.92) 20.4 (12.4)

11.1 (9.1)

0.017

0.006

<0.001

per 10 cc/ 0.014 sec 0.77 (0.62–0.95) per 10 cc/ 0.116 sec, 0.79 (0.59–1.06)

Table 2 Multivariable Logistic Regression Model for Prediction of Persistent DO, N=326 Odds Ratio (95% CI) Sling procedure TOT Bladder Neck SPARC TVT Max Cystometric capacity, per 100 cc

p-value <0.001

1.00 6.90 1.51 2.18 0.74

(reference group) (3.34–14.25) (0.61–3.71) (1.07–4.44) (0.63–0.86)

<0.001

Conclusions: When treating women with mixed incontinence, age, nocturia, MCC, and choice of sling procedure impact persistence of DO and UUI. There is a need for ongoing prospective research in this area to determine the role of preoperative testing for urinary incontinence. Patients should be clearly informed of the possibility of DO persistence and its sequelae according to sling type.

17 The NICE guideline on the management of female urinary incontinence: what the experts think Basu M1, Duckett J1, Moran P2, FreemanR3 1 Medway NHS Foundation Trust, United Kingdom, 2 Worcester Royal Hospital, 3Derriford University Hospital

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Industry Support: No Objective This study had the objective of investigating the opinions of members of the British Society of Urogynaecology (BSUG) regarding the recommendations contained in the UK National Institute of Health and Clinical Excellence Guideline entitled “The management of female urinary incontinence”. Background In October 2006 the National Institute for Health and Clinical Excellence (NICE) issued Guideline Number 40: The Management of Urinary Incontinence in Women. This is an attempt to rationalise “best practice advice” of this common, often overlooked health problem, which represents a large socioeconomic burden to affected women, their relatives, care-givers and society as a whole. The guideline lays down advice on all aspects of management including assessment, conservative management options and medical and surgical treatments. Whilst the majority of the recommendations in the guideline are already common practice, there were some statements which are regarded as controversial. We therefore aimed to survey the opinions of urogynaecologists practising in the UK regarding the guideline. Methods A 21 point questionnaire was developed and sent to all UK based members of the British Society of Urogynaecology (BSUG). BSUG is a specialist society who’s membership is comprised of Obstetricians and Gynaecologists with an interest in urogynaecology. The Society was set up in 2001 on the advice of the then President of the Royal College of Obstetricians and Gynaecologists (RCOG) to help set and raise standards in the management of pelvic floor disorders in women including urinary incontinence. BSUG works closely with the RCOG and provides a focus for research, training, audit and guideline development. BSUG supports audit and guideline development. Each point in the questionnaire was a statement from the NICE guidance, with participants being asked whether they strongly agree, agree, neither agree nor disagree, disagree or strongly disagree. The questionnaire was designed with the aim of meeting the objective of surveying opinion of BSUG members regarding the NICE guideline. It was decided to use closed format questions in order to both make the questionnaire easier to answer and later analyse, and to eliminate observer bias. The responses that were used were chosen as they were deemed to be the less likely to lead the respondent. The stems were taken directly from the NICE guideline in order to avoid bias in the questions. The questionnaire was reviewed by all authors for clarity and ease of

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answer. The results were collated and inputted into a Microsoft Excel database. Percentages were calculated. Results There were 134 completed questionnaires out of a total 209, giving a response rate of 64%. There were two areas where the NICE guideline was thought to be unsatisfactory with the majority of respondents disagreeing with the advice: statement 4: “In women who clinically have pure stress urinary incontinence, multichannel cystometry should not routinely be used prior to surgical treatment.” A total of 80% of respondents either disagreed or strongly disagreed with the recommendation. Secondly 72% of respondents disagreed that immediate release oxybutynin should be used as first line treatment (Statement 8 “The first line drug treatment of women with OAB or mixed UI should be immediate release nonproprietary oxybutynin, if bladder training is ineffective”). A small but significant minority (25–39%) disagreed about the statements regarding the use of duloxetine. When asked if the guidance overall reflected their current practice, 7.5% strongly agreed and 49.3% agreed. In terms of changing their practice to comply fully with the guidance, 38.8% disagreed and 13.4% strongly disagreed. Conclusions The majority of the guidance formalises current practice amongst gynaecologists and urogynaecologists practising in the UK. There are significant concerns regarding some of the recommendations, and the results indicate that over half of respondents would not change their practice to follow these recommendations. 18 Ultrasonographic assessment of polypropylene implants after transvaginal repair of cystocele and/or rectocele with the Prolift® kit Velemir L, Fatton B, Amblard J, Savary D, Jacquetin B, Urogynecology Unit, CHU Clermont-Ferrand, France Industry Support: No Objective This study aimed to analyse the ultrasonographic appearance of polypropylene implants after transvaginal polypropylene reinforcement of the pelvic fascias and to compare it with the postoperative physical examination. Background The assessment of the local result obtained after transvaginal prosthetic reinforcement of the pelvic fascias is essentially based on physical examination including vaginal inspection with Valsalva maneuver and palpation. However,

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as careful as can be this physical examination, it rarely provides a clear explanation for recurrence and/or vaginal pain. In this context, we aimed to test if postoperative ultrasonography of polypropylene implants would be helpful to understand such unexpected outcome. Methods Ninety-one patients who had been operated on for cystocele and/or rectocele with the Prolift system (Gynecare®) between march 2005 and august 2006, underwent an introital and vaginal ultrasonography (7.5 MHz endovaginal probe, angulations=90°) at their postoperative check-up (=1 year). Two distances were systematically measured at rest and during Valsalva maneuver on a sagittal view: distance 1 between the proximal extremity of the anterior implant and the urethrovesical junction, distance 2 between the proximal extremity of the posterior implant and the anorectal junction. The aspect of the implants was analysed and classified as regular (no folding, no wave or easy unfolding of the implant with the endovaginal probe) or irregular (persistent folds or wavy aspect). The maximal thickness of the implant was measured on a sagittal view. The ultrasonographic data were compared with the following parameters obtained at concomitant physical examination: values of Ba and Bp, global percentage of mesh shrinkage estimated by transvaginal implant palpation, presence or absence of any pain triggered by implant palpation. All the data were prospectively recorded and analysed with the software SEM. Results Forty-six anteroposterior implants, 29 anterior implants and 16 posterior implants were studied. Mean follow up was 17.9 months (12–27). The maximal thickness of the anterior and posterior implants was correlated with the percentage of anterior (r=0.458, p<0.001) and posterior (r=0.688, p< 0.0001) implants shrinkage. An association of a maximal thickness >5 mm with an irregular aspect of the implant had a positive predictive value of 100% and a negative predictive value of 94.8% of painful mesh shrinkage in this series. The distance 1 was significantly increased at rest and during Valsalva maneuver in the group with cystocele recurrence (Ba=-1) compared with the group without cystocele recurrence (p<0.001). The distance 2 was significantly increased at rest and during Valsalva maneuver in the group with rectocele recurrence (Bp=1) compared with the group without rectocele recurrence (p<0.001). The percentage of anterior mesh shrinkage was correlated with the distance 1 measured at rest (r=0.267, p<0.05) and during Valsalva maneuver (r=0.299, p<0.01). The percentage of posterior mesh shrinkage was correlated with the distance 2 measured at rest (r=0.578, p<0.0001) and during Valsalva maneuver

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(r=0.612, p<0.0001). Finally, the ultrasonography supported the theory that recurrences were mainly attributable to a combination of shrinkage and displacement of the proximal part of the implants. It also showed an important mesh remodelling with thickening and shrinkage in patients with pain triggered by implant palpation. Conclusions In this study, the ultrasonography seems to be a useful complement for clinical assessment after transvaginal polypropylene reinforcement of the pelvic fascias. It allows to observe and to measure objectively the remodelling of the implant suggested by a careful physical examination. The thickness and the irregular aspect of the implant are two objective indicators of mesh shrinkage. These ultrasonography data suggest an explanation for both recurrences and postoperative pain or tenderness observed after mesh augmentation: excessive scaring of the surrounding tissue might lead in some patients to severe mesh shrinkage with, in one hand, a possible displacement of the mesh under the vaginal wall leading to recurrence and, on the other hand, a tenderness of the peri-prosthetic tissues resulting in dyspareunia. 19 Modified PISQ-12 for use in a general female population; the PISQ-9 Aschkenazi S1, Rogers R.2, Beaumont J1, Gamble T1, Botros S1, Sand P1, Goldberg R1 1 Evanston Northwestern University, United States 2 University of New Mexico, United States Industry Support: No (n/a) Objective: To test the validity and reliability of the shortform Pelvic-Organ-Prolapse/Urinary-Incontinence Sexual Questionnaire (PISQ-12), as well as a shorter modified version (the PISQ-9; includes only the 9 general sexualfunction items, Table 1) in a general female population without POP/UI, and to determine normative mean total scores in a sexually-active cohort of women without bothersome pelvic floor dysfunction. Background: Female sexual dysfunction is believed to be highly prevalent, estimated to occur in 39%-53% of the general population. The PISQ-12 is a condition-specific sexual function questionnaire for women with POP and/or UI that is shown to be valid and reliable. It is a short form (12-item) of a 31-item questionnaire that assesses 3 sexualfunction domains: 1-Behavioral/Emotive, 2-Physical, and 3-Partner related. It has been validated in heterosexual, sexually active women with POP/UI. The PISQ-12 has good validity, reliability and is responsive to change in

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sexually active women with POP and/or UI. In addition, the PISQ-12 is easy to understand and use, and is rapidly completed by the respondent. It has been used widely to assess the effect of non-surgical therapy, as well as pelvic floor reconstructive surgery on sexual function in women with POP/UI. Scores for the PISQ 12 are calculated as total and individual item scores to allow for comparison of responses to individual questions. Of the 12 questions, 9 are general sexual-function questions, and 3 directly pertain to women with UI/POP. Being a condition-specific questionnaire, the PISQ-12 has not been validated for use in a general population of women that do not have POP/UI. In view of the validity, reliability, ease of use and short time needed to complete the questionnaire, as well as the familiarity of the short PISQ-12 among physicians treating women with POP/UI, we aimed to test whether both the PISQ-12, and the modified version, the PISQ-9, could precisely and accurately assess sexual function in a general population of women without pelvic floor disorders. Methods: A cross-sectional multi-questionnaire survey of sexually-active women was completed by 557 twins at two twin annual gatherings in 2005–2006. Participants provided demographics and completed the PISQ-12, a sexualfunction questionnaire specific for women with POP/UI, as well as a general female sexual-function questionnaire, the Index-of-Female-Sexual-Function (IFSF). Patients also completed the Pelvic-Floor-Distress-Inventory-20 (PFDI20), the Beck-Depression-Inventory-II (BDI-II) and the Pelvic-Pain-and-Urgency/Frequency scale (PUF). PISQ-12 and PISQ-9 scores were compared to IFSF, BDI-II (scores= 13=minimal/no depression) and PUF scores (interstitial cystitis=15, normal=4). Cronbach’s-alpha and Spearmancorrelation coefficients were calculated for internal consistency and convergent-validity of the 9 general sexual function questions of the PISQ-12 in a population without POP/UI. Results: Total PISQ-12 and PISQ-9 scores correlated significantly with IFSF total scores (Spearman-coefficient, 0.65 and 0.66, respectively P<.0001). Mean PISQ-12 and PISQ-9 total scores of sexually-active women without vs. with bothersome pelvic floor complaints were significantly better (40.0 +/-4.3 vs. 37.1 +/- 5.2, p<.0001, Effect-Size (ES)=0.65 and PISQ-9 28.1 +/- 4.1 vs. 25.8 +/- 4.8, p<.0001, ES=056). Similarly, PISQ-12 and PISQ-9 scores were worse in women with depressive symptoms vs. those without, and in those with high vs. low PUF scores. Cronbach’s alpha values in sexually-active women were 0.73 and 0.72 for total PISQ-12 and PISQ-9 scores, respectively.

Int Urogynecol J (2008) 19 (Suppl 1):S1–S166 Table 1 The PISQ-9: Sexual-function questionnaire modified for use in a general heterosexual, female sexually-active population 1. How frequently do you feel sexual desire? May include wanting to have sex, planning to have sex, frustration due to lack of sex, etc. 2. Do you climax (have an orgasm) when having sexual intercourse with your partner? 3. Do you feel sexually excited (turned on) when having sexual activity with your partner? 4. How satisfied are you with the variety of sexual activities in you current sex life? 5. Do you feel pain during sexual intercourse? 6. When you have sex with your partner, do you have negative emotional reactions such as fear, disgust, shame or guilt? 7. Does your partner have a problem with erections that affects your sexual activity? 8. Does your partner have a problem with premature ejaculation that affects your sexual activity? 9. Compared to orgasms you have had in the past, how intense are the orgasms you have had in the past six months?

Always Usually Sometimes Seldom Never

Always Usually Sometimes Seldom Never

Always Usually Sometimes Seldom Never

Always Usually Sometimes Seldom Never

Always Usually Sometimes Seldom Never

Always Usually Sometimes Seldom Never

Always Usually Sometimes Seldom Never

Always Usually Sometimes Seldom Never

Much Less Same less intense intensity intense

More Much intense more intense

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Conclusions: PISQ-12 and PISQ-9 scores of sexually-active women without POP/UI strongly correlated with scores of a general sexual-function questionnaire and were lower in women with depressive symptoms or pain-of-bladder origin. Normative scores were suggested for both questionnaires. The results indicate that PISQ-12 or PISQ-9 may be used for comparative studies in a sexually-active female population without pelvic floor complaints, greatly enhances the target population of this evaluation instrument.

Incidence of true occult incontinence =

4 33

¼ 12:12%

Conclusions: 1 out of 16 patients (6.3%) with advanced prolapse had false negative urodynamic testing for occult incontinence. Our study confirm the fact that despite advance in urodynamic technology, a false negative rate of approximately 6% should be quoted while counseling patient for surgery with advance prolapse but no complaint of incontinence.

20 False Negative Rate of UD Testing in Diagnosing Occult Incontinence Hessami S, Hassan K, Guan X, Diarbakerli F, Yung M, Mount Sinai School of Medicine, Saint Joseph Regional Medical Center, United States

21 The Virtual Urogynaecology Clinic Jha S1, Radley S1, Jones G2, Farkas1 1 Sheffield Teaching Hospitals NHS Trust, United Kingdom, 2 University of Sheffield, United Kingdom

Industry Support: No

Industry Support: No

Objective: In this study we seek to determine false negative rate of urodynamic testing in diagnosing occult incontinence (masked incontinence) in patients with advance prolapse. Background: Urinary incontinence may be masked in patients with advance prolapse (Stage 3 or 4) due to kinking of the urethra. Some of these patients develop urinary incontinence after surgery for prolapse. Methods: Retrospective chart review of 45 consecutive charts of patients that had undergone pelvic reconstructive surgery for advance prolapse from 01/01/2006 to 12/31/2006. Inclusion criteria: All patients that had undergone pelvic reconstructive surgery for advance prolapse, and had no subjective complaint of incontinence. Exclusion criteria: Patient with advanced prolapse with incontinence history. Results: The 45 patients with advanced prolapse underwent urodynamic testing (UD testing), and 29 were identified as having occult incontinence and 16 having no incontinence. After pelvic reconstructive surgery, 1 out of the 16 (6.3%) continent patients complained of post-operative urinary incontinence.

Objective To evaluate the ‘Virtual Urogynaecology Clinic’ (VUC) Background ePAQ-PF (electronic Personal Assessment Questionnaire Pelvic Floor) is a web-based interactive detailed assessment tool for pelvic floor disorders and has been validated in both primary and secondary care (BJOG, 2005). It may be used on-line as well as installed on local networks or individual computers. The Virtual Urogynaecology Clinic (VUC) combines electronic interviewing using ePAQ-PF with telephone consultation. Patients are identified by review of referral letters and contacted by administrative staff to assess their willingness to complete epaq-online & take part in the VUC. A date and time for telephone consultation is agreed and an information leaflet posted, providing them with details on how to use epaq-online (www.epaq-online.co.uk) and make their results available to their VUC clinician. All epaq-online data are collected anonymously, via a password-protected web site. Access to ePAQ data is only possible for registered clinicians, who also have express permission from an individual patient. Following completion, encrypted ePAQ data may be personalised, incorporated in the patient’s clinical record & transferred to the ePAQ hospital database. Methods Between November 2007 and March 2008, 38 women were assessed in the VUC (mean age 45, range 23–65). Following VUC consultations, women were posted a summary of the consultation including relevant patient information leaflets and details of further follow up arrangements. Women were also sent postal questionnaires relating to their experience and views of the VUC. These included the

Advance prolapse with no complaints of urinary incontinence (n=45) UD Testing Occult Incontinence (n=29) Reconstructive Surgery, w/ Anti-incontinence Surgery (n=11)

No Incontinence (n=15)

No Incontinence (n=16)

Reconstructive Surgery, w/o antiincontinence surgery (n=18)

Reconstructive Surgery No Incontinence (n=15)

Incontinence (n=3)

Incontinence (n=1), 6.3%

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Patient Experience Questionnaire (PEQ), Patient Enablement Index (PEI) and QQ-10 (10-item instrument relating to the value & burden of questionnaire use during the clinical episode). Results The mean waiting time between referral & VUC was 28 days (range 7-46). A total of 23 women (61%) returned completed postal questionnaires. Primary complaints (measured by ePAQ-PF) were: Stress incontinence (79%), Overactive bladder (50%), Prolapse (27%), Bowel problems (24%) & Sexual dysfunction (24%). At the time of VUC, 79% had treatment planned or initiated, 39% were referred for physiotherapy, 44% were scheduled for urodynamics, 8% were referred to another consultant clinic and 12% had follow-up appointments arranged in the urogynaecology clinic. Data from the postal questionnaires (PEQ, PEI & QQ-10) were transformed onto scales of 0-100 and analysed using simple descriptive statistics. Positive aspects (communication and value: 0=worst and 100=best possible) had mean scores of 84 (SD 16) and 77 (SD 16) respectively. Negative aspects (barriers to healthcare and burden of using ePAQ: 0=best and 100=worst possible) had mean scores of 15 (SD 15) and 25 (SD 16) respectively. Conclusions The VUC represents a potentially major shift in the delivery of urogynaecology services, offering rapid initial assessment and initiation of treatment of pelvic floor disorders. Patient satisfaction and acceptability are high, particularly in relation to communication and access. Early experience with the VUC indicates the potential for improved efficiency as well as quality of care. Patients generally find the system easy & rewarding to use. The implications of not seeing & examining patients at their initial assessment need careful consideration, though urinalysis and pelvic examination can and should be routinely carried out in primary care. Women may find VUC consultations less stressful and more acceptable as they are aware that pelvic examination will not be performed. A randomised controlled trial is now underway, comparing VUC with standard care, utilising the same instruments applied in the present observational study as well as evaluating cost effectiveness, efficiency & the patient experience. Studies are also required to evaluate the use of this approach system in different patient groups (prolapse and incontinence, young and old) and in other clinics and clinical situations where ePAQ is used; colorectal surgery, physiotherapy and urology.

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34 ROLE OF OUTPATIENT BEDSIDE RENAL ULTRASOUND SCREENING FOR HYDRONEPHROSIS IN SEVERE UTEROVAGINAL /VAULT PROLAPSE Charn L, Heng Fok W, How Chuan H KK Hospital, Singapore Industry Support: No Objective: To determine the role of outpatient Bedside Renal Ultrasound Screening for Hydronephrosis in Severe Uterovaginal /Vault Prolapse. Background: It is known that women with severe uterovaginal prolapse /or vault prolapse may have hydronephrosis if left untreated. We want to evaluate the incidence of this locally using the bedside ultrasound by our urogynaecological department to assess the kidneys and to compare our findings with those performed by our Radiology department. Methods: This is a retrospective case-series study of 121 patients who presented with severe uterovaginal or vault prolapse at the urogynaecological centre of our hospital during the period from March 2006 to December 2007. All the patients with at least grade 4 cystocele or 4th degree uterovaginal procidentia/vault descent are routinely screened for hydronephrosis with the bedside ultrasound machine in the clinic. The cases are then routinely sent to the Department of Diagnostic imaging to be have a formal renal ultrasound at the next appointment and will usually have a blood test for renal function (urea, electrolytes and creatinine) pre-operatively. Renal ultrasound at the clinic is done by a core team of 2 urogynaecolgical fellows and 2 consultants who are trained in the usage of US kidneys. The criteria for hydronephrosis is taken as renal pelvis >1 cm. The results for the renal ultrasound done at the clinic by us (urogynaecologist) were compared to the that done by the our radiology colleagues. Cases of severe uterovaginal/ vault prolapse(procidentia) during the study period who had at least a screening bedside renal ultrasound and another formal renal ultrasound done at the radiology department were included in the study. Spss version 16 and open epi version 2.2 were used. Agreement was tested using Cohen’s kappa coefficient. Results: There were a total of 121 cases of severe uterovaginal/vault prolapses, and this could be further broken down to 14 vault prolapses and 107 uterovaginal prolapses. The mean age of the study population was 66.1 with a range of 46–89. The median duration of months the patients felt the lump was out of position was 12 months with a range from 1–120 months.

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The severity of the prolapse (as defined by the Baden and Walker system of classification) in our study population: 97.6% had grade 3 cystocele or more 59.7% had grade 3 rectocele or more Out of the cases 107 cases with an intact uterus, all had 3rd degree cervical descent or more 14 cases had previous hysterectomies performed and 85.7% of the cases had 3rd degree Vault descent or more. The overall incidence of hydronephrosis in our study was 20.6% (25/121 cases). The incidence of hydronephrosis in severe vault prolapse was 1 out of 14 cases=7.1%. The incidence of hydronephrosis in severe uterovaginal prolapse was far higher with 24 out 103 cases=22.4%. However, there was no statistical significance between the two in terms of the incidence of hydronephrosis. (p=0.18>0.05). The results for the renal ultrasound done at the clinic by us (urogynaecologist) were compared to the that done by the our radiology colleagues. Left and right kidneys were separately evaluated. Using the bedside ultrasound to screeni for hydronephrosis, we obtained the following results: Sensitivity: 66.67% Specificity: 87.68% Positive predictive value: 50.985 Negative Predictive value: 93.19% Cohen’s kappa (unweighted) coeeficient was 0.4834 (0.3591–0.6077); indicating moderate agreement of the bedside screening ultrasound compared to the one done by the radiologist.In terms of simple percentages, about 84.2% of our ultrasound findings correlated to the findings by our rasiology colleagues. Conclusions/Clinical Importance: It is important to diagnose hydronephrosis pre-operatively because it is an indication for surgery in severe prolapse and should be recorded for medico-legal reasons in the notes if present pre-operatively. Using bedside ultrasound to evaluate the kidneys in these cases of severe prolapse routinely will save cost and time for our patients if the quality of our bedside ultrasounds matches the standard at diagnostic imaging department. Our study has shown that the renal ultrasound done at bedside may be useful as screening tool with good specificity and negative predictive value, in that patients who do not have gross hydronephrosis at the clinic may, in most cases be spared from undergoing a routine formal renal ultrasound by our radiology colleagues.

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35 The effect of maximal and submaximal pelvic floor contractions on bladder neck elevation and intraabdominal pressure Baessler K, Junginger B Pelvic Floor Centre, Charite University Hospital, Germany Industry Support: No Objective The aim of this study was to assess the effect of maximal and submaximal voluntary pelvic floor muscle contractions (PFMC) on the bladder neck (BN), transverse abdominis (TrA) and internal oblique (IO) muscles and on the intraabdominal pressure (IAP). Background Pelvic floor rehabilitation programs include a range of exercises and strategies and often maximal pelvic floor contractions. Their simultaneous effects on bladder neck elevation and intraabdominal pressure as well as cocontractions of the abdominal muscles have not been studied. Methods We studied 14 nulliparous, premenopausal women without pelvic floor symptoms, pelvic organ prolapse and previous pelvic floor surgery who were able to voluntarily contract the pelvic floor muscles. Intraabdominal pressure was recorded with an intrarectal pressure probe. The position of the bladder neck was imaged on perineal ultrasound. Images were saved and analysed with the assessor blinded to the level of effort of contractions. Thickness of the transverse and internal oblique abdominis muscles during the tasks was measured using a second abdominal ultrasound probe placed on the upper right-lateral abdomen. Tasks: 1- measurements at rest, 2- maximal PFMC, 3perceived 50% of maximal PFMC (perform a PFMC half as strong as your last maximal contraction), 4- perceived 25% of maximal PFMC (perform a contraction half as strong as your last 50% contraction), 5- perceived 75% of maximal PFMC (perform a contraction three-quarters of your maximal contraction, almost a maximal contraction). The power calculation based on previous bladder neck measurements revealed that 34 subjects were required to demonstrate a difference of 4 mm with a power of 80% and a=0.05. Results The age of the 14 women ranged between 21–49 years (median 35). There was a significant BN elevation already at 25% of PFMC. BN movements at 75% and 100% of PFMC were not statistically significantly different from 50% of PFMC; Table). IAP increased significantly with increasing amount of effort of pelvic floor contractions. The thicker the IO at 50% of PFMC the smaller the BN

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movement (Spearman -0.64, p=0.019). Co-contraction of the TrA was demonstrable at every pelvic floor contraction. Discussion A significant bladder neck elevation can already be achieved with a perceived effort of only 25% of a maximal pelvic floor contraction. A maximal pelvic floor contraction does not further elevate the bladder neck after 50% of effort. The intraabdominal pressure increased drastically with maximal power which might cause bladder neck descent.

Table The Median (range) of the bladder neck movements (BN vector), intraabdominal pressure increases and the thickness of the transverse abdominal and internal oblique muscles are summarised Rest

BN vector mm TrA mm 2.3 (1.4-5.1) IO mm 7.6 (3.5-12.1) IAP cmH2O

25% PFMC

50% PFMC

75% PFMC

100% PFMC

3.7 (0.5-10.3) 3.1 (2.1-5.6) 8.4 (4.2-14.2) 5.5 (1-12)

5.1 (1.6-18.4) 3.0 (2.1-5.9) 8.3 (4.2-13.2) 11.0 (3-30)

4.8 (0.9-32) 3.6 (2.3-8.6) 9.2 (4.4-14.8) 16.5 (2-43)

6.2 (1.8-32) 4.2 (1.6-9.6) 9.9 (5.4-13.6) 32.0 (6-114)

Figure The mean increments of the intraabdominal pressure, bladder neck elevation and transverse abdominal and internal oblique thickness increases are displayed. 40

IAP (cmH2 O)

30 20 10

BN (nm) IO (mm) TrA (mm)

0 Rest

25% PFMC

50% PFMC

75% PFMC 100% PFMC

Conclusions Maximal pelvic floor muscle contractions are not necessary to elevate the bladder neck and have the disadvantage of increasing the intraabdominal pressure undesirably due to co-contractions of the abdominal muscles. Further studies are needed to evaluate the impact on women with pelvic floor disorders in whom the increased IAP might neutralize a bladder neck elevation.

36 Perineal, transvaginal and endorectal ultrasonography for assessing synthetic and biological grafts used in prolapse surgery: a proposed methodology Lim J, Carey M Royal Women’s Hospital, Australia Industry Support: No Objective: To describe a methodology for assessing synthetic and biological grafts used in prolapse surgery by two (2D) and three-dimensional (3D) perineal, transvaginal and endorectal ultrasonography. Background: Synthetic and biological grafts have been increasingly used in prolapse surgery. Important issues associated with graft usage include problems of dyspareunia and mesh exposure, bowel and bladder dysfunction and the possible breakdown and absorption of biological grafts. Pelvic ultrasonography has the potential to provide important information about how grafts perform in vivo and new insights into our understanding of graft related complications. This abstract describes an ultrasound protocol that can be used to systematically assess the physical relationships and functional properties of grafts used in prolapse surgery. Methods: This technique uses a B-K Medical ultrasound scanner (Pro Focus Yellow Colour Doppler Ultrasound Scanner), 2050 High Resolution Ano-Rectal Transducer (for 3D transvaginal and endoanal ultrasound), 8802 High Frequency Abdominal Transducer (for perineal ultrasound), and 8848 Bi-Plane Rectal Transducer or 8658 Trans-rectal bi-plane Transducer (for 2D transvaginal ultrasound). A dynamic perineal study with valsalva is performed to measure pelvic organ descent. Graft movement with valsalva can be visualized and measured during perineal scanning. 2D transvaginal scanning of the anterior and posterior compartments is undertaken in a static fashion to measure graft-tissue thickness (between graft and bladder and graft and vaginal lumen), graft size, and relationship to fixed anatomical landmarks. It is also used in conjunction with dynamic maneuvers that allows visualization of graft movement or the presence of recurrent cystocele or rectocele. It is important not to place too much force on the transvaginal probe so as to impede any pelvic organ descent or graft movement during dynamic maneuvers. The 3D transvaginal and endorectal scans provide 3D block images of tissues surrounding the ultrasound probe. 3D block images can be retrospectively manipulated to obtain the measurements required. Measurements of graft length and width may be obtained on vaginal and endorectal blocks, and these measurements may be compared to each

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other as well as with the measurements obtained with 2D ultrasound. Measurements of tissue thickness are best obtained from the transvaginal block for graft to bladder or vaginal lumen thickness, whilst tissue thickness between graft to rectal lumen and distance between graft and external anal sphincter are best measured on endorectal ultrasound. Results: Following prolapse surgery with graft augmentation, using this pelvic ultrasound protocol we have been able to determine: 1. distance between the graft and vaginal lumen to assess cases of dyspareunia or possible graft exposure. 2. distance between graft and bladder in patients with bladder dysfunction or pain. 3. distance between graft and rectal lumen to assess cases of lower bowel dysfunction or pain. We found that tissue thickness between graft and rectal lumen was best measured with 3D endorectal ultrasound. 4. overall size and dimensions of each mesh after incorporation into pelvic tissues. Sequential scanning may demonstrate any mesh “shrinkage”. 5. movement or displacement of graft with dynamic manoeuvres where recurrent prolapse is suspected. 6. if, and over what time frame, biological grafts become absorbed.

Figure 1 Transvaginal 3D ultrasound of posterior PROLIFT prosthesis

Detailed images of mesh were obtained, and in some cases mesh interstices were visualized (figure 1). We found the almost complete absence of biological graft remaining in some subjects with recurrent prolapse. Conclusion: Our early experience with 2D and 3D perineal, transvaginal and endorectal ultrasonography based on the protocol described in this abstract has provided us with important insights into the in vivo performance of synthetic and biological grafts used in prolapse surgery.

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37 Pelvic floor dysfunction in Women with Parkinson Disease Jha S1, Clarke C2, Toozs-Hobson P1 1 Department of Urogynaecology, Birmingham Women’s Hospital, United Kingdom2Department of Neurology, University of Birmingham and City Hospital Industry Support: No (n/a) Aims: To assess the impact of Parkinson disease (PD) on pelvic floor function in women and establish the impact on their quality of life. Background: Parkinson’s disease (PD) belongs to a group of conditions called movement disorders. It is characterized by muscle rigidity, tremor, a slowing of physical movement (bradykinesia) and, in extreme cases, a loss of physical movement (akinesia). The symptoms are a result of decreased stimulation of the motor cortex by the basal ganglia, normally caused by the insufficient formation and action of dopamine, which is produced in the dopaminergic neurons of the brain. PD is both chronic and progressive. The motor symptoms of PD have been extensively studied, but the impact on pelvic floor function is underreported and requires further research. Methods: This was a prospective postal questionnaire study of women with PD. Patients were asked to complete the Pelvic Floor Distress Inventory (PFDI 20)1 to assess prolapse symptoms, faecal incontinence and urinary incontinence and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)2 for sexual function. We assessed quality of life with the Parkinson’s Disease Questionnaire 39 (PDQ 39)3. The PFDI -20 has 3 components ie Pelvic Organ Prolapse Distress Inventory (POPDI), Colorectal - Anal Distress inventory (CRADI) and Urinary Distress Inventory (UDI). The PDQ-39 comprises 39 questions with five different options of answer related to the frequency of the disease manifestation. Answers refer to impact of the illness on the patient’s life in the previous month, as explained be¬fore the interview. The PDQ-39 is a multidimensional instrument approaching physical, emotional, and environmental factors that are useful in the medical practice. It is easily under¬stood and handled by patients, thus allowing a bet¬ter assessment of the disease progression and drug therapy. Demographic data included: age, ethnicity, BMI, parity, HRT use, previous hysterectomy, prolapse surgery and continence surgery (Table I). The results were compared with historical controls. Linear regression was used to correlate PDQ 39 with PFDI (individual and total scores) and PISQ in those women who were sexually active. Results were analysed using SPSS version 14. Results: The response rate was 65% (35/54). The mean PFDI score was 65.52 with mean individual Pelvic Organ

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Prolapse Distress Inventory (POPDI), Colorectal - Anal Distress inventory (CRADI) and Urinary Distress Inventory (UDI) Scores being 18.85, 22.25 and 24.45 respectively. The PISQ score was 15.18 but only 37% of women were sexually active (Table II). The total mean PDQ 39 was 35.77 and was significantly correlated to the PFDI scores (p<0.002) and PISQ scores (p<0.01), with the highest correlation being to the POPDI scores.

Table I Demographic data of respondents Variable

Mean/ %

+/- SD

Age BMI Parity Smoker Hysterectomy Diabetes Previous prolapse surgery Previous continence surgery

72.30 24.6 3.5 0% 17% 0% 3.3% 6.7%

9.53 4.83 2.08

– –

Table II Mean scores for PFDI- 20 (POPDI-6 + CRADI-8 + UDI-6), PDQ-39 and PISQ-12 Score

Mean +/- SD

POPDI-6 CRADI-8 UDI-6 PFDI-20 (Total Score) PDQ-39 PISQ-12

18.85 22.25 24.45 65.52 35.77 15.18

20.06 21.89 25.44 56.74 15.10 10.12

PFDI- 20:Pelvic Floor Distress Inventory; POPDI-6:Pelvic Organ Prolapse Distress Inventory; CRADI-8:Colorectal - Anal Distress inventory; UDI-6:Urinary Distress Inventory; PDQ-39: Parkinson’s Disease Questionnaire; PISQ-12: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire

Conclusion: In women with PD, Quality of life is significantly worse with worsening Pelvic Floor Dysfunction and sexual function. The presence of prolapse related symptoms appears to impact on quality of life more than colorectal and urinary problems. The prevalence of pelvic floor dysfunction in women with Parkinson Disease does not appear to be different to age-matched historical controls. References (1) Barber et al. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders. Am J Obstet Gynecol 2005; 193(1):103–113. (2) Rogers et al. A short form of the PISQ-12. Int Urogynecol J Pelvic Floor Dysfunct 2003; 14(3):164–168. (3) Jenkinson et al. Self-reported functioning and well-being in patients with Parkinson’s disease: comparison of the SF36 and the PDQ-39. Age Ageing 1995; 24(6):505–509.

38 Is cystometry an unreliable witness? Renganathan A, Cartwright R, Cardozo L, Srikrishna S, Robinson D, Vella M King’s College Hospital, United Kingdom Industry Support: No Objective: To review urodynamic traces collected as part of an international multi-centre Phase II trial of a novel medication for overactive bladder and to assess whether adequate reliability could also be achieved for the diagnosis of detrusor overactivity (DO). Background: To be used as a research instrument, urodynamic testing must achieve good reliability and reproducibility. Poor quality control observed during review of urodynamic traces from multi-centre trials [1], led to the development of the International Continence Society (ICS) guidelines for Good Urodynamic Practice [2]. With well implemented quality control criteria, it has been shown that excellent inter-rater reliability (IRR) can be achieved for numerical cystometrogram variables [3]. Methods: 50 urodynamic traces, including free uroflowmetry, filling cystometry and pressure flow studies, were performed at 14 urology and urogynaecology centres in Europe between February 2006 and June 2007. Explicit quality control criteria, based on the ICS guidelines [1], governed the performance and interpretation of urodynamics by local urodynamicists at each centre, and the inclusion of each patient into the trial. Two separate reliability analyses for cystometry were performed. Three central reviewers independently assessed a random sample of 20% of cystometrograms submitted for numerical variables, including pves, pabdo and pdet at baseline, and at maximum cystometric capacity (MCC), and the volume at MCC. Two central reviewers also assessed the full set of 50 cystometrograms, recording the presence or absence of detrusor overactivity (DO). For both analyses, variables were then compared with the assessments made by the reviewers at the recruitment centres. For all continuous variables, including pressure measurements and volumes, agreement was assessed using both intra-class correlation, and either paired t-test or one-way ANOVA for mean values. Diagnosis of detrusor overactivity was assessed using Cohen’s unweighted Kappa statistic. All the statistical analyses were performed using SPSSv14. Results: Table 1 shows full results for reliability of central assessment of numerical variables. For the three reviewers no significant differences were observed between mean values,

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and Intra-class correlation coefficients (ICC) were all excellent, ranging between.830 and.997 (p all=<.001). Table 2 compares the central and recruitment centre assessments of continuous variables, again finding no significant difference in mean values, and ICCs ranging from.624 to.994 suggesting good inter-rater reliability. Table 1 IRR among central reviewers Mean values

One way ANOVA

ICC

n=10

Reviewer Reviewer Reviewer F 1 2 3

p value ICC p value

Baseline pves Baseline pabd Baseline pdet MCC pves at MCC pabd at MCC pdet at MCC

10.7

11.5

12.4

.031 .970

.997 .000

11.5

12.1

12.2

.033 .965

.995 .001

1

0.6

0.8

.068 .935

.830 .000

318.8 33.9

324.3 33.3

323 31.8

.012 .988 .011 .989

.995 .000 .998 .000

16.5

17.5

17.5

.015 .985

.992 .000

15.8

16.2

15.5

.003 .997

.987 .000

practice and training. However since the observation of detrusor overactivity can only be made when an involuntary detrusor contraction is associated with the subjective report of the presence of urgency by the patient, objective assessment of detrusor overactivity may be fundamentally unsuitable for central evaluation as used in multi-centre studies. Conclusions: Excellent inter-rater reliability can be achieved for the numerical cystometrogram variables when assessed by trained urodynamicists, but reliable interpretation of detrusor overactivity remains a challenge. Further recommendations from the ICS, regarding training in urodynamics and implementation of good practice guidelines may be required.

39 Is AUA Symptom Score A Predictor For Female Bladder Outlet Obstruction? Pandey P1, Hegde L2, Marsh C3, Monahan L3 1 Jayaraman Medical Associates, United States, 2Department of Mathematics & Statistics, United States, 3Western Maryland Health System, United States Industry Support: No

Table 2 IRR between central and local reviewers (paired t test) Mean values

Paired t-test

ICC

n=10

Central reviewer

Local reviewer

p value

ICC

p value

Baseline pdet MCC pdet at MCC

.80 322.03 15.83

.50 311.5 20.9

.783 .106 .125

.624 .994 .987

.024 .000 .000

The two central reviewers showed excellent agreement in the independent assessment of detrusor overactivity, with Cohen’s unweighted kappa of 0.83. However central reviewers agreed that cystometry supported the interpretation assigned by local reviewers in only 64% of cases, with Cohen’s unweighted Kappa of only 0.24, indicating low reliability. This study confirms that with rigorous quality control criteria, cystometric pressure and volume variables can be reliably assessed. However in a population of patients with overactive bladder, the observation of detrusor overactivity is still not reliably reproduced. The discrepancy between kappa values for comparison of central reviewers and comparison of central and recruitment centre reviewers (0.83 versus 0.24) suggests that to some extent this can be overcome by standardisation of equipment,

Objective: Female bladder outlet obstruction (BOO), usually defined with urodynamic parameters, is commonly seen in community urologic practice. This study is aimed to evaluate American Urological Association (AUA) symptom score as predictor for Female BOO. Material & Methods: Charts of female patients undergoing urodynamic assessment of lower urinary tract symptoms was reviewed. Information on AUA symptom [(1) Feeling of incomplete emptying, (2) Frequency, (3) Intermittent Stream, (4) Urgency, (5) Weak Stream, (6) Straining and (7) Nocturia] score and urodynamic parameters - maximum flow rate (Qmax), maximum detrusor pressure (Pdet max), voided urinary volume and residual urinary volume was recorded. Criteria for bladder outlet obstruction, reproducible in 2 voiding cystometrogram studies, was defined as Qmax <15 cc/ sec and Pdet max >25 cm of water. Results: 285 patients underwent urodynamic evaluation for assessment of their voiding dysfunction. Bladder outlet obstruction [mean maximum flow rate (Qmax) 7.084 mls/sec, St. Dev. - 4.379; Pdet max - 45.8 cm of water, St. Dev. 22.01] was demonstrated in 61 patients (mean age 59.6 years). On univariate analysis, Qmax demonstrated weak dependence on Urgency (p=0.08) and Intermittent Stream (p=0.06); while residual urinary volume demonstrated dependence on Straining (p=0.01) and Urinary Frequency (p=0.06). Pdet max did not

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demonstrate significant dependence to any of AUA score related symptoms. Conclusion: Urodynamic parameters for female bladder outlet obstruction demonstrate weak dependence on Urgency and Intermittent Stream. Composite AUA score did not show significant association with female bladder outlet obstruction.

lated a mean circumference of 29.3 cm. Subtraction of individual bony arc measurements (lb) resulted in the required muscular length (RML). The “strain” or “stretch ratio” of the muscle required to allow delivery of a Caucasian baby of average size was calculated as previously described (2), both from dimensions at rest (see Formula 1) and on maximal Valsalva. The data was analysed with descriptive statistics.

40 How much does the puborectalis muscle have to distend in vaginal childbirth Svabik K1, Shek K2, Dietz H2 1 Charles University in Prague, First Factulty of Medicine, Ob/Gyn Dept., Czech Republic2Nepean Clinical School, University of Sydney, Australia

Formula1 : Ereq ¼ðCreg
CrestÞ=ðCrest
lbÞ

Industry Support: No Objective: This study was designed to define the degree of stretch/strain required of the puborectalis component of the levator ani muscle in childbirth. Background: Biometry and function of the levator ani muscle in the human female is likely to be of importance for vaginal childbirth. The birth canal is defined not only by the rigid bony pelvis but also by the levator. The main purpose of this muscle in the human female is to close off the abdominal cavity caudally while allowing for elimination of faeces and urine and intercourse, requiring limited dimensions and distensibility. Vaginal childbirth implies an entirely different set of requirements. The levator has to distend to a much greater degree, preferably without reaching its elastic limit. Methods: We examined 227 nulliparous women at 36–38 week’s gestation. The assessment consisted of a history, a clinical examination including Bishop Score, and 4D ultrasound imaging using a GE Kretz Voluson 730 Expert system. Volume data sets were acquired with the patient supine with empty bladder at rest, on maximal Valsalva and during pelvic floor muscle contraction (PFMC). The stored volumes of 224 women were processed using proprietary software; 3 datasets were missing when post-processing was undertaken. Minimal hiatal diameters, circumference and area were measured as previously described (1). In order to determine muscle strain, we measured the bony part of the hiatus, and this was subtracted from the circumference to obtain the muscular component of the levator hiatus. To estimate required distension at vaginal birth we used neonatal biometric data obtained in a Caucasian population (http://www.pubcare.uu.se/ubcos/ birth/stbirth.htm#NY78B). Assuming an ellipsoid shape of the fetal head and a circumference determined by the biparietal and sub-occipito-bregmatic diameters we calcu-

where Ereq = strain to reach the required muscular length; Creg = required hiatal circumference for birth of average Caucasian baby; Crest = hiatal circumference at rest; lb = bony arc length. Results: We analysed the volume datasets of 224 nulliparous women at a mean gestational age of 37.1 weeks (range 35.6-39.1). The mean BMI before pregnancy was 24.96 (15.3-46.33), BMI at examination 30.61 (19.37-50.29), and mean age was 25.4 years. Over 91% of women were of Caucasian background (6% part Caucasian, 3% Asian, Polynesian or Indian). The mean strain required for vaginal delivery (assuming an average Caucasian baby delivered from the occipito- anterior position) was calculated as 1.46 (range 0.61 - 2.74; SD 0.39) from resting length, and 1.06 (range 0.24-2.43; SD 0.43) when calculated from dimensions at maximal Valsalva. This implies that, from dimensions at maximal Valsalva, some women will have to distend the levator hiatus by only 24%, others by 243%. Conclusion: It is a basic fact of clinical obstetrics that the ability of women to give birth vaginally seems to vary greatly. In this study we have obtained normative data for the required distension of the puborectalis muscle in a largely Caucasian population. It appears that the population distribution for this parameter is very wide. The strain required for vaginal delivery of an average sized Caucasian baby, on top of the distension obtained by maximal Valsalva, varied from 24% to 243%. There clearly are enormous inter-individual variations in the distension required of the puborectalis muscle in Caucasian women at term, even assuming an optimal fetal position. It is plausible that in some women the required distension will result in the muscle reaching its elastic limit, causing permanent injury. The wide population spread for required puborectalis muscle strain documented by us questions the appropriateness of using individual imaging datasets for modelling pelvic floor function in childbirth, and may explain some of the variation in obstetric outcomes observed in nulliparous women. References: 1. Ultrasound Obstet Gynecol 2005; 25: 580–585. 2. Ultrasound Obstet Gynecol 2008; 31: 201–205.

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41 Revisit of the validity of the IIQ-SF and UDI-SF in incontinent women Tanu C1, Arunkalaivanan A2 1 Sandwell and West Birmingham Hospitals NHS Trust, United Kingdom, 2Department of Urogynaecology and Urodynamics, United Kingdom,

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scores of UDI and IIQ were higher in all three groups (Table2). However, there is no significant difference between each groups: p=0.981 (IIQ scores) and p=0.443 (UDI). Table 1 Demographic and Symptom features Variable

DO (142)

UDSUI (72)

Mixed UI (30)

p value

Age Parity Increased Frequency (yes/no) Urgency (yes/no) Urge* incontinence (yes/no) Nocturia (yes/no) Stress Incontinence* (yes/no)

53±14 2(1–3) 82/51

58±13 3(2–3) 32/32

51±9 2(1–3) 10/15

0.1 0.737 0.072

82/52 74/59

29/32 31/32

11/14 5/20

0.097 0.005

48/83 86/45

22/41 56/8

5/20 22/3

0.273 0.001

Industry Support: No Objective: We aimed to assess the validity of the short forms of Incontinence Impact Questionnaire (IIQ-SF) and the Urogenital Distress Inventory (UDI-SF) in incontinent women with an abnormal urodynamic diagnosis. Background: The Incontinence Impact Questionnaire (IIQ) was designed by Shumaker et al. to assess the impact of urinary incontinence on activities and emotions in women. The Urogenital Distress Inventory (UDI), which is meant to complement the IIQ, was developed at the same time by the same group to assess the degree to which symptoms associated with incontinence are troubling. Short forms of the IIQ and UDI were developed with the original data on the full-length questionnaire. Regression analyses suggested that a 7- to 8-item questionnaire would accurately predict the IIQ long from total score, and a 6-item form would predict the UDI long form. Methods: All women who presented with urinary incontinence between January and December 2007 were evaluated with urodynamic assessment by using LifeTech™ equipment at a filling speed of 20- 50 ml/minute. Prior to urodynamic assessment, all women had completed the IIQSF, UDI-SF pre-installed in the machine and the scoring was calculated by the software provided with the machine. IIQ-SF questionnaire consists of Physical activity, travel, social relationship and emotional health as subsegments. UDI-SF consists of obstructive/discomfort, irritative and stress symtopms as components. Women were classified into 3 groups based upon the diagnosis at the end of urodynamic assessment: Detrusor overactivity(DO), urodynamic stress incontinence (UDSUI) and mixed urinary incontinence (MUI). Women with normal studies (n=6) have been excluded as the number is too small for comparison. The overall score of UDI and IIQ were taken into account for analysis. The data was analysed using SPSS™ release 14.0. Results: A total of 244 urodynamic traces were available for analysis. 142 women had detrusor overactivity, 72 were diagnosed as Urodynamic stress incontinence and 30 had mixed urinary incontinence. The demographic, symptom and urodynamic charateristics are presented in the attached Tables 1 and 2. The maximum flow rate (MFR) and voided volume (VV) are significantly less in DO group compared to the UDSUI and MUI groups (p<0.001). The overall

DO – Detrusor Overactivity; UDSUI – Urodynamic Stress incontinence; Mixed UI – Mixed urinary incontinence Age- (Mean ± Standard deviation); Parity (Median, range) * - statistically significant. Table 2 Comparison of Urodynamic parameters with Incontinence Impact Questionnaire (IIQ) and Urinary Distress Inventory (UDI) scores Variable

DO (142)

UDSUI (72)

Mixed UI (30)

p value

FDV MCC EDP MFR VV IIQ UDI

57(31–86) 282±109 11(5–19) 16(9–21) 97(1–268) 67(36–100) 50±18

79(31–145 357±107 8 (4–13) 21(15–27) 226(19–355) 69(34–100) 54±23

61(49–126 388±101 6 (4–10) 24(18–26) 335(0–461) 67(43–95) 47±19

0.003 <0.001 0.004 <0.001 <0.001 0.981 0.443

FDV- First desire to void; MCC- Maximum Cystometric capacity; EDP – End -detrusor pressure; MFR- Maximum Flow Rate; VVVoided volumeMCC & UDI (Mean±Standard deviation) All other variables are described as median and interquartile range.

Conclusion: The overall scores of UDI-SF and IIQ-SF correlate well with the severity of urinary incontinence by the symptoms and the urodynamic findings. Nevertheless, there is no significant difference of scores amongst the DO, UDSUI and MUI groups. 42 Sitting and Crouching Over the Public Toilet Seat and Its Effect on Micturi Yang K1, Chen S2, Chen S1, Chang C3, Wu H3, Chou C3 1 Central Taiwan University of Science and Tecnology Institute of Nursing, Taiwan, 2China Medical University Department of Nursing, Taiwan3, China Medical University Hospital/Department of Urology, Taiwan

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Industry Support: Yes (Industry-initiated, full sponsorship) Objective: In this study, we investigated the sitting position and the non-sitting positions (partly squatting, crouching over) in uroflowmetric parameters and post voiding residual urine (PVR). Background: The literature demonstrated that the women prefered to take a non-sitting position while using the sitting-type public toilets. How non-sitting positions effect women’s micturition is needed. Methods: Forty-five normal healthy women were recruited, with a mean age of 23.2±4.6 years (range 18–34 years). Each woman was measured with uroflowmetry and PVR in the sitting, partly squatting, and crouching over the sittingtype public toilets. A weight transducer urodynamic device (Medical Measurement Systems MMS Flowmarst) was used for uroflowmetric measures, such as delay time, time to peak flow, the maximum flow rate (Qmax)). PVR were measured using transabdominal ultrasound (BIV6400) immediately after each voiding. Results: “Delay time” was statistically significantly shorter in sitting compared to in partly squatting and in crouching over position respectively. “Time to peak flow” was statistically significantly shorter in sitting compared to in crouching over position. However, no difference was found in the maximum flow rate (Qmax), corrected maximum flow rate (CQmax), voiding volume (VV), voiding time (VT) and post voiding residual urine (PVR) among three voiding positions. Conclusions: Compared to non-sitting positions, sitting position to void does have shorter “delay time” and “time to peak flow”. Key words: crouching, micturition, sitting, public toilet seat, uroflowmetry, residual urine. 43 How best to evaluate tomographic pelvic floor ultrasound findings? Dietz H, Shek K University of Sydney, Australia Industry Support: No Objective: In this study we intended to determine which levels of the levator hiatus are most strongly associated with alterations in pelvic organ support. Background: Tomographic ultrasound has greatly simplified pelvic floor assessment by translabial 4D ultrasound. Abnormalities of the insertion of the levator ani on the inferior pubic ramus and pelvic sidewall can be documented on a single frame and assessed at a glance. Methods: This is a sub-analysis of a study conducted in 296 nulliparous women carrying a singleton pregnancy who were

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seen at 36–38 weeks’ gestation and again at 3–4 months postpartum. They underwent an interview and 4D translabial Ultrasound. We analysed postpartum changes in bladder neck descent and hiatal area as indicators of altered pelvic organ support. Tomographic ultrasound was performed on volumes obtained at maximal pelvic floor contraction, at 2.5 mm slice intervals, from 5 mm below to 12.5 mm above the plane of minimal hiatal dimensions, i.e., 8 slices per patient.

Figure Tomographic ultrasound images of a normal pelvic floor (A) and a minor form of unilateral trauma. On palpation the hiatus itself was intact, as was the insertion of the puborectalis on the inferior pubic ramus, but there was a gap in the puborectalis in the region of the obturator foramen, implying detachment of the muscle from the arcus tendineus levatoris ani

Results: The mean age of patients who returned for a postnatal appointment (n=208, 70%) was 27 (range 18–40). The majority had had a normal vaginal delivery (n=99, 48%), 31 were seen after vacuum or forceps (15%) and 78 after Caesarean Section (38%). 26 (20% of those after vaginal delivery) were diagnosed with an avulsion injury. A total of 1664 tomographic slices were assessed bilaterally, and 386 single side abnormalities were detected. An abnormality in slices 3 to 8 was associated with increased bladder neck descent postpartum (P=0.038 to P<0.001) and increased hiatal area on Valsalva (P=0.029 to P<0.001). This was not the case for the two most distal slices (1 and 2). Conclusions: We found no association between defects observed on tomographic ultrasound below the plane of minimal hiatal dimensions and indices of increased hiatal distension or bladder neck descent on Valsalva. This implies that defects observed below this plane are either irrelevant for pelvic organ support or artefactual. The latter may be due to the fact that the reference plane used by us is Euclidean, i.e., flat, while the true hiatal plane may be non- Euclidean, i.e., warped. 44 A pilot randomised study to determine if rectal distension alters urodynamics findings? Panayi D, Khullar V, Spiteri M, Hendricken C, Fernando R, Dept of Urogynaecology, St. Marys Hospital, United Kingdom Industry Support: No (n/a) Objective: The aim of the study was to assess how rectal distension affects urodynamics parameters and diagnosis.

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Background: The rectum and bladder are derived from the same embryological structure and share the same peripheral nerve supply and central nervous system sensory interpretation. It is reasonable to suspect that there is an interaction between bladder and rectal function. A study on a small number of healthy volunteers has demonstrated that a full rectum can alter bladder sensations (1) and a full bladder can lead to decreased anorectum filling sensation. Constipation is a symptom that commonly co-exists with lower urinary tract symptoms. It is a spectrum of obstructed constipation and slow transit time. Some women have either or a composite of these two symptoms. Currently there is no reliable model for constipation. Treatment of constipation as yet does not form part of national or international guidelines of in management of urogynaecological conditions. Methods: Women completed a full history, including urinary and bowel history, and examination prior to urodynamic investigation. Women with any bowel disease, or history of bleeding per rectum were excluded. Women then underwent uroflow studies and then urodynamics. This consisted of filling and voiding cystometry including provocative measures including coughing, listening to running water and handwashing. The filling phase of urodynamics was carried out twice. On one occasion with the rectal balloon filled with 150 ml of normal saline, causing the rectum to be distended, and another occasion with rectal balloon empty. Women were randomised, using the closed envelope method, into having the rectal balloon distended during the first or during the second filling phase and therefore acted as their own controls. First desire, strong desire and bladder capacity were recorded as well as urodynamics diagnosis. Results: Thirty patients were recruited, 16 reported mixed urinary incontinence (53%), 5 had isolated OAB symptoms (17%) and 9 (30%) reported isolated stress urinary incontinence. Patients with distended rectum had statistically significant lower maximum bladder capacity, and lower bladder volume at which first and strong desire was felt. In 4 patients (13%) a diagnosis of DO was found with the rectum was distended but not when the rectum was empty. There were no cases of bursting, displacement of, or retention of or any adverse events associated with insertion of the rectal balloon. Table Filling cystometry data with and without rectal distension N=30

Mean volume (ml) Mean volume (ml) With rectal distension Without rectal distension

First 107 Desire Strong 246 desire Bladder 307 Capacity (Wilcoxon Signed Rank)

194

p<0.001

344

p<0.001

413

p<0.001

Conclusion: This device is a safe and effect model for obstructed defaecatory symptoms. Rectal distension has a significant effect on urodynamics parameters and diagnosis should be considered when taking a bowel history from a woman and prior to carrying out this investigation. References 1. De WS, Wyndaele JJ. Impact of rectal distention on the results of evaluations of lower urinary tract sensation. J Urol 2003 Apr;169(4):1392–4.

45 Investigating illness perception in women with lower urinary tract symptoms Cortes E, Basra R, Basra H, Kelleher C, Guy’s and St Thomas’ Hospital, United Kingdom Industry Support: No Objective The aim of this study was to investigate illness perception in women with LUTS using the validated brief-illness perception questionnaire (B-IPQ). Introduction Ongoing research over the past 30 years has demonstrated the importance of illness representations to patient behaviour. Changing patients’ illness perceptions has been shown to improve recovery following myocardial infarction, and other selfregulatory interventions in illnesses as diverse as diabetes and AIDS have also improved patient outcomes. The B-IPQ is a theoretically derived measure that assesses the cognitive representations or models of illness that patients adopt in order to make sense of and respond to symptoms. Negative beliefs and expectations which patients may have about their illness and/or their prescribed treatment make them less likely to adhere to any prescribed treatment. The (B-IPQ) uses a single-item nine domain approach to assess perceptions on a continuous linear scale. We used eight of its nine subscales in our study. All of the domains are rated using a 0-to-10 response scale. Five of the domains assess cognitive illness representations: consequences (domain 1), timeline (domain 2), personal control (domain 3), treatment control (domain 4), and identity (domain 5). Two of the items assess emotional representations: concern (domain 6) and emotions (domain 8). One item assesses illness comprehensibility (domain 7). Methods Women referred for urodynamics (UD) from a urogynaecology outpatient clinic in a tertiary care unit were recruited. According to local protocols urodynamic studies are performed in women with symptoms of stress inconti-

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nence who have failed conservative management, and women with mixed incontinence and overactive bladder who have failed to respond to antimuscarinic and behavioural therapies. 100 Patients were sent study details and the study questionnaires by post prior to their appointment. The questionnaire pack consisted of a structured questionnaire detailing demographic data and previous treatments and the B-IPQ. Patients aged over 18 years, who could understand written English were recruited. Patients with urogenital prolapse (>/= grade 2), bladder pain and neuropathic bladder symptoms were excluded from the study. The study was granted ethical approval by the local research ethics committee. Results 86 patients completed and returned the study questionnaires. The mean age of participants was 57 years. Following UD; 10 patients had normal studies, 24 had urodynamic stress incontinence (SI), 23 had a diagnosis of detrusor overactivity (DO), and 28 had mixed incontinence (MI). Statistical analysis by domains (Table 1) revealed that patients with no UD diagnosis did not differ in their scores when compared to women with DO or MI. However, when compared with patients with SI they were significantly less concerned about their bladder problem (p=0.02), less affected emotionally (P=0.001), and felt their lives were less affected by their condition (p=0.006). Comparing SI with DO patients, sufferers of SI felt their lives were more affected by their problem (p=0.02), thought their problem would last for longer (p=0.025), they experienced more their bladder symptoms (p=0.029), were more concerned about their bladder problem (p=0.001), and were more affected emotionally (p=0.0008). There were no significant differences in their control over their bladder, belief in help provided by treatment or their understanding of their condition. Comparison between MI and DO, showed MI patients believed their problem would last longer (p=0.01), had worse control of their bladder (p=0.01), and experienced worse symptoms (p=0.007). Compared with SI, MI were significantly more concerned about their bladder condition (p=0.043). Patients with DO Reported lower symptom severity (identity domain) when compared with the other groups.

Conclusion The Brief-IPQ is a valid tool in the assessment of patient’s perception of their bladder condition. Contrary to previous studies, our data suggests that people with SI have higher scores in emotional impact, concern, and how much their lives are affected compared with patients with mixed incontinence and detrusor overactivity. This may reflect the symptoms severity of the population studied, the success of coping strategies in OAB, and the increased failure of pelvic floor exercises in elderly patients (mean age 60), when compared with conservative therapies in patients with DO/MI. Overall, there is poor understanding of the nature of their condition in all groups. Identifying patients’ perception of their illness may also allow clinicians address the most bothersome aspects of patient’s LUTS improving treatment satisfaction and patient’s outcome.

Table 1 Brief-IPQ results by domains and bladder condition

Neg UD SI DO MI

N

Consequences

Timeline

Personal control

Treatment control

Identity

Concern

Illness comprehensibility

Emotions

10 24 23 28

5 7.14 5 6.84

7.42 8.76 6.31 8.58

3.62 3.71 5.51 3.2

5 7.2 7.12 5.6

5 6.81 4.58 7.08

6 9.42 5.94 7.8

3.12 5.92 4.11 4.92

5.12 8.21 4.88 6.6

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Prolapse (22–33), (88–94), (115–120), (146–163) 22 Vaginal Surgery a part of General Gynaecology: Consultant and trainee views Sharma S, Louca O North West London Hospitals, United Kingdom Industry Support: (n/a) Hypothesis/aims of study The role of the Obstetric and Gynaecology Consultants (O&G Consultant) in the National Health Service in United Kingdom (UK) is evolving to take in to consideration the changes in service needs and the specialist training programme. The impact of the shorter training programmes (Calman training (1995) and Modernising Medical Education (2007)) and European Working Time Directives on future operative gynaecology is still not clear. The aim of this questionnaire survey was to find out the views of the Consultants and the middle grade trainees in the United Kingdom (UK) as to what level of expertise is required to perform gynaecological vaginal surgery. Study design, materials and methods This study was conducted in two parts- A 3 page postal questionnaire survey of all UK O&G Consultants and an email questionnaire survey of UK middle grade trainees. The consultants were asked about their views on who (General O & G consultant, Gynaecologist with special interest in Urogynaecology, subspecialist in Urogynaecology) should ideally perform a) Vaginal floor repairs (VFR) and b) vaginal hysterectomy (VH). The trainees were asked about their views for the future (next 5–10 years). Demographics including information regarding the consultant’s current operating workload and trainee’s exposure to these operations were also collected. Results From the consultant postal questionnaire survey- 359 responses were analysed (37% response rate). Only 38% (VFR) and 24% (VH) of respondents felt that surgery should be performed only by an Urogynaecologist or an O&G consultant with a special interest in Urogynaecology. When the responses, were further analysed against the year when MRCOG was obtained, there was a trend to the younger consultants opting for a specialist to perform both VH and PFR. This was more obvious for vaginal floor repair than for vaginal hysterectomy.

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Analysis of the demographics of the consultants showed that most (67%) of the respondents were in the 41–55 years age group. The majority of the consultant belonged to District General Hospital (67%).Two thirds of the consultants performed/supervised more than 3–4 vaginal floor repair procedures per month. Nearly half of the consultants performed/supervised more than 3–4 vaginal hysterectomies per month. Trainee survey was done by an initial e-mail followed by two reminders which generated 75 responses. Majority of the respondents felt that vaginal floor repair (59%) and vaginal hysterectomy (55%) should be done either by a Gynaecologist with special interest or a subspecialist in Urogynaecology. Twenty one percent and 37% of the trainees had done no VFR and VH respectively in the last year. While, 47%and 42% had done between 1 and 5 VFR and VH respectively in the same time period. When asked if the last year’s operating experience was similar to the year previous to that, 20% of trainees felt that their operative experience had been even lower. Interpretation of results Majority of the current consultants believe that vaginal floor repairs and vaginal hysterectomy should be done by the General O&G consultants. However, the current workload does not allow all the generalists adequate numbers to achieve the targets proposed by the RCOG. (1,2) There is a trend with the current trainees holding a view that sub-specialists/ special interest gynaecologists should be performing vaginal surgery especially VFR in the future. This may be due to inadequate experience and exposure to vaginal surgery during their training. Concluding message This study highlights three issues- One, there is not enough operating opportunities for all General O&G consultants to maintain skills in vaginal surgery. Secondly, the current training may not be adequate for all trainees to develop the skills required for vaginal surgery. Thirdly, there is a trend towards the junior consultants and present trainees holding a view that vaginal floor repair surgery and vaginal hysterectomy should be ideally done by gynaecologists with special interest in urogynaecology or subspecialty trained gynaecologist. This supports the RCOG views on future workforce. References 1) Development of clinical and organisational standards in gynaecology. RCOG, Draft Document 2007. 2) Clinical Standards (2002) - Advice on Planning the Service in Obstetrics and Gynaecology. RCOG, RCOG Press (2002) ISBN1 900364 78

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23 Survey among gynaecologists on surgical characteristics that influence the use of a needlesuspension technique with mesh. Hinoul P1, Goossens A2, Roovers J2 1 Ziekenhuis Oost Limburg, Belgium 2Academic Medical Center University of Amsterdam, Netherlands, Industry Support: No (n/a) OBJECTIVE: This is the first study that aims to identify relevant factors that affect surgeons when considering the use of meshes in the surgical treatment of urogenital prolapse. BACKGROUND: Evidence regarding the use of vaginal meshes in the treatment of certain types of urogenital prolapse is increasing(Cochrane 2007). However, in the decision taking to adopt a surgical technique using mesh, several other factors may also play a role. This study was designed to measure the individual contribution of these factors. METHODS: Based on the advise of 20 experts in the field of urogynaecology a top 6 list was composed of the characteristics of a novel surgical mesh technique that were expected to have the most influence on the decisionmaking to adopt this technique. The 6 characteristics selected were: 1. Required surgical skills (easy procedure vs difficult procedure), 2. Cost price (inexpensive versus expensive), 3. Postoperative pain: (Little postoperative pain versus severe postoperative pain), 4. Available scientific evidence to support use of the novel procedure (high level of evidence versus low level of evidence), 5. Mesh characteristics (low risk of erosion (defined as <5%) versus high risk of erosion (defined as >5%), 6. Duration of hospital admission (short (defined as < 3 days) versus long (defined as >3 days). Then we developed a questionnaire of 16 cases (“vignettes”) with different combinations of the 6 characteristics being present or absent. All 440 members of the Flemish Society for Obstetrics and Gynaecology and all 180 members of the Pelvic Floor working party of the Dutch Society for Obstetrics and Gynaecology were asked to anonymously respond to this questionnaire and rate for each “vignette” their willingness to adopt the novel procedure on a seven point Likert scale ranging from 1 (=will certainly not perform this procedure) to 7 (=will certainly perform this procedure). The characteristics of the responders were summarized using descriptive statistics. Mixed model analysis of variance was used to determine the relative effects of the six characteristics of the new mesh technique (SPSS 14.0). By modelling interaction terms between the features and subgroup indicators, we

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tested for subgroup differences on the influence of mesh features. RESULTS: The response rate was 46%, being higher among the Dutch (107/180=59%) than the Flemish (181/440=41%). The average score for the general gynaecologist’s (n=158) was 2.56 (sd 1.71) in comparison to 2.88 (sd 1.81) by the group of surgeons specialized in urogynaecology (n=105) (p<0.010)) In the table the regression coefficients per factor are shown, expressing the impact of the six different characteristics on willingness to adopt this new technique. A negative number means that the absence of the characteristics results in a lower willingness to adopt the procedure. The level of scientific evidence and the mesh related erosion risk influenced the willingness the most. Postoperative pain, costs, required surgical skilsl and duration of hospital admission had a much lower impact on the phycians’ willingness to adopt. Parameter

Estimate/beta coefficient

Std error

95% C.I.

Intercept Level of scientific evidence Mesh characteristics Postoperative pain Costs Required surgical skills Duration of admission

5.07 -1.59 -1.53 -0.82 -0.41 -0.26 -0.18

0.059 0.035 0.035 0.035 0.035 0.035 0.035

4.96-5.19 -1.66–1.53 -1.59–1.46 -0.89–0.75 -0.48–0.34 -0.32–0.19 -0.24–0.11

CONCLUSION: Gynaecologists are willing to adopt novel surgical mesh techniques if the provided scientific evidence is high and the mesh related erosion risk is low. 24 Long-Term anatomical and functional results after trans-vaginal cystocele repair using a tension-free polypropylene mesh. LETOUZEY V, de TAYRAC R, DEFFIEUX X, FERNANDEZ H Department of Obstetrics and Gynecology, University Hospital, France Industry Support: No Objective: To report the long term (>5 years) anatomical and functional outcome of trans-vaginal cystocele repair using a tension free polypropylene mesh. Background: The anterior vaginal wall prolapse repair with no mesh is associated with a recurrence rate up to 40%. Synthetic mesh reinforcement was proposed since 1996. Long term data are missing.

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Methods: This study is a descriptive case series of 63 women with cystocele from 1999 to 2001. The polypropylene mesh (GyneMesh, Gynecare, Ethicon, France) was placed from the retropubic space to the interior part of the bladder in a tension free fashion. A physician, different of prolapse repair’s surgeons, reported functional results (satisfaction, anal and urinary symptoms, dyspareunia and pelvic pain) and anatomical results. Patients were declared anatomically treated with cystocele grade 0 or 1 (Ba< -1, POPQ). Results: Fifty four patients returned for follow up (85.7%) with a mean follow up of 79 months (+/- 11). At follow up, 50 women were anatomically cured (80%). We had 13 (20%) grade 2 and no grade 3 or 4. No re-intervention for cystocele recurrence was needed. There were a total of ten (16%) vaginal erosion. 6 (10%), 2 (3%) and 2 (3%) de novo vaginal exposition were respectively diagnosed at 1, 4 and 6 years of follow up. Two out of 14 patients with sexual intercourse had dyspareunia (14%), associated with vaginal erosion of the mesh. Clinical examination had found 100% of mesh retraction. There were a total of three cases of vaginal local pain (4%), for patients with no sexual activities. Eight patients had needed second surgery for symptomatic vaginal erosion (13%), and one for symptomatic retraction (2%). Conclusions: Cystocele repair using tension-free polypropylene mesh is associated with a low rate of pelvic organ prolapse recurrence. New mesh with low weight and no systematic hysterectomy could significantly decrease mesh erosion. 25 Sexual impact of transvaginal cystocele repair using an unfixed intervesicovaginal polypropylene mesh Velemir L1, Krief M1, Savary D1, Fatton B1, Boda C1, Mansoor A2 1 Urogynecology Unit, CHU Clermont-Ferrand, France, 2 Centre hospitalier Paul Ardier, France Industry Support: No Objective To assess the impact on sexually active women of transvaginal cystocele repair using an unfixed intervesicovaginal polypropylene mesh Background Synthetic grafts are being increasingly used to reinforce anterior vaginal wall repair to improve long-term results and prevent cystocele recurrence. However, there is a raising concern about the effects of these grafts on the functional results of surgery, particulary sexual function. De novo dyspareunia rates of 12–27% have been reported after transvaginal cystocele repair with polypropylene mesh.

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Animal and clinical studies have shown that natural scarring process following transvaginal mesh placement might be excessive in some patients causing an important mesh remodelling. In these cases, the mesh thickens, shrinks and causes a tension under the vaginal wall leading to dyspareunia. In our experience with unfixed intervesicovaginal polypropylene mesh in cystocele repair we observed free retraction of mesh and in nearly all cases the absence of mesh tension under the vaginal wall. Methods Data concerning sexually active patients were taken from our computer data base concerning our prospective longitudinal observational study of all patients operated on, between 2001 and 2007, of at least symptomatic POP-Q stage 2 cystocele with polypropylene mesh. All patients had a complete preoperative evaluation including urologic, gynaecologic, proctologic and sexual symptoms review, and physical examination. In addition, patients completed a comprehensive condition-specific self administered sexual questionnaire. Cystocele repair was performed transvaginally using an intervesicovaginal polypropylene mesh including two short caudal extensions sutured on each side of the bladder neck to the puboccygeus muscle, two lateral wings placed in the paravesical space in contact with the pelvic fascia arcus tendineus, a central body supporting the bladder and a long tail placed in the intervesicovaginal space and supported by uterosacral ligaments plicature. The mesh used was either a heavy polypropylene (76 g/m2, Prolene®, Ethicon) or an ultralight polypropylene (22 g/m2, Novasilk®, Coloplast). Concomitant hysterectomy, complementary repair of other compartments and mid-suburethral sling were performed according to the clinical situation. Postoperatively, a condition-specific comprehensive sexual questionnaire including all questions from the PISQ-12 was mailed to these patients during January 2008. Statistical analysis was conducted with software SEM. Results One hundred and five sexually active patients were operated on between 2001 and 2007. Seventy-seven questionnaires were returned (73.3%) and retained for the study. Mean follow-up was 28.1 months (range 6–72). Mean age at surgery was 59.6 years (range 27–77). Fiftyone patients had a heavy polypropylene mesh and 26 an ultralight polypropylene mesh. Postoperatively, 62 patients (80%) were sexually active. Improvement, no change or worsening of sexual function was noted in respectively 28 (45.2%), 28 (45.2%) and 6 (9.7%) patients. Discomfort during intercourse was significantly reduced postoperatively (26% prior to surgery vs. 11.3% after surgery, p=0.031). No significant difference was found in pre and postoperative dyspareunia rate (23.4% vs. 19.4%). Among the 18 women with preoperative dyspareunia, 9 were cured, 7 were unchanged and 2 became sexually inactive. Among the 59

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patients without dyspareunia preoperatively, postoperatively 41 were sexually active without dyspareunia (69.4%), 13 became sexually inactive (22%) and 5 (8.4%) presented de novo dyspareunia (10.3% in the heavy polypropylene group and 5% in the ultralight polypropylene group). Of the 15 patients who became sexually inactive postoperatively, 8 argued a problem with their partner, 4 an absence of sexual desire and 3 a personal choice. Conclusions Our results suggest that, for the very great majority of sexually active patients, transvaginal cystocele repair with unfixed polypropylene mesh does not alter or even improves sexual function. Less than 10% of women report a negative sexual impact. The use of an ultra light polypropylene mesh seems to improve the sexual results, but this data should be assessed in further studies with more cases. 26 EVALUATION OF A CLINICAL PATHWAY FOR TENSION-FREE VAGINAL MESH (TVM) PROCEDURE IN 300 PATIENTS WITH PELVIC ORGAN PROLAPSE Kato K, Suzuki S, Yamamoto S, Furuhashi K, Suzuki K, Murase T Japanese Red Cross Nagoya First Hospital, Japan Industry Support: No Objective: The aim of this study was to evaluate a clinical pathway for the tension-free vaginal mesh (TVM) procedure in 300 patients with pelvic organ prolapse (POP). Background: Gynecare ProliftTM, a pelvic floor repair system based on the TVM concept, has been used worldwide since 2005 due to less-invasiveness, uterine preservation, and durability achieved by the transvaginal use of synthetic material. Nevertheless, POP has been underestimated as non-life-threatening disease of passé elderly women, and no such devices have had governmental approval in Japan. Therefore, the Japanese surgeons have begun to cut soft polypropylene mesh (GynemeshTM PS, 25×25 cm) into a similar shape as ProliftTM and to insert their arms through the obturator foramen and sacrospinous ligament using custom-made needles. Methods: Between May 2006 and December 2007, 305 consecutive women with POP quantification stage 3 or 4 were planned to undergo the TVM procedure in a single general hospital. Five were excluded due to concomitant planning of hysterectomy for specific cervical or ovarian pathology, and a clinical pathway (removal of the indwelling urethral catheter on the next morning, discharge on postoperative day 3 or earlier) was applied to the remaining 300 women whose mean age was 65.9±8.0 years (mean ± standard deviation, range: 38–89). Sixty-six cases (22.0%)

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had a past history of hysterectomy and/or pelvic organ prolapse repair. We prospectively evaluated the perioperative complications, duration of urethral catheterization, and postoperative hospitalization in this case series. Results: We applied isolated anterior mesh in 157 cases (TVM-A group), isolated anterior mesh and Manchester procedure in 29 cases (M group), both anterior and posterior mesh in 107 cases (TVM-AP group), and isolated posterior mesh in 7 cases (TVM-P group). The mean operation time in these 4 groups was 35±12, 75±20, 76± 19 and 55±19 min, respectively. The mean intraoperative blood loss in these 4 groups was 10±16, 22±23, 35±125, and 29±34 g, respectively. Only one case (0.3%) had blood loss over 200 g, and none needed blood transfusion. The perioperative complications were 11 cases (3.7%) of bladder injury, 2 cases (0.7%) of vaginal wall hematoma, 1 case (0.3%) of rectal injury, and 1 case (0.3%) of temporary hydronephrosis. We infiltrated the vaginal wall by saline with vasoconstrictor and dissected the bladder laterally at the so-called “litchee” or “nata de coco” layer while keeping the pubocervical fascia on the vaginal wall. Bladder injury mainly occurred during blunt dissection through small incision when this layer was unclear due to adhesion. The bladder and rectal injuries were recognized and cautiously repaired using two suture layers during surgery. Afterwards, the anterior mesh was inserted as usual, whereas the posterior mesh was aborted for fear of an increased risk of infection. The indwelling urethral catheters were removed on the next morning as in the clinical pathway in 287cases (95.6%), and no patients required clean intermittent catheterization at home. Postoperative hospitalization was within 3 days as indicated by the pathway in 280 cases (93.3%). Among 20 cases who had longer postoperative hospitalization, 14 stayed according to their own wishes. Thus, those who needed longer hospitalization due to perioperative complications were 6 cases (2.0%) consisting of 2 cases of bladder injury (day 4 and day 5), 1 each case of temporary urinary retention (day 5), blood loss over 200 g (day 6), rectal injury (day 11), and hydronephrosis (day 11). There was no significant difference in the postoperative hospitalization between the patients under 65 years (3.0±0.3 days) and those over 65 years (3.2 ± 0.9 days). Two patients (0.7%) were rehospitalized within one month after discharge; one due to bleeding from vaginal wall hematoma and the other due to increased gluteal pain, both of whom were conservatively managed and discharged within a short period. During follow-up of 3–12 months, mesh exposure occurred in 7 cases (2.3%), 2 of them required a hospitalized surgical management. Conclusions: Even in early learning phase, the TVM procedure could be done with relatively few perioperative complications. Both young and elderly patients generally

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accepted the clinical pathway of discharge on postoperative day 3 or earlier in spite of the situation that Japanese want to be hospitalized longer due to inexpensive hospitalization and culture. Minimally-invasive mesh procedures such as TVM are anticipated to change the management of POP which has been regarded as a trivial matter in some countries although it is actually one of the most important diseases affecting the quality of life (QOL) in latter half of women’s life. 27 MANAGEMENT OF PELVIC ORGAN PROLAPSE BY VAGINAL PESSARIES – ONE YEAR FOLLOW UP Oliver R, Lim J, Thakar R, Sultan A,, Mayday University Hospital, United Kingdom Industry Support: No Objective. The aim of our study was to prospectively evaluate prolapse, bladder, bowel and sexual symptoms 12 months after pessary insertion using a validated questionnaire and to assess risk factors for failure. Background. Pelvic organ prolapse (POP) has a lifetime prevalence of 30% with an 11% risk for surgery. Although there is evidence that vaginal pessaries are an effective and simple method of alleviating symptoms of POP at 4 months, long term data is not available (1). Evidence to assess the effectiveness of the pessary is necessary as well as identification of the factors associated with failure. Methods. We conducted a prospective longitudinal study in a POP clinic. Women referred between June 2002 and August 2007 with symptomatic POP were given the option of either pessary or surgery. Pessary success was defined as adequate reduction of prolapse, without discomfort or expulsion. Failure was defined as the inability to retain or need for removal due to complications. All women who had a pessary inserted completed a Sheffield prolapse symptom questionnaire before insertion, at 6 and 12 months (2). Friedmans test was used to compare symptom changes and risks factors for failure was ascertained by logistic regression analysis. Results. 322 women chose to have a pessary. Mean age was 70.6 yrs (SD=12.8) and median parity was 2 (range 0–8). There were 300(93.2%) Caucasians, 5(1.6%) Afro-caribbean and 17(5.3%) Asians.

S85 Figure 1 Flow of participants through the study Women with symptomatic POP, n=322 F ailure at 6 mths = 93

Lost to follow up =3

Pessary expulsion surgery = 39 Complications surgery = 12 Expulsion declined further = 29 Complications declined further = 13

Success at 6 mths =225

Patients wish surgery = 43 Other indications surgery = 4 Patients wish No pessary = 5 Community no information = 6

Lost to follow up = 7

Completed 6 mths = 167

Failure at 12 mths = 5

Success at 12 mths = 152

Pessary expulsion surgery = 4 Complications surgery = 1

Completed 12 mths = 146

Patient’s wish surgery, = 3 Other indications surgery =1 Community no information = 2

Vaginal symptoms There was significant symptom relief and its degree of bothersome between baseline and 6 months (p=<0.001), but no relief between 6 and 12 months. The symptoms were awareness of a lump in or coming out of the vagina and dragging lower abdominal pain. Bladder symptoms The need to push the prolapse back to empty the bladder (p=<0.001) improved between baseline and 6 months, but no relief between 6 and 12 months, with a similar improvement in the degree of bothersome. There was no significant relief of voiding difficulties, urge or stress incontinence. Urgency as well as the degree of bothersome, improved significantly at 12 months (p= 0.002), but not at 6 months. Bowel symptoms There was no significant improvement in fecal urgency, fecal incontinence, digitation and obstructed defecation symptoms between baseline and 6 months and between 6 and 12 months. Quality of life There was a significant improvement in enjoyment of life and interference with physical activity between baseline and 6 months, with no relief between 6 and 12 months. Low back pain significantly improved from baseline to 6 months (p= <0.001), but no difference between 6 and 12 months. Sexual activity There was no significant change in sexual activity and the frequency of intercourse. Risk factors for pessary failure The following risk factors were found not to be significant in predicting pessary failure; Hysterectomy (p=0.141), Previous repair (p=0.080), Cystocele (p=0.992), Rectocele(p=0.824), Enterocele(p=0.714), Vault/Uterovaginal prolapse (p=0.922). On multivariate regression, Age (p= 0.002) and Parity (p=0.038) were significantly associated with failure to retain pessary. On univariate regression the results are similar with Age (p=<0.001) and Parity (p= 0.036) showing significance. Conclusions. This study demonstrates that vaginal pessary is an effective and simple method of alleviating prolapse symptoms twelve months after their use. To date this study is the largest

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prospective trial to assess the effectiveness of pessary usage in the long term. Additionally this study has used validated questionnaires which strengthen the robustness of the results. In absence of a randomized trial, this study provides the best available evidence of the effectiveness of pessary use. References. 1. Effect of Vaginal Pessaries on Symptoms Associated With Pelvic Organ Prolapse. Obstet Gynecol (2006) 108; 93–99. 2. Development and psychometric testing of a symptom index for pelvic organ prolapse. J Obstet Gynaecol. (2006) 26; 241–52. 28 Three-dimensional pelvic ultrasonography versus MRI for imaging mesh used in prolapse surgery Lim J, Dobrotwir A, Carey M Royal Women’s Hospital, Australia Industry Support: Yes (Investigator initiated, partial funding) Objective: To compare the ability of pelvic three-dimensional (3D) ultrasonography and MRI to accurately assess mesh size and position, and the functional support provided by mesh in vivo following 5 different mesh augmented procedures for prolapse. Background: Mesh has been used in prolapse surgery in order to obtain more durable support than traditional colporrhaphy. However, mesh has been associated with problems including dyspareunia, mesh exposure, irritative bladder symptoms, rectal pain, and lower bowel dysfunction 1,2. Currently, the evaluation and management, including further surgery, of these problems has been based largely on clinical assessment. 3D ultrasonography and MRI has the potential to provide important information, in addition to clinical assessment, on outcomes and complications following prolapse surgery with mesh. Methods: IRB approval was obtained for this study. We analysed the 3D ultrasonography and MRI images of 10 women whom had undergone one of 5 different mesh augmented procedures (2 subjects per group) for prolapse. These procedures were laparoscopic sacral colpopexy (LSC), anterior and posterior vaginal repair with mesh, anterior and posterior vaginal repair with mesh and vaginal support device, total Prolift, and combined Apogee/ Perigee. 3D ultrasonography and MRI images were independently analysed to assess: distance between the mesh and vaginal lumen; distance between mesh and anal/ rectal lumen; distance between mesh and bladder; anatomical relationship of the mesh to ischial spines, pubic symphysis, and external anal sphincter; size and dimensions of each mesh after incorporation into pelvic tissues; and the presence of any pelvic organ prolapse or movement of the

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mesh with dynamic manoeuvres. After ultrasonography and MRI images were analysed independently, both MRI and 3D ultrasonography operators reached consensus on the accuracy and ease of obtaining predetermined measurements, and the utility of each imaging modality. Results: 3D ultrasonography was able to accurately determine all mesh sizes and the tissue thickness measurements except for the LSC group. With MRI we were unable to measure any of the individual mesh sizes or determine 25% of the mesh-tissue thicknesses specified in the study. This was largely due to the clarity with which mesh appears on ultrasonography compared to MRI and the ability of 3D ultrasonography to provide magnified views and fine detail of structures in close proximity to the probe. This degree of detail with ultrasonography enabled us to make observations such as mesh being less than 1 mm away from bladder and rectal lumen in cases when fascial placation was not performed (in Prolift and Apogee/Perigee cases) but this was not possible with MRI. Where there was a large disparity in mesh-tissue thickness between ultrasonography and MRI, explanations (usually artifact in MRI images) could be found for these disparities upon review of the images by both ultrasonography and MRI operators. This study also demonstrated the functional and diagnostic information attainable by 3D ultrasonography such as mesh coverage, dynamic mesh support, and mesh proximity to various viscera. Both modalities were effective at detecting the presence of recurrent prolapse, but only ultrasonography was able to detect mesh movement during dynamic maneuvers. MRI provided better assessment of mesh in the LSC group and provided a better view of mesh and its relationship with anatomical structures higher in the pelvis. Conclusion: Our results demonstrate that 3D ultrasonography appears to be superior to MRI for imaging synthetic mesh following vaginal mesh augmented pelvic organ prolapse surgery. On the basis of this limited study, 3D ultrasonography appears to have sufficient consistency and accuracy in obtaining mesh and tissue measurements in a variety of vaginal mesh augmented procedures to support its use as a diagnostic or research tool in the future. 1. Milani R, et al. BJOG. 2005 Jan;112(1):107–11. 2. Lim J, Carey M, et al. Int Urogynecol J (2007) 18 (Suppl 1):S38-S39 29 Multi-center trial evaluating the 6 and 12 mo efficacy and safety of the Perigee System with IntePro Moore R1, Beyer R2, Jacoby K3, Freedman S4, McCammon K5, Gambla M6 1 Atlanta Urogynecology Associates, United States, 2Women’s Health Care Specialists, United States, 3Urology Northwest, United States, 4Sheldon Freedman MD , United States,

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Eastern Virginia Medical School, Dept of Urology, United States, 6Central Ohio Urology Group/Urology Surgeons, United States Industry Support: Yes (Industry-initiated, full sponsorship) Objective: The purpose of this study was to evaluate the 6 and 12 mo efficacy and safety of mesh placement along the anterior vaginal wall. Background: In an ongoing, prospective, multi-center trial, 8 U.S. Sites implanted women with anterior vaginal wall prolapse (> Stage II). All sites received IRB approval prior to enrollment. Methods: Each patient underwent placement of Type I, polypropylene mesh (Perigee System with IntePro™, American Medical Systems, Inc., Minnetonka, MN, USA) employing a transobturator approach. At the time of implant, the cystocele was not reduced nor repaired under the mesh. Additional reconstructive and incontinence procedures were completed as indicated. Women having concomitant hysterectomy or a history of anterior wall graft were excluded. Primary endpoint was the percent of patients with < anterior Stage I (“success”) at follow-up. Secondary endpoints included, but were not limited to, procedure time, estimated blood loss, and device-related complications. Patients were seen post-operatively at 6 weeks, 3 mos, 6 mos, and 12 mos and will be followed prospectively through 24 mos. Results: 112 patients were implanted. Currently, 99 patients have completed their 6 mo follow-up, and 85 have reached their 12 mo follow-up (mean follow-up: 15.25+7.7 mos). Patient demographics include: ethnicity (Caucasian: 96.3%, Hispanic: 2.8%, African American: 0.9%), age: 60.7 years (27, 87), BMI: 27.5+6.0, gravida: 3.2+1.7, para: 2.8+1.5, prior cystocele repair: 22.9%, menopausal: 87.1%, prior hysterectomy: 54.1%. The Perigee only procedure time was 29.2±13.2 min; total procedure time (skin-to-skin) was 86.6±44.1 min. Concomitant repairs included vault suspension (62.4%), incontinence (69.7%), and rectocele repair (64.2%). Estimated blood loss for Perigee, only, was 69.0+74.1 cc. Hematocrit at baseline, immediately following the procedure, and at postop day 1 was: 39.7± 3.5, 33.2±3.9, and 33.0±3.8. There were two devicerelated perioperative complications: a bladder perforation and a hematoma. The bladder perforation was (1 cm) lateral to the ureteral orifice, occurred during dissection, and was immediately repaired. The surgery resumed and the Perigee was implanted without any postop sequalae. The hematoma formed behind the vaginal incision and required intraoperative drainage. The patient did require transfusion, postoperatively, and was the only patient that required transfusion out of the 112 patients for an overall rate of <1%. There were no erosions into the surrounding viscera.

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Eleven patients (9.8%) did experience a mesh extrusion into the vagina with an average time to onset of 211.2 days, post-op (38–686). 7/11 (6.25%) patients required surgical intervention and the others (3.6%) healed with conservative intervention or observation. Only two (1.8%) extruded patients had low vaginal estrogenicity (determined from a cytological vaginal wall maturation index); the remaining extruded patients (8.0%) had moderate (7/11, 6.25%) or high (2/11, 1.8%) vaginal estrogenicity. Two (1.8%) patients reported de novo urge, with incontinence; both have resolved. De novo stress incontinence was reported in 4 (3.6%) patients. Two patients were treated with a subsequent monarc. The other 2 patients both received concomitant incontinence slings at the time of the Perigee implant: one failed and was replaced; the other patient is being treated with medication. All other device-related complications occurred at a rate less than 1%, including pain. Objective success rates (
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findings to conclude all women undergoing prolapse surgery must undergo an incontinence procedure concomitantly. Methods: Records of 205 women who underwent Abdominal Sacrocolpopexy (ASC) by 8 surgeons during the time period 2005–2007, inclusive, in 5 university and private practice Urogynecology clinics, were identified through billing records and reviewed. Baseline demographics, preoperative (pre-op) history and physical examination, pre-op urodynamics results, operative procedure, 6 week post op visit, and the last recorded visit for the patient at each clinic were recorded and analyzed. Results: The mean age of women who underwent ASC during the study period was 60.9 (35–89). Pre-op urodynamics confirmed stress incontinence in 83 women, 13 of whom were diagnosed with occult or potential stress incontinence. Sixty women underwent midurethral sling & 24 women underwent a Burch procedure. At the 6 week visit, 23 (11.2%) of the 205 women reported any incontinence: 36 had undergone and anti-incontinence procedure (21 had RPU,15 had sling) and 12 had no incontinence procedure. Thirty-five women (17%) reported any urgency and/or frequency: 13 (37%) of these patients had pre-op detrusor overactivity (DO), 20 (57%) had sling or RPU, and 15 had no incontinence procedure. Six women had residual urine of >100 ml at 6 week follow-up. Mid-term follow up was available for 147 women with mean follow-up (f/u) of 41.5 weeks (range 8–96). At midterm f/u, 21 women (14.2%) reported any incontinence: 10 had an RPU or sling and 11 had no incontinence procedure. Twenty-eight women (19%) reported any urgency-frequency post -op compared to 55 women (27%) pre op. Of the women with urgency/frequency: 16 had pre-op DO, 14 had an RPU or sling & 14 had no incontinence procedure. Overall only 6 (3%) of women had incontinence severe enough to request further treatment. Four women had an interval midurethral sling, 1 scheduled a periurethral bulking injection, 1 interstim was scheduled for severe DO and 1 requested treatment for persistent nocturia. There were 70 women who did not demonstrate Urodynamic Stress Incontinence or occult stress incontinence preoperatively and who did not receive an incontinence procedure at the time of ASC. At the 6 week visit, 4 of these women demonstrated any symptoms of incontinence. Of these 70 women, 58 have had a mid-term follow up visit. At this interval, 4 women had any complaint of incontinence. Conclusions: Using urodynamic evaluation of lower urinary tract function to determine whether or not to perform an incontinence procedure at the time of ASC appears to be a highly effective approach. Blindly performing incontinence

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procedures at the time of all prolapse surgeries is not supported by our data. 31 Perigee versus Anterior Prolift in the treatment of Cystocele Shek K1, Dietz H1, Rane A2, Goh J3 1 University of Sydney, Australia, 2James Cook University, Australia, 3Griffith University, Australia Industry Support: Yes (Investigator initiated, partial funding) Aims: The aim of this study was to compare the mediumterm clinical outcomes and ultrasound findings of 2 commonly used mesh techniques, using data obtained in surgical audit projects. Background: In recent years, there has been growing interest in the use of transobturator polypropylene mesh in cystocele repair, especially for large and recurrent cystocele. Short term data suggest that anterior compartment mesh repair is safe and effective, but to our knowledge there have been no studies to date comparing the different methods currently in use. Methods: 103 patients were seen in the context of surgical audits after Perigee TM (PE) or Prolift TM (PR) transobturator mesh repair at three urogynaecological units. The assessment included a standardized interview, clinical examination for prolapse grading and 3D translabial ultrasound performed supine position after voiding.. Matching of groups required the removal of 8 datasets. The resulting groups (30 PR and 65 PE) were well matched for duration of follow- up (0.65 vs. 0.71 yrs), age (60 vs 63 years) and vaginal parity (2.4 vs 2.9), previous hysterectomy (43% vs 49%) and previous anterior repair (13% vs 29%). Results: There were no statistically significant differences between groups for satisfaction rate (67% vs. 75%), subjective cure/ improvement (97% vs. 91%), and significant cystocele (Stage 2+, 10% vs. 12%). The point Ba was on average at -1.83 (SD 1.12) in the PR group and -1.45 (SD 1.21) in the PE group (P=0.14). More women in the PE group described recurrent prolapse symptoms (28% vs. 10%, P=0.053), but this did not reach significance. There were no differences in erosion rate (4/65 vs. 1/30). Bladder neck descent was similar (23.5 vs. 25.2 mm, as was the lowest point reached by the bladder on ultrasound (-0.2 vs. -0.7 mm). Total mesh width was also similar (26 vs. 23 mm). The gap between pubis and mesh seemed to be wider after Prolift (24 vs 21 mm, P=0.052), although this result did not reach significance. The figure shows typical ultrasound findings after Perigee and Anterior Prolift mesh repair.

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Conclusions: In this comparative series, no significant differences were found between Perigee and Anterior Prolift in terms of subjective and objective clinical outcomes and ultrasound findings, although there were trends towards more prolapse symptoms in the Perigee group and a larger pubis- mesh gap in the Prolift arm. Our findings may serve as pilot data for future randomised controlled trials. 32 Genetic and Environmental Influences on Stress Urinary Incontinence: Results of a Large Population-Based Classical Twin Study Nguyen A, Aschkenazi S, Gamble T, Botros S, Sand P, Goldberg R Evanston Incontinence Center, Northwestern University, United States Industry Support: No Objective: To explore the extent to which genetic and environmental factors influence the development of stress urinary incontinence (SUI). Background: Whereas prior studies have hypothesized that SUI is multifactorial in nature and explained by both environmental and genetic factors, the aim of this study is to use a classical twin analyses to investigate the relative contributions of genetic and environmental influences in a large community based sample of monozygotic (MZ) and dizygotic (DZ) twins. Method: Structural equation models (SEM) were fitted to data obtained from surveys collected from 751 twin sister pairs (n=1502) with 652 MZ pairs and 99 DZ pairs, obtained from the world’s largest annual gathering of twins held at the Twins Days Festival in Twinsburg, Ohio from 2003–2007. SEM, also known as covariance modeling, is a

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general approach for the analysis of variance, correlations and heritability. MX software was utilized for this analyses.1 Stress urinary incontinence was elicited by an affirmative answer to the question, “Do you leak urine with coughing, straining, laughing, physical activity or exercise?” SEM were configured with three latent variables which model possible effects of: additive genes (A), shared environment (C), and individual-specific environment (E). We used a sequential modeling technique to assess the model fit, by using -2 log likelihood ratio test and Akaike Information Criterion. 2 Heritability can be estimated from the most parsimonious model that includes an additive genetic effect. Results: There were 638 MZ and 99 DZ twin sister pairs with complete data pertaining to SUI. The mean age was 41.7±16.1 years (range 18 - 85), and the mean BMI was 26.1±6.4 (range 13.5 - 55.8), with race comprised of 89.5% white, 6.0% Black, 2.0% Hispanic, and 2% of other ethnicities. There was no difference in general demographics: age, race, parity, bmi, menopausal status, mode of delivery or prior surgery between MZ and DZ twins. The overall prevalence of SUI was 42.3% and 49% in MZ and DZ twins respectively. The tetrachoric correlation was 0.789 in MZ, and 0.748 in DZ twins. The tetrachoric correlation was 0.789 in MZ, and 0.748 in DZ twins. Both correlations are significant indicating a high concordance of SUI amongst MZ and DZ twins. The concordance was not found to be significantly higher in MZ versus DZ twins with MZ correlation nearly equaling DZ correlation, and largely overlapping 95% confidence intervals (MZ: 0.721– 0.845; DZ: 0.536–0.882) both indicating that genetic effects were not contributory. Univariate model-fitting procedures supported this finding. Sequential structural equation modeling of the categorical data revealed that the CE model including shared environmental and unique environ-

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mental effects provided the best fit (Table). The hereditability of SUI in the ACE model was 8.26% (95%CI: 0%52%) which was not statistically significant. Shared environmental factors contributed to approximately 70.63% (95%CI: 27.95–83.50) of the variance among twins compared to unique environmental factors which contributed 21.1% (95%CI: 15.5–27.84), both of which were significant. Table Best-Fitting Model to Assess Variation of Genetic and Environmental Components for Stress Urinary Incontinence Model ACE AE CE E

-2lnL 1779.790 1788.696 1780.003 2033.578

df 1483 1484 1484 1485

Δdf

Χ2

probability

1 1 1

8.906 0.213 253.575

0.003 0.644 <0.001

NOTE: Model in bold type indicates the most suitable model according to the principle of parsimony. Abbreviations: df: degrees of freedom Conclusion: This classical twin study, analyzing over 1500 predominantly Caucasian twins, strongly suggests that SUI is explained by environmental factors and is not inherited or determined by genetics as has been previously hypothesized. Stress incontinence, in other words, is for these women a product of ‘nurture’ rather than ‘nature’. Future studies will be focused on applying this model to a more racially diverse sample. In the meantime, these findings should reinforce the need to focus efforts squarely on preventable environmental risk factors - such as traumatic childbirth - and to abandon the notion that SUI represents a woman’s predetermined genetic fate. Reference: 1. Neale MC, Boker SM, Xie G, Maes HH. Mx: Statistical modeling, 7th ed. Richmond, VA: Virginia Commonwealth University, 2006. 2. Neale MC, Cardon LR. Methodology for Genetic Studies of Twins and Families. Dordrecht, The Netherlands: Kluwer Academic Publishers, 1992. 33 Site-Specific Prolapse Surgery. II. Vaginal Paravaginal Repair Augmented With Either Synthetic Mesh or Remodelling Xenograft. Reid R, Luo K Hunter New England Health, Australia Industry Support: No Background: Cystocoele repair has been problematic for several reasons. Pelvic anatomy is extremely complex; the

difficulty of curing prolapse increases with time and tissue weakness; and reparative efforts have been confounded by 100 years of mechanically inappropriate surgical strategies. In normal women, the levator plate acts as a dynamic backstop, absorbing most of the Valsalva forces. Conversely, pelvic connective tissue is basically an embryologic mesentery, anchoring the pelvic viscera to the axial skeleton. Main suspensory role is to stabilize the organs over the posterior levator plate, where the levator plate works most effectively. Unfortunately, muscle damage sustained at childbirth is not reparable. Hence, strategies for re-suspending sagging pelvic organs are unduly reliant upon the repaired connective tissue. Anything that either weakens or strengthens the endopelvic fascia therefore assumes great surgical importance. In this respect, prolapse repair is similar to herniorrhaphy, where surgical strategies now address both mechanical and metabolic factors. Objective: To investigate whether tissue augmentation delivered any additional benefit, over and above effective mechanical repair. Methods: Study design was a retrospective review of 167 consecutive rotatory cystocoele repairs operated at a pelvic floor referral practice between 1997?2007. One hundred eight tissue augmented vaginal paravaginal repairs (90 second generation xenografts and 18 synthetic mesh implants) were compared with 59 historical controls (treated by native tissue VPVR). Women were prospectively evaluated by symptom severity inventories, standardized physical exam and urodynamic testing if indicated. Main outcome measures were “same site” prolapse recurrence; worsened or de novo urgency, voiding dysfunction or dyspareunia; and major peri-operative complications. Initial reliability of cystocoele repair was evaluated by chi-squared test of early anatomic and functional outcomes. Repair durability over the succeeding ten years was gauged by Kaplan-Meier survival analysis and logrank test. Results: Augmented VPVR’s outperformed native tissue repairs by a margin of 28.6% [91.2% versus 62.6%; logrank X2=8.9, p-value=0.0028<0.05]. Cumulative probability of objective anatomic success was 0.94 at 1 year and 0.912 at 2, 3, and 4 years in the augmented group versus 0.846 at 1 year and 0.775, 0.719 and 0.69 at 2, 3, and 4 years after native tissue repair. Cox proportional hazards modelling estimated the hazards ratio (ie, relative risk of repair failure) to be 0.306 (95% CI: 0.131 - 0.731). Stated in another way, the use of a suitable bridging graft reduced the risk of repair failure by an average of 69.4% (range=26.9-86.9%). On subgroup analysis, success rates improved incrementally with increasing adherence to the “∼hernia principles”. Functional outcomes in both groups were excellent and perioperative complication rate was 4.7%. Conclusions: (1). Prolapse repair appears analogous to herniorrhaphy. Effective and durable repair demands two

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things: that the specific fascial tears (not the secondary bulges) be repaired without tension, and that degenerative tissue bordering the site of the original fascial tear be overlaid with a tissue augmentation material, appropriate to the site of implantation. (2). The fundamental objective of VPVR is to completely rebuild the pubocervical septum, from arcus to arcus and from pubic ramus to pericervical ring. Doing this operation by suture-only technique satisfies the mechanical dictates of the hernia principles, but not the metabolic ones. Conversely, use of an appropriate bridging graft serendipitously simplifies the technical task of VPVR (reducing prolapse persistence from 18.6% to 4.6%), as well as rejuvenating adjacent connective tissue (reducing prolapse recurrence from 14.6% to 4.9%). (3). It is intuitive for surgeons to choose an inert permanent material, such as synthetic mesh or a crosslinked biological. Unfortunately, such prostheses always evoke a foreign body inflammatory reaction; this can be either beneficial or morbid. However, if a biologic implant is prepared in a way that preserves normal collagen structure and functional matrix molecules, host cells will repopulate and constructively remodel the bridging graft. Using these tissue engineering principles, a temporary xenograft can be transformed into a permanent layer of aponeurotic host tissue, without the potential for mesh pain or erosion. Thus, the 28.6% improvement in five-year durability attending xenograft-augmented cystocoele repair is of considerable importance - especially since use of biomaterials made the operation quicker and more readily standardised than VPVR’s done with native tissue. 88 Long term follow-up of a randomized controlled trial comparing abdominal and vaginal surgical correction of uterine prolapse. Roovers J, Bleijenberg E, Schagen van Leeuwen J, Scholten P, van der Vaart H AMC Amsterdam, Netherlands Industry Support: No Objective To compare the long-term effects of vaginal hysterectomy (combined with anterior and/or posterior colporraphy) and abdominal sacrocolpopexy (with preservation of the uterus) as surgical correction of uterine prolapse. Background Between january 1998 and July 2000 we enrolled 84 patients in a randomized controlled trial (RCT) comparing abdominal and vaginal prolapse surgery in patients with stage 2 (POP-Q) or more uterine prolapse. The short term results showed that the vaginal approach resulted in a lower risk on surgery for recurrent prolapse, less overactive bladder symptoms, less obstructive micturition symptoms and lower morbidity.1,2

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The ICS and IUGA have recommended to perform long term follow-up of RCTs but most investigators fail to do so. We present data of 8 year follow-up of our trial to evaluate whether our initial conclusions hold true on the long term. Methods This RCT was performed in three Dutch teaching hospitals. Patients were excluded in case of a uterus sized more than 12 weeks of gestational age, the presence of an adnexal mass, a history of more than two abdominal pelvic surgical procedures, extreme obesity (Quetelet index>35 kg/m2), prior inflammatory bowel or pelvic disease and fecal incontinence because of an anal sphincter defect. For the purpose of this long-term follow-up evaluation, patients were asked to complete the urogenital distress inventory (UDI), the defecation distress inventory (DDI) and the incontinence impact questionnaire (IIQ). All these questionnaires have been validated in Dutch. To these questionnaires we added questions to objectify whether patients had undergone additional treatment for prolapse, micturition, defecation of sexual symptoms and whether they felt these symptoms had changed as compared to before surgery. All medical files were studied to check whether the information provided by the patient was correct and to collect data on post-operative care of non-responders. All patients were invited to the outpatient clinic to undergo a pelvic examination including POP-Q scoring. During this visit the information provided by the patient about post-operative care was also checked. Results Seventy-four (88%) of 84 women were still alive and could be traced for this long-term evaluation. Of these 74 patients, 60 (80%) completed the questionnaire and 31 (42%) visited the hospital to undergo pelvic examination. The mean follow-up time was 94 months (range 84 - 120 months). Eight (19%) of the 42 patients in the vaginal group and 18 (43%) of the patients in the abdominal group (Fisher’s Exact (FE) Test p=0.03) visited a physician after primary surgery because of pelvic floor symptoms. In the vaginal group 87% reported that prolapse symptoms had improved as compared to before primary surgery, whereas in the abdominal group only 68% reported so (FE Test, p=0.09). Re-operation was performed in 11 (26%) patients of the abdominal group and 6 (14%) of the vaginal group (FE Test, p=0.28). IIQ scores and POP-Q scores were similar for both groups. The table shows UDI and DDI scores before and after surgery. Micturition and defecation symptoms had more adverse effect on quality of life in the abdominal group than in the vaginal group. The difference in the constipation/ obstruction domain of the DDI was statistically significant. Conclusions Long term results of this RCT are consistent with short term results and show that vaginal hysterectomy with anterior and/or posterior colporraphy is preferable to abdominal

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sacrocolpopexy with preservation of the uterus, as surgical correction of uterine prolapse. References 1. BJOG (2004) 111; 50–56. 2. Neurourol Urodyn (2005) 24;334–40.

We registered asymptomatic contractions in:

89 Preservation of uterus when treating prolapse by Prolift TM does not significantly reduce risk of early post surgical complications and failures Cosson M, Jean Charles C, Debodinance P, Lucot JP, Rubod C, Boukerrou M Gynecologic surgery unit, University Hospital Jeanne de Flandres, LILLE, FRANCE

We saw no symptomatic retraction. Short term recurence of prolapse (stage=2 POPQ) was found in

Industry Support: No AIMS Our aim was to study the repercussion of conservation of the uterus both on perisurgical complications and early anatomic results when treating prolapse by vaginal surgery Prolift,,¢. MATERIAL, METHODS. We studied a retrospective survey made during two years in two centers and including 217 patients, mean age 63, 9, prolapse = to stage 3 according to POPQ classification. At time of surgery, 53 patients had undergone previous hysterectomy. The others still had their uterus, presurgical assessment included cervical smears, pelvic echography, endometrial biopsy. 164 women chose to keep their uterus, 23 though had a concomitent hysterectomy. Mean followup after surgery was 10 weeks and analysed per or post surgical complication. Post-surgical clinical examination detected the cases with or without symptomatic retraction of the prosthesis or anatomical failures. Statistical analysis compared the different groups using X2 and Fisher test. RESULTS During procedure we registered 2 bladder injuries (1,2%) in the group where uterus was kept and 1 (1,8%) in the group with previous hysterectomy. 1 hemorragia (4,3%) occurred during hysterectomy, an urethral injury (1,8%) in a patient with a previous hysterectomy. Immediately after surgery no severe complication needed re intervention. In the post operative course we found mesh exposures: – – –

3 (1, 8%) when uterus had been kept. 1(2%) after previous hysterectomy 1(4, 3%) among patients with concomitant hysterectomy.

– – –

– – –

32 (19, 5%) when uterus had been kept. 11 (20, 7%) in the group with previous hysterectomy. 2 (8, 6%) when hysterectomy was performed during the cure of prolapse

13 patients who had kept their uterus (7,9%) 0 of the patients with previous hysterectomy (0%) 4 with per surgical hysterectomies (17,3%)

The rate of early failure is significantly higher when uterus is kept than in the case of past hysterectomy (p=0,003). There was no significant difference for the patients who had chosen a concomitent hysterectomy.

Mesh Exposition Mesh Contractions Recurence (stage≥2) erosions retractions Relapse (stage≥2)

N= % N= % N= % N= % N= % N= %

Uterus kept N=164 3 1,8 32 19,5 13 7,9 3 1,8 32 19,5 13 7,9

Concomitant hysterectomy N=23 1 4,3 2 8,6 4 17,3 1 2 11 20,7 0 0

Total N=187

P

4 2,13903743 34 15,6682028 17 9,09090909 4 1,84331797 43 19,8156682 13 5,99078341

0,43 0,2 0,13 0,98 0,84 0,03

CONCLUSION In our survey, to keep or not uterus does not significantly change the rate of peri-surgical complications. Nevertheless, we do detect a non significantly lower rate of persurgical complications, prosthetic exposure (2% /4%) and short term anatomical failures (8% /17%) when uterus is kept. Therefore keeping the uterus during a complete ProliftTM procedure for genital prolapse does not significantly increase the risk of early anatomic failures. Asymptomatic and painless prosthetic retraction, though, is higher when uterus is kept but, once more not in a significant way. This underlines that keeping the uterus seems interesting but needs to be strictly evaluated by prospective comparative studies.

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90 A Prospective Multi-Center Clinical Trial Evaluating the Apogee System for the Treatment of Posterior Vaginal Wall and Apical Prolapse Lukban J1, Erickson T2, Virelles M3, Flaherty J4, Beyer R5, Moore R6 1 Eastern Virginia Medical School, United States, 2 Rosemark Womencare Specialists, United States 3 Institute for Women’s Health & Body, United States, 4 Intermed, United States, 5Women’s Health Care Specialists, United States, 6Atlanta Urogynecology Associates, United States Industry Support: Yes (Industry-initiated, full sponsorship) Objective: To evaluate the efficacy and safety of the Apogee® System (AMS, Minnetonka, MN) in pelvic organ prolapse repair. Background: In an ongoing, prospective, multi-center study involving 13 US sites, women with posterior vaginal prolapse (>Stage II) and/or apical descent (>Stage II) were enrolled for primary posterior mesh implant. All sites received IRB approval prior to inclusion. Methods: Each patient underwent placement of an apical polypropylene strip with a 5 x 14 cm (approximate) cape of polypropylene mesh (Apogee with IntePro,,¢) or porcine dermis (Apogee with InteXen® LP) employing a bilateral transgluteal approach. Primary endpoint was the percent of patients with Stage < I (“cure”) at follow-up, with clinical evaluations performed by an unblinded practitioner. Secondary endpoints included, but were not limited to, procedure time, estimated blood loss, device-related complications, quality of life (PFDI and PFIQ-7), and patient satisfaction (Patient Satisfaction Survey). Patients were seen postoperatively at 6 weeks, 3 months, 6 months and 12 months, and will be followed prospectively through 2 years. Results: Two-hundred women underwent the procedure with a mean follow-up of 8.6 months (range 0.4 - 14.7). Baseline demographics included a mean age of 60.8 years (range 33 - 90), mean BMI of 28.5 (range 18.0 - 53.1), and mean parity of 3.1 (range 0 - 9). The majority were postmenopausal (88.3%). Just less than half (49.2%) were on estrogen replacement therapy for at least 4 weeks prior to surgery. At baseline, 96.4% of patients presented with posterior vaginal prolapse, 52.5% had posterior enterocele, and 25.8% had apical or uterine descent. Hysterectomy was performed at the time of Apogee placement in 48 (24.0%) patients. Additional reconstructive procedures were preformed as indicated with the exception of concomitant repairs in the same vaginal segment. Poly-

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propylene (PP) was used in 174 (87%) patients and 26 (13%) received porcine dermis (PD). Average procedure time for Apogee only was 45.8 + 20.8 minutes. Mean EBL was 69.7 + 63 cc and no patient required transfusion. No intra-operative complications were attributed to the Apogee trocars including trauma to the rectum or the bowel. Six and twelve month follow-up data were available on 169 (84.5%) and 90 (48.0%) patients, respectively. Objective posterior wall cure rates at 6 and 12 months were 92.8% and 92.2% (91.4% and 90.6% for PP; 100% and 100% for PD), with apical cure rates of 97.0% and 93.3% (96.5% and 92.0% for PP; 100% and 100% for PD). Extrusions (vaginal exposure of mesh) were seen in 14 (7.0%) PP patients, with none reported in those receiving PD. Six (3.0%) patients with extrusion required revision in the operating room while the remaining patients were treated conservatively (local estrogen and/or trimming in the office) or observed. With respect to extrusion sites, mesh exposure occurred along the midline incision in 42.8%, distal vagina in 57.1%, and at the apex in 14.3%. One (0.5%) erosion (mesh into viscus) was reported involving the anterior rectum, 2 cm proximal to the anal verge. Detected 13 months postoperatively on routine fecal occult blood testing, the site was managed surgically by trimming a 3–4 mm corner of visible polypropylene mesh and closing the defect in two layers. No anatomic or functional compromise was incurred following correction. Other device-related complications occurred at or below 1%, with the following complications reported by number of patients: infection of the apical incision in 1 (0.5%), buttock discomfort in 1 (0.5%), perineal discomfort in 2 (1.0%), vaginal discomfort in 1 (0.5%), dyspareunia in 2 (1.0%), hematoma in 1 (0.5%), and rectal pain in 1 (0.5%). QOL questionnaires (PFDI, PFIQ-7) showed improvement, with percent improvements of 69.4% and 69.0% for the mean PFDI summary score; and 68.9% and 72.0% for the mean PFIQ-7 summary score. Regarding patient satisfaction, 99.4% and 98.9% of patients had an overall feeling of “a lot” (83.4% and 85.1%) or “some” (16.0% and 13.8%) improvement”; 88.1% and 86.2% were “very” (34.3% and 36.2%) or “extremely” (53.8% and 50.0%) satisfied; and 97.0% and 95.7% would recommend the procedure to a friend at 6 and 12-months, respectively. Conclusions: The Apogee System appears to be effective in the treatment of patients with posterior vaginal wall and/or apical prolapse, with good anatomic durability through 6 and 12 months. The risks and benefits of employing mesh in the posterior compartment should be thoughtfully considered. Follow-up through 24 months is ongoing.

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91 CHARACTERISTICS OF VAGINAL TISSUE WITH AND WITHOUT PROLAPSE Jean Charles C, Cosson M Surgical Gynaecology, Hopital Jeanne de Flandres, Lille medical university Lille France Industry Support: No Importance of the problem Physiopathology of genital prolapse is complex, treatment essentially surgical, long term anatomic results too often somewhat disappointing. We try to offer a better understanding of the question using modelisation of the pelvic cavity. Such a mechanic model could yield better knowledge of yet unexplained physiopathology, evaluate alteration of pelvic statics in a specific and objective manner and understand the impact of different treatments. To build up this model, we must define the biomechanical characteristics of involved tissues. The aim of our study is to characterize normal and pathologic vaginal wall and fascia. Material, methods Samples of vaginal tissue were withdrawn on 30 patients suffering from prolapse (pathological tissue), and 10 fresh cadavers of women without prolapse (sane tissue). Protocol was approved by the ethical committee. We realized uniaxial traction on standardized samples. Results were interpreted as the non linear deformation of an incompressible, elastic material, subjected to high tractions. We could define two characteristic parameters, C0 and C1. C0 is the rigidity of vaginal tissue submitted to small deformation, C1 the rigidity when deformation is important. Statistical study of both CO and C1 allowed to compare normal and pathological vaginal tissue. Results On the anterior wall of pathological vagina, CO and C1 are measured at 0,004 and 0,017, on the posterior wall, at 0,00093 and 0,13. For sane vaginal tissue, CO and C1 were 0,00045 and 0,0055 on the anterior wall, 0,00049 and 0,000075 for posterior wall. Difference between the two groups “sane and pathologic”is significant when comparing respectively anterior and posterior face of vagina (p<0,05). We also compared anterior and posterior face of sane tissue along the transversal direction. CO and C1 were 0,00038 and 0,0027 for the anterior wall, 0,0045 and 0,01 for the posterior wall. We also have here a significant difference (p<0,05). Conclusion

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Prolapsed vaginal tissue is significantly more rigid than sane tissue both on anterior and posterior wall. This could explain the high rate of relapse after some autologuous repairs, as we use a mechanically deficient and more rigid vaginal tissue. Our work also shows a significant difference between anterior and posterior vaginal wall and fascia, seen both in patients with or without prolapse. So we suggest it might be interesting to adapt the characteristics of prosthetic implants to the vaginal wall affected by prolapse. 92 Sacrospinous Hysteropexy and Vaginal Hysterectomy for Uterine Descent: A Randomized Study. Dietz V1, Schraffordt Koops S2, van der Graaf Y3, Heintz P3, van der Vaart C3 1 Catharina Ziekenhuis Eindhoven, Netherlands, 2Meander Medical Center, Netherlands, 3University Medical Center Utrecht, Netherlands Industry Support: No Objective: A vaginal hysterectomy and a sacrospinous hysteropexy were compared on recovery time, anatomical outcomes, functional outcomes and quality of life. Background: In the Netherlands, a vaginal hysterectomy is considered standard practice in case of a uterine descent. A sacrospinous hysteropexy, in which the cervix is attached to the sacrospinous ligament, can also be performed in women who want to preserve their uterus. In literature, the sacrospinous hysteropexy was associated with a shorter recovery time compared to a vaginal hysterectomy and was equally effective in terms of anatomical outcomes1–3. Methods: A randomized study was performed to compare a vaginal hysterectomy to a sacrospinous hysteropexy in case of a uterine descent stage 2–4. Hospital stay and recovery time was measured. Gynecological examination was performed before and one year after surgery, functional outcomes and quality of life were measured with validated questionnaires before surgery and at one year follow up4. Differences were tested with a paired- and unpaired Student t-test, chi- square test and the Confidence Interval Analysis. Results: 66 Women with a stage 2–4 uterine descent were randomized into the study (Figure 1). 35 Women were randomized to a vaginal hysterectomy and 31 women were randomized to a sacrospinous hysteropexy, combined with additional surgery when indicated (colporrhaphy anterior, colporrhaphy posterior and tension free vaginal tape). No differences were found in baseline characteristics. Mean

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age was 62 years (SD=10) after a sacrospinous hysteropexy and 64 years (SD=9) after a vaginal hysterectomy. Median hospital stay was one day shorter after a sacrospinous hysteropexy (3 versus 4 day, P=0.03). Returning to daily activities was comparable in both groups (34 days, SD=13 after a sacrospinous hysteropexy, 33 days, SD=21 after a vaginal hysterectomy, P=0.9) but women after a sacrospinous hysteropexy returned to working activities 23 days earlier compared to women after a vaginal hysterectomy (43 days, SD=21 versus 66 days, SD=34, P=0.02). 513 women with uterine descent stage 2-4 wanting operative correction 104 met exclusion criteria

71 randomized

34 assigned vaginal hysterectomy

338 refused participation, preferred one of the treatments or were not asked to participate

1 hyperplasia of endometrium 1 no surgery because complaints decreased

2 no surgery because complaints decreased

31 vaginal hysterectomy

31 POPQ 27 questionnaires

35 sacrospinous hysteropexy

1 year followup

1 year after surgery

Sacrospinous Vaginal Difference P-value hysteropexy hysterectomy (95%CI) (n=34) (n=31)

LOCF

n(%)

Uterine stage 27 (79) descent/vaginal 0–1 vault descent stage 7 (21) 2–4 Cystocele stage 17 (50) 0–1 stage 17 (50) 2–4 Rectocele stage 28 (82) 0–1 stage 6 (18) 2–4

n(%)

%

30 (97)

17 (2–32)

0.03

-15 (-38–9)

0.2

-11 (-32–9)

0.3

1 (3) 11 (35) 20 (65) 22 (71) 9 (29)

Table 2 Domain scores of the Urinary Distress Inventory (UDI) and Incontinence Impact questionnaire (IIQ) before and after surgery according to surgical approach

37 assigned sacrospinous hysteropexy

1 withdrew consent before surgery (too much bother)

Table 1 Stage of prolapse one year after surgery according to surgical approach

33 POPQ 31 questionnaires

In Table 1, the stages of prolapse are shown one year after surgery. The difference in risk for recurrent prolapse stage 2 or more of the apical compartment was 17% (95% CI: 2 to 30) in favour of the vaginal hysterectomy. Pre operatively, 4 women in the sacrospinous hysteropexy group were diagnosed with a stage 4 prolapse. All these women had a recurrent apical prolapse. No significant differences in risk were found in the anterior and posterior compartment. Surgery because of recurrent prolapse was performed or planned in 4 women (12%) after a sacrospinous hysteropexy and in 2 women (6%, P=0.5) after a vaginal hysterectomy. No differences were found in domain scores on quality of life and urogenital symptoms between the 2 procedures one year after surgery (Table 2).

Before surgery 1 year after surgery SSH N=34 UDI domain scores: Overactive 22 bladder (20) Urinary 11 incontinence (14) Obstructive 11 micturition (19) Genital 55 prolapse (30) Pain 22 (19) IIQ domain scores: Physical 17 functioning (23) Mobility 20 (18) Emotional 13 health (15) Social 6 functioning (12) Embarrassment 10 (14)

VH N=31

SSH VH Difference N=31 N=27 (95%CI)

P-value

25 (24) 10 (16) 23 (26) 64 (32) 24 (25)

11 (18) 6 (8) 3 (9) 2 (5) 11 (18)

12 (17) 6 (11) 8 (16) 4 (13) 7 (21)

0.5 (-10.1–11.1) 0.3 (-4.8–5.4) -5.0 (-13.6–3.6) -2.5 (-7.9–2.9) 2.5 (-7.3–12.4)

0.9

23 (23) 26 (17) 12 (19) 14 (18) 16 (14)

3 (9) 7 (13) 5 (8) 2 (7) 4 (11)

12 (22) 12 (15) 6 (11) 3 (8) 6 (16)

-9.9 (-18.5–- 1.3) -3.6 (-10.5–3.3) -2.0 (-6.9–3.0) -0.9 (-4.7–2.8) -2.6 (-9.4–4.2)

0.06

1.0 0.1 0.5 0.4

0.3 0.5 0.6 0.5

Conclusions: The sacrospinous hysteropexy for uterine descent was associated with a shorter median hospital stay

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and an earlier return to working activities. More recurrent apical prolapses were found after a sacrospinous hysteropexy at one year follow up. Recurrent apical prolapse was associated with a high pre operative stage of prolapse. Functional outcomes and quality of life did not differ between the procedures. Data on longer follow up are needed to state if one procedure is superior to the other. References: 1. Maher CF, Cary MP, Slack CJ, Murray CJ, Milligan M, Schluter P (2001) Uterine preservation or hysterectomy at sacrospinous colpopexy for uterovaginal prolapse. Int Urogynecol J 12:381–385 2. Hefni M, El-Toukhy T, Bhaumik J, Katsimanis E (2003) Sacrospinous cervicocolpopexy with uterine conservation for uterovaginal prolapse in elderly women: An evolving concept. Am J Obstet Gynecol 188(3):645–650 3. Brummen HJ, van de Pol G, Aalders CIM, Heintz APM, van der Vaart CH (2003) Sacrospinous hysteropexy compared to vaginal hysterectomy as primary surgical treatment for a descensus uteri: effects on urinary symptoms. Int Urogynecol J 14:350–355 4. van der Vaart CH, de Leeuw JR, Roovers JP, Heintz AP (2003) Measuring health-related quality of life in women with urogenital dysfunction: the urogenital distress inventory and incontinence impact questionnaire revisited. Neurourol Urodyn 22:97–104 93 A Randomized Comparison of two vaginal surgery for pelvic organ prolapse: histerectomy with vaginal sacrospinous ligament fixation versus histeropexy with repair of pelvic floor using mesh. Carramao S, Lopes E, Auge A, Lemos N, Lunardelli J, Aoki T Faculdade de Ciências Médicas da Santa Casa de Misericórdia de São Paulo, Brazil Industry Support: No Objective: Comparison of the two surgeries techniques to correction of pelvic organ prolapse and to report the anatomic results of histerectomy with vaginal sacrospinous ligament fixation versus histeropexy with repair of pelvic floor using mesh. Design A prospective observational study. Population 28 women with International Continence Society pelvic organ prolapse quantification stage 3 or more pelvic organ prolapse were categorized into the 2 groups: group I hysterectomy with vaginal sacrospinous ligament fixation (n=14); group II, hysterectomy and pelvic reconstruction floor with mesh (n=14). Preoperative and postoperative complications, functional outcomes, and anatomical recurrences were assessed.

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Results The median follow-up was 6 months in all surgery groups. Statistical Analysis utilized was Kruskal-Wallis’Variancy analyses In the complication rates and functional outcomes, no difference was noted, or operation time 130 minutes to group I, versus 120 minutes to groupII and hemoglobin loss 175 mL to group I versus 120 mL to group II. There wasn’t a significant difference in the cumulative anatomical cure rates. Objective success rate was 93,75% at 6 months of follow-up, for two groups, the anatomical results were similar, between the two groups.. Conclusion: Vaginal surgery using mesh is an effective procedure for pelvic organ prolapse. The results of histerectomy with vaginal sacrospinous ligament fixation and the results of histeropexy with repair of pelvic floor using mesh were similar. However further studies are required to establish the role of the surgery described in this study. Keywords Hysterectomy. Graft. Uterine prolapse. 94 Anatomical and functional assessment of prolapse repair by vaginal route using a collagen coating polypropylene mesh. A french prospective multicentre study. 3-year results de Tayrac R1, Eglin G2, Villard P3, Devoldère G4, Renaudie J5, Guilbaud O6 1 Caremeau University Hospital, France, 2 Clinique Champeau, France, 3CHPL de la Loire, France 4 Clinique Sainte Isabelle, France, 5Clinique du Colombier, France, 6Centre Hospitalier, France Industry Support: Yes (Industry-initiated, full sponsorship) Objective The aim of this multicentre study was to report the threeyear anatomical and functional results of a collagen-coated low-weight polypropylene mesh protected by an absorbable hydrophilic film in genital prolapse repair by vaginal route. Background A RCT has shown that results of prolapse repair via vaginal approach could be improved when a polypropylene mesh is used as tissue support (1). However, non protected heavyweight meshes were associated with a high rate of local complications such as vaginal erosions and dyspareunia (2). Methods This study included a consecutive series of 230 patients between March 2003 and June 2004 in 13 centres. All the patients were operated via the vaginal route with a lowweight (38 g/m2) and highly porous (average porosity: 89%, pores over 1.5 mm) polypropylene monofilament mesh, coated with a hydrophilic film composed of atelocollagen, polyethylene glycol and glycerol (Ugy-

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texTM, manufactured by Sofradim, France). The absorbable coating reduces the risk of adhesions between the mesh and the vaginal scar during the healing’s inflammatory peak (3). Prolapse severity was evaluated using the POP-Q system. In order to evaluate the patient’s quality of life, the validated PFDI and the PFIQ questionnaires have been used preoperatively and during follow-up. Mean age was 64 years old +/-11. 35 patients (15.2%) were treated for recurrence. 134 patients had preoperatively normal sexual activity (57.8%). Preoperatively, cystocele were stage II in 84 patients (40.2%), stage III in 102 (48.8%) and stage IV in 23 (11%). Rectocele were stage I/II in 73 patients (59.3%), stage III in 37 (30.1%) and stage IV in 13 (10.6%). Preoperatively, mean PFDI and PFIQ were 88/300 and 60.7/300, respectively. Anterior, posterior and anterior/posterior repair with that mesh were performed in 66, 21 and 143 patients, respectively. Vaginal hysterectomy was associated in 77 patients (33.5%). Results Among 210 evaluable patients (two centres stopped their participation to the study), 159 patients were evaluated (76%) between 2 to 3 years. Mean follow-up was 36.7 months +/-7. The success rate for cystocele was 141/ 157 (89.8%) and the success rate for rectocele was 153/157 (97.5%). Postoperatively, mean PFDI and PFIQ were significantly improved: 25.3/300 (p<.001) and 15.1/300 (p<.001), respectively. There was no postoperative infection of the mesh. Overall, 22 vaginal erosions occurred (13.8%), including 10 cases after the 2nd year, and 16 patients had necessitated another procedure for partial excision of the mesh. Over the 3-year, the rate of erosions was 13/70 (18.6%) on patients with concomitant hysterectomy and 9/140 (6.4%) on patients with no concomitant hysterectomy (p=.03). On women who return to postoperative sexual activity (n=92), mild or moderate dyspareunia were reported in 14 (15.2%) and severe dyspareunia occurred in one (1.1%). The global rate of a second procedure (erosions excluded) was 5% (8/159): 2 haematomas, 3 dyspareunias, 3 recurrences. Conclusion Both anatomical and functional efficacy of anterior and posterior repair for moderate to severe genital prolapse with a collagen coating polypropylene mesh was confirmed at three-year. The rate of vaginal erosions had increased from 6.3 to 13.8% between the one-year and the three-year evaluation. Concomitant hysterectomy increases significantly the rate of erosions. References 1. Julian TM: The efficacy or Marlex mesh in the repair of severe, recurrent vaginal prolapse of the anterior midvaginal wall. Am J Obstet Gynecol 1996;175:1472–5. 2. Milani R, Salvatore S, Soligo M, Pifarotti P, Meschia M, Cortese M. Functional and anatomical outcome of anterior

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and posterior vaginal prolapse repair with prolene mesh. Br J Obstet Gynaecol 2004;111:1–5. 3. de Tayrac R, Alves A, Thérin M. Collagen-coated versus non-coated low-weight polypropylene meshes in a sheep model for vaginal surgery. A pilot study. Int Urogynecol J Pelvic Floor Dysfunct 2007;18(5):513–20. 115 Transvaginal repair of genital prolapse by the Prolift technique: outcome one year after surgery. Dedet B1, Rubod C1, Boukerrou M1, Debodinance P2, Cosson M1 1 Departement of Surgical Gynecology, France, 2Departement of Obstetric and Gynecology, France Industry Support: No Objective: The aim of this study was to evaluate the anatomical and functional results one year after transvaginal mesh repair of genital prolapse using the Prolift system. Background: This retrospective study includes 114 patients in two centers. 80 (70,2%) patients had a stage 3 (at the hymen) or 4 (beyond the hymen) anterior prolapse, 57 (50%) patients had a stage 3 or 4 uterine prolapse and 50 (43,8%) patients had a stage 3 or 4 posterior prolapse. Assessment at one year post operatively included the condition-specific pelvic organ prolapse quantification system (POP-Q). Patients’ average age was 63 (28–90) and the average BMI was 27,1 (17–43). Method: A complete mesh was used for 62 patients (54,4%), an isolated anterior mesh for 22 others (19,3%) and an isolated posterior mesh for the remaining 30 (26,3%). 23 patients (20,1%) had previous hysterectomy and 14 (12,3%) patients underwent a vaginal hysterectomy during the transvaginal repair procedure. Inside-out (TVT-O) trans-obturator uretral sling for surgical treatment of female stress urinary incontinence was associated for 50 patients (43,8%). Results: Patients were assessed by a physician who was not the initial surgeon. We report recurrence of cystocele (stage 2 only) in 8 cases (8,6%), recurrence of hysterocele in 6 cases (7%) and recurrence of rectocele for 5 (5,7%) other patients. Recurrence of urinary stress incontinence was observed in one case (2%); the other urinary symptoms were dysuria in 5 cases (4,4%) and over active bladder in 3 cases (2,6%). No case of de novo stress urinary incontinence was observed.

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No case of granuloma was observed but 3 patients presented mesh exposure (2,6%). Mesh retraction occurred in 23 cases (20,2%) but no patient were re-operated for symptomatic contraction. Conclusion: According to the results of this study of one year follow-up, Prolift repair appears to be a good and safe technique to repair pelvic organ prolapse. Anatomical and functional results must be assessed with a long-term follow-up to confirm the effectiveness and safety of the procedure. 116 A Prospective Multi-Center Clinical Trial Evaluating the Apogee System for the Treatment of Posterior Vaginal Wall and Apical Prolapse: A Sub-analysis of Apical Extrusions With or Without Concomitant Hysterectomy Lukban J1, Patel M2, Van Drie D3, Weprin S4, Zylstra S5, Vera R6, Nguyen J, Moore R 1 Eastern Virginia Medical School, United States, 2Piedmont Urology Associates, United States, 3Grand Valley Gynecologists, PC, United States, 4Huey and Weprin Ob Gyn, United States, 5Milford Regional Medical Center, United States, 6Texas Tech University Health Science Center OB/ GYN Department, United States Industry Support: Yes (Industry-initiated, full sponsorship) Objective: To describe the incidence of apical extrusions (vaginal exposure of mesh) in patients receiving the Apogee® System (AMS, Minnetonka, MN, USA) in pelvic organ prolapse repair with or without concomitant hysterectomy. Background: In an ongoing, prospective, multi-center study involving 13 U.S. sites, women with posterior vaginal prolapse (> Stage II) and/or apical or uterine descent (> Stage II) were enrolled for primary posterior mesh implant. Concomitant hysterectomy was performed at the discretion of the operating surgeon. All sites received IRB approval prior to inclusion. Methods: A sub-analysis was performed to evaluate patients who received a concomitant hysterectomy versus those who did not receive hysterectomy at the time of Apogee insertion. Each subject underwent placement of an apical polypropylene strip with a 5×14 cm (approximate) cape of polypropylene mesh (Apogee with IntePro,,¢) employing a bilateral transgluteal approach. Primary endpoint for the parent study was the percent of patients with Stage < I (“cure”) at follow-up, with clinical evaluations performed by an unblinded practitioner. Secondary endpoints included, but were not limited to, procedure time,

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estimated blood loss, and device-related complications including sites and incidence of extrusions. Patients were seen postoperatively at 6 weeks, 3 months, 6 months and 12 months, and will be followed prospectively through 2 years. Continuous measurements were compared using a two sample t-test for difference of means. Frequency measurements were compared by Fisher’s exact test. Results: 174 women underwent the procedure with a mean follow-up of 8.4 months (range 0.4–14.7). Forty-six (26%) had concomitant hysterectomy and 128 (74%) had Apogee alone. Demographic data and outcomes are presented in the table below.

Mean Age (range*) BMI (range) Mean Parity (range) Menopause, n (%*) Estrogen Replacement, >4 weeks pre-op, n (%) Prior Hysterectomy, n (%) Procedure (min) - Apogee (mean + SD) EBL (cc), Apogee (mean+SD) Posterior Prolapse, % (n) ⋅Baseline (>/=Stage II) ⋅6-mo (/= Stage II)* ⋅6-mo (
Apogee without Hysterectomy (n=128)

Apogee with Hysterectomy (n=46)

62.5 (33.0 - 90.0) 28.4 (18.0 - 46.9) 3.2 (0 - 9) 122 (96.9%) 67/128 (52.3%)

54.4 (34.0 - 87.0) 29.1 (20.4 - 53.1) 2.9 (0 - 6) 27 (60.0%) 17/45 (37.8%)

93 (72.6%)

–

46.95±21.62 69.3±63.0

45.02±19.92 70.4±71.9

⋅98.4% (125/127) ⋅90.1% (91/101) ⋅90.4% (47/52)

⋅88.6% (39/44) ⋅95.0% (38/40) ⋅91.3% (21/23)

⋅20.5% (26/127) ⋅96.0% (97/101) ⋅90.4% (47/52) 8.6% (11/128) ⋅3.1% (4/128) ⋅5.5% (7/128)

⋅43.2% (19/44) ⋅97.5% (39/40) ⋅95.7% (22/23) 6.5% (3/46) ⋅4.3% (2/46) ⋅2.2% (1/46)

⋅4.7% (6/128) ⋅0.8% (1/128) ⋅4.7% (6/128)

⋅2.2% (1/46) ⋅2.2% (1/46) ⋅2.2% (1/46)

*Statistical difference across the treatment groups (p<0.05). **Includes those who received local estrogen and/or trimming in the office or observed.

Overall rates of extrusion were similar in both groups (p= 0.763). Vaginal exposure of mesh was seen apically in 0.8% of those receiving Apogee alone and in 2.2% of those receiving a concomitant hysterectomy. Conclusions: Incidence of apical extrusion seems to be infrequent in patients receiving Apogee with IntePro with or without hysterectomy at 6 and 12 months postoperatively. Follow-up through 24 months is ongoing.

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117 Transvaginal mesh (TVM) reconstruction with TOT sling for vaginal prolapse concurrent with stress urinary incontinence: its efficacies on lower urinary tract symptoms (LUTS) and quality of life (QOL) Obinata D, Sato K, Mochida J, Sugimoto S, Yamaguchi K, Takahashi S Nihon University School of Medicine, Department of Urology, Japan Industry Support: No Objective We evaluated LUTS in women with POP, and clinical efficacies of TVM reconstruction with/without TOT sling for the treatment of POP and stress urinary incontinence (SUI). Methods Between Jan. 2006 and Jan. 2008, 196 female patients with POP underwent TVM reconstruction. The mean age was 66.6 years (range, 52–84). One hundred fifty six of 196 (79%) cases showed SUI preoperatively, which was confirmed by one hour pad test or stress test with a vaginal tampon. After obtaining written informed consents, 39 patients underwent TVM alone, and 156 cases with SUI underwent TVM concomitant with TOT sling. Anterior TVM repair were performed in 145 individuals, and Anterior/posterior TVM in 51 cases. All the patients underwent evaluations consisting of determination of vaginal prolapse according to the POP quantification (POP-Q) system, international prostate symptom score (IPSS), its QOL score, International Consultation on Incontinence Questionnaires Short Form (ICIQ-SF), overactive bladder questionnaires (OAB-q), Prolapse-QOL Questionnaires (P-QOL), maximum flow rate (MFR), and postvoid residual (PVR) before and three months after the surgery. Results Twenty three individuals were qualified as grade II in POPQ system, 109 and 64 were grade III and IV, respectively. All cases had cystocele including 26 cases with posthysterectomy vaginal vault prolapse, 21 cases with a uterine prolapse and 37 cases with rectocele. POP was cured (grade 0) in 180 cases (91%) after the surgery. Although we found 4 cases with grade 2 or 3 postoperatively, all the cases showed an improvement with down-grade from grade 4. 80% of all case had LUTS (IPSS; 1 or more). Ninety individuals (45%) showed less than 8 points of IPSS (mild LUTS), 52 (27%) showed 8 to 20 (moderate LUTS), and 54 (28%) showed 20 points or more (severe LUTS). OAB-q score significantly correlated with the grades of POP-Q (p=.013). Postoperatively, all the subscores of IPSS except for nocturia, greatly improved (p<.0001), and 80% of all cases were qualified as mild (Table 1). Nocturia also showed a significant improvement; from 1.6 points to 1.3 (p=0.049). QOL score of IPSS, and ICIQ-SF significantly improved (from 5.0 to 1.0; p<.0001, and from 6.1 to 2.5;

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p=.01, respectively). Except for one case with TOT sling who experienced transient de-novo overactive bladder symptoms, average score of the each domain of OAB-q improved postoperatively (p<.0001). All the domains of P-QOL except for personal relationships, improved postoperatively. Insufficient improvement of the Personal relationship domain seemed due to deterioration of sexual function within relatively short-term periods after the surgery. Ten of 39 cases (25%) who underwent TVM alone showed postoperative de-novo SUI. In contrast, 152 cases (96%) who underwent TVM concomitant with TOT, experienced cure of SUI, and no patients deteriorated SUI. Among the two groups, no differences of the improvements in IPSS, QOL score, and P-QOL were observed. Although MFR did not change postoperatively, PVR improved postoperatively; from 71 ml to 48 (p=.002) (Table 2). Table 1 LUTS grade according to IPSS before and after the TVM surgeries (n=196)

Mild LUTS Moderate LUTS Severe LUTS

Before (%)

After (%)

90 (45) 52 (27) 54 (28)

156 (80) 27 (19) 1 (1)

Table 2 Changes in the parameters evaluated before and after the TVM surgeries (n=196)

IPSS QOL of IPSS ICIQ-SF OAB-q Qmax (ml/s) PVR (ml)

Before (SD)

After (SD)

P value

10.8 (10.1) 4.5 (1.5) 7.0 (5.7) 69 (22) 20 (10) 71 (114)

4.6 (5.3) 1.8 (1.3) 2.2 (3.2) 89 (12) 18 (11) 48 (83)

<0.001 <.001 .01 <.0001 N.S 0.02

Conclusion Overall anatomical cure rate was 91%. 80% of all POP case had LUTS preoperatively. TVM improved IPSS, ICIQ-SF, OAB-q and P-QOL. The short-term efficacies of TVM reconstruction are excellent for both POP and LUTS. Concomitant TOT sling may prevent postoperative SUI. TVM concomitant with TOT sling may be a reasonable option for the treatment of POP concurrent with SUI. Further studies with longer follow-up should be needed. 118 EFFICACY AND SAFETY OF TRANSVAGINAL MESH KITS IN THE TREATMENT OF UPPER VAGINAL PROLAPSE: A SYSTEMATIC REVIEW Feiner B1, Jelovsek J2, Baessler K3, Maher C1

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Wesley Urogynaecology Unit, Wesley Hospital, Brisbane, QLD, Australia, 2Department of Obstetrics and Gynecology, Cleveland Clinic, Cleveland, OH, USA, 3Charité University Hospital Berlin, Department of Gynaecology, Hindenburgdamm, Berlin, Germany Industry Support: No Background: The use of synthetic meshes is becoming increasingly popular in pelvic reconstructive surgery. Specially designed repair devices offer a minimally invasive and easy to use alternative to the conventional and well audited surgical procedures. In the treatment of upper compartment prolapse, vaginal meshes have been utilized for both uterine and vault suspension. However, there is an increasing concern regarding lack of information on safety and efficacy of these newly employed procedures that gained a major role in contemporary pelvic floor surgery despite a paucity of supportive evidence. Objective: Our objective was to perform a systematic review to satisfy an urgent need for a meta-analysis of all currently available data (conference abstracts and published articles) on commonly used vaginal mesh kits in the treatment of upper compartment prolapse. Methods: Medline database and conference proceedings of the International Continence Society, the International Urogynecological Association, American Urogynecologic Society and Society for Gynecologic Surgeons were searched for relevant trials between 2005 and 2007. Original articles and conference abstracts reporting the use of mesh kits in the treatment of uterine and vault prolapse were included. Data was extracted and weighted averages were calculated on variety of parameters including number of participants, length of follow-up, objective success and complication rates. Objective success was defined as symptomatic or asymptomatic prolapse less than Stage 2 of the Pelvic Organ Prolapse Quantification system(1) or Grade 2 of the Baden-Walker Halfway System(2). Complications were categorised using the valid Dindo system for classifying surgical complications (3), which is based on the extent of intervention required for the management of each complication. Results: Thirty studies totalling 2653 patients with upper vaginal prolapse, including 20 conference abstracts and 10 peer reviewed articles were identified. Mean follow-up was 36 weeks. Objective success rates were: ApogeeTM 95%, ProliftTM 85% and Posterior Intravaginal Slingplasty (PIVS) 88% and mean complications included: 18%, 17% and 12% respectively. Mesh erosion was the most commonly reported complication (mean 8%) in all procedures. Six precent of patients undergoing placement of transvaginal mesh using a mesh kit required surgical intervention under anesthesia for a device-related complication.

Int Urogynecol J (2008) 19 (Suppl 1):S1–S166 Table 1 Weighted averages analysis of the reviewed procedures ApogeeTM ProliftTM PIVS No. of patients Mean follow-up (weeks ± SD) Obj. success (% ± SD) Total complication rate (% ± SD) Dindo Grade I (%) Dindo Grade II (%) Dindo Grade III (%) Dindo Grade IIIa (%) Dindo Grade IIIb (%) Dindo Grade IV (%)

Polypropylene

525 26±15

1295 30±12

655 178 46±36 78±47

95±4

85±9

88±12 92±5

18±10

17±11

12±6

7±0.3

4.8 6.5 6.3 0.4 5.9 0

6.0 4.1 6.4 0.5 6.0 0.1

3.2 3.2 5.7 0.6 5.0 0

1.5 1.5 3.8 2.3 1.5 0

Conclusions: On limited data quality available, transvaginal mesh-based procedures are effective in restoring anatomy in the treatment of upper compartment prolapse, but no conclusions can be made on functional outcomes. Unique mesh-related complications should be taken into consideration when selecting the suitable approach for each individual patient. Well conducted RCT’s, comparing vaginal mesh procedures with traditional surgeries for upper compartment prolapse are required. 1. BUMP RC, MATTIASSON A, BO K, et al. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 1996;175:10–7. 2. BADEN WF, WALKER TA. Genesis of the vaginal profile: a correlated classification of vaginal relaxation. Clin Obstet Gynecol 1972;15:1048–54. 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. 119 Long term ring pessary use for Pelvic Organ Prolapse Sarma S, Parkin K, Allen W, Karantanis E, Moore K Pelvic Floor Unit, Australia Industry Support: No Objective: To determine the long term success rate and complication rate for vaginal ring pessaries in women with prolapse Background: Up to 50% of parous women may develop some degree of pelvic organ prolapse. Current treatments include physiotherapy, mechanical devices (ring pessaries) and surgery. Mechanical devices aim to alleviate the symptoms of prolapse and avoid or delay the need for surgery. Complications including ulceration, bleeding and

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vaginal discharge are well know to occur but the current literature includes only studies with a median duration of 2 years follow up. Our Pelvic Floor Unit has been providing a weekly prolapse clinic since 1992. We carried out a retrospective review of women attending from 1992 to 2002. Unit policy at that time was to offer all women an open choice as regards the use of a pessary or to have surgery. Methods: A retrospective review of all patients who presented with symptoms of prolapse to the pelvic floor unit from 1/1/99 to 31/12/02. These charts were searched for by database and by hand. Demographic details were gathered including age, parity, BMI, prolapse symptoms, physical examination and choice of management for prolapse, length of use and rate of complications. Results: During the study period there were 27,732 attendances at the Pelvic Floor Unit. 291 patients presented with prolapse as a main complaint during this time. 38 patients were identified who had a successful ring pessary fitting and returned for follow up appointments. A further 37 had a bladder neck support device for mixed prolapse and stress incontinence. Of the 38 patients with a ring pessary the average age was 69 (48–82), parity 2.6 (0–5). 36/38(94.7%) were postmenopausal, 2/36(5.5%) used systemic HRT and another 31/36 (86.1%) used local vaginal oestrogen. The average length of pessary use was 3.6 years (range 1 month - 12 years and 3 months),with a median of 12 months. Only 23.6% (9/38) continued to use a ring pessary at the study point. Of the 38 patients, complications occurred in 15(39.4%). These comprised of bleeding in 6 patients(of whom 3 had recurrent bleeding), severe malodorous vaginal discharge (2), extrusion of device from vagina in 5, severe stress incontinence (1) and vaginal discomfort(1). However not all patients with complications discontinued using the ring: and some patients stopped using the ring because they preferred surgery not because of complications. Of the 38, 14 chose surgery (of whom only 5 had actually suffered complications). 5 patients changed from a ring to an Introl device, 3 opted for no further prolapse treatment, 1 died and 6 sent a letter that they had moved to other gynaecologists or GP’s. Conclusions: We are living in an aging society and will continue to see more women with prolapse. Many women are unable to self remove and insert ring pessaries and require regular attendances at busy gynaecological clinics. With less than a quarter of women persisting with ring pessary use and a third experiencing complications, we suggest that this information be given to women when they attend for advice and management for the prolapse and consideration be given to offering surgical management sooner for those who are medically fit.

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120 Results from the LAS Trial, an RCT comparing open abdominal to laparoscopic sacrocolpopexy for the treatment of post hysterectomy vault prolapse Pantazis K1, Freeman R1, Thomson A2, Frappell J1, Bombieri L1, Waterfield M3 1 Plymouth Hospitals NHS Trust, United Kingdom, 2 Worcestershire Acute Hospitals NHS Trust, United Kingdom, 3Peninsula Medical School, United Kingdom Industry Support: No Objective To test the clinical equivalence of open and laparoscopic sacrocolpopexy for the treatment of post-hysterectomy vaginal vault prolapse Background Post-hysterectomy vaginal vault prolapse (PHVP) is believed to complicate 11.6% of hysterectomies performed for prolapse and 1.8% of those performed for other indications. The most efficient surgical treatment for PHVP is abdominal sacrocolpopexy with mesh. The laparoscopic type of sacrocolpopexy appears to be equally efficient in a number of case series but to date there are no randomised controlled trials (RCT) comparing the open and laparoscopic techniques. This is the first RCT to test the clinical equivalence of open and laparoscopic sacrocolpopexy. Methods A prospective multi-centre RCT comparing open abdominal to laparoscopic sacrocolpopexy with mesh. We report on the 12 week data from the pilot study, which was contacted to allow sample size calculation and access study feasibility. The sample size of the pilot was estimated at 30 cases for both arms on the assumption of a reasonably normal distribution of values. The primary outcomes were the level of the vaginal apex (change of point C on Pelvic Organ Prolapse Quantification systemPOPQ) and the subjective Patient Global Impression of Improvement (PGI-I score 1–7, 1 being best improvement and 7 being worst deterioration). Inclusion criteria included all women presenting with symptomatic vault prolapse ICS Grade 2 or more on POPQ. Exclusion criteria included those medically unfit for a sacrocolpopexy or those who required any concomitant pelvic surgery. All the surgeons performing study operations, were experienced in this type of surgery and most are acting as preceptors in national advanced skills training programmes. Both open and laparoscopic procedures were standardised by the investigators to the most possible extent. Also, the post-operative management was standardised and default discharge day from hospital was day-2 for both procedures. The subjects were randomised by procedure and not surgeon.

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Results The mean age in both groups was similar (open=59.6 yrs, laparoscopy=63.4 yrs), as well as, parity (open=3, laparoscopy=2.53) and BMI (open=27.4 kg/m2, laparoscopy= 27.7 kg/m2). Thirteen out of 30 women answered ‘yes’ to the question ‘do you ever leak urine?’ before surgery (8/15 in the open and 5/15 in the laparoscopy group). Mean Point C elevation at 12 week follow-up was similar in the 2 groups (open=6.0 cm, laparoscopy=6.2 cm, p= 0.707). The mean value for PGI-I score was similar (median for open=1, median for laparoscopy=1, p=1). The mean haemoglobin drop on day-2 post-operatively was significantly lower in the laparoscopy group (open=2.446 mg/dl, laparoscopy=1.353 mg/dl, p=0.008, 95% CI= 0.304–1.882). The mean operating time was similar in the two groups (open=155 min, laparoscopy=162 min, p=0.693), as well the duration of stay in the hospital (median for open= 4.5 days, median for laparoscopy=3.0 days, p=0.075) No severe adverse events were encountered with either of the procedure types. Conclusions Both open abdominal and laparoscopic sacrocolpopexy appear equally effective both in terms of correcting the anatomy and in terms of patients’ subjective impression of improvement. The limited sample size of the pilot phase, which we report on, is not suitable for definitive conclusions, however the agreement between objective and subjective cure rate is likely to be indicative of overall equivalence. The smaller intra-operative blood loss might be an element of superiority of the laparoscopic approach. The similar surgical time for the two procedures suggests equivalence, where the surgeons are competent to perform the type of surgery they are allocated to; it is noted that the laparoscopic sacrocolpopexy is considered

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to require the highest level of minimal access surgical skills. 146 Magnetic resonance imaging of abdominal versus vaginal prolapse surgery with mesh Ginath S1, Vardy M2, Luchs J3, Shahryarinejad A2, Olivera C2, Garely A3 1 Wolfson Medical Center and Sackler School of Medicine, Israel, 2Mount Sinai School of Medicine, United States, 3 Winthrop University Hospital, United States Industry Support: No Objective The aim of the study is to compare two surgical approaches in patients with symptomatic prolapse of the vaginal apex, with normal controls, by analyzing MRI measured pelvic landmark relationships and quality of life (QOL) measures, before and after surgery. Methods Prospective pilot study of a multicenter surgical trial (n=16). Normal controls consisted of 6 nulliparous volunteers without prior pelvic surgery, with a uterus, and prolapse < stage 2. The study group included 10 parous (3.0±1.0) women with a uterus and prolapse of the vaginal apex = stage 2, requesting definitive surgical correction. Five patients underwent ASCP (Group A) (using MPM from the cervical stump to the sacral promontory), and 5 patients underwent vaginal MPM kit repair (total ProLift, Gynecare/Ethicon, Sommerville, NJ, USA) (group B) at the discretion of the operating surgeon. Subtotal hysterectomy was performed in all five patients in group A. None of the patients in group B underwent hysterectomy. All study patients underwent pre-op and 3

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Table 1 Control group (n=6) Study group A Study group B Study group Study group B Pre-op.(n=5) Pre-op. (n=5) A Post-op. (n=5) Post-op.(n=5) POPq-C QOL:

SF-36 (Daily activities - range 10–30) PFIQ-7 (Pelvis/vagina - range 0–21) PFIQ-7 (Bladder/urine - range 0–21) PFDI-20 (range 0–60) MRI (at rest): Bladder neck to PCL (cm) e angle at rest (°) h angle at rest (°) g angle at rest (°)

-6.3±1.2 26.5±7.1 0±0 2.0±3.3 4.7±9.2 -2.0±0.6 135.2±10.9 14.3±7.9 -9.8±14.1

0.4±0.9* 22.2±4.4 2.8±2.9 4.6±4.6 13.8±9.9 0.2±1.4* 161.4±37.1 26.2±10.4* 7.0±8.8*

-0.3±1.5* 24.6±3.9 5.8±5.4* 8.0±3.0* 22.2±4.3* -1.0±1.2 164.0±27.1* 26.6±14.7 12.6±11.2*

-7.2±1.6^ 28.6±1.7^ 1.8±2.7 2.0±2.8 4.6±4.4 -1.1±0.8 154.4±16.9‡ 16.0±13.3 17.8±13.6‡

-5.8±0.4# 27.2±2.2 0±0# 0.8±1.8# 8.2±8.3# -0.8±1.1 139.0±17.6 16.2±7.3 13.6±10.2‡

*comparison between the study group pre-operatively and the control group (p<0.05) ^comparison between the study group A pre-operatively and post-operatively (p<0.05) # comparison between the study group B pre-operatively and post-operatively (p<0.05) ‡ comparison between the study group post-operatively and the control group (p<0.05)

months post operative POPQ exam, dynamic MRI at rest and during maximal valsalva, validated health status, quality of life (QOL) and sexual function questionnaires (SF-36, PFIQ7, PISQ-12, PFDI-20). Results Study group patients were significantly older than control (59.7±9.3 versus 27.4±3.5 years, p=0.003). The main findings in comparison between the control group and the study group (preoperative and postoperative) are summarized in Table 1. Conclusions ASCP compared to Prolift for vaginal apical support are similar at three months as indicated by POPQ, QOL measures, and MRI analysis. Both treatment returned POPQc and QOL measures to values comparable to nulliperous controls by 3 months. Changes in the g angle, even post-operatively, may reflect levator atrophy. Longer follow-up with larger numbers seems warranted. 147 A study to examine the expectations of women having prolapse surgery Tincello D1, Godfrey K1, Harris N2, Pitchforth E1, Mayne C2 1 University of Leicester, United Kingdom, 2University Hospitals of Leicester NHS Trust, United Kingdom Industry Support: Yes (Investigator initiated, partial funding) Objective: To explore women’s expectations and experiences of prolapse surgery using a qualitative analysis of recorded semi-structured interviews. Background: Uterovaginal prolapse is a common condition and it has been estimated that a woman’s lifetime risk of surgery is

Comparison of support through analysis of MRI, pelvic angles, and distances (Figure 1) was performed by an experienced radiologist. Data was analyzed by SPSS statistical software using Mann-Whitney Rank Sum test and chi-square test. Although the patients in the study group B were significantly older than study group A patients (67.2±8.4 years versus 53.6±8.3 years, p=0.03), they were no significant differences in terms parity, menopausal status and BMI. There was no difference in general health and quality of life scores between the groups postoperatively. There was no difference in any of the above MRI landmarks postoperatively. 11%, with a recurrence rate of 29%. Cure after surgery for prolapse has commonly been assessed by either anatomical cure or resolution of physical symptoms. Little work has been conducted to determine what women expect from surgery and how they may judge a successful outcome despite a growing emphasis on women centred care.. Methods: Purposive sampling was used to recruit women who had recently experienced prolapse surgery, both first time and repeat procedures, in one UK tertiary referral hospital. With consent, women participated in semi-structured interviews that were audio recorded and transcribed in full. The interviews explored the decision making process leading to surgery, women’s expectations of the surgery and experience until time of interview. Analysis was systematic and iterative, based on the constant comparative method using Nvivo7 software. Results: Thirty women participated in the qualitative study. The analysis showed that prior to surgery women experienced considerable physical symptoms such as bleeding, backache, difficulties in urination but for many the psychological symptoms and impact on life were predominant. Women described overwhelming feelings of depression and not having a life. Women’s expectations of surgery

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were in turn framed by expectations of returning to normality and being able to fulfil functions and roles in everyday life. Women made reference less often to anatomical cure or physical symptoms. Women recalled that information received from health professionals focused on the procedural aspects of surgery such as anaesthesia. The degree to which women independently sought information or actively participated in decision making varied considerably. Although women set normality as an individual goal from the surgery, post-operatively they were unsure what could be considered “normal”, whether the transition to normal functioning would be gradual and what timeframe was realistic. Social networks played a key role throughout from seeking help, forming expectations of surgery and short and long term adaptation following surgery. Conclusions: The qualitative interviews show the complexity of factors influencing women’s expectations and perceived success of prolapse surgery. Most notably there is discordance between previously used measures such as anatomical cure and women’s expectations which were driven by social functioning. There are important findings for health professionals particularly in terms of the provision of information and post-operative follow-up. 148 COLPOSUSPENSION OF THE SACROSPINOUS LIGAMENT: AN EFFICIENT PROCEDURE? OUTCOMES IN A SERIES OF 120 PATIENTS Gonzalez Garcia A, Menendez E, Perez Gil S, Duplá Parugues B, Camporro J Pelvic Floor Unit. Hospital de Cabueñes Industry Support: No OBJECTIVES: To analyze the evolution after five years of the vaginal walls static in cases of uterine prolapse or vaginal vault treated via sacrospinous ligament colposuspension following the Nichols-Richter’s technique, as well as to detect any complications occurred during surgery. MATERIALS AND METHODS: A descriptive, retrospective study of 120 sacrospinous colposuspension cases undertaken in our service between September 1999 and September 2007 which also required additional, simultaneous surgical procedures (these being the cause for a major percentage of the complications) was carried out. Results are shown in “real form”, based on the findings of the vaginal static both before and after the procedure, and in “virtual form”, applying the evolutive probability formulae of the survival analysis according to the number of patients which had reached each of the different follow-up intervals.

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Anterior vaginal wall, posterior vaginal wall and vaginal vault prolapse rates were assessed before surgery, on a monthly basis and on the last visit for each patient. In order to determine the average relapse rates (both globally in each visit and for each prolapsed component), the same numerical value as the ordinal value on the Baden scale is assigned. RESULTS: Both global averages and prolapsed component average values for each follow-up interval are shown in the Tables. The prolapse global average before surgery was 2.32; one month after surgery, 0.15, and on the last visit, 0.42. The graphs also show the accumulated evolution (in percentage) of the three components of the vaginal static (i.e. anterior vaginal wall, posterior vaginal wall, and vaginal vault) on the first post-surgery visit and at 6, 12, 24, and 48 months after surgery. CONCLUSION: Attaching the vaginal vault to the sacrospinous ligament poses no great technical difficulty, and allows us to tackle medium to medium-high prolapse cases. Its efficacy obviously suffers from the expected wear of time, but preserves adequately the corrections of the vaginal vault and the posterior vaginal wall. However, the shift it causes to the direction of the vaginal axis makes it almost compulsory to implant a supplementary mesh under the anterior vaginal wall to avoid or at least minimize its subsequent relaxation. 149 Risk of Recurrent Cystourethrocele Following Sacrospinous Ligament Fixation: 6 months and 1 year Follow-up. Han H, Ng P, Lee L KK Women’s & Children’s Hospital, Singapore Industry Support: No Objective: The aim of this study was to evaluate the recurrent rate of cystourethrocele following sacrospinous ligament fixation (SSF) for vault or severe utero-vaginal prolapse. Background: Sacrospinous ligament fixation is the surgical procedure of choice for treating vault and severe utero-vaginal prolapse. The success rate of SSF had been reported at 90–96%. Reports by some authors however, had shown that SSF had increased the recurrence rate of cystourethrocele. Therefore this study was necessary to support or disprove this finding. Methods: This was a retrospective study on the 272 patients who underwent SSF at our centre from 1st Jan 2001 till 31st Dec 2004. Data analysed include age at surgery, parity BMI,

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severity of prolapse, the types of surgery, types of operation performed, operation details and the outcome. Operation details noted include duration of surgery, blood loss, perioperative complications and whether mesh was used during the repair. Immediate post-operative observation details included length of stay in hospital, febrile episodes, duration of buttock pain and urinary tract infection. The symptoms looked into during follow-up included presence or absence of sexual activity, dyspareunia, buttock pain or lump at intoritus. Examinations were carried out to assess the degree of prolapse using Baden Walker classification. All data was analysed using SPSS version 9.0 statistics programme. Results: The 1-year cure rates were 85.3%, 74.6% and 73.1% for grades 2, 3 and 4 cystourethrocele respectively. All patients with grade 2 cystourethrocele had no mesh. Gynemesh® was inserted into 21 patients with grade 3 and 61 patients with grade 4 cystourethrocele. Cure rates for grade 3 cystourethrocele with mesh was 76.2% and 73.8% in patients without mesh. For patients with grade 4 cystourethrocele, the cure rate was noted to show a significant improvement, from 67% (without mesh) to 73.8% (with mesh). Conclusions: The recurrence rate for cystourethrocele in patients with SSF was high, especially for patients with grades 3 and 4 cystourethrocele. Mesh had only improved the cure rates for both groups marginally. References: Am J Obstet. Gynecol. 1996; 175: 1476–1482 Am J Obstet. Gynecol. 2001; 184: 1357–1364 Am J Obstet. Gynecol. 2001; 185: 1307–1313 150 Reducing Length of Stay in Transvaginal Pelvic Organ Prolapse Repair McAchran S, Goldman H Cleveland Clinic, Cleveland, OH United States Industry Support: No (n/a) Background & Objectives In an effort to improve efficiency and decrease cost there is a move towards shorter post-operative hospital stays. We sought to evaluate whether patients undergoing major prolapse repair could be safely discharged on post-operative day #1 (POD#1) when a strict care pathway is followed. Methods A retrospective chart review of all patients presenting for surgery with a single surgeon at a single hospital from February 2005 to July 2007 was performed. A postoperative care pathway was followed. PACU records

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hospital charts were reviewed to extract the following data points: date and time of admission to PACU, date and time of discharge, patient age, type of anesthesia, whether or not post-operative lab work was ordered, transfusion of blood products, emergency room (ER) visits in the next 30 days, readmissions within 7 days and within 30 days, and whether or not the patient was discharged home with a urethral catheter. Results 111 transvaginal POP repairs were performed during the study period. 17 cases were excluded for either concomitant surgical procedures by a second surgeon (16) or incomplete data (1) leaving a study population of 94 patients. The 94 cases were comprised of 6 anterior repairs, 10 posterior repairs, 7 colpocleises, 11 sacrospinous fixations, and 60 repairs using transvaginal mesh. The median age of patients was 58 years (range 35–93). The mean LOS was 28:27 hours and the median was 25:45 hours. 86% were discharged on post-operative day 1. 85% (80/94) were performed with general anesthesia. The remainder were performed under spinal anesthesia. Post-operative labs were ordered on 10/94 (10.64%). No transfusions were required. 3/94 (3%) of patients presented to the ER within 30 days and 2 were readmitted within 7 days: one for abdominal pain and one for urinary retention. Neither required further intervention. One patient was readmitted within 30 days and was treated for a lower extremity DVT. 75% of patients were discharged home without a urethral catheter. Conclusions Transvaginal repair of POP can be performed safely with the majority of patients requiring only an overnight hospital stay. As we continue to evaluate minimally invasive approaches to this problem, this data will provide a benchmark against which to compare the benefit of newer approaches. 151 An Integrative Approach To Managing Constipation: D.R.O.P.S. Werda J1, Moore K2, Patton V2 1 St George Hospital, Australia, 2Pelvic Floor Unit, St George Hospital, Australia Industry Support: No Introduction: Many women who are diagnosed with rectocele also suffer constipation1. The aim of this study is to use an integrative approach to manage constipation with a program of lifestyle changes: D.R.O.P.S. (Diet, Routine/Relaxation/Exercise, Oils, Position, Stress management). We used the BBUSQ2 (Birmingham Bowel & Urinary Symptoms Questionnaire) to measure the response to the interventions.

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Materials & Methods: Inclusion criteria were all patients who had suffered with chronic constipation for a minimum of 3 years and had received previous treatment without success. Exclusion criteria were a history of coeliac disease, crohns disease and diarrhoea. Data was collected on age, gender and constipation history. The primary outcome measure used was the BBUSQ (comprising four subscale domains), which was given pre and post treatment. A food and bowel diary was used to assess and formulate a management plan. Treatment Outline for Bowel Management Program: D.R.O.P.S 1. Diet/Fluids ∼Fibre-25–45 gms increased gradually to meet patient’s individual needs. ∼Fibre sources were soluble/insoluble/resistant starch. Patients encouraged to eat food in its most natural unaltered state to gain maximum amount of vitamins, minerals, fibre, fluid and avoid additives and preservatives. Some patients require food exclusion to identify sensitivities that may contribute in decreasing bowel motility e.g. lactose, gluten. ∼Patients were educated to eat meals in a relaxed, calm environment to allow digestive juices to work and to chew food properly with no gulping. ∼Recommended to start day with hot water and lemon juice to initiate digestion, promote production of gastric juices, kick-start digestive enzymes/hormones within GIT. Small regular meals were encouraged to increase the metabolic rate. ∼Fluids, non-caffeine, were titrated to patient’s medical requirements eg. CCF, renal impairment or fluid restrictions. Nutritive fluids were encouraged eg. fresh juices, fruit and vegetable/water/herbal teas. 2. Routine/Relaxation/Exercise ∼Patients were instructed to find a time each day for defaecation, preferably 15– 20 minutes following a meal when they could sit undisturbed on the toilet, read and relax. ∼Exercise - patients were instructed to undertake regular exercise at least 3 times per week, to increase peristalsis and pump lymphatic waste. Their health, fitness, medical conditions and age were taken into consideration. 3. Oils ∼Olive oil (1 Tablespoon BD) was used to decrease the surface tension within colon contents, soften the stool and facilitate mild peristaltic contraction. ∼Short term use of natural laxative agents, tolerable to patient was used to gain an initial clean out eg. Herbalax, Aloe Vera juice, Senna, Movicol, Magnesium. 4. Position ∼To reduce the ano-rectal angle patients were required to sit on toilet with feet up on a small stool leaning forward with legs slightly apart and relax their abdominal muscles.

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5. Stress Management ∼ Education in managing daily life stressors on an individual basis was undertaken following comprehensive history. The strategies included deep breathing, walk away from stressful situations, balancing work and leisure time, planning rewards, holidays and short breaks and learning to say no. Results: These treatments were conducted by a Nurse Continence Adviser who specialised in this subject. Treatment was given to 130 male/female patients over 3 years. Urogynaecologists, Colo-Rectal Surgeons and General Practitioners referred the patients for management of refractory constipation. This data reflects the most recent 44 who completed pre and post outcome measures with a mean age of 64.27yrs. The D.R.O.P.S treatment gave significant improvement in all subscales of the BBUSQ. Constipation score changed from 70.42(22.2) pre treatment to 51.62(14.2) post treatment p=0.000 (Wilcoxin). Evacuatory score changed from 38.2(14.67) pre treatment to 16.39(10.37) post treatment p=0.000 (Wilcoxin). Urinary score changed from 25.86 (12.7) pre treatment to 23.15 (22.7) post treatment p=0.005. The Faecal Incontinence score changed from 9.02 (11.82) pre treatment to 13.2 (17.87) post treatment p=0.068, this result reflects an increase in urgency and frequency of stool post treatment of constipation. Conclusions: D.R.O.P.S. is an effective integrative bowel management plan which should be considered in patients with rectocele. 1 Management of Genital Prolapse. BMJ 2002; 324 (7348): 1258 2 Psychometric evaluation of 2 comprehensive conditionspecific quality of life instruments for women with pelvic floor disorders AM J Rectocele Obstet Gynecol. 2001; 185; 1388–95 152 Prospective clinical assessment of the Total TransVaginal Mesh (TVM) technique for treatment of Pelvic Organ Prolapse - 3 year results Cosson M1, Rosenthal C2, Debodinance P1, Clave H3, Berrocal J4, Jacquetin B5 1 Service de Gynécologie, France, 2Clinique Saint-Germain, France, 3Clinique Saint George, France, 4Clinique de L’Europe, France, 5 Maternité Hôtel Dieu, France Industry Support: Yes (Industry-initiated, full sponsorship) Objective The objective of the study was to evaluate the long-term safety and effectiveness of the Trans-Vaginal Mesh (TVM) technique for anterior, posterior and vault prolapse repair.

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In 2006, one-year results were reported; now we present our 3-year post-TVM results. Background The TVM technique involves a polypropylene mesh of specific size and shape that is secured tension free by extension arms that pass through the arcus tendineous via a transobturator approach anteriorly and through the sacrospinous ligament via a transgluteal approach posteriorly. Methods Women from 8 French centres with symptomatic POP (POP-Q Stage II-IV) were invited to participate in this prospective study. It was a requirement of the protocol that patients were to have either prior or concurrent hysterectomy. Follow-up visits were planned at 6 weeks, 6 months, and 1, 3 and 5 years post-TVM. Assessments included: POP-Q, Quality of Life (QOL) and Prolapse Symptom Inventory (PSI). The primary endpoint was prolapse recurrence rate at 12 months post-TVM. Procedural success was defined as POP-Q Stage < II, without further re-intervention. Results 90 women participated in the study. Mean age was 65.2 years; 18 had prior hysterectomy and 72 underwent concurrent hysterectomy. Total mesh repair was performed in 89 women; 1 woman had anterior repair only. 85 women returned for 3-year follow-up. Overall recurrence rate was 18.8% (90% CI 12.2 to 27.2), which remained stable compared to the recurrence rate at 1 year (18.4%, 90% CI 11.9 to 26.6). Of the 16 failures, 14 were Stage II, with the leading edge remaining at or above the hymen. These small defects were considered to be related to the proximal retraction of the mesh, rather than a clinically significant recurrence. One patient had Stage III posterior wall recurrence, and 1 patient had undergone further repair. Improvements in QOL and PSI observed at 1 year were maintained to 3 years (baseline to 3 years: 3.4 to 0.1 and 13.9 to 2.1, respectively). Prior to surgery, vaginal pain was reported in 28.9%. This reduced to 13.8% and 9.4% by 1 and 3 years, respectively. Moderate or severe vaginal retraction was reported in 9.4% of patients, compared to 12.6% at 1 year. At baseline, 32.2% of patients reported suppressed or impaired sexual activity due to prolapse at baseline, and this rate reduced to 6.9% and 9.4% at 1 and 3 years, respectively. Of the 39 sexually active at 3 years, 6 (15.4% of the sexually active patients) complained of dyspareunia. These case comprised 2 de novo cases ongoing from the 1-year evaluation; 1 reporting intermittent dyspareunia throughout the study; 1 patient who had reported dyspareunia prior to surgery, which resolved post-surgery and recurred at 3 years, and 2 de novo cases at 3 years. Since surgery, there have been 13 patients with mesh exposure; 8 have resolved and 5 (5.9%) were ongoing at the 3-year follow-up. Of these, 4 were asymptomatic and

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did not require treatment, and 1 case underwent partial mesh excision following the 3-year assessment. Conclusions These results demonstrate that TVM provides stable anatomical and QOL improvements through to 3 years with a low rate of mesh exposure and complications. 153 Site-Specific Prolapse Surgery. I. Reliability and Durability of Native Tissue Paravaginal Repair Reid R1, Lou K1, You H2 1 Hunter New England Health, Australia, 2Macquarie University Statistics Dept, Australia Industry Support: Background: The anterior vaginal wall is a fascial diaphragm, tautly strung between the pericervical ring and the urogenital diaphragm, and attached laterally to the two fascial white lines. The pubocervical fascia functions like a trampoline, giving all direction support to the proximal urethra and bladder base. It was traditionally believed that the central fascia of this suspensory hammock attenuates after childbirth, thus forming the bulge of a cystourethrocoele. In reality, healthy fascia is like canvas. It does not stretch, but will tear at pre-determined points. As a matter of engineering principle, these pre-determined points of weakness lie where the lines of force concentrate: namely along the peripheral margins, not within the central hammock. Rotatory cystocele formation has three elements: an apical defect, a lateral defect on at least one side and a fulcrum about which rotation can occur. Correcting this pattern of connective tissue damage in accordance with biomechanical principles mandates ‘site-specific’ repair of the causative fascial avulsions, either with permanent suture or by placement of a mesh bolster. Objective: To compare native tissue abdominal (APVR) and vaginal paravaginal repair (VPVR), and to investigate whether surgical outcome was independent of operative route. Methods: Retrospective review of 111 consecutive rotatory cystocoele repairs, from a pelvic floor referral practice between 1997?2007. Women were prospectively evaluated by symptom severity inventories, standardized physical exam and urodynamic testing if indicated. Treatment was by surgeon assignment, 52 women having APVR and 59 having VPVR. Main outcome measures were ‘same site’ prolapse recurrence; worsened or de novo urgency, voiding dysfunction or dyspareunia; and major peri-operative complications. Initial anatomic and functional reliability of cystocoele repair were evaluated by chi-squared test. Repair durability over the succeeding ten years was gauged by

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Kaplan-Meier survival analysis, logistic regression and Cox proportional hazards models. Results: At six month follow-up exam, APVR showed a trend towards greater dependability [48 of 52 (92%) versus 48 of 59 (81%); ?2 = 2.84, p-value = 0.09]. Over the succeeding 10 years, abdominal repair proved 19% more durable than native tissue VPVR [46 of 52 (88.5%) versus 41 of 59 (69.5%); logrank test ?2=5.472, p-value=0.02]. Functional outcomes were broadly equivalent, with excellent resolution of bulge discomfort (89% vs 82%), improved stress (83% vs 69%) and urge (63% vs 43%) incontinence rates and a 50% decrease in overall dyspareunia. Peri-operative complication rate was 5.4%.

Conclusions: (1). Kaplan-Meier curves reached an absolute plateau within 40 months, denoting that paravaginal repair by either route was reliably curative of cystocoele. (2). The abdominal approach had a 19% relative advantage, reflecting the fact that APVR sutures are placed into stronger tissues and close the fascial defects with less suture-line tension. (3). Although traditional anterior colporrhaphy does not repair the actual sites of anatomic damage, plication repairs are sometimes durable, presumably through the formation of a non-specific scar plate beneath the vesical neck and bladder base. Quantifying the reparative value of ‘site-specific’ repair therefore requires correction for such non-specific scarring. Long-term efficacy of anterior colporrhaphy was estimated from the literature and from the observed outcomes of prior cystocoele repairs in our study population. Even after correction, at least 35–54% of the long-term success from native tissue VPVR was clearly attributable to ‘sitespecific’ re-suture of the causative defects in the endopelvic fascia. (4). Whether a 69.5% success rate from native tissue VPVR truly justifies the additional surgical effort involved in paravaginal repair, instead of anterior colporrhaphy (as a palliative treatment) or mesh augmented PVR (as a more robust curative procedure) is perhaps debatable.

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154 IVS versus I-STOP for infracoccygeal sacropexy procedure: a comparative study Deffieux X1 , Faivre E, de Tayrac R 2, Frydman R, Fernandez H 1 Hopital ANtoine Beclere, France, 2 CHU Nîmes Industry Support: No Objective To evaluate the results of infracoccygeal sacropexy procedure using IVS and I-STOP tape for the cure of vaginal vault prolapse. Background Uterine and vaginal vault prolapse are commonly treated by some form of vaginal repair, using Richter sacrospinous colpopexy (attaching vaginal vault to the sacrospinous ligament), McCall culdoplasty, or sacro-colpopexy (that treat the 3 stages of pelvic organ prolapse (POP)). The good efficacy of the sacrospinous fixation is well established. However, complications are not rare, including per- and post-operative hemorrhage and perineal buttock or vaginal pain. New “mini-invasive” procedures are supposed to diminish the complication rates associated with sacrospinous fixation. The infracoccygeal sacropexy was first described by Petros for the repair of vaginal vault prolapse. This procedure entails the placement of a synthetic tape through the ischiorectal space on both sides to the level of the vaginal vault where it is fixed in the midline. The tape is introduced by a specially designed tunneler via a transgluteal approach. There is very few published data on the efficacy and safety of infracoccygeal sacropexy for uterovaginal prolapse. The use of multifilament polypropylene (IVS) is associated with a high rate of complications such as vaginal erosion of the tape. The current study is the first one that compares the use of two types of slings (IVS and ISTOP) for infracoccygeal sacropexy procedure. Methods The current study is a descriptive retrospective analysis of a continuous series of 87 women, median age 64 years (IQR 53–70), who have undergone infracoccygeal sacropexy procedure. Among them, 59 (68%) had clinically major utero-vaginal prolapse (grade 3 or 4 according to the Baden & Walker classification), and 27 (32%) had minimal or moderate utero-vaginal prolapse (grade 1 or 2). Patients were followed up at 6 weeks, 3 months and annually. Surgical approach was as follows: after opening the ischiorectal fossa into a transversely incised posterior vaginal fornix, a sling is inserted by trans-gluteal approach: IVS (n = 53) or I-STOP (n33). Bilateral gluteal skin incisions were made 3 cm lateral and below the external anal sphincter. The IVS or I-STOP tunneller was placed into the ischiorectal fossa, and then turned inwards for

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passage through the rectovaginal fascia, so as to reach the transverse vaginal incision. The procedure is repeated on the contralateral side. The tape was secured to the vaginal vault and also to the remnants of the uterosacral ligaments. Mean follow-up was 15 months (+/- 10). Recurrence free survival curve is given in Figure 1.

155 Do Ureteral Orifices Change Their Location after Pelvic Reconstructive Surgeries? Dain L, Abramov Y Carmel Medical Center, Israel Industry Support: No

0.6 0.4

IST IVS

0.0

0.2

Recurrence free survival

0.8

1.0

Recurrence free survival in both groups

0

10

20

30

40

Times (months)

Results No rectal perforation was observed. Eight patients were lost to follow-up. Mean follow-up was 18.1 months (+/-15.2) for I-STOP group and 32.4 months (+/-13.5) for IVS group; p<0.0001. Vaginal extrusion of the mesh was observed in 5 cases (9%) in IVS group and in none case in I-STOP? group. POP recurrence rate was 13.8% (n=4) in I-STOP group and 18.0% (n=9) in IVS group; p=0.79. Univariate and multivariate analysis concerning POP recurrence and patients’ satisfaction revealed no independent factor (Age, post menopausal status, hormone replacement therapy, parity, previous hysterectomy, concomitant hysterectomy, pre operative utero/vaginal prolapse grade, concomitant anterior colporraphy, concomitant anterior synthetic mesh, concomitant posterior synthetic mesh, concomitant sub urethal sling, concomitant posterieur colporraphy). Conclusion New macroporous monofilament polypropylene meshes, such as I-STOP device, seem to sharply diminish the risk of vaginal extrusion of the sling following infracoccygeal sacropexy procedure.

Background and Objective: Pelvic organ prolapse is a common disorder, affecting more than one third of all women above the age of 40. Around 11% of all women in the U.S. will undergo at least one reconstructive pelvic surgery during their lifetime. Since these surgeries are often associated with a substantial risk for ureteral obstruction, cystoscopy after intravenous dye injection and demonstration of ureteral patency is highly recommended. Nonetheless, it is currently unknown whether these surgeries are associated with any displacement of ureteral orifices, which may complicate the cystoscopic examination. This information may be of importance for pelvic reconstructive surgeons and may shorten cystoscopic and total operative time. We therefore aimed to assess possible displacement of ureteral orifices after pelvic reconstructive surgeries. Materials and Methods: Between August and December 2007 all patients undergoing vaginal hysterectomy with an anterior colporrhaphy for advanced uterovaginal prolapse in our institution also underwent cystoscopy with filling of the bladder up to 400 cc and placement of ureteral catheters before and after surgery. Dye was injected intravenously in all patients shortly prior to the second cystoscopy in order to assess ureteral function. The direct distance between the urethrovesical junction and each ureteral orifice as well as the vertical distance between the urethro-vesical junction and the inter-ureteric ridge were measured, and each ureteral orifice location was marked on an X-Y coordinate of the posterior bladder wall before and after surgery. A paired student t-test was used for comparisons between pre- and postoperative ureteral location. Results: Thirteen women aged 44–80 years were identified and included in the study. All underwent vaginal hysterectomy and anterior colporrhaphy with pre- and postoperative cystoscopy without evidence for urinary injury. Postoperatively ureteral orifices were noted to migrate distally (closer to the urethrovesical junction), (right: 0.62±0.27 cm, p= 0.002, left: 0.65±0.29 cm, p=0.002) and laterally (right: 0.32±0.51 cm, p=0.048, left: 0.32±0.44 cm, p=0.33). Bulging of the trigone area (a trigonal “hump”, 1.7±0.7 cm high) appeared postoperatively in all patients.

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Conclusions: Transvaginal hysterectomy and anterior colporrhaphy are associated with significant distal and lateral displacement of both ureteral orifices. This phenomenon is probably caused by the central condensation of endopelvic connective tissue during anterior colporrhaphy, which is represented by the “trigonal hump”. These findings are of potential importance for pelvic reconstructive surgeons, and may facilitate faster evaluation of ureteral patency postoperatively. Moreover, they may have implications on the preferred equipment to be used for cystoscopic visualization of the ureters. Using 70 rather than 30 degrees optical devices, which may provide better visualization of the displaced ureteral orifices, is a potential implication which seems to deserve further investigation. References: 1. Olsen AL, Smith VJ, et al. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol 1997 Apr; 89(4):501–6. 2. Gustilo-Ashby AM, Jelovsek JE, et al. The incidence of ureteral obstruction and the value of intraoperative cystoscopy during vaginal surgery for pelvic organ prolapse. Am J Obstet Gynecol 2006 May; 194(5):1478–85. 3. Kwon CH, Goldberg RP, et al. The use of intraoperative cystoscopy in major vaginal and urogynecologic surgeries. Am J Obstet Gynecol 2002 Dec; 187(6):1466–71. 156 Colpocleisis: a good option for the management of pelvic organ prolapse Ghosh A, Arunkalaivanan A Sandwell and West Birmingham Hospitals NHS Trust, United Kingdom Industry Support: No OBJECTIVE: To analyse the efficacy of Colpocleisis in the treatment of pelvic organ prolapse in selected elderly women and to assess the cost effectiveness of this procedure when compared with the pessary use in the National Health Service (NHS). BACKGROUND: Colpocleisis is an operative technique intended at complete closure of the vagina. First performed by Neugebauer in 1867 and published by LeFort in 1877, colpectomy and colpocleisis have been considered obsolete and with a high incidence of de novo stress urinary incontinence (SUI). However, this procedure has been revisited and performed by the gynaecologists in recent years. METHOD: From January 2005 to December 2007, 41 women with a mean age of 77 (range 63–94) underwent total or Le Fort colpocleisis for Stage 3 or 4 uterine or vault prolapse. All patients had associated enteroceles, cystoceles and rectoceles and were multiparous - median parity 4

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(range 2–10). 17 (41%) women had concomitant urinary incontinence and underwent urodynamic studies after reduction of prolapse using a pessary. Of these 17 women, 5(30%) had a confirmed urodynamic stress incontinence; 9 (52%) had mixed urinary incontinence; 3 (18%) had detrusor overactivity. 3 women underwent transurethral injection of Zuidex™and 2 underwent transobturator tape procedure along with colpoclesisi.. Economic analysis was done by the procedure coding department. RESULT: 12(27%) had undergone hysterectomy and 5(12%) had prolapse repair; 22(54%) tried pessary in the past. 12 (30%) women required total colpocleisis, 29(70%) needed Le Fort Colpocleisis. 22(54%) of the procedures were performed under local Anaesthesia and 19(46%) were done under general anaesthesia. Procedure lasted from 20 to 65 minutes (Mean 33±14) and the estimated blood loss ranged from 50 to 200 ml (Mean 77±12). Median Hospital stay was 1 day (range 1–7 days). No perioperative complications were reported. Overall there were no significant complications apart from 5(12%) who developed postoperative infecton; 1 had urinary tract infection.Of the 17 (41%) women who had reported urinary incontinence prior to the procedure, 12(71.4%) were cured of incontinence following the procedure. At a median follow-up of 6 months, 40/41 (97.5%) has been cured of prolapse symptoms. One woman developed persistent vulvovaginal pain and requested revision of the procedure. Economic analysis is follows: cost of the procedure is £635; Hospital stay £135; two appointments (initial and followup) £250. Therefore overall cost of the procedure is £1025 whereas Pessary costs £12.43; Each OPD visit £100 over 10 year period - £2000 + inflation. CONCLUSION: Colpocleisis is an effective and safe method for treatment of advanced pelvic organ prolapse in high risk elderly women and is a cost effective procedure in the NHS. KEY WORDS: Colpocleisis, Pelvic Organ Prolapse, urinary incontinence 157 Laparoscopic paravaginal repair for anterior compartment prolapse Vanspauwen R, Seman E, Behnia-Willison F, Cook J, O’Shea R, Keirse M Flinders Medical Centre, Australia Industry Support: No Objective Surgical cure of anterior compartment prolapse remains elusive. Anterior colporrhaphy remains popular [1] in spite of it not addressing the lateral defects found in two thirds of cystocoeles and a consequent failure rate of up to 70% [2]. Lateral defect (paravaginal) repair was first described in

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1909 [3], popularised as an open procedure in the mid 1970’s and adopted laparoscopically in the mid 1990’s. The aim of this study was to evaluate the long term results of the laparoscopic paravaginal repair. Methods We present a prospective observational study of 362 patients who underwent a laparoscopic paravaginal repair between February 1999 and December 2006. All patients were assessed pre- and postoperatively using the Pelvic Organ Prolapse Quantification (POPQ) system. A Burch colposuspension was performed in 122 cases to address symptomatic urethral hypermobility. Recurrences were treated with graft-reinforced anterior colporrhaphy. Results With a mean age of 60 years (31–89), mean weight 79 kg (48–120), mean parity 2.9 (0–9), the average hospital stay was 4.2 days. With follow-up to five years, the objective success rate was 75%. Of the initial 57 failures, 20 patients underwent a graft-reinforced anterior colporrhaphy. This increased the cure rate by 10%, producing a two stage success rate of 83%. In addition 37 patients had an asymptomatic midline cystocoele and declined further surgery, producing a subjective success rate, in this group overall of 88%. These results are in keeping with our initial published data [4, 5]. Conclusions Laparoscopic paravaginal repair followed by selective, interval graft-reinforced anterior colporrhaphy achieves an anatomic cure rate greater than 80% and low morbidity. References: 1. Vanspauwen R, Seman E, Cook J, O’Shea R, BehniaWillison F, Dwyer P. Survey on the Surgical Management of Prolapse in Australia and New Zealand in 2007. Abstract IUGA 2008. 2. Weber AM, Walters MD. Anterior vaginal prolapse: Review of anatomy and techniques of surgical repair. Obstet Gynecol. 1997;89:311–318. 3. White GR. Cystocele: a radical cure by suturing lateral sulci of vagina to white line of pelvic fascia. J Am Med Assoc. 1909;53:1707–1710. 4. Seman EI, Cook JR, O’Shea RT. Two year experience with laparoscopic pelvic floor repair. J Am Assoc Gynecol Laparosc. 2003;10:38–45. 5. Behnia-Willison F, Seman EI, Cook JR, O’Shea RT, Keirse MJ. Laparoscopic paravaginal repair of anterior compartment prolapse. J Min Inv Gyn. 2007;14:475– 480.

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158 High effectiveness and satisfaction one year after Tension free Vaginal Mesh (Prolift®) surgery. Withagen M1, Vierhout M1, Milani A2 1 Radboud University Nijmegen Medical Centre, Netherlands, 2 Reinier de Graaf Hospital, Netherlands Industry Support: No Objective: The aim of this study is to evaluate the Prolift® (Tension free Vaginal Mesh) procedure after one year follow-up in two centres. We want to determine effectiveness, subjective satisfaction and safety of the procedure. Background: Pelvic organ prolapse is common and is seen in 50% of the parous women1. A wide variety of abdominal and vaginal surgical techniques are available for the treatment of prolapse. In recent years the use of synthetic mesh or biologic graft in pelvic reconstructive surgery to prevent recurrence has increased considerably. Methods: It is a prospective cohort study. In two centres, specialised in pelvic organ dysfunction, prolapse surgery with the Prolift® system was undertaken from September 2005 onward, especially in patients with recurrent prolapse. Preoperatively all patients underwent a pelvic organ prolapse quantification (POP-Q) assessment and filled in a diseasespecific quality of life questionnaire (Pelvic Floor Distress Inventory (UDI and DDI), and Pelvic Floor Impact Questionnaire (IIQ))2. Surgery was performed by four gynaecologists, trained for the Prolift procedure. Complications were registered. Patients were examined six months and one year after surgery. (POP-Q and disease-specific quality of life questionnaires and Patient Global Impression of Improvement (PGI-I)3 questionnaire) Data were analysed with SPSS, version 14.0.1, Wilcoxon Signed Rank test was used. Results: 126 patients underwent prolapse surgery with a Prolift® procedure. 21 patients had a Prolift ® anterior, 53 had a Prolift® posterior, 27 had a Prolift® totalis and 25 had Prolift® anterior+posterior. Median age was 65 years (range 32–89)and 72% was postmenopausal. 64.3% of the patients underwent a previous prolapse operation. Median operating time was 55 minutes (range 30–150). Median blood loss 100 ml (range 50–1200). Complications occurred in 7 cases (5.6%) during operation, 3 bladder lesions (2.4%), 2 serosa lesions of the rectum (1.6%), 2 haemorrhage over 500 ml (1.6%). Median hospital stay was 4 days (range 2–11 days). Post-operative 17 patients (13.5%) had temporary urinary retention. Relevant POP-Q stages are shown in table 1. The stages are all statistically significant different. Objective success (POP-Q stage 0+1) in the anterior compartment is 84.1%, in the posterior compartment 89.1% and in the middle compartment 88%. Exposure of the mesh was seen in 12 (9.5%) patients. Two in the anterior compartment, 7 in the

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posterior compartment, 2 in the middle compartment and 1 unknown compartment. Table 2 shows disease-specific quality of life. All scores have significantly improved one year after the operation, except for the DDI incontinence. PGI-I after one year shows 93.7% subjective improvement.

2. Measuring health-related quality of life in women with urogenital dysfunction: the urogenital distress inventory and incontinence impact questionnaire revisited. Neurol Urodyn 2003;22:97–104. 3.. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol 2003;189:98–101.

Table 1 POP-Q stage in the treated compartment

N Stage 0 Stage 1 Stage 2 Stage 3 Stage 4

Anterior preoperative

Anterior after 12 months

Posterior preoperative

Posterior after 12 months

Middle preoperative

Middle after 12 months

71 0

69 46 (66.7%) 12 (17.4%) 10 (14.5%) 1 (1.4%)

103 7 (6.8%)

101 72 (71.3%) 18 (17.8%) 9 (8.9%)

51 1 (2.0%)

50 17 (34%) 27 (54%) 4 (8%)

2 (2.8%) 11 (15.5%) 52 (73.2%) 6 (8.5%)

0

4 (3.9%) 45 (43.7%) 41 (39.8%) 6 (5.8%)

2 (2.0%) 0

22 (43.1%) 4 (7.8%) 17 (33.3%) 7 (13.7%)

2 (4%) 0

Table 2 UDI, DDI and IIQ score

UDI overactive bladder UDI incontinence UDI obstructive micturation UDI discomfort/pain UDI genital prolapse DDI constipation DDI obstructed defecation DDI pain DDI incontinence IIQ physical functioning IIQ mobility IIQ social functioning IIQ embarassment IIQ emotional health

Pre-operative Median (range) n=126

After 12 months Median (range) n=126

P value

33.3 (0–100)

11.1 (0–88.9)

<0.001

16.7 (0–100) 33.3 (0–100)

16.7 (0–100) 0 (0–83.3)

0.012 <0.001

33.3 (0–100) 66.6 (0–100) 0 (0–83.3) 8.3 (0–75)

0 0 0 0

(0–100) (0–83.3) (0–66.7) (0–58.3)

<0.001 <0.001 <0.001 0.001

0 (0–83.3) 0 (0–83.3) 33.3 (0–100)

0 (0–66.7) 0 (0–100) 0 (0–100)

0.506 0.006 <0.001

22.2 (0–100) 11.1 (0–100)

11.1 (0–100) 0 (0–100)

<0.001 <0.001

0 (0–100) 22.2 (0–100)

0 (0–83.3) 0 (0–77.8)

0.032 <0.001

Score range 0–100, a high score means more bother.

Conclusions: Tension free Vaginal Mesh (Prolift®) is a highly effective and safe treatment for pelvic organ prolapse. Randomised controlled trials are necessary to compare effectivity and safety of this new technique with classic techniques. References 1. A 25-year experience with 519 anterior colporrhaphy procedures. Obstet.Gynecol.78.6 (1991): 1011–18.

159 Does lateral elevation of the distal pubocervical fascia during anterior colporrhaphy obstruct the urethra? Rauff S, Lee J, Chung P National University Hospital, Singapore Industry Support: No Objectives: We report on the changes in the voiding parameters of women who had the adjunctive step of vaginal paravaginal (via the transobturator approach) repair procedure incorporated into their anterior colporrhaphy for the treatment of moderate and severe cystocoele. The transobturator paravaginal repair (ToPVR) contributes to the lateral support of the distal vaginal repair. We hypothesized that in achieving better transverse support, the urethral integrity will be compromised to some extent, potentially increasing risk of bladder outlet obstruction. Methods & Materials: 21 women were consecutively operated on for symptomatic = stage 2 pelvic organ prolapse between January 2007 to March 2008 in the Department of Obstetrics and Gynaecology, National University Hospital, Singapore. All had site-specific fascial repair and transobturator paravaginal repair (ToPVR) to treat the central and lateral defects of the cystocoele. ToPVR is a new adjunctive surgical technique that loops a non-absorbable suture round the full thickness of the obturator complex (membrane, fascia & muscles) and weaves the pubocervical fascia onto the obturator fascia medially (see other abstract: The Transobturator Paravaginal Repair (ToPVR) - a new technique to treat lateral defects of Anterior Vaginal Wall Prolapse). Nineteen patients had clinically significant=2 grade hysterocoele for which concurrent vaginal hysterectomy was performed. Vault suspension procedures were prophylactically performed in this group; including 4 uterosacral pedicle approximation, 2 modified McCall’s culdoplasty, 6 right sacrospinous fixation and 7 high uterosacral ligament suspension. The remaining 2 women had their uteri conserved, of which - one had ilioccocygues hysteropexy. Post-operatively, the women were followed up at 1 week, 2, 6 & 12 months intervals. Surgical outcomes were analyzed in detail according to sites of defects. Direct and associated complications were also documented. At 1 week or 2 months post-surgery, uroflowmetry was carried out.

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Results: The mean age of the 21 patients was 65.5 years (range 48–85 years). There were no intra-operative or immediate post-operative complications directly related to the surgery. All except 2 patients were discharged home on post-op day 3 after a successful trial of void. 2 patients stayed longer (post-op day 8 & 28) due to medical reasons (pneumonia, DVT/PE). Two women had an indwelling urinary catheter re-inserted on discharge but had it successfully weaned off by post-op day 12. Table 1 describes the uroflowmetry parameters of the cohort. Uroflowmetry results were considered invalid if the voided volume obtained was less than 150 ml. There was no significant differences between the pre- and postoperative mean peak flow rates (22.8 vs. 22.1 ml/s, p= 0.870), mean average flow rates (9.9 vs. 9.6 ml/s, p=0.900) and mean voided volumes (352 vs. 306 ml, p=0.418). The mean residual volume was significantly lower after surgery (101 vs. 36, p=0.013). Table 1 Pre- and post-operative uroflowmetry results Pre-Op (n=17) Peak flow rate (ml/s) Average flow rate (ml/s) Voided volume (ml) Residual volume (ml)

Post-Op (n=15)

P values

22.8 (8.4–64.9) 22.1 (10.4–42.4) 0.870 9.9 (3.3–29.3) 9.6 (3.6–21.6) 0.900 352 (122–800) 101 (0–300)

306 (125–426) 36 (0–140)

0.418 0.013*

*denotes p-value which is statistically significant (p<0.05)

Conclusions: The restoration of the anterior vaginal wall lifts the bladder base cranially, re-aligning the vesico-urethral axis to one that is more efficient for micturition. Bladder emptying is dependent on the competence of detrusor contractility and adequacy of urethral relaxation. Measuring the maximum detrusor pressure at voiding before and after surgical treatment may add more information in the assessment of bladder-urethral coordination. Nevertheless, post-void residual volume is a fair surrogate marker of indicating voiding efficiency. The study demonstrated that transverse lifting of the distal anterior vaginal wall on each side, in the attempt to recreate the lateral sulci amongst those with severe lateral defects, was not complicated by bladder outlet obstruction. In a future follow up study between conventional anterior vaginal repair (AVR) and the currently described composite AVR, the impact on voiding function will be further scrutinized. 160 Transvaginal cystocele repair with an ultra-light polypropylene mesh Novasilk° using a new technique of unfixed intervesicovaginal mesh: a prospective study. MANSOOR A, VELEMIR L, GOBIET J, SAVARY D Centre Hospitalier d’Issoire, France

Industry Support: No Background and Objective: Results of vaginal cystocele repair with native tissue is disappointing. The use of polypropylene mesh improves anatomical results but the vaginal mesh tolerance in terms of pain, dyspareunia and mesh exposition is problematic. The primary aim of this study was to evaluate the efficacy of a new ultra-light polypropylene mesh, 22 g/m2 (Novasilk° Coloplast) in the treatment of at least grade 2 cystocele POP-Q classification using an unfixed mesh technique. The secondary aim was to access shrinkage of the mesh and vaginal erosion and their consequences on pain and dyspareunia. Method: This prospective longitudinal observational study recruited women needing pelvic reconstructive surgery for symptomatic prolapse with cystocele at least grade 2, point Ba POP -Q classification. Informed consent was obtained after information about mesh complications. Pre and post operative assessment used Kings college Prolapse Quality of life(PQoL), sexual questionnaire PISQ-12 and POP-Q classification. Cystocele repair is done with mesh reinforcement, which is tailored from a Novasilk° sheet 15×15 cm and contains a main body 6×4 cm with an anterior neckline, two large lateral arms 4×5 cm, a long posterior tail 4×7 cm. It is positioned in the vesico- vaginal space through a sagittal full thickness vaginal incision leaving the fascia against the vagina. The arms are pushed laterally through the endopelvic fascia and remains in contact with the arcus tendineous levator ani, The anterior part of the mesh is attached to the retro-pubic insertion of the pubococcygeus muscles with a Prolene 2/0 suture. The posterior tail is left free in a space created by dissecting the posterior side of the bladder from its peritoneum and rests freely on the Mac Call utero- sacral plication. Median and posterior prolapse are treated with specific technique (vaginal hysterectomy with utero-sacral or sacrospinous ligament vaginal vault fixation, posterior repair without myorraphy). Stress incontinence, if associated, is treated with TOT. Patients are reviewed for evaluation post operatively at 6 months and annually. Failure of cystocele repair is considered for Ba=-1 cm. Results: Fifty patients operated between 07/2006 and 04/ 2007 have mean follow up of 10,7 months (6–17). Mean age 66,9 years (40–92), parity 2,6 (0–7), 4 patients had prior hysterectomy, 5 prolapse surgery and 4 incontinence surgery. Thirty-six patients had grade 3 and 4 cystocele (ICS) pre-operatively. The anatomic correction rate of cystocele is 86% with recurrent intra vaginal cystocele in 6 patients and 1 grade 3, all are asymptomatic and did not need re-operation. Voiding symptoms are significantly corrected (60% vs 10% p<0,005). Symptoms associated with POP decreased from 90% to 2%, p<0,0001. Rectal voiding symptoms were improved, 34% pre operatively to

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10% post operatively. No major operative complication occurred. Vaginal mesh exposition occurred in 1 patient (2%). Twenty-two patients were sexually active preoperatively and 20 post operatively, among them, 8 (40%) found no change, 8 (40%) patients found improvement and 3 (15%) advocated worsening in their sexual life. Of the 3 patients complaining of dyspareunia, 2 said it was related to surgery, 10% de novo dyspareunia and one to dryness. The mesh was well soft in 47 patients, light tension is felt in 3 patients. Conclusion In this study, we observed good vaginal tolerance of Novasilk with satisfactory anatomic results. POP symptoms are significantly corrected and sexual life is respected. The unfixed technique used in this series with an ultra-light polypropylene mesh may explain the good vaginal tolerance, as the mesh can retract freely, thus reducing shrinkage, mesh exposition and dypareunia. 161 The quality of life after the prolapse surgery; a comparison of prolene mesh suspension with classical methods Halaska M1, Krcmar M1, Feyreisl J2, Krofta L2, Martan A1, Svabik K1 1 Department of OB/Gyn, Teaching Hospital Na Bulovce, 1st Faculty of Medicine, Charles University, Czech Republic, 2Institute for the Care of Mother and Child, 3rd Faculty of Medicine, Charles university, Czech Republic Industry Support: Yes (Investigator initiated, partial funding) Objective: Objective evaluation of the success rate of new techniques (Prolift) comparing them with the classical method (fixation of the vaginal cuff on the sacrospinous ligament Amreich-Richter) on statistically significant population and the assesment of quality-of-life before and after all performed operations. Background: Lot of work in the field of therapy and prevention of pelvic organ prolapse during the last decades was done. The most important gain seems to be the implementation of new operation techniques, which can succesfully solve the pelvic organ prolapse or vaginal cuff’s descent following hysterectomy. On the other hand, many patients with inadequate treatment still remain. One study shows, that 30% of women out of 150 000 treated for prolapse, needed reoperation. The presumable reason of those unsatisfying results is the variability of surgical techniques and surgical teams themselves. Based on recent anatomical findings special mesh implants were developed, which should improve anatomical and functional results of operative procedures. But what is exactly the optimal result of reconstructive surgery - superior anatomic effect or

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subjective patients’ comfort? There have been no studies yet, which could elucidate the impact of these new techniques on the quality of patients’ life. The quality-oflife hasn’t been systematically reviewed but nowadays it has become the main topic of research interest in all urogynecology centers around the world. The new procedures also bring new complications, which should be documented, too. Such randomised comparation in large population hasn’t been ever published. Pilote, corporate studies mostly proved superior anatomical effect with the minimum of side-effects. But those studies were frequently performed on statistically insignificant population with unclear long-term effects including de novo generated complications. Methods: Our study was approved by the Ethics committee. All participants signed the informed consent. Study design is open, randomized, prospective, comparative and multicentric with the population of 500 patients divided into 3 groups (A-150, B-200, C-150) according to the prevailing type of descent. Group A includes patients with anterior descent treated with Prolift anterior; B group includes the patients with total prolapse of vaginal cuff after hysterectomy - divided randomly by computer into 2 subgroups (subgroup B 1 - treated with Amreich procedure, subgroup B2 - treated with total Prolift procedure). Group C consists of patients with dominant posterior defects and will be treated with Prolift posterior. Examination set up comprises history including exclusion. All participants undergo urodynamics (cystometry, rest and stress profilometry and uroflowmetry) according to ICS standards and ultrasonography (according to EUGA recommendations). Magnetic resonance scan will be used in all patients in B group. All patients fill out standardized questionnaires (PISQ, ICIQ, UIQ, CRAIQ, POPIQ, UDI, CRADI, POPDI), which are integrated into similar projects in world literature. All these examinations have been performed before and 3 to 6 months after the operation. Operations has been carried out during first two years of the study, the last year will be used for evaluation of the results. Check of type, frequency and relevance of peri- and postoperative complications has also been performed. Statistical evaluation includes the process of contingent squares, parametrical analysis for quantitative magnitude levels, classic regression analysis and logistic regression with SAS 9 pack (ANOVA and t-tests). Due to small amount of patients in group B we didn’t compare the parameters of magnetic resonance. Our study is registered at FDA. Results: The number of patients in each group as they’ve been operated until now are listed in Table 1. The number of patients we were able to evaluate until the deadline shows Table 2. The results in collected data are shown in table 3 and 4. No significant differences have been found,

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but there haven’t been evaluated enough patients yet. There’s a summary of our complications in Table 5. Table 1 The number of patients in each group as they’ve been operated until now group A

group B

group C

total

65

47

55

167

Table 2 The number of patients we were able to evaluate until the deadline

Table 5 Summary of our complications complications/ group A group perioperative 1x heavy bleeding with 2x re-operations 1x large protrusion 1x bleeding postoperative

group A

group B-Amreich

group B-Prolift totalis

group C

total

10

6

4

10

30

Table 3 The results in collected data. No significant differences have been found, but there haven’t been evaluated enough patients yet

group B

group C

1x vesical perforation

0x

1x bleeding 1x hematoma

2x small protrusions 4x SUI de novo 1x hematoma 1x dyspareunia 2x small protrusions 4x SUI de novo 2x posterior descent

1x hematoma 1x small protrusion 3x SUI de novo 1x UUI de novo 1x anterior descent

Variable

Mean

SD

SUI - stress urinary incontinence, UUI - urge urinary incontinence

CC max before FDV before MUCP rest before MUCP stress before FUL rest before FUL stress before PVRV before Q max before gamma angle before p distance before CC max after FDV after MUCP rest after MUCP stress after FUL rest after FUL stress after PVRV after Q max after gamma angle after p distance after

421,5 210,5 57,5 54,2 27,8 16,9 36,8 27,5 116,2 27,1 441 244,4 55 53,2 29,5 19,1 29,1 28,4 108,1 26,4

101,2 98,9 22,6 29,3 5,6 14,1 75,5 12,3 32,7 5,8 79,5 115,5 26,8 39,2 6,4 15,6 11,7 69,4 19,9 4,4

Conclusions: The preliminary limited results showed no significant differences in all measured parameters. All patients declared the improvement of subjective symptoms of prolapse. The most frequent postoperative complication appears to be stress urinary incontinence, however up to date we haven’t got enough patients for examination.

Table 4 The results in collected data. No significant differences have been found, but there haven’t been evaluated enough patients yet Variable

Mean

SD

p

CC max before FDV before MUCP rest before MUCP stress before FUL rest before FUL stress before PVRV before Q max before gamma angle before p distance before

-19,5 -33,9 2,5 0,2 0 -2,2 7,6 -0,9 0,9 0,8

120 141 18,1 10,2 1 4 37 7,9 7,1 6,9

0,3807 0,1975 0,4508 0,8151 0,1327 0,0051 0,2675 0,5383 0,0424 0,5476

162 Anatomical and functional results for posterior prolapse repair with transobturator collagen coated mesh material: 6 and 12 months follow up results of a prospective multicentre study Vollebregt A1, van der Vaart H2, Gietelink D3 1 Spaarne Hospital Hoofddorp, Netherlands, 2 UMC Utrecht, 3Amphia Hospital Breda Industry Support: Yes (Investigator initiated, partial funding) Objective: To asses the anatomical and functional results of a rectocele repair with collagen coated transobturator vaginal mesh material (Avaulta® posterior) after a follow up of 6 and 12 months. Background: With a recurrence rate of 29% after classical vaginal prolapse repair, mesh augmentation in vaginal prolapse surgery has become increasingly popular. The recently introduced transobturator approach of polypropylene mesh appears to be effective, however large studies with long term follow up are lacking. Methods: From December 2005 onward a prospective multicentre study of patients operated with a transobturator collagen coated mesh (Avaulta®) because of a symptomatic vaginal prolapse in 4 centres is started. Before surgery the prolapse was staged according to the POP-Q classification.

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All patients fill in a disease specific QoL questionnaire preand 6 and 12 months postoperatively. At this time forty seven percent received a posterior prolapse repair (n=127). In 87 patients medium term follow up was available. Results: Median age (± SD) was 60 ± 11 (range 36-85), median parity 2 (range 1-6), and median BMI was 25 (1835). Fifty patients (58%) had previous prolapse surgery and in 34% a previous rectocele repair was performed. In Table 1 anatomical results after 6 and 12 months follow up are presented. No symptomatic recurrence rectocele stage = 2 as found after 6 and 12 months. Eight de novo cystoceles were diagnosed after 6 months. In 6/8 de novo cystoceles were symptomatic and operatively corrected. After 12 months 10 de novo cystoceles were found, two were symptomatic and operatively corrected. Table 2 shows a highly significant improvement in urogenital prolapse symptoms together with obstructive defecation and constipation symptoms after 12 months. Table 1 Stage Baseline N=83 Q2 11 (13.3%) e1 72 (86.7%) Descensus uteri/vaginal Q 2 24 (30.3%) vault e1 58 (70.7%) Recto/enterocele Q2 83 (100%) e1 0 (0)%)

Prolapse Cystocele

6 months N=65 13 (20%) 52 (80%) 3 (4.6%) 62 (95.4%) 2 (1.5%) 63 (98.5%)

12 months N=30 10 (33.3%) 20 (66.7%) 1 (3.3%) 29 (96.7%) 2 (6.7%) 28 (93.3%)

Values are numbers (percentage)

Table 2

UDI domains Overactive bladder Obstructive micturition Discomfort/ pain Urinary incontinence Genital prolapse DDI domains Constipation

Baseline 6 pBaseline 12 pmonths value* months value* N=53 N=83 N=33 N=33 36.4 (4.0) 28.3 (3.9) 34.0 (4.6) 25.6 (6.2) 59.9 (5.0)

32.2 (4.3) 25.8 (3.9) 25.1 (4.6) 18.6 (3.4) 7.6 (3.1)

22.0 (6.5) Obstructive 20.1 defecation (3.8) Painful 11.0 defecation (2.7) Fecal 13.1 incontinence (3.2)

7.6 (3.3) 7.2 (2.0) 9.7 (3.4) 8.8 (2.3)

0.295 0.540 0.110 0.262 0.000

0.206 0.000 0.728 0.185

37.2 (5.4) 26.6 (4.6) 30.1 (5.7) 32.8 (10.5) 57.8 (5.9)

32.0 (6.0) 25.0 (5.3) 20.4 (4.9) 23.9 (4.1) 7.8 (4.0)

23.2 (9.0) 16.7 (3.3) 8.3 (3.0)

6.1 (2.3) 8.1 (3.5) 2.8 (1.6) 13.5 (4.1)

14.6 (4.5)

0.258 0.786 0.045 0.402 0.000

0.067 0.004 0.057 0.818

Incontinence for gas

37.3 (4.4)

36.0 (6.6)

0.792

41.2 (5.5)

33.3 (5.6)

0.118

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Conclusions: The Avaulta® posterior collagen coated mesh for genital prolapse repair shows to be highly effective in anatomical and functional results after 6 and 12 months follow up. 163 Prophylactic uterosacral ligament suspension at hysterectomy - a survey of Austrian gynecologists Aigmueller T, Dungl A, Geiss I, Hinterholzer S, Riss P Dept. of Obstetrics & Gynecology, Vienna, Austria Industry Support: No Objective The aim of this study was to obtain an estimate of the method of vault fixation during abdominal and vaginal hysterectomy. Background There are several methods available to fixate the vagina at the time of hysterectomy with the aim to prevent posthysterectomy vaginal vault prolapse. However, little is known about the actual use in daily practice. Austria (8 million inhabitants) seems to be ideally suited for a survey of current practice, since the country has public health insurance with universal healthcare and access to medical and surgical care. There is only a very small private sector of health care. Method In order to obtain information about standardized or not standardized fixation of the vault during abdominal or vaginal hysterectomy we contacted all 86 departments of gynecology at public hospitals in Austria and requested the following data for the year 2005: Was a method for vault fixation used during whether abdominal or vaginal hysterectomy, and if the method used was a standardized procedure. In addition we asked for the total number of hysterectomies and total number of operations for vault prolapse. Results 65 depatments of gynecology out of the 86 contacted (response rate 76%) answered to our request. 58 departments out of the 65 (89%) indicated fixation of the vault during hysterectomy, 34 (52%) departments provided information about the standardized methods used. At vaginal hysterectomy (31 responses): 15x attachment of uterosacral pedicles to vagina, 5x attachment of uterosacral and round ligament to vagina, 5x attachment of uterosacral ligament to vagina and tying of pedicles, 2x attachment of round ligament to vagina, 1x attachment of adnexal

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pedicles to vagina, 1x attachment of uterosacral ligament and adnexal pedicles to vagina, 1x McCall and 1x semicircular culdoplasty At abdominal hysterectomy (20 responses of standardized procedures) 16x attachment of uterosacral pedicles to vagina, 1x Culdoplasty semicircular, 1x McCall, 1x attachment of the round ligament to vagina and 1x attachment of uterosacral and round ligament to vagina. In addition, data of the 65 departments of gynecology which responded to our request included 7645 hysterectomies (37% performed abdominally, 54% vaginally and 9% LAVH) and 548 procedures for posthysterectomy vault prolapse, giving a frequency for posthysterectomy vaginal vault prolapse requiring surgical repair of 6 to 7% (assuming that vault prolapse takes on the average 10 years to develop and that the total number of hysterectomies has decreased by 10% between 1995 and 2005). Conclusion In Austria most gynecologic surgeons (89%) perform fixation of the vault during hysterectomy to prevent vault prolapse. During both vaginal and abdominal hysterectomy the attachment of uterosacral pedicles to vagina was the procedure of choice. The frequency for posthysterectomy vaginal vault prolapse requiring surgical repair, which was evaluated simultaneously, was 6 to 7%. References Cruikshank SH, Kovac SR. Randomized comparison of three surgical methods used at the time of vaginal hysterectomy to prevent posterior enterocele. Am J Obstet Gynecol. 1999 Apr;180(4):859–65 Cruikshank SH. Preventing vault prolapse and enterocele after vaginal hysterectomy. South Med J. 1988 May;81(5):594–6

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Video presentations (46–51), (133–138) 46 Repair of posterior vaginal wall prolapse: Correction of apical transverse fascial defect Castillo P, Espaillat L, Davila G Cleveland Clinic Florida, United States Temple University, United States Industry Support: No OBJECTIVE: To illustrate how restoring integrity of the endopelvic fascia in the posterior vaginal wall can resolve most posterior compartment prolapse. BACKGROUND: Rectocele repair represents one of the most commonly performed procedures by pelvic surgeons. A rectocele is a herniation of the posterior vaginal wall resulting from a defect in the rectovaginal septum, not the vagina or rectum. It can be caused by either a discrete tear in the septum or by attenuation of these tissues. Rectovaginal defects vary considerably and discrete tears can occur in any location or direction along the rectovaginal septum. With careful surgical dissection defined tears can often be found. Specifically, transverse apical fascial defects often times may be the underlying cause for posterior wall prolapse. Restoring continuity of the endopelvic fascia from the vaginal apex to the perineal body will restore anatomy and function as well as resolve symptoms often associated with a rectocele. METHODS: The posterior colporrhaphy and discrete fascial defect repair may be combined. Following careful dissection of the vaginal mucosa off of the closely adherent underlying rectovaginal fascia, an apical fascial tear is identified. The detached fascial edge is reapproximated to its apical attachment site at the cervical ring or cardinaluterosacral ligament complex with interrupted permanent sutures thus restoring continuity of the endopelvic fascia. The fascia overlying the levator ani muscles can then be plicated in the midline, anterior to the rectovaginal fascia in an interrupted fashion using delayed absorbable suture. A perineorrhaphy is then performed to normalize the genital hiatus and provide vertical support to the lower vagina. Minimal if any vaginal mucosa is then resected and closed in a traditional fashion. CONCLUSION: Correction of the discrete fascial defect at the time of posterior colporrhaphy re-establishes endopelvic fascial integrity from apex to perineum, levator plate integrity, anterior rectal wall support, normal vaginal caliber and length, and integrity of perineal body.

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47 Cystoscopic technique for extraction of intravesical mesh erosion. Ghoniem G, Mahdy A, Elmissiry M Cleveland Clinic Florida, United States Industry Support: No BACKGROUND & OBJECTIVE: In this video we demonstrate a technique of exclusive cystoscopic extraction of intravesical mesh erosion. METHODS: A 68 year old G7P6 female patient was presented to us with suprapubic discomfort and recurrent UTI 10 month after TVT trechnique. Cystoscopy revealed mesh erosion inside the bladder close to the left ureteric orifice. After induction of adequate anesthesia, the patient was prepped and draped in the usual lithotomy position. Using a 22-French cystoscope with 30 degree and 70 degree lenses, the mesh was found inside the bladder with penetration of the left lateral wall lateral to the left ureteral orifice. Both ureteral orifices and trigone looked within normal. Using endoscopic scissors, the mesh was first cut in its exit site on the left lateral wall flush with the mucosa. This allowed retraction of the mesh also away from the left ureteral orifice by 2 cm. Using Bugbee cautary, an opening was made over the mucosa on the entrance site of the mesh at the bladder base and the incision was deepened into the superficial detrusor muscle layer to allow cutting of the mesh and proper healing of the mucosa later on. The mesh was then cut at its base using endoscopic scissors again inside the detrusor muscle. The mesh was grasped with a grasping forceps, removed. Results: The patient returned home on outpatient basis and no postoperative complications were encountered. Follow up cystoscopy after 3 month revealed complete healing of the exit site at the lateral wall as well as the entrance site at the bladder base. Conclusions: Cystoscopic extraction of intravesical mesh erosion is safe, feasible and effective. It provides a good alternative to the more invasive approaches like the suprapubic and or the vaginal approach with minimal morbidity and rapid recovery. 48 Simple Sling Incision for Treatment of iatrogenic Urethral Obstruction Moore C Cleveland Clinic,Cleveland, OH United States Industry Support: No

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Objective: To prove that simple sling incision is an effective, simple, and safe treatment for women with iatrogenic urethral obstruction. Background: Bladder outlet obstruction (BOO) is reported to occur in 5– 20% of women after anti-incontinence surgery. BOO after pubovaginal slings results excessive ventral tension on the urethra. In the past urethral obstruction from pubovaginal slings was treated with urethrolysis. However, urethrolysis is not without morbidity, including significant bleeding and urethral injury. Sling incision offers an effective, simple and safe alternative for women with iatrogenic bladder outlet obstruction after a pubovaginal sling. Methods: Two patients, one with a synthetic mid-urethral sling, and one with a biologics bladder neck sling, underwent simple sling incision for the treatment of iatrogenic urethral obstruction. The patient is placed in dorsal lithotomy position with steep Trendelenburg. A foley catheter is placed to drain the bladder. The anterior vaginal wall is infiltrated with a mixture of lidocaine and epinephrine. For synthetic mid-urethral slings the incision in the anterior vaginal wall incision is made 2 cm from the urethra meatus. In a biologic bladder neck sling the incision is made more proximal overlying the bladder neck. In both cases the sling is identified using careful sharp and blunt dissection. A right angel clamp is then used to create a plane between the sling and urethra and gently spread. The sling is then incised. The vaginal wall is then closed. Results: Simple sling incision is an effective and less morbid treatment for iatrogenic urethral obstruction than urethrolysis. 70–90% of women undergoing simple sling incision for the treatment of iatrogenic urethral obstruction due to a sling will have significant improvement in their obstructive voiding symptoms. Recurrent stress urinary incontinence is seen in approximately 20% of women after sling incision. Conclusion: Simple sling incision is an effective, simple, and safe treatment for women with iatrogenic urethral obstruction after placement of a pubovaginal sling and should be used as a first-line treatment. 49 TVT Secur Surgical Technique and Learning Tips and Tricks Lucente V, van Raalte H, Molden S Institute for Female Pelvic Medicine, United States Industry Support: No (Investigator initiated, no external funding)

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Objective: The purpose of this video is to demonstrate our learned techniques and tips in placement of the new TVT-Secur minisling for the treatment of stress urinary incontinence (SUI). Background: Surgical treatment of stress urinary incontinence has evolved over the past 10 years, now involving standard placement of mesh tapes at the level of the midurethra. Continuing the trend toward less invasive surgical techniques, new “minisling” procedures are the most recent treatment option now available. These slings theoretically offer decreased patient morbidity and discomfort and hold the potential for use as an office procedure. Methods: The video was created by editing 3 separate operative procedures together to highlight the key procedural steps and emphasize important tips and tricks learned over time to achieve maximum dryness rates. Positioning, anesthesia and the two different types of sling placement are also described. Informed consent was obtained from each patient and IRB approval was granted. Results: During our initial use of TVT Secur we recognized a learning curve with apparent improvement in dryness rates after modifying our original surgical technique. The video highlights the key learning points we have experienced. These include techniques such as: minimal hydrodissection, limited periurethral dissection to the pubic rami, proper hand placement during tape delivery, and attention to insertion direction throughout device delivery. Significant improvement in dryness rates were also realized after use of a malleable retractor was implemented for insertion device removal. This allowed for minimal disruption of the mesh tape during the removal. Cough testing was used for initial sling adjustment. Repeat cough testing was then used after removal of the first inserter for final adjustment prior to removal of the second insertion device. We have found that placement of the TVT Secure must be tighter against periurethral tissues to ensure optimal dryness as compared to its predecessors. In a retrospective chart review of 77 patients with six week follow-up was also performed. All patients had the procedure performed under local/regional with sedation.. The average age was 60 years (±13.1) with a BMI of 29 (±5.6) and parity of 3 (±1.3). 37 patients (50.6%) underwent concomitant prolapse surgery at the time of sling placement. The mean OR time was 26.3 (±8.6) minutes and mean EBL was 45.4 (±40.6) ml. In total, 27 patients (35.1%) received the “U” placement while 50 (65.9%) received the “hammock” configuration. Of these, 53 (68.8%) displayed no post-op SUI, 2 patients (2.6%) experienced voiding dysfunction with 1 patient undergoing sling revision, and only 1 patient (1.3%) complained of pain at six weeks. Of the 24 (31.2%)

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patients with persistent SUI, 40% were improved compared to pre-op and did not desire further treatment. Compared to the overall cure rate, the last 25 patients demonstrated a higher cure rate of 80%. Conclusions: Preliminary results of the TVT-Secur procedure suggest it to be as efficacious as its predecessors, the midurethral retropubic and transobturator pubovaginal slings, for the surgical treatment of SUI. There appears to be a slight but clinically insignificant increase in blood loss. There is a real learning curve as demonstrated by the improvement in outcomes seen over time. The new TVT-Secur has displayed a significant decrease in post-operative discomfort and suggests a decrease in voiding dysfunction. 50 New minimally invasive procedures for stress urinary incontinence. Simultaneous comparison between MiniArc and Needleless Meschia M, Baccichet R, Riva D, Ricci L, Spreafico L, Dept. Obstetrics and Gynecology,Magenta, Italy Industry Support: No Aim: To evaluate the feasibility and further on the efficacy of two different single incision minimally invasive procedures for the treatment of stress urinary incontinence. Background: The video shows a simultaneous comparison between two new single incision minimally invasive procedures, MiniArc and Needleless, for the treatment of women suffering from primary stress urinary incontinence. Differences in the shape, length of the tape and devices used for the insertion of the sling are discussed. Methods: The single incision new minimally invasive procedures for stress urinary incontinence, MiniArc and Needleless, provide support to the urethra by means of a short polypropylene tape of 8.5 and 11 cm length respectively. The tapes are inserted, with different devices, through the obturator internus muscle on both sides of the female pelvis. The tapes look different with the MiniArc one ending with a non absorbable polypropylene tip while the Needleless tape is designed with two small pockets at its edges to allow the passage of a Kelly clamp With the patient in lithotomic position a 2 cm vaginal incision is performed just 1 cm below the external urethral meatus and dissection of para-urethral spaces is carried on. The dissection ends at the level of the descending pubis ramus without penetrating the fascia covering the obturator internus muscle. The MiniArc tape is positioned under the urethra using a special designed needle on which the tip of the polypropylene sling is inserted while with the Needleless procedure a simple Kelly clamp is used for penetrating the muscle.

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Once the tape is inserted on both sides of the pelvis the tension of the sling is adjusted and the vaginal epithelium is then closed Results: Data on the efficacy of these two new minimally invasive procedures for the cure of SUI are still preliminary on small number of patients with short follow-up. Nevertheless experimental data on animals showed that the insertion of a short arm sling through the endopelvic fascia provided similar pull-out forces at the insertion and later on as conventional retropubic suburethral slings, suggesting that both could be equally effective for urethral support. Conclusions: MiniArc an Needlelees are two minimally invasive techniques that can be performed as day surgery procedures. No post-operative pain or urinary difficulty have been reported by patients undergoing both procedures. Prospective studies on large number of patients are required to evaluate the long term efficacy. 51 EndoFast Reliant™ System - a novel soft tissue fastening technique Alcalay M1, Von Theobald P2 Chaim Sheba Medical Center, Israel, 2CHU de Caen, France, Industry Support: Yes (Industry-initiated, full sponsorship) Objective: The aim of this video is to present a new surgical technique for Pelvic Organ Prolapse (POP) repair. Background: Mesh reinforcement during prolapse repair is advocated to reduce failure rate. The available techniques for mesh placement are using special trocars that blindly penetrate the obturator fossa and the ischiorectal fossa, exposing the patient to potential complications such as bleeding and visceral injury. The EndoFast Reliant™ system is a new method for reinforcement of the pelvic floor in a minimally-invasive procedure with a system comprised of a mesh and soft tissue fasteners (Endogun Medical Systems, Kibbutz Haogen, Israel). The fasteners are easily deployed in narrow spaces into the soft tissue and support substantially more weight than needed for Pelvic Organ Prolapse repair. The system enables minimal dissection and mesh attachment by palpation directly through the dissection space, as shown in the video. The device was developed to enable direct mesh attachment into connective tissue, therefore potentially reducing intra and post-operative complications and pain. Methods: This video contains an animation demonstrating the use of the EndoFast Reliant™ system, followed by clips from an actual cystocele repair and detailing the steps involved in the procedure. In addition, it displays the pelvic x-ray following the procedure.

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A 61 year old, otherwise healthy female patient with cystocele POP-Q stage 3 was operated for cystocele repair using the EndoFast Reliant™ system. Patient is placed in a modified dorsal lithotomic position. Longitudinal midline incision is made at the anterior vaginal wall. Deep dissection is performed between the vaginal epithelium and the bladder base. Following dissection, the mesh is inserted via the incision, and the fasteners anchor the mesh into the soft tissue adjacent to the ischial spines and posterior symphysis in the anterior compartment. Results: The film highlights the use of the EndoFast Reliant™ system in prolapse repair surgery. There were no intra- or post-operative complications. To date, this surgical procedure has been performed on 15 patients with 6-month follow-up data for 12 patients. Detailed clinical data is presented in another abstract submitted to this conference. Conclusion: The EndoFast Reliant™ system is a minimal invasive procedure for mesh placement, avoiding the use of trocars. This video demonstrates the ease of use of the system. This procedure is a simple and efficacious procedure for treatment of prolapse, which makes it an attractive option for mesh use during prolapse repair. 133 Tricks of the trade in Interstim II® Implant: A true minimally invasive surgery (MIS) Ghoniem G, Elmissiry M, Abdelwahab H Cleveland Clinic Florida, United States Industry Support: No BACKGROUND AND OBJECTIVE: Sacral nerve stimulation is now gaining a wide acceptance in treating patients with voiding dysfunction refractory to conservative therapy. Many innovative improvements including the latest Interstim-II made the sacral neuromodulation a real minimally invasive surgery. In this video we demonstrate some tricks of the trade in Interstim II® Implant procedure. METHODS: The first trick is in the localization of S3; we modified the Chai’s Technique by adding fluoroscopy to identify the S3 foramen and all the medial borders of the sacral foramina. The lower ends of the SI joints are connected with a transverse line and the midline is marked. The line of the medial borders of the sacral foramina is located 2 cm lateral to the midline and the point of entry for S3 is located on this line about 1” above the transverse line. After local anesthesia, a 3.5 inch needle is advanced into the right S3 foramen with 60 degree angle under fluoroscopic guidance. External stimulation is done and both motor and sensory responses are confirmed. A guidewire is introduced through the needle which is then removed

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allowing the cannula to go over the guidewire into the S3 foramen. Then we do the second trick by bending the tip of the guide wire before introducing the quadruple lead through the canula over the guidewire. This will figure a J-hooking of the lead that will ensure good placement of the lead along the course of S3 root. Fluoroscopy confirms good position of the four leads. Re-simulation is done to confirm good responses on all the leads. At the same side, a 4 cm incision is made after local anesthesia. A pocket is created in the subcutaneous tissue. The quadruple lead is routed under the skin, exited into the wound, and then connected to the IPG secured by a screwdriver. Test of impedance is then done to ensure that the circuit is intact and working well. RESULTS: At our institution, we performed this technique for 18 patients with FDA approved indications for neuromodulation. The procedure was done under local anesthesia with sedation as an outpatient procedure. All patients reported minimal pain, no infection, with symptomatic improvement. CONCLUSIONS: Sacral nerve stimulation using Interstim II® Implant is a safe and effective alternative technique for the treatment of various types of voiding dysfunctions refractory to conservative treatment. 134 Intravaginal prosthetic repair of recurrent apical and anterior vaginal prolapse using the “Capio O.A.” system Meschia M, Baccichet R, Ricci L, Spreafico L Dept. Obstetrics and Gynecology, Italy Industry Support: No Aim: To accomplish a bilateral sacrospinous suspension with minimal tissue dissection and to provide durable support of the bladder using a synthetic polypropylene mesh, avoiding the external passage of needles through the skin and ensuring continuity between the anterior vaginal compartment and the apex. Background: The rationale is to perform an intra-vaginal repair of recurrent vaginal prolapse anchoring the vaginal cuff to the sacrospinous ligaments with minimal tissue dissection and to provide durable support of the anterior vaginal compartment by fixing a 15 x 15 cm macroporous polypropylene mesh to the arcus tendineous fasciae pelvis using the Capio system as sutures carrier for both procedures. This technique avoids passage of needles through the skin and obturator membrane minimizing the risk of any blind passage of the needle and provides support to the bladder covering the entire distance between the pelvic side walls.

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Methods: After injection of saline solution, an incision of the posterior vaginal wall is carried on starting 2 cm below the vaginal apex and ending at the level of the hymenal ring. A blunt dissection of the pararectal space is performed on the right side of the patient and the sacrospinous ligament identified and palpated. With the Capio system a n° 0 prolene suture is passed through the ligament. On the left side, the anatomical dissection of the pararectal space is shown and the sacrospinous ligament easily visualized. Again the ligament is transfixed with n° 0 prolene suture using the Capio carrier. Following the placement of sutures on both sides, the anterior vaginal wall is then opened and the bladder dissected away from the vagina. The paravesical space is entered and the descending pubic arch is palpated. Using the Capio system three n° 0 prolene sutures are placed on both sides of the pelvis: the first through the sacrospinous ligament just medially to the ischial spine, the second in the mid part of the arcus tendineous fasciae pelvis and the third distally at the level of the pubic bone. A 15×15 cm macroporous polypropylene mesh is then anchored to the sutures and tied on both pelvic side walls. The 15 cm width of the mesh is required proximally to cover entirely the distance between ischial spines, ensuring support, and to re-establish continuity between the anterior compartment and the vaginal apex. Prolene sutures on the sacrospinous ligaments are then anchored to the vaginal apex and tied before closure of the posterior wall is entirely accomplished. Results: To date few patients have been operated on using the technique described above and preliminary results in the short run are encouraging. The technique has several advantages when compared with the commercially available kits for prolapse repair. There is no blind passage of the needles through the lateral pelvic walls. The mesh is of reasonable size to cover the anatomical distance between ischial spines and the arcus tendineous fasciae pelvis on each side of the pelvis without leaving any lateral defect uncovered. Anchoring the mesh proximally to the sacrospinous ligaments the anatomical continuity between anterior vaginal compartment and the apex is ensured providing a durable support to the pelvic organs. Conclusions: The technique is as easy to perform as those advocating the use of available kits for prolapse repair and we believe is particularly indicated for the repair of recurrent vaginal prolapse. 135 Laparoscopic Repair of Vesicovaginal Fistula Rosenblatt P, Hanaway K Boston Urogynecology Associates, United States

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Industry Support: No Objective: To describe a laparoscopic approach to vesicovaginal fistula repair. Background: This is a 53 y/o G1P1 who underwent a TAH/BSO for a symptomatic fibroid uterus. She noticed leakage of urine from her vagina immediately post-op and was diagnosed with a vesicovaginal fistula. Despite conservative management with foley catheter drainage, her symptoms persisted. Five months later, a vaginal closure of the fistula was attempted. She continued to leak and was referred to our office for evaluation. We performed a Latzko procedure three months after the initial attempt at repair, but her symptoms persisted. The decision was made to proceed with a laparoscopic repair of the vesicovaginal fistula. Methods: Both ureters were stented at the start of the procedure to help identify them intra-operatively and to protect them from injury. The fistula tract was also stented with a ureteral catheter. Using a three way foley, sterile water with indigo carmine was used to backfill the bladder and help delineate its border. The Ace harmonic scalpel was used to dissect the anterior vagina from the bladder. Due to scarring from previous surgeries, an unintentional cystotomy was created. This was eventually repaired with 2–0 vicryl sutures using intracorporeal knot tying. The cystoscope light was used to help direct our dissection to the fistula tract. The white stent in the fistula tract was visualized through the laparoscopic incision at the vaginal apex. The fistula tract was isolated and dissected off of the healthy vaginal and bladder tissue. The clean edges of bladder mucosa were reapproximated using 2–0 vicryl sutures. The vaginal incision was also closed in a similar manner. The anterior peritoneal reflection was interposed between these two layers. Results: A foley catheter to continuous drainage was left in place for two weeks after the procedure. Conclusions: This case report of a laparoscopic vesicovaginal fistula repair demonstrates an alternative approach to traditional open vesicovaginal fistula repair. 136 Large vesicovaginal fistula repair Jean-Michel M, Espaillat-Rijo L, Davila G Cleveland Clinic Florida, United States Temple University, United States Industry Support: No OBJECTIVE: To demonstrate the surgical management of a large vesicovaginal fistula. BACKGROUND: An 83 year old multiparous female developed a 5 cm vesicovaginal fistula as a result of a

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neglected pessary, which had eroded into the bladder. The fistula was located on the proximal aspect of the anterior vaginal wall with a second-degree midline cystocele. METHODS: A vaginal approach was used. The fistulous tract is dissected and ultimately excised after wide mobilization of the endopelvic fascia and bladder off the anterior vaginal wall. The bladder mucosa was reapproximated without tension in 2 layers and the endopelvic fascia was closed in 2 layers including a midline plication. The most proximal plication suture incorporated the pubocervical fascia and the cervix, resulting in restoration of level I support. The vaginal mucosa is then closed. RESULTS: Cystoscopy demonstrates an intact bladder and patent ureters. CONCLUSIONS: Large vesicovaginal fistula repair is an uncommon complication of pessary use that can be managed successfully from a vaginal approach. 137 Transobturator cystocele repair using biocompatible porcine dermal graft (Perigee/ InteXen) Ghoniem G, Elmissiry M, Abdelwahab H, Mahdy A, Langford C Cleveland Clinic Florida, United States

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carmine to ensure no bladder or ureteral injury exists. Excess vaginal epithrlium is trimmed and the vaginal wall is closed by continuous interlocking sutures leaving the last 2 sutures interrupted to allow for any collected hematoma to drain spontaneously. Final adjustment of the graft is done and the arms are cut flush with the skin. Urethral catheter and vaginal pack are placed for 24 hours then removed. RESULTS: We performed this technique for 26 patients with grade II ot more cystocele. After a mean follow up of 8.5 months, no recurrence > stage I was noticed. Intraoperative complications included one case of bladder perforation and one incidental cystotomy. Graft related comlpications included wound dehiscence (1) and one vaginal erosion (1). In the last case, we interestingly found the erosion to be related to the (Riv-Fix) part of the upper right arm of the mesh. This part of the graft is the knob at the connection between the synthetic arm and the biologic mesh. Both cases were treated conservatively at the clinic. CONCLUSIONS: Our short term results with perigee using the noncrosslinked porcine dermis graft (Intexen®) show this is an efficient method of anterior vaginal wall prolapse repair with high success rate and lower incidence of patient morbidity. Importantly, the use of this biocompatible material may have a role in decreased incidence of mesh erosion.

Industry Support: No BACKGROUND & OBJECTIVE: In this video we demonstrate the technique of cystocele repair using transobturator approach with biocompatible porcine dermal graft (Perigee®/ InteXen®) METHODS: With the patient in the lithotomy position and after adequate anesthesia, local infiltration of the anterior vaginal wall with a mixture of marcaine and epinepherine is done followed by midline incision. The cystocele is dissected using both sharp and blunt dissection all the way to the sulci. Four skin markings are done for the enterance of the passers with the upper markingss at the level of the clitoris and the lower ones 3 cm below and lateral to the site of the upper passers. Stab incisions are made in the skin and the proximal passing is performed at the bladder neck level guided by the finger in the vagina. Perigee arms are attached to the passers and pulled to the skin incisions then the posterior passing is performed 1 cm anterior to the ischeal spine and slightly superiorly. This assures good elevation of the anterior vaginal wall. The lower arms are attached and pulled in the same manner and the surrounding sheath facilitates their passing. The dermal fraft is fixed to the periurethral ligament lateral to the bladder neck to prevent its displacement. The graft is then trimmed according to the vaginal wall length and then fixed to the uterosacral ligament in both site further supporting the vault. Cystoscopy is done after injection of Indigo

138 Removal of Extruded Vaginal Mesh Swartz M, Goldman H Cleveland Clinic, United States Industry Support: No Objective: Our aim is to demonstrate that, by adhering to certain surgical principles, excision of extruded vaginal mesh can be relatively simple with minimal patient morbidity. Background: Polypropylene mesh is increasingly used for pelvic floor reconstructive surgery. While it offers a reliable repair, mesh extrusion can occur. This can range from simple vaginal extrusion to more extensive involvement of the bladder or rectum. In most cases, with timely detection and proper management, mesh erosion that fails conservative management can be handled such that morbidity is minimized. Methods: A 71 year old female underwent an anterior transvaginal mesh repair. Approximately two years postoperatively, she developed some vaginal discharge and was noted to have a two cm extrusion on physical exam. Conservative management with local estrogen cream was attempted, but the extrusion persisted. Therefore, definitive excision was

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performed in the operating room. Prior to mesh excision, she was evaluated with office cystoscopy to rule out bladder involvement. We believe several principles are important in repair of mesh erosions. First, the vaginal skin edges should be debrided and edges generously undermined. Exposed mesh should be completely excised with no remnants remaining where the incision will be closed. Care should be taken to avoid bladder or rectal injury with careful dissection. Cystoscopy and bladder filling are techniques to ensure no bladder injury is present. The vaginal skin should be reapproximated with absorbable suture in a tension-free closure. Results: The operative time was 45 minutes and the EBL was 10°cc. This patient was discharged to home on the day of surgery. She is currently doing well. Conclusions: Mesh extrusion can occur, and it is important to understand how to manage this complication in an era of increasing mesh use for vaginal reconstruction. With timely recognition and treatment, simple mesh extrusion should result in minimal patient morbidity.

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Pregnancy/ Sexual dysfunction (76–81), (95–101) 76 Vaginal delivery compared with elective caesarean section: The views of pregnant women and clinicians Turner C, Solomon M, Benness C, YoungJ, Ludlow J Royal Prince Alfred Hospital, Australia Industry Support: No Objective: This study aimed to quantify the risk of morbidity from vaginal delivery that pregnant women would be prepared to accept before requesting an elective caesarean section and to compare these views with those of clinicians. Background: Vaginal delivery may be associated with significant short and longterm complications. These can arise from direct trauma to the pelvic floor and anal sphincter complex or from neuropraxia of the pudendal nerves. Complications secondary to vaginal delivery include urinary and anal incontinence and pelvic organ prolapse as well as other maternal and neonatal adverse outcomes. These consequences can be costly and devastating for the woman and/or infant. The incidence of these complications is significantly lower following confinement by elective LSCS, and women legally and ethically have the right to choose this option. There are diverging views between clinicians with regard to the performance of elective LSCS versus vaginal delivery, and there is paucity of information about the views of pregnant women on this issue. Therefore, this study was undertaken to ascertain which potential complications were important to pregnant women, and to measure the maximum level of risk of complications they would be prepared to accept before opting for an elective LSCS. These views are compared with those of midwives, obstetricians, and the surgeons who deal with the complications that may occur. Methods: The study design is a cross-sectional survey performed in a major teaching hospital, of primigravid women and midwives, and a national sample of relevant medical specialists. ie: primiparas (n=122), midwives (n= 84), obstetricians (n=166), urogynaecologists (n=12) and colorectal surgeons (n=79). Information was obtained by face to face interviews with the pregnant women, and by distributed questionnaires to the midwives and clinicians. The women all had a single, uncomplicated pregnancy and were less than 26 weeks gestation. The clinicians had an identical self administered questionnaire and were asked to respond as if they themselves or their partner were pregnant. Main outcome measures: Maximum level of risk participants would be prepared to accept before opting for

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an elective caesarean section for each of 18 potential complications of vaginal delivery. Utility scores for each complication were calculated, with higher scores (closer to 1) indicating a greater acceptance of risk. Ethics committee approval was obtained. Results: There were statistically significant differences between the four clinician groups when the mean utility scores were compared. Midwives were always prepared to take greater risks and colorectal surgeons the least. Pregnant women were willing to accept higher risks than clinicians for all 18 potential complications. They were least accepting of the risks of severe anal incontinence (mean utility score 0.32), emergency Caesarean Section (0.51), moderate anal incontinence (0.56), severe urinary incontinence (0.56), fourth degree tears (0.59), and third degree tears (0.72) The views of midwives were closest to those of pregnant women with only 2% of pregnant women and 11% of midwives opting for an elective LSCS in a future pregnancy. Urogynaecologists and colorectal surgeons were the most risk averse, with 42% and 41% respectively stating they would request an elective Caesarean for themselves or their partners. Female clinicians had a significantly higher mean utility score (greater acceptance of risk) than males for 16 of the 17 scenarios. Women seeing a private obstetrician during their antenatal period were more willing to have a prolonged labour than the women attending public antenatal clinics. Conclusions: Pregnant women are able to quantify the different levels of risk they are prepared to take before requesting an elective LSCS. This study shows that they are willing to accept significantly higher risks of potential complications of vaginal delivery than clinicians involved in their care. Pregnant womens’ views were more closely aligned to midwives than to medical specialists. 77 Does second stage of labour in water protect against pelvic floor dysfunction. A retrospective study using ICI modular questionnaires. Cortes E, Basra R, Kelleher C Guy’s and St Thomas’ Hospital, United Kingdom Industry Support: No Objective The aim of this study was to investigate the effects of labour on pelvic floor function two years after first vaginal water birth compared with “land” vaginal delivery, using ICIQ modular questionnaires. Background The short and long term consequences of vaginal delivery on pelvic floor function are widely documented (1). Multiple factors have been identified as causative agents

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of nerve, collagen and muscle damage. More recently, studies performed on the levator ani muscle following vaginal delivery have shown a highly significant increase in muscle repair activity following vaginal delivery when compared with other skeletal muscles and non pregnant levator ani samples. It has also been demonstrated that muscle repair capacity decreases with age. Previous studies on waterbirth have suggested that a shorter 2nd stage of labour when conducted in water. Although a prolonged 2nd stage is associated with greater pelvic floor function damage, it remains unclear whether a shorter 2nd stage has a protective effect. Methods A retrospective study was conducted on primiparous women who had a spontaneous vaginal waterbirth (WB) or landbirth (LB). All women had normal vaginal deliveries with no recorded complications or difficulties. All women in the WB group conducted the second stage of labour in the birthing-pool. There was no medical intervention in any of the groups. Women were contacted two years after delivery, and asked to complete the ICIQ Vaginal Symptoms and Urinary Incontinence Long Form (KHQ) questionnaires. Results 131 women participated in the study. 77 and 54 women who delivered by WB and LB respectively, satisfied the inclusion criteria. The 2nd stage of labour was significantly shorter in the WB group. The majority of women reported mild vaginal, urinary, and sexual dysfunction in both groups, although this did not reach statistical significance. The duration of the 2nd stage of labour did not correlate with the severity of urinary and vaginal symptoms or quality of life two years after delivery. Only women aged >35 years reported significantly more severe urinary symptoms when compared with younger women, regardless of their mode of delivery. There were no significant differences in vaginal symptoms when looking at age. Conclusions Waterbirth is associated with a shorter second stage of labour, however this does not appear to be protective against pelvic floor dysfunction. Increasing maternal age at first vaginal delivery is associated with greater lower urinary tract dysfunction with no differences in vaginal symptoms. The LA muscle is the main active structure providing pelvic floor support and continence in women. Our findings would support recent evidence suggesting there is a decline in muscle repair capacity with age, following muscle damage. References 1- Allen RE, Hosker GL, Smith AR, Warrell DW. Pelvic floor damage and childbirth: a neurophysiological study. Br J Obstet Gynaecol 1990; 97(9): 770–9

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2- Snooks SJ, Setchell M, Swash M, Henry MM. Injury to innervation of pelvic floor sphincter musculature in childbirth. Lancet 1984; 2:546–50. 78 Evaluation of changes in sexual function six months after first delivery Diez-Itza I, Murgiondo A, Paredes J, Ibanez L, Arrue M, Belar M Hospital Donostia, Spain Industry Support: No Objective: The aim of this study was to evaluate the changes in sexual function six months after first delivery using the validated PISQ-12 questionnaire. Background: Short-term postpartum sexual problems are highly prevalent, ranging from 22% to 86%. These have been related to different psychological aspects and also to the damage of the pelvic floor during childbirth. The physical changes can be reflected as pain, urinary or faecal incontinence or pelvic organ prolapse. The PISQ-12 is a specific self-report questionnaire used to assess sexual function in women with pelvic floor disorders. It has been validated also in women with out those symptoms to ensure the generalizability of the instrument (1). This questionnaire includes 12 items relating to women sexual life in three different aspects: Behavioural emotive, physical and partner related. Methods: A longitudinal study was undertaken to evaluate the impact of first pregnancy and delivery on the sexual function. The study group was selected from the primigravid women, who came to give birth at our Public Health Hospital from April to September, 2007. We excluded: Multiple pregnancy, gestational age of less than 37 weeks, previous vaginal urogynecological surgery or malformations. Sexual function was assessed at enrolment, and six months after delivery using the recently validated Spanish version of the PISQ-12 questionnaire (2). We encouraged pregnant women to answer the questionnaire considering their sexual life six months before pregnancy. This questionnaire was scored with a 5 point (0–4) Likert scale to each question, and was evaluated total and per item basis. Higher values were indicative of greater dissatisfaction. Statistical analyses were used for mean comparison (Ttest paired) and proportion comparison (Chi-square). Results We recruited 426 pregnant women and all of them answered the PISQ-12 questionnaire. From the total, 341 (80%) attended the six months follow up visit and 323 were

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sexually active and answered the questionnaire, forming the study group. Mean age was 31.21 years (range 18–46), mean BMI was 23.45 (range 15.99- 44.20) and mean gestacional age was 278.85 days (range 259–301).The delivery mode was vaginal in 285 (88.2%) cases and caesarean section in 38 (11.8%). Episiotomy was performed in the 77%, and epidural anaesthetics in the 94.1% of the vaginal deliveries. The mean PISQ-12 score was significantly higher after delivery (8.26±3.98 vs.6.56±2.98; p=0.000) indicating worsening in sexual function. In both before pregnancy and after delivery the repercussion of the urinary incontinence items in the total score was low (table 1). Table 1 Analysis of the differences in the PISQ-12 score per item basis P Value

PISQ-12

PISQ-12 score

Summary questions:

Before pregnancy (mean, SD)

After delivery (mean, SD)

1. Frequency of sexual desire 2. Frequency of climax when having sexual intercourse 3. Frequency of feeling excited when having sexual activity 4. Satisfaction with the variety of sexual activities 5. Feeling pain during sexual intercourse 6. Urine incontinence with sexual activity 7. Restriction of sexual activity because incontinence 8. Avoid sexual intercourse because of bulging in the vagina 9. Negative emotional reactions 10. Problem with erections that affects sexual activity 11. Problem with premature ejaculation 12. Intensity of orgasm now compared with the past

1.41±0.63 0.91±0.82

1.85±0.76 1.04±0.96

0.000 0.004

0.47±0.69

0.71±0.86

0.000

0.66±0.69

0.83±0.87

0.000

0.71±0.74

1.10±0.99

0,000

0.08±0.31

0.14±0.43

0.027

0.01±0.13

0.02±0.14

0.76

0.03±0.26

0.06±0.34

0.123

0.15±0.43

0.24±0.57

0.003

0.07±0.27

0.08±0.31

0.38

0.19±0.52

0.17±0.48

0.36

1.94±0.61

2.11±0.72

0.000

We also evaluated the individual changes in the PISQ-12 score. The value after delivery was the same in 56 (17.3%) women. In 73 (22.6%) women there was a decreased value, indicating improvement in sexual function. The remaining 194 (60.1%) cases had a higher score reflecting deterioration in sexual function. Taking into account the mode of delivery (caesarean section vs. vaginal delivery) the distribution of the individual changes in the PISQ-12 score

was similar (it was the same in 15.8% vs. 17.5%, p=0.78; it improved in 26.3% vs. 22.1%, p=0.56; it worsened in 57.9% vs. 60.4%; p=0.77). Finally, we evaluated the PISQ-12 questionnaire per item basis, and we observed significative differences in the behavioural emotive factor questions and also in some of the physical aspects as the feeling of pain in sexual intercourse and urine incontinence with sexual activity. The results are show in Table 1. Conclusions The sexual function after first delivery measured with a specific questionnaire get worse in more than 60% of primiparous women. There are no differences taking into account the mode of delivery. It appears that changes in behavioural emotive, feeling pain during intercourse and urine incontinence are the principal causes. References 1. Int Urogynecol J 2003;14:164–68 2. Actas Urol Esp 2008; 32(2): 211–19 79 Female sexual dysfunction is not associated with urogenital symptoms van der Vaart H, Wegewijs M, Roovers J University Medical Center Utrecht, Netherlands Industry Support: No Objective The objective of this study is to inestigate whether there is an association between urogenital symptom severity and female sexual dysfunction (FSD). Background Female sexual dysfunction is believed to be positively associated with urogenital symptoms. However, sexual functioning is dependent on many other factors beside urogenital symptoms. If the influence of these (potential confounding) factors is not accounted for, information on an association between FSD and urogenital symptoms might be biased. Methods In a prospective study 112 consecutive women visiting our outpatient urogynaecology clinic were invited to participate. They filled out a questionnaire consisting of demographic and personal characteristics, the Female Sexual Functioning Index (FSFI) and the Urogenital and Defecatory Distress Inventory (UDI and DDI). The latter two are used to score the presence and severity of several bladder and bowel dysfunction symptoms on a scale from 0 - 100, and are validated in the authors country. A higher score indicates more bother. The UDI consists of the incontinence, overactive bladder, obstructive micturition, pain and genital prolapse scale. The DDI scores symptoms and

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bother on constipation, obstructive defecation, pain with bowel movement and incontinence domains. The FSFI uses a cut-off score of less then 26.55 on a scale from 0 - 36 for the diagnosis of FSD. Results Half of the women (56) participating were classified as having FSD. The table shows the results of the factors that were significantly associated with FSD in univariate analyses. After multivariate analyses it was shown that only being postmenopausal remained significantly associated with FSD. Table Univariate and multivariate analysis for sexual dysfunction

Age Pelvic organ prolapse ≥ stage 2 Smoking Postmenopausal status UDI obstructive micturition UDI prolapse DDI constipation DDI obstructive defecation DDI pain

Univariate analyses OR (95% CI)

Multivariate analyses OR (95% CI)

p-value

1.08 (1.03–1.12) 2.2 (1.0–4.8)

0.98 (0.91–1.07) 1.4 (0.4–4.4)

0.90 0.60

0.3 (0.1–1.0) 6.1 (2.7–13.9)

0.2 (0.1–0.9) 8.8 (1.7–44.6)

0.05 0.00

1.01 (0.99–1.03)

1.00 (0.99–1.05)

0.06

1.01 (0.99–1.03) 1.02 (0.99–1.04) 1.02 (0.99–1.04)

1.00 (1.00–1.02) 0.99 (0.96–1.03) 1.00 (0.96–1.04)

0.26 0.72 0.99

1.03 (0.99–1.05

1.03 (0.98–1.07)

0.22

Conclusions The prevalence of FSD in our study equals that found in other studies, both in studies focusing on women with urogenital symptoms as well as in general population studies. Taking other factors into account, urogenital symptoms appeared not to be an independent risk factor for FSD. The presence of FSD was most dependent on being postmenopausal. 80 Pelvic Floor and Prolapse Assessment [PAPA]- A year after Childbirth Srivastava R, Thakar R, Sultan A Mayday University Hospital, United Kingdom Industry Support: No Objective: To prospectively evaluate the effects of pregnancy and childbirth on the pelvic floor and prolapse stage a year after childbirth.

Background: Pregnancy and childbirth have been incriminated as major aetiological factors of pelvic floor dysfunction and prolapse1. However there is lack of prospective data using validated objective measures. Methods: From April 2005 to July 2006 pregnant women were invited to participate in the study. They were evaluated four time points: 22 and 36 weeks (antepartum), 14 weeks and 12 months postpartum. The outcomes measures weresymptom scores (Sheffield prolapse questionnaire), Pelvic Organ Prolapse Quantification (ICS Staging system), pelvic floor strength (Oxford scale), bladder neck mobility (vector analysis on transperineal scan) and vaginal pressure measures at rest and squeeze (ECL-ELITE perineometer). Statistical comparisons between the different time intervals were made using the Wilcoxon’s signed rank and the paired t-test. Results: A total of 179 women (96 primiparous, 83 multiparous) were followed up at year following childbirth. Symptoms relating to stress urinary incontinence and associated Quality of Life (QoL) were significantly higher at 22 weeks, but significantly lower scores were obtained at 14 weeks and 1 year postpartum. The prolapse symptoms score (p=.000) and QoL (p=.000) were significantly higher at 1 year compared to 22 weeks. While no woman had greater than stage 2 prolapse at any of the four time points, the overall POP-Q stage was highest at 14 weeks postnatal which remained significantly high at 1 year compared to the antenatal period (Table 1). Table 1 POP-Q Stage distribution POP-Q Stage

22 weeks Antepartum n (%)

14 weeks postpartum n (%)

1 year postpartum n (%)

Significance**

0 1 2

126 (32.2) 209(53.5) 56 (14.3)

21 (7.7) 166 (61) 85 (31.3)

50 (28.6) 86 (49.1) 39 (22.3)

p=.031 (1 year vs 22 weeks) p=.000 (1 year vs 14 weeks)

Although there was down-staging of prolapse at 1 year when compared to 14 weeks postpartum (22.3% vs. 31.3% stage 2) it remained higher than at 22 weeks. The pelvic floor strength did not show any significant difference through pregnancy, childbirth and 1 year postpartum. Bladder neck mobility on vector analysis was seen to increase progressively through pregnancy and childbirth and was significantly higher 1 year compared to 22 weeks and 14 weeks. Perineometer measures of vaginal pressures at rest and squeeze was significantly worse at 14 weeks compared to 22 weeks and 1 year postpartum. At 1 year the

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resting and squeeze pressures was however comparable to the 22 weeks (Table 2).Further subanalysis of obstetric variables including mode of delivery will be available for presentation. Table 2 Bladder neck mobility and Perineometer pressures Outcome Measure

22 weeks antepartum) Mean (SD)

14 weeks postpartum Mean (SD)

1 year Significance postpartum (2-tailed) Mean (SD)

Bladder neck 1.032 (.55) mobility

1.0753 (.53) 1.204 (.46) p=.000 (1 year vs 22 weeks) p=.002 (1 year vs 14 weeks) Perineometer 46.06 (8.50) 40.00 (8.23) 44.79 p=.233 resting (12.01) (1 year vs pressure 22 weeks) p=.000 (1 year vs 14 weeks) Perineometer 59.77 54.20 58.73 p=.347 squeeze (11.29) (12.44) (12.66) (1 year vs pressure 22 weeks) p=.005 (1 year vs. 14 weeks)

Conclusions: This is the first prospective study evaluating the long-term impact of pregnancy and childbirth on the pelvic floor function and prolapse status. These findings suggest that childbirth has a persistent effect on the pelvic floor in terms of symptoms, prolapse and increased bladder neck mobility at one year following childbirth. The pelvic floor however seems to be most vulnerable immediately after childbirth with weaker pressures but improves to pre-delivery levels a year later. The proportion of stage 2 prolapse on the POP-Q was also highest at 14 weeks postpartum with some downstaging a year later but not attaining pre-delivery status. Attention needs to be directed towards protecting the pelvic floor during childbirth by identifying risk factors and implementing strategies to minimise disruption to pelvic floor function. References 1.Pregnancy, labor, delivery and pelvic organ prolapse. Obstet Gynecol 2002; 100:981–86. 81 Female sexual function 2 years after first delivery - an analysis of a telephone survey Geiss I, Hinterholzer S, Dungl A, Riss P LandesKliniKum Thermenregion Moedling, Austria

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Industry Support: No Objective: The purpose of this survey was to investigate the effect of a first delivery on female sexual function after 2 years. Background: The literature primarily addresses effects of pregnancy and childbirth on resumption of intercourse and dyspareunia. There are only few data available about the impact on desire, arousal, orgasmic function and frequency of sexual activities. Most of the studies investigate the postpartum period up to six months.1 We wanted to focus on long term changes in sexual function according to the international classification of female sexual dysfunction (FSD).2 Methods: We performed a one step telephone survey two years after first delivery. Inclusion citeria were defined as primiparous women two years after their delivery irrespective of the mode of delivery. Exclusion criterium were difficulties in understanding the German language. Demographical and delivery data (such as mode of delivery, tear or episiotomy and the newborns APGAR, birth weight and gender) were abstracted from our perinatal database. Institutional review board approval and informed patient consent were obtained. Telephone interviews were done by two female investigators. If we missed a patient, we tried to call her again. After calling a patient twice without reaching her, we stopped further contacts. At the beginning of each telephone interview the female doctor introduced herself to the patient and asked for her consent to proceed with the questions. The women were asked about the time of the first sexual intercourse after labour and about their actual sexual function 2 years after the childbirth. We collected data about frequency of sexual activities, desire, arousal, pain and orgasmic function. Breast feeding and contraceptives were assessed as well as if the patient lived in the same household with a partner. At the end the patient had to evaluate her overall satisfaction about her actual sexual life and about her sex life prior to pregnancy. We asked the patient to scale her overall satisfaction with the actual sex life from 1(excellent) to 5 (poor). Results: The survey included 210 patients. The mean age was 27.8 years (range 18 and 43). The duration of the telephone interviews was about 5.3 minutes (range 2 to 17). We talked to 87 patients (41%), 123 patients (59%) could not be reached. The reasons for these problems were: incorrect telephone numbers in 67 cases (32%), and inability to reach the patients after 2 attempts in 56 cases (27%). 4 patients declined to answer the questions on the phone.

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2 patients asked for examination and personal contact. One of those two women wanted to have a medical consultation together with her husband. Desire, arousal, orgasmic function and dyspareunia were described as similar to that prior to pregnancy. 11 patients (13%) reported improvement of genital sensation or intensity of orgasm. Approximately 23% of the women complained about dyspareunia. Our question about the change in frequency of sexual activities showed a quite clear result - 76% reported a decrease of sexual contacts, compared to the time before pregnancy. The overall satisfaction 2 years after the first delivery was 2.3 on our 1 (excellent) to 5 (poor) scale, slightly less than the satisfaction reported by the patients before pregnancy (2.0). Conclusion: Overall women were satisfied with their sexuality 2 years after a first delivery. A number of women reported improvement of genital sensation and intensity of orgasm. The frequency of sexual activities decreased in 76% of patients. Literature 1. Conolly AM, Thorp J, Pahel L. Effects of pregnancy and childbirth on postpartum sexual function: a longitudinal prospective study. Int Urogynecol J (2005) 16:263–267 2. Basson R. et al. Report of the international consensus development conference on female sexual dysfunction: definitions and classifications. J Urology, March 2000, Vol. 163, 888–893 95 The effect of vaginal childbirth on levator hiatal dimensions Shek K, Dietz H University of Sydney, Australia Industry Support: No Aims: The aim of our study was to determine changes in levator hiatal dimensions after childbirth. Background: Vaginal delivery is a risk factor for pelvic organ prolapse. This may be mediated by trauma to the insertion of the puborectalis muscle found after vaginal childbirth. Pelvic organ descent has also been found to be significantly correlated with hiatal area at rest and on Valsalva in nulliparous women with an intact levator muscle. It seems reasonable to hypothesize that changes in levator hiatal dimensions after vaginal childbirth may be an aetiological factor in the development of female pelvic organ prolapse, even if there is no obvious macroscopic trauma to the muscle.

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Methods: 296 nulliparous women carrying an uncomplicated singleton pregnancy were seen at 36–38 weeks’ gestation and again 3–6 months postpartum. They underwent an interview and 4D translabial ultrasound after voiding, in the supine position. Hiatal diameters, circumference and area were measured at rest, on maximal Valsalva and pelvic floor muscle contraction (PFMC). To determine muscle strain, we measured the bony part of the hiatus. Muscle strain on Valsalva and PFMC were calculated as previously described. Delivery data were collected from the hospital database.

Figure Antepartum and postpartum ultrasound images (single slice axial planes in the plane of minimal hiatal dimensions) of a patient with left sided avulsion after Forceps delivery. The hiatal area on maximum 2 Valsalva at 38 weeks (on the left, image A) was 15.6 cm . It was 2 measured at 29.3 cm at 4 months postpartum (image B)

Results: Mean age was 25.8 (17.7 to 40) years at first presentation. Mean BMI was 30.7 (19.2 to 52.3). Of 296 women, 208 (70%) returned for a postnatal assessment after normal vaginal delivery (n=99, 48%), vacuum or forceps (n=31, 15%) and Caesarean Section (n=78, 38%). After Caesarean Section the hiatal area was reduced from 20.9 to 18.9 cm2 (P=0.003). After vaginal delivery there was a 7% increase in hiatal area on Valsalva from 21.1 to 22.6 cm2 (P=0.019). After vaginal delivery with avulsion injury (which occurred in 20% of women delivered vaginally), there was approximately a 25% increase in hiatal area on Valsalva from 20.5 to 25.6 cm2 (P=0.003). In cases with avulsion injury, hiatal area on PFMC also increased significantly (P=0.001), and strain on PFMC was reduced by about half (P=0.008). Conclusions: Vaginal childbirth results in enlargement of the levator hiatus. The minimal hiatal area on Valsalva appears to be be significantly increased 3–6 months after vaginal childbirth, especially if the puborectalis muscle is avulsed from the pelvic sidewall. Traumatic overdistension of the puborectalis muscle after vaginal delivery may be another mechanism leading to enlargement of the levator hiatus and pelvic organ prolapse, but numerically it is probably of lesser importance compared to avulsion injury.

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96 Pelvic floor muscle training in the prevention and treatment of urinary incontinence in women - what is the evidence? A systematic review. Brostrom S, Lose G Department of Obstetrics and Gynecology, Glostrup Hospital, Copenhagen, Denmark Industry Support: No Objective Pelvic floor muscle training (PFMT) is advocated as a firstline low-risk intervention to prevent and treat female urinary incontinence (UI). Time, effort and costs are invested, and PFMT should be continually assessed as new evidence emerges. Our aim was to update the literature search to include recent evidence, including the use of PFMT in the prevention of UI. Methods The PUBMED and Cochrane databases were searched up to 31 December 2007 using the term “urinary incontinence” in combination with either of these: “prevention”, “therapy”, “rehabilitation”, “pelvic [floor] [muscle] training”, “Kegel”, “pelvic [floor] exercises”, “conservative therapy” and “physiotherapy”. Studies were included if they used random or quasi-random allocation of participants to PFMT and either no treatment, placebo/sham treatment or comparison treatment (e.g. routine care). Primary outcomes were tabulated, but if possible rates of continence after treatment, i.e. cure rates (objective and subjective, where available) were calculated, and relative risks (RR), with 95% confidence intervals (CI), for cure after PFMT were calculated. For preventive peripartum PFMT, cure was defined as the absence of UI at follow up. Formal metaanalysis was not attempted. Results We identified nine studies with 5026 randomized participants to compare peripartum PFMT to routine care for the prevention of UI, and 31 studies with 3348 randomized patients comparing PFMT to no treatment, to placebo/sham treatment, to routine care or to other active therapy for UI. Two large studies of 1169 and 1800 women contributed heavily to the evidence on peripartum PFMT, while studies on PFMT to treat established UI were quite small with a median population size of 50 (range 18–747). Only four studies described an a priori power calculation, and with the many quite small studies it was not possible to ascertain if the evidence is sufficient to answer the relevant questions on the clinical role of PFMT. Only two studies used patient blinding (sham stimulation) and only a third of the studies reported blinded outcome assessment. Some of the studies reporting the largest treatment effect could be biased by the lack of blinding. The external validity of several studies is

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reduced by the failure to use intention-to-treat analysis. Various modalities of PFMT were employed - from a single verbal instruction to 12 weeks of twice-weekly visits with a physiotherapist using bio-feedback - making it near impossible to draw any global conclusions on PFMT. Few studies applied objective measures of cure (e.g. pad test). Conclusions The evidence indicates a lack of clinically relevant efficacy of peripartum PFMT on lower urinary tract function. The evidence on the role of PFMT in established UI is inconclusive, as indicated by the studies of PFMT compared to no/sham treatment or routine care providing objective measures of cure. Focusing on subjective cure, the evidence is also equivocal. There is a paucity of data on the effect of PFMT on quality of life, though the available data are not convincingly in favor of PFMT. One study provides a good estimate of the immediate objective response to be expected after PFMT in established UI, showing a median decrease of incontinence episodes during PFMT of 34.7%, while the median decrease of sham treatment was 28.9% (1). Other studies demonstrated a similar modest immediate inherent efficacy of PFMT roughly one less leak per two days - comparable to the modest efficacy of pharmaceutical treatments of SUI and overactive bladder syndrome when compared with a drug placebo (2–3). All but two studies on PFMT in established UI assessed outcomes at the end of the treatment period, thus in effect only estimating the immediate treatment response to PFMT. Of considerably more clinical relevance is the long term efficacy of PFMT, and here the evidence is scant. A critical reappraisal of PFMT is needed, and judgments on the place of PFMT in current clinical practice should be reserved until further evidence has unequivocally demonstrated a clinically relevant efficacy. It is important to counsel patients on realistic expectations when suggesting PFMT, and - given the poor cure rates, the natural progression of disease, and the available surgical alternatives in SUI - it is important to schedule appropriate follow-up so the patient can be offered more effective treatment, if PFMT fails. References 1/ JAMA 2003; 290: 345–52. 2/ JAMA 2002; 288: 2293–9. 3/ J Urol 2005; 173: 1647–53. 97 Persistent anal sphincter defects after primary repair of Obstetric Anal Sphincter Injuries (OASIS) - Does it affect quality of life? Sultan A, Roos A, Thakar R Mayday University Hospital, United Kingdom

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Industry Support: No Objective To establish the effect of persistent internal anal sphincter (IAS) and/or external anal sphincter (EAS) defects on symptoms, manometry and quality of life (QoL) following primary repair of OASIS. Background OASIS are a major contributory factor in the development of anal incontinence in women. Despite a primary repair up to 61% continue to suffer from anal incontinence. A previous study of 56 women who sustained OASIS has shown that the presence of a combined defect of the IAS and EAS is significantly related to bowel symptoms 6 to 8 weeks post partum (1). Furthermore an association between IAS defects and severe symptoms of fecal incontinence has been demonstrated (2). However the effect of persistent IAS and/or EAS defects on QoL has not been studied. Methods All women who sustained OASIS and attended the perineal clinic (including tertiary referrals) between 2002 and 2007 were included. As part of protocol all women completed the Manchester Health Questionnaire (MHQ) and had anorectal manometry and endoanal ultrasound performed. The MHQ allows for scoring bowel related symptoms and its effect on QoL. For analysis subjects were divided into 4 groups: an intact anal sphincter complex, an IAS defect alone, an EAS defect alone or a combined IAS/EAS defect. Statistical analysis was performed using Mann Whitney U test and Chi Square or Fisher’s Exact test when applicable. Odds ratios (OR) were reported with 95% confidence interval. A p-value <.05 was considered significant. Results Of 516 women, 429 (83%) had an intact anal sphincter complex, 49 (10%) an isolated IAS defect, 17 (3%) an EAS defect and 21 (4%) a combined IAS/EAS defect on endoanal ultrasound. Mean follow-up was 10.6 (SD 9.5) weeks after delivery, mean age and parity was 30 (SD 5.4) years and 1.3 (SD 0.55) respectively. Compared to intact sphincters, combined defects were significantly associated with a higher risk of incontinence of liquid stool, OR 4.30 (1.33 - 13.86) (p.028). Isolated IAS or EAS defects were not associated with incontinence of liquid stool when compared to an intact sphincter. Other symptoms of anal incontinence were not significantly different (Table 1). The QoL domains Social Limitations (p.034), Emotions (p.045) and Severity Measures (p.040) were significantly more affected in the IAS defect group compared to no defect. Mean scores in the isolated EAS and combined anal

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sphincter defect groups were not significantly different from an intact sphincter complex. The mean maximum resting pressure (MRP) was significantly lower in the IAS alone (p.02) and combined defect group (p<.001) compared to no defect. IAS alone, EAS alone and combined defects were all associated with a significantly lower mean maximum squeeze pressure (MSP) compared to an intact sphincter. Anal length was significantly shorter in the IAS defect (p.002) and the combined defect group (p 0.017), when compared to no defect (Table 2).

Fecal urgency Flatus Liquid stool Solid stool

No defect (n=429)

IAS alone (n=49)

EAS alone (n=17)

IAS+EAS (n=21)

130 (31) 88 (21) 22 (5) 10 (2)

21 (43) 8 (16) 4 (8) 0 (0)

3 3 0 0

4 8 4 1

(18) (18) (0) (0)

(20) (38) (19) (5)

Table 1 Patients [n (%)] with symptoms as per endoanal scan finding

Table 2 Mean anal sphincter pressures in mmHg and anal length in mm

Mean MRP Mean MSP Anal length

No defect (n=430)

IAS alone (n=50)

EAS alone (n=17)

IAS + EAS (n=21)

51.9 86.9 26.1

47.5 78.6 23.4

47.4 67.1 26.2

38.2 65.5 22.7

Conclusions Although a persistent combined IAS/EAS defect is associated with symptoms of anal incontinence and decreased anal sphincter pressures and length, impaired QoL was only associated with isolated IAS defects. It is therefore important to identify the full extent of injury at delivery in women who sustain OASIS, paying particular attention to the repair of the IAS. This is of extreme importance as it is very difficult to repair IAS as a secondary procedure when women present with fecal incontinence. References 1: Am J Obstet Gynecol (2005) 193; 530–6. 2: Am J Obstet Gynaecol (2007) 196; 217.e1–217.e5. 98 Relationship between anorectal symptoms and investigation findings, in women with third degree perineal tears. Al-Salihi S, Lim J, Sloane K, Mills V, Carey M The Royal Women’s Hospital in Melbourne, Australia

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Industry Support: No Objective: We aimed to explore the relationship between anorectal symptoms and the results of anorectal investigations (endoanal ultrasonography and manometry), as well as surgical repair methods in women whom had recently sustained a third degree perineal tear. Background: Anal incontinence occurs in 4% of women following childbirth and is usually the result of anal sphincter muscle damage and/or nerve injury. There appears to be an inconsistent relationship between the presence of anal sphincter muscle defects (by endoanal ultrasound) and lower bowel symptoms which may be explained by other pathophysiological factors such as nerve injury, tissue damage and rectal prolapse. Methods: Fifty-five consecutive women with third degree perineal tears referred to a dedicated perineal clinic in a tertiary referral hospital were assessed. All patients were assessed clinically and screened for the presence lower bowel symptoms using the Cleveland Clinic Continence Score (CCCS) within 12 months of delivery. Endorectal ultrasound and manometry studies were also performed, and a chart review was undertaken to determine the method (end to end or overlapping) and type of suture material used to repair the anal sphincter. The relationship between CCCS, and manometry findings as well as the presence and size of any anal sphincter defects were assessed. We compared the type of suture material used as well as method of anal sphincter repair with the residual anal sphincter defect size on ultrasound, and also compared the method of repair with CCCS and manometry findings. Results: Mean age was 29.8 years (SD of 6.4) and parity 1.2 (SD of 0.44). The mean follow up period was 6.4 months (SD of 2.4). The mode of delivery was reported as a normal vaginal delivery in 51% of subjects; ventouse delivery in 24%; and forceps delivery in 25%. Suture material used to repair the anal sphincter included: PDS (45%), Vicryl or Dexon (30%), and other types of suture material (25%). An end-to-end repair of the anal sphincter muscle was recorded for 44% of subjects, an overlapping repair for 27%, and the type of repair was not specified in 29%. There was a statistically significant correlation between CCCS and resting and squeeze pressures on manometry (linear regression model; p=0.007) (figures1 & 2). However, there was no correlation between CCCS and presence, or size of anal sphincter defects (p=0.4), nor was there a correlation between the method of anal sphincter repair and CCCS (p=0.22), or presence or size of anal sphincter defects (p=0.43). No correlation between the type of suture used and the defect size on ultrasound was found (p=0.220).

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Conclusion: Our results demonstrated a significant correlation between abnormal anorectal symptoms (using CCCS) and anorectal manometry in women with a recently sustained third degree perineal tear. We were unable to demonstrate any correlation between anorectal symptoms and the presence of any residual anal sphincter muscle defect on endoanal ultrasound, or any differences in terms of abnormal anorectal symptoms and the method of anal sphincter repair. These results are suggestive of a multi-factorial pathophysiological process leading to abnormal lower bowel symptoms following deliveries complicated by a third degree tear.

Figure 1 CCCS relation to resting pressure

Figure 2 CCCS relation to squeeze pressure

99 Do Bladder Pain Syndrome/Interstitial Cystitis (BPS/ IC) treatments positively influence the disturbed sexual response system of female patients? Lazar D1, Pflüger H2 1 Dept. of Urology, Hanuschkrankenhaus, Austria, 2Dept. of Urology, Community Hospital Hietzing, Austria

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Industry Support: No Objective: To assess the effects of BPS/IC on the sexual response system of female patients and the possible improvement of symptoms of sexual dysfunction through various paths of treatments Background: In our pilot study of 2005 with 20 female Austrian BPS/IC patients, using the IFSF (Index of Female Sexual Function) and the Sexual Stress Scale, we were able to show that sexual dysfunction was significantly higher than in healthy controls. As influences of social variables or treatment efficacy are not measured with these instruments further research was a desideratum. Methods The Sexological Questionnaire for Chronic Disease (SQCD) focussing on the influence of chronic disease on all aspects of sexual functioning and relationship issues and including a variety of demographic data, was used for this purpose. The questionnaire was extended by us by introducing time levels before and after outbreak of the disease and after medical treatments. The end version of altogether 137 items was placed on the websites of German and British self help groups for about a year. Separate questions on diagnosis and types of treatment of the syndrome were added. Results 78 German and 37 English patients responded and were compared with 87 age matched healthy controls. The age of patients ranged from 72 to 17 years, with a median age of 44 years. While no significant differences existed between patients before the outbreak of the disease and their age matched controls, female sexual dysfunctions rose significantly in all categories with hypoactive sexual desire order on top. Sexual activities with partners decreased while masturbation practices remained constant and more satisfactory. However, relationships with partners are not more unstable than in the healthy controls. The disease was mainly diagnosed by urologists (72.97% UK, 70.13% Germany), with an average time of 6 years between outbreak of disease and correct diagnosis. Sixteen different types of treatments were offered for choice. Regular bladder instillations belong to the most common treatments (48.7% UK, 50.7% Germany). The use of analgesics is significantly higher (64.9%) in the UK, compared to Germany (49.4%). Psychotherapy is more common in Germany (20.8%) than in the UK (8.1%). On the whole, the treatments have not significantly contributed to an improvement of the sexual well being of the patients. Conclusions The outbreak of BPS/IC seriously affects all aspects of sexual functions in female patients. Paths of treatment to

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ease BPS/IC vary to some degree in the UK and Germany but have not led to significant improvement of the sexual disorders in either country. 100 Outcome of primary repair of Obstetric Anal Sphincter Injuries (OASIS) - Does the grade of tear matter? Roos A, Thakar R, Sultan A Mayday University Hospital, United Kingdom Industry Support: No Objective To assess risk factors and outcome of different grades of OASIS after primary repair and its effect on symptoms and quality of life (QoL). Background OASIS is divided into four grades with increasing extent of sphincter damage: Grade 3a<50% external anal sphincter (EAS) thickness torn; 3b>50% EAS thickness torn; 3c= EAS and internal anal sphincter (IAS) torn; 4th degree=3rd degree + torn anorectal epithelium (1). It is shown that after 14 years of follow up the extent of sphincter damage is an independent risk factor for the development of fecal incontinence (2). At short term follow up subjects with fourth-degree tears were significantly more likely to report new bowel symptoms compared to those with third-degree tears, possibly secondary to higher rates of persistent defects of the anal sphincter complex (3). Methods Between 2002 and 2007 all women seen at follow up after primary repair of OASIS were asked to complete the Manchester Health Questionnaire (MHQ), which scores the presence of bowel problems and its effect on QoL, and had anorectal manometry and endoanal ultrasound done. Risk factors for OASIS known from literature were analysed to identify a relationship with the grade of tear by using univariate and multivariate logistic regression. Categorical variables were analysed using Chi Square test or Fisher’s Exact test and continuous variables by Mann Whitney U test. Odds ratios (OR) were reported with 95% confidence interval (CI). A p-value <0.05 was considered significant. Results Of 487 women, mean time of follow-up 9.6 (SD 6.0) weeks and mean age 30 (SD 5.4) years, 205 (42%) sustained a 3a tear, 198 (41%) a 3b tear and 84 (17%) a 3c/4th degree tear. There was no difference in symptoms between subjects with a 3a and 3b tear. Therefore analysis was performed combining grade 3a and 3b (minor tears) and grade 3c and 4 (major tears). Subjects with a major tear had a higher risk of leakage of loose stool compared to subjects with a minor

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tear, OR 2.61 (1.31 - 5.21). The results as per grade of tear are shown in Table 1. Comparing mean QoL domain scores showed no difference between a 3a and 3b tear, but the QoL domains Role Limitations (p 0.029), Physical Limitations (p 0.046) and Severity Measures (p 0.017) were significantly more affected in the major tear group compared to a minor tear. A significantly lower mean maximum resting (MRP) and squeeze pressure (MSP) was seen with increasing grade of tear (Table 2). Compared to a minor tear, subjects with a major tear had a significantly lower MRP (p<0.001) and MSP (p<0.001).

References 1: RCOG Guideline No 29; July 2001 2: Acta Obstet Gynecol Scand (2001) 80; 830–834. 3: Am J Obstet Gynecol (2005)193; 530–6. 101 Dyspareunia treatment with botulinum toxin A Hurt K1, Halaska M2, Sottner O2, Vojtech J 1 OBGYN clinic Radotin Prague, Czech Republic, 2 OBGYN clinic Teaching Hospital, Charles University Prague, Czech Republic Industry Support: No

Table 1 Symptoms per grade of tear [n (%)]

Fecal urgency Flatus incontinence Loose stool Solid stool

3a (n=205)

3b (n=198)

3c/4 (n=84)

60 (30) 37 (18) 8 (4) 4 (2)

53 (27) 38 (19) 8 (4) 2 (1)

32 (38) 22 (26) 8 (10) 3 (4)

Table 2 Mean anal canal pressures in mmHg

Mean MRP Mean MSP

3a (n=205)

3b (n=198)

minor tear (n=403)

major tear (n=84)

54.47 90.77

49.69 82.32

52.12 86.61

45.19 76.19

With increasing grade of tear significantly more IAS defects were seen on scan. Four percent of women with a 3a tear, 11% with a 3b tear and 39% with a 3c/4th degree tear had a persistent IAS defect. The risk of developing a persistent IAS defect was higher with a major tear compared to a minor tear, OR 7.72 (4.36–13.67). EAS defects were significantly more common in subjects with a 3b or 3c/ 4th degree tear compared to those with a 3a tear. Two percent of women with a 3a tear, 11% with a 3b tear and 11% of women with 3c/4th degree tear had a persistent EAS defect. There was no difference between minor and major tears. Epidural use appeared to be the only independent factor predicting a major tear compared to a minor tear, OR 2.57 (1.14 - 5.80) in women using epidural analgesia compared to those who were not. Conclusions After primary repair for OASIS a 3c/4th degree tear has a poorer outcome than a 3a/3b tear, in terms of symptoms of fecal incontinence, QoL and anal sphincter pressure which could be due to a higher risk of persistent defects in the IAS. Interestingly, compared to a minor tear, the single independent factor associated with a major tear was epidural use.

Objectives: Dyspareunia is a symptom of multiple and varied disease states and may have multiple causes with components of both organic and psychiatric dysfunction. Dyspareunia is known as a recurrent or persistent genital pain, associated with sexual intercourse in either a male or a female. In women, it is generally defined as genital pain occurring with penetration or during or after intercourse but not exclusively vaginismus (a common type of insertional dyspareunia caused by intense involuntary contraction of the perineal muscles surrounding the outer one third of the vagina). So called true dyspareunia is recurrent and associated with a disruption of normal functioning. The disturbance causes marked distress or interpersonal difficulty. It is not always necessary to know the cause of dyspareunia if there is not obvious organic reason. Relaxation exercises may help a woman regain control over vaginal muscles, reducing pain and making sexual intercourse more pleasurable. In our group of patients we followed improvement of dyspareunia after the administration of botulinum toxin type A (DYSPORT) injected into the levator ani muscles, into the perineum and adjacent rectovaginal septum. We extended our group of patients and follow up for the period of more than two years. Material and Methods: 45 women, aged 25–48 years, were treated for dyspareunia. We observed parity, history of deliveries, state of perineum after the delivery, frequency of intercourse and character of pain. They were treated with 40 units of (DYSPORT) injected into the puborectalis and pubococcygeus muscles, perineum and adjacent rectovaginal septum. They were compared with a group of 50 women with the similar problems, but using only common treatment methods like exercises and common painkiller administrations. 8 punctures were performed, every with 5 units of botulotoxin A. We followed up the patients one week after the administration and every two months until the period of two years. We evaluated an individual response to a drug administration. Results: Rapid improvement of disorders in the above mentioned group had been proven on a P<0.001 level

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using Logistic Regression statistical evaluation method. Only one patient with vaginism was lost to follow up and ten required additional dosis of 40 units four, eight and twelve months after the first administration separately. Conclusion: Botulinum toxin A injected into the pelvic muscles, perineum and rectovaginal septum in relative low doses induces long lasting reduction of dyspareunia and improvement of life comparing to controls using classical methods for lowering their disorders. Keywords:Botulinum toxin; dyspareunia; vulvodynia; pelvic pain; pelvic floor; vulva/pathology; female;pain

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Posterior Compartment/ Coloproctology/ Surgical Complications

quality rather than rectocele (see Table). However, there was a significant association between stool quality and rectocele depth (r=0.276, P=0.006) suggesting that stool quality influences functional anatomy. Stool quality was not a confounder of the relationship between true rectocele and symptoms when tested by regression analysis.

(82–87), (102–108) 82 Rectocele or stool quality: What matters more for obstructed defecation? Dietz H University of Sydney, Australia

Table The relationship between symptoms of obstructed defecation and prolapse on the one hand and anatomical findings/ stool quality on the other hand. X2 test for categorical variables, 2- sample t-test for continuous variables. RC = rectocele Symptom

Clinical RC

Rectal descent

True RC

Stool Form

Freq. straining (30%) Chr. constipation (23%) Vag. digitation (15%) Incpl. emptying (35%) Vaginal lump (43%)

n.s. n.s. n.s. n.s. P=0.003

n.s. n.s. n.s. n.s. P=0.014

n.s. n.s. P=0.009 n.s. n.s.

P<0.001 P<0.001 n.s. P=0.014 n.s.

Industry Support: No Objective: This prospective observational study was designed to investigate the role of stool quality on symptoms commonly associated with rectocele, that is, symptoms of obstructed defecation and prolapse. Background: Rectocele is a common condition seen in patients presenting with symptoms of prolapse and/or obstructed defecation. True rectocele, that is, pocketing of the anterior vaginal wall due to a defect of the rectovaginal septum, is thought to be associated with symptoms of obstructed defecation. However, there are many women who present with a true rectocele and are completely asymptomatic for bowel dysfunction. Methods: This was a prospective observational study. Two hundred and forty- two women were assessed in a tertiary urogynaecological unit. History taking included questions regarding chronic constipation, incomplete bowel emptying, straining at stool and vaginal digitation, as well as symptoms of prolapse. Stool quality was assessed by the patients themselves, using the Bristol Stool Form Scale. Translabial ultrasound for the diagnosis of rectocele was performed using a variety of commercial 2D and 3D capable equipment. Findings were rated as positive for a true rectocele if a discontinuity was identified in the anterior rectal wall on Valsalva maneuver, resulting in a diverticulum of the anterior vaginal wall measuring 10 mm or more in depth (‘true rectocele’. Results: The 242 women had a mean age of 53 (17–85) years. 86% were vaginally parous. Presenting symptoms were stress incontinence (72%), urge incontinence (60%), and symptoms of prolapse (43%). Bowel symptoms were reported as given in the table which also shows the association between symptoms on the one hand and stool quality and presence/ depth of a rectocele on the other hand. Median stool quality was 4 (1–7), and 97 women (40%) were found to have a true rectocele. Vaginal digitation was the only symptom significantly associated with true rectocele. The other symptoms of obstructed defecation queried in this study were associated with stool

Conclusions: Stool quality seems to be of greater relevance in the aetiology of symptoms of obstructed defecation than the presence of a rectocele. This was true even when using imaging criteria for a true rectocele rather than just surface anatomy. The presence of a true rectocele was significantly associated only with vaginal digitation, while stool quality was associated with straining at stool, chronic constipation and incomplete emptying. Our findings imply that successful rectocele repair should not be expected to alleviate symptoms of obstructed defecation, with the exception of vaginal digitation. Straining at stool and chronic constipation clearly do not constitute an indication for rectocele repair. 83 Early Experience with Mesh Excision for Adverse Outcomes after Transvaginal Mesh Placement Using Mesh Prolapse Kits Ridgeway B1, Walters M1, Paraiso M1, Barber M1, McAchran S2, Goldman H2 1 Cleveland Clinic Department of Obstetrics, Gynecology, and Women’s Health Institute, United States, 2Cleveland Clinic Glickman Urological and Kidney Institute, United States Industry Support: No (n/a) Objective: To determine the indications, types of complications, and postoperative outcomes in patients choosing to undergo removal of vaginal mesh previously placed with a mesh kit for the treatment of pelvic organ prolapse. Background: Despite the relative paucity of data, there has been increased adoption of pre-packaged minimally inva-

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sive procedural kits for the vaginal placement of mesh or graft to correct pelvic organ prolapse. Insertion involves the blind passage of trocars through small perineal incisions into the obturator foramen and ischiorectal fossa to facilitate placement of mesh or graft. Since most of these procedural kits have been recently introduced, current data on complications, efficacy, and long-term outcomes are limited. During the last 36 months, our institution has cared for a number of patients with significant mesh-related complications following transvaginal placement of mesh with some mesh prolapse kits. After attempts of conservative management, these patients required extensive mesh excision to treat their symptoms. Methods: The electronic medical record was reviewed for all patients who underwent surgical excision of transvaginal mesh from January 1, 2005 to October 1, 2007 at a tertiary care medical center. Patients were identified by searching the medical record using ICD-9 codes (57295 revision or removal of prosthetic vaginal graft [vaginal approach] and 57296 revision or removal of prosthetic vaginal graft [abdominal approach]) and by searching staff physician operative case logs. At time of last follow up, patients reported degree of pain using a 10 point scale, level of improvement, sexual activity, and continued symptoms. Results: Nineteen patients were identified as having undergone mesh excision during the study time period. The mean age (±SD) was 59.6 (±10.9) years, the median (range) parity was 3 (1–7), and 84% had undergone previous hysterectomy. All patients except for two (89%) had undergone either anterior or total Prolift® and only three patients (16%) sought surgical care from the physician who originally placed the transvaginal mesh. The indication for removal was chronic pain (32%), dyspareunia (32%), recurrent pelvic organ prolapse (42%), mesh erosion (63%), and vesicovaginal fistula (16%), with most patients (84%) citing more than one reason. The median latency to presentation for treatment was 17 (0–96) weeks, while the median latency to surgical intervention was 38 (10–103) weeks. Fifty-eight percent underwent additional surgery to correct recurrent pelvic organ prolapse at the time of mesh excision. The surgical approach was vaginal in 79% of cases, while 16% used a combined vaginal and laparoscopic approach, and 5% used a combined vaginal and abdominal approach. The median (range) estimated blood loss was 175 (25–400) mL, the median postoperative length of stay was 2 (0–3) days and there were no major intraoperative complications. Post-operatively, one patient developed a rectovaginal hematoma that required a blood transfusion, three patients suffered from urinary tract infections, and one patient required readmission for diarrhea. Fifteen patients (79%) were available for followup. Median follow-up time was 31 (4–75) weeks. Patients reported a median pain score of 0 (0–8), with 87%

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reporting improvement of their initial complication. All but one patient stated they would undergo mesh excision again and 87% stated that, knowing what they now know, they would not have transvaginal mesh placed. After mesh excision, no patient complained of significant vaginal bleeding or discharge, but 20% complained of a bulge or something falling in the vaginal area and only 33% were sexually active. Conclusions: Indications for removal of vaginal mesh include chronic pain, dyspareunia, recurrent prolapse, and mesh erosion. Mesh removal appears to be safe with a low complication rate and high relief of symptoms, though some symptoms can persist. 84 The registration and reporting of operative complications caused by medical devices for incontinence and POP surgery in Denmark Sorensen H, Sander P, Lose G Dept. of Gynecology and Obstetrics, Glostrup University Hospital, Denmark, Denmark Industry Support: No Objectives: To get an overview of which medical devices for incontinence and pelvic organic prolapse (POP) surgery are currently on the Danish marked, and how the medical companies and the authorities are managing operative complications. Background: During the recent years many new medical devices for urine incontinence- and pelvic organic prolapse (POP) surgery have been introduced on the Danish marked. The legislation follows the EU-directives, and medical device need only CE-approval before launching. This means that new products can be introduced without clinical data. The Danish National Board of Health (DNBH) and the Danish Medicines Agency (DMA) have no registration of CElicensed medical devices for incontinence and POP surgery. Methods: Data was collected by telephone interview between September 2007 and January 2008. A standardized questionnaire was used, with questions about 1) which devices and duration since launching in Denmark, 2) how did the companies collect information about operative complications, 3) did the companies receive information about operative complications and 4) did the companies report operative complications to the authorities. Before calling, the manufacturers/distributors received an information letter requesting an interview with a key-account person, working specific with medical devices for incontinence and POP surgery. The DNBH and the DMA were contacted by mail and telephone asking for reports on complications.

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Results: 10 manufacturers/distributors are currently on the Danish marked. All the interviews were conducted, nine by telephone, one oral interview. 1) Currently on the Danish marked are nine different slings for incontinence surgery, six different bulking agents and twelve meshes for POP surgery (three biological, nine synthetic). The devices had been marketed in Denmark from one month to fifteen years. 2) 40% of the manufacturers/distributors had an incident report following the medical devise, of which three had informed the surgeons to use it in case of complications. All claimed having trained their sales staff to ask the buyers/surgeons for complications or problems regarding their products, when revisiting the departments, in order to collect information of complications. 3) 60% of the manufactures/distributors had received information about complications. 4) In case of complications 90% of the manufacturers/ distributors claimed, that the surgeon was responsible for reporting to the authorities. 80% of the manufacturers/distributors reported, they would report complications to the DMA and 50% to the DNBH, if they received information of lack of report from the surgeon. All complications were registered in a company database. All companies had an individual procedure in registration and reporting complications, all reporting further back to head organization waiting for specific instructions. The DNBH had no information available on reported complications. The DMA had over a period from January 2001 to October 2007 received four reports of minor complications, all from one company regarding one product. The DMA has the formal responsibility of collecting reports about complications, and to do follow up. Conclusions: The Danish Medical Agency has the formal responsibility to collect, register and act on complications. However, hardly anything is reported to DMA. The surgeons and the companies do not seem to report complications systematically. Consequently there is no surveillance system on medical devices, once they are launched, even though medical devices can be marketed without clinical data. This is inappropriate. 85 Retrospective Analysis of Patients with TVT/ TVT-O Complicated by Tape Erosion Sharifa S, Han H, Lee L, Tseng A KK Women’s & Children’s Hospital, Singapore Industry Support: No

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Objective: The aim of this study was to analyse the complications and management of patients with Tension-free vaginal Tape (TVT)/ Tension-free Vaginal Tape-Obturator (TVT-O) tape erosion. Background: Tenson-free vaginal Tape (TVT)/ Tension-free Vaginal Tape-Obturator (TVT-O) are minimal invasive surgical procedures and the main anti-incontinence treatment procedures worldwide. The surgical procedure involves the placement of a tension-free, synthetic polypropylene mesh in the mid-urethral region of patients. The biological properties of each synthetic mesh clearly influence the erosion rate with large pore polypropylene mesh considered to have the most reliable tissue biocompatibility. The rates of vaginal and urethral erosion associated with TVT and TVT-O mesh are 0.7% and 1.8% respectively. This study was an internal audit of patients at our centre who underwent TVT/ TVT-O surgical procedures with tape erosion. With the findings in this study, the surgeon would gain a clearer understanding of the risk factors causing mesh erosion. In addition, the presenting symptoms, treatment and prognosis of tape erosion in this group of patients could also be analysed. Methods: This is a retrospective review of all patients with vaginal tape erosion after Gynecare®TVT/ Gynecare ®TVT-O system “inside-out” between January 2001 and December 2005. Nine hundred and thirty eight women diagnosed with urodynamic stress urinary incontinence underwent TVT/ TVT-O operations (TVT: 690, TVT-O: 248). Post-operatively, all patients were followed up at 1 week, 1 month, 6 months, 1 year and then at yearly intervals for up to 5 years. Urodynamic study was conducted at 6 months after surgery. Peri-operative and post-operative data for the patients were analysed and all subsequent medical and surgical interventions were recorded. Results: A total of 17 (1.8%) patients experienced vaginal tape erosion after their TVT/ TVT-O operations during the study period. Fourteen (2%) patients had TVT erosion and 3 (1.2%) patients had TVT-O erosion. Most patients (14 patients-82%) were asymptomatic and erosion was diagnosed by vaginal examination during follow up visits. Three (18%) patients complained of dyspareunia and in 2 of the patients the spouses complained of irritation to their penis during intercourse. Tape erosion was lateral to the urethra (in vaginal sulcus) either on the left or right side in 15 patients. Midline erosion under the urethra was diagnosed in 2 cases and cystoscopy was done to exclude urethral erosion. Erosions less than 5 mm in size were treated with local estrogen or the eroded tape was excised. Nine patients (53%) were treated initially with topical

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vaginal estrogen as pessary or cream for 6 to 8 weeks. Two of them had complete resolution of the erosion and no further management was required., However no improvement was registered for 7 patients with local estrogen. When the erosion size was less than 5 mm and easily visualised it was excised. Erosions more than 5 mm in size were excised in day surgery (OR) under general anaesthesia. Vaginal flaps were mobilised and the vaginal walls were closed for 8 patients. With the exception of one (defaulted follow-up), all patients had complete resolution. Two of them reported mild recurrent stress incontinence after the removal of the TVT tape. Six patients were taken to OR for further management. One patient had bladder erosion and another reported minimal asymptomatic erosion. One patient defaulted follow-up and the remaining 3 patients had the eroded part of the tape removed and vaginal skin was mobilised and closed. Conclusions: Vaginal tape erosion after TVT/ TVT-O is an uncommon and minor complication. Tape erosion management is a relatively simple process that should result in a favourable outcome for the patients. References: J. Urol. 2004; 171(2): 762–764 J. Urol. 2002; 168(1): 144–146 BJU Int. 2004; 94(1): 110–113 86 Posterior sacrospinous ligament fixation using the CapioTM needle driver. An anatomical study. de Tayrac R1, Cayrac M1, Ouazid I2, Prudhomme M1, Costa P1, Delmas V2 1 Caremeau University Hospital, France, 2Bichat University Hospital, France Industry Support: Yes (Investigator initiated, partial funding) Objective: To study anatomical risks after posterior sacrospinous ligament fixation using the CapioTM needle driver (Boston Scientific). Background: Posterior sacrospinous ligament fixation is an effective treatment of uterine or vaginal vault prolapse by vaginal route. The procedure should be simplified using a specific needle driver in order to reduce dissection. Currently, there is no data on anatomical position of the fixation. Methods: A simplified bilateral posterior sacrospinous ligament fixation was performed on six fresh cadavers using the CapioTM needle driver. Cadavers were installed in gynecologic position. Posterior sacrospinous ligament fixations were performed after a posterior vaginal wall incision on the midline and a simplified dissection of both pararectal fossae. Therefore, we have performed a postero-lateral pelvic side wall dissection, after open pelvic surgery and organs removal.

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Results: Eleven sacrospinous ligaments (SSL) were available for analysis. Mean length (+/-SD) of SSL was 51.0 +/9.2 mm and mean width at the level of fixation (+/-SD) was 23.5 +/-5.7 mm. No rectal injury was observed. Fixations were in the SSL in all cases, but reached the deeper part of the SSL in 5/11 cases (45%). Mean distance between fixation and ischial spine was 21.6 mm (range 13 to 30). Mean distance between fixation and pudendal nerve and sciatic nerve were 16.1 mm (range 4 to 32) and 16.5 mm (range 2 to 27), respectively. No difference was observed between right and left side. Conclusions: Posterior sacrospinous ligament fixation using the CapioTM needle driver seems to be reproducible with low anatomical risks. However, the fixation should be at least at 20 mm medially to the ischial spine in order to reduce neurological risks. 87 Does the constipation questionnaire from the Rome III Criteria demonstrate test-retest reliability? Kundi N, Panayi D, Fernando R, Rameez M, Khullar V, Imperial Healthcare NHS Trust, United Kingdom Industry Support: No Objective The aim of our study is to assess the reliability of the constipation questionnaire based on the Rome III Criteria. Background Subjective questionnaires are central to the diagnosis and treatment of many functional disorders and are widely used in urogynaecology and colorectal practice. The Rome III Criteria are the latest evidence based diagnostic tool for functional disorders which replaced the previous Rome II Criteria1. Different studies show a wide range of prevalence rates of constipation2. The Rome Criteria are considered as the gold standard diagnostic tool for functional bowel disorders. However, the reliability and validity of the Rome III Criteria has not been tested. Methods Women attending general gynecology, urogynaecology and colorectal outpatient clinics of a tertiary referral hospital were prospectively studied. The Women were asked to complete the constipation questionnaire derived from the Rome III Criteria. This was a multiple choice questionnaire which consisted of 17 questions. Responses ranged from “never/rarely”, through “sometimes” and “often”, “most of the time” to “always” except for question 1 where the question was “in the last 3 months how often did you have discomfort or pain anywhere in your abdomen?” which had 6 possible responses ranging between “never” to “every day”. Questions 2, 3 and 16 included responses with “yes” or “no”. After the women completed the questionnaire in clinic

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they were given a copy of the questionnaire with a prepaid envelope and asked to complete it after at least 2 weeks. Results Sixty three women returned and correctly completed the repeat questionnaire. From this sample of patients, 6/63 (10%) of patients were diagnosed as having constipation from the 1st questionnaire, 5/6 (83%) of these patients were identified using the repeat questionnaire. 57/63 (91%) of patients were not diagnosed with constipation in the 1st questionnaire, repeating the questionnaire 55/57 (97%) of these patients were not constipated in the 2nd questionnaire. The relationship between the women’s answers to each individual question in the 1st and repeat questionnaire was assessed using the Mann Whitney and Wilcoxon Test. We found that answers to Q1, 2, 3, 7 and 17 for the studied patient group were significantly related between the two questionnaires (P>0.05 indicating that the groups do not differ with respect to the test variables). Six out of seventeen questions (33%) were significantly related. 1st Questionnaire

Repeat Questionnaire

Question

Mean answer

Question

Mean answer

Mann Whitney U test

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

5.00 1.74 1.56 2.10 1.92 1.64 2.23 1.64 1.54 1.77 1.87 1.97 1.62 1.49 1.54 1.31 2.28

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

1.59 0.91 0.50 1.10 1.20 0.87 1.31 1.00 0.66 0.90 0.94 1.17 1.00 0.94 0.98 0.50 1.16

0.085 0.138 0.252 0.008* 0.007* 0.000* 0.676 0.000* 0.000* 0.000* 0.000* 0.000* 0.000* 0.022 0.000* 0.000* 0.604

Table 1 Mean scores for each question of the constipation questionnaire comparing the first and repeat questionnaire. Lack of significance indicates the scores were not different between the 2 questionnaires (P>0.05=no sig difference between2 variables)

The inter-rater reproducibility of patients’ responses from the 1st questionnaire to the repeat questionnaire was assessed. The Cronbach’s alpha score was 0.861 (p>0.05). Conclusion There was a statistically significant inter-rater reproducibility of the Rome III constipation questionnaire showing

good reproducibility. However, review of the individual questions is required as we demonstrated poor relationships between the 1st and 2nd questionnaires. References 1. Neurogastroenterol Motil 2007; 19: 783–6. 2. Am J Gastroenterol. 2001 Nov;96(11):3130–7. 102 Removing the cervix at hysterectomy - an unnecessary intervention? Thakar R1, Ayers S1, Srivastava R1, Manyonda I2 1 Mayday Universitry Hospital, United Kingdom 2 St George’s Hospital and Medical School, United Kingdom Industry Support: No (Investigator initiated, no external funding) Objective: The aim of this study was to prospectively evaluate the long-term effects of total abdominal hysterectomy (TAH) and subtotal abdominal hysterectomy (STAH) on bladder, bowel and sexual function, pelvic organ prolapse, psychological status and quality of life (QoL). Background: An enduring debate in the late 1980’s and the 1990’s was whether subtotal hysterectomy might confer advantages over the total procedure with regard to sexual, urinary and bowel function, since the former entails minimal neuroanatomical disruption. A recent Cochrane review1 found no evidence of any difference between total and subtotal hysterectomy on sexual, urinary and bowel function on short-term follow-up. Methods: 279 women who participated in a previously published2, randomised, double-blind, multicentre trial comparing TAH and STAH were invited to complete questionnaires used in the previous study to assess urinary, bowel and sexual function, psychological function (General Health Questionnaire-28) and QoL (Short Form-36 questionnaire). Pelvic organ prolapse was assessed using the validated International Continence Society Pelvic Organ Prolapse Quantification system. Data analysis was undertaken using SPSS V11. Data screening indicated that many variables were skewed. Therefore nonparametric statistics were used to examine differences between groups (Chi Square for categorical data, Mann Whitney for remaining variables). Longitudinal analyses of group differences and changes over time, controlling for confounding variables where necessary, were carried out using ANCOVA if parametric assumptions were fulfilled. Where assumptions were violated, variables were dichotomised and examined using Chi square.

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Results: 179 women completed the long-term follow-up, which comprised 64% of the original sample. Ninety women in the TAH group and 89 in the STAH group were followed up at a mean of 9?1 years. Both groups were equally matched for age, weight and parity. Table 1, Table 2 and Table 3 show urinary, bowel and sexual function nine years after STAH and TAH. There were no significant differences in quality of life and psychological function between the two groups. Two women in the STAH group were found to have cervical prolapse. None had cervical cancer. Table 1 Urinary function

Stress incontinence Urgency Frequency of micturition Nocturia Strain to void Poor stream Incomplete emptying Urge incontinence Feelings of prolapse Prolapse – stage 1 - stage 2

STAH n (%)

TAH n (%)

53(59.6%) 56(63.6%) 20(26.7%)

50(56.2%) 50(58.1%) 23(29.9%)

χ2 =0.20 χ2 =0.55 χ2 =0.19

p=.76 p=.53 p=.72

09(10.7%) 15 (17%) 12(13.6%) 27 (31%) 35(40.7%) 10(12.8%) 32(49%) 0 4(6.2%)

19(23.2%) 16(18.4%) 13(14.9%) 34(39.5%) 34(39.5%) 9 (11.4%) 31 (50%) 06 (9.7%)

χ2 =4.59 χ2 =0.05 χ2 =0.06 χ2 =1.36 χ2 =0.02 χ2 =0.07

p=.03 p=.84 p=.83 p=.26 p=1.0 p=.81

χ2 =0.64

p=.72

χ2 =1.01 χ2 =0.31 χ2 =3.41 χ2 =0.13 χ2 =0.38 χ2 =0.05 χ2 =0.29

p=.407 p=.662 p=.102 p=.814 p=.571 p=1.0 p=1.0

Table 2 Bowel function STAH n (%) TAH n (%) Constipation Strain to empty bowels Digitation Use of laxatives Urgency of stools Incontinence of flatus Incontinence of stools

16 (20%) 13(15.3%) 04 (5.1%) 09(10.5%) 15(17.4%) 04 (5.1%) 01 (1.2%)

12(14.1%) 11(12.4%) 11(13.6%) 11(12.2%) 19(21.1%) 05 (6%) 02 (2.4%)

Table 3 Sexual function STAH TAH Mean (SD) Mean (SD) Frequency of intercourse Reduced intercourse Sexual desire Strength of desire Initiation of intercourse Attaining orgasm Multiple orgasm

2.19 (0.95) 1.89 (0.80)

U=1952.5

p=.04

1.68 (0.66) 1.59 (0.69)

U=2313.5

p=.54

2.94 (1.37) 2.89 (1.27) 3.06 (1.03) 3.33 (1.08)

U=1977.5 U=2186.5

p=.28 p=.48

2.06 (0.7)

U=2032

p=.71

Ease of orgasm Relationship with partner Deep dyspareunia Superficial dyspareunia Vaginal lubrication

2.77 (0.63) 2.59 (0.78) 1.45 (0.65) 1.30 (0.55)

U=2106 U=2055.5

p=.50 p=.50

14 (20.3%) 20 (31.3%) χ2 =2.10 df 1, p=.16 11 (15.7%) 13 (20.3%) χ2 =0.48 df 1, p=.50 43 (62.3%) 34 (53.1%) χ2 =1.15 df 1, p=.29

Urinary and bowel function variables did not change significantly over time for women in both groups. Compared to before surgery women in the STAH and TAH group reported various changes in sexual function. A significant decrease in frequency of intercourse (p<.001), frequency of sexual desire (p<.001), ease of attaining orgasm (p<.001) and strength of desire (p=.006) was noted. Analyses examining whether reduced sexual function was due to age revealed that being older was only associated with less frequent orgasms (Pearsons r -.23, p=.009). Similar analyses of the effect of bilateral salpingo-oophorectomy (BSO) found that women who had a BSO reported less frequent intercourse (U=1855, p=.019), less sexual desire (U=1497, p=.002), less initiation of intercourse (U=1682.5, p=.046), less orgasms (U=1616, p=.005), and less strength of sexual desire (U=1598.5, p=001). Conclusions: This is the largest randomised study with the longest followup to date demonstrating no major differences in urinary, bowel, sexual function, quality of life and psychological function between women who had TAH and STAH. Women who have a subtotal hysterectomy are not at increased risk of pelvic organ prolapse or cervical cancer. This suggests that the cervix does not need to be routinely removed at hysterectomy unless it is the patient’s choice. References 1. Total versus subtotal hysterectomy for benign gynaecological conditions. Cochrane database of Systematic Reviews 2006. Issue 2. 2. Outcomes after total and subtotal hysterectomy New Engl J Med 2002:347;1318–1325. 103 The evalution of rectoceles in terms of anatomy, pathophysiology, symptoms and surgical success Sivaslioglu A Etlik Women’s Health and Maternity Teaching Research Hospital, Turkey Industry Support: No

1.96 (0.79)

2.98 (0.82) 2.70 (0.99) U=2077 1.89 (0.91) 1367 (0.85) U=2061.5

p=.45 p=.57

Objective: The aim of the study was to clarify the true incidence of isolated rectocele and the relationship between symptoms and posterior compartment defects.

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Background: One hundred consecutive patients who were operated for the posterior compartment defect have been evaluated in terms of anatomy during surgical procedure. The posterior vaginal wall incised in full thickness starting from the posterior fornix reaching to the internal hymenal ring just above the posterior fourchette. The rectovaginal fascia was dissected off from the rectum and the fascia was left over the incised vaginal flaps. The fixation points of rectovaginal fascia and the defects on the fascia were evaluated. Methods: The correlation between anatomic findings and symptoms were investigated. The study has compared pre and postoperative symptoms. The mean duration of follow up was 14 months. Results: Isolated rectocele (a defect in the rectovaginal fascia and rectal bulging through this defect towards posterior vaginal wall) was only noticed in 7 patients (7%). The rest of the study population (n=93) had a tearing off rectovaginal fascia from uterosacral ligament(s) and the torn fascia aggregated just over the lower rectum, moreover, intestinal bulging was seen in all cases. Nocturia was the commonest symptom in patients who had a torn fascia and the prevalence was 80%. Nocturia was not observed in patients who had isolated rectocele. After the posterior compartment surgery nocturia was treated in 90 cases (%95). Conclusions: Nocturia should be regarded as the main symptom of vaginal posterior compartment defects. The rectovaginal fascia has detached from its upper fixation points (uterosacral ligaments, posterior cervix) in most of the cases who had posterior compartment defect. Isolated rectocele is so unusual. 104 Vulvodynia evaluation by oximetry Hurt K1, Halaska M2, Driak D2, Sottner O2, 1 OBGYN clinic Radotin Prague, Czech Republic, 2OBGYN clinic Teaching Hospital, Charles University Prague, Industry Support: No Objectives: Vulvodynia, although believed in the past to be uncommon, is now recognized as a fairly frequent syndrome. Data from a population-based study funded by the National Institutes of Health (NIH) found that 15.7% of women reported lower genital tract discomfort persisting 3 months or longer. Vulvodynia is defined as a chronic vulvar burning, stinging, rawness, soreness, or pain in the absence of objective clinical or laboratory findings to explain these symptoms.

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Vulvodynia is divided into 2 classes: vulvar vestibulitis syndrome is vestibule-restricted burning/pain and is elicited by touch; dysesthetic vulvodynia is burning/pain not limited to the vestibule and may occur without touch/pressure. Standard therapy includes treating neuropathic pain. Additional therapies include: pelvic floor rehabilitation combined with surface electromyography, interferon alfa, estrogen creams, and surgery. In our previous observations we proved significant correlation between lower oxygenation of perineum and vulvodynia symptoms in a small group of patients. We wanted to investigate whether optical measurement of tissue oxygen saturation in the perineum of affected woman differs to that free of any problems if we include larger amount of data of suffering patients. Hypoxia is significantly detrimental to the synthesis of the collagen and the differentiation of fibroblasts, and therefore quality of perineal tissue. Material and Methods: 25 women, aged 28–55 years with objective vulvodynia and a minimum 2-year history of chronic pelvic disorders were observed. We measured their perineum oxygenation in the area of posterior labial commisure with an optical infrared pulse gadget. Controls, free of any problems had been measured under the same conditions. Further data like amount of deliveries, and problems with intercourse were included in our study as well. Results: We evaluated the oxygenation of perineum our suffering patients via oximetry. We had compared the data with the group of controls including the other significant data. For the statistical evaluation we used the method of logistic regression. On a significancy of (P<0.01) we proved statistical important decrease of oxygenation of the perineal tissue between the group of affected women and the controls. Conclusion: Perineal tissue hypoxia can cause adverse formation of perineal collagen and thus influence adverse sensation of the whole perineal area. Outputs of this method could be widely used for diagnostics of perineal disorders. Keywords: oximetry; vulvodynia; dyspareunia; pelvic pain; pelvic floor; vulva/pathology; female;pain 105 Prognostic factors for erosion: Use of Prolene® mesh in pelvic floor surgery Rondini C, Wenzel C, Alvarez J, Morales A, Descouvieres C, Aros S Facultad de Medicina Clinica Almana-Universidad del Desarrollo, Chile Industry Support: No

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Objective: To evaluate factors that could allow the develop of vaginal erosions in patients who underwent a pelvic floor surgery in which a Prolene® mesh was used. Study design: A retrospective study was done in 867 patients who had a pelvic floor surgery with polipropilene mesh use. 712 (82.1%) underwent a transobturator tape (TOT) for stress urinary incontinence (SUI) and 155 patients (17.9%) with apical prolapse defined as a POP-Q stage > II went to one of three different apical techniques: 64 (7.4%) underwent an abdominal sacral colpopexy (ASCP), 63 (7.3%) a posterior intravaginal sling tape (IVS) technique and 28 (3.2%) a anterior or total Prolift like technique. Erosion rate was assessed. Erosion was defined as visualization of the mesh in vagina three months after surgery. In all patients, meshes were tailored in the operating room (OR) during surgery. The mesh used was a 30×30 cm. Prolene® mesh. Prognostic factors studied were age, parity, body mass index (BMI), status of the first surgeon (attending or resident), history of previous pelvic floor surgery and type of surgery (TOT, ASCP, IVS like or Prolift like). Chi-Square for categoric variables and T-Student for continuos ones were used at the univaried analysis. Finally, a multivaried analysis was done. Results: The mean follow up time in patients with and without erosion was 24.5 and 29.2 months respectively (p=0.08). The erosion rates according to the previously mentioned factors were as follows: Age (years): 53.6 vs. 56.5 (p=0.1); Parity: 3.6 vs. 3.7 (p= 0.6); BMI: 27.6 vs. 30 (p=0.02); Previous pelvic surgery: 3.5 vs. 4.9 (p=0.45); status of the first surgeon (attending or resident): 3.7 vs. 3.5 (p=0.89); The erosion rate for each surgery type was: TOT: 1.7%, ASCP: 1.6%, IVS like technique: 14.3% and Prolift like technique: 28.6%. The multivaried analyisis showed that only the type of surgery is statistically significant as a prognostic factor for erosion (P=0.01, CI95% 0.8–0.9). Conclusion: Our results show that the type of surgery was the only independent prognostic factor for erosion. Given it’s high rate, we strongly don’t recommend the use of Prolene® meshes tailored in OR in Prolift and IVS like techniques. 106 VAGINAL MESH CONTRACTION: DEFINITION, CLINICAL PRESENTATION AND MANAGEMENT Feiner B, Maher C Wesley Urogynaecology Unit, Wesley Hospital, Brisbane, QLD, Australia, Australia

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Industry Support: No Background: High recurrence rates following conventional prolapse surgeries have lead to the introduction of synthetic meshes into the field of pelvic reconstruction, aiming to reinforce the failing native tissue and achieve more favourable and lasting anatomical outcome. In the recent years, several mesh-based prolapse repair kits, consisting typically of a central mesh graft with extension arms, have been gaining popularity among Urogynaecologists and pelvic surgeons, by offering a minimally invasive approach. Yet, the tendency of these meshes to shrink by greater than 50%, once incorporated with the tissue(1), can result in mesh contraction, a unique complication which although causing much agony to patients and frustration to their doctors, has never been properly defined. Objective: In this case series we define, for the first time, the symptoms, physical findings and suggested management of vaginal mesh contraction. Methods: We present our data on 11 consecutive patients who have experienced mesh contraction following vaginal mesh kit procedures for pelvic organ prolapse. Results: All 11 patients underwent vaginal reconstructive surgeries employing synthetic meshes with extension arms. Six patients underwent an isolated anterior mesh procedure, one patient had an isolated posterior mesh, 2 patients had both anterior and posterior mesh placement and 2 underwent a total vaginal mesh procedure. The most common presenting symptom was persistent severe vaginal pain and/ or deep dyspareunia in those who were sexually active. The pain is worse with activity, especially walking. On pelvic examination there was always significant focal tenderness over a certain portion of the mesh, most commonly at the junction between the main graft and one or more of the extension arms, as well as along the arms. In all cases the involved mesh arm felt like a prominent contracted band. Accompanying findings in a proportion of patients were mesh erosion (4 cases) and vaginal shortening (Total Vaginal Length 5–6 cm) and tightening (2 cases). In our experience, conservative management including vaginal oestrogen therapy, pelvic floor exercises and vaginal dilators did not relieve the symptoms associated with mesh contraction. Although application of oestrogen cream/pessaries could improve the viability of the vaginal epithelium, especially in post-menopausal women, and might be of benefit in the managing minor mesh erosion, the majority of patients included in this series required a further surgical intervention under general anesthesia. Nine patients underwent mobilization of the mesh, division of the contracted arm from the main graft and partial excision of the arm or the contracted mesh. Mesh erosions were concomitantly oversewn with or without partial excision. Of the 6 patients that were reviewed following surgery, 3 had compete resolution of the symptoms, one kept complaining of deep vaginal pain although on

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examination the vagina was loose with no contracture or localized tenderness, and in two cases there was only a small reduction in the pain with the full length of the mesh (Total Vaginal Mesh) being tender to palpation. One of these patients underwent complete removal of the mesh followed by a dramatic symptomatic relief with the remaining patient having persisting pain and vaginal contracture. The remaining patients will be operated on in the coming weeks. Conclusion: Vaginal mesh contraction is a significant complication, especially among sexually active women. It is characterized by persistent vaginal pain and/or deep dyspareunia with localized tenderness on examination and often a palpable prominent band over the contracted mesh arm. Management involves division of the contracted arm from the main graft with partial excision of the mesh. In extreme cases a complete removal of the mesh maybe beneficial. Longer term follow-up is required to determine the outcome following surgical management and newer grafts with diminished contraction properties would minimise this serious complication. 1. Gauruder-Burmester A, Koutouzidou P, Rohne J, Gronewold M, Tunn R. Follow-up after polypropylene mesh repair of anterior and posterior compartments in patients with recurrent prolapse. International Urogynecology Journal And Pelvic Floor Dysfunction 2007;18(9):1059–1064. 107 The Rome III constipation questionnaire: a Delphic and unreliable tool in diagnosing constipation. DIGESU A, Kundi N, Panayi D, Lee R, Fernando R, Khullar V Urogynecology Department, St. Marys Hospital, Imperial College London, United Kingdom Industry Support: No (n/a) Objective: The aim of our study was to evaluate whether the constipation questionnaire based on the Rome III Criteria correctly identifies patients with constipation. Background: Constipation is a functional disorder comprising a wide range of distinct symptoms relating to bowel movement frequency, stool consistency and ease of defecation1. The reported prevalence of constipation in the Western countries varies between 2–34%2. Very few clinical rating scales for constipation have been assessed for sufficient psychometric properties to be an adequate diagnosing tool. The Rome Criterion is the most widely used tool for diagnosing functional bowel disorders including constipation3. It has continually evolved over the last 20 years through input from different organizations ending to the most recent version known as the Rome III diagnostic criteria.

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Accordingly to this criteria patients would be defined as constipated if they meet the following three criteria: defecating symptoms over a 3 month period, loose stools rarely present without the use of laxatives, insufficient criteria for irritable bowel syndrome (IBS). Although the use of constipation questionnaire based on the Rome III Criteria has been suggested, the validation of this questionnaire has never been published in the literature. Methods: Women attending general gynecology, urogynecology and colorectal outpatient clinics of a tertiary referral hospital were prospectively studied between February and March 2008. All women were studied using a completed history including bowel symptoms, a four days bladder and bowel diary and asked to fill in a self completion constipation questionnaire based on the Rome III Criteria whilst waiting prior to their appointment. Symptoms of constipation were defined accordingly to the patients’ perception of constipation. All women were consented and instructed how to complete the questionnaire. This multiple choice questionnaire included 17 questions. Responses ranged from “never/ rarely”, through “sometimes” and “often”, “most of the time” to “always” except for question 1 “in the last 3 months how often did you have discomfort or pain anywhere in your abdomen?” who have 6 possible responses ranging between “never” and “every day”. Questions 2, 3 and 16 included responses ranging from “yes” to “no”. Results: Two hundred and one women were studied. The mean age was 47 (range 18 - 88). Only 28% of women (56/201) reported to suffer from constipation. Out of these women 71% (40/56) have defecating symptoms over a 3 month period (criteria I), 44% (25/56) had loose stools rarely present without the use of laxatives (criteria II) and 44% (25/56) had insufficient criteria for irritable bowel syndrome (IBS) (criteria III). However only 8 of these women (14%) could be defined as constipated accordingly to the Rome III diagnostic Criteria. One hundred and forty-five women (72%) did not report symptoms of constipation. Out of these women 37% (53/ 145) have defecating symptoms over a 3 month period (criteria I), 45% (65/145) had loose stools rarely present without the use of laxatives (criteria II) and 24% (35/145) had insufficient criteria for irritable bowel syndrome (IBS) (criteria III). 9% of women (13/145) who do not reported symptom of constipation would be defined as constipated accordingly to the Rome III diagnostic Criteria. Conclusions: Our study showed that the constipation questionnaire based on the Rome III Criteria under diagnose this condition since up to 85% of women who report symptoms of constipation would not be defined as constipated based on these criteria. In the light of our results this questionnaire also seems to

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misdiagnose constipation since up to 10% of women who do not complain any bowel symptoms would be defined as constipated accordingly to these criteria. A standard unique definition for constipation is still missing and a simple, more reliable, easier to use clinical tool, with less strict criteria is needed. References: 1.Gastroenterology. 1982 Sep;83(3):529–34. 2.Am J Gastroenterol. 2001 Nov;96(11):3130–7. 3.Aliment Pharacology Therapy 2008 Apr;27(8):638–48 108 The Angle of Episiotomy Before and After Delivery: A Significant Change Kalis V, Karbanova J, Horak M, Lobovsky L, Kralickova M, Rokyta Z University Hospital Pilsen, Czech Republic Industry Support: No Objective: An angle of 40°–60° has been documented as fulfilling the criteria for the definition of mediolateral episiotomy (MLE). On the other hand, European survey revealed that the definition of MLE differs widely. Just recently some authors have been focusing on an exact placement of the cut on the perineum and have defined a localization of MLE by its beginning, direction, length, depth. Tincello used a pictorial questionnaire. Using four standard texts an angle of 40°-60° has been calculated as fulfilling the criteria for the definition of MLE. In Andrews’ trial, an angle of 40°-60° has also been selected as a reference point. The MLE parameters were measured in the lithotomy position immediately after episiotomy repair. Background: Because of the perineal distension due to the crowning head and oedema of perineal tissues, the stretched perineum is larger at the time of cutting the episiotomy than at the time of episiotomy repair (and any time after). To our knowledge, the real angle at which the episiotomy was cut has not been measured and recorded. Also, the exact timing of episiotomy has not been studied by any trial so far. The aim of this trial was to compare the angle of MLE at the time when the episiotomy is cut and the angle after its repair, also to assess the use of knowing the angle of MLE after repair, and to evaluate the documented lower limit of 40° for MLE. Methods: A cohort of 50 randomly allocated women undergoing their first vaginal delivery were asked to participate. All deliveries in the cohort were assisted by the same specialist registrar, who also performed and sutured all episiotomies and measured all studied parameters. All measurements were performed in the lithotomy position at the time immediately before cutting episiotomy, and after the episiotomy repair. Statistical analysis was

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processed by the statistical software CRAN 2.4.0. and STATISTICA 98Edition. Results. During this period 55 MLE were performed by a trained specialist registrar. No instrumental delivery was made in this cohort. 50 women signed a detailed informed consent and were included in this trial. There was a statistically significant difference between the angle of MLE at the time the episiotomy was cut (40°) and the after its repair (22.5°; p<.0001) throughout the cohort. The only significant parameter was the timing of MLE. Conclusion. During vaginal delivery, there are unbalanced loads exerted on the walls of birth canal which cause an asymmetric deformation of the birth canal and its surroundings. At the time of crowning, the region of the perineum is subjected to a significantly high three-dimensional deformation. After labour, the perineum deformation disappears due to the relaxation of the perineal tissues. The significant change in geometry of the perineal region causes the difference between the observed episiotomy angles at the time of crowning and after perineal repair. This small trial shows that the angle of episiotomy is significantly different at the time of cutting and after the repair. If MLE is cut at an angle of 40° at the time of crowning, the median angle between episiotomy and midline is 20° (the mean angle 21.3°) after the repair. None of the resulting angles of the 42 episiotomies performed at the time of the crowning was higher than 30° after repair, which was the mean angle in a cohort of third degree tears in a study by Eogan. The only group where the difference between angles is not so overt, is in women, whose episiotomy was performed before crowning of the perineum. However, this subgroup also reached statistical significance. It seems that the angle measured after repair can not currently be used in evaluating the placement of episiotomy cutting, thus in evaluating of pros and cons of MLE. The lower limit for the definition of MLE, defined as 40°, seems to be too acute an angle and a risk factor for anal sphincter injury. At the time of preliminary analysis, after the first 50 women, considering the clinical impact of placing an episiotomy in such close proximity to the anal sphincter, the authors decided to interrupt this study for ethical reasons.

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Basic Science/Epidemiology (139–145), (182–199) 139 THE IMPACT OF STANDARDIZED ORIFICES ON THE INTEGRATION AND RETRACTION OF POLYPROPYLENE MESHES: In vivo stereological analyses. Palma P, Cardia F, Riccetto C, Palma T Universidade de Campinas, Brazil Industry Support: No Introduction: The increased use of polypropylene meshes in reconstructive pelvic surgery has led to complications inherent to the use of synthetic materials, such as retraction, exposure and infection. We performed an in vivo experimental study aiming at evaluating the retraction of monofilament polypropylene meshes and improving its incorporation through standardized orifices of 5 mm in diameter. Method: In this study, we evaluated the morphology and volumetric density of collagen fibers in meshes with and without standardized orifices, as well as its retraction through radiographic and direct measurement of the meshes. The sample consisted of 15 female Wistar rats, which were sacrificed 90 days after the implant. The abdominal wall was removed and an x-ray was taken before its preparation for histological and stereological study. The volumetric density of the collagen fibers was calculated by stereological tool in three compartments: skin, Colles’ fascia and mesh, the latter located between the Colles’ fascia and the aponeurosis of the rectus abidominalis muscles. Results: There was no retraction of the polypropylene meshes, neither in the radiographic analysis nor in the direct measurements taken before and after the surgical implantation. The histological and stereological analysis disclosed organized collagen fiber deposition in the orifices and less inflammatory reaction than the control meshes with no orifices. Conclusions: There was no retraction of this type of mesh in either group. The histological and stereological results suggest that the standardized orifices facilitated tissue integration and may have clinical application.

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Faculty of Medicine and Health Sciences, UAE University, 4 Department of Biostatistics, Faculty of Medicine and Health Sciences, UAE University, 5Department of Physiology, Faculty of Medicine and Health Sciences, UAE University Industry Support: No (n/a) Objectives We studied the effect of human chorionic gonadotrophin [hCG] on the in-vitro detrusor muscle contractions in female rats. Background Pregnancy results in decreased urinary bladder contractility and therefore specific hormonal changes during pregnancy may be primarily responsible. The detrusor muscle and epithelium of the normal female urinary bladder contain low levels of functional hCG receptors. hCG antagonizes the action of oxytocin and prostaglandin in human and rat myometrium and induces relaxation of vascular smooth muscles in rats. We hypothesized a hitherto unknown biological role for hCG: an inhibitory effect on bladder contractility during pregnancy since this is a time of hCG dominance. Methods Two adjacent detrusor muscle strips from the bladder dome of 18 female Wistar rats (230–250gm) were mounted in organ bath for recording of isometric tension. Carbachol (10–9–10–3 M), alpha,beta methylene adenosine 5′-triphosphate [ATP] (10–9–10–3 M) and potassium chloride [KCl] (10–4–10–3 M) were applied (n=6X3 groups). Concentration-response curves, before and after addition of hCG (100 iu/ml) or oxybutynin (10–5 M) to either muscle strip, were compared. Results All curves were displaced to the right by hCG in a concentration-dependent manner with significant inhibition of contractions induced by carbachol (p<0.001) and KCl (p =0.016)- Figure 1. Estimated order of potency of inhibition was carbachol>KCl>alpha,beta-methylene ATP. The overall inhibitory effect of hCG was significantly less than oxybutynin (p<0.001). (a) 4000 before hCG

140 Effect of human chorionic gonadotrophin on detrusor contractions in rats. Rizk D1, Osman N2, Shafiullah M3, Nagelkerke N3, Fahim M5 1 Department of Obstetrics and Gynaecology, faculty of Medicine, Ain Shams University, Egypt, 2Department of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences, UAE University, 3Department of Pharmacology,

Active tension

3500

after hCG

3000 2500 2000 1500 1000 500 0 -5

2X-5

-4

2X-4

Carbachol (log molarity)

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Industry Support: No

(b) 4000 before OH

Active tension

3500

after OH

3000 2500 2000 1500 1000 500 0 -5

2X-5

-4

2X-4

-3

Carbachol (log molarity)

(a) 3500

Active tension

before hCG 3000

after hCG

2500 2000 1500 1000 500 0 -3

2X-3 3X-3 4X-3 5X-3 6X-3 7X-3 8X-3 9X-3

-4

KCl (log molarity)

(b) 3500

before OH

Active tension

3000

after OH

2500 2000 1500 1000 500 0 -3

2X-3 3X-3 4X-3 5X-3 6X-3 7X-3 8X-3 9X-3

-4

KCl (log molarity)

Conclusions hCG significantly inhibited in vitro detrusor contractions induced by depolarization (KCl) and cholinergic (carbachol), but not purinergic (alpha,beta-methylene ATP), stimulation in a dose-dependent manner in female rats. 141 OBSTETRIC FISTULAE IN SUDANESE WOMEN: SOCIAL and CULTURAL FACTORS ABUL GASIM M AZZA MEDICAL COMPANY, Sudan

OBJECTIVE: Reproductive health is a well-accepted barometer of the development milestone of a country. The Sudan has some of the poorest reproductive health indicators and is ranked as 139 out of 177 countries in the WHO Human Development Report. Whilst pursueing clinical and surgical research at the Abbo Fistula Hospital in Khartoum, Sudan, a full assessment of the social and cultural factors affecting the women with this condition was undertaken by the authors. The aim was to provide some pilot data to update national reproductive health databases, elucidate healthcare processes, and to provide a framework for social and psychological support in women undergoing restorative surgery. BACKGROUND: Data on obstetric fistula in Sudan is hard to obtain, because of the social stigma associated with his condition. Patients tend to avoid hospitals and social environs. The data to hand suggests that most women with obstetric fistula in Sudan hail from the western states, including Darfur. Darfur accounts for 20% of Sudan’s landmass and has a population of 6.7 million people. It is divided into 3 states, of which West Darfur has the highest fistula rate. It also has the poorest infrastructure, health service, and is currently within the civil war zone. METHODS: This is a prospective, hospital-based, nonrandomized study. 164 patients, awaiting surgery, were recruited from the Abbo Fistula Centre, the largest fistula centre in Sudan. Consent was taken from all patients. In the case of illiterate patients, verbal consent was taken and witnessed by an independent social worker. Those excluded from the study were those in who the fistulae were of a non-obstetric origin and who were not Sudanese. A standard questionnaire was used looking into the social, cultural, economic, and personal history of each patient. 40 variables including the background of the respondent, age at interview, age at marriage, use of health services, barriers to medical care, mobility, daily activites as well as marital and social relations were considered. RESULTS: The average age at interview was 26 years, with the majority originating from rural areas (particularly West Darfur) and having no formal education. Over 50% were married before the age of 18. Most patients have a low socio-economic status, with over 50% of patients having a monthly income of less than 100 USD. As a consequence of the fistula, the majority were divorced by the time they came to hospital. 54% were primiparous with little or no antenatal care. 25% had recieved medical care during their pregnancy. Almost 80% delivered at home, 18% delivered by forceps and 4% by caesarean section. The vast majority, 95%, had a stillbirth. The main barriers to access medical care were a long distance from a hospital facility, expensive travel costs, and conflict in the area. All social parameters

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were affected. Most patients did not participate in their community’s social activities. The main deleterious effects on their lives were psychological breakdown, social isolation and marital disharmony. None of the women in this study has access to any form of contraception. DISCUSSION: The main social and cultural determinats of developing an obstetric fistula in this study were rural living, poor education, malnutrition, early marriage, adolescent pregnancies, primiparity, lack of access to health care facilities with resultant poor obstetric outcome, and economic viablity. The authors feel that improving literacy and offering education to these women can raise the economic and social status for them, thus probably reducing the incidence of obstetric fistulae. Two-thirds of the patients came from Darfur, and this indicates that the Darfur crisis does have a serious impact on maternal morbidity and pregnancy outcome. Many patients who survived the ordeal of fistula and the associated childlessness continue to have major social and psychological problems. The root of all these problems remains poverty, which is a well-documented derminant of obstetric fistulae all over the world. CONCLUSIONS: It is imperative that health-care providers work with woman’s group at a local level, and the government at a national level, to raise awareness about the need for education, the risks of early marriage and adolescent pregnancies, and the need to for access to medical health care facilities (including the use of the partogram, which is still not widely used in Sudan). This will mean changing cultural ideals, improving access to education and access to health care faciltities. But, perhaps most importantly it maens they must provide the means for enabling the empowerment of the women themselves by any means necessary.

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142 Type I collagen and matrix metalloproteinase 9 gene polymorphisms in the p PIFAROTTI P, ANTONAZZO, CAZZANIGA G, TERZAGHI F, SOMIGLIANA E, BUONAGUIDI A INSTITUTE OF OBSTETRICS AND GYNECOLOGY II L. MANGIAGALLI, UNIVERSITY OF MILAN, Italy Industry Support: No Objective: to evaluate the frequency of the polymorphism in the Sp1 binding site in the first intron of one of the type I collagen genes COL1A1 and polymorphic site -1562 in the promoter region of the MMP-9 gene in patients with pelvic organ prolapse. Background: pelvic prolapse is a major health problem for women in the menopausal years. The etiology of genital prolapse is probably multifactorial. Traditional predisposing factors are thought to be advancing age, childbearing, obesity and menopause. Recent evidences suggest that pelvic organ prolapse has a genetic component. The importance of the genetic background is also suggested by the elevated prevalence of the disease in patients affected by disorders of type I and III collagen such as the EhlersDanlos and the Marfan syndromes. On the other hand, given the very low estimated incidence of these genetic disorders, the prevalence of the mutations underlying their development is basically irrelevant to explain the genetic predisposition to genitourinary prolapse. A role for one or more genes involved in collagen synthesis, stability and/or turnover is quite plausible in this regard. The supportive structures of the genitourinary region consists in a connective tissue whose main constituents are collagen, elastic fibers and proteoglycans. The mechanical stability of the genitourinary tract depends on intact, functional collagen

Figure 1 Measurement of the hiatal area on PFMC (left, 15.7 cm2), at rest (middle, 22.9 cm2) and on Valsalva (right,30.2 cm2) in a patient with right-sided avulsion

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fibers to support the bladder neck, urethra and pelvic organs. Moreover, continuous tissue remodelling makes the relationship between the production of collagen and its degradation critical to the maintenance of tensile strength. Collagen fibres are stabilized by intermolecular covalent crosslinks by pyridinoline. Their degradation depends on the activity of proteinases secreted from connective-tissue cells, including the matrix metalloproteinases (MMPs) and cathepsins. So far, various members of the MMP family have been identified in humans, some of which are capable of cleaving fibrillar collagen while others degrade the resulting denatured peptide. There are several reports in the literature suggesting a decreased collagen content in vescicovaginal fascia, abdominal skin and round ligament in the prolapse tissue compared with controls. In particular, prolapse was shown to be associated with a 25% loss of collagen in the tissue, whilst elastin content remained unchanged. This decrease in collagen was even more evident in women with urinary incontinence. Furthermore, the vaginal epithelium of women with prolapse showed a significant increase in collagenolytic activity, indicated by higher levels of MMP2 and MMP9. Methods: Between may 2004 and may 2007, one hundredtwenty four women with > stage II pelvic organ prolapse (POP group) were considered for the study. Ninety agematched women without pelvic pathologies were recruited at the menopause outpatient clinic to serve as controls. Inclusion criteria were age=80 years and caucasian race. Exclusion criteria were: previous hysterectomy or previous pelvic surgery for pelvic organ prolapse or stress urinary incontinence, and malignant conditions. The mean age of the patients was 61.8±11 years. The mean parity was 2.8± 1.1 and 2.2±1.0, respectively. The BMI was 20.6±1.6 in POP group and 22.7±1.2 in controls group. At enrolment blood samples were collected in sodium citrate from a peripheral vein and stored at -20°C. Genomic DNA was extracted with standard techniques. The polymorphism in the Sp1 binding site in the first intron of one of the type I collagen genes COL1A1 and polymorphic site -1562 in the promoter region of the MMP-9 gene were evaluated by polymerase chain reaction and restriction analysis. Results: table shows the prevalence of the polymorphisms COL1A1 and MMP-9 in POP and controls groups. There was no significant difference between women with and those without POP in the distribution of any of the genotypes evaluated. Moreover, we found an higher familiarity for pelvic organ prolapse in POP group than controls patients (POP: 43/124 (35%); Controls: 14/90 (16%); p<0.002; OR 2.9 (95%CI 1.5–5–7)).

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Genotype COL1A1

Controls (%)

POP(%)

G/G G/T T/T Genotype MMP-9 C/C C/T T/T

57 (64%) 27 (30%) 5 (6%)

67 (54%) 48 (39%) 9 (7%)

69 (77%) 19 (21%) 2 (2%)

91 (73%) 28 (23%) 5 (4%)

Conclusions: the polymorphism at the Sp1 binding site of the gene encoding alpha-1 chain of type 1 collagen and polymorphic site -1562 in the promoter region of the MMP9 gene are not associated with an increased risk of pelvic organ prolapse in women. Moreover the high familiarity suggests that genetic effects contribute to the occurrence of pelvic prolapse. 143 The effect of levator avulsion on hiatal dimension and function Abdool Z1, Shek C2, Dietz H2 1 Pretoria Academic Hospital, South Africa, 2Nepean Clinical School, Sydney, Australia Industry Support: No Objective: In this observational study we intended to define whether levator trauma is associated with abnormal hiatal biometry and/ or biomechanical properties of the muscle. Background: The levator ani muscle plays a major role in pelvic organ support. Significant levator trauma/damage as a result of vaginal childbirth can result in pelvic floor morbidity and likely is a factor in the aetiology of female pelvic organ prolapse. Methods: 414 patients underwent a physical examination and transperineal ultrasound in a tertiary urogynaecological unit. Imaging was performed with the patient supine and after bladder emptying. Datasets obtained at rest, on maximal Valsalva and on maximal pelvic floor muscle contraction (PFMC) were processed offline for hiatal diameters, area and circumference as well as strain (a component of elasticity) on PFM contraction and Valsalva. Results: Mean age was 55 years (range 19–89). 29 (7%) of 414 women were nulliparous, 49 (11.8%) were vaginally nulliparous. 43% described symptoms of prolapse, 67% of stress incontinence and 67% of urge incontinence. In 21.4% of parous women an avulsion was diagnosed, and in 8.6% it was bilateral. Levator trauma was strongly associated with increased coronal hiatal diameters at rest, on Valsalva and on contraction (all P<0.001), axial diameters on Valsalva and contraction, and increased hiatal area. The relative risk of ballooning (i.e., a hiatal area on Valsalva of >=25 cm2)

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was 3.5 (CI 1.7–6.5) in unilateral and 3.96 (CI 1.7- 9.2) in bilateral avulsion. Avulsion increased muscle distensibility (positive ‘strain’) on Valsalva by almost 50% (P<0.001). Negative ‘strain’ (muscle fibre shortening) on PFMC was reduced by more than 50%, but only in women with bilateral avulsion (P<0.001). Measure

Midsagittal hiatal diameter (rest) Coronal hiatal diameter (rest) Hiatal area (rest)

No avulsion

5.81 (0.84) 4.36 (0.59) 18.05 (4.8) Midsagittal hiatal 6.65 diameter (Valsalva) (1.11) Coronal hiatal diameter 5.14 (Valsalva) (0.86) Hiatal area (Valsalva) 25.83 (8.27) Midsagittal hiatal 4.63 (0.8) diameter (PFMC) Coronal hiatal 4.09 diameter (PFMC) (0.58) Hiatal area (PFMC) 14.63 (3.79) Strain (Valsalva %) 25.79 (22.086) Strain -16.58 (PFMC %) (10.7)

Unilateral avulsion

Bilateral P value avulsion

5.91 5.74 (0.73) (0.83) 4.61 4.97 (0.6) (0.7) 19.59 (4.37) 19.44 (4.27) 7.32 7.15 (0.98) (0.93) 5.82 6.39 (0.96) (0.89) 32.27 9.39 32.14 (6.95) 5.16 5.32 (0.78) (0.95) 4.37 4.89 (0.78) (0.69) 16.65 18.17 (5.07) (4.6) 37.25 37.73 (22.58) (18.33) -15.5 -7.97 (11.23) (13.52)

NS <0.001 0.048 <0.001 <0.001 <0.001 0.018 <0.001 <0.001 <0.001 <0.001

Table 1 Hiatal dimensions and strain in patients with intact muscle, unilateral and bilateral avulsion. Figures are means and standard deviations. NS = no significant. ANOVA statistics.

Conclusions: Avulsion is associated with altered levator biometry, both static and dynamic. The most marked effect is on coronal diameters, but axial diameters and area are also affected. In addition, the biomechanical properties of the muscle are altered, with increased distensibility and reduced contractile function. Avulsion is associated with a relative risk of 3.5–4 of hiatal ballooning. 144 Identification of Urinary Cytokines in Patients with Overactive Bladder (OAB) Faruqui N1, Ghoniem G1, Elmissiry M1, Mahdy A1, AbdelMageed A2 1 Cleveland Clinic Florida, United States, 2Tulane University Health Sciences Center, United States Industry Support: Yes (Investigator initiated, partial funding)

Objectives: To detect abnormal cytokine levels in urine of patients with overactive bladder (OAB) compared to normal. Background: Urine cytokine assays have been studied in various bladder and kidney disorders with the hope of understanding the pathophysiology and developing a noninvasive, reliable predictor of disease progression and evaluate the response to treatment. The traditional explanations for OAB include increased activity of smooth muscle or up regulation of muscarinic receptors in the detrusor. We suggest that acetylcholine (Ach) release from neuronal and nonneuronal urothelium directly or indirectly excites afferent nerves in the suburothelium and detrusor triggering uncontrolled contractions. Stretching of bladder wall as in filling may stimulate the urothelium to release Ach, ATP, nitros oxide (NO) and urothelial derived inhibition factor. One or more of these substances can activate sensory nerve endings in the lamina propria and urothelium where M2 and M3 receptors are present, leading to urgency. We hypothesize that overactive bladder can produce inflammatory cytokines as a result of afferent neural plasticity or from neurogenic or urothelial dysfunction. Methods: Prospective, controlled single blind study including twenty healthy women (control), 20 women suffering from overactive bladder (group II) and other 20 women with culture proven UTI (group III) were selected for the study. Urine samples were collected and centrifuged, and mixed with protease inhibitor solution, pH 7.4 to prevent protein degradation, frozen, and stored at -80oC. Urinary total proteins were quantified using BCA protein microassay kit in accord with manufacturer’s instructions. (Pierce Biotechnology, Inc. Rockford, IL). Differential expression profile analysis of cytokines in urine samples of normal, OAB and UTI were performed using a human cytokine protein chip. (Ray Biotech, Inc. Norcross, GA) The levels of each cytokine (expression as fold change relative change relative to the internal controls) were expressed and compared as mean +/- SE in normal subjects, OAB patients and patients with UTI. Results: We herein present the initial results of the cytokines expression in all the three groups. Majority of the cytokines showed positive increase in the expression in the OAB and UTI group as compared with the control. B lymphocyte chemo attractant (BLC), (4+/-2.7, 1.3+/-0.9 mean +/- SE for OAB and UTI respectively), BMP 4 (5+/-2, 1.5+/-0.8 mean +/- SE for OAB and UTI respectively) and BMP 6 (4 +/-2, 1.3+/-0.8 mean +/- SE for OAB and UTI respectively) showed very high expression (more then 5 fold increases) in both OAB and UTI group. It’s interesting to note that all these 3 cytokines have a low expression in the control group. The cytokines with more then 10 fold increase specifically in OAB were agouti-related protein

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(AGRP), b-NGF (nerve growth factor), BTC, IL 11 and CCL 28 with mean +/- SE - 7+/-3, 8+/-4, 9.8+/-5, 9+/-4, and 11+/-5 respectively. The cytokines with more then 5 fold increase in UTI group alone were Angiopoietin-2, CK ß 8–1, FGF-9, and IL-8, with the mean +/- SE 3+/-2, 1.4 +/- 0.8, 3.8 +/-2, and 6 +/- 4 respectively. Angiogenin, BDNF, epidermal growth factor and IL 10 were commonly low in all the three groups. IL 3, IL 12, IL 13, IGF-I-SR and IGF BP 6 were selectively low in OAB. It’s again interesting to observe that B-NGF, BTC, CCL-28, HGF and IL 7 were low in UTI group. The final results are underway. Conclusions: There is specific elevation of agouti-related protein (AGRP), b-NGF (nerve growth factor), BTC, IL 11 and CCL 28 in OAB group, whereas there are differences in expression of cytokines in OAB and UTI group. This finding may give insight into the pathophysiology of the disease entity in future. 145 The greatest taboo - urinary incontinence, depression and cancer Elenskaia K1, Haidvogel K2, Heidinger3, Doerfler D1, Umek W1, Hanzal E1 1 Department of Obstetrics and Gynecology, Medical University of Vienna, Austria, 2Landeskrankenhaus Steyr, Austria, 3Medical University of Vienna, Austria Industry Support: No (Investigator initiated, no external funding) Objective To evaluate how much of a taboo UI is and how it compares to other medical conditions that may also pose a taboo issue like depression and cancer. Background Urinary incontinence (UI) is a highly prevalent condition with more than 200 million people worldwide being affected. While physical health does not necessarily have to be impaired much, restriction of social activities leads to isolation, a significant reduction in quality of life and will often bring about subsequent morbidity. Despite its prevalence, many patients suffering from UI go undiagnosed and untreated. Patients often hesitate to report the problem, and health care professionals often do not ask about it. In a study Minassian (2003) estimated that just one in four patients actively seeks medical attention. The reason for this may lie in the shame, embarrassment, and stigma associated with this condition, which in turn pose significant barriers to seeking professional treatment. Although mentioned by many narrative reviews and included in some epidemiological papers on UI, surprisingly we found no data addressing the taboo of UI exclusively.

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Methods/Design A 13-question self-administered questionnaire was developed and face validity tested by 2 of the authors (KH, EH). The anonymous questionnaire contained simple questions on gender and age and then asked yes/no questions on whether test persons knew people with UI, or suspected other people to be incontinent, if they would address this issue with the suspected person, and if the thought that UI was a taboo issue in the society. On a scale from 0 - 10 they were then asked to grade the amount of embarrassment and anxiety if they themselves were incontinent, compared to depression or cancer. A few questions on knowledge of the condition of UI and to whom test persons would turn to in case of UI concluded the short questionnaire, which took about 5 minutes to fill in. A convenience sample of 150 test persons from waiting areas of a teaching hospital and in private practices of general practitioners in Austria agreed to take part in the study, with an additional 10 persons (6.2%) declining after being informed about the subject. Data were analysed with the SPSS 10.0.5 software package using the U-test, Chi-square-test, Yates-correction, Fisher’s exact test and Kolmogorov-Smirnov normality test where appropriate. Results 8 (5.3%) questionnaires had to be excluded because of missing data leaving 142 for analysis. There were 96 (67.6%) female and 46 (32.4%) male test persons answering the questionnaires. Mean age was 43 (15–100) years with no normal distribution and younger age groups overrepresented according to the Kolmogorov-Smirnov normality test. 60,6% thought that UI is a taboo in Austria. To be incontinent was considered to be very embarrassing as compared to depression or cancer in 32.0%, 9.3%, and 7.3% (p=0.001, 2-tailed), respectively. Female and male test persons knew incontinent persons in 50.7% and 24.3% (p=0.001, 2-tailed), respectively. 38 (26.8%) of 142 test persons thought that UI is an untreatable condition. Conclusion UI, despite its high prevalence is still considered a taboo in by 60% of our Austrian test persons. The level of embarrassment of UI is highest amongst the comparators depression and cancer. There appears to be a gender specific difference in the perception of incontinent persons with women knowing more people suffering from the condition. A relatively high number of test persons displayed a poor knowledge about the treatability of UI. 182 SACROSPINOUS HYSTEROPEXY AND ANTERIOR MESH - ISN’T THAT A PERFET MATCH? Feiner B, Gietelink L, Maher C Wesley Urogynaecology Unit, Wesley Hospital, Brisbane, QLD, Australia

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Industry Support: No Background: While uterine preservation has been attractive to women with uterovaginal prolapse, clinicians have remained concerned regarding the high rate of anterior compartment prolapse following the sacrospinous colpopexy and sacrospinous hysteropexy. Recent RCT’s have demonstrated that synthetic mesh in the anterior compartment reduces the risk of anterior compartment prolapse recurrence as compared to native tissue repairs(1). It has also been suggested that hysterectomy should not be performed at the time of mesh utilization due to a five time increased risk of mesh complications(2). Despite these recommendations there is no information in the literature regarding the efficacy and safety of sacrospinous hysteropexy and anterior mesh repair in the management of uterovaginal prolapse. Objective: The aim of this study is to prospectively evaluate the sacrospinous hysteropexy when used in conjunction with anterior compartment mesh reinforcement in women with advanced uterovaginal prolapse during the last two years. Methods: Patients with uterovaginal prolapse who desired uterine preservation underwent a comprehensive surgery including anterior repair with mesh (Gynecare Prolift), sacrospinous hysteropexy and posterior (native tissue) repair. All patients were evaluated pre and post-operatively by medical standardised questionnaires and pelvic examination according to the pelvic organ prolapse quantification system. Postoperative evaluation was performed by an independent investigator and included validated symptomimpact and quality of life questionnaire, patient satisfaction on VAS and willingness to recommend surgery to a friend. Objective success was defined as less than stage 2 prolapse at all compartments. Patient’s demographics, peri-operative information and pre/post-operative symptoms and examination results were collected and analysed. Results: Between November 2005 and August 2007, 119 consecutive patients underwent the above mentioned surgery. A TVT-O procedure was performed concomitantly in 23 cases. After a mean follow-up period of 13 months (5–27), 102 patients were available for review, 94 of whom were examined and the remaining 8 could not attend the review appointment, but did fill in the questionnaire and the satisfaction scale. The mean age of participants was 61 (range 33–83), the mean parity was 3 (0–8) and the mean BMI was 25 (17– 36). Operating time was 58 min on average (25–140) with mean estimated blood loss of 161 ml (50–600). Following surgery, the mean hospital stay was 4 days (2–8) and the mean length of catheter use was 5 days. At follow-up, the mean patient’s satisfaction rate was 8.5 (±1.8) and 93% stating they would recommend the surgery to a friend.

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Pelvic examination of 94 patients reviled the following results: The overall objective success rate was 76%. Anterior compartment - objective success rate was 87% with 12/94 failures, of whom 9 were asymptomatic. In 11 of the 12 failures, the leading-most point was at -1 and only in one case it was at 0. Upper compartment - objective success rate was 88% with 11/94 failures, of whom 5 were asymptomatic. In 3 of the 11 failures, the cervix was at -1 and in 8 cases it reached the hymenal ring on maximal Valsalva. Isolated uterine prolapse was detected in 8 of the 11 recurrences and combined uterine and anterior wall prolapse in 3. Posterior compartment - Objective success rate was 96% with 4/94 failures, of whom 2 were asymptomatic. Intraoperative and postoperative complications included 2 cases of blood loss greater than 400 ml, 1 posterior wall hematoma, 5 urinary tract infections, 1 case of persistent unilateral thigh pain, 10 cases of mesh erosion and 5 cases of dyspareunia. Seven of the 10 mesh erosions measured 1×1 cm or less and 6 were asymptomatic. All were initially treated with topical oestrogen and 5 underwent surgical intervention. Of the 5 patients with dyspareunia, 3 reported de-novo dyspareunia and 2 have experienced persisting symptoms. Three patients had mesh contraction on physical examination. Conclusion: The combination of sacrospinous hysteropexy, anterior mesh and posterior repair for the treatment of advanced uterovaginal prolapse is reasonably effective in restoring the anatomy and achieving favourable bladder, bowel and sexual function, with acceptable complications. Further rigorous evaluation on this surgical technique is on going. 1. Hiltunen R, et al. Low-weight polypropylene mesh for anterior vaginal wall prolapse: a randomized controlled trial. Obstetrics And Gynecology 2007;110(2 Pt 2):455–462. 2. Belot F, et al. Risk factors for prosthesis exposure in treatment of genital prolapse via the vaginal approach. Gynecologie, Obstetrique & Fertilite 2005;33(12):970–974. 183 Gender Differences in the Prevalence of Chronic Constipation in Individuals With and Without Overactive Bladder Symptoms: Results From the EPIC Study Irwin D1, Khullar V2, Kopp Z3, Milsom I4, Kelleher C5 1 University of North Carolina - Chapel Hill, United States, 2 Imperial College, St Mary’s Hospital, United Kingdom, 3 Pfizer Inc, United States, 4Sahlgrenska Academy at Goteborg University, Sweden, 5St. Thomas’ Hospital, London, United Kingdom

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Industry Support: Yes (Industry-initiated, full sponsorship) Objective: The objective of this analysis was to evaluate the prevalence of chronic constipation among individuals with and without overactive bladder (OAB) symptoms. Background: Constipation is a relatively prevalent condition (2%-27%) in the general population, and higher rates are usually reported among the elderly (Crane et al, Clin Geriatr Med 23:721–734, 2007). Constipation can be an acute or chronic condition that may lead to a worsening of bladder symptoms such as OAB (Ouslander, Urology 60:50–55, 2002), and some medications used to treat bladder symptoms are also associated with increased rates of constipation (Chapple et al, Eur Urol 48:5–26, 2005) Methods: This was a cross-sectional population-based survey of people aged >=18 years in Canada, Germany, Italy, Sweden, and the United Kingdom. Telephone interviews were administered to a geographically stratified random sample of people. Respondents answered a series of bladder symptom questions and were classified as currently having OAB and any type of urinary incontinence (UI) symptoms as defined by the International Continence Society. They also reported whether they had ever been diagnosed with chronic constipation. Age- and genderspecific prevalence rates of chronic constipation were calculated for individuals in the survey population with and without OAB symptoms, and were weighted for the age and gender distribution within each country at the time of the survey. Results: A total of 19,165 men and women responded to the survey. The overall prevalence of reported chronic constipation was 2% among men and 4% among women in the entire survey population (Table 1). Age-related prevalence of chronic constipation increased linearly in those without OAB, whereas in both women and men with OAB the prevalence of chronic constipation was highest in the 18 to 39-year-old group. The rate of chronic constipation in both women and men with OAB was more than double than in those without OAB (women, 8.7% vs 3.2%; men, 4.4% vs 1.7%, respectively). Among all age groups, the prevalence of chronic constipation was higher among women compared with men. Both women and men with OAB and any type of UI experienced more constipation than those who were continent (women, 10.7% vs 6.8%; men, 6.0% vs 3.7%, respectively; Table 2). Women with OAB including UI reported the highest prevalence of chronic constipation (10.7%). Table 1 Prevalence (%) of Chronic Constipation in Adults

Men

18–39 y

40–59 y

60–69 y

70+y

Total

1.4

1.6

2.4

4.4

2.0

With OAB Without OAB Women With OAB Without OAB

6.0 1.0 3.1 9.5 2.4

4.0 1.4 3.1 7.5 2.5

4.0 2.1 4.6 7.5 4.1

3.4 4.7 6.9 9.2 6.2

4.4 1.7 4.0 8.7 3.2

Table 2 Prevalence (%) of Chronic Constipation in Adults by UI status Prevalence Men with OAB and UI Men with OAB without UI Women with OAB and UI Women with OAB without UI OAB with UI Total OAB without UI Total

6.0 3.7 10.7 6.8 9.2 5.2

Conclusions: The highest prevalence rates for chronic constipation across all age categories were found among women, particularly those with OAB symptoms; the prevalence of chronic constipation in both women and men with OAB was highest in the 18 to 39-year-old group. Women with OAB and UI reported the highest rates of chronic constipation. Some antimuscarinic treatments for OAB and some OAB symptom coping behaviors, such as limiting fluid intake, may lead to a worsening of constipation. Further research is needed to examine the association of chronic constipation as an independent risk factor for OAB symptoms and to determine how to effectively comanage both OAB and chronic constipation, especially in younger and older female patients. 184 Mechanical Imaging: A New Technology to Measure Vaginal Biomechanical Properties van Raalte H1, Lipetskaia L2, Egorov V3 1 The Institute for Female Pelvic Medicine, United States, 2 St. Luke’s Hospital and Health Network, United States, 3 Artann Laboratories, United States Industry Support: No Objective: The objective of this study is to demonstrate the potential use of mechanical imaging technology to measure and compare biomechanical properties of the vaginal wall in women with and without pelvic organ prolapse. Background: Biomechanical properties of the vaginal walls have been correlated with the development of pelvic organ prolapse, however current tools to measure these properties are either invasive or involve the deformation of vaginal tissue to obtain measurements. In addition, these tools must be applied to individual vaginal sites during measurements, offering a somewhat restricted evaluation of overall vaginal

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properties. Mechanical imaging (MI) is a new modality of medical imaging, based on principles similar to those of manual palpation [1]. MI is capable of imaging and recording the sense of touch by measuring surface stress patterns using a small and easily manipulated pressure sensor array. The changes in surface stress patterns as a function of pressure and time are closely related to elastic composition and geometry of the examined region. By measuring and recording these changes, MI can produce a 2D or 3D reconstruction of the internal structures of soft tissues [2 Methods: Thirteen women were enrolled in the study and underwent transvaginal MI evaluation. The women enrolled included 5 women with normal pelvic support, 3 of which had had prior reconstructive pelvic surgery, and 8 women with current pelvic organ prolapse. MI was performed utilizing a vaginal probe, similar in dimensions to a transvaginal ultrasound probe, which was comprised of two separate pressure sensor arrays and orientation sensors. The images were obtained in an office setting at the time of routine vaginal examination. Imaging results were electronically recorded and then analyzed at Artann Laboratories. Results: Among women with and without prolapse, the elasticity coefficient is calculated as the slope (Es) of scanhead applied force versus elevation angle of the probe and is used to characterize the elasticity of the vaginal wall against which the scanhead has been pressed. Comparison of a woman with normal pelvic support to a woman with pelvic organ prolapse revealed a measurable difference in elasticity coefficient (Es) values. Es values were 0.18±0.01 in a patient with normal support compared to 0.025±0.01 in a patient with Stage 3 prolapse for the anterior compartment. Similarly, Es values were 0.11±0.01 in a patient with normal support compared to 0.035±0.01 in a patient with Stage 2 prolapse for the posterior compartment. Using these values, the ratio of normal-to-prolapse vaginal wall elasticity as detected by the MI device was found to be 7.2 for the anterior compartment and 3.1 for the posterior compartment. For patients with prior reconstructive surgery, areas of previous scar tissue and graft placement could be easily seen on mechanical imaging with a measurable increase in tissue rigidity. Even within the vaginal site of graft placement, areas of increased rigidity, such as mesh arms used in graft kits, could be visually discerned. Conclusions: Our findings suggest that MI offers a noninvasive, quantitative evaluation of vaginal elasticity with the potential for a more comprehensive evaluation of overall vaginal support structures.]. In a transvaginal scanning application, MI can produce a real-time, circumferential evaluation of the vaginal walls and their biomechanical characteristics. The potential gynecologic application of the MI could impact our further understanding of risk factors for the development of prolapse,

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individual variations in biomechanical properties and provide insight into optimal approaches for surgical repair. This last application is particularly important with the increasing use of graft materials for pelvic reconstructive surgery and the need to more extensively evaluate the functional properties of the vaginal walls following these repairs. 1. Sarvazyan A.P. “Mechanical Imaging: A new technology for medical diagnostics”, Int. J. Med. Inf., 1998, vol. 49, pp. 195–216. 2. Sarvazyan A.P. “Model-based Imaging.” Ultrasound in Med. & Biol., 2006, vol. 32(11), pp. 1713–1720. 185 Genome-based diagnosis for experimental cystitis TSENG L, CHEN I Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Taiwan University of Sydney, Australia Industry Support: Objective: The purpose of this work is to provide a comprehensible approach, which accounts for the molecular events leading to the solutions as to the roots of experimental cystitis based on all significantly differential expressed genes derived from DNA microarray hybridization. Background: The cascade of genome-derived medicine has now compelled us to transform traditional medicine by a new wave of genome-based medicine and diagnosis for cystitis. Methods: A system of fixed effect logistic regression model is described to compare experimental cystitis bladder epithelial cells with normal ones using DNA microarray hybridization, revealing the precise derangement of gene function that underlies experimental cystitis. In this note, we study a gene expression model on bladder epithelial cells from 10–12 week old female mice by intravesicle challenge with lipopolysacchraide (LPS), substance P, ovalbumin (OVA) or saline. Results: The results were very interesting.Firstly, several types of neuron responsible hypothalamus- and pituitarysecreting hormone receptors are found to participate the pathophysiological changes through experimental cystitis indicating that inflammation in bladder peripheral tissues let neuronal signals hypothalamus and active anti-inflammatory signals from the central nervous system. Secondly, lots of signaling lignads with their associated receptors from immune, endocrine and nervous systems are found to involve in the pathophysiological changes through experimental cystitis status implying the active communication between immune and nervous systems. Thirdly, we have found the transcriptional regulations of experimental cystitis-induced bladder smooth muscle contraction status,

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including the level of contractile force, the nervous system development, energy homeostasis and tissue homeostasis, and the presence of mitochondrial oxidative stress promoting various pathogeneses of experimental cystitis. Conclusions: If we can scan a patient’s entire genome on bladder epithelial cells, our approach described here has accounted for the molecular events leading to the solution of the mechanisms of cystitis in the variation in the genome.

187 Anal and urinary incontinence in nulliparous women -prevalence and risk factors Roos A1, Thakar R1, Ilczyszyn A1, Walther B1, Sultan A2, 1 Mayday University Hospital, United Kingdom, 2Medical Research Council Laboratorie

186 Characterization and Differentiation of Human Muscle Derived Stem Cells Lu S1, Yang A2, Wei C2, Chen K2, Chang L3 1 National yang-Ming University, Taiwan, Province Of China, 2Taipei-Veterans General Hospital, Taiwan, Province Of China, 3National Yang-Ming University, Taiwan, Province Of China

Objective To establish the prevalence and risk factors of urinary (UI) and anal incontinence (AI) in nulliparous women, using a survey of nuns based in the UK. Background UI and AI are a common and distressing problem for women. Despite this, there is paucity of data regarding associated risk factors and prevalence. Although obstetric risk factors are well defined there have been few studies undertaken in nulliparous women. UI has been reported in 9% to 69% women (1). A study conducted in the USA in a mainly postmenopausal and nulliparous population found that the prevalence of UI was 50% (2). Methods All catholic convents in the UK were invited by letter to take part. A validated questionnaire measuring the severity of UI (3), combined with a similarly structured questionnaire to assess AI was sent to all convents who agreed to participate. Univariable analysis was performed using either Chi Square or Fisher’s Exact test, and Student’s T-test where applicable, after which multivariable regression or logistic regression models were fitted. Incontinence of feces and flatus were analyzed together as AI. Odds ratios (OR) were reported with 95% confidence intervals. A p value <.05 was considered significant. Results Of 177 convents 87 replied and 31 agreed to take part. Questionnaires were sent to 202 nuns and 167 were returned. 22 were excluded from analysis as they admitted to bearing children. Of 145 nulliparous women the mean age was 71 (SD 12) years and mean BMI 25 (SD 5.2). None were smokers, 95% were postmenopausal and 21% had previously or were currently using hormone replacement therapy (HRT). 38 (26%) had undergone pelvic surgery (23 had hysterectomy; 6 had UI surgery). Eighty-seven women (60%) experienced UI, and 32% reported this as troublesome. 41% complained of stress UI, 16% of urge UI, 38% of mixed UI and in 5% the type of UI was unknown. The frequency of urinary loss was less than once/week in 46%, 23% once or more/week, and 28% had daily loss of urine. 14% lost large amounts of urine rather then drops/small amounts.

Industry Support: No Objective: To isolate, purify, characterize and differentiate the human muscle derived stem cells (MDSCs) for the potential management of stress urinary incontinence and bladder reconstitution Background: MDSCs isolated from rat were proved to form myotube and demonstrate contractility and increasing compliance of scaffold. These cells could have the potential to become functional biomaterial for the management of voiding dysfunction. Materials and Methods: Isolation of human muscle derived stem cells with modified preplate technique, CD 34positive stem cell isolation, invitro differentiation of MDSCs, myogenic, adipogenic and osteogenic induction of D 34+ cells, immunolabeling procedures for flow cytometry, flow cytometry analysis, immunohistochemical staining, lipid droplet staining with Oil Red O, Alkaline phosphatase staining, and immunofluorescence study were done. Results: The MDSCs were isolated using modified preplate technique and were purified using Dyna-bead method. The growth doubling time of MDSCs was about 45 hours. Immunohistochemical staining showed positive for several CD markers, VCAM, VEGFR-2, CXCR4, CD56, and Desmin staining. Using special growth factors, the MDSCs could be differentiated into smooth muscle, skeletal muscle, adipocyte, and osteocyte. The differentiation was proved by immunohistochemical study. Conclusions: The isolation, purification, characterization and differentiation of MDSCs were successfully conducted. The MDSCs provide another novel way for the management of urinary sphincter deficiency and bladder reconstitution.

Industry Support: No

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Women with UI have a significantly higher mean BMI (26) compared to continent women (24), p=.020. BMI was categorized in 3 groups: low (<19, N=9), normal (19–29, N=97), and high values (=30, N=18). Women with BMI values =30 were more likely to be incontinent than women with normal BMI values, adjusted OR 3.94 (1.05–14.78). There was no significant association between age and UI. Women who ever used HRT were more likely to have UI than those who never used HRT, OR after adjusting for age 3.19 (1.21–8.37). However on adjusting for BMI the association was no longer significant. The severity of UI increases significantly with decreasing BMI (p=0.045). There was no significant association of any risk factor with stress UI. Women with urge UI were significantly (p=.039) older compared to continent women (77 vs 70 years). Women with urge and mixed UI had significantly higher BMI values than continent women (p = .032 and.035 respectively). Women with BMI =30 were 9.7 times more at risk to have urge UI (p=.027) and 6.1 times more at risk for mixed UI (p=.019) compared to women with normal BMI. AI was reported by 78 (54%) women [fecal 22(15%) and flatus incontinence 76(52%)]. 24% of women with incontinence of flatus experienced this problem daily. 23% of women who complained of fecal incontinence experienced it daily. Overall AI symptoms were troublesome in 35%. AI was not significantly associated with any risk factor except the existence of UI, OR 2.96 (1.49–5.88). Flatus incontinence [OR 3.03(1.52–6.04)], and fecal incontinence [OR 3.52 (1.13–11.02)], were also associated with UI, but on multivariate analysis only incontinence of flatus remained significant, OR 2.23 (1.03–4.80). The frequency of incontinence of both flatus and feces was lower in women who ever used HRT compared to women who had never used HRT (p=.015 and.038 respectively). This remained significant after adjusting for age and BMI. The frequency of flatus incontinence appeared to increase with age. However after adjusting for BMI this association was no longer significant. Conclusions UI and AI affects over 50% of nulliparous women and one third found the impact to be troublesome. This highlights that while childbirth is an important incriminating factor, UI and AI also occur frequently in nulliparous women. Positive associations include urge UI and aging, as well as UI and increasing BMI suggesting that weight reduction may be beneficial. This study could form the basis for larger cross-sectional studies to identify other risk factors that may be associated with incontinence.

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References 1: Urology (2003) 62; 16–23. 2: Obstet Gynecol (2002) 100; 226–229. 3: Obstet Gynecol (2001) 98; 1004–10. 188 TISSUE ENGINEERING WITH MUSCLE-DERIVED STEM CELLS FOR VAGINAL RECONSTRUCTION IN THE RAT MODELS Ho M, Heydarkhan S, Vernet D, Kovanecz I, Ferrini M, Bhatia N Harbor-UCLA Medical Center, United States Industry Support: No Objective: The objective of this study is to investigate whether tissue engineering with muscle-derived stem cells (MDSC) implanted on a biodegradable graft material can regenerate vaginal tissues. Specifically, we have investigated in the rat models whether: a) MDSC implanted on biodegradable polymeric materials (Vicryl mesh, Polyglactin 910), which serve both as a surgical graft for temporary support and as a scaffold for guiding tissue regeneration, generate in vitro and in vivo smooth muscle cells (SMC) and other cell types; b) implanted MDSC express specific markers applicable to their detection upon implantation into the defective vagina after hysterectomy and partial vaginectomy; and c) implanted MDSC regenerate smooth muscle and stimulate vaginal tissue repair. Background: Although surgical techniques for correction of vaginal or pelvic organ prolapse have undergone many modifications, there still remains an unacceptable high reoperation rate for persistent or recurrent prolapse. The role of biological and synthetic grafts in the pelvic reconstruction of vaginal prolapse is controversial. Tissue engineering with MDSC holds promise for providing effective pelvic and vaginal support through tissue repair and regeneration. MDSC are capable to give rise to several cell lineages, including the differentiations into myofibers, smooth muscle cells, endothelial cells, and neural cells. In order to promote muscle/tissue regeneration, stem cells may be implanted directly into the defective tissues. However, direct cell injection therapies are insufficient in the case of pelvic organ prolapse because mechanical support is necessary to restore and maintain the anatomy while new functional muscles/tissues are formed. Tissue engineering with stem cells using biodegradable material, that can serve both as a graft for temporary support and as a scaffold for guiding tissue regeneration, is a novel and promissory approach for pelvic reconstruction. Methods: MDSC were prepared from skeletal muscle by the pre-plating procedure, grown on monolayer, or on polymeric grafts (Polyglactin 910 Vicryl mesh), under 2.5%

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or 20% fetal bovine serum with or without TGFß1, and tested for differentiation by immunocytochemistry (ICC), quantitative western blot, and real time PCR. Putative MDSC markers were screened by DNA microarrays (SuperArray) followed by RT-PCR, ICC, and western blot. MDSC on polymeric grafts were labeled with nuclear marker 4,6-diamidino-2-phenylindone (DAPI) and implanted on the vagina of rats that underwent hysterectomy and partial vaginectomy. Control group with intact vagina and studied group with defective vagina were employed. Vaginal reconstructions were carried out with either polymeric graft alone or polymeric graft and MDSC. Rats were sacrificed after 4, 8, and 12 weeks. Dual immunofluorescence was used to detect MDSC differentiation and hematoxylin/eosin was used for histology. Results: MDSC, both on monolayer and on grafts, differentiated in vitro into smooth muscle cells (SMC), as determined by a-smooth muscle actin (ASMA), calponin, and smoothelin. For in vivo studies, MDSC expressed Oct4 and myoglobin, in addition to myst 4, Nanog, Notch 3, Wnt 1, CD63, and muscle creatine kinase are potential markers. Both fluorescent nuclear marker 4,6-diamidino-2phenylindone (DAPI) and myoglobin antibody detected MDSC implanted in the vagina, and dual DAPI/ASMA indicated their conversion to SMC at 4 weeks. Vaginal tissue repair was stimulated by implanted MDSC on biodegradable polymer graft, as compared to the biodegradable graft alone, by differentiating into SMC and restoring normal histology of the vagina at 4, 8, and 12 weeks. Conclusions: Tissue engineering with MDSC implanted on the biodegradable polymer (Polyglactin 910) is a novel and promising approach for vaginal reconstruction. The implanted MDSC regenerate smooth muscle and stimulate vaginal repair in a rat model.

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Method: In this study, we evaluated the morphology and volumetric density of collagen fibers in meshes with and without standardized orifices, as well as its retraction through radiographic and direct measurement of the meshes. The sample consisted of 15 female Wistar rats, which were sacrificed 90 days after the implant. The abdominal wall was removed and an x-ray was taken before its preparation for histological and stereological study. The volumetric density of the collagen fibers was calculated by stereological tool in three compartments: skin, Colles’ fascia and mesh, the latter located between the Colles’ fascia and the aponeurosis of the rectus abidominalis muscles. Results: There was no retraction of the polypropylene meshes, neither in the radiographic analysis nor in the direct measurements taken before and after the surgical implantation. The histological and stereological analysis disclosed organized collagen fiber deposition in the orifices and less inflammatory reaction than the control meshes with no orifices. Conclusions: There was no retraction of this type of mesh in either group. The histological and stereological results suggest that the standardized orifices facilitated tissue integration and may have clinical application. 190 Alterations in response of vaginal extracellular matrix tissue to vagifem treatment in women with pelvic organ prolapse Thiem A1, Anthony F2, Monga A1 1 Urogynaecology, Princess Anne Hospital, United Kingdom 2 Developmental Origins of Health and Disease, University of Southampton, United Kingdom Industry Support: No

189 THE IMPACT OF STANDARDIZED ORIFICES ON THE INTEGRATION AND RETRACTION OF POLYPROPYLENE MESHES: In vivo stereological analyses. Palma P, Cardia F, Riccetto C, Palma T Universidade de Campinas, Brazil Industry Support: No Introduction: The increased use of polypropylene meshes in reconstructive pelvic surgery has led to complications inherent to the use of synthetic materials, such as retraction, exposure and infection. We performed an in vivo experimental study aiming at evaluating the retraction of monofilament polypropylene meshes and improving its incorporation through standardized orifices of 5 mm in diameter.

Objective: In this ongoing randomised, controlled study our aim was to determine how locally applied oestrogen (Vagifem®, 25mcgr Oestradiol) given over a three month time period influences the mRNA expression of MMP2, elastin and collagen XVII as well as the protein production of elastin and collagen I of vaginal skin involved in POP. Background: The mechanism of pelvic organ prolapse (POP) is poorly understood but it has proposed that oestrogen might alleviate or improve some POP symptoms and or may influence surgical outcome. However, previous studies have not been conclusive in showing improvements in pelvic organ disorders, but oestrogen has been shown to increase pro-mmp2 and new collagen formation in stress incontinent women (1). Interestingly, the use of Raloxifene or Levomeloxifene, a selective oestrogen receptor modulator (SERM) may result in symptomatic prolapse (2,3). Recent studies have shown altered connective tissue

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properties such as change in Collagen XVII and elastin in women with pelvic floor disorders compared to controls Material and Methods: 16 postmenopausal women with at least stage II POP were recruited and used intravaginal Vagifem for three months. A full thickness vaginal wall biopsy from prolapsed tissue was taken before application and three months after treatment. Part of the tissue was embedded in paraffin and underwent immunohistological staining. The percentage elastin and collagen I content was measured using computer-assisted image analysis (Zeiss KS400 software, Image Associates, Bicester, UK). Another piece of tissue was frozen in liquid nitrogen and later RNA extracted using Trizol reagent, then mRNA expression was measured relative to GAPDH using Real Time PCR.

MMP2 mRNA Elastin mRNA Elastin protein CollagenXVIImRNA ERalpha mRNA Collagen I protein

Pre(mean +/-SEM)

Post(mean +/-SEM)

P value

n=

0.45+/-0.078 1.19+/-0.49 17.44+/-1.22 1.53+/-0.15 0.95+/-0.095 28.71+/-1.21

1.22+/-0.16 2.26+/-0.62 19.12+/-0.94 0.83+/-0.09 0.94+/-0.097 33.53+/-0.96

0.0016** 0.074 0.19 0.0006*** 0.63 0.0003***

16 16 16 16 16 16

Conclusion: We were able to show that locally applied oestrogen is up-regulating the message for MMP2 while not affecting the oestrogen receptor ER alpha. However, the message for the adhesive collagen XVII is down-regulated while collagen I protein is increased significantly. Although message and protein for elastin appeared to rise this did not reach significance. Overall this study demonstrates that topical oestrogen is having positive effects on message and protein production of key factors involved in remodelling and improving vaginal tissue characteristics with short term application. Longer term application could enhance these effects. (1) BJOG: An International Journal of Obstetrics and Gynaecology Volume 109 Issue 3 Page 339–344, March 2002 Simon Jackson, Mark James, Paul Abrams (2002) The effect of oestradiol on vaginal collagen metabolism in postmenopausal women with genuine stress incontinence (2) Cellular and molecular characterisiation of pelvic ligaments fibroblasts: effects of gonadal steroids Authors: Al-Azzawi, Farook, Ewies, Ayman A.A. Issue Date: 2006 Publisher: University of Leicester (3) Am J Obstet Gynecol. 2002 Sep;187(3):521–7.

Adverse events that are associated with the selective estrogen receptor modulator levormeloxifene in an aborted phase III osteoporosis treatment study. Goldstein SR, Nanavati N. 191 DOES GENETIC POLYMORPHISM IN THE TRANSCRIPTION FACTOR SP1- BINDING SITE OF THE GENE COLIA1 ENCODING ALPHA-1 CHAIN OF TYPE I COLLAGEN PREDISPOSE WOMEN TO PELVIC ORGAN PROLAPSE? Feiner B1, Fares F2, Azam N2, Auslender R3, Rosen T4, Abramov Y4 1 Division of Urogynecology and Reconstructive Pelvic Surgery, Carmel Medical Center, Haifa, Israel, 2Laboratory of Molecular Genetics, Carmel Medical Center, Haifa, Israel, 3Department of Obstetrics and Gynecology, Carmel Medical Center, Haifa, Israel, 4Division of Urogynecology and Reconstructive Pelvic Surgery, Carmel Medical Center, Haifa, Israel Industry Support: No Background: The possibility of genetic predisposition to pelvic floor dysfunction has been in the focus of profound research during the last decade. Observations of an exceptionally high prevalence of pelvic organ prolapse among female individuals within certain families, occurring at a young age, often in the lack of recognized risk factors, strongly support the existence of such predisposition. A single nucleotide polymorphism in the gene encoding a-1 chain of type I collagen (COLIA1) was found to be associated with an increased risk for stress urinary incontinence(1). Since these two pathologies are believed to share a common etiologic basis, we wished to explore the possible role of the COLIA1 polymorphism in pelvic organ prolapse. Objective: The aim of this study is to determine the prevalence of the COLIA1 polymorphism among women with advanced pelvic organ prolapse. Methods: Patients with advanced pelvic organ prolapse [(stage 3–4 by the Pelvic Organ Prolapse Quantification system(2)] and healthy controls with mild (stage 1) or no prolpase were evaluated by medical interview, validated symptom-impact questionnaires and pelvic examination. Women with known connective tissue disorders (such as Marfan syndrome, Ehrler Danlos syndrome, etc.), ongoing pregnancy, cancer involving the pelvic organs or stress urinary incontinence were excluded from the study. DNA was extracted from peripheral blood leucocytes and a twostep polymerase chain reaction was performed to determine the presence or absence of the COLIA1 polymorphism in each sample. The ?2 test was used to compare the

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prevalence of various genotypes among patients from the study and control groups. The association between each genotype and the risk to develop advanced pelvic organ prolapse was calculated and reported using odds ratios and 95% confidence intervals. A p value <0.05 was considered statistically significant for all comparisons. Results: There were 33 participants in the study group and 38 in the control group. The two groups were matched with respect to age, BMI and parity, with a small difference in mean age which was not statistically significant. Other non-obstetric risk factors for pelvic organ prolapse were also similarly prevalent between the two groups, including menopause, smoking and chronic constipation. Genetic analysis of the entire studied population revealed the following distribution of genotypes at the SP1 - binding site of the COLIA1 gene: GG-71.8%, GT26.8% and TT-1.4%. There was a higher prevalence of the heterozygous state (GT) in the study as compared to the control group (Table 1). The calculated odds ratio for pelvic organ prolapse was more than twice higher for patients carrying any genotype other than GG compared to those who had the native GG genotype (Table 2). However, this difference did not reach statistical significance (p=0.11). Moreover, the only participant who was found to carry the homozygous state (TT) was in the control group. The prevalence of a T allele at the Sp1- binding site of the COLIA1 gene was higher in the study group (Table 1), resulting in an odds ratio of 1.65 for each copy (Table 2). This finding too was not statistically significant. Table 1 Distribution of genotypes and alleles Genotype/Allele

Study group (n=33) (%)

Control group (n=38) (%)

P value

GG GT TT G allele T allele

21 (63.3) 12 (36.4) 0 (81.8) (18.2)

30 (78.9) 7 (18.4) 1 (2.6) (88.2) (11.8)

0.11

0.29

Table 2 Odds ratios (95% confidence intervals) for POP Genotype/Allele

Odds Ratio (95%CI)

GG GT and/or TT G allele T allele

1 2.143 (0.747–6.149) 1 1.654 (0.649–4.217)

Conclusion: The COLIA1 polymorphism seems to be associated with an increased risk for pelvic organ prolapse,

however, a larger sample size is probably required to determine the significance of this association. 1. SKORUPSKI P, KROL J, STAREGA J, ADAMIAK A, JANKIEWICZ K, RECHBERGER T. An alpha-1 chain of type I collagen Sp1-binding site polymorphism in women suffering from stress urinary incontinence. Am J Obstet Gynecol 2006;194:346–50. 2. BUMP RC, MATTIASSON A, BO K, et al. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 1996;175:10–7. 192 Functional and morphological effects of urinary diversion in rat Liu G, Lin Y, Li M, Xiao N, Daneshgari F, Department of Biomedical Engineering and Glickman Urological Institute, The Cleveland ClinicFoundation, Cleveland OH, United States Industry Support: No Objectives: To develop a new urinary diversion (UD) model in rat and examined the effects of acute and chronic of UD on bladder, urethra, and vagina. Background: The bladder undergoes marked alterations in response to diabetes. Polyuria and hyperglycemia are involved in the pathogenesis of diabetes cystopathy. To examine the mechanistic effects of hyperglycemia without polyuria on bladder, we aimed to develop a new urinary diversion (UD) model in rat and examined the effects of acute and chronic of UD on bladder, urethra, and vagina. Methods: Female Sprague Dwaly rats were distributed into age-matched normal control (n=6), sham urinary diversion (n=12), and urinary diversion (UD) group (n=12). Urinary diversion was performed by surgical connection of the ureters to uterine cervix. Sham procedure included laparotomies and isolation of ureters only. No surgery was performed in normal control animals. One or 8 weeks after procedures, the lower urinary tract function was assessed by conscious cystometry (CMG) and leak point pressure (LPP) measurement. Then, the bladder, urethra and vagina were harvested for histological examination and quantification of three primary tissue components: smooth muscle, urothelium, and collagen. Results: All the animals survived the procedures to the end of experiments. The bladder weight decreased significantly in UD group. CMG measurement showed decreased intercontractile intervals and voided volume per micturition in the UD compared to control and sham group. The compliance was significantly reduced in UD rat. However, there were no significant differences in peak micturition pressure in UD rat, and LPP was similar among the control,

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sham and UD group. Histology examination showed that, as a percentage of the total cross sectional area in bladder, smooth muscle and urothelium areas decreased, and collagen increased in1-week and 8-week UD rat compared with controls. UD caused thickened mucosa, lamina propria, infiltration of lymphocytes, and ulcers of vagina in 1 and 8-week UD rats. Urethra showed decreased striated muscle in 8-week UD rat. Conclusions: Urinary diversion causes functional and morphometric alterations of the bladder, urethra and vagina in a non-time dependent manner. Creation of a UD model is feasible as an experimental model for testing the impact of polyuria on the bladder. 193 Analysis of birefringence (optical density) of periurethral muscles and collagen of female rats under effect of testosterone. Feitosa I, Palma P, Riccetto C, Vidal B, Maciel L, Fraga R UNICAMP Universidade Estadual de Campinas-Sao Paulo, Brazil Industry Support: No OBJECTIVE The purpose of this study was to analyze the effect of androgen supplementation in peri-urethral muscles and collagens fibers of females rat Winstar non-ophorectomized using polarized light microscopy. BACKGROUND The urinary continence is determined by the integrity of the tissues of the structures that support the urethra, represented by ligaments, fascias and pelvic floor muscles. The internal mechanisms that maintain urethral resistance are also relevant, such as striated and smooth peri-urethral muscles and extracellular matrix. Several studies showed that the administration of methyltestosterone in oophorectomized rats increased significantly the content of collagen in bladder and urethra, when compared to estrogen replacement alone. The authors suggested that the trophy effects of androgens on epithelium, mucosa and connective tissue of urethra would be of benefit in maintaining sphincter pressure. However, the morphological result of hormonal interaction with the lower urinary tract is not completely understood, and the model of female pseudo-hermaphroditism would correspond to a supplementation of androgens to the genitourinary system at a specific stage of woman’s life. Most studies in the literature did not have the priority to objectively analyze the influence of androgens on tissues involved with pelvic support, which implies in the predisposition and pathogenesis of pelvic organ prolapses.

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The analysis of pelvic tissues (collagen and periurethral muscles), using polarized light microscopy brings important and accurate informations about molecular ultrastructure and organization of these cells and tissues. METHODS This project was approved by the Ethical Committee for Experimental Studies. Thirty adult rats (female, virgins, Wistar), aged 90 days, were randomly assigned into two groups and received the following treatment for 60 days: Group 1C (Controls, Non-ooforectomized): 15 rats receiving daily doses of 0,1 ml/day of subcutaneous (SC) placebo. Group 2M (Non-ooforectomized): 15 rats receiving daily doses of 0,075 mg/Kg of SC methyltestosterone. Treatment started 30 days after the procedure and by the end of the treatment; the bladder, urethra, vagina and pelvic floor muscles were removed en bloc. The blocs were fixed in 4% paraformaldehyde and imbibed in Histosec (Merck Darmstadt, Germany). The specimens were prepared in the usual manner and two cuts of 7 um traversal to the rectum were obtained. Images were obtained with Olympus Bx 51 microscope and were analyzed with Image Pro-Plus 5.1 System. The parameter analyzed was optical density. All the slides were evaluated by the same investigator. Each slide had four fields analyzed. Statistic analysis were done using the Minitab-12™software (State College, PA) - Mainn Withney test p value was 0,05 (p<0,05). RESULTS The first analysis made was the calculation of optical density in perineal muscles of placebo and testosterone groups. 197 calculations were made from 15 slides for control group from which the following measurements were taken: Optical density, total area and standard deviation. For testosterone group 95 calculations were made from other 15 slides, with the same parameters analyzed. (Table 1) TABLE 1 Comparison between Optical Density values of periurethral muscles of the two groups of rats Group n

Median

Standard Deviation

Placebo 197 Testosterone

65,42 95

0,0045 84,76

The second analysis evaluated the birrefringence of collagen in both groups. 555 measures were made from placebo group and 511 from testosterone group. (Table 2)

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TABLE 2 Comparison between Optical Density values of periurethral collagen of the two groups of rats Group n

Median

Standard Deviation

Placebo 555 Testosterone

95,94 511

0,0001 100,86

The results of Table 1, that presents the analysis of periurethral muscles show a statistically significant difference between the two groups, with the testosterone group having birrefringence levels greater than control group. In table 2, that analyses periurethral collagen, data shows that testosterone group had an increase in frequency of higher values of optical density, with statistically significant difference when compared to control group. These data allow us to presume a better molecular organization and a better function of these tissues. CONCLUSION Even though recent studies don’t clarify the real role of androgens in tissue morphology of lower urinary tract of female mammals, our research showed that the group that received testosterone had an increase in the birrefringence (optical density) of periurethral muscles and collagen, what is consistent with a better molecular organization under the effect of this hormone. 194 TRPV1 mediates the uterine capsaicin-induced NMDA NR2B-dependent cross-organ reflex sensitization in anesthetized rats Peng H1, Huang P2, Chen G3, Lin T 1 Department of Physiology, Chung-Shan Medical University H, Taiwan 2 School of Medicine, Kao-Hsiung Medical University, 3 Department of Obstetrics and Gynecology, Chung-Shan Medical University Hospital, Chung-Shan Medical, Industry Support: No Spinal cord-mediated cross-organ sensitization between the uterus and the lower urinary tract may underlie the high concurrence of obstetrical/gynecological inflammation and lower urinary tract syndrome characterized by urogenital pain. However, the neural pathway and the neurotransmitters involved are still unknown. We tested the hypothesis that the excitation of capsaicin-sensitive primary afferent fibers arising from the uterus through the stimulation of transient receptor potential vanilloid 1 (TRPV1) induces cross-organ sensitization on the pelvic-urethra reflex activity. Capsaicin (1–100 μM, 0.05 cc) was instilled into the uterus to induce cross-organ reflex sensitization. Activation of capsaicin-sensitive primary afferent fibers by capsaicin

instillation into the uterine horn sensitized the pelvicurethra reflex activity that was reversed by a pretreatment with capsaizepine, a TRPV1-selective antagonist, in the uterine horn. Intrathecal injection of AP5, a glutamatergic N-methyl-D-aspartate (NMDA) antagonist, and Co-101244, an NMDA NR2B-selective antagonist, both abolished the cross-organ reflex sensitization caused by capsaicin instillation. These results demonstrated that TRPV1 plays a crucial role in contributing to the capsaicin-sensitive primary afferent fibers mediating the cross-organ sensitization between the uterus and the lower urinary tract when there is a tissue injury. 195 Genome-derived Diagnosis for Interstitial Cystitis TSENG L1, Chen I2, Lee C, Han C 1 Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Taiwan, 2University of Sydney, Australia Industry Support: Objective: The purpose of this work is to provide a comprehensible approach, which accounts for the molecular events leading to the solutions as to the roots of Interstitial Cystitis (IC) based on all significantly differential expressed genes derived from DNA microarray hybridization. Background: The novelty of genome-scale sequencing consists in its replacing the traditional medicine by a new wave of genome-based medicine and diagnosis for IC. Though several potential candidate IC markers were isolated from the urine of patients with IC, they were merely a few molecules surrounded by the networks of molecular interactions and biological coordination. We need to develop some fundamental tools to detect the mechanisms of IC on this genomic scale. Methods: A system of fixed effect logistic regression modeling is described to compare interstitial cystitis (IC) bladder epithelial cells with normal ones using DNA microarray hybridization, revealing the precise derangement of gene function that underlies IC. In this note, study a gene expression model on bladder epithelial cells from six different human IC subjects taking into consideration their age- and gender- matched controls. Results: The results were very interesting. Firstly, complex metabolic reactions, including carbohydrate, lipid, amino acid, nucleotide, cofactors, vitamins and xenobiotics metabolisms, are found to have a strong relationships with bladder smooth muscle contraction through IC status. Secondly, we have found the transcriptional regulations of IC-induced bladder smooth muscle contraction status, and the presence of mitochondrial oxidative stress promoting various pathogeneses of IC. Thirdly, there is an indication of the mast-cell activation mediated by the high-affinity

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receptor of Fc episilon RI triggering allergic inflammation through IC status.Conclusions: If we can scan an IC patient’s entire genome on bladder epithelial cells, our approach described here has accounted for the molecular events leading to the solution of the mechanisms of IC in the variation in the genome. With the human genome sequence in hand, we can use genome-derived diagnosis for IC, investigate IC at the genetic level and, in time, to develop treatments or cures on the basis of this understanding. In any case, the prospect of conquering IC can be entertained. 196 Relationship between pelvic floor dysfunction and interstitial cystitis in a Urogynecology referral center Hart S, Tidwell N, Downes K, Hoyte L University of South Florida College of Medicine, United States Industry Support: No Objective: To evaluate the relationship between pelvic floor dysfunction and interstitial cystitis (IC) in a Urogynecology referral center. Background: Interstitial Cystitis (IC) is a complex disorder in which patients present with a variety of urinary and pelvic floor complaints. Unfortunately, the true underlying cause of this condition remains unknown, and treatment directed specifically at the bladder continues to provide suboptimal results. There is limited evidence that suggests an association between IC and pelvic floor dysfunction, but the true prevalence and severity of this particular IC co-morbidity remains unknown. The Pelvic Floor Distress Inventory (PFDI) and the Pelvic Floor Impact Questionnaire (PFIQ) were developed as quality-of-life instruments for women with pelvic floor disorders. The short forms of these questionnaires (PFDI-20 and PFIQ-7) were designed and validated to allow clinicians to follow patients in an office setting. The Pelvic Pain and Urgency/Frequency (PUF) questionnaire is a validated, symptom based interstitial cystitis questionnaire mainly used in the diagnosis and follow-up of this condition. Our goal was to examine the relationship between pelvic floor dysfunction and interstitial cystitis using these validated questionnaires in a Urogynecology referral center. Methods: The charts of all patients presenting to the Urogynecology Clinic for the evaluation or treatment of interstitial cystitis between April 2007 and March 2008 were reviewed. Patients with a previous diagnosis, or those given a diagnosis of interstitial cystitis, were selected. The diagno-

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sis of interstitial cystitis was based on symptoms, questionnaires, and diagnostic tests including cystoscopy with hydrodistension, anesthetic challenge test, potassium sensitivity test and multichannel urodynamic evaluation. Total and subset scores from the PUF, PFDI-20 and PFIQ-7 questionnaires, as well as patient’s age and duration of symptoms, were included in the analysis. Statistical analyses were conducted using SPSS for Windows (version 15.0, SPSS Inc., Chicago, IL). Results: A total of 71 charts were selected for the study. Six charts were excluded due to incomplete data, leaving a remaining 65 charts for data extraction and analysis. The average age of the patients included in the analysis was 36 yrs (range: 18–72). Approximately 50.8% of these women had their pain for less than 2 yrs, 29.2% have had pain for 2–5 years and 20% have had pain for greater than 5 years. In patients with a PUF score < 10 (n=6), the mean PFDI score was 55.03 and mean PFIQ score was 29.67. In patients with a PUF score between 10–20 (n=26), the mean PFDI score was 86.29 and mean PFIQ score was 78.22. In patients with a PUF score >20 (n=33), the mean PFDI score was 119.11 and the mean PFIQ score was 124.52. Using a Non-Parametric Spearman’s Rho correlation, a significant association was seen between the total PUF score and the total PFDI score (r=0.484, p-value=0.01), between the total PUF and total PFIQ, (r=0.478, p-value= 0.01), between the PUF symptom index and total PFDI score, (r=0.493, p-value=0.01), and between total PFDI score and the bladder component of the PFIQ questionnaire (r=0.455, p-value=0.01). We also examined whether there were differences in scores on the PUF and PFDI that were dependent on the duration of disease. ANOVA and the nonparametric Kruskall-Wallace tests revealed that there were no significant differences between the three duration of symptoms groups for either measure. Conclusion: The severity of interstitial cystitis symptoms correlated with severity of pelvic floor dysfunction symptoms, and is not dependent on the duration of symptoms. This demonstration of a symptom gradient suggests that both IC and pelvic floor dysfunction have a common underlying mechanism, or relationship, that has not been elucidated. The results from this study suggest that an evaluation for pelvic floor dysfunction should be considered for all patients suspected of having IC. 197 Can 2D translabial ultrasound be used to diagnose levator avulsion? Dietz H, Shek K University of Sydney, Australia

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Industry Support: No Objective: We tested validity and reproducibility of a new method for diagnosing levator trauma by 2D translabial ultrasound in a prospective observational study. Background: Childbirth-related trauma to the puborectalis muscle is common and associated with female pelvic organ prolapse. It can be diagnosed by palpation, but Magnetic resonance imaging and 3D pelvic floor ultrasound seem more repeatable. However, both methods are not universally available. Methods: 75 women seen in a urogynaecological unit were examined for major levator trauma (‘avulsion injury’) by palpation, 2D and 3D ultrasound (US). For 2D US we used an oblique parasagittal translabial approach to line up the main transducer axis with the fiber direction of the puborectalis muscle. The operator using 2D US was blinded against all other findings. A test- retest series for 2D assessment of the puborectalis muscle was conducted in 35 patients. Cohen’s kappa was used to test for agreement between methods and observers. Figure: 2D parasagittal oblique views of the puborectalis muscle obtained by translabial ultrasound (A showing an avulsion on the patient ‘s right, marked by a *, B an intact muscle on the patient’s left). Image C shows a tomographic representation of the puborectalis in the same patient, with the avulsion evident in most slices (marked by *).

Results: Mean age was 54 years (range 26–82), median vaginal parity was 2 (range 0–9), with 67/75 women having given birth vaginally. Presenting complaints were stress incontinence (69%), urge incontinence (55%) and prolapse symptoms (53%). Avulsion defects were found in 28%. Agreement between observers for diagnosis of avulsion by 2D US was 87%, equating to a Cohen’s kappa of 0.56 (CI 0.33- 0.80). Agreement between tomographic 3D US and 2D US was 87%, with a kappa of 0.61 (CI 0.45–0.77). Agreement between palpation and 2D US also showed a kappa of 0.61 (0.45- 0.77). The commonly observed association between prolapse and defects was strongest for 3D tomographic US. Conclusions: Avulsion of the puborectalis muscle can be diagnosed with 2D Ultrasound, using an oblique parasagittal translabial approach. The finding of a discontinuity

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between the hyperechogenic muscle and the pelvic sidewall is moderately reproducible and agrees moderately well with palpation and 3D US. However, it seems less reproducible than 3D ultrasound or magnetic resonance imaging, and it is less strongly associated with anterior compartment prolapse, suggesting reduced validity in comparison to tomographic 3D ultrasound. However, the method may still prove to be valuable in clinical practice, especially when used to confirm findings obtained on palpation. 198 Temporal Effects of Vaginal Distension and Bilateral Pudendal Nerve Transection on Leak-Point Pressure and Urethral Anatomy in Female Mice Lin Y1, Tseng L1, Lo T1, Wang A1, Liu G2, Daneshgari F2 1 Chang Gung Memorial Hospital/ Chang Gung University College of Medicine, Taiwan, 2Cleveland Clinic, Cleveland, Ohio, United States Industry Support: No (n/a) Objective- Vaginal distension (VD) and pudendal nerve injury (PNI) have been used for creation of stress urinary incontinence (SUI) in rats. We have recently reported successful induction of SUI in mice by VD. In this study, we aimed to examine the time course of recovery after VD and PUI in mice and to investigate the possible mechanism of SUI caused by these models. Background- Stress urinary incontinence (SUI), the most common type of urinary incontinence, affects approximately 25 million Americans of all ages with disproportionably higher prevalence among women. However, the exact reason causes SUI is still unclear. Birth trauma resulting from vaginal delivery is one of the widely recognized risk factors in the genesis of SUI in women. Animal models of SUI have been used over the last decade to help the investigators to understand the pathogenesis of SUI. Vaginal Distension (VD) and Pudendal Nerve Injury (PUI) have been used to created SUI in rats. The use of mice in many other lines of translational research has provided the opportunity to take advantage of knock out and transgenic technology to conduct mechanistic studies of the related disease. Methods - Seventy two virgin female C57BL/6 mice were randomly distributed into three groups. Vaginal distention (VD) group underwent VD for 1 hour, using a modified 6Fr. Foley catheter with a balloon dilated to 0.3 ml. Pudendal nerve transection (PNT) group received bilateral PNT, as described beofre. Sham VD group only received insertion of the uninflatted 6-Fr Foley catheter for 1 hour. Each group was divided into four subgroups for performing leak-point pressure (LPP) at 0, 4, 10, and 20 days, after VD or PNI. All mice underwent suprapubic tube(SPT) implantation 2

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days before performing LPP. After sacrifice, the urethras of the mice were harvested for histological examination and examination of NF-200 immnoreactive nerve terminals. The differences between groups were compared with two sided Student t-test at 0.05 significance level. Results - LPPs were significantly lower 0, 4 and 10 days after VD (10.88±1.52, 10.04±2.36, and 10.93±2.11 cm H2O, p<0.05) compared to sham VD (32.02±4.30, 30.20± 5.90, and 26.72±1.89 cm H2O). LPPs 20 days after VD (20.47±2.98 cm H2O) and sham VD (25.66±3.26 cm H2O) showed no significant differences (p=0.196), indicating the recovery of the continence in mice occurs 20 days after VD. LPPs were significantly lower 0, 4, 10 and 20 days after PNI (6.85±2.63, 5.01±1.30, 6.90±2.43, and 4.10±0.62 cm H2O, p<0.05) than control (sham VD). Histological examination showed no significantly difference in the thickness of urethral striated muscle between all subgroups. The density of immunoreactive neurofilaments in the urethra was significantly reduced 4 and 10 days after VD(2.61±0.05, 2.88±0.19%, p<0.05) and 4, 10, and 20 days after PNT(2.45±0.11, 2.27±0.28, 2.57±0.65%, p< 0.05). The density of neurofilaments 20 days after VD (3.59±0.35%) was similar to 20 days of Sham VD(4.44± 0.09%, p=1.00), indicating the source of recovery of continence function may be related to recovery of these nerve terminals. 50

LPP(cmH20) LS Means

PNT

40

Sham

30

VD

20 10 0 0

4

10

20

Neurofilaments(%) LS Means

Days 5.5 PNT

5

Sham

4.5

VD

4 3.5 3 2.5 2 0

4

10

20

Days

Conclusions - VD and PNI cause durable SUI in female mice, as measured by LPP. SUI after VD recovers by 20 days. Such recovery is temporally associated with recovery of the NF-200 immunoreactive nerve terminals in the urethra, indicating a key role for these elements in recovery of continence mechanisms after VD. Our created models could be used for mechanistic investigation of SUI by

taking advantage of transgence and knock out technology in mice. 199 Appearance of the Levator Ani Muscle Subdivisions in Endovaginal 3-Demensional Ultrasonography Shobeiri S, LeClaire E, Nihira M, O’Donohuge D The University of Oklahoma Health Sciences Center, United States Industry Support: Yes (Investigator initiated, no external funding) Objective: 1) To authenticate the levator ani subdivisions visible on endovaginal and endoanal 3D ultrasonography. 2) To formulate a system for visualization of the levator ani subdivisions visible on endovaginal 3D ultrasonography. Background: When one dissects the levator ani muscles, the area under the pubic bone is dense with bands of entertwined muscles. Given that we use terms such as pelvic floor spasm, levator spasm, and pelvic floor weakness, understanding the basic consepts of pelvic floor’s muscular structure is essential to formulating our opinions. Kearney and colleagues proposed a nomenclature that is based on the attachment points of the levator ani muscles (1). Therefore the muscles under the pubic bone are clarified as puboanalis, pubovaginalis, and the puboperinealis as the subdivisions of the pubovisceralis muscle. The same group showed excellent reliability and reproducibility of visualizing these muscles using magnetic resonance imaging in nulliparous volunteers (2). More recently 3D and 4D translabial ultrasonography methods for the assessment of puborectalis muscle have been published extensively by a few centers around the world. There are no anatomic or correlative studies substantiating the ultrasonic descriptions in these studies. The levator ani subdivisions are assessed by 3D endovaginal ultrasonography which we used in the current study. Methods: After obtaining appropriate IRB approval 5 fresh frozen pelves were utilized. Immediately after the pelves were defrosted for 36 hours and brought to room temperature in an external bath a 3D transrectal and transvaginal ultrasonography was performed. BK Medical (Wilmington, MA) with a 2050 probe with 3D imaging technology was used for acquisition of images and stored on digital media for future comparison. The visible structures and possible defects were tagged with biopsy needles and by dye localization. The findings were cataloged and photographed. The findings were recorded digitally and correlated with the cadaveric dissections. The location of the pubovaginalis, puboperinealis, puboanalis, puborectalis, and the iliococcygeal muscles were identified

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from 6 centimeters cephalad the hymen to +3 cm caudad to the hymental ring. 3-D endovaginal ultrasounds of 22 nulliparous women with normal pelvic floor were obtained and a three level system was constructed. Level I contained the superficial transverse perineal muscle and the perineal body. Level II contained the pubovaginalis, puboperinealis, puboanalis, puborectalis muscles, and level III contained the iliococcygealis muscle. The clarity of the structures, and the origin insertion points were assessed by two blinded reviewers at each level planes. Additionally, the planes were manipulated as needed to visualize the entire target muscle. Results: Our cadaveric specimens were from 50–65 yearsold females. Two had intact pelves and three were posthysterectomy. Puboperinealis muscle had mixed echogenicity and was located immediately cephalad to the perineal body. The puboanalis muscle was identified as two triangular hypoechoic area cephalad to the perineal body. The pubovaginalis muscle was identified as dense muscular band at the level of midurethra in cadavers, and as hypoechoic areas causing heart shape angulation of the anterior vaginal mucosa. These structures were readily visualized., and the transvaginal and the transanal in fresh

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pelves confirmed that the entirety of the levator ani subdivisions were visualized. In the control group of 22 nulliparous subjects, the entirety of the target muscle was visualized using 3D ultrasonography in any given plane. The appearance of each muscle was varied depending on the direction it travels. There was 92%, 96%, and 85% agreement for level I, II, and III muscles respectively. Conclusions: 1) The location of the pubovaginalis, puboperinealis, puboanalis, puborectalis, and the iliococcygeal muscles as seen by 3D endoanal and endovaginal ultrasonography were authenticated through anatomic dissection of fresh frozen pelves. 2) Subdivisions of the levator ani muscle were reliably visualized using a systematic approach utilizing 3D endovaginal ultrasonography. References) 1) Kearney R. Sawhney R. DeLancey JO. Levator ani muscle anatomy evaluated by origin-insertion pairs. Obstet Gynecol. 2004;104:168–73. 2) Margulies RU. Hsu Y. Kearney R, et al. Appearance of the levator ani muscle subdivisions in magnetic resonance images. Obstet Gynecol. 2006;107:1064–9.