Int Urogynecol J (2012) 23 (Suppl 2):S43–S244 DOI 10.1007/s00192-012-1875-z

2012 IUGA ABSTRACTS

Oral Presentations 37th Annual IUGA Meeting, Brisbane, Australia, 4–8 September 2012

1 CHANGES IN TISSUE COMPOSITION OF THE VAGINAL WALL OF PREMENOPAUSAL WOMEN, THE EFFECT, NOT THE CAUSE OF POP Kerkhof, MH1; Leunglohing, M1; Bril H1; Bleeker, M2; Belien, JA2; Niessen, HW2; Brölmann, HA2; Ruiz, Zapata AM2; Helder, MN2 1 Kennemer Gasthuis, Heemstede, Netherlands, 2VU Univ. Med. center, Amsterdam, Netherlands. Objective: To test the following hypotheses: 1) There will be a significant difference between the features at the non-POP site compared to the POP-site within the same woman with POP. 2) There will be no significant differences in the features between the precervical region of women without POP compared to the precervical region (non prolapse site) of women with POP Background: Pelvic organ prolapse (POP) is a result of mechanical failure in the pelvic floor tissue that supports the abdominal and pelvic organs. Although many studies reported on changes in connective tissue composition to explain failure mechanisms in POP, the presented data are conflicting due to different biopsy sites and unclarity about which vaginal layers are actually analyzed. Also, results are often biased by age and menopausal status. Moreover, it is impossible to distinguish whether the observed changes are the result of intrinsic (genetic) or acquired (environmental) effects (i.e. cause or effect of POP) In this study we applied a novel approach to try to unravel cause-effect relationships in POP. We compared histological features of both the (normal) precervical anterior vaginal wall and the prolapsed anterior vaginal wall of women with POP to evaluate acquired effects. We compared these data with tissue of the precervical anterior vaginal wall of age-matched controls without POP to identify possible intrinsic effects.

Methods: Upon medical ethical committee approval and acquiring informed consent, biopsies were collected from two groups: A control group of 12 premenopausal, Caucasian women undergoing hysterectomy for benign gynaecological diseases, and a case group of 13 premenopausal, Caucasian women undergoing prolapse surgery (POP-Q stage >2). Patients and controls were matched for age, parity and smoking. In both groups, full thickness vaginal wall tissue biopsies were taken from the apex of the anterior vaginal cuff after hysterectomy. In POP-women an additional full thickness vaginal wall sample was taken from the POP site during anterior colporrhaphy. All samples were embedded in paraffin and histologically verified as full thickness samples. Representative sections were immunostained for microvessels (CD 31), smooth muscle cells (desmin) and elastin (EvG). Stained sections were digitally scanned and areas between 0.55 and 0.64 mm2 were selected. A computerized morphometric analysis was executed. Adjacent sections were immunostained for the extracellular matrix proteins collagen I, III, IV and V. However, computerized morphometric analysis for these sections was technically impossible, and a scoring system with four grades (absent, light, moderate or strong) was applied instead by two independent, blinded observers. Statistical analysis was performed using the independent student T test, with Levene’s equality test of variances, Mann Whitney and the Wilcoxon signed-ranks test. Results: There were no statistically significant differences between case and control group in the precervical vaginal wall tissue with respect to microvessel density, elastin or smooth muscle cells (SMC) , nor in the amount of collagen I, III and V. Collagen IV was only detected in the basement membrane in all samples. When comparing the POP with the non-POP site in the same POP patient, a significantly higher percentage of SMC was found in the muscularis layer of the POP site (29 % vs 20 %, p<0.05). There was no significant difference in the amount

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of collagen I, III and V. There was a tendency, however, of a higher amount of collagen III in the non-POP site compared to the POP site of the same patient. The same pattern was seen in a sub-analysis of only the severe POP patients (POPq>3). Conclusions: It is suggested that POP is caused by a decrease in amount of SMC, elastin and microvessels, and/or by an increase of collagen III and V with loss of collagen I. Our results imply that POP is not likely to be caused by these changes, since we did not observe differences in these parameters between healthy controls and the non-POP site of POP patients. Interestingly, and to our knowledge not reported before, our results show a significantly higher amount of smooth muscle cells at the POP site in the muscularis layer compared to the non-POP site of the same patient. The difference we see in SMC may indicate an accommodation of the connective tissue to either the increased permanent mechanical load / pressure caused by the prolapse, or the tissue weakening due to decreases of collagen fiber thickness, organization, and/or collagen crosslinking status. A comparison of both the POP site and the non-POP site of the case group to the control group separately shows that the percentage of SMC at the non-prolapse site was clearly lower. The changes in connective tissue that we found in vaginal wall of prolapsed tissue are probably the effect, rather than the cause of pelvic organ prolapse. References (optional): M.H. Kerk hof: None. M. LeungLoHing: None. H. Bril: None. M. Bleeker: None. J.A. Belien: None. H.W. Niessen: None. H.A. Brölmann: None. A.M. Ruiz zapata: None. M.N. Helder: None.

2 EFFECTS OF CYCLIC MECHANICAL LOADING AND SURFACE SUBSTRATE ON FIBROBLASTS FROM WOMEN WITH DIFFERENT POP-Q STAGE Ruiz, Zapata AM1; Kerkhof, MH2; Zandieh-Doulabi, B3; Brölmann, HA1; Smit, TH1; Helder, MN1 1 VU Univ. Med. center, Amsterdam, Netherlands, 2Kennemer Gasthuis Hosp., Haarlem, Netherlands, 3Academic Ctr. for Dentistry Amsterdam (ACTA), Amsterdam, Netherlands. Objective: To test the hypothesis that phenotypic changes in POP fibroblasts result in altered FB-matrix interactions and ECM homeostasis-related factor expressions in response to mechanical loading. Background: Pelvic organ prolapse (POP) affects about 50 % of all women over 50 years old. Surgical treatments are unsatisfactory since recurrences remain high. New therapies like cell-based tissue engineering, and understanding

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the underlying mechanisms of POP are therefore urgently needed. POP is a result of mechanical failure of pelvic floor tissue. Mechanical properties of tissues are governed by interactions of cells with their micro-environment. In the pelvic floor, fibroblasts (FBs) are the mechanosensitive cells responsible for extracellular matrix (ECM) homeostasis. Homeostatic compounds include collagens, the collagen degrading matrix metalloproteinases (MMPs), and tissue inhibitors of metalloproteinases (TIMPs). Methods: Upon informed consent, FBs were isolated from vaginal wall of mild (POP-Q stage II) or severe (POP-Q stage IV) POP patients, and from the precervical region of control patients treated for non-POP related conditions. 150,000 FBs/well were seeded on 6-well uncoated or collagen I-coated bioflex® plates and subjected or not to cyclic mechanical loading (CML) (Flexercell; 10 % stretch, 0,2 Hz) for 48 h. Collagens I and III, MMP-2 and TIMP-2 gene expression, MMP activity, and/or protein levels were assessed. Statistical analysis was performed using one-way ANOVA followed by Tukey-Kramer’s post-hoc test. Results: Downregulation of both collagen I and III genes was observed in mild and severe POP-FBs (cf. healthy FBs) in uncoated plates (fig. 1a, 1c), but in collagencoated wells only in mild POP-FBs (fig. 1b, 1d). The MMP-2 (fig. 1e, 1f) and TIMP-2 (fig. 1 g, 1 h) genes showed similar expression levels in all FBs independent of coating and loading conditions, except for downregulation of MMP-2 in unloaded mild POP-FBs on collagencoated wells (fig. 1f). On uncoated plates, a gradual decrease in secreted MMP-2 activity was observed from healthy to mild to severe POPFBs, whereas faint but similar activity was seen in collagencoated wells. Interestingly, CML induced MMP-2 activity only in uncoated plates, in particular in healthy FBs. TIMP2 protein was demonstrated only on collagen I coated plates. Conclusions: Our data show that, in the absence of a “normal” collagenous ECM, collagen gene expression and active MMP-2 levels were lowered in POP vs. healthy FB, and that no secreted TIMP-2 protein was observed in all FBs. In contrast, on a collagenous ECM, collagen expression appeared largely unaffected, whereas faint but similar MMP-2 activity and secreted TIMP-2 protein were present in all FBs. CML acted primarily on MMP-2 activity levels in abnormal collagenous conditions. We conclude that POP fibroblasts show differential responses in aberrant collagenous surroundings. Restoration of ECM along with mechanical loading seem to improve diseased FB remodelling capacity, which may favour development of new cell-based tissue engineering concepts for POP treatment.

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Figure 1. Relative expression of extracellular matrix remodeling related genes. Fibroblasts from healthy, mild or severe POP patients were subjected or not to cyclic mechanical loading (+/- CML) on uncoated (a, c, e and g) or collagen I coated plates (b, d, f and h). Each row represents a different gene: Collagen IaI (a) and (b); Collagen 3aI (c) and (d); MMP-2 (e) and (f); TIMP-2 (g) and (h). Values were normalized to house keeping genes (YWHAZ and hUBC), expressed as a percentage of healthy control and represents the mean±SD, *p<0.05, **p<0.01, ***p<0.001; compared to the first bar unless indicated otherwise.

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Figure 2. MMP-2 and TIMP-2 proteins secreted by fibroblasts from healthy, mild or severe POP patients after 48 h of cyclic mechanical loading (CML) under different substrates (+/-collagen I). a) Zymogram showing MMP-2 activity. Inactive (pro) MMP-2 is present in all the samples evaluated. Active MMP-2 was only present when fibroblasts were cultured on uncoated plates (left blot). Human-recombinant MMP-2 was used as positive control. b) Western blot demonstrating that TIMP-2 was released by fibroblasts only in the presence of collagen I (middle blot). As positive control, cell lysates from derma stem cells were used. For both experiments, low serum media which was not exposed to cells was used as negative control.

References (optional): A.M. Ruiz Zapata: None. M.H. Kerkhof: None. B. Zandieh-Doulabi: None. H.A. Brölmann: None. T.H. Smit: None. M.N. Helder: None.

3 RANDOMIZED TRIAL COMPARING PROLIFT TOTAL AND NATIVE TISSUE VAGINAL REPAIR WITH SACROSPINOUS FIXATION IN PATIENTS WITH VAGINAL VAULT PROLAPSE AND LEVATOR ANI AVULSION INJURY, 1-YEAR FOLLOW-UP Svabik, K; Masata, J; Martan, A; el Haddad, R; Hubka P 1st Faculty of Med., Charles Univ. in Prague, Gen. Univ. Hosp. in Prague, Prague, Czech Republic. Objective: The primary aim was to compare, with a 1-year follow-up, the efficiency of two standard surgical procedures for vaginal vault prolapse—Prolift total and sacrospinous fixation with native tissue vaginal repair—for patients who have suffered at least two compartment prolapse after hysterectomy and been diagnosed with levator ani avulsion injury. Background: We have data indicating that avulsion injury is closely associated with prolapse. We decided to define and diagnose—by means of 4D ultrasound—the high risk group of women and test whether they might benefit from one of those standard surgical techniques. Methods: This is a single-centre, prospective, randomised interventional trial of two standard surgical procedures for post-hysterectomy vaginal vault prolapse: Prolift total (Prolift) and sacrospinous vaginal fixation (Amreich-Richter procedure) with native tissue vaginal repair (SSF). All eligible patients had undergone hysterectomy and attended our urogynecological unit during the period from 5/2008 to 12/2010 with at least two compartment prolapse (POPQ≥II). They were diagnosed by 4D ultrasound with avulsion injury and then

randomly divided into two groups. The POPQ classification for prolapse was used, and diagnosis of avulsion injury was performed by 4D ultrasound tomographic imaging using the levator urethra gap measurement in three axial slices (at minimal hiatal dimension and two above, 2.5 mm apart, during the pelvic floor muscle contraction—PFMC) The randomisation process was carried out the night before surgery by email from a remote centre. Both procedures were performed by two experienced surgeons who are familiar with both the procedures. The follow-up period was 1 year, with intermediate check-up after 3 month, to diagnose any complications and to plan subsequent antiincontinence procedure in case of urinary incontinence. The preoperative and postoperative assessment procedures were identical. (POPQ examination, Pelvic floor 4D ultrasound). Preoperative levator assessment and avulsion diagnosis from 4D volume was performed at the time of diagnosis (2–3 months prior to surgery) to fulfil the main inclusion criteria. Other stored volume analysis was performed offline after completion of the study with appropriate software. Prior to the study power analysis was performed. Descriptive analyses are provided and comparisons between the groups were performed by two-sample ttest, using Statistica 10-StatSoft.Inc software (Tulsa,USA). The failures were defined as any point at POPQ>-1, while the ultrasound criteria for failure was defined as urethra or bladder below the lower margin of the symphysis at maximal Valsalva more than 10 mm. The failures were analysed using Pearson Chi-Square test. Results: During the study period there 592 patients underwent surgery for some sort of compartment prolapse in our unit: 132 were after hysterectomy and 70 of them had avulsion injury. They were randomised into two groups: 36 patients in the Prolift group and 34 patients in the SSF group. There were no drop-outs

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during the follow-up process. The reliability of the randomisation process and preoperative data is summarized in Table 1.

Preoperative Age Height (cm) Weight (kg) BMI parity Aa Ba C TVL Ap Bp GH PB Hiatal Area— Valsalva (cm2)

Prolift N036 63.4 163.8 73.1 27.2 2.14 1.306 4.111 2.111 8.111 0.389 2.417 4.778 3.639

SSF N034 62.5 163.0 74.8 28.2 2.17 0.882 3.618 1.471 8.029 0.706 2.441 4.559 3.941

t

p

0.404 0.561 −0.688 −1.103 −0.207 1.164 0.845 0.690 0.396 −0.807 −0.036 0.886 −1.179

0.687 0.576 0.494 0.274 0.837 0.248 0.401 0.492 0.693 0.423 0.971 0.379 0.243

43.522 43.117 0.137

Prolift SD 8.614 6.173 9.894 3.215 0.833 1.721 2.435 3.897 0.919 1.761 2.872 0.989 1.150

SFF SD 10858 5.815 10.602 4.188 0.673 1.274 2.450 3.863 0.797 1.508 2.743 1.078 0.983

0.891 12.491 12.223

The results at 1-year follow-up are summarized in Table 2

1 year follow-up Aa Ba C Ap Bp GH PB TVL Hiatal Area Valsalva (cm2) UVJ Valsalva (cm) Bladder Valsalva (cm)

Prolift N036 −2.417 −2.389 −6.167 −2.333 −2.333 3.333 4.556 7.361 29.576

SSF N034 −0.853 −0.118 −3.235 −1.765 −1.353 3.500 4.794 7.147 36.992

t

p

−7.019 −7.533 −4.618 −2.278 −2.839 −0.978 −1.115 0.833 −2.682

0.000 0.000 0.000 0.026 0.006 0.331 0.269 0.408 0.009

Prolift SD 0.649 0.645 1.298 0.717 0.717 0.632 0.843 1.073 7.443

SFF SD 1.158 1.684 3.568 1.304 1.937 0.788 0.946 1.077 14.248

−1.163 −0.008 −6.415 0.000 0.744 0.762 −1.076 1.231 −10.365 0.000 0.721 1.111

The reference point for UVJ (uretro-vesical junction) and bladder descent is the lower margin of symphysis There was one failure in the Prolift group (2.8 %) and 22 failures in the SSF group (64.7 %), (Pearson Chi-Square: 30.39; p<0,001), according to the POPQ examination and clinical failure definition. In addition, there was 1 failure in the Prolift group (2.8 %) and 21 failures in the SSF group (61.7 %) according to the ultrasound criteria. The protrusion rate in the Prolift group was 8.3–3 % cases. The vaginal spotting (discharge) rate in the SSF group was 14.7–5 % cases. (Pearson Chi-Square:0.701; p00.402). There were 3

cases in the SSF group who underwent re-operation for symptomatic prolapse diagnosed at the 3-month intermediate follow-up. Conclusion: The classical Amreich-Richter procedure in patients with prolapse after hysterectomy and avulsion levator injury has a higher failure rate and was significantly inferior to the Prolift total procedure. This is one of the first prospective randomised study adopting the 4D ultrasound diagnosis of levator avulsion into the indication algorithm for prolapse surgery. K. Svabik: Grant /Research Support; Grant Agency of the Ministry of Health of the Czech Republic, grant NT12147-4, Charles University in Prague—UNCE 204024. J. Masata: Grant /Research Support; Grant Agency of the Ministry of Health of the Czech Republic, grant NT12147-4. A. Martan: Consultant; Ethicon Womens Health and Urology, Astelas and Bard. Grant / Research Support; Grant Agency of the Ministry of Health of the Czech Republic, grant NT12147-4. R. El Haddad: None. P. Hubka: None.

4 COMPARISON BETWEEN UGYTEX® TRANSVAGINAL MESH AND TRADITIONAL ANTERIOR COLPORRHAPHY IN THE TREATMENT OF ANTERIOR VAGINAL WALL PROLAPSE: RESULTS OF A FRENCH RCT de Tayrac, R1; Cornille, A1; Eglin, G2, Guilbaud O.3, Mansoor A.4, Fernandez H.5; 1 Nimes Univ. Hosp., Nimes, France, 2Champeau Private Hosp., Beziers, France, 3Chartes Hosp., Chartes, France, 4 Issoir Hosp., Issoir, France, 5Kremlin Bicetre Univ. Hosp., Kremlin Bicetre, France. Objective: To compare the efficacy of polypropylene meshes coated with collagen (Ugytex®, SofradimCovidien) and the use of native tissue (anterior colporrhaphy) in the treatment of anterior vaginal wall prolapse in vaginal surgery (stage 2 or more). Background: Since the first publication in 1996, the use of meshes in vaginal surgery is increasingly used in the treatment of pelvic floor dysfunctions. Recently a protest movement against meshes amounted to United States, justifying the implementation of studies with high level of evidence. Methods: Prospective, randomized and multicentric study conducted between April 2005 and December 2009. The principal outcome was to compare the rate of anatomic recurrence of anterior vaginal wall prolapse of stage 2 or more in the POP-Q classification, 12 months after surgery, in patients aged 60 or more. Secondary outcomes were to compare functional results

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using validated and specific questionnaires and to study the mesh-related morbidity. Results: 147 patients were included, randomized and analyzed, 72 in the anterior colporrhaphy group and 75 in the mesh group. Two patients with bladder injury (1.4 %) occurred during dissection, were excluded from the study. At one year (mean of 17+/-9 months in the colporrhaphy group and 16+/-8 months in the mesh group), anatomical success rate was significantly higher in the mesh group (89 %) than in the colporrhaphy group (64 %) (p00.0006). The absence of anatomical and functional recurrence (no bulging symptoms) was also better in the mesh group (68.7 % vs 47.8 %, p0 0.007). Two patients were reoperated in the colporrhaphy group for anterior vaginal wall prolapse recurrence (2.8 %) with mesh surgery. There was no significant difference regarding minor complications (transitory fever, hemorrhage without transfusion, vaginal or obturator hematoma, urinary retention). Erosion rate was 9.5 % (4 patients reoperated, one medically treated and two lost to follow-up). Global reoperation rate was 13.9 % in the colporrhaphy group (1 evacuation of hematoma, 1 section of mid-urethral sling, 2 anterior mesh for recurrence, 1 posterior colporrhaphy and 3 sub-uethral slings, 2 unrelated with prolapse: breast cancer and bladder polyp) and 10.7 % in the mesh group (4 mesh erosions, 1 section of obturator arm for dyspareunia, 2 posterior meshes, 1 sub-urethral sling) (p00.5). There was a tendency of increasing pain in the mesh group (pain minimum one time for 19 % of patients in colporrhaphy group and 28 % in mesh group, p 00.2) or during examination (pain minimum one time for 15 % of patients in colporrhaphy group and 28 % in mesh group, p00,06). De novo dyspareunia rate at follow-up was 7.7 % in the colporrhaphy group and 5.2 % in the mesh group (p00.5). Rates of de novo stress urinary incontinence were similar in both groups (12 % for mesh group and 11 % for colporrhaphy group, p00.8). The analysis of quality of life questionnaires (PFIQ, PFDI and PISQ-12) showed global improvement but no statistical difference between groups. Satisfaction rates were high in both groups (92 % for colporrhaphy group and 96 % for mesh group). Conclusions: The use of trans-obturator Ugytex® mesh in vaginal surgery for the treatment of anterior vaginal wall prolapse reveals at 1 year better anatomical and functional success rates than traditional anterior colporrhaphy, with no increased morbidity in the mesh group. R. De tayrac: Consultant; Boston Scientific. Grant / Research Support; Boston Scientific, SofradimCovidien. A. Cornille: None. G. Eglin: Grant /Research

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Support; Sofradim-Covidien. O. Guilbaud: None. A. Mansoor: None. H. Fernandez: Grant /Research Support; Ethicon, Nordic Pharma.

5 RANDOMISED CONTROLLED TRIAL OF POSTHYSTERECTOMY VAGINAL VAULT PROLAPSE T R E AT M E N T W I T H E X T R A P E R I T O N E A L VAGINAL UTEROSACRAL LIGAMENT SUSPENSION WITH ANTERIOR MESH REINFORCEMENT VS SACROCOLPOPEXY (OPEN/LAPAROSCOPIC) Y. N. Lim1, A. Rosamilia 1, P. L. Dwyer 1, J. Alvarez 1, F. Chao 2, C. Murray 1, A. Leitch 2, L. Schierlitz 1, A. Desouza 1, E. Thomas 1, G. Agnew 1, J. Lee 2 1 Mercy Hosp. for Women, Heidelberg, Australia, 2Monash Med. Centre, Moorabin, Australia. Objective: To compare the efficacy of vaginal extraperitoneal uterosacral ligament suspension (VEULS) with anterior mesh to laparoscopic/abdominal sacrocolpopexy (SCP) for post-hysterectomy vault prolapse Background: Previous RCT’s have shown that abdominal sacrocolpopexy is superior to vaginal sacrospinous fixation (VSSF) for vault prolapse1,2. However, these studies were biased as meshes were used in the abdominal group but not the vaginal group. At the time this study was designed, VEULS was the vaginal approach of choice for our units and we hypothesized following publication of a large case series that this may provide comparable results to sacrocolpopexy.3 Methods: This was an IRB approved, multicentre open randomised study. Inclusion criteria was post-hysterectomy anterior & vault prolapse of ≥stage 2 POPQ. Exclusion criteria were: past history of urogenital fistula, SCP, VEULS or major mesh complications. Primary outcome was the number of women with anterior or apical prolapse of ≥stage 2 POPQ. Secondary outcomes were changes in urogenital symptoms & their impact on QOL & sexual function(measured with PFDI-20, PFIQ-7, PISQ-12), and short to medium term complications. Assuming an anterior/vault recurrence rate of 13 % for the ASCP group and 25 % recurrence rate for the vaginal group, 55 subjects in each arm were required to achieve a one-sided α level of 0.05 and power of 80 %. UltraPro (Ethicon,NJ) meshes were used in both groups. In the vaginal group, meshes were implanted with overlay fashion after fascial plication, and VEULS were performed with two 0 PDS sutures on each side. SCP’s were performed laparoscopically or abdominally at surgeon’s discretion. Where stress incontinence surgery was required, midurethral slings were performed. Between 2006 and 2011, a total of 80 eligible patients were randomised. The study was ceased early due to long recruitment time and changes to surgical technique that were occurring

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outside of the study. A dataset of 32 VEULS and 38 SCP cases with mean follow up of 14.1(SD10.9) months were available for analyses. Table 1 shows the comparisons of demographics Table 1 Variables Age BMI Parity Previous POP surgery Postmenopausal Sexually active Concomitant post vag repair Concomitant sling

Vaginal Group (n032) 63.0 27.3 3.1 57.6 % 97.0 % 45.4 % 40.6 % 9.4 %

SCP group (n038) 64.2 26.7 2.7 48.6 % 96.9 % 52.6 % 13.2 % 7.9 %

p-value 0.58 0.58 0.27 0.46 0.98 0.55 0.01 0.59

Results: Surgical time was significantly longer (p<0.05) in the SCP group (mean 169.2 min) than the vaginal group (mean 94.5 min). Otherwise, there were no significant differences between hospital stay (3.6 vs 3.8 days, p00.72) and catheter days (1.9 vs 2.1, p00.66). Whilst there were not any individual peri-operative morbidity variables that were significantly more common in either group, the total no of cases with peri-operative complications (cystotomy, pelvic haematoma, wound hernia & infection, mesh exposure) were more common in the SCP group (13 vs 4, p00.045) than the vaginal group. Specifically, there was no statistically significant differences in mesh exposure complications (2 in vaginal group and 3 in SCP group p00.58). Table 2 show the comparison of pre- & post-operative POPQ and VAS scores (mean follow up 14.1 months) POPQ Aa Ba C Gh Pb TVL Ap Bp VAS at 12 months

Pre-op Vaginal group 0.61

Pre-op SCP P value group 1.47 0.75

Post-op Vaginal group −1.30

Post-op SCP P value group −1.59 0.34

1.61 0.91 4.23 3.72 8.94 0.06 0.70

2.05 1.03 4.34 3.54 9.00 −0.16 0.41

−1.27 −5.87 3.83 3.70 7.50 −2.17 −2.17 83.5

−1.38 −6.94 3.82 3.68 8.65 −1.65 −1.89 81.2

0.41 0.89 0.54 0.33 0.80 0.72 0.66

0.74 0.07 0.95 0.88 <0.05 0.09 0.08 0.74

Overall, the objective success rates (anterior or vault prolapse
higher point C but other anatomical and subjective outcomes measures were comparable to those of VEULS with anterior vaginal mesh reinforcement. There were, however, more peri-operative morbidities with sacrocolpopexy group but no differences in medium term mesh complications between the 2 approaches. Further longer term follow up is planned. References: 1. AJOG 2004; 190:20–6 2. AJOG 1996; 175(6):1418–21 3. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Apr;20 (4):427–3 Y.N. Lim: None. A. Rosamilia: None. P.L. Dwyer: None. J. Alvarez: None. F. Chao: None. C. Murray: None. A. Leitch: None. L. Schierlitz: None. A. Desouza: None. E. Thomas: None. G. Agnew: None. J. Lee: None.

6 2012 COCHRANE REVIEW:SURGICAL MANAGEMENT OF PELVIC ORGAN PROLAPSE C. Schmid 1 , C. Maher 2 , B. Feiner 3 , K. Baessler 4 , C. Glazener 5 1 RBWH Brisbane Urogynaecology, Brisbane, Australia, 2 Wesley Urogynaecology Unit, Wesley Hosp., Brisbane, Australia, 3Div. of Urogynecology and reconstructive pelvic surgery Dept. of Obstetrics and Gynecology Hillel Yaffe Med. Ctr. Technion Univ., Rappaport Faculty of Med., Hadera, Israel, 4Charité Univ.smedizin Berlin Campus Benjamin Franklin and Mitte, Berlin, Germany, 5Hlth.Res. Unit, Univ. of Aberdeen, Aberdeen, United Kingdom. Objective: This meta-analysis of Randomised Controlled Trials summarises the evidence of the effects of surgery in the management of pelvic organ prolapse and is a major update of 2010 review. Methods: All Randomised Controlled Trials that evaluated surgical interventions for managing pelvic organ prolapse, and were published or presented prior to February 2012, were identified from MEDLINE, CINAHL, the Cochrane Central Register of Controlled Trials (CENTRAL) and hand searching of journals and major conference proceedings. Trials were excluded if the sample size was <20 in each arm and review time was <6 months. Trials quality was assessed and data extracted independently by two reviewers. Meta-analyses were performed on a variety of objectives and evidence based conclusions were drawn accordingly. Results: Fifty-four randomised controlled trials were identified evaluating 5786 women. For anterior vaginal wall prolapse, standard native tissue anterior repair was associated with more recurrent anterior compartment prolapse than when supplemented with a polyglactin mesh inlay (RR 1.39, 95 % CI 1.02 to 1.90) or porcine

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dermis mesh inlay (RR 2.08 95 % CI 1.08 to 4.01); but data on morbidity and other clinical outcomes were lacking. Standard anterior repair was associated with more anterior compartment failures on examination than any polypropylene mesh repair ( RR 3.15 95 % CI 2.50 to 3.96) and the effect was similar whether the mesh was performed as an overlay (RR 2.14, 95 % CI 1.23 to 3.74) or via a transobturator fixation (RR 3.50, 95 % CI 2.71 to 4.51). The transobturator mesh was equally effective if the mesh was self-styled (RR 3.41 95 % CI 2.64 to 4.74) or a commercial mesh kit was utilised (RR 3.53 95 % CI 2.62 to 4.74). The subjective failure rate was also higher after traditional (no mesh) anterior repair as compared to polypropylene mesh repair (28 % versus 18 % RR 1.57 95 % CI 1.18 to 2.07). However, the reoperation rate for prolapse was similar at 14/459 (3 %) after the native tissue repair as compared to 6/470 (1.3 %) following mesh repair (RR 2.18 95 % CI 0.93 to 5.10) and no differences in quality of life data, or de-novo dyspareunia was identified. Blood loss (MD 64 ml 95 % CI 48 to 81),operating time (MD 19 mins 95 % CI 16 to 21) and recurrences in apical or posterior compartment (RR 1.85 95 % CI 1.01 to 3.37) was significantly higher with transobturator meshes than for native tissue anterior repair. Mesh exposure were reported in 10.4 % (41/393) with surgical interventions being performed in 6.3 % (34/ 540). Two trials compared native tissue vaginal repairs and a combination of total, anterior or posterior polypropylene mesh repairs in women with prolapse involving anterior, posterior and/or apical compartment. They demonstrated the recurrence rate on examination (native tissue 75/117, 65 % versus 61/115, 53 % polypropylene mesh) and the subjective failure rate (19/113 versus 17/ 105) were both similar between the groups with a mesh extrusion rate of 16.5 % and 7 % requiring surgical intervention. The total reoperation rate for prolapse, stress urinary incontinence or mesh complications after native tissue repair was 4/117 (3.4 %) as compared to 11/110 (10 %) after the combined polypropylene meshes. As previously reported abdominal sacral colpopexy was better than vaginal sacrospinous colpopexy in terms of a lower rate of recurrent vault prolapse on examination (3 % versus 15 %) (RR 0.23, 95 % CI 0.07 to 0.77) and less dyspareunia (RR 0.39, 95 % CI 0.18 to 0.86). In new single studies the sacral colpopexy had a higher success rate on examination and lower reoperation rate than the high vaginal uterosacral suspension and transvaginal polypropylene mesh. Five RCT’s compared native tissue repairs and transobturator mesh procedures and native tissue repair group had significantly lower risk of de-novo SUI (RR 0.64 95 % CI 0.42 to 0.97 ) and reoperation rates for prolapse, stress urinary

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incontinence or mesh complications 5.2 % (23/439) as compared to 11.1 % (50/448) in mesh group (P<0.01). Conclusion: Abdominal sacral colpopexy has superior outcomes as compared to sacrospinous colpopexy, uterosacral colpopexy and transvaginal polypropylene mesh. The use of mesh or graft inlays at the time of anterior vaginal wall repair reduces the risk of recurrent anterior wall prolapse on examination. Anterior vaginal polypropylene mesh also reduces awareness of prolapse however these benefits must be weighed against increased operating time, blood loss, posterior or apical prolapse and reoperation rate for mesh exposures associated with the use of polypropylene mesh. There was no difference in anatomical and subjective outcomes when native tissue vaginal repairs were compared to multi-compartment transvaginal polypropylene mesh, however, the mesh group was associated with a significantly higher reoperation rate. Further adequately powered randomised controlled clinical trials are required. C. Schmid: None. C. Maher: None. B. Feiner: None. K. Baessler: None. C. Glazener: None.

7 PESSARY USE AS A CONSERVATIVE TREATMENT FOR PELVIC ORGAN PROLAPSE S. Ramsay, L. Tu Université de Sherbrooke, Sherbrooke, Canada. Objective: The objectives of this retrospective study are to evaluate whether long-term use of vaginal pessaries is an appropriate conservative treatment for women with pelvic organ prolapses (POP) and to assess the complications related to this therapeutic option. Background: POP is a common condition, particularly among older women. Apart from surgical options, it can be managed conservatively, an attractive option for our aging population. Although the use of pessaries is common worldwide, there is no consensus on the use of different types of device, the indications, the pattern of maintenance or replacement, nor the follow-up care due to lack of appropriate studies addressing these issues. Methods: From 1998 to 2010, 429 women with POP had a pessary trial following a thorough history and gynecological exam. Vaginal atrophy and constipation were addressed prior to the trial. Patients received instructional documentation about pessary maintenance and were encouraged to use topical estrogen and mucolytic cream at home. A follow-up appointment was scheduled at 1 month where a pessary maintenance regime was chosen (self-maintenance, maintenance by nurses in regional clinics or by nurses in our own

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clinic). Additional follow-up visits were then scheduled yearly, or before as patient needs. Data gathered included descriptive information regarding each patient, specific information concerning pessary use, incidence of vaginal erosions or other associated morbidities, and subjective satisfaction rate ranging from not satisfied, satisfied, very satisfied and extremely satisfied. Results: Average age at presentation was 71.1 9.7 years old. 50 % of patients had had hysterectomy and 22 % had had a prior prolapse surgery. 62 % (n0258) of women had a successful pessary trial, which was defined as a one-month use of the pessary with subjective improvement of symptoms and no significant complication. Median duration of pessary use was 35 months (1– 136). 96 % of women were very satisfied or extremely satisfied with their pessaries. 66 % (n0170) of patients could handle pessary by self-maintenance, while 23 % (n059) needed assistance from a regional nurse, and 11 % (n 028) necessitated maintenance by our clinic nurses. Among these three groups, 71 %, 61 %, and 43 % of the patients respectively continued using the pessary. 12 % (n030) of women eventually used the pessary intermittently. Being in the pessary selfmaintenance group was associated with a prolonged use of the pessary (38 months vs 30 months for the nurse group vs 27 months for the clinic group, p 0 0.021). Mucolytic cream use was also associated with a prolonged use of the pessary (38 vs 26 months, p0 0.001). The overall erosion rate was 16 % and was not associated with the degree of prolapsus. Constipation and longer duration of pessary use were associated with higher rates of erosions (23 vs 12 %, p00.027, and 45 vs 33 %, p00.015 respectively), while sexually active women had a significantly lower rate of erosions (7 vs 21 %, p00.007). Multivariate analysis demonstrated that erosions are associated with older age (p00.011), constipation (p 00.018), and use of topical estrogen (p0 0.001). The severity of vaginal atrophy increased with older age (p<0.001) and older patients were therefore more likely to use topical estrogen (p<0.001). Both the severity of vaginal atrophy and intensive estrogen treatment before pessary trial were associated with a higher rate of erosions (p<0.001 and p00.004). There was no major complication. 66 % (n 0170) of women who underwent a successful pessary trial are still using a pessary. Main reasons for pessary use cessation included discomfort, cumbersome maintenance, occult or exacerbated urinary incontinence, exacerbated constipation, and recurring vaginal erosions. Conclusions: Based on our experience, the pessary is an effective and safe alternative treatment for women with troublesome POP. These results show that patient’s satisfaction is excellent and that the majority of women

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who underwent a successful pessary trial continue to use the pessary through time. There was no major complication related to the treatment after a median follow up of 35 months. Pessary self-maintenance regime appears to be an important aspect of pessary management as it leads to a prolonged use of the pessary. Regular maintenance and follow-up are essential, especially as the occurrence of vaginal erosions is difficult to predict. Vaginal erosions are more frequent in older patients with more severe vaginal atrophy, and do not seem totally preventable by the use of topical estrogen. S. Ramsay: None. L. Tu: None.

8 PELVIC-FLOOR MORPHOLOGY: A PREDICTOR OF PHYSIOTHERAPY SUCCESS FOR WOMEN WITH STRESS AND MIXED URINARY INCONTINENCE C. Dumoulin, S. Pontbriand-Drolet, A. Tang, S. Maddill, M. Morin; Res. Ctr., Montreal Geriatric Inst., Montreal, Canada. Objective: To determine if pelvic floor muscle (PFM) morphology at baseline and measured by anatomical magnetic resonance imaging (MRI) can predict responsiveness to PFM muscle physiotherapy in women with stress or mixed urinary incontinence (UI). Background: According to the 4th International Consultation on Incontinence, we know relatively little about how, hence are unable, to discriminate, pre-treatment, between women who will and will not respond to PFM muscle physiotherapy.(1) Methods: Baseline PFM morphological parameters and post-PFM muscle physiotherapy continence status were analyzed in women, aged 60 and over, participating in a prospective quasi-experimental pre-test, post-test cohort study. The study assessed eight potential predictors (i.e., baseline PFM morphological parameters) under three conditions, at rest, during a PFM contraction and during straining: 1) the pubococcygeal line, 2) the anorectal angle, 3) the H-line, 4) the M-line, 5) the PCL/H-line angle, 6) the height of the urethrovesical (UV) junction, 7) the height of the uterocervical junction, and 8) the UV junction approximation. Images were taken through dynamic MRI in the sagittal plane with a Siemens Magnetom Trio 3.0 T and an iPAT torso/pelvis coil centered on the pubic symphysis. The women participated in a 12-week PFM muscle physiotherapy program (class and home exercises), an intervention known to be effective for UI.(2) Physiotherapy responsiveness was calculated as a combined

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score and defined as 1) a post-treatment reduction of 50 % or more in the number of mean UI episodes per day, as measured on a 3-day bladder diary, and 2) a post-treatment reduction of 50 % or more in the original IIQ impact score.(3) Univariate analysis was used to examine the associations between each of the 24 predictors (3 conditions X 8 predictors) and the dependent variable (responsiveness to physiotherapy). Predictors that reached significance were subject to a backward stepwise logistic regression analysis to determine which combination of predictors best explained responsiveness. A ROC-curve was then constructed to identify a decision threshold. Results: Forty women with a mean age of 68.42 (5.32) and stress or mixed UI participated: 25 (62.5 %) were classified as responsive post-intervention and 15 (37.5 %) were not. In the univariate analysis, women with 1) a shorter UV junction approximation on straining, 2) a shorter M-line at rest, 3) a smaller PCL/H-line angle at rest, and 4) a longer UV junction height at rest (p≤.005) were more likely to demonstrate responsiveness (be improved) following physiotherapy. Thus, these four parameters (potential predictors) were retained for logistic regression analysis; ultimately, two were associated with responsiveness: UV junction height at rest (perpendicular distance between the anterior aspect of the UV junction and the pubococcygeal line) and UV junction approximation on straining (perpendicular distance between the UV junction and the pubic axis), although, the latter did not make a statistically significant contribution to the model. There was a good model fit with a chi-square of 20.94 (p<0.001), indicating that, combined, the two predictors had reliably distinguished in the pre-treatment phase between those post-treatment participants who were responsive (improved) and those who were not (no improvement). This model, based on 2 of the 4 PFM morphological parameters, explained between 42 % (Cox and Snell R2) and 58 % (Nagelkerke R2) of the outcome variability and correctly classified 84.2 % of the participants. When the full model was applied (4 parameters), the success rate increased to 86 %, only a small improvement. According to the findings, women with a longer UV junction height at rest prior to PFM muscle physiotherapy were 1.35 times more likely to be improved after PFM training (OR 1.35; 95 % CI: 1.08–1.67; p<0.001). Finally, the area under the ROC-curve was 0.82 (95 % CI: 0.67–0.96; p<0.001). Using a cutoff point of 11.41 mm, participants’ responsiveness to the PFM muscle physiotherapy was predicted with a sensitivity of 77 % and a specificity of 83 %. Conclusion: There was a strong correlation between participants’ pre-treatment PFM morphology and the outcome of PFM physiotherapy. The study found that a UV junction height at rest of 11.41 mm or longer

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was predictive of responsiveness to PFM physiotherapy. This novel information needs to be validated through larger prospective controlled trials. Further, given the high cost of MRIs, proxy variables that can be measured by more cost-effective and widely-available clinical tools (e.g., ultrasound, dynamometer) also need to be identified. References: 1. 4th International Consultation on Incontinence, 2009; ISBN 0-9546956-8-2. 2. Cochrane Database of Systematic Reviews 2010 Jan 20; (1): CD005654. 3. Qual Life Res. 1994;3(5):291–306. C. Dumoulin: Employee (full or part time); University of Montreal. Grant /Research Support; Canadian Institute of Health Research, Fonds de la recherche en Santé du Québec. S. Pontbriand-Drolet: None. A. Tang: None. S. Maddill: None. M. Morin: None.

9 HOW TO DETERMINE ‘BALLOONING’ OF THE LEVATOR HIATUS ON CLINICAL EXAMINATION B. Gerges, I. Kamisan Atan, K. Shek, H. Dietz Univ. of Sydney, Penrith, Australia. Objective: To define abnormal distensibility of the levator hiatus using the ICS POPQ system. Background: The levator hiatus is the largest potential hernial portal in the human body. Herniation is common, resulting in female pelvic organ prolapse (FPOP) and rectal intussusception/ prolapse. Hiatal dimensions determined on imaging are a strong predictor of FPOP (1) and FPOP recurrence. A clinical equivalent can be recorded as Gh +Pb on the ICS prolapse quantification system (POPQ). The sum of Gh+Pb is strongly associated with symptoms and signs of FPOP (2). Methods: This study utilizes data obtained at a tertiary urodynamic service. Appointments consisted of a standardised interview, ICS POP-Q and 4D translabial pelvic floor ultrasound (US) (3) . Measurement of Gh+Pb was undertaken on maximal Valsalva, by the senior author, or by staff under his direct supervision. Hiatal dimensions on Valsalva were determined by offline analysis of stored volume data sets (3) at a later date, blinded against all other data. Levator avulsion was diagnosed using tomographic ultrasound imaging(3). We then tested Gh+Pb against symptoms (vaginal lump or bulge) and signs (ICDS POP-Q stage 2+) of FPOP, using receiver operator curve statistics, and stratified abnormal patients into ‘mild’, ‘moderate’, ‘marked’ and ‘severe’ clinical ballooning.

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Figure 1. Determination of Gh+Pb using the POPStix ™ disposable wooden ruler (a) and measurement of hiatal dimensions on US (b).

Results: A total of 477 patients were seen between 9/10 and 2/12. Of those, US volume data sets were missing due to equipment unavailability (42) and clerical error (3), leaving 432. Mean age was 56.7 (19–86), mean BMI was 29.1 (17.3–55.7). They complained of stress incontinence (73 %), urge incontinence (73 %), frequency (29 %), nocturia (43 %), symptoms of voiding dysfunction (31 %) and prolapse (51 %). Most were vaginally parous (91 %), 31 % had had a previous hysterectomy, 21 % a previous incontinence or prolapse procedure. On examination, 79 % of patients had a significant prolapse (ICS POPQ stage 2+), which was a cystocele in 64 %, uterine prolapse in 12 %, an enterocele in 5 % and a rectocele in 54 %. In 13 cases Gh+Pb could not be determined due to lack of equipment, omission, absence of the anus, or access problems, leaving 419 data sets. On average, Gh was measured at 4.2 (range, 1.5–8.5) cm, Pb at 3.8 (range, 2.0–7.0) cm, giving a sum of 7.9 cm on average (range, 4.2–13.0) for Gh+Pb. The sum of Gh+Pb was strongly associated with symptoms (p<0.001) and signs (P<0.001) of FPOP. The area under the curve on receiver operator curve statistics was determined as 0.707 (0.658–0.755) in predicting symptoms of FPOP, and as 0.890 (0.854–0.925) for predicting objective FPOP of stage 2 or higher, with 7 cm giving a sensitivity of 80 % and a specificity of 81 % for the latter. We then stratified the 309 patients with abnormal (ie.7 cm or higher) Gh+Pb measurements into mild, moderate, marked and severe ballooning (Table 1), compromising between easily remembered cut-off numbers and quartiles.

Table 1. Stratification of degrees of clinical ballooning by measuring Gh+Pb (n0419). Category

N

Symptoms Clinical Levator Mean of prolapse prolapse avulsion hiatal stage 2+ area on Valsalva 110 32 % 44 % 7% 20.5 cm2 89 47 % 79 % 10 % 27.3 cm2

Normal (<7 cm) Mild ballooning (7.0–7.99 cm) Moderate ballooning 98 (8–8.99 cm) Marked ballooning 67 (9–9.99 cm) Severe ballooning 55 (10 cm or higher)

50 %

98 %

20 %

31.5 cm2

76 %

100 %

37 %

35.1 cm2

78 %

98 %

53 %

41.9 cm2

Conclusions: Clinical ballooning (Gh+Pb) is a strong predictor of symptoms and signs of FPOP. We propose to define mild ballooning as Gh+Pb 07.0–7.99 cm, moderate ballooning as 8.0–8.99 cm, marked ballooning as 9.0–9.99 cm and severe ballooning as 10 cm or more. Increasing degrees of ballooning are associated with increasing likelihood of symptoms and signs of FPOP, with increasing prevalence of levator avulsion, and with a larger hiatal area measured on translabial 4D US. References: 1. Ultrasound Obstet Gynecol 2008; 31: 676–80 2. Am J Obstet Gynecol 2012;206: e241–244 3. Int Urogynecol J 2011; 22: 1221–1232 B. Gerges: None. I. Kamisan Atan: None. K. Shek: None. H. Dietz: Grant /Research Support; GE Medical Educational grant A$ 9000.

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10 M U S C U L O S K E L E TA L PA I N E VA L U AT I O N OF PATIENTS WITH INTERSTITIAL CYSTITIS T. V. Sanses1, G. Chelimsky 2, D. Zhang 3, J. Janata 1, T. Mahajan 1, B. Fenton 4, A. Askari 1, R. Elston 5, T. Chelimsky 2, Icepac Study Group 1 Univ. Hosp. Case Med. Ctr., Cleveland, OH, 2Med. Coll. of Wisconsin, Milwaukee, WI, 3Case Western Reserve Univ. Sch. of Med., Cleveland, OH, 4SUMMA Hlth.System, Akron, OH, 5Case Western Reserve Univ., Cleveland, OH. Objectives: To determine the distribution and correlations of pain across five body locations in women with Interstitial Cystitis (IC) and healthy age-matched women. Background: Despite extensive research, the etiology of IC pain remains elusive. We hypothesized that deep muscular pelvic pain in patients with IC is due to a generalized pain disorder with altered afferent signaling. Therefore, the pain is not limited to the pelvic area, but rather a more centralized disorder. Methods: This study represents the initial results from the multicenter prospective cohort trial Interstitial Cystitis Elucidation of Psychophysiologic and Autonomic Characteristics (ICEPAC). Subjects with IC, myofascial pelvic pain disorder (MPP), 1st degree female relatives of women with IC without pelvic pain, and healthy agematched women underwent muscular tender point assessment in 5 areas: 18 generalized body tender points as described for fibromyalgia, 10 abdominal muscle tender points, 6 inguinal, 6 inner thigh and 5 pelvic area tender points. Pain was assessed using a 0–10 Numeric Rating Scale (NRS) as part of a standardized physical examination. We calculated the overall intraclass correlation (ICC), where the classes are the body locations, and the 10 pairwise correlations across the 5 locations of pelvic, body, lower extremity, abdominal and inguinal tender points. Similar results were obtained for the raw measurements and with a logarithm transform of (NRS+1). Positive pairwise correlations across all body locations and overall intraclass correlation (ICC) would support our hypothesis of generalized pain disorder, rather than a local pathological process. Results: We examined the initial 45 subjects enrolled in four groups: 17 patients with IC, 5 with only MPP, 3 1st degree female relatives of IC patients, and 20 healthy age-matched women. Due to small numbers of women in MPP and 1st degree relatives, they were excluded from this analysis. We found no difference in age (39.2± 16.5 versus 39.2±16.6 years, p00.99) and mean Body Mass Index (29.6 ± 6.8 versus 26.3 ± 7.4,

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p 00.17) between patients with IC and healthy agematched women respectively. The range of mean NRS pain scores for different body locations in subjects with IC was 4.1–5.2 as compared to healthy controls 0.2–1.0. The mean pelvic NRS pain score in subjects with IC was significantly higher than in healthy controls (4.91± 3.34 and 0.19±0.31, p<0.01) The ICC was positive in both groups. The ICC coefficients for women with IC and healthy age-matched controls were 0.58 and 0.541, respectively. Within the group of women with IC, the pairwise correlation coefficients were high between pelvic and abdominal (0.70), and between pelvic and inguinal (0.73) muscle groups. Similar but smaller correlations were noticed in healthy controls, with highest correlation coefficients between pelvic and abdomen (0.52), and between pelvic and lower extremity (0.47). Conclusions: Our hypothesis that muscular, including pelvic, pain in women with IC is due to a generalized pain disorder with altered afferent signaling is supported by our preliminary findings of positive pairwise correlations across all body locations and positive overall ICC. These results are promising and will be confirmed after the final enrollment is completed. Table 1. Musculoskeletal pain evaluation of women with interstitial cystitis across different body locations. pairwise correlation coefficients Muscle groups Healthy Pelvic Body Extremity Abdominal Inguinal Interstitial Pelvic cystitis Body Extremity Abdominal Inguinal

Pelvic Body Extremity Abdominal Inguinal 1.000 .258 .465 .526 .300 1.000 .317 .483 .700 .729

.258 1.000 .750 .749 .683 .317 1.000 .695 .444 .483

.465 .750 1.000 .580 .792 .483 .695 1.000 .761 .571

.526 .749 .580 1.000 .558 .700 .444 .761 1.000 .683

.300 .683 .792 .558 1.000 .729 .483 .571 .683 1.000

T.V. Sanses: Grant /Research Support; NIDDK grant R01-DK083538 NIH NIDDK Interstitial Cystitis Elucidation of Psychophysiologic and Autonomic Characteristics (ICEPAC). G. Chelimsky: Grant /Research Support; NIDDK grant R01-DK083538 NIH NIDDK Interstitial Cystitis Elucidation of Psychophysiologic and Autonomic Characteristics (ICEPAC). D. Zhang: None. J. Janata: None. T. Mahajan: None. B. Fenton: None. A. Askari: None. R. Elston: None. T. Chelimsky: Grant /Research Support; R01-DK083538 Neurophysiologic & Autonomic Characterization of Interstitial Cystitis/Painful Bladder Syndrome.

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11 WHATARE THE BEST MEASURES OF SYMPTOMATIC P O S T E R I O R P R O L A P S E ? E X P L O R AT I O N OF OBSTRUCTED DEFECATION SYMPTOMS AND MEASURES OF POSTERIOR PROLAPSE C. L. Grimes 1, E. S. Lukacz1, C. Nager 1, K. Y. Dyer 2, S. A. Menefee 2, G. Diwadkar 2, J. Tan-Kim 3 1 Univ. of California San Diego, La Jolla, CA, 2Kaiser Permanente San Diego, San Diego, CA, 3Kaiser Permanente, San Diego, CA. Objective: We aimed to determine if any symptom based measure of obstructed defecation correlates with any anatomic based measure of posterior vaginal wall prolapse. Background: The relationship between symptoms of obstructed defecation and anatomic findings in the posterior vaginal wall is unclear and not well studied using validated measures. These data represent the second phase of a study assessing optimal measures for assessment of obstructed defecation and posterior prolapse. The first phase of this study tested the inter- and intra-rater reliability of proposed anatomic measures performed in clinic and the operating room. This work, presented at AUGS and IUGA 2011, demonstrated fair to strong reliability of the anatomic measures described in Table 1. This second phase seeks to further assess the validity of these measures by examining any correlation between posterior vaginal wall anatomy and obstructed defecation prior to surgical intervention. Methods: This is a convenience sample of women with and without prolapse and with and without obstructed defecation seeking care at 2 Urogynecology clinics between 07/2010 and 02/2012. In addition to basic demographics and standard POPQ evaluation, a series of validated questionnaires commonly used to assess obstructed defecation were administered. Supplemental anatomic measures of the posterior compartment were also performed. Subjects undergoing surgery had repeat examination under anesthesia in the operating room immediately after induction of anesthesia. Table 1 describes the measures explored. Correlations between symptoms by overall score or individual item and anatomic measures were explored using Spearman rank correlations, Goodman-Kruskal Gamma, and Broad Sense Agreement (a stronger indicator of correlation, used for correlations between continuous and binary scales). Power calculation determined that 34 subjects would detect a correlation of 0.5 between functional outcome measures and anatomical outcome measures with an alpha of 0.05 and power of 0.8. 120 subjects were recruited in order to assure that 34 subjects would undergo a posterior compartment procedure in order to assess the sensitivity of these measures to change. Results: Of the 120 women recruited, the mean age was 57 years (standard deviation 15) with a median posterior wall descent (Bp) of −0.5 cm (range −3 to +9). Overall 37 % reported splinting, 42 % straining, and 46 % manual

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evacuation. 38 women had posterior compartment surgery. Despite statistically significant correlations, there were very few fair or strong correlations (>0.40) between any individual symptom measure or total score and any proposed anatomic measure. A rectovaginal pocket detected in clinic was correlated with PFDI 4/bother from splinting (correlation 0.51), ODS 5/frequency of enema use (1.0), ODS 8/stool consistency (0.52). A rectovaginal pocket detected in the operating room was correlated with ODS 5/frequency of enema use (1.0). Conclusions: Overall, no individual or combined symptom set of obstructed defecation correlated well with standard POP-Q measures or other anatomic measures of posterior prolapse. Only a rectovaginal pocket correlated fairly with a symptom of obstructed defecation: bother from splinting. These data suggest that the relationship between anatomy and symptoms is not direct. Based on these data we cannot recommend any one specific question or set of questions from commonly used validated instruments to assess the impact of posterior vaginal wall prolapse on obstructed defecation. SYMPTOMS PFDI—Pelvic Floor Distress Inventory (range 0–300) [1] CRADI-Colorectal Anal Distress Inventory subscale of the PFDI (range 0–100) [1] PFDI-O-sum of PFDI questions 4, 7, 8 (range 0–12) PFDI #4-splinting (range 0–4) PFDI #7-straining (range 0–4) PFDI #8-manual evacuation (range 0–4) ODS-Obstructed Defecation Score (validated colorectal scale) (range 0–31) [2] ODS #1-mean time spent at toilet to defecate (range 0–4) ODS #2-number of attempts to defecate per day (range 0–4) ODS #3-frequency of anal / vaginal digitation “splinting” (range 0–4) ODS #4-frequency of laxative use (range 0–4) ODS #5-frequency of enema use (range 0–4) ODS #6-frequency of incomplete/fragmented defecation (range 0–4) ODS #7-percent of straining at defecation (range 0–4) ODS #8-stool consistency (range 0–3) CLINIC ANATOMICAL MEASURES POPQ points: Bp, Ap, gh+pb* Transverse gh*-the diameter of the genital hiatus of protruding prolapse during strain Digit pocket*-Y/N subjective presence of a pocket in the posterior vaginal wall during digital rectal exam Digit laxity*-Y/N subjective presence of posterior wall laxity past the hymen during digital rectal exam OPERATING ROOM ANATOMICAL MEASURES Allis test*-An Allis is placed 3 cm proximal to the hymenal ring and pulled distally, measured in cm from the hymen (range−3 to +3) Forcep Test* [3]-Y/N subjective reduction of bulge when an open curved ring forceps is placed into the vagina posteriorly and spread to 3–4 cm laterally OR-Digit pocket*-Y/N presence of a pocket in the posterior vaginal wall during digital rectal exam under anesthesia OR-Digit laxity *-Y/N presence of posterior wall laxity past the hymen during digital rectal exam under anesthesia

*Inter-and intra-rater reliability of these measures has been previously described (AUGS and IUGA 2011)

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References: [1] Am J Obstet Gynecol. 2001; 185(6): 1388–95. [2] Colorectal disease. 2008; 10(1): 84–8. [3] Clinical Obstetrics and Gynecology. 1993; 36(4): 939–51. C.L. Grimes: Grant /Research Support; AUGS Foundation Fellow Research Award. E.S. Lukacz: None. C. Nager: None. K.Y. Dyer: None. S.A. Menefee: None. G. Diwadkar: None. J. Tan-Kim: None.

12 IS THE REAL TIME OPEN MAGNETIC RESONANCE IMAGING (MRI) PROCTOGRAM A USEFUL TOOL IN THE ASSESSMENT OF WOMEN WITH PELVIC ORGAN PROLAPSE PRIOR SURGERY? F. Puccini, A. Digesu, A. Bhide, P. Gallo, C. Dell’utri, N. Colacurci, P. Piffarotti, A. Tubaro, W. Gedroyc, R. Fernando, V. Khullar; Imperial Coll. London, London, United Kingdom. Objectives: To compare two different modalities of dynamic magnetic resonance imaging (MRI) proctogram in assessing pelvic anatomical and functional abnormalities. Background: Defaecation disorders are relatively common in multiparous women. Functional assessment of the anorectum is vital to determine the cause of these disorders and to plan appropriate surgical management. Defaecating proctography with conventional fluoroscopy in conjunction with manometric measurements is currently the gold standard imaging method to assess functional and anatomic disorders, but it does not allow to visualize clearly the soft tissues of the pelvic floor. MRI has been proven to be superior in soft tissues resolution to better evaluate the pelvic floor compartments and pelvic organs and their anatomical defects thus being a potential useful tool in the assessment and management of women with pelvic organ prolapse (POP) and defaecatory disorders prior surgery. Dinamic MRI proctography provides helpful information such as mucosal intussusception, enterocele, pelvic floor descent and/or the position of the rectocele with regards of the pelvic floor muscle plane, thus guiding clinicians in the preoperative assessment of those women as well as planning a most appropriate surgical repair. It is usually performed with patient lying supine, which is a non-physiological as well as unpractical position to assess the bowel in both static and dynamic conditions such as during defecation. An open configuration dynamic MRI system, which allows the patient to undergo the test in erect sitting position, coupled with the ability to obtain rapid scans at close to real-time, without any concern for radiation exposure has been recently proposed. This new system enables a better assessment of

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all the pelvic soft tissues such as bladder, bowel and/or uterocervical prolapse. Despite all these promising perspectives, extensive data demonstrating an effective usefulness in gaining additional static and/or dynamic information of the real time open configuration MRI system are lacking so far. Methods: Consecutive women with POP and defecatory symptoms who underwent to MRI proctogram between 2007 and 2011 were retrospectively studied. Static and dynamic imaging of the pelvic floor organs were assessed by experienced radiologists. The presence of anterior rectocele, mucosal intuscusseption, pelvic floor descent and/or impaired defecation were evaluated. For MRI proctograms done in the erect sitting position a 0.5 T open magnet scanner was used. Images were obtained in real time in the sagittal plane with no interslice gap. MRI proctograms carried out in the supine position in real time a 1.5 T scanner with 10 mm slices with no interslice gap was used. Pelvic floor static and/or dynamic disorders were assessed and reported by experienced radiologists. We analysed the reports of these proctograms and compared findings such as rectocele, intussusception, defacation and pelvic floor descent between the 2 positions. All women were consented for this study. A chi square test (p<0.05) and version 20 SPSS software were used for the statistical analysis. Results: A total of 333 women were studied. 144 patients had a dynamic MRI proctogram in the conventional supine position, while 189 underwent the new open real time system in the erect sitting position. The findings of the 2 positions are compared in table 1 with the relevant p value. The presence of intussusception during straining was significantly higher in those images in the erect sitting position (p 00.002) compared with the supine group. There was no significant difference regarding the other findings between the 2 positions. Table 1. Erect sitting and supine MRI findings Anterior rectocele at rest Anterior rectocele during straining Intussusception at rest Intussusception during straining Impaired defecation Pelvic floor descent

Erect sitting 9% 77.7 % 2% 49.6 % 45.1 % 36.8 %

Supine 6.3 % 76.7 % 1.6 % 33.3 % 56.6 % 12.5 %

p value 0.358 0.820 0.736 0.002 0.38 <0.001

Conclusions: Our study has demonstrated that erect sitting and supine MRI proctograms are similar in assessing functional and anatomical disorders of the anorectum. The erect sitting position may better replicate physiological conditions during evacuation, is a more acceptable test as it allows the patients to defaecate in a more physiological position and

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appears to better demonstrate intussusception during straining as well as pelvic floor descent compared to the supine position. F. Puccini: None. A. Digesu: None. A. Bhide: None. P. Gallo: None. C. Dell’Utri: None. N. Colacurci: None. P. Piffarotti: None. A. Tubaro: None. W. Gedroyc: None. R. Fernando: None. V. Khullar: None.

13 BENIGN JOINT HYPERMOBILITY SYNDROME (BJHS) IN WOMEN WITH LOWER URINARY TRACT SYMPTOMS (LUTS); PREVALENCE AND ASSOCIATION WITH URODYNAMIC DIAGNOSIS A. Derpapas, G. Vijaya, A. G. Digesu, P. Gallo, P. Robshaw, A. Bhide, P. Upadhyaya, C. Hendricken, C. Dell’utri, R. Fernando, V. Khullar St Mary’s Hosp., Imperial Coll. Hlth.care NHS Trust, London, United Kingdom. Objective: To determine the prevalence of BJHS amongst women with lower urinary tract symptoms and explore its relationship with urodynamic diagnosis. Background: Benign Joint Hypermobility Syndrome (BJHS) is a hereditary connective tissue disease due to collagen disorders causing laxity of synovial joint ligaments. The reported prevalence BJHS varies in the literature largely due to the use of varying screening and diagnostic criteria.1 Extra-articular manifestations of this syndrome may involve the genitourinary system as well as the autonomic nervous system. The presence of adrenoreceptor hyper-responsiveness among patients with the BJHS supports the hypothesis of dysautonomia being an extraarticular manifestation of this syndrome.2 The prevalence of urinary incontinence (UI) appears to be significantly higher in women with BJHS, reaching 69 % in questionnaire-based surveys.3 It has also been suggested that stress urinary incontinence (SUI) is more common amongst women with BJHS than age- and parity-matched controls. There is however scarce data to date exploring the relationship between LUTS and BJHS by using objective measures, such as filling cystometry and pressure flow studies. Methods: This is an observational study which took place at a university hospital between March–December 2011. Women presenting in a tertiary urogynaecological centre underwent conventional or video urodynamic investigations as part of the assessment of their lower urinary tract symptoms. All women were assessed for JHM with a validated 5-point self-reported questionnaire for detecting the condition. Scoring 2 or higher in the questionnaire suggests JHM with a sensitivity of 85 % and a specificity of 90 %.

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Urodynamic diagnosis was made based on the 2002 International Continence Society report on standardisation of terminology in lower urinary tract function. Primary outcome of the study was prevalence of BHJS amongst women with LUTS whereas secondary outcome included calculation of the odds ratio for women with BHJS to be diagnosed with either urodynamic stress incontinence (USUI), detrusor overactivity (DO) or mixed incontinence. Chi-square test was used to calculate odds ratio within 95 % Confidence Interval with P 0.05 level of significance. Results: Two hundred and seventy-one women in total were recruited. The mean age of participants was 52±12 years and the mean BMI±SD was 26± 8 kg/m2. Benign joint hypermobility syndrome was diagnosed in 84/271 women (30.9 %). There were no differences in age and BMI between women with and without BJHS. Filling cystometry findings were as follows: urodynamic stress urinary incontinence (USUI) in 43/271 (15.9 %) women, detrusor overactivity (DO) in 126/271 (46.5 %) women and urodynamic mixed incontinence (UMI) in 37/271 (13.7 %) women. In 51/271 women (18.8 %), the urodynamic diagnosis was inconclusive. Amongst patients with BJHS the most common urodynamic diagnosis was DO (38 %), followed by USUI (17 %), whereas MUI was found in 10 % of patients. The most likely diagnosis for women in the BJHS group was that of USUI, however this was not statistically different to the diagnoses of DO and MUI. Table 1 shows the odds ratios and the 95 % CI for the different urodynamic diagnosis amongst women with BJHS. Table 1. OR and 95 % CI for the different urodynamic diagnoses in women with BJHS. BJHS group (n084)

USUI 1.74(0.80–3.01) P00.18

MUI 0.80 (0.37–1.74) P00.57

DO 0.77 (0.55–1.55) P00.78

Conclusions: The prevalence of BJHS amongst women with LUTS was almost 31 %, which is significantly higher than that previously quoted in general epidemiological studies in the western world. Although women with BJHS seemed to have a higher risk of developing stress urinary incontinence, this was not significantly higher than the risk for DO or mixed urinary incontinence. Our findings contradict with previous suggestions that the laxity of the pelvic floor ligaments in women with BJHS results in higher incidence of SUI. Our findings indicate at a more complex link between connective tissue disorders and LUTS which could imply a more prominent role of autonomic dysfunction in this specific group of patients. Further support of this

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hypothesis is required in large cohorts including sufficient numbers of controls. References: 1. Man Ther. 2007 Nov;12(4):298–309 2. Am J Med. 2003 Jul;115(1):33–40 3. Am J Obstet Gynecol. 2000 May;182(5):1021–3 A. Derpapas: None. G. Vijaya: None. A.G. Digesu: None. P. Gallo: None. P. Robshaw: None. A. Bhide: None. P. Upadhyaya: None. C. Hendricken: None. C. Dell’utri: None. R. Fernando: None. V. Khullar: None.

14 U R E T H R A L P R E S S U R E R E FL E C TO M E T RY DURING INTRA-ABDOMINAL PRESSURE INCREASE-AN IMPROVED WAY TO CHARACTERIZE SUI AND CONTINENT WOMEN M. Saaby, N. Klarskov, G. Lose Herlev Hosp., Univ. of Copenhagen, Herlev, Denmark. Aim: To assess the urethral closure mechanism by means of urethral pressure reflectometry (UPR) at rest and during intra-abdominal pressure increase by strain in SUI and continent women. Background: The UPR technique enables simultaneous measurement of pressure and cross-sectional area along the entire length of the urethra and avoids the common artifacts encountered with conventional methods (1). Since the first reports the technique has been further developed for use during squeeze and intra-abdominal pressure increase by strain. Methods: Women with bothersome and urodynamic proven SUI were consecutively recruited from the outpatient clinic. Continent volunteer women with negative cough stress test and an International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) score of 0 were recruited via a clinical trial website. Assessment included medical history, ICIQ-SF, pelvic examination, cough stress test, filling cystometry, padweighing test (2 × 24 h), incontinence episode diary (7 days) and UPR measurements. UPR measurement: The UPR polyurethane bag was placed in the urethra and connected to a syringe, a computer and a probe containing an acoustic transmitter and a microphone. By means of the syringe, the pressure in the polyurethane bag was raised from 0 cm H2O to 200 in 7 s thereby distending the bag, and the crosssectional area within the bag (and thus the urethra) was measured with acoustic reflectometry and the urethral opening pressure (Po) obtained. The abdominal pressure

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(PAbd) was measured with an air filled catheter in the rectum. Measurements were conducted at rest and during intraabdominal pressure increase by strain (10 times at various PAbd). The related values of PAbd and Po were plotted into an abdomino-urethral pressuregram (2) (figure 1A). Linear regression of the values was conducted, and the slope of the line and the intercept with the yaxis were found. The slope is the ratio of the urethral opening pressure increase in relation to the abdominal pressure increase and is termed “Abdominal to urethra Pressure Impact Ratio” or “APIR”. The equation of the pressuregram line was generated: Po0(APIR x PAbd)+intercept. This was used to calculate Po at various values of PAbd, e.g. 50 cm H2O (Po-Abd 50). The pressuregram-LPP, which is defined as the intercept with the equilibrium line of x0y (figure 1A) was also calculated. Results: 25 SUI women and 8 continent volunteer women were included in the analyses. The two groups did not differ with respect to age, body mass index or menopausal status, but the SUI women had had more vaginal deliveries. Po-rest and APIR were significantly different (p<0.0005 and p00.002, respectively) in SUI and continent women but could not completely separate the two groups (figure 1B-C). The pressuregram-LPP was “infinite” in 2 of the SUI and in 6 of the continent women. Median Po-Abd 50 was 67 cm H2O in SUI and 104 cm H2O in continent women (p<0.0005), with a complete separation of the two groups (figure 1D). Po-Abd 50 was highly significantly negatively correlated with ICIQSF, pad test and number of incontinence episodes per week. Po-rest is thought to represent the permanent contribution to the urethral closure mechanism whereas APIR presumably expresses the adjunctive closure forces (incl. urethral support) during intra-abdominal pressure increase by strain. The P o at a given PAbd represents the resulting joint permanent and adjunctive closure forces at that particular PAbd , for example at 50 cm H 2 O. Conclusions: We conducted UPR measurements of the urethral opening pressure at rest and during intraabdominal pressure increase by strain, and new parameters were obtained by use of the pressuregram: APIR and Po-Abd 50. Po-Abd 50 could completely separate SUI and continent women, it showed a highly significant negative correlation with ICIQ-SF, pad test and number of incontinence episodes per week and it was found to be an excellent measure of SUI severity.

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Figure 1. a Pressuregram with urethal opening pressures obtained at 10 different levels of increased intra-abdominal pressure. b, c and d Po-rest. APIR and Po-Abd 50 in SUI and continent women. Median[range]. LLP: Pressuregram leak point pressure. APIR: abdominal to urethral pressure impact ratio. Po-rest: urethral opening pressure at rest. Po-Abd 50: urethral opening pressure at 50 cm H2O abdominal pressure. SUI: stress urinary incontinent.

References: (1) BJU Int 2007;100(2):351–6. (2) J Biomech 1997;30(1):19–25. M. saaby: None. N. Klarskov: None. G. Lose: None.

15 STEREOPHOTOGRAMMETRY OF THE PERINEUM DURING VAGINAL DELIVERY R. Zemcik1, J. Karbanova 2, V. Kalis 2, L. Lobovsky 1, M. Jansova 1, Z. Rusavy 2 1 Univ. of West Bohemia, Pilsen, Czech Republic, 2Univ. Hosp., Faculty of Med., Charles Univ., Pilsen, Czech Republic. Objective: To analyze the deformation of the perineum during normal vaginal delivery in order to propose which

clinical steps might be beneficial when executing manual perineal protection. Background: The main problem in evaluating this obstetric intervention has been the lack of technical ability for describing the procedure to allow for a clear understanding and reproducibility. The aim of this study was to describe and quantify the deformation and strain of the perineal structures during the final part of delivery and, deriving from the data collected, to suggest a modification of manual perineal protection which might decrease the degree of perineal tension. Methods: A study group of 10 women at term with delivery included after signing an informed consent. The inclusion criteria were primiparity, vertex presentation, noninstrumental vaginal delivery without episiotomy, neonatal weight more than 3000 g.

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A modified hands-poised technique performed concurrently with stereophotogrammetry were used to analyze and quantify the perineal strain at the final stage of the delivery. The accoucheur’s hands did not touch the perineum before the crowning. At the time of crowning of the fetal head, the modified ,,hands-poised“ technique was used. The hands were applied to the perineum at the time of expulsion and not before. Stereophotogrammetry is a non-invasive method which allows for the reconstruction of the object’s surface in three-dimensional space using a pair of images taken from two different positions at the same time. If two states are processed this way, i.e. before and after the object’s deformation, it is possible to assess displacements and also the components of mechanical strain (deformation) by comparing the corresponding displacement vectors of the individual points on the surface. Herein, the perineal region was marked with small dots to define a pattern composed of triangles. The position was calculated for each dot as it moved in time and, consequently, the displacements and strains were calculated for each triangle. Results: As the complex material properties of the perineal tissues are not known with any precision, only strain values commonly used in mechanics, such as the maximum (ε1) and minimum (ε2) principal strains, maximum shear strain (γmax) and equivalent strain (εeq), are investigated. These strains are independent of the position of cameras. In this work, the strain is investigated for each patient at the last possible moment of delivery, just before the fetal head expulsion, and in contrast to the original configuration. The highest tissue strain (mean 177 %, 95 % CI: 106.3– 248.5) is in a transverse direction at the level of the fourchette (i.e. 1 cm was transversely stretched and deformed to 2.77 cm during the final stage of vaginal delivery). This strain is more than four times higher than the maximum antero-posterior strain (mean 43 %, 95 % CI: 28.6–57.4). Of the obstetric variables measured, head circumference and neonatal weight were found to be statistically significant in relation to the perineal transverse and antero-posterior maximum strains ratio. Conclusions: This study shows quantified stereophotogrammetric data regarding the perineal strain and its direction at the final stage of delivery. Based on the results, a technique of manual perineal protection has

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been proposed. Further experimental and clinical studies are needed, however, to evaluate whether this proposed technique may assist in reducing obstetric perineal trauma.

R. Zemcik: Grant /Research Support; European Regional Development Fund (ERDF), project European Centre of Excellence, NTIS—New Technologies for Information Society, CZ.1.05/1.1.00/02.0090. J. Karbanova: None. V. Kalis: None. L. Lobovsky: None. M. Jansova: Grant / Research Support; European Regional Development Fund (ERDF), project European Centre of Excellence, NTIS—New Technologies for Information Society, CZ.1.05/1.1.00/ 02.0090. Z. Rusavy: None.

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16 LEVATOR HIATUS DIMENSIONS CHANGE DURING PREGNANCY—A 3D/4D ULTRASOUND STUDY J. Stær-Jensen 1 , F. Richter 2 , G. Hilde 3 , K. Bø 3 , M. Ellström Engh 1; 1 Akershus Univ. Hosp., Lørenskog, Norway, 2Univ. of Oslo, Faculty Div. Akershus Univ. Hosp., Lørenskog, Norway, 3 Norwegian Sch. of Sport Sci., Dept. of Sports Med., Oslo, Norway. Objective: The aim of the present study was to investigate if there are changes in the biometry of the pelvic floor muscle during pregnancy, by evaluating the relative change of the levator hiatus at 22 and 37 weeks of gestation, using 3D/4D transperineal ultrasound. Background: The pubovisceral muscle (PVM), the most medial part of the levator ani complex bordering the levator hiatus (LH), plays a significant role in supporting the pelvic organs [1]. There is substantial evidence of an association between vaginal delivery and pelvic organ prolapse, often explained by changes to PVM biometry during delivery, resulting in a larger LH postpartum. Indirect evidence of an increase in LH dimensions during pregnancy has been presented: women who delivered by cesarean section had smaller LH area after childbirth than in late pregnancy [2]. Few studies have monitored the PVM during pregnancy [3] and to our knowledge no axial plane data has yet been published. Methods: Nulliparous pregnant women in the second trimester were included in this prospective cohort study. At gestational weeks 22 and 37, the women underwent a 3D/4D transperineal ultrasound examination at rest, maximal pelvic floor muscle contraction and Valsalva with a 4–8 MHz curved array 3D/4D ultrasound transducer in the lithotomy position after voiding. In the axial plane of minimal hiatal dimensions using render mode, the anterior-posterior (LHap) and right-left (LHrl) diameters and the area (LHarea) of the LH were measured. With a two-sided alpha of 0.05 and a power of 80 %, a sample size of 47 was required to detect a 5 % change in LHarea at rest. Mean values and standard deviation (SD) for demographic data and LH measurements at weeks 22 and 37 were computed. Changes in axial measurements from week 22 to 37 were calculated as mean differences with 95 % confidence interval using paired sample t-test. P-values< 0.05 were considered significant.

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Results: Ninety-two women were included in this study. Mean age was 28.8 years (SD 4.1) and mean prepregnancy BMI 24 kg/m2 (SD 4.2). At first examination, mean gestational week was 21.1 (SD 1.4), and 37.1w (SD 1.0) at the second. Mean values of LH dimensions at 22 weeks of gestation are presented in Table 1. We found significant increase for all LH dimension measurements from gestational week 22 to 37 (Table 2). The most marked change was found for LHarea on Valsalva and at rest, with increases in size of 20.7 % and 19.2 % respectively. Table 1. Mean measurements and SD for LH dimensions at 22 weeks of gestation. N092 (LHarea Valsalva n090) Mean (SD) at 22 weeks

LHap (cm) LHrl (cm) LHarea (cm2)

Rest

Contraction

Valsalva

4.6 (0.7) 3.7 (0.4) 11.7 (2.2)

3.8 (0.6) 3.3 (0.4) 9.1 (1.8)

5.3 (1.0) 3.9 (0.5) 15.4 (4.4)

Table 2. Changes in LH dimensions given as mean differences and percentual change from gestational week 22 to 37 with 95 % confidence interval (CI) for rest, contraction and Valsalva (Val). N092 (LHarea Valsalva n090); p<0.001

LHap (cm) LHrl (cm) LHarea (cm2)

Mean difference (CI)

% change

Rest

Contraction Val

Rest Contraction Val

0.52 (0.43– 0.61) 0.13 (0.07– 0.19) 2.24 (1.84– 2.64)

0.23 (0.15– 0.50 11.3 6.0 0.3) (0.33– 0.66) 0.20 (0.14– 0.21 3.6 6.3 0.26) (0.13– 0.28) 1.10 (0.48– 3.19 (2.5– 19.2 12.1 0.8) 3.8)

9.4 5.3 20.7

Conclusions: Our findings show that morphological changes of the PVM take place during pregnancy. There is an increase in all hiatal dimensions from 22 to 37 weeks of gestation, which may contribute to preparing the pelvic floor muscles for the considerable distension during vaginal delivery. The findings indicate that the changes in pelvic organ support are not solely caused by delivery, but also by the physiological changes during pregnancy. Further studies

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are needed to understand the clinical importance of these findings. References: 1. Ann. N.Y. Acad. Sci. 1101: 266–296 (2007). 2. Obstet Gynecol. 2009 Jun;113(6):1272–8. 3. Aust N Z J Obstet Gynaecol. 2004 Feb;44(1):19–23. J. Stær-Jensen: Grant /Research Support; This study was supported by grants from the Norwegian South-Eastern Regional Health Authority. F. Richter: Grant /Research Support; Norwegian South-Eastern Regional Health Authority. G. Hilde: Grant /Research Support; Norwegian Research Council. K. Bø: None. M. Ellström Engh: None.

17 DOES EPISIOTOMY DAMAGE THE PELVIC FLOOR? M. Von Muhlenbrock Lopez1, K. L. SHEK 2, R. GUZMAN ROJAS 2, H. P. DIETZ 2 1 Facultad de Med. Clínica Alemana de Santiago-Univ. del Desarrollo, Santiago, Chile, 2Nepean Clinical Sch., Univ. of Sydney, Penrith, Australia.

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Objective: The aim of this study was to evaluate the effect of episiotomy on levator morphology, in preparation for a randomized controlled trial. Background: Episiotomy is one of the commonest surgical procedures. While in the past it was regarded as protective of pelvic floor trauma, current evidence does not support this view. A recent Cochrane review suggests that a policy of restrictive episiotomy may be superior to routine episiotomy[1]. Tears to the levator ani (‘avulsion’) occur in 10– 35 % of primiparous women delivering vaginally [2], and the effect of episiotomy on such trauma is unknown. Methods: This is a retrospective study on 639 primiparous women, recruited in 2 prospective studies, between 1/07 and 9/11. At 36–38 weeks and 3–6 months postpartum, participants underwent an interview, clinical examination, and 4D pelvic floor ultrasound [2]. Volume analysis was performed offline to measure hiatal area on valsalva, bladder neck and cystocele descent, and to diagnose levator avulsion on tomographic ultrasound imaging (TUI)[3]. We analysed potential predictors of trauma, including age, BMI, ethnicity, delivery mode, birthweight, length of 2nd stage, epidural analgesia, syntocinon use, episiotomy and major perineal trauma.

Fig. 1. Left—sided levator avulsion as seen on pelvic floor TUI (right part of the figure, with (*) indicating the avulsion. The left image shows a cystocele to 15 mm below the symphysis pubis. S0symphysis, B0bladder, R0rectocele, A0anal canal.

Results: Of 639 nulliparous women originally recruited, 500 returned for a 3–4 month follow up (78 %). In 6 cases, we were unable to locate ultrasound volumes, three were pregnant, and one had had a second child, leaving 490 for analysis. Mean gestational age at first assessment was 36.4 weeks (33.2–38.3), mean age was 29.5 years (18–45); 84 % (n 0411) were Caucasian, average BMI was 29.5 (20.9–56.5). They delivered

vaginally in 75 % (n 0368) of cases (NVD in 267 [54.4 %], Vacuum in 67 [13.7 %] and Forceps in 34 [6.9 %]). 122 women (24.9 %) had a caesarean section. Length of 1st stage was calculated at a median of 463 min, and 2nd stage as 80 min. Syntocinon was used in 42 % (n0206), an epidural in 45 % (n0220), and the mean birthweight was 3459 g. Of those who delivered vaginally, 26.9 % (n099) had an episiotomy,

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47.6 % (n0175) any degree of perineal tear, 17 a 3rd or 4th degree tear (4.6 %), and 19.8 % (n073) a vaginal tear. At follow-up, we diagnosed avulsion in 55 women (11.2 % overall, or 14.9 % of vaginal deliveries). Hiatal area on Valsalva was 21.4 (8.6–52.9) cm2, and on comparing those measurements with antenatal values, we diagnosed irreversible overdistension (‘microtrauma’) in 151 patients (30.8 %). Table 1 shows the results of uni- and multivariate analysis. On multivariate analysis, accounting for multiple interdependencies between episiotomy and demographic / obstetric variables, episiotomy became nonsignificant (OR 0.5–2.2). The only parameters remaining significant were BMI, the length of the 2nd stage of labour, Forceps and major perineal tears. Uni and multivariate analysis of demographic and obstetric predictors of levator avulsion Parameter

OR (CI) for avulsion (univariate analysis) Maternal 1.077 (1.018– age (yrs) 1.138) BMI 0.89 (0.82–0.97)

P0 0.0082

OR (CI) for avulsion (multivariate analysis)

0.0049 0.871 (0.796– 0.953) <0.001 1.006 (1.001– 1.010)

2nd st. of 1.008 (1.004– labour 1.012) (m) Episiotomy 2.07 (1.138–3.765) 0.017 Forceps 5.803 (2.732– 0.001 3.622 (1.577– 12.326) 11.522) Major 4.404 (1.6–12.116) 0.0041 4.263 (1.156– perineal 11.344) tears

P0

0.002 0.0187

0.0043 0.0272

Conclusions: In this large observational series, we found that episiotomy was associated with avulsion of the puborectalis muscle on univariate analysis. This relationship disappeared on multivariate analysis. Hence, this study provides no evidence for a damaging effect of episiotomy on the pelvic floor. On the other hand, there is no evidence of episiotomy being protective either. Our results may have limited bearing on populations in which episiotomy is performed routinely rather than selectively. References: 1. Cochrane Database Syst Rev. 2009 Jan 21;(1): CD000081. 2. Int Urogynecol J 22:1221–1232 3. Int Urogynecol J 22 (6):699–704 M. Von muhlenbrock lopez: None. K.L. Shek: None. R. Guzman rojas: None. H.P. Dietz: Grant /Research Support; Educational grant from General Electric Medical Ultrasound (US$9000).

18 DIAGNOSIS OF OBSTETRIC ANAL SPHINCTER INJURIES.....TIME FOR RE-APPRAISAL OF TRAINING J. O. Daly, R. Thakar, A. H. Sultan, K. Van-Delft Croydon Univ. Hosp., London, United Kingdom. Objective: To prospectively identify the rate of underclassification of obstetric anal sphincter injuries during childbirth and study the impact of this on anorectal symptoms and function. Background: The correct application of the established diagnostic criteria for Obstetric Anal Sphincter Injuries (OASIS) (1) is vital for accurately describing the structures involved, degree of trauma and as a prognostic factor for anorectal dysfunction (2). It has been established that with a systematic examination, 99 % of OASIS can be recognised clinically (3). There remains the question of how often OASIS is recognised but the full extent is not appreciated i.e. under-classified, such that the risk of anorectal dysfunction is higher than it would otherwise be. This may impact on the quality of life and ongoing management of the patient. Methods: All women who sustained OASIS between March 2003 and September 2011, at a NHS district general hospital were included. Clinical staff were aware of the recommended examination technique and classification of OASIS (1). All patients with OASIS were referred to the perineal clinic after 3 months. Bowel symptoms were assessed using the St Mark’s incontinence score (SMIS). Other concomitant symptoms such as perineal pain, urinary symptoms and wound infection were recorded by the clinician. All women underwent anal manometry and endoanal ultrasonography (EUS), which was performed using a 10-MHz 360º rotating probe (BK Medical). All data was collected prospectively and stored in standardised institutional databases. We define under-classification when the grade of trauma diagnosed at delivery is less than that seen on EUS e.g. clinical diagnosis of a grade 3a (<50 % external sphincter thickness (EAS) torn) sphincter injury but evidence of an internal anal sphincter (IAS) injury using EUS. The SMIS was categorised into asymptomatic, 0, minor symptoms, 1–4, and major symptoms, 5+, and analysed using a Chi-square test.. The student t-test was used to compare means of anal manometry and anal length, and chi-square performed to compare proportions of those with concomitant symptoms. Results: 1088 cases of OASIS resulted from 30568 vaginal deliveries with an annual rate of 1.9–4.6 %. Of these, 948 (87.1 %) attended for follow-up at a mean duration of 10.9 (SD 9.3) weeks, of which 921 (84.6 %) had EUS.

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Three hundred and seventy eight sustained a 3a tear, of which 35 (9.5 %) patients were under-classified as seen on EUS i.e. 3b (>50 % EAS thickness torn) or greater tear. Of these, 18 (51.4 %) had persistent defects, 15 IAS and 9 EAS. One patient required a secondary repair.

Three hundred and sixty five sustained a 3b tear of which 51 (14.0 %) were under-classified on EUS i.e. 3c tear (IAS also torn). There were persistent IAS defects in 47 (92.1 %) and full thickness EAS defects in 18 (35.3 %). One patient required a secondary repair. Further results are contained in Table 1.

Table 1. Comparison of correctly and incorrectly classified OASIS by SMIS, concomitant perineal symptoms, anorectal physiology and anal length. Classification at delivery Classification at EUS SMIS (Max 24) 0 1-to-4 5+ Concomitant symptoms

3a 3b Under-classified n (%) Correct N (%) 20 (66.7) 229 (79.8) 8 (26.6) 39 (13.5)

2 (6.7) 24 (68.5) Mean (95 % CI) Maximum resting pressure (mmHg) 48.0 (42.9–53.1) Maximum squeeze pressure (mmHg) 83.3 (73.4–93.2) Anal Length (mm) 22.9 (21.1–24.7)

19 (6.6) 136 (43.6) Mean (95 % CI) 53.5 (52.0–55.1) 93.1 (90.3–95.9) 25.2 (25.8–31.4)

P Value Under-classified n (%) Correct N (%) 0.15 33 (66.7) 181 (71.0) 0.09 8 (16.7) 49 (18.9)

P Value 0.59 0.76

0.71 <0.01*

0.37 0.36

0.03* 0.03* 0.02*

9 (18.0) 29 (56.9) Mean (95 % CI) 43.7 (40.7–46.7) 74.4 (69.1–79.7) 21.25 (19.6–22.9)

25 (10.0) 151 (48.8) Mean (95 % CI) 50.4 (48.9–51.9) 85.1 (82.4–87.9) 24.9 (24.3–25.6)

0.01* 0.01* 0.01*

*Student t-test, **Chi-Square

Conclusions: One in eight women with OASIS were shown to have a greater severity of trauma than that diagnosed at delivery with persistent defects in up to 90 %. The anal length, resting and squeeze pressures were significantly lower in the underdiagnosed group. Although there was no difference in St Mark’s Incontinence scores between the two groups at 11 weeks follow-up it is known that that women with defects are at high risk of developing anal incontinence in alter life. References: 1. RCOG Green-top Guideline No.29, London, 2007. 2. Ultrasound Obstet Gynaecol 2010; 36: 368–374. 3. BJOG. 2006 Feb;113(2):195–200. J.O. Daly: Grant /Research Support; RANZCOG Rsearch Foundation Brown Craig Travel Fellowship. R. Thakar: None. A.H. Sultan: None. K. Van-Delft: None.

19 SIMILAR REDUCTION IN OASIS RATE ACROSS ALL SUBGROUPS OF WOMEN DEFINED BY RISK FACTORS AFTER IMPLEMENTATION OF A PERINEAL PROTECTION PROGRAM K. Laine, F. Skjeldestad, A. Staff Oslo Univ. Hosp., Oslo, Norway. Objective: The primary aim of the present study was to compare the incidence of OASIS across two time periods, before and after implementing the training program for manual perineal protection, aimed at reducing the incidence of OASIS. A secondary aim was to study the

incidence of OASIS in subgroups of women defined by risk factors. Background: Obstetric anal sphincter injury (OASIS) is a serious complication of a vaginal delivery with incidences varying from 1% to 6 % in different countries and between delivery units. OASIS occurs even in otherwise uncomplicated deliveries. OASIS may cause pain, discomfort and anal incontinence (AI). Maternal, fetal and obstetrical risk factors have been widely studied with focus on non-modifiable patient related factors such as maternal age, ethnicity, fetal weight and head size, while risk factors unrelated to the delivering woman or the infant size, such as the accoucheurs’ management of the second stage of delivery, have been less investigated. Attempts to create risk-scoring systems to predict OASIS on an individual level have not been successful. In 2004 the Norwegian National Board of Health criticized the delivery units for a high incidence of OASIS, at that time being 4.5 % of vaginal deliveries, and required that hospitals should implement programs to reduce the OASIS rate. Since then, reducing the incidence of OASIS has been a national aim in Norway, and improved perineal protection techniques have been recommended. In our department, a practical training program to improve manual perineal protection of perineum during second stage of delivery was implemented in 2008. The training program and the package of procedures to protect perineum have previously been described in two published studies. Methods: A population based cohort study at a large obstetrical unit in Norway, with 7000 deliveries annually, was established. During the study periods 2003–05 and 2008–10, the study population comprised 31 709 vaginal deliveries.

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Women with OASIS were identified from the labor protocols on the delivery unit and crosschecked with individual electronic and paper-based medical charts. In addition, patients with the diagnosis OASIS (ICD-10 code O70.2 or O70.3) were searched in the electronic hospital discharge register and 13 additional patients with OASIS were identified. Surgical description of OASIS repair in the medical record for each woman was carefully read to validate the OASIS diagnosis, and false positive cases were excluded (n022). Information of maternal and fetal clinical characteristics and obstetrical interventions were collected from the hospital obstetric database and patient medical records. The incidence of OASIS was analyzed by risk factors in both univariate and multivariate logistic regression analyses. Adjusted odds ratios (aORs) with 95 % CI are reported from multivariate logistic regression analysis. Results: Among the 31 709 vaginal deliveries during the study years, 907 women with OASIS were identified, 591 in the first time period and 316 in the second of the study periods. Over-all incidence of OASIS was reduced from 4.0 % in the first time period to 1.9 % in the second time period, with similar reduction consistently across all subgroups defined by risk factors, regardless of parity or delivery mode. This reduction remained unchanged when adjusting for risk factors. The majority of the OASIS occurred among women at low OASIS risk. Conclusions: A 50 % reduction of OASIS appears simultaneously with the implementation of a perineal protection program in our department and this effect has maintained over the following years. Selective focus on high risk patients in attempts to reduce incidence of OASR is of limited value, as the prevalence of women with high OASIS risk is low, and the majority of OASIS occurs in deliveries with lower risk. Effective perineal protection procedures aiming at reducing occurrence of OASIS should be offered to all delivering women, not only to women in high OASIS risk. K. Laine: None. F. Skjeldestad: None. A. Staff: None.

20 LEVATOR HIATUS BIOMETRY AND LEVATOR ANI BEHAVIOUR IN WOMEN WITH PROVOKED VESTIBULODYNIA S. Thibault-gagnon, C. Goldfinger, C. F. Pukall, S. Chamberlain, L. MCLEAN Queen’s Univ., Kingston, Canada. Objective: To determine if there are measureable differences in levator hiatus biometry and levator ani behaviour between women with provoked vestibulodynia (PVD) and women without genital pain using 4D translabial ultrasound imaging. Background: PVD is the most common cause of dyspareunia in young women [1]. PVD is characterized by pain felt at the vulvar vestibule when pressure is applied to the area, resulting in painful vaginal penetration during intercourse as well as tampon insertion and gynecological examination. Research suggests that the pelvic

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floor muscles (PFMs) may play a role in the onset and/or maintenance of PVD. When evaluated subjectively through vaginal palpation, women with PVD present with higher PFM tone and lower PFM strength in comparison to women without a history of genital pain [2]. 4D translabial ultrasound is a promising tool for objectively investigating the role of PFM impairments in PVD. Methods: Twenty-one women with PVD and 23 women without a history of genital pain participated in this casecontrol study. All participants were nulliparous and without any other urogynecological conditions. Following a gynecological examination to ascertain eligibility, all participants were assessed using 4D translabial ultrasound. Participants were imaged in the supine position after bladder emptying, under three conditions: at rest, on maximal voluntary pelvic floor muscle contraction (PFMC), and on maximal Valsalva maneuver. The area of the levator hiatus was measured in the plane of minimal hiatal dimensions [3] at rest, on PFMC, and on Valsalva; see Figure 1. Ultrasound data were analyzed offline. The investigator was blinded to all clinical data during data analysis. Group differences in descriptive variables [age, body mass index (BMI)] and levator hiatal area at rest, on PFMC and on Valsalva were assessed using the independent samples t-test. The Chi-square test was used to compare groups on hormonal contraceptive use. To determine group (PVD, control) main effects on the percent change in hiatal area during PFMC and Valsalva, separate analyses of covariance (ANCOVAs) were performed for each task, and included group as a factor and rest measurement as a covariate. Figure 1. The levator hiatus area is bordered by the solid tracing. SP symphysis pubis, U urethra, V vagina, A anus, LA levator ani.

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Results: The two groups were similar in age, BMI and hormonal contraceptive use. Mean age for the women in the PVD group was 23.3 years (SD 4.5, range 19– 38), and 21.2 years (SD 2.5, range 18–28) for women in the control group. In the PVD group, the mean duration of symptoms was 4.6 years (SD 4.1, range 0.7–17). The women with PVD had smaller levator hiatuses at rest and on maximal Valsalva, and demonstrated significantly less hiatal enlargement on Valsalva, as compared to controls. No group main effect was found for levator hiatal reduction on PFMC. See Table 1. Table 1. Levator hiatus (LH) area at rest, on pelvic floor muscle contraction, & on Valsalva. LH area REST (cm²) LH area PFMC (cm²) LH area VALSALVA (cm²) Change on PFMC (%) Change on Valsalva (%)

PVD 11.03±1.93 8.62±1.73 13.88±3.77 −20.73±11.08 24.10±20.36

Control 12.65±2.84 9.33±1.80 18.96±5.89 −25.38±8.44 54.46±38.80

p-value 0.032 0.193 0.003 0.491 0.013

Conclusion: Compared to women without genital pain, women with PVD appear to have a smaller levator hiatus and a lower capacity to lengthen the levator ani on Valsalva, which supports previous research findings of high PFM tone in women with PVD. PFM contractile ability as measured by ultrasound appeared to be similar in both groups, in contrast to previous findings of lower PFM strength in women with PVD. Future work should aim to investigate the role of ‘active’ versus ‘passive’ components of muscle force (i.e., muscle activity vs. muscle stiffness) as they relate to findings of higher PFM tone in women with PVD. References: 1. J Am Med Wom Assoc. 2003;58:82–88. 2. J Psychosom Obstet Gynaecol. 2005;26:107–113. 3. Ultrasound Obstet Gynecol. 2005;25(6):580–585. S. Thibault-Gagnon: Grant /Research Support; Scholarship/Fellowship support from National Vulvodynia Association, Physiotherapy Foundation of Canada, College of Physiotherapists of Ontario, Ordre professionel de la physiothérapie du Québec. C. Goldfinger: None. C.F. Pukall: Grant /Research Support; Operating funds support from Canadian Institutes of Health Research, National Vulvodynia Association. S. Chamberlain: None. L. McLean: Grant /Research Support; Operating funds support from National Vulvodynia Association, Infrastructure support from Canadian Foundation for Innovation, Ontario Innovation Trust.

21 DYSPAREUNIA IN RELATION TO PELVIC FLOOR MUSCLE FUNCTION—A LONGITUDINAL STUDY F R O M P R E G E S TAT I O N T O S I X M O N T H S POSTPARTUM M. Kolberg1, G. Hilde 2, J. Stær-jensen 1, F. Richter 1, M. Ellström Engh 1, K. Bø 3; 1 Akershus Univ. Hosp., Dept of Obstetrics and Gynecology, Lørenskog, Norway, 2Norwegian Sch. of Sport Sci., Dept. of Sports Med.,, oslo, Norway, 3Norwegian Sch. of Sport Sci., Dept. of Sports Med.,, Oslo, Norway. Objective: The aim of the present study was to investigate the presence of dyspareunia from pregestation to 6 months postpartum. Further, to study dyspareunia in relation to pelvic floor muscle (PFM) function. Background: To date there is scant knowledge on female sexual dysfunction (FSD) in relation to PFM function. Dyspareunia is pain or discomfort related to sexual intercourse (1), and is an area of controversy with respect to prevalence, underlying causes and treatment (2). Methods: Three hundred nulliparous pregnant women, mean age at inclusion 28.7 (range 19–40, SD 4.3) and prepregnancy BMI 23.9 (SD 3.9) were included in this prospective cohort study. Inclusion criteria: ability to speak and understand the native speaking language. Exclusion criteria: multiple pregnancies or premature birth <32w. Ongoing exclusion criteria: previous miscarriage after week 16, still birth and serious illness of mother or child. International Consultation on Incontinence Modular Questionnaire, sexual matters module (ICIQ-FLUTSex) were used to collect data regarding the presence of dypareunia and the perceived impact of dyspareunia on sexual life, on a scale ranging from 0 to 10. Zero being no impact and 10 major impact. Dyspareunia was defined as one or more episodes of pain during intercourse the last 3 months before the pregnancy and the last 4 weeks at gestational week 22 and 37, 6 weeks- and 6 months postpartum. Questions regarding pregestational dyspareunia were asked retrospectively. Vaginal resting pressure (VRP), maximum voluntary contraction (MVC) and PFM endurance were measured at gestational week 22, 6 weeks- and 6 months postpartum with fiberoptic pressure transducer connected to a vaginal balloon catheter (camtech AS) in combination with visual observation. The method is assessed to be reliable and valid (3). Background variables are reported as means with range and SD and descriptive variables as frequencies. VRP, MVC and PFM endurance are reported as means and SD. Between groups comparisons were analysed with Independent Samples T-Test. P-values<0.05 were considered significant.

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Results: Women not having sexual intercourse were 15 (5 %) at gestational week 22, 50 (18 %) at gestational week 37, 182 (65 %) at 6 weeks- and 20 (10 %) at 6 months postpartum. 83 (27.7 %) of the 299 women having sexual intercourse reported dyspareunia during the last 3 months before pregnancy, 87 (30.5 % ) of 285 at gestational week 22, 94 (41 %) of 227 at gestational week 37, 52 (52.5 %) of 99 at 6 weeks- and 81 (44.7 %) of 181 at 6 months postpartum. Mean perceived impact of dyspareunia was 3.4 (SD 2.5) prepregnancy, 3.5 (SD 2.3) at gestational week 22, 4.0 (SD 2.5) at gestational week 37, 4.7 (SD 2.9) at 6 weeks- and 4.5 (SD 2.9) at 6 months postpartum. There were no statistically significant differences in VRP, MVC and PFM endurance in women with and without dyspareunia at gestational week 22, 6 weeks- and 6 months postpartum (Table 1). Table 1. Vaginal resting pressure (VRP) (cmH2O), maximum voluntary contraction (MVC) (cmH2O) and PFM endurance (cmH2O 10 s) in women with (1) and without dyspareunia (0) at gestational week (GW) 22 (N 1087, N 00198), 6 weeks- (N 1052, N 0047), and 6 months postpartum (PP) (N 1081, N 00100). Means and SD. GW22 1

0

6 weekspp

6 monthspp

1

1

0

0

VRP

43.1 42.9 34 30.7 35.3 34.2 (11.3) (9.3) (11.3) (7.2) (9.1) (8.6) MVC 33 36 22.2 21.8 34.9 30.4 (18.4) (17.7) (14.8) (17.2) (18.9) (18.7) Endurance 223.5 248.9 158.2 160.3 270.2 244.6 (133.3) (131.5) (115.5) (121.9) (157.2) (161.4)

Conclusions: To our knowledge this is the first longitudinal study on dyspareunia following first time pregnant mothers from gestational week 22 to 6 months postpartum, including clinical assessment of PFM function. The prevalence of dyspareunia was high even before pregnancy, rose during pregnancy and was 45 % at 6 months postpartum. There was no difference in VRP, MVC or PFM endurance in women with and without dyspareunia. Future randomized controlled trials are warranted to assess the effect of PFM training on dyspareunia. References: 1. Int Urogynecol J (2010) 21:5–26 2. J Sex Med 2009;6:40–48 3. Neurourol Urodyn 9:479–487 M. Kolberg: Employee (full or part time); Akershus University Hospital, Dept of Obstetrics and Gynecology. G. Hilde: Employee (full or part time); Norwegian School of Sport Sciences, Department of Sports Medicine,. J. Stær-Jensen: Employee (full or part time); Akershus University Hospital, Dept of Obstetrics and Gynecology.

F. Richter: Employee (full or part time); Akershus University Hospital, Dept of Obstetrics and Gynecology. M. Ellström Engh: Employee (full or part time); Akershus University Hospital, Dept of Obstetrics and Gynecology. K. Bø: Employee (full or part time); Norwegian School of Sport Sciences, Department of Sports Medicine,.

262 PREVALENCE AND PREDICTORS OF PELVIC FLOOR DYSFUNCTION IN PRIMIPS - 4P STUDY C. M. Durnea, A. S. Khashan, S. S. Tabirca, L. C. Kenny, B. A. O’reilly Cork Univ. Maternity Hosp., Cork, Ireland. Objective: This study aims to look at various factors involved in pregnancy and delivery amongst a cohort of nulliparous women, identify the risk factors for postnatal Pelvic Floor Dysfunction (PFD) and delineate the group of patients who might be at higher risk of having these complications. Background: Pregnancy and childbirth are recognised as major aetiological factors in the subsequent development of PFD1,2. However, the precise role of pre-pregnancy, antenatal and intrapartum events in the aetiology of PFD is poorly understood. Methods: This is a prospective, longitudinal, observational cohort study nested within the SCOPE (Screening for Pregnancy Endpoints www.scopestudy.net) Ireland study. A validated Australian PFD questionnaire was completed by 730 low risk, primiparous women when recruited at 15 weeks’ gestation with a particular focus on pre-pregnancy symptoms. Women then completed the same questionnaire approximately 12-18 months postnatally. This data was combined with labour and delivery information. Multiple ordered logistic regression was used to compare the association of 20 risk factors with postnatal PFD. Results: We have detected a high background prepregnancy incidence of PFD (urinary: urgency-41%, urge incontinence12%, stress incontinence-19%, faecal: urgency-48%, incomplete evacuation-43%, frequency-18%, prolapse: vaginal pressure or heaviness- 3%, sexual dysfunction: dyspareunia-32%, decreased vaginal sensation-12%, vaginal laxity-5 %). Prenatal symptoms had shown high postnatal persistence (Persistent Postnatal PFD group -PPPFD) in all dysfunction sections: urinary-88%, faecal-93%, prolapse-39%, sexual79%. Apart from the prolapse dysfunction section, the number in the PPPFD group was greater than in the asymptomatic prenatally group with De Novo Postnatal PFD (DNPFD), consisting of: urinary-77%, faecal- 92%, prolapse-13%, sexual-62% among all postnatally affected participants. PPPFD

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had a higher median score and Interquartile Range (IQR) compared to DNPFD group: bladder- 3(1-6) vs. 1(0-2), bowel4(2-6) vs. 2(0-2), sex- 2(1-4) vs. 1(0-2), prolapse median score was around 0 due to low numbers. These differences were statistically significant. Prepregnancy PFD score had worsened in approximately half of participants with persistent postnatal pathology: urinary-48%, faecal-41%, prolapse-13%, sexual45%. Postnatal bothersome rate (Tab. 1) increased 2-4 folds vs. prenatal one, except bowel section, where it remained unchanged. Postnatal bothersome grade was higher in the persistent pathology compared to de novo postnatal onset group. Table 1. Bothersome comparison Bothersome grade

Bothered* prenatally

Urinary 63(86 %) 8(11 %) 2(3 %) 73(10%) Faecal 1 148(76 %) 2 36(19 %) 3 10(5 %) Tot. Bothered 194(27 %) Prolapse 1 4(57 %) 2 3(43 %) 3 0 Tot. Bothered 7(1 %) 1 2 3 Tot. Bothered

1 2 3 Tot. Bothered

Sexual 51(76 %) 13(19 %) 3(4 %) 67(9 %)

Bothered* Postnatal Postnatal postnatally DNPFD PPPFD bothersome* bothersome*

123(83 %) 23(15 %) 3(2 %) 149(20 %)

94(90 %) 9(9 %) 1(1 %) 104 (70 %)

27(64 %) 13(31 %) 2(5 %) 42(58 %)

135(78 %) 31(18 %) 7(4 %) 173(24 %)

62(83 %) 11(15 %) 2(3 %) 75(43 %)

71(74 %) 20(21 %) 5(5 %) 96(51 %)

18(62 %) 6(21 %) 5(17 %) 29(4 %)

15(63 %) 4(17 %) 5(21 %) 24(83 %)

1(33 %) 2(67 %) 0 3(50 %)

126(75 %) 31(18 %) 11(7 %) 168(24 %)

102(78 %) 21(16 %) 8(6 %) 131(78 %)

21(62 %) 10(29 %) 3(9 %) 34(51 %)

* Out of total bothered in the group

The highest risk factor associated with postnatal PFD was presence of prenatal symptoms - Odds Ratio (OR) and Confidence Interval [CI] 5.08 [3,28-7,86], followed by young maternal age OR 2.43 [1.33-4.44], induction of labour OR 2.12[1.01-4.48], use of epidural OR 1.54[1.08-2,17]. Women in the affected group were twice as likely to be delivered by forceps however, its impact on PFD didn’t reach statistical significance OR 1.38[0.8-2.7]. Many features of PFD were reduced by Caesarean Section OR 0.110.48 p<0.05 . A statistically significant increase in prolapse

dysfunction was associated with foetal birth weight 200 g. higher than median. Conclusion: This study demonstrated a high rate of prepregnancy pelvic floor dysfunction in nulliparous population followed by high postnatal persistence, which has not been described previously. Among postnatally affected participants, persistent prepregnancy symptomatic women predominated and their bothersome grades were higher. Approximately half of pre-pregnancy affected individuals postnatal PFD scores worsened and their median scores were higher compared to de novo postnatal symptomatic group. Caesarean Section reduced the risk of severe postpartum PFD. However, prepregnancy PFD is the highest impact risk factor associated with postnatal PFD. We concluded therefore, that an individually tailored approach to mode of delivery should be used for patients with severe prepregnancy PFD. References: 1. MacLennan AH et al. The prevalence of pelvic floor disorders and their relationship to gender, age, parity and mode of delivery. BJOG. 2000;107(12):1460-70. 2. Casey BM et al. Obstetric antecedents for postpartum pelvic floor dysfunction. Am J Obstet Gynecol. 2005;192 (5):1655-62.

22 MOST OF THE PATIENTS WITH SUBURETHRAL SLING FAILURE HAVE TAPES LOCATED OUTSIDE THE HIGH-PRESSURE ZONE OF THE URETHRA M. Bogusiewicz, A. Stankiewicz, M. Monist, M. Woźniak, A. Wieczorek, T. Rechberger Med. Univ. of Lublin, Lublin, Poland. Objective: Aim of the study was to determine the location of tapes in relation to the urethral length in patients with recurrent stress urinary incontinence seeking help due to failed sling procedures. Background: Urethral profile measurements and lateral urethrocystography identified the section of the urethra which is crucial for continence mechanism, termed highpressure zone of the urethra. It extends between the point of maximum urethral closure pressure and the urethral knee and has been calculated to lie between 53 % and 72 % of the functional urethral length, where pubourethral ligaments attach [1]. Recent ultrasound studies showed that the best results of suburetral slings are achieved when tape is positioned directly under this zone [2, 3].

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Methods: The study group comprised of 61 patients admitted our department or attending our out-patient clinic due to failure of treatment with suburethral sling procedures. The patients underwent sling procedures 6 months to 5 years earlier between 2004 and 2010. In all cases recurrence of SUI was noted within 6 months after surgery. The age of the subjects ranged from 35 to 82 years (mean 60.0±9.9 years), BMI from 18.2 to 38.3 (mean 28.4±4.2), parity from 0 to 5 (mean 2.4±1.1). All women complained of stress urinary incontinence. The diagnosis was confirmed by physical examination, cough test and urodynamic studies. In 3 patients de novo urgency concomitant with permanent urine leakage developed shortly after the surgery. Forty-nine (80.3 %) women were initially treated with a transobturator sling and 12 (19.7 %) with a suprapubic procedure. Twenty patients had the original sling performed at our department whereas 41 remaining in other institutions. Position of tapes was evaluated with a linear array of a biplane transducer, frequency range 9–12 MHz (type 8848, B-K Medical, Herlev, Denmark) using an ultrasound scanner ProFocus 2202 (B-K Medical, Herlev, Denmark). During examination the patient was recommended to have a comfortably full bladder and was placed in a dorsal lithotomy position. The transducer was inserted into vagina in a neutral position with no compression on the urethral complex and surrounding structures. Three-dimensional acquisition was performed by rotation of the transducer from the right side (9 o’clock position) to the left side (3 o’clock position) of the patient. Obtained 3D volumes were used for data analysis. The position of the tapes relative to the urethra was evaluated on the midsagittal view. The midsagittal plane was assumed when the lumen of the urethra was visualized along the entire length of the urethra, from the bladder neck to external urethral meatus. The reference point was set at the midpoint on the tape. The length of the urethra was measured from the bladder neck to the external urethral meatus following the urethral lumen, taking into account its curve. The position of the tapes relative to the percent of the urethral length was calculated considering the bladder neck as the proximal end of the urethra. Measurements were done independently by two investigators (M.B. and A. S) and mean values were used for analysis. Test-retest reproducibility analysis and intraclass correlation coefficients of the parameters showed excellent interobserver agreement r00.96, CI 95 %, (0.85–1.08), r<0.001. Results: The tapes were easily visualized in all investigated patients. Typically, a tape was seen as a hyperechogenic area under the urethra. However, in several patient who had undergone sling surgery 4–5 years earlier tapes

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were poorly seen probably due to their ingrowth by the connective tissue. In these cases acoustic shadow produced by the tape was helpful in determination of tape location. Only 13 (21.3 %) patients had tapes positioned between 50th and 75th % of the urethral length. In 45 (73.8 %) of women examined the tape was found below the 50th and in 3 (4.9 %) over the 75th %. In 2 out of 3 patients with de novo urgency tapes were found to lie close to the bladder neck. Conclusions: In majority of the investigated patients the tape localization was found outside the high-pressure zone of the urethra (i.e. under the proximal half of the urethra). The position of a tape outside this zone may be considered as a cause of suburethral sling failure. References: 1. Int Urogynecol J 1996;7:81–6. 2. Neurourol Urodynam 2008;27:485–90. 3. Ultrasound Obstet Gynecol. 2012;39:210–4. M. Bogusiewicz: Grant /Research Support; Medical University of Lublin grant no 460. A. Stankiewicz: None. M. Monist: None. M. Woźniak: None. A. Wieczorek: None. T. Rechberger: None.

23 WHAT HAPPENS WITH SINGLE INCISION TAPE (TVT-S) AFTER SURGERY, IN COMPARISON WITH TVT-O? AN ULTRASOUND STUDY — RESULTS FROM A RANDOMIZED TRIAL J. Masata, K. Svabik, P. Hubka, R. Elhaddad, P. Drahoradova, A. Martan Obstet, Gynecol, Dept, Charles Univ., 1st Faculty of Med., Prague 2, Czech Republic. Objective: The aim of this study was to assess possible reasons for the lower efficacy of the TVT-S procedure in comparison to TVT-O, based on postoperative monitoring of the position of the tape and its descent. The hypothesis was that the reason for the lower efficacy of TVT-S procedure may be primary malposition of the tape, or poor fixation, leading in time to an increase in tape mobility after the procedure. Background: Synthetic midurethral slings are at present considered the gold standard for surgical treatment of stress urinary incontinence, but they are also associated with some complications. To reduce the occurrence of such complications, transobturator tapes were introduced, followed by single incision tapes. In our randomize trial we have prove the lower efficacy of TVT-S procedure, both H and U approach, as compared to the TVT-O procedure (results of

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primary outcomes were published previously). However, as part of the patient monitoring procedure ultrasound examinations were performed, especially post-operative monitoring of the tape Methods: Between January 2007 and November 2009, 197 women with proven urodynamic stress urinary incontinence (USI) were included in the randomized trial. The study was approved by the local ethics committee. The recruitment period for the study started in November 2006 and ended in October 2009. During the study period 711 patients were indicated for surgical treatment for SUI: 408 of them were suitable for the study, and 205 patients agreed with randomization and signed informed consent prior to treatment. 197 of these underwent randomization: 67 were allocated to TVT-O, 64 to TVT-SH and 65 to TVT-S U (all those patient received the planned surgery). Based on pre-study statistical calculations it was indicated that the required sample size for final statistical analysis in each group was 65 patients (allocation ratio 1:1:1). The study was only intended to establish differences in efficacy between TVT-O and TVT S groups. Pre-operatively the patients underwent a complete urogynaecological examination, including ultrasound examination. The position of the bladder neck and its descent was assessed, as was the position and descent of the tape after surgery: the upper and lower tape margins. Checks were planned for 3 months, 1 year, 2 years and 3 years after surgery. For a subgroup of patients we added ultrasound examination on the first day after surgery (this examination was not mandatory, because we were unable to provide it during the weekends). Results: There were no significant differences in patient characteristics before surgery as regards. Median follow-up after surgery was 2 (SD 0.8) years. Three months after surgery 95.4 % subjects in the TVT-O group, 82 % in the TVT-SH group and 76.7 % in the TVT-S U group had negative stress test (p 00.006). At the end of survey 92.6 % subjects in the TVT-O group, 68.8 % in the TVTSH group and 69.2 % in the TVT-S U group had negative stress test (p<0.001). For comparison of tape behaviour we used only those patients who had the ultrasound scan on the first day after surgery and also had ultrasound scans 3 months after surgery and at the end of the survey. We thus analysed 117 patients, 42 in the TVT-O group, 38 in the TVT—SH group and 37 in the TVT-S U group. After surgery there was no difference between the position of the tape at rest and at maximal Valsalva between the TVT-S and TVT-O groups. The length of the upper and lower tape descent was similar (Tab.1). In TVT-O patients the mean length of upper tape margin descent increased from 6 mm on the first day after

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surgery to 9 mm 3 months after surgery; afterwards it remained stable. In contrast, for TVT-S patients there was further increase in the tape descent after 3 months, the increase being up to 16 mm. Conclusions: Increased tape descent in the TVT-S groups corresponds with the increased number of patients with positive stress test. It therefore appears, based on the results of this comparative study, that fixation of the single incision tape—TVT-S—in both positions U and H is inadequate. Table 1a Position of the upper tape margin at rest and its descent after surgery

N

TVT-S H

TVT-S U

TVT-O

42

38

37

17.3±5.3 10.0±5.6 7.8±5.5

17.5±4.2 12.8±4.2 7.7±4.1

NS NS NS

14.6±4.4 9.8±5.6 9.3±4.5

15.1±5.3 10.1±6.2 11.5±5.3

14.7±4.5 13.1±5.6 13.8±4.6

NS 0.03 <0.0001

15.4±4.1 10.2±6.3 10.1±5.5

16.2±5.4 10.9±5.8 14.5±6.5

15.9±5.0 12.8±6.7 16.6±5.7

NS NS 0

1.Control Y at rest (mm) 17.2±4.4 X at rest (mm) 11.1±5.3 descent (mm) 6.0±4.3 3. months control Y at rest (mm) X at rest (mm) descent (mm) Last control Y at rest (mm) X at rest (mm) descent (mm)

p

Table 1b Position of the lower tape margin at rest and its descent after surgery 1.Control Y at rest (mm) X at rest (mm) descent (mm) 3. Months control Y at rest (mm) X at rest (mm) descent (mm) Last control Y at rest (mm) X at rest (mm) descent (mm)

11.2±4.5 11.6±5.1 5.4±3.4

11.2±6.3 13.2±4.8 7.2±5.8

9.2±4.8 14.5±4.3 6.3±3.7

NS NS NS

9.4±4.8 12.4±4.0 8.4±4.2

7.3±5.2 12.2±4.1 8.2±3.9

6.6±5.1 15.3±5.1 11.7±3.7

NS 0.01 <0.0001

9.7±4.6 12.7±5.0 8.9±4.8

8.4±5.4 12.8±4.2 11.9±5.7

8.1±5.4 14.9±4.8 13.7±4.8

NS NS <0.0001

Values are given as mean±SD J. Masata: Grant /Research Support; Grant Agency of the Ministry of Health of the Czech Republic, grant NS 10586-

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3/2009. K. Svabik: Grant /Research Support; Grant Agency of the Ministry of Health of the Czech Republic, grant NS 10586-3/2009.. P. Hubka: None. R. ElHaddad: None. P. Drahoradova: None. A. Martan: Grant /Research Support; Grant Agency of the Ministry of Health of the Czech Republic, grant NS 10586-3/2009.

24 DOES SURGERY FOR URINARY INCONTINENCE IN WOMEN AFFECT THEIR USE OF SYMPTOMRELIEVING MEDICATIONS? R. Guldberg, S. Brostrøm, U. S. Kesmodel, L. Kærlev, J. K. Hansen, J. Hallas, B. M. Nørgård Odense Univ. Hosp., Odense C, Denmark. Does surgery for urinary incontinence in women affect their use of symptom-relieving medications? Objective: To examine the use of symptom-relieving medications before and after surgery for urinary incontinence (UI), with the aim of assessing if surgery affects the use of the medications. Background: The field of medications for UI has been through an intensive market-derived development over the last decades, resulting in high-grade evidence from mostly 12-week industry-sponsored registration studies. In the same period, surgical treatment has undergone an intensive development as well, with the introduction of minimally-invasive sub-urethral sling procedures for SUI. The relationship of the symptom-relieving medications and surgery for UI has not previously been studied. Methods: All primary surgical procedures for UI in female patients were extracted from the Danish National Patient Registry. The study population included women age over 18 years having first-time surgical procedure for UI in a gynecological department in the county of Funen (5 hospital departments), Denmark in 1996–2006 and extended to include department from the whole Region of Southern Denmark (including Funen) from 2007 to 2010 (14 hospital departments). Concomitant or prior surgery for pelvic organ prolapse was not an exclusion criterion. The information on relevant medications was retrieved from the Odense University Pharmacoepidemiologic Database with 1995–2011. Exposed women: women having redeemed one or more prescriptions of symptom-relieving medications (ATC G04BD N06AX21) within 365 days preceding surgery.

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Unexposed women: women not having redeemed prescriptions on the medications within 365 days preceding surgery. Covariates included for adjustment: age, type of surgery (TVT/TVT-/Bulking), estrogen use prior to surgery, comorbidity, and calendar time. Results: A total of 3.888 women had a primary surgical procedure for UI in the study period, of these, 368 (9.5 %) were exposed to symptom-relieving medications prior to surgery. A total of 1403 prescriptions were redeemed in the study period: 1403 prior to surgery, 260 within 0–60 days after surgery, and 1352 within 60–365 days after surgery. Exposed women (n0368): 111 (30.2 %) and 147 (39.9 %) had redeemed at least one prescription of symptom-relieving medications within respectively 0–60 and 60–365 days after surgery. Unexposed women (n03.520): 30 (0.9 %) and 165 (4.7 %) had redeemed at least one prescription of symptom-relieving medications within respectively 0–60 and 60–365 days after surgery. The crude and adjusted risk of short term postoperative use (within 0–60 days) of symptom relieving medications were 50.2 / 35.5 [95 % CI 32.9–76.7 / 22.0–57.3], and the risk of long term postoperative use (within 60–365 days) were OR 13.2 / 7.5 [95 % CI 10.4–17.6 / 5.6–10.9] Conclusions: This is an original study with strengths of uniqueness and completeness of data sources. We found, that the use of symptom-relieving medications did change after surgery for UI, although there is a high risk of continuing the use of the medications after surgery. Of the former users, 39.9 % continue and 60.1 % stop using symptom-relieving medications. Of former not-users, there were 4.7 % new users within 1 year of surgery. R. Guldberg: None. S. Brostrøm: None. U.S. Kesmodel: None. L. Kærlev: None. J.K. Hansen: None. J. Hallas: None. B.M. Nørgård: None.

25 BULKING AGENT INJECTION FOR STRESS URINARY INCONTINENCE: OUTCOMES BASED ON LOCATION AND PERIURETHRAL DISTRIBUTION OF MACROPLASTIQUE® AS DETERMINED BY 3DIMENSIONAL ENDOVAGINAL ULTRASOUND A. Hegde, A. Smith, V. Aguilar, G. Davila Cleveland Clinic Florida, Weston, FL. Objectives: To identify the optimal site of injection of a synthetic silicone-based bulking agent (Macroplastique®,

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Uroplasty, Minnetonka, MN) with the help of 3dimensional endovaginal ultrasound (3D EVUS) and also to identify intra operative sonographic parameters that could be used to predict short term outcomes following injection of the bulking material. Background: Success rates following Macroplastique® injection are highly variable (1). The optimal site of injection is still unclear and the decision to perform repeat injections is largely empirical and is generally based on patient reporting on the post-procedure impact on continence (2). Thus identifying the optimal site of injection and other intra operative clinical parameters that can reliably predict outcomes following the injection is highly desirable. Methods: Ultrasound parameters in 100 treatment naïve patients from April 2009 to January 2011, in whom 3D EVUS was performed post transurethral injection of the bulking agent, were retrospectively analyzed. 360 ° 3D EVUS scan was performed with BK 2502 transducer. The location, volumes and distance of the hyperechoeic densities from the urethrovesical junction, as seen on 3D EVUS, were assessed. The circumference of the urethra was divided into four quadrants in a clockwise fashion: left upper, left lower, right lower and right upper and the % cross sectional area of each quadrant filled with the bulking material, was assessed. Based on clinical outcomes, the patients were divided into two groups: Group A (n 072): patients who were cured or improved following treatment and Group B (n 028): patients who were not improved or worsened. The location, volumes,

periurethral distribution and the distance of the hyperecheoic densities from the urethovesical junction, as seen on 3D EVUS, were compared between the two groups. Results: The two groups were similar with respect to their demographic data, prior anti-incontinence procedures, the amount of bulking material injected and the median weeks of follow-up (p > 0.05). On 3-D EVUS, the two groups were not significantly different with respect to the volumes visualized and the mean distance of the hyperechoeic densities from urethrovesical junction (p > 0.05). Group A had a greater proportion of women with the bulking material located in the proximal urethra while the mid urethral location was found to be significantly more in Group B (p 0 0.036, table 1). The odds of finding a circumferential periurethral distribution in Group A was 13.62 times the odds in Group B (95 % CI: 5.12–56.95). When the location of the injection and the type of periurethral distribution were considered together, it was found that when the site of injection was proximal, the odds for circumferential distribution in Group A was significantly greater than that in Group B (table 1, figure 1). Conclusion: Injection of MPQ® in proximal urethra is associated with best short term clinical outcomes. Where 3-dimensional ultrasound is available, circumferential periurethral distribution of the injected material can be used as a reliable intra-procedure ultrasound parameter to help predict outcomes following the injection.

Table 1. Distribution of the bulking material as seen on 3D evus Location Proximal Uretha Total Midurethra Total Both proximal and midurethra

Distribution Circumferential* Partial^ Circumferential* Partial^ Circumferential* Partial^

Total

Group A N (%) 33 (84.62) 6 (15.38) 39 9 (69.23) 4 (30.77) 13 17 (85)

Group B N (%) 2 (20) 8 (80) 10 3 (25) 9 (75) 12 2 (33.33)

3 (15) 20

4 (66.67) 6

*More than 50 % of three successive quadrants or all four quadrants filled ^Less than 50 % of three consecutive quadrants or only 2 or 1 quadrant filled

Odds ratio (95 % CI) 22 (3.056–203.488)

P value <0.001

6.750 (0.88 to 61.247

0.047

11.333 (1.015–172.673)

0.028

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Figure 1. Macroplastique® symmetrically distributed around the proximal urethra

References: 1. Advances in Urology 2011; 1–14. 2. Urology 2003; 62: 232–236. A. Hegde: None. A. Smith: None. V. Aguilar: None. G. Davila: None.

26 WHY IS THE SUCCESS RATE HIGHER W I T H R E T R O P U B I C S L I N G S C O M PA R E D TO TRANSOBTURATOR SLINGS IN WOMEN W I T H S T R E S S U R I N A RY I N C O N T I N E N C E AND INTRINSIC SPHINCTER DEFICIENCY: AN ANALYSIS FROM AN URODYNAMIC POINT OF VIEW J. Alvarez, P. Dwyer, F. Kaplan, L. Schierlitz, A. De Souza, K. Cvach Mercy Hosp. for Women, Heidelberg, Victoria, Australia. Objective: To identify the urodynamic parameters which may improve our understanding why retropubic slings are more successful than transobturator slings in the treatment of stress urinary incontinence (SUI) associated with intrinsic sphincter deficiency (ISD). Background: Recent data suggests that retropubic mid urethral slings perform better than transobturator slings in patient’s with SUI associated with ISD (1). However, the mechanism whereby retropubic slings are more successful in this patient subgroup still remains unclear. One theory is that placement of the retropubic sling at a greater perpendicular axis to the urethra, and therefore surrounding a greater area of the urethra, increases outlet resistance. Methods: An ancillary study was performed using data from a RCT evaluating retropubic vs transobturator slings for the treatment of stress urinary incontinence in patients with intrinsic sphincter deficiency. One hundred and sixty-four women were randomized to receive a TVT or TOT sling. 138 patients underwent urodynamic assessment preoperatively and at 6 months postoperatively regardless of the incontinence surgery outcome.

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Changes in urodynamic parameters were correlated with a successful outcome, defined in this study by the absence of SUI during post-operative urodynamics (cured). We analyzed the following urodynamic variables: Un-instrumented maximum peak flow (fQMax), Abdominal Leak Point Pressure (ALPP), Mean urethral closure pressure (MUCP), Detrusor Pressure at peak flow (PDet@QMax), Bladder outlet obstructive index (BOOI0PDet@QMax x 2Qmax). Data are reported on those women with complete urodynamic assessment at both time points. Results: There were no demographic or urodynamic differences between the two groups prior to surgery. When urodynamic parameters among the overall UDS- cured group vs the UDSFailure group were analyzed, a statistically significant difference was found in the following pre vs post-operative results: fQ Max (ml/sec) 29.32 vs 10.65 (p00.001), BOOI -35.87 vs -24.13 (p0 0,012), PVR (ml) 18.60 vs 31.21 (p00.046). When analyzing the cured group within each arm, both retropubic and transobturator slings had a statistically significant change from pre- to post operative fQMax : TVT pre 30.46 vs post 19.16, p0 0.001 and TOT pre 28.09 vs post 18.15, p00.032. Only TVT had a significant difference in pre vs post-operative BOOI: TVT pre 37.07 vs post -18.96 p00.005 and TOT pre -34.56 vs post -29.72, p00.477. The other UDS parameters (MUCP, PDet@QMax) were not statistically significant. When analyzing the failure group within each arm, the only UDS parameter that was statistically significant was the ALPP (cm H2O): TVT pre 34.56 vs 49.25 p0 0.041 and TOT pre 40.87 vs 40.03 p00.830. Conclusions: Both retropubic and transobturator midurethral slings significantly increase urethral outlet resistance without causing urinary retention. The increase in ALPP seen post operatively following TVT insertion suggests that retropubic slings may perform better in women with ISD due to the dynamic interaction between the sling and urethra during abdominal pressure changes. Further studies evaluating the dynamic interaction between mid-urethral slings and the urethra during pressure maneuvers are needed. References: (1) Three-year follow-up of tension-free vaginal tape compared with transobturator tape in women with stress urinary incontinence and intrinsic sphincter deficiency. Obstet Gynecol. 2012 Feb;119(2 Pt 1):321–7. J. Alvarez: None. P. Dwyer: None. F. Kaplan: None. L. Schierlitz: None. A. De Souza: None. K. Cvach: None.

27 PELVIC FLOOR MUSCLE TONE IN WOMEN W I T H A N D W I T H O U T S T R E S S U R I N A RY INCONTINENCE M. V. Monteiro, T. S. Barros, A. M. Fonseca, R. R. Gontijo, E. M. Figueiredo, J. S. Barros, M. C. Cruz Univ. FERAL OF MINAS GERAIS, BELO HORIZONTE, Brazil.

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Objective: To document the pelvic floor muscle tone of women with or without stress urinary incontinence (SUI) and investigate the relationship between SUI occurrence and pelvic floor muscle tone. Background: Muscle tone is one of the functions of the pelvic floor muscles (PFM) and has an important role in maintaining urinary continence. The investigation of the relation between PFM functions, particularly muscle tone, with the functions of the urinary system may contribute to an improvement in the comprehension of the continence mechanisms and, consequently, to the enhancement of health practices to women with SUI who present risk factors elated to the mechanic/elastic properties of the PFM. The aim of this study was to document the muscle tone of women with or without stress urinary incontinence (SUI) and investigate the Relationship between SUI occurrence and PFM tone. Methods: Cross-sectional observational study, with 78 participants with the diagnosis of SUI and 74 without SUI were included. Socio-demographic and clinical data were investigated. The pelvic floor muscle tone of the participants was assessed by digital palpation and quantified by a clinical scale with scores ranging from 0 to 5. A descriptive statistical analysis was realized to characterize the sample and the chi-square test was used to investigate the ssociationbetween the occurrence of SUI and tone. Results: The incontinent group showed significant lower values of PFM tone compared to the continent group. The median PFM tone of women with SUI was 2 (IQR 2–3; 95th percentile 3) and the median PFM tone of women without SUI was 3 (IQR 3–4; 95th percentile 4), with a significant difference between groups (p<0.001). Conclusions: This is the first study to document the pelvic floor muscle tonus in women with or without stress urinary incontinence, using a validated and reproducible ordinal scale, which assesses the tone according to the mechanic/elastic properties of the muscles; and evidenced the association between stress urinary incontinence and PFM tone. Thus, future studies and clinical approach of incontinence focusing on this aspect are warranted. References (optional): M.V. Monteiro: None. T.S. Barros: None. A.M. Fonseca: None. R.R. Gontijo: None. E.M. Figueiredo: None. J.S. Barros: None. M.C. Cruz: None.

28 BULKING AGENTS FOR URINARY INCONTINENCE IN WOMEN: A SYSTEMATIC REVIEW P. K. Matsuoka, J. M. Haddad, A. M. Pacetta, E. C. Baracat Univ. of Sao Paulo, Sao Paulo, Brazil.

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Objective: To evaluate the different intraurethral bulking agents for urinary incontinence (UI) in women. Background: The UI is defined as a complaint about involuntary loss of urine.1 The majority of UI cases are conservatively managed by pelvic floor physiotherapy. If this treatment proves unsatisfactory, then surgical intervention may be necessary. A wide range of surgical procedures is available for stress UI. However, some patients with intrinsic sphincter deficiency and significant decreased urethral mobility may be managed with periurethral bulking injections.2 Various bulking agents have been used, however, there is no objective data in the literature that determine which substance should be ideal for intraurethral injections to treat UI.3. Methods: A systematic review of the literature was performed, searching PubMed, Lilacs and Embase Database to April 1st, 2012. We used a high sensibility and low specificity search strategy, formulated from key words and synonyms for urinary incontinence, bulking agents, injections and intraurethral injections. The selection criteria for the studies included randomized controlled trials. The subjects were women with urinary incontinence. The primary outcomes were considered clinical and urodynamic parameters. Secondary outcomes were the adverse effects of the bulking agents. Two reviewers performed data collection and analysis, independently. All selected studies were classified according to the Levels of Evidence Scale of Oxford and Jadad scale. The results were presented as a weighted mean difference for quantitative variables and as odd ratio for qualitative variables, both with 95 % of confidence interval. Results: Initially, 826 studies were identified by the formulated search strategy. But only ten eligible trials fulfilled the necessary prerequisites for the systematic review. After methodology analysis of the selected articles, we excluded five studies that had Jadad 1b. In this review, 821 patients were included. Altogether, the review included trials of six different types of intravesical instillation: collagen, solid silicone elastomer, autologous fat, pyrolytic carbon, calcium hydroxyapatite and dextran copolymer. The first trial compared solid silicone with collagen and showed an improvement of at least 1 Stamey grade in 12 months (p<0.001), in favour of silicone. Stamey grading is a 4 level scale of incontinence severity ranging from 0_continent-dry to 3_total incontinence regardless of the activity. Nevertheless, in the other outcome measurements, such as quality of life, pad test, patient and physician assessment there was no difference between silicone and collagen efficacy. Another trial compared autologous fat with placebo did not show significant difference in efficacy compared to placebo. Moreover, one patient died because of pulmonary embolism, due to autologous fat injection. Next, the use of pyrolytic carbon showed to be as effective as collagen injections, after 1 year of follow-up. And the necessary volume material of the substance is significantly smaller using pyrolytic carbon.

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Finally, the study that evaluated the dextran copolymer via periurethral versus via transurethral injections considered as dry only if they had 100 % improvement and no leakage episodes. The mean improvement was not significantly different between the two groups at 3, 6 and 12 months’ follow- up. Although the postoperative urinary retention was significantly higher in the periurethral group (p < 0,05). The measured outcomes were evaluated by a large variety of instruments. Therefore, we could not perform a meta-analysis with common variables of the studies. Conclusion: We concluded that in the systematic review there are few randomized clinical trials that evaluate bulking agents for UI. Further randomized clinical trials, including studies testing more recent drugs, are required for evaluation of inthrauretral therapies for UI. References 1) Neuronol Urodyn 2010;29(1):4-20 2) Can. 2010 Sep;32(9):893–904 3) Urology. 2005;65:898–904. P.K. Matsuoka: None. J.M. Haddad: None. A.M. Pacetta: None. E.C. Baracat: None.

29 BODY MASS INDEX AND OUTCOME OF SINGLE INCISION SLINGS M. Meschia, G. Rossi, S. Bertini, A. Sommacal, S. Foina, F. Sandretti, P. Barbacini; OspedaIe G. Fornaroli, Magenta, Italy. Objective: The purpose of this study was to assess the potential impact of obesity on single incision slings success rates and patient’s satisfaction 1 year following surgery. Background: Obesity is an increasing health problem world-wide and several epidemiological studies have identified a positive association between obesity and an increased incidence of stress urinary incontinence. Most of the studies investigating the potential impact of obesity on mid-urethral slings outcomes have not demonstrated differences in outcome by BMI. Single incision slings (SIS) have been recently introduced in the clinical practice for the treatment of SUI in women. Concerns regarding lower cure rates for currently available SIS have recently been raised in a meta-analysis comparing single incision slings and standard mid-urethral slings (1). Methods: After obtaining institutional review board approval we reviewed the records of women who underwent single incision sling procedure between November 2006 and October 2009. Pre- and postoperative evaluation included the following: a detailed urogynecologic history, a physical examination, a cotton swab test, a stress test in the supine and standing positions with a comfortably filled bladder (300 ml) and a multichannel urodynamic evaluation. The ICIQ-SF (International Consultation on Incontinence-short form), W-IPSS (Women

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Irritative Prostate Symptoms Score), PGI-S (Patient Global Impression of Severity) and PGI-I (Patient Global Impression of Improvement) questionnaires were used to evaluate the impact of incontinence and voiding dysfunction on QoL and to measure patient’s perception of incontinence severity and improvement. Exclusion criteria for being treated with a single incision sling procedure were: previous anti-incontinence surgery, pelvic organ prolapse requiring treatment, any coexistent pelvic pathology, urethral hypomobility (Δ Q-tip ≤ 20°) and detrusor overactivity. The outcome of surgical treatment was estimated both subjectively and objectively using the same tools as before surgery 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’. Urodynamic techniques and measurements, terms, and diagnostic criteria conform to the recommendations of the International Continence Society. Women were divided into three different group according to their BMI following the recommendations of the World Health Organization; normal weight (BMI< 25 Kg/m2), overweight (BMI 25 to 29.9 Kg/m2) and obese (BMI ≥ 30 Kg/m2) All patients were informed about the study and procedure and gave their informed consent. The Statistical Package for Social Sciences (SPSS 14.0) was used for data analysis. Results: A total of 206 subjects had a single incision sling procedure during the study period of whom 95 underwent the TVT-secur (Ethicon, Women Health & Urology, Sommerville USA) and 111 the Ajust (CR Bard Inc.USA) procedure. Population’s demographic and clinical characteristic were similar between patients undergoing the procedures and no difference was seen in the number of patients in each BMI category. At 1 year follow-up there were 196 women available for the analysis:69 were normal weight subjects, 91 overweight and 36 obese. Overall the subjective and objective cure rates for the whole sample were 82 % and 85 % respectively with no differences between procedures (78 % vs 85 % and 81 % vs 90 %). There was a trend towards lesser efficacy of single incision sling with increasing body weight being the difference significant between obese women (BMI≥30) and normal subjects (BMI<25) both subjectively and objectively: 69.5 % vs 88.4 %, p00.03; and 75 % vs 91.3 %, p00.049. Accordingly there was a significant difference in the mean scores of the ICI-SF and PGI-I questionnaires between these two groups: 5.8±6.2 vs 2.5±3.9, p00.001 and 2.11±1.16 vs 1.53±0.7, p00.002.

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Conclusions: Our study shows that comparing obese and normal weight women undergoing single incision slings those with higher BMI have a lower subjective and objective cure rate 1 year after surgery. This finding was also associated with a significant higher scores at the ICI-SF and PGI-I questionnaires in obese women demonstrating that this group of patients have a lower perception of cure than normal weight subjects. References: 1. Eur Urol 2011, doi: 10.1016/j.eururo.2011.05.003 M. Meschia: None. G. Rossi: None. S. Bertini: None. A. Sommacal: None. S. Foina: None. F. Sandretti: None. P. Barbacini: None.

30 PELVIC FLOOR MUSCLE FUNCTIONS IN CONTINENT AND INCONTINENT WOMEN M. V. Monteiro, R. R. Gontijo, T. S. Rodrigues, J. S. Barros, A. M. Fonseca, E. M. Figueiredo, S. A. Triginelli; Univ. Federal Of Minas Gerais, Belo Horizonte, Brazil. Objective: To describe the pelvic floor muscle functions in women with or without urinary incontinence and investigate if there is difference between continent and incontinent women regarding to pelvic floor muscle functions. Background: The literature clearly reports the relation between pelvic floor muscles (PFM) and the urinary incontinence mechanism. PFM training has been recommended as the first line treatment for urinary incontinence. However, evidence regarding the PFM functions in continent and in incontinent women including muscle strength, endurance, contraction ability and coordination is lacking. Most studies do not investigate all PFM functions, neither the association of those with the urine loss on effort symptom. In addition, few studies describing the PFM function in a cohort of continent women. Therefore, to improve the understanding of the continence mechanism, which may lead to more successful therapeutic approaches to incontinent women, this study aimed to describe the PFM functions in women with or without urinary incontinence and to investigate if there is any difference between continent and incontinent women regarding to these functions. Methods: Cross-sectional observational study with continent and incontinent women (with loss on effort symptom—stress or mixed incontinence). Sociodemographic, clinical data and PFM functions were investigated. Perioneometry (Peritron®) was used to measure muscle strength and vaginal palpation was used to measure muscle resistance, contraction ability and

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coordination. The data collected in the assessments were statistically analyzed by a descriptive analysis. The descriptive data and the PFM functions were compared between groups by the Mann Whitney and by the chisquare tests. Results: The continent and the incontinent group included 86 and 75 participants respectively. There was a significant difference in all PFM functions investigated (P<0.01), even after controlling for possible confounding factors. For muscle strength, the incontinent group (median026 cmH2O) showed significant higher values of muscle strength compared to continent group (median 037.30 cmH2O, p 00.006). For muscle resistance, the incontinent group (median 022 s.) showed significant worse resistance compared to the continent group (median030 s.p00.002). The chance to identify participants without the contraction ability in the incontinent group was 6.06 (2.17–16.67; p 00.001) times higher than the continent group and the chance to observe participants without coordination in the incontinent group was 55.76 (12.7–243.8; p 00.000) times higher than in the continent group. There was a predominant use of abdominal muscle in both groups. Conclusion: This study showed that there is difference between continent and incontinent women in all PFM functions. This study results inform Physiotherapists the values related to PFM strength and endurance, in continent and incontinent women. Furthermore, the difference in PFM contraction ability and coordination in these two groups found in this study suggest that future studies and clinical approach of incontinence focusing on these aspects are warranted. M.V. Monteiro: None. R.R. Gontijo: None. T.S. Rodrigues: None. J.S. Barros: None. A.M. Fonseca: None. E.M. Figueiredo: None. S.A. Triginelli: None.

31 POST-OPERATIVE ADJUSTABILITY OF A NOVEL SINGLE INCISION SLING: FOR HOW LONG?; AN ANIMAL STUDY E. Kocjancic1, A. Sedlar 2 1 Univ. of Illinois at Chicago, Chicago, IL, 2Univ. Med. Ctr. Ljubljana, Ljubljana, Slovenia. Objective: In this study, we compare the force required to adjust the mesh tension at the time of insertion and at various time points after surgery to determine if and for how long post-operative adjustability is feasible. Background: The latest trend in single incision slings is the ability to adjust the sling intraoperatively after the anchors

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have been placed. Sometimes, however, adjustment of the mesh tension after surgery is desirable. Methods: The Coloplast Altis®, single-incision transobturator adjustable sling, was used for this study. It is comprised of: a fixed anchor, a dynamic anchor, and a tensioning suture that runs through the dynamic anchor and allows adjustment of mesh tension at the time of (or after) the surgery. Four 6-month old New Zealand white rabbits were used for the study with four slings implanted into the obturator internus muscle. Three out of four meshes in each animal were used for force measurements, the remaining mesh was used in a separate study. A commercial force gauge was used to mesaure the force required to adjust the tension of the mesh. A steady force, expressed in newtons (N), was applied to the mesh perpendicular to the plane of the muscle until adjustment of the tension was achieved at the time of implantation (day 0), as well as 1, 7, 14, and 21 days after implantation. Results: Average forces required to adjust the mesh tension for each time point after implantation are presented in the

graph. The average force needed to adjust the mesh tension amongst days 0, 1, and 7 were similar (3.6 N, 7.6 N, 5.7 N respectively). However, on days 14 and 21 the mean force required was significantly higher; over 23 N, at which point the mesh broke. The percent increase in mean force required to adjust the mesh tension on days 1, 7, 14 and 21 compared to day 0 were 111 %, 58 % and greater than 500 %, respectfully. Conclusions: Forces required to adjust the mesh tension on days 1 and 7 are similar to the time of implantation (day 0) . On days 14 and 21 forces required are much higher causing the mesh to fail before the tension was adjusted. It appears that the optimal time to adjust the sling post-operatively is within 7 days after implantation. Beyond this time, re-tensioning is not possible without structural damage to the mesh and tissue. These findings leave open the possibility to adjust the tension of the sling up to a week after surgery. Further studies are needed to extrapolate these findings to human subjects.

References (optional): E. Kocjancic: Consultant; BARD, Coloplas, AMS. A. Sedlar: None.

Netherlands, 4Amphia Ziekenhuis, Breda, Netherlands, 5 Groene Hart Ziekenhuis, Gouda, Netherlands. Objective: To compare surgery related pain, efficacy and complications between the single-incision mid urethral tape ( Ajust®) and midurethral tension free vaginal tape—obturator (TVT-O®) incontinence operations. Background: The tension-free vaginal transobturator tape (TVT-O®) procedure was designed to treat female stress urinary incontinence without the risk of bladder perforation associated with the retropubic approach. However, after the TVT-O® procedure some women reported groin pain, probably induced by perforation of the adductor muscles of the upper leg. The new singleincision minisling, Ajust®, does not perforate these

32 A RANDOMIZED CONTROLLED TRIAL COMPARING THE TVT-O® WITH THE AJUST® AS PRIMARY SURGICAL TREATMENT OF FEMALE STRESS URINARY INCONTINENCE. K. J. Schweitzer1, G. J. Cromheecke 1, A. L. Milani 2, H. W. Van Eijndhoven 3, D. Gietelink 4, E. Hallenleben 5, C. H. Van Der Vaart 1 1 Umc utrecht, Utrecht, Netherlands, 2Reinier de Graaf Gasthuis, Delft, Netherlands, 3 Isala Klinieken, Zwolle,

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muscles, and is therefore assumed to cause less operative pain. With respect to efficacy it is not established yet, if these minislings are as good as traditional transobturator tapes. Materials en Methods: From April 2011 to August 2011, women with clinically proven (stress test) stress urinary incontinence participated in a single-blinded randomized controlled trial. After written informed consent they were randomized in a 2:1 design for either a single incision mid urethral tape (Ajust®) or transobturator tape (TVT-O®). Preoperatively, all women were assessed by urogynecological history and vaginal examination including stress test. The severity and impact of the incontinence was assessed by a set of validated questionnaires, namely the urogenital distress inventory ( UDI ) , the Incontinence impact Questionnaire ( IIQ), the Patient Global impression of severity (PGIS) and Patient Global impression of improvement (PGII). Women were blinded to the type of procedure by using a sham skin incision in the Ajust® group. Postoperative pain was evaluated through the Visual Analog Scale (VAS) one and 2 h after surgery, daily for the first 3 days and subsequent weekly up to 6 weeks after surgery. Postoperatively, all women were evaluated by a vaginal examination including stress test and the same set of questionnaires, 6 weeks, 6 months and 1 year after surgery. Results: A total of 156 women were randomized. The Ajust® group consisted of 100 women and the TVT-O® group of 56. Seven women, 3 in the Ajust® group and 4 in the TVT-O® group, resigned after randomization, 3 women originally assigned to the Ajust® mistakenly received a TVT-O® and were, as protocol violations, excluded from further analysis. At this moment 3 women are planned for surgery, leaving 92 in the Ajust® group and 51 in the TVT-O® group. Baseline characteristics were not significantly different between both groups. No major complications or urinary tract injuries occurred and none of the women required blood transfusion. The VAS score was significantly lower in the Ajust® group in the first week after surgery (Fig.1). There was no significant difference in analgesic use. In the Ajust® group 2 intra-operative vaginal perforations occurred that were corrected directly. The mean operating time was significantly shorter for the Ajust® procedure (9.15± 3.7 min vs. 11.02±2.3 min p00.003). Success was classified as ‘very much improved’ or ‘much improved’ on the Patient Global Impression of Improvement. At 6 weeks postoperatively, both procedures scored high but not significantly different, 94 % for the Ajust® group and 91 % for the TVT-O® group. At 6 weeks

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postoperatively UDI urinary subscale showed a reduction from 44±20 to 6±13 after Ajust® and 42±20 to 4±10 after TVT-O® (p 00,8 ). Preliminary data of 84 patients, 53 patients in the Ajust® and 31 in the TVT-O® group, with 6 months follow up show no significant difference for the urinary incontinence subscale of the UDI. The success rate reported by women is 91 % for the Ajust® procedure and 87 % for the TVT-O® procedure. Conclusion: This study demonstrates that Ajust® is an effective technique that causes less postoperative pain until 1 week after surgery when compared with TVT-O®. In addition, preliminary data of our 6 months follow up show comparable effectiveness. K.J. Schweitzer: None. G.J. Cromheecke: None. A.L. Milani: None. H.W. van Eijndhoven: None. D. Gietelink: None. E. Hallenleben: None. C.H. van der Vaart: None.

33 5 YEARS OUTCOME OF MID-URETHRAL SLINGS— TVT VS TVT-O: A RETROSPECTIVE COMPARATIVE STUDY S. Narang, H. C. Han, L. C. Lee, H. F. Wong KK Women’s and Children’s Hosp., Singapore, Singapore. Objective: To compare the long-term outcome of Tension Free Vaginal-Tape (TVT) and Tension Free Vaginal TapeObturator (TVT-O) over a 5-year period. Background: TVT and TVT-O are commonly used slings for the treatment of female stress urinary incontinence (SUI). The choice of mid-urethral sling tape for treatment of female SUI depends in part on a surgeon’s preference and experience. Many studies have shown the superiority of one tape over others, but there is no generalized consensus. There are also studies that have compared the long-term outcomes of various mid-urethral slings and have found comparable results. Methods: This was a retrospective comparative study involving 2 groups—patients who underwent TVT from 2002 to 2004; and patients who underwent TVT-O from 2004 to 2006. Case records were reviewed and data collected included the pre-operative evaluation using a standardized clinical performa, erect stress test (EST) and urodynamic findings. Intra-operative details included duration of surgery, peri- and post-operative complications. Surgery outcomes in terms of cure or improved were assessed at 6 months, 1 year and 5 years. Results: There were a total of 911 patients—492 patients who underwent TVT from 1st January 2002–31st December 2004; and 419 patients who underwent TVT-O from 1st

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January 2004–31st December 2006. Parameters for patients from both the TVT and TVT-O group were comparable except for BMI [TVT: 26.59 ± 5.09 vs TVT-O: 25.53 ± 4.36, p<0.001] and previous incontinence surgery [TVT: 3.7 % vs TVT-O: 9.3 %, p<0.001]. Bladder perforation occurred in fewer TVT-O patients as compared to TVT patients (0.5 % vs 4.3 %, p<0.001). Mean hospital stay was longer for TVT than TVT-O patients (2.35 ±1.28 days vs 1.56±1.27 days). The need for prolonged catheterization ≥7 days was more common in the TVT than TVT-O group (2.4 % vs 1.6 %). 374(76 %) patients in the TVT group and 337(80.4 %) patients in the TVT-O group were available for follow-up at 5 years. The subjective cure rates at 6 months, 1 year and 5 years for the TVT group were 90.7 %, 91.2 % and 73 % respectively; and 92.7 %, 92.8 % and 64.4 % respectively for the TVT-O group. The objective cure rates at 6 months for TVT were 83.3 % and 94.6 % for TVT-O. The improved rates at 6 months, 1 year and 5 years for the TVT group were 8.5 %, 8.4 % and 18.2 % respectively; and 6.9 %, 7.2 % and 27.9 % respectively for the TVT-O group. Conclusions: TVT and TVT-O are comparable in terms of success rates at 6 months and 1 year. TVT-O was found to be associated with lesser peri-operative complications. At 5 years, TVT had higher success rates than TVT-O. More long-term data is awaited for better evaluation of such outcome differences. S. Narang: None. H.C. Han: None. L.C. Lee: None. H.F. Wong: None.

34 EFFICACY OF MIRABEGRON IN PATIENTS WITH AND WITHOUT PRIOR TREATMENT WITH ANTIMUSCARINIC THERAPY FOR OVERACTIVE BLADDER: PRESPECIFIED ANALYSIS OF THREE RANDOMISED PHASE III STUDIES V. Nitti1, S. Herschorn 2, V. Khullar 3, J. Cambronero 4, J. Angulo 5, M. Blauwet 6, C. Dorrepaal 7, E. Siddiqui 8, N. Martin 6; 1 NYU Langone Med. Ctr., New York, NY, 2Univ. of Toronto, Toronto, Canada, 3St Mary’s Hosp. Imperial Coll., London, United Kingdom, 4Infanta Leonor Hosp., Madrid, Spain, 5Hosp. Univ.rio De Getafe, Madrid, Spain, 6Astellas Pharma Global Dev., Deerfield, IL, 7Astellas Global Pharma Dev., Leiderdorp, Netherlands, 8Astellas Pharma Europe Ltd, Staines, United Kingdom. Objective: The objective of this pooled analysis was to examine the efficacy of mirabegron across three phase III

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studies (NCT00689104, NCT00662909 and NCT00912964) in patients with overactive bladder (OAB) with or without previous antimuscarinic therapy. Background: Oral antimuscarinic agents are currently the mainstay of pharmacotherapy for the treatment of OAB. However, some patients have a suboptimal response to these agents or find that antimuscarinic therapy is limited by adverse events such as dry mouth and constipation [1]. In the absence of an alternative therapeutic class, these patients either persist with an unsatisfactory treatment or discontinue therapy. Mirabegron is a potent and selective β3-adrenoceptor agonist developed for the treatment of OAB and may provide an alternative therapeutic option in these patients. A recent post hoc analysis from a phase III study supports the efficacy of mirabegron in treatment-naïve patients as well as patients who discontinued prior antimuscarinics due to inadequate efficacy or poor tolerability [2]. Methods: This analysis utilized pooled data from three randomised, double-blind, placebo-controlled studies (NCT00689104, NCT00662909 and NCT00912964) in which treatment arms assessed the efficacy of mirabegron (50 or 100 mg). This analysis assessed the efficacy of mirabegron compared with placebo in subpopulations of OAB patients with or without previous antimuscarinic treatment (tolterodine, solifenacin, oxybutynin, trospium, darifenacin, or fesoterodine). All randomised patients who took at least one dose of double-blind study drug and who had a micturition measurement in the baseline diary and at least one post-baseline visit diary with a micturition measurement were included in the Full Analysis Set (FAS). All patients in the FAS who had at least one incontinence episode in the baseline diary were included in the Full Analysis SetIncontinence (FAS-I). The co-primary endpoints were change from baseline to Final Visit (End of Treatment) in mean number of incontinence episodes/24 h (FAS-I) and mean number of micturitions/24 h (FAS). Change from baseline for the co-primary endpoints was analysed using analysis of covariance (ANCOVA) with treatment group, gender and study as factors and baseline value as a covariate. Results: Overall there were 3542 patients included in the pooled FAS population; approximately half of the population (n01852) had previously used antimuscarinics (placebo n0704, mirabegron 50 mg n0688, and mirabegron 100 mg n0460). Of the 2317 patients in the FAS-I population, 1360 patients had previously used antimuscarinics (placebo n0518, mirabegron 50 mg n0 506, mirabegron 100 mg n0336). Patient demographics and baseline characteristics were comparable across the

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mirabegron and placebo groups. In the FAS population, approximately 72 % were female; mean age was 59 years. Among patients with previous OAB medication, the reason for discontinuation of previous OAB medication was similar across all treatment groups. Mirabegron 50 and 100 mg demonstrated statistically significant improvements in mean number of incontinence episodes and micturitions/24 h from baseline to Final Visit in patients with previous OAB medication compared with placebo (Table). A statistically significant improvement in micturitions/24 h was also observed with mirabegron 50 and 100 mg in treatmentnaïve patients. Conclusions: The selective β3-adrenoceptor agonist, mirabegron, significantly improved OAB symptoms versus placebo in patients with OAB who were either antimuscarinic treatment-naïve or previously treated with antimuscarinic agents. References: 1. Eur Urol 2008; 54: 543–62 2. Poster presentation at the 27th Annual Meeting of the European Association of Urology, Paris, France, February 2012. Table. Mean adjusted difference versus placebo (with 95 % CI) for the co-primary endpoints in treatment naïve and previously treated OAB patients mirabegron 50 mg Previously treated with OAB medication Mean number N0506 of incontinence -0.57 (−0.81,−0.33) episodes/24 h (FAS-I) Mean number N0688 of micturitions/ −0.74 (−1.01,−0.47) 24 h (FAS) No previous OAB medication (treatment naïve) Mean number N0356 of incontinence −0.15 (−0.44, 0.14) episodes/24 h (FAS-I) Mean number N0636 of micturitions/ −0.33 (−0.62,−0.05) 24 h (FAS)

mirabegron 100 mg N0336 −0.50 (−0.77,−0.22) N0460 −0.69 (−0.99,−0.38) N0241 −0.27 (−0.60, 0.06) N0430 −0.36 (−0.68,−0.04)

V. Nitti: Consultant; Astellas Pharma. S. Herschorn: Consultant; Astellas. V. Khullar: Consultant; Astellas. J. Cambronero: Consultant; Astellas. J. Angulo: Consultant; Astellas. M. Blauwet: Employee (full or part time); Astellas. C. Dorrepaal: Employee (full or part time); Astellas. E. Siddiqui: Employee (full or part time); Astellas. N. Martin: Employee (full or part time); Astellas.

35 EMPOWERING PATIENTS TO BECOME EXPERTS IN THEIR CLINICAL MANAGEMENT I. Giarenis, A. Rantell, H. Mastoroudes, E. Nellist, D. Robinson, L. Cardozo; King’s Coll. Hosp., London, United Kingdom. Objective: 1. To assess patient knowledge about urinary incontinence (UI). 2. To assess whether a structured educational program can improve patient knowledge about UI. Background: Despite the high prevalence of UI and the available options in community and hospital care only onethird of women ever seek medical advice regarding their incontinence¹. The lack of knowledge about UI has been identified as one of the main causes for reluctance to seek professional care². Studies in other chronic conditions have shown that increased patient knowledge improves compliance with treatment and reduce levels of disease symptoms. Methods: This was a prospective observational study in a tertiary referral urogynaecology unit. Consecutive women attending a 1.5-hour educational program run by a urogynaecology nurse and a pelvic floor physiotherapist were recruited to the study. This program, entitled ‘Bladder Training Class’, is run twice a month in our unit for women complaining of lower urinary tract symptoms, who present to our outpatient clinic for the first time. Normal anatomy and physiology are discussed and the terminology is clarified. Prevalence and symptoms of pelvic floor dysfunction are described. Treatment options such as pelvic floor muscle training, diet and fluid intake modification, bladder retraining, medications and surgical management are presented. Women were asked to complete a questionnaire with demographic data (age, menopausal status, occupation, education, household income, ethnicity) and their presenting complaint. They were also asked to complete the 12-item UI scale of the validated Prolapse and Incontinence Knowledge Quiz (PIKQ)³. Each item scale is given a score of 1 if answered correctly and a score of 0 if not answered correctly. Higher scores indicate greater knowledge. The questionnaires were collected by the class instructors and the patients attended this interactive workshop. At the end of the class participants were asked to complete the UI scale of the PIKQ again. Based on the results of a pilot study that showed a standard deviation of 2.78, a sample of 70 patients was required to detect a difference in PIKQ (UI) score of 1.00, for achieving an 80 % statistical power and 5 % significance level, assuming a 15 % non-response rate. SPSS (V 17 Chicago Illinois) was used for statistical analysis. The paired and unpaired t-tests, the Wilcoxon matched

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pairs signed rank test and Kendall’s tau correlation were used as appropriate. P<0.05 was considered to be statistically significant. Results: Seventy patients were recruited to our study with a median age of 54 years (range 19–78) and a median parity of 2 (range 0–8). 50 % of our sample were white Caucasian women and the rest included a variety of racial / ethnic groups. The mean total score for the UI scale of the PIKQ was 8.00 +/−2.48 (mean +/−SD) before the educational program. Women with higher education scored higher before the ‘bladder retraining class’ (p00.031). There was no statistically significant correlation between the PIKQ scores and the household income (p00.112) or ethnicity (p00.108). The mean total score for the UI scale of the PIKQ was 10.07 +/−1.89 after the educational program, revealing a significant improvement of patient knowledge (p<0.001). Individual scores were also statistically significantly better in 10 out of 12 items of the UI scale of the PIKQ (figure 1). Figure 1 (PIKQ, 12-item individual mean scores)

There was no statistically significant correlation between the improvement of knowledge and the education (p 00.127), the income (p 00.367) or the ethnicity (p 00.955). Conclusion: This structured educational program was effective in improving patient knowledge about UI regardless of the ethnic group and the socioeconomic status. Implementation of such programs as part of the routine care provision could improve patient satisfaction and increase compliance with treatment. References: 1. BJU Int 2004; 93:324–30 2. BJOG 2009;116:726–730 3. Int Urogynecol J 2008;19:1283–1289 I. Giarenis: None. A. Rantell: Grant /Research Support; Pfizer. H. Mastoroudes: None. E. Nellist: None. D. Robinson: Consultant; Astellas, Ferring, Gynaecare,

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Pfizer. Grant /Research Support; Astellas, Pfizer. L. Cardozo: Consultant; Allergan, Astellas, Ethicon, Merck, Pfizer, Teva. Grant /Research Support; Pfizer.

36 PATIENT-REPORTED OUTCOME OF SOLIFENACIN TREATMENT IN WOMEN WITH OVERACTIVE BLADDER—MULTICENTER, OPEN-LABEL STUDY I. But1, S. Orešković 2, M. Faganelj But 3 1 Univ. Med. Ctr., Maribor, Slovenia, 2Dept. of Gynaecology and Obstetrics, ZAGREB, Croatia, 3Health Centre ZZFBM Maribor, Maribor, Slovenia. Objective: The aim of this patient-reported outcome study was to estimate the real efficacy and tolerability of solifenacin in treatment of OAB patients with focus on urgency and Qol. Background: Urgency and urgency incontinence represent two most bothersome symptoms of overactive bladder (OAB) both causing a significant decrease in quality of life (QoL) of affected women. The mainstay of OAB treatment are antimuscarinics and with solifenacin being one among them. In this independent study we wanted to test the success of treatment as estimated by patients. Methods: 100 consecutive OAB women who experienced at least one urgency episode (UE) daily were included in this independent, prospective, multicentric, open-label study. All patients received solifenacin 5 mg once daily for 3 months and filled out the 3-day voiding diary, symptoms/adverse events screening tool and validated questionnaires (UDI— Urogenital Distress Inventory, IIQ—Incontinence Impact Questionnaire). Urgency was assessed by a simple 4-step Urgency Perception Score (UPS) where steps 3 and 4 represented urgency and urgency incontinence, respectively. The UE botherness was assessed on a VAS (Visual Analog Scale) score where number 0 meant no bother and number 100 represented unbearable bother. After 1 month and 3 months of treatment all patients filled out all above listed questionnaires, additionally, patients assessed also the success and tolerability of solifenacin treatment. Results: Between June 2010 and December 2010 we recruited 100 women with OAB. The average age of patients was 54.4 years (from 25 to 78 years) and their average BMI amounted to 27.7 kg/m2. They experienced OAB problems for 84 months on the average. The estimated average bother of urgency on a VAS scale was 72.9. The 3-month treatment was completed by 91 women. The frequency, intensity and botherness of urgency episodes significantly decreased at 4 weeks and after 3 months (p<0.000, Table 1). All OAB symptoms asessed at 3 months have significantly improved (p<0.05) when compared to the first month of treatment, bedwetting

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being the only exception (p00.86). At the start of the study 66 out of 91 patients (72.5 %) complained on UUI, this number decreased after 1 month to 60 (65.9 %) and to 62.6 % after 3 months (57 patients). Decrease in urgency led to a significant improvement in QoL (r00.45, p00.000). The improvement in QoL after 3 months of treatment is presented in Figure 1. The most common adverse event was dry mouth which occurred in 35.2 % women at 4 weeks, this prevalence decreased to 27.7 % at 3 months. The overall success rate of treatment based on VAS scale was 74.2 %. Conclusions: After introduction of solifenacin to women with OAB the urgency intensity, frequency and botherness significantly improved. The UEs after 3 months were significantly improved not only when compared to the start of treatment but also when compared to the end of first month of treatment. The improvement in OAB symptoms had led to a better QoL, and the greatest improvement in QoL was observed in physical activity and travel domain, followed by the improvement in social activity and emotional health domain. Patients estimated the treatment success at 73.8 % and this seemed to be in a direct correlation with the improvement of OAB symptoms (UDI Irritative Score). The prevalence of dry mouth increased during the first month of treatment when roughly one third of patients (35.2 %) complained about this problem. This prevalence then decreased at the end of the 3-month treatment interval when only every forth patient (27.7 %) reported dry mouth. Despite of high prevalence of dry mouth this AE was the main reason for discontinuation of treatment in one patient only. Concluding message: In our study, solifenacin treatment of women with OAB was effective and well tolerated. All OAB symptoms significantly improved after 3 months what led to a better QoL. Both, objective and objective improvement of symptoms were observed. The only significant adverse event was dry mouth. I. But: Consultant; ASTELLAS, PFIZER, AMERICAN MEDICAL SYSTEMS. S. OreškoviĆ: None. M. Faganelj but: None.

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Background: A recent European consensus report (1) has given a grade A recommendation for the use of botulinum toxin-A(BTX-A) in the treatment of idiopathic detrusor overactivity (IDO). However, there is a lack of longer term data (2) regarding repeated injections in women with IDO in the published data. We present the cohort of 33 women who underwent botulinum toxin-A injections examining the efficacy and safety of BTX-A in IDO. Materials and methods: All 33 women had 3 or more injections with an initial dose of 500 units of Dysport with subsequent injections between 500 and 750 U, administered by a trigone-sparing flexible/rigid cystoscopic technique. The women were offered to either flexible (under local anaesthesia) or rigid cystoscopy (under general anaesthesia) based upon their choice. An informed consent was obtained in all cases. Efficacy was measured using voiding diaries and quality of life (QoL) assessed with International Consultation on Incontinence Questionnaire (ICIQ-SF). This project was approved by the clinical effectiveness department and the drugs & therapeutics committee (DTC). Therefore ethical approval is not required. Results: 33 successfully treated women with Dysport™ were eligible for this study. Age-Mean 59.3±13.2 Parity-Mean 2.8 ±1.8 , range ( 0–7) BMI-Mean 32.03 ±7.2 Mean duration between 1st and 2nd injection is 15.2± 7.2 months whereas between 2nd and 3rd is 19.2±10 months (p00.025 –Wilcoxon signed ranks test). 2 women developed UTI and required CISC. 3 women required dose escalation to 750 units. Table 1. ICIQ analysis Variable 1st injection 2nd injection

Pre-injection ICIQ Score 17.3±4.9

Post-injection ICIQ Score 7.24±4.9

P value* 0.000

17±3.1

6.29±6.3

0.000

*Wilcoxon signed ranks test 37 REPEATED BOTULINUM TOXIN TYPE A INJECTIONS FOR WOMEN WITH INTRACTABLE DETRUSOR OVERACTIVITY: A PROSPECTIVE OUTCOME STUDY L. Abeywickrama, A. Arunkalaivanan, M. Baptiste City Hosp., Bitrmingham, United Kingdom. Objective: The aim of this study is to describe the outcomes of the women who underwent repeated injections of BotulinumToxin-A (Dysport).

Conclusion: Based upon the results above, BTX-A (Dysport) injections are effective and safe after repeated administration in patients with idiopathic detrusor overactivity. The duration of the injection tends to get prolonged after the second injection. References: 1. Eur Urol 2009;55:100–20. 2. Urology 2010;75:552–8. L. Abeywickrama: None. A. Arunkalaivanan: None. M. Baptiste: None.

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38 INTERMITTENT CATHETERISATION AFTER BOTULINUM TOXIN INJECTION: IS IT REALLY NECESSARY OR JUST MEDDLESOME? L. Collins, S. Sathiananthamoorthy, S. Swamy, A. S. Kupelian, H. Horsley, K. Gill, J. Malone-lee UCL, Div. of Med., London, United Kingdom. Hypothesis: The occurrence of an anomaly does not necessarily imply that anything should be done about it. A vagary of modern culture is to advise corrections for deviations from what are perceived to be normal responses, without empirical evidence justifying such actions. Clinicians are no less prone to this than the wider public. Several guidelines suggest that assessment of an elderly person, with lower urinary tract symptoms (LUTS) should include a measurement of postmicturition residual volume (PVR). It is true that the elderly void less efficiently however, there are no data to support this practice, nor any justification for taking a remedial action on finding a “significant” residual. It has been argued that by ignoring such an anomaly, the clinician would do harm. This is the logical fallacy of “question begging” where an action is advocated when the justification rests only on the assumed veracity of an unproven conjecture. A similar practice occurs with the management of patients who have intra-detrusal botulinum toxin (botox) injections. It has been recommended that patients who, after botox, are found to have a PVR of ≥200 ml or ≥150 ml, should be started on clean, intermittent self-catheterisation (CISC). Why and where is the evidence? Botox reduces bladder contractility so hydronephrosis is not a plausible risk. Do we have data to suggest that incomplete bladder emptying after botox injection, causes infection? The answer is that there are none. This study used an observational method to test the hypothesis that patients with significant voiding problems, after having botox injections, would be unharmed if CISC was not used. If no signal of disadvantage was observed, a formal RCT would not be justified because of a priori and no justification for CISC in this context exists. Methods: Recruitment and data collection were undertaken in a single, specialist incontinence service in the UK between 2010 and 2011. Patients being treated for recalcitrant LUTS by use of botox injections were recruited into the study having given written consent. Patients with acute retention of urine; or voiding symptoms alleviated by drainage of the residual volume were excluded. Patients were serially reviewed after their botox treatment and their PVR monitored using ultrasound measurements; symptoms were recorded, and microscopy and microbial culture undertaken. The data were analysed by a blinded researcher

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Results: 190 patients were studied (M019, F0171; mean age054; sd015). 30 patients (16 %; F 026, M04) used CISC: 18 patients used CISC prior to Botox (7 had MS; 11 had other spinal pathology); 12 had retention symptoms relieved by removal of residual and in them CISC was instituted. The mean PVR of patients not using CISC was 179 ml (95 % CI0156–204; Max0725 ml). For those using CISC the mean PVR was 545 ml (95 % CI062–1027 ml). There were no between-group differences in treatment response, urgency, frequency, incontinence, voiding, or pain symptoms. There were no differences in pyuria or positive urine culture, and no evidence of differences in renal biochemistry throughout follow-up. The figure illustrates the resolution of elevated PVR volumes, unaided by CISC. There were no differences between those who used CISC and those who did not; other than patients who used CISC did so because they had troublesome voiding symptoms relieved by removing the retained urine. As a group these evinced higher residual volumes. Concluding message: CISC, initiated on the basis of an arbitrary PVR volume, confers no apparent benefit, and should be abandoned as unnecessarily meddlesome. The intervention has a role after botox injection, but only in patients with appropriate neurological or other diseases that threaten the upper tracts. The only other indication appears to be troublesome voiding symptoms, helped by CISC. There are no data to imply that a RCT would be a justified imposition. The newer approach would make intra-detrusal botulinum toxin injections more acceptable to many patients Figure: Resolution of PVR volumes over time in patients not using CISC

L. Collins: None. S. Sathiananthamoorthy: None. S. Swamy: None. A.S. Kupelian: None. H. Horsley: None. K. Gill: None. J. Malone-Lee: None.

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39 MOTOR AND/OR SENSORY RESPONSE DURING PERCUTANEOUS TIBIAL NERVE STIMULATION ( P T N S ) - D O T H E Y P R E D I C T T R E AT M E N T OUTCOME? A. Digesu 1, F. Puccini 1, C. Hendricken 1, A. A. Bhide1, V. Khullar 1, A. Tubaro 2, G. Caccia 3, S. Testorio 3, M. Cavadini Bellinato 3, C. Zecca 4, C. Gobbi 4; 1 Imperial Coll. London, London, United Kingdom, 2 Ospedale Sant’Andrea, Rome, Italy, 3Ospedale Beata Vergine, Mendrisio, Switzerland, 4Ospedale Civico, Lugano, Switzerland. Objective: To evaluate the prevalence of motor and sensory responses during PTNS and whether they are important parameters to predict the treatment outcome in women with refractory Overactive Bladder (OAB) symptoms. Background: PTNS is a minimally invasive peripheral neuromodulation technique suggested as effective second line treatment for patients with refractory OAB. It uses a retrograde pathway to stimulate the S3 sacral nerve plexus. The direct stimulation of the posterior tibial nerve is supposed to elicit a motor and/or sensory response in the foot. Motor response includes curling/flexion of the big toe and/ or fanning of the other toes. Sensory response includes a radiating sensation under the sole of the foot and/or in the toes. Some authors suggested starting conventional treatment only if a motor response is elicited during the testing phase, despite the sensory response that occurs almost always. However a motor response is often more difficult to achieve, so it is common practice to treat patients with sensory response alone. The prevalence of motor and/or sensory response during PTNS is still not known. Methods: Women with OAB symptoms unresponsive to at least 2 or more anticholinergics, were prospectively treated with PTNS weekly for a total of 12 sessions. All patients were counselled and evaluated with saline urodynamics prior to entry in the study. Patients who did not consent or were unable to attend/complete the weekly treatment sessions were excluded. OAB symptoms were assessed using a 3-day frequency volume chart, patient perception of bladder condition (PPBC) questionnaire, patient perception of intensity of urgency scale (PPIUS), Kings Health QOL questionnaire (KHQ) and Overactive Bladder Questionnaire (OABq) before and after treatment. Patient perception of treatment satisfaction was assessed using a visual analogue scale (VAS) at the beginning and at the end of the 12 PTNS sessions. Patients were defined responders if they reported an improvement of the OAB symptoms ≥50 %. Sensory, motor and mixed sensory/motor responses were compared between responders and no responders. A chi square test and version 19.0 SPSS software were used for the statistical analysis.

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Results: 86 women (mean age 58 years, range 30–78) were included in the study. 3 patients did not completed the 12 week course of PTNS therefore were excluded. 56 % (47/83) of patients reported an improvement of the OAB symptoms ≥50 %. Sensory only, motor only and mixed sensory/motor responses were found in 64 % (53/83), 6 % (5/83) and 30 % (25/83) of patients respectively. The most common sensory response was a radiating sensation under the sole of the foot as well as the foot (53 %). Out of those, 2 women also reported a sensation of genital stimulation. The most common motor response was the flexion of the big toe (83 %). The sensory and motor responses are shown in table 1. The prevalence of sensory, motor as well as mixed sensory/motor responses in the responders and no responders are shown in table 2. The outcome of PTNS was not affected by age, stimulation voltage, body mass index or duration of symptoms (p value>0.05) A sensory response alone or in combination to motor response during PTNS was better associated with a successful outcome than the presence of a motor response alone (p0 0.001). Only 7 % (2/30) of patients had a persistent motor response during each PTNS session. Both women who had a sensation of genital stimulation on PTNS reported a 100 % treatment satisfaction on VAS. Table 1 Sensory response (n078) A radiating tingling sensation under the sole of the foot/tight only A radiating tingling sensation in the toes Both Motor response (n030) Curling of the big toe Flexion of the big toe Fanning of the other toes

number 7

% 9

18 53

23 68

1 25 4

4 83 13

Table 2 Sensory response only Motor response only

Responders 33 (62 %) 2 (40 %)

No-responders 20 (38 %) 3 (60 %)

Both Sensory and Motor response

16 (64 %)

9 (36 %)

Conclusions: A sensory response on PTNS seems to be the best predictive factor for a successful treatment. A pure motor response is more difficult to achieve and it is very rarely is evoked during each session. Therefore a radiating sensory response on the foot and/or tight or a sensation of genital stimulation should ideally be aimed for in order to achieve a more successful treatment outcome. A. Digesu: None. F. Puccini: None. C. Hendricken: None. A.A. Bhide: None. V. Khullar: None. A. Tubaro: None. G. Caccia: None. S. Testorio: None. M. Cavadini Bellinato: None. C. Zecca: None. C. Gobbi: None.

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40 REAL WORLD USE OF ANTIMUSCARINIC MEDICATION AND THE IMPLICATIONS FOR CLINICAL PRACTICE R. K. Basra1, V. Khullar 2, C. J. Kelleher 1 1 Guys & St Thomas’ NHS Fndn. trust, London, United Kingdom, 2Imperial Hlth.care, London, United Kingdom. Objective: Clinical studies of antimuscarinic medication (AM) for the treatment of OAB primarily focus on tolerability & efficacy of treatment with a view to long term/life-long treatment despite evidence that the severity & impact of OAB fluctuates. So, do all patients with OAB require long-term/life-long AM treatment, & does discontinuation suggest the treatment doesn’t work? The aim of this study was to investigate the patterns of medication use & long term persistence with AM in patients with idiopathic overactive bladder (OAB) in clinical practice with a view to informing personalised multimodality management plans. Background: Persistence with AM in clinical practice is low. Most real world studies are retrospective & involve analysis of prescription data which may not capture true patterns of medication use by patients. Real world data suggests that the most rapid decline in medication use is within the first 30 days, with discontinuation rates of 43–83 %. Over one-third of patients never collect a 2nd script for AM, & at 1 year treatment <5 % are renewing scripts. Patients are thought to discontinue treatment for a number of reasons including adverse events & inadequate symptom control. It is possible that more intensive & patient focused input in the initial stages of treatment of OAB may encourage better persistence with lifestyle/ behavioural modification & AM & thus improve treatment outcomes. Methods: Women with idiopathic OAB referred to 2 tertiary urogynaecology centres were recruited into a prospective study investigating the management of OAB in clinical practice. After a baseline & 6 week visit, patients attended 3 monthly follow-up for 12–24 months. All patients were offered conservative/lifestyle advice & AM unless there were contraindications to its use. Persistence with treatment was evaluated by direct questioning. Medication discontinuation, treatment holidays, switches & periods of cessation & re-treatment were recorded. In addition, patients completed validated health related quality of life (HRQL) questionnaires at study visits. Results: 133 patients were recruited into a prospective longitudinal study of the real world management of OAB & completed 1 year of follow-up. 68 patients completed 2 year

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follow-up. The graph below shows persistence with AM over 2 year. Persistence with AM was 12 % at 1 year. The mean duration of AM use in women completing 12 & 24mths follow-up was 17.5 week & 27.2 week respectively. At 2 year no patient was regularly renewing their prescription; however a proportion of patients had a supply to use when symptoms were exacerbated. The pattern of medication use was intermittent; which was both intentional & non-intentional. Intentional intermittent use was in patients who wanted treatment holidays, stopped AM due to adverse events or lack of symptom relief. Unintentional intermittent AM use was in patients who failed to collect their repeat prescription in time, or did not understand that they should continue medication after the initial supply finished. HRQL data analysis showed mean improvement over the follow-up period regardless of the duration of AM use. Conclusions: Despite low long-term use of AM, HRQL continued to improve suggesting factors other than use of AM alone are important in determining outcomes from treatment of OAB. In this study a 6 week visit following initiation of lifestyle/behavioural measures & AM provided an important opportunity to engage patients with treatment & encouraged better short-term persistence with treatment than other real world studies have reported. Ultimately persistence in the longer term may be the same but engaging patients & improving early stage treatment may be of significant benefit. Treatment adherence long term does not appear to suggest that treatment does not work merely that long term persistence is not the norm. Advocating treatment holidays & intermittent use of AM may be an acceptable & to many patients a more effective treatment protocol. References: 1. BJU Int doi: 10.1111/j.1464-410X.2012.11023 R.K. Basra: None. V. Khullar: Consultant; Pfizer, allergan, astellas. C.J. Kelleher: Consultant; Astellas, Pfizer.

41 STEADY-STATE PHARMACOKINETICS OF OXYBUTYNIN AND N-DESETHYLOXYBUTYNIN FOLLOWING TWO DOSING INTERVALS WITH THE OXYBUTYNIN VAGINAL RING (4 MG/DAY) IN A COHORT OF HEALTHY FEMALE SUBJECTS W. F. Lamberton 1, S. Hong 2, C. Hendy 1, H. Weiss3, D. H. Waters 4; 1 Novum Pharmaceutical Res. Services, Pittsburgh, PA, 2 Novum Pharmaceutical Res. Services, Houston, TX, 3Teva Pharmaceuticals, Petah Tikva, Israel, 4Teva Pharmaceuticals, Horsham, PA.

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Objectives: This study was designed to evaluate the pharmacokinetics (PK) of the R- and S-enantiomers of oxybutynin and its major metabolite N-desethyloxybutynin (NDEO) following insertion of the 4 mg/day oxybutynin vaginal ring (Oxy VR) to healthy females. Background: Oral antimuscarinic agents are the most widely prescribed therapy for overactive bladder (OAB) but anticholinergic side effects (eg, dry mouth and central nervous system effects) are common and often lead to discontinuation of therapy. Oxybutynin (Oxy) is administered clinically as a racemic mixture of R- and Senantiomers. Although the R-enantiomer is 10- to 100fold more potent in terms of anticholinergic effects, it is unclear to what extent the antispasmodic effects are stereoselective.1 Side effects from oral Oxy have largely been attributed to N-DEO, whose plasma concentration can reach 4- to 10-fold times that of the parent compound due to extensive first-pass metabolism.2,3 Oxy VR is a new delivery system being developed for women with OAB to provide a treatment option with less extensive first-pass metabolism, resulting in fewer anticholinergic effects and improved tolerability over existing therapies. Methods: This open-label, multicenter study was conducted in 3 cohorts (2 cohorts with single insertions of 30 and 35 days each and 1 cohort with 2 insertions totaling 44 days) of nonpregnant healthy women aged 18–65 years. Results are presented for the 2-insertion cohort, in which the first Oxy VR was inserted on Day 1 and removed on Day 30, when another VR was inserted and kept in place for 14 days. Blood samples were collected on an inpatient basis at frequent intervals beginning pre-dose until 48 h post-insertion of each VR. Blood samples were also collected (inpatient and outpatient basis) post-insertion at regular but less frequent intervals until 30 days after the initial VR insertion and for 14 days after the second VR insertion. The plasma concentrations of the R- and S-enantiomers of Oxy and NDEO were measured by fully validated chiral assay analytical procedures. PK parameters (Cmax, Tmax, AUC0-30, AUC0-44, and Css) for R-Oxy, S-Oxy, R-N-DEO and S-NDEO were calculated. Safety was evaluated on the basis of adverse events (AEs). Results: Twenty female subjects aged 22–64 years (mean 43.0±13.7 years) participated in this cohort. All 20 subjects completed the 2 dosing periods. Except for 3 missing samples on Days 34, 35, 36 for one subject, and Days 24 and 17 for one subject each, all 56 scheduled PK samples were collected from the 20 subjects. Key PK parameters are tabulated below for all 4 analytes. Mean Cmax, AUC0-30, AUC0-44 and Css of NDEO all remained at or below 2-fold times that of Oxy. Css for both enantiomers of Oxy and N-DEO were achieved within 2–4 days of the first VR insertion and

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remained stable until the first VR was removed on Day 30. When replaced on Day 30 with a new VR that was worn for 14 days, no significant accumulation of any analyte was noted. Within approximately 24–36 h of inserting the second VR, plasma concentrations of all analytes were at pre-removal/replacement steady-state levels. AEs were mostly mild or moderate. Of 72 AEs reported while the Oxy VR was inserted, the most frequent was headache (n 09; 45 %). Safety and PK data from 2 other cohorts (37 subjects inserting a single Oxy VR 4 mg that was worn for 30 or 35 days) were similar to data collected during the first insertion in the 2-insertion cohort. Conclusions: The PK of R- and S-enantiomers of both Oxy and N-DEO following insertion of a 4 mg/day Oxy VR have been well-characterized. Steady-state plasma concentrations of Oxy and metabolites are achieved rapidly and are stable; on VR removal/replacement, pre-removal/replacement steady-state levels return after 24–36 h. Plasma levels of N-DEO (both R and S forms) remain ≤2-fold that of Oxy. Oxy VR 4 mg/day administered for up to 44 days was welltolerated. References: 1. Pharm Res 2001;18:1029–34. 2. Paraplegia 1991;29:84–91. 3. Xenobiotica 1992;7:859–69. Table: PK Parameters after Insertion of Oxy VR 4 mg/day on Day 1 (for 30 Days) and Day 30 (for 14 Days) in 20 Healthy Female Subjects PK Parameter R-Oxy Cmax, ng/ml±SD 2.500± 0.568 Tmax, hr±SD 240.0± 222.2 AUC0-30, ng•hr/ 1373.9± ml±SD 300.2 AUC0-44, ng•hr/ 2114.6± ml±SD 451.2 Css, ng/ml±SD 1.922± 0.525

S-Oxy 3.598± 1.012 244.8± 213.8 1964.0± 713.8 3010.4± 1083.7 2.683± 1.098

R-N-DEO 5.025± 1.837 243.3± 206.5 2659.7± 1067.3 4069.8± 1625.2 3.418± 1.553

S-N-DEO 4.790± 4.711 247.5± 184.7 2513.1± 2358.4 3855.1± 3563.9 3.391± 3.350

Cmax0maximum plasma concentration; Tmax0time to maximum plasma concentration; AUC0area under the plasmaconcentration vs time curve; C ss 0steady state plasma concentration. W.F. Lamberton: Employee (full or part time); Novum Pharmaceutical Research Services. S. Hong: Employee (full or part time); Novum Pharmaceutical Research Services. C. Hendy: Employee (full or part time); Novum Pharmaceutical Research Services. H. Weiss: Employee (full or part time); Teva Pharmaceuticals. D.H. Waters: Consultant; Teva Pharmaceuticals.

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42 QUALITY OF LIFE ASSESSMENT TWO YEARS POST SURGICAL TREATMENT FOR PELVIC ORGAN PROLAPSE USING TRANSVAGINAL MESH E. J. Stanford1, R. D. Moore 2, J. R. Roovers 3, C. Courtieu 4, R. Beyer 5, J. C. Lukban 6, E. Bataller 7, S. E. Sutherland 8 1 Auburn Regional Med. Ctr., Auburn, WA, 2Atlanta Med. Res. Inst., Atlanta, GA, 3Academic Med. Ctr. Univ. of Amsterdam, Amsterdam, Netherlands, 4CMC Beausoleil, Montpellier, France, 5Women’s Hlth. Care Specialists, PC, Kalamazoo, MI, 6Eastern Virginia Med. Sch., Div. of Urogynecology, Norfolk, VA, 7Hosp. Clínic i Provincial de Barcelona, Univ. de Barcelona, Barcelona, Spain, 8Metro Urology, Ctr.s for Female Urology, Minneapolis, MN. Objective: To assess the impact of the Elevate Anterior/ Apical (EAA) on quality of life (QOL) at 24 months. Table of Contents & & &

Methods Results Conclusion

Methods: One hundred forty-two women with anterior vaginal prolapse and/or apical descent≥Stage II, were enrolled at 16 investigational sites (10 US, 6 EU). All received transvaginal polypropylene mesh insertion with no external needle passes anchored bilaterally to the sacrospinous ligaments and obturator foramen. All patients’ quality of life were assessed pre-operatively and at 6, 12 and 24 months post-procedure using 3 validated questionnaires: Pelvic Organ Prolapse Urinary Incontinence Sexual Function Questionnaire (PSIQ-12) for sexually active subjects, Pelvic Floor Impact Questionnaire (PFIQ-7), and Pelvic Floor Distress Inventory (PFDI). Baseline and 24-month results are presented along with number of subjects reporting improvement. Subcategory scores for the PFIQ-7 (urinary impact questionnaire, UIQ, and pelvic organ prolapse impact questionnaire, POPIQ) and PFDI (urinary distress impact, UDI; pelvic organ prolapse distress index anterior, POPDI Anterior; and pelvic organ prolapse distress inventory POPDI) at baseline and at 24 months are also presented. Tests used for statistical analysis were paired t-test and Wilcoxon signed rank test as appropriate. A pvalue of <0.05 was considered significant. Results: All QOL scores showed significant improvement from baseline through 24 months. Forty-five women who were sexually active at baseline completed the 24-month PISQ-12 and demonstrated significant improvement (p0<0.001). PFIQ-7 and PFDI scores as well as the subcategory scores for UIQ, POPIQ, UDI, POPDI Anterior, and POPDI were significantly improved at a p-value of <0.001.

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Conclusion: Analysis of the results from this study indicate that at 24 months, the EAA procedure is associated with improved QOL scores when compared to baseline when assessed using the PSIQ-12, PFIQ-7, and PFDI questionnaires. Table 1. Questionnaire scores Questionnaire PISQ-12

PFIQ-7 UIQ

POPIQ

PFIQ-7 Total

PFDI UDI

Baseline Mean±SD (95 % CI) 32.0±8.4 (29.4, 34.5) (N045)

24 M Mean±SD (95 % CI) 36.3±6.1 (34.4, 38.1) (N045)

# of any P-value improvement from baseline 36 (80 %) <001T

25.9±23.5 (21.7, 30.1) (N0124) 18.5±23.9 (14.2, 22.7) (N0123) 54.8±56.1 (44.7, 64.9) (N0121)

4.7±12.5 (2.5, 6.9) (N0124) 1.9±7.2 (0.6, 3.1) (N0123) 9.3±24.8 (4.9, 13.8) (N0121)

91 (73.4 %)

<.001S

69 (56.1 %)

<.001S

101 (83.5)

<.001S

82.5±50.6 (73.5, 91.5) (N0124) POPDI Anterior 33.2±26.9 (28.4, 38.0) (N0124) POPDI 103.3±59.1 (92.8, 113.8) (N0124)

20.5±25.0 114 (91.9 %) <.001S (16.0, 24.9) (N0124) 9.4±14.8 93 (75.0 %) <.001S (6.8, 12.0) (N0124) 24.8±32.3 112 (90.3 %) <.001S (19.1, 30.6) (N0124)

T P value from paired t-test; S P value from Wilcoxon signed rank test E.J. Stanford: Consultant; American Medical Systems Inc. Grant /Research Support; American Medical Systems Inc. R.D. Moore: Consultant; American Medical Systems Inc. Grant /Research Support; American Medical Systems Inc. J.R. Roovers: Consultant; American Medical Systems Inc. Grant /Research Support; American Medical Systems Inc. C. Courtieu: Consultant; American Medical Systems Inc. Grant /Research Support; American Medical Systems Inc. R. Beyer: Consultant; American Medical Systems Inc. Grant /Research Support; American Medical Systems Inc. J.C. Lukban: Consultant; American Medical Systems Inc. Grant /Research Support; American Medical Systems Inc. E. Bataller: Consultant; American Medical Systems Inc. Grant /Research Support; American Medical Systems Inc. S.E. Sutherland: Consultant; American Medical Systems Inc. Grant /Research Support; American Medical Systems Inc.

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43 CARE-SEEKING FOR ACCIDENTAL BOWEL LEAKAGE H. W. Brown1, S. Wexner 2, E. S. Lukacz 1 1 UC San Diego Hlth. System, La Jolla, CA, 2Cleveland Clinic Florida, Weston, FL. Objective: To characterize factors associated with careseeking among women with accidental bowel leakage (ABL) Background: Despite a well-documented significant negative impact on quality of life, most patients with accidental bowel leakage (ABL) do not seek care for their condition. Rates of care-seeking for ABL range from 8 to 34 % in the US . In one study of over 500 women with ABL, those with more severe ABL and those who perceived their overall health status as fair or poor were more likely to see a physician for ABL . In a smaller study of 130 women with ABL seeking general gynecologic care, those with leakage of solid stool and those with more embarrassment related to their condition were more likely to seek care . Methods: A sub-analysis of 938 women with ABL identified in an internet community-based internet survey of 5,817 US women ≥45 years old was performed. Demographics, medical history, severity of incontinence, quality of life, coping and care-seeking were assessed

using questions derived from validated questionnaires including the Wexner Continence Grading Scale. ABL was defined as at least 1 episode of stool leakage in the past year in the absence of acute diarrheal illness. Women with ABL were asked, “Have you ever talked to a physician about accidental leakage of stool and/or gas?” and were designated ‘care-seekers’ or ‘silent-sufferers’. Factors associated with care-seeking on univariate analysis with p<0.1 were included in a backwards logistic regression model. Results: The response rate overall was 85 % (5,817/ 6,873) with care-seeking data available for 86 % (938) of 1,096 women with ABL (18.8 % prevalence). 85 % were White, 6 % African-American, 5 % Hispanic/Latina, and 4 % other; median age 55–59 years; 87 % were insured. Only 29 % (268/938) of women with ABL sought care for ABL. Care-seekers were more likely to have a primary care physician (PCP), have heard of ABL, and have suffered longer with more severe leakage (Table 1). Conclusions: More than two-thirds of women with ABL do not seek care. Because those with a PCP and those who have heard of the condition are more likely to seek care, educating the public about ABL and encouraging establishment of care with a PCP may decrease silent suffering.

Table 1. Sample description and multivariate model predicting care-seeking All women with ABL Care-Seekers ABL Silent-Sufferers p-value Adjusted Odds p-value ABL (N0938) (N0268) (N0670) Ratio Predicting Care-Seeking (95%CI) n (%) n (%) n (%) Married Lives alone Age: 45–54 year 55–64 65–74 75 + Race: White (Ref) Black / African-American Asian Hispanic / Latina / Spanish Origin American Indian / Alaska Native Other Education less than high school

509 (54.3) 266 (28.4) 274 (29.2) 343 (36.6) 281 (30.0) 40 (4.3)

152 (56.7) 71 (26.5) 77 (28.7) 99 (36.9) 81 (30.2) 11 (4.1)

357 (53.5) 195 (29.1) 197 (29.4) 244 (36.4) 200 (29.9) 29 (4.3)

0.340 0.423 0.995

N/A N/A N/A

N/A N/A N/A

796 (84.9) 60 (6.4) 19 (2.0) 44 (4.7) 8 (0.9) 11 (1.2)

221 (82.5) 15 (5.6) 4 (1.5) 19 (7.1) 5 (1.9) 4 (1.5)

575 (85.8) 45 (6.7) 15 (2.2) 25 (3.7) 3 (0.4) 7 (1.0)

0.060

–

–

39 (4.2)

19 (7.1)

20 (3.0)

0.023

–

–

High school Some college

368 (39.2) 307 (32.7)

94 (35.1) 89 (33.2)

274 (40.9) 218 (32.5)

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Table 1. (continued) All women with ABL Care-Seekers ABL Silent-Sufferers p-value Adjusted Odds ABL (N0938) (N0268) (N0670) Ratio Predicting Care-Seeking (95%CI) n (%) n (%) n (%) Completed college Employed Income≥$40,000 per year Considers health fair or poor Health insurance Has a Primary Care Physician (PCP) Has urinary incontinence Has heard of fecal or bowel incontinence Has severe ABL (Wexner score ≥10) Has been experiencing ABL for*: <1 year 1–5 years >5 years

p-value

224 (23.9) 402 (42.9) 397 (44.9) 269 (28.7) 811 (86.5) 855 (91.2) 671 (71.5) 423 (45.1) 348 (37.1)

66 (24.6) 113 (42.2) 117 (45.5) 99 (36.9) 238 (88.8) 253 (94.4) 189 (70.5) 154 (57.5) 151 (56.3)

158 (23.6) 289 (43.1) 280 (44.7) 170(25.4) 573 (85.5) 602 (89.9) 482 (71.9) 269 (40.1) 197 (29.4)

0.786 0.814 <0.001 0.184 0.027 0.664 <0.001 <0.001

(1.228, 2.265) (2.106, 3.907)

N/A N/A 0.028 N/A 0.041 N/A .001 <0.001

242 (26.0) 529 (56.8) 161 (17.3)

42 (15.8) 147 (55.3) 77 (28.9)

200 (30.0) 382 (57.4) 84 (12.6)

<0.001 1.00 (referent) 1.687 (1.133, 2.513) 4.127 (2.560, 6.655)

<0.001 0.010 <0.001

N/A N/A 1.443 N/A 1.880 N/A 1.668 2.868

(1.041, 2.000) (1.025, 3.447)

*: Missing data for 6 cases References: 1. Gastroenterology. 2005;129(1):42–9. 2. Am J Gastroenterol. 1996;91(1):33–6. 3. Am J Obstet Gynecol. 2005;192(5):1637–42. H.W. Brown: None. S. Wexner: Consultant; Oceana, Ventrus, Renew Medical, Inc., Mediri Therapeutics, Medtronic. E.S. Lukacz: Consultant; Pfizer, Johnson and Johnson. Grant / Research Support; Johnson and Johnson, Renew Medical, Inc..

44 ARE WOMEN USING LONG-TERM CONTAINMENT PRODUCTS FOR URINARY INCONTINENCE WILLING TO EXPLORE FURTHER TREATMENT? J. Scobie, K. Agur, J. Mehiso, M. Hair, W. Agur NHS Ayrshire & Arran, Kilmarnock, United Kingdom. 1. Objective: To investigate patients’ awareness of and willingness to explore further treatment options in relation to age, type of UI and degree of satisfaction with pads. 2. Study design, materials and methods: Only 27 % of the women using pads for urinary incontinence (UI) have expressed their interest in seeking further help (1). No previous study has investigated the patients’ awareness of and willingness to explore further treatment options in relation to age, type of UI and degree of satisfaction with pads. It is important to healthcare professionals to identify the antecedents of such willingness for the purposes of targeted treatment and resource allocations. 3. Methods: 600 questionnaires (ICIQ-UI-SF, Urgency Perception Scale and Satisfaction with treatment) were randomly sent to women aged 18–90 whose addresses were on the ‘pad

user register’ in a catchment area of a university hospital with a total population of 350,000 (urban and rural). Patients were divided into 3 groups according to age (<65, 65–74 and 75 years or over). Women were categorised into 4 groups according to type of UI (SUI, UUI, MUI and Other UI). Women were asked to rate their level of satisfaction with pads, awareness of and willingness to explore further treatment options on an 11-point Likert scale. 4. Results: The number of returned questionnaires with complete data was 219 (38.3 %). Mean age is 67 years (range: 18–87). The mean duration of pad usage is 5.9 years (SD0 6.27) and the median daily pad usage is 4 (range: 1–10). Overall, 73 % or respondents were ‘happy’ with pads. Only age was found to significantly alter the degree of satisfaction where the ‘happy’ group having a mean age 6.1 years older than the ‘not happy’ group (p<0.01, 95%CI: 2.23–9.86). There was no significance difference between daily pad usage and age or use of anti-muscarinics. However, patients using more pads were significantly more likely to report higher interference with everyday life and higher level of urgency. The relationship between daily pad usage and willingness to explore further treatments did not reach statistical significance (p00.07). Women with Mixed UI used more pads per day as compared to other UI groups but that did not reach statistical significance (p00.07). Women in the Mixed and Other UI groups had significantly higher scores of interference with QoL (p<0.05) and were significantly more aware of the available treatment options compared to the Stress or the Urgency groups (p<0.05). However, all groups had similar rates of willingness to explore further treatments.

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Almost a third of respondents were willing to explore further treatment options such as physiotherapy, bladder training, medications and surgery. There was a significant positive correlation between frequency of leakage and willingness to explore medications or surgery (p<0.01) but not physiotherapy or bladder training (p00.86). Four factors closely associated with willingness to explore medication/surgery: frequency of leakage, level of urgency, interference with everyday life and level of satisfaction with pads. Pearson’s r correlations showed that interference with everyday life (0.51 95%CI: 0.30–0.71, p<0.001) and satisfaction with pads (0.39 95%CI: 0.59–0.19, p<0.001) to be the strongest antecedents of the willingness to explore further treatment. A stepwise linear regression model was also significant (p<0.001). We believe this study is unique and the first to explore these factors in some details. It provides professionals with the characteristics of women who are more likely to explore further treatment and reduce pads consumption. In our study, the strongest predictors of willingness to explore further treatment options (medications or surgery) were the degree of interference with everyday life and the level of satisfaction with pads. An increase of 1 point in the interference scale, on average, gave an increase of 0.51 points in the willingness score and an increase in one point in the satisfaction scale gave a decrease of 0.39 points in the willingness score. 5. Conclusions: One third of women using pads for UI in the community are willing to explore further treatments. The degree of interference with everyday life and the level of satisfaction with pads are the most important predictors for such willingness. 6. References: Int Urogynecol J 2006;17(3):234–8. J. Scobie: None. K. Agur: None. J. Mehiso: None. M. Hair: None. W. Agur: None.

45 PSYCHOLOGICAL PREDICTORS OF PHYSIOTHERAPY TREATMENT FOR PELVIC FLOOR DYSFUNCTION Z. Khan1, C. Whittall 1 , L. Osborne 2 , P. Reed 3 , S. J. Emery 1 1 Singleton Hosp., swansea, United Kingdom, 2Swansea Univ., swansea, United Kingdom, 3 SWANSEA Univ., swansea, United Kingdom. Aims: The purpose of the study is to identify the psychological predictors of outcome for physiotherapy treatment for pelvic floor dysfunction in women. This knowledge should enable better-targeted services, and form the foundation for the

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development of novel psychological adjuncts to physiotherapy treatment that will help to allocate treatment resources more effectively and efficiently. Background: Pelvic floor disorders (PFD) are estimated to effect 1 in every 3 females. Physiotherapy is recommended as the first line treatment in the management of these disorders and can be an effective and conservative alternative to surgery. However, the outcomes of physiotherapy can be variable, and identifying the predictors of success is a key research question. Methodology: The study was a prospective observational study including 124 consecutive women referred to the Urogynaecological Physiotherapy Service at Singleton Hospital. The department runs a 6-monthly intensive physiotherapy programme including 4 class sessions and 2 individualized sessions. On admittance to the 6-month physiotherapy programme (one session per month), patients: (1) underwent an assessment of their pelvic floor strength(Oxford grading) and prolapse grading. (2) Provided subjective assessments of their condition (Queensland pelvic floor questionnaire), and data regarding other demographic characteristics (e.g., age, BMI, past medical history); and (3) completed a questionnaire to assess their psychological health i:e Hospital Anxiety and depression scale (HADS), these parameters were repeated after completing all six sessions. Comparison was made between the patients’ state of anxiety and depression and the severity of their symptoms Results: 124 women were recruited to participate in the study. 109/124 completed the questionnaires at initial assessment. (HAD and Queensland questionnaire). There was a positive correlation with the severity of depression and the severity of pelvic floor dysfunction. The correlation was strongest with bladder dysfunction followed by bowel, sexual and least with prolapse scores. Pearson Correlation(r) between Depression scores and pelvic floor disorders: Total (/112) physical score Number of XY Pairs 94

Bladder Function (/42) 93

Bowel Function (/36) 94

Prolapse Symptons (/15) 87

Sexual Function (/19) 86

Pearson r

0.4429

0.3396

0.329

0.04233

0.2528

95 % confidence interval

0.2639 to 0.5924

0.1459 to 0.1354 to −0.1699 to 0.04320 to 0.5082 0.4984 0.2508 0.4411

P value (two-tailed)

<0.0001

0.0009

0.0012

0.697

0.0188

P value summary

****

***

**

Ns

*

Is the correlation significant? (alpha00.05) R square

Yes

Yes

Yes

No

Yes

0.1961

0.1153

0.1082

0.001792

0.06392

Int Urogynecol J (2012) 23 (Suppl 2):S43–S244

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Comparative data was available for 50 patients who completed the 6 months of study. Among these patients, there was a significant improvement in all domains of pelvic floor dysfunction after physiotherapy intervention. When the patients were divided into HAD categories, it was found that the benefit was greatest for patients who were not depressed. (Significant improvement in overall scores, bladder and bowel dysfunction but no improvement in prolapse and sexual dysfunction) Mildly depressed patients benefited in terms of overall scores and prolapse symptoms whereas the severely depressed patients did not benefit in any of the parameters of PFD. Patients with no underlying depression but high scores of PFD did benefit from physiotherapy. (p-0.002) Analysis of the objective data on oxford grading of pelvic floor muscle strength showed that patients who do not suffer from anxiety/ depression showed some degree of improvement in all cases(100 %) whereas the improvement was 75 % in moderately and severely depressed patients. Paired T-Test analysis of groups of patients before and after 6 months of physiotherapy:

All patients

Bladder function (/42) 0.00***

Bowel function (/36) 0.0224*

Prolapse symptom’s (/15) 0.0117*

Sexual function (/19) 0.0266*

Total (/112) physical score <0.0001****

Normal

0.0028**

0.0083**

0.1596 ns

0.0574 ns

0.0018**

Mild depression

0.0599 ns

0.6208 ns

0.0239*

0.3345 ns

0.0136*

Moderate/severe depression

0.1527 ns

0.2488 ns

0.7971 ns

0.4793 ns

0.1945 ns

Conclusion: This study shows that there is a direct correlation between the severity of depression and the severity of pelvic floor dysfunction. The patients who are not depressed are the most likely to benefit from physiotherapy intervention whereas the severely depressed patients do not show any symptomatic improvement even after 6 months of treatment. This study raises the question whether a targeted approach should be undertaken for patients referred for pelvic floor physiotherapy. Other adjunct therapies should be considered in moderately and severely depressed and anxious patients. Z. khan: Grant /Research Support; NISCHR GRANT. C. whittall: None. L. Osborne: None. P. Reed: Grant / Research Support; NISCHR GRANT. S.J. Emery: None.

46 LAPAROSCOPIC HYSTEROPEXY- 1–4 YEARS FOLLOW UP OF WOMEN POST OPERATION P. Rahmanou, B. White, N. Price, S. Jackson Dept. of Urogynaecology, John Radcliffe Hosp., Oxford, United Kingdom. Objective: To demonstrate the technique of laparoscopic hysteropexy for uterine prolapse and evaluate outcome. Short-term outcome on 51 women was published in 2010[1], we now report a larger cohort over a longer postoperative period. Background: Traditionally vaginal hysterectomy has been the procedure of choice for treatment of uterovaginal prolapse. However, hysterectomy does not address the underlying pathophysiology of poor connective tissue support and recurrent prolapse is commonly seen[2]. Uterine conserving re-suspension surgery has allowed preservation of fertility in younger women presenting with uterine prolapse but is not widely offered to other women. We postulate that uterine mesh re-suspension will augment weak connective tissue, providing stronger apical support than hysterectomy and reduce recurrent prolapse. We have offered this as an alternative to hysterectomy for all women presenting with uterine prolapse who wish to consider surgery and report the outcome. Methods: The investigation was designed as a prospective observational study in a teaching hospital urogynaecology unit. The technique of laparoscopic hysteropexy, which involves suspension of the uterus from the sacral promontory using a bifurcated polypropylene mesh has previously been described[1]. One hundred and eighty two consecutive women who under went laparoscopic hysteropexy, with or without additional vaginal repair, from 2007 until 2010 were invited to attend a dedicated clinic. Participants were interviewed, symptoms were assessed using the International Consultation on Incontinence Questionnaire for Vaginal Symptoms (ICIQ-VS) and uterovaginal support was measured objectively by using the pelvic organ prolapse quantification (POP-Q) scale. These were compared with preoperative data. Operative and postoperative complications and women’s satisfaction were also noted. Approval was obtained from the regional audit committee. Results: One hundred and forty one agreed to participate. Mean age was 54.9 years (range 31–76). The mean interval from operation was 2.1 years (range 1–4.4). 120 (85 %) had a concomitant posterior colpoperineorrhaphy and 29 (21 %) had an anterior compartment repair. Global impression of significant improvement for prolapse was 89 % at time of review. 92 % of participants would recommend the operation to other

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women. The results from ICIQ-VS and POP-Q are summarized (Table 1 & 2). Wilcoxon sign ranks test showed that the differences between the postoperative and pre-operative scores are significantly different for all parameters (p < 0.001). There was one incident of intra-operative complication with hysteropexy and two had developed a further apical prolapse surgery. No mesh erosion or other mesh complication was observed. Conclusions: Laparoscopic hysteropexy is a safe surgical alternative to vaginal hysterectomy for uterine prolapse. 1–4 year outcome suggests high patient satisfaction and low rates of apical prolapse recurrence. Longer term follow up and randomized controlled studies are required to compare outcome with hysterectomy. References: 1. BJOG, 2010. 117(1): p. 62–8. 2. Obstet Gynecol, 2007. 110(3): p. 625–32. Table 1. Objective outcomes of laparoscopic hysteropexy: POP-Q measurements. POP-Q Measurements (cm)

Preoperative

Mean

Aa 0.1

Median 0

Post Operative

Ba 0.5

C 1.3

D −0.9

Ap −0.6

Bp −0.3

0

1

−1

−1

0

Range

3 to −3 4 to −3 8 to −2

6 to −6

3 to −3

4 to −3

n

136

137

139

136

136

137

Mean

−1.5

−1.3

−5.2

−7.2

−2.8

−2.7

−2

−5

7

−3

−3

Median −2 Range

2 to −3 2 to −3 0 to −8

n

140

Change (postop.- Mean −1.6 preop.) Median −1

−3 to −10 −1 to −3 −1 to −3

140

140

140

140

140

−1.8

−6.5

−6.0

−2.2

−2.4

−2

−6

−6

−2

−2

Range

3 to −6 2 to −7 −1 to −14 14 to −13 0 to −6

0 to −7

n

136

137

137

139

136

136

Table 2. Subjective outcome of laparoscopic hysteropexy: ICIQ-VS vaginal symptoms questionnaire score. Preoperative

Post Operative

Change (postop.-preop.)

Mean

31.8

43.0

7.9

Median

31

42

8

Range

8 to 52

12 to 58

0 to 10

n

77

61

77

Mean

7.7

14.1

1.8

Median

6

9.5

1

Range

0 to 31

0 to 58

0 to 10

n

139

88

139

Mean

−23.9

−26.1

−5.9

Median

−22

−27

−7

Range

3 to −48

16 to −58

3 to −10

n

76

41

76

VS0Vaginal symptoms score; SM0Sexual matters score; QOL0Quality of life score P. Rahmanou: None. B. White: None. N. Price: None. S. Jackson: None.

47 NOVEL LAPARO-CYSTOSCOPIC MANAGEMENT OF INTRAVESICAL MESH EROSION D. P. Miller1, T. Capes 2 1 Milwaukee Urogynecology, Wauwatosa, WI, 2Aurora Urogynecology, Milwaukee, WI. Stress Incontinence and Prolapse are now treated by a very large number of surgeons. Graft usage has become commonplace particularly for the treatment of SUI. While there is no evidence of an increased rate of complications, the absolute number of mesh erosions and surgical misadventures is rising with the number of procedures performed. Intravesical mesh erosion is particularly challenging as cystoscopic instrumentation provides poor triangulation. There is limited ability to simultaneously dissect, grasp, and excise while maintaining the video field. This has led to procedure failure with erosion recurrence, and in some cases, the need for open surgical procedures. This patient underwent a retropubic sling procedure 6 months prior to admission with an unrecognized entry into the bladder. Post-operative pain, tissue edema and fluid leakage eventually led to the diagnosis of bladder mesh erosion. This video demonstrates a novel transcutaneous assistance for mesh excision utilizing small caliber laparoscopic instruments under cystoscopic guidance. There are key technical points in successfully perfor ming the procedure . The patient must be monitored intraoperatively for fluid overload and hyponatremia if excessive fluid were to collect in the Space of Retzius. A needle is used to map out the most efficient trocar placement. Care is taken to avoid traumatizing the mucosa which would lead to bleeding and an obscured visual field. The mesh is placed on strong traction to cause the mesh edges to retract after cutting. If 2–3 mm instruments are used, the cystotomies created are small and minimal postoperative catheterization is necessary. The procedure is performed as an outpatient and is associated with minimal postoperative pain. D.P. Miller: None. T. Capes: None.

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48 SURGICAL MANAGEMENT OF MESH IN THE URETHRA AND BLADDER J. M. Evans, M. Karram The Christ Hosp./Univ. of Cincinnati, Cincinnati, OH. Objective: We present three difficult cases of intraurethral mesh removal due to placement of midurethral slings within the wall or lumen of the urethra. Abstract Body: While erosion of a midurethral sling in the vagina occurs in <1 % of cases, mesh within the urethra usually occurs only if the sling material was placed within the urethra at the time of surgery. Removal of synthetic materials from the urethra can require extensive and complex removal of portions of the urethra due to tissue ingrowth of the mesh as well as reconstruction of the urethra. Our cases highlight several examples of mesh placed in the urethra, surgical techniques for proper removal of all synthetic materials, and reconstructive techniques to restore urethral anatomy. This is accomplished with wide dissection, excellent vascular pedicles, and tension free closure in several layers. Alternatives to antiincontinence procedures, such as a rectus fascia sling, are also discussed. Conclusion: Although rare, it is important to recognize and appropriately manage synthetic mesh placed in the urethra. These surgeries can be highly complex and may require removal of portions of the urethra as well as adequate reconstruction with or without the use of a vascular pedicle. J.M. Evans: None. M. Karram: Consultant; AMS.

49 SURGICAL TREATMENT OF MULTIPLE BLADDER CALCULI ASSOCIATED WITH IRREDUCIBLE UTEROVAGINAL PROLAPSE D. R. Karp, N. T. Galloway Emory Univ. Sch. of Med., Atlanta, GA. Objective: The objective of this video is to illustrate a transvaginal approach to the surgical management of coexistent bladder calculi and irreducible complete uterine procidentia. The presence of bladder calculi in women and associated pelvic organ prolapse is rare. Previous reports advocate the removal of bladder stones through a suprapubic abdominal approach in order to aid for easier removal and minimize the

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risk for vesicovaginal fistula formation. Other routes described are transvaginal, cystoscopic, and by extracorporeal lithotripsy. This video illustrates the surgical management of a patient who underwent transvaginal cystolithotomy with a concomitant obliterative repair of obstructed uterovaginal prolapse. The patient is a 76 year widowed nonsexually active female from Bhutan who presented with a 22 year history of worsening symptomatic pelvic organ prolapse. On examination complete uterine procidentia was noted with nodularity along the anterior portion of the vagina in the area of the bladder. Given her significantly exteriorized prolapse, we opted to perform her procedure through a transvaginal approach. Preoperatively through use of translation services, we had a thorough discussion with the patient and her family regarding surgical routes for her prolapse. After extensive discussion we opted to proceed with a complete transvaginal approach under spinal anesthesia in the form of a transvaginal cystolithotomy with concomitant Lefort colpocleisis. The cystolithotomy is performed in conjunction with the colpocleisis immediately after denudation of the anterior vaginal epithelium. When performing an intentional cystotomy for bladder stone extraction, a vertical incision is preferred to avoid ureteric injury. After closure of the bladder in two layers the Lefort colpocleisis is completed. Care is taken to avoid the cystotomy suture line during the imbrication sutures that are placed with the colpocleisis. The procedure is completed with a perineorrhaphy in order to assure good perineal support for the repair. Intraoperatively 11 stones were removed with the largest stone measuring 2.5 cm in diameter. Total stone burden was 45 g and approximately 15–20 cm in all. The patient was discharged home with a foley catheter on postoperative day #1. Cystogram on postoperative day #10 showed a normal bladder contour without filling defects or leak of contrast from the bladder. The patient is doing well without recurrence of prolapse or complaints of urinary incontinence. Conclusion: The presence of vesical calculus in the cystocele should be considered in the setting of irreducible pelvic organ prolapse. A complete transvaginal surgical approach with cystolithotomy with a concomitant obliterative procedure under spinal anesthesia is safe and well-tolerated even in the setting of large bladder stone burden. D.R. Karp: None. N.T. Galloway: None.

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50 ROBOTIC ASSISTED RECTOPEXYAND COLPOPEXY FOR RECTAL PROLAPSE K. A. Greene, J. E. Sanchez, M. L. Campbell, J. E. Marcet; Univ. of South Florida, Tampa, FL. Robotic Assisted Rectopexy and Colpopexy for Rectal Prolapse—Video Presentation Abstract: This video demonstrates a technique for robotic assisted combined rectopexy with colpopexy without the use of mesh for rectal prolapse. This case features a 61-year-old female who presents with complaints of tissue protruding through her rectum and fecal incontinence. On exam, she was found to have circumferential, full-thickness rectal prolapse and perineal descent. After patient positioning in low lithotomy, laparoscopic access is achieved via port placement at the umbilicus, midclavicular and anterior axillary lines bilaterally in the typical “W” configuration. The procedure is commenced with elevation of the rectum out of the pelvis to expose the sacral promontory and provide visualization of the right ureter. The peritoneum is incised over the rectosigmoid mesentery at the level of the sacral promontory. Right lateral dissection is continued within the presacral space with care to preserve the right ureter and hypogastric nerve. At this level, the hypogastric nerves originate from the nervous tissue overlying the bifurcation of the aorta. They then condense into 2–3 mm bundles bilaterally as they receive further innervation from S2 and S3. They travel within and posterior to the presacral fascia toward the genitourinary structures. Preservation of the hypogastric nerves is key to avoiding urinary and sexual dysfunction. The incision is then carried anteriorly towards the rectovaginal fold. The dissection is then performed from right to left across the rectovaginal fold. The rectovaginal space is further developed with assistance of a sponge stick in the vagina. Additionally, a rectal exam is performed to ensure complete dissection to the pelvic floor. Dissection is then continued along the left side of the rectum in a similar fashion. The dissection is carried down to the pelvic floor in the presacral space to the level of the levator ani muscles. This distal dissection ensures full mobilization of the rectum. A 2–0 nonabsorbable braided suture is placed through the anterior longitudinal ligament at the level of S2. This suture is then used to pexy the right rectal stalk. The left side is then pexied in a similar fashion. In addition, the retained rectopexy suture on the left is used to begin the colpopexy. After appropriate tensioning of the rectopexy, the sutures are then used to incorporate the apex of the vagina to complete the colpopexy portion of the procedure. Appropriate tensioning is paramount to avoid obstruction of the rectum with the colpopexy sutures. The peritoneum is then reapproximated to obliterate the cul de sac.

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Postoperative exam revealed resolution of rectal prolapse and good perineal support. The patient’s postoperative course was uncomplicated. She was discharged home on postoperative day # 1 doing well and tolerating regular diet. At 6-month follow-up, she had no recurrence of rectal prolapse and good perineal support. Given that rectal prolapse and posthysterecomy vaginal vault prolapse often occur together, our institution routinely performs colpopexy with rectopexy for rectal prolapse to provide additional support to the pelvic floor. K.A. Greene: None. J.E. Sanchez: None. M.L. Campbell: None. J.E. Marcet: None.

51 CADAVERIC COMPARISON OF THE PLACEMENTS OF SINGLE INCISION SLINGS E. Kocjancic1, A. Sedlar 2 1 Univeristy of Illinois at Chicago, Chicago, IL, 2Univ. Clinical Hosp., Ljubljana, Slovenia. In the past decade we have witnessed changes in the surgical treatment for stress urinary incontinence (SUI), moving from open colposuspensions towards vaginal tension-free retropubic and transobturator slings. Evolution of surgical technique has moved towards reducing the size of the sling and number of incisions. This video evaluates the differences among of single incision slings (SIS), surgical techniques and technical limitations. Dissection techniques for the placement of SIS are very similar. There are two types of anchor based SIS- nonadjustable and adjustable. The non-adjustable slings all have the same type of introducer for placement. The anchoring of these slings varies from a single anchor to a multiple tined anchor. The rigidity of the tined based anchors makes the insertion of the second anchor challenging and may require a larger incision. With the nonadjustable slings the tensioning adjustments are possible only with the introducer attached to the anchor. Releasing tension to the sling may result in greater complications and damage to the anchor which can result in a less efficient anchoring force. The next generation of single incision slings has the common characteristic of adjustability after insertion and has a deeper anchor insertion. Adjustable slings have one fixed and one dynamic anchor. The insertion of the slings very based on the type of introducer. The dynamic anchor allows the tensioning and releasing of the sling without moving the anchor. This can be performed using the same technique that is utilized for tensioning of the traditional tension free slings. Single incision slings have the potential advantage to reduce complications but the different tensioning techniques could

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affect outcomes. Further clinical evaluations are needed to address efficacy of these procedures. E. Kocjancic: Consultant; Coloplast, Bard, AMS, Astellas, Allergan, Pfizer. Shareholder; Nexhand. A. Sedlar: None.

52 SURGICAL MANAGEMENT OF SYNTHETIC PELVIC MESH COMPLICATIONS FOR PROLAPSE REPAIR AND INCONTINENCE 2006–2011 J. M. Evans, M. Karram The Christ Hosp./Univ. of Cincinnati, Cincinnati, OH. Objectives: To describe the characteristics of a case series of 104 consecutive patients referred with mesh complications which warranted surgical management. Materials and Methods: Retrospective chart review was performed on 396 charts via ICD-9 codes to identify 104 subjects who presented with mesh complications requiring surgical intervention (Dindo Grade III). Demographics and index surgery data, complications, prior attempts at conservative or surgical management , and type of interventions and outcomes at our center were recorded. Comparative statistics were performed for subjects who had synthetic sling complications alone or complications related to mesh for prolapse repair. Results: 104 subjects were identified who met eligibility criteria. 39 (37.5 %) had mesh placed for pelvic organ prolapse (TVM), 43 (41.3 %) for stress urinary incontinence (SUI), and 22(21.2 %) had a combined procedure for prolapse and incontinence. Demographic data was consistent between all groups. Of midurethral slings placed, 33 (55.9 %) were retropubic slings, 18 (30.5 %) were transobturator approach, and 8 (13.6 %) were single incision mini-slings. For TVM, 38 (59.4 %) were trocar based mesh kits, 9 (16.7 %) were direct access, or direct overlay systems, and 7 (13 %) involved free mesh or sacral colpopexy. Ten charts did not record the type of mesh employed. Vaginal mesh erosion was present in 63(60.6 %) of subjects including 40(67.2 %) in the TVM group and 8(13.7 %) of synthetic slings (OR 4.1, 4.5–28). Other common presenting symptoms included 63 (60.6 %) with pelvic pain, 46 (44.2 %) with dyspareunia, 28 (26.9 %) with recurrent prolapse, and 39 (37.5 %) with recurrent incontinence. 39 (37.9 %) of subjects had prior conservative or surgical management by another provider prior to presentation. The TVM group underwent more aggressive attempts at removal of the mesh to the obturator internus muscle or attempt at full mesh excision than with synthetic slings alone (P00.02). The TVM group was also more likely to have repairs for recurrent prolapse at the time of mesh excision (P00.017), and intraoperative cystotomy was more common (P00.05).

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83 % of subjects underwent one surgical intervention, 17 % undergoing two or more surgeries. The average number of surgeries for the TVM group at 1.28 (range 0–5) and for slings alone was 1 (range 0–2) which was statistically significant (p00.002, 0.1–0.44). Three subjects in the TVM group eventually underwent extensive reconstructive procedures such as McIndoe procedure and sigmoid neovagina due to vaginal obliteration and fibrosis. Subjects with TVM complications had a 1.6 times more office and surgical encounters than the sling alone group (P00.03, CI 0.38–9.4). Conclusion: Procedures involving removal of TVM tend to be more extensive and complex than surgical interventions for synthetic sling complications. In addition, complications of TVM placement require more office visits and more surgical interventions than mesh complications with synthetic slings alone. Further analysis comparing specifics of subjective cure following surgical correction of a mesh complication should be pursued in order to fully understand the patient impact of these interventions. J.M. Evans: None. M. Karram: Consultant; AMS.

53 TIME TO FIRST IDENTIFIED MESH EXTRUSION FOLLOWING VAGINAL SYNTHETIC MESH REPAIR WITH APOGEE® AND PERIGEE® MESH KITS S. Lin, L. Hayward, J. Smalldridge Middlemore Hosp., Auckland, New Zealand. Objective: To identify factors associated with synthetic mesh extrusion. Background: A number of mesh kits are available for surgical management of pelvic organ prolapse. Mesh extrusion rates of 4.6–28 % have been cited; however follow up has mostly been short. There is a paucity of long term data on mesh extrusion and outcomes. Methods: All women who underwent vaginal mesh repair with Apogee® and/or Perigee® Intepro® and Intepro Lite® between February 2005 to December 2011 were included. Criteria for mesh insertion were recurrent prolapse POPQ≥ 2 or primary repair POPQ stage ≥ 3. Patients were assessed at 6 weeks, 6 months, 12 months and yearly thereafter for mesh extrusion symptoms and examination findings. Results: 125 Perigee and 80 Apogee synthetic mesh kits were implanted in 147women. Median follow up was 99 and 133 weeks respectively. 38 % of women underwent surgery for recurrent prolapse. From October 2009 Intepro was replaced with Intepro Lite mesh . Demographics and surgical details are shown in Table 1. Mesh extrusion rates according to the mesh type are shown in Figure 1.

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The overall mesh extrusion rate was 13.6 % with a mean time to extrusion of 81 weeks. The distribution of the size, timing and site of extrusion are shown in Figure 2. 97 % of women with mesh extrusion were treated conservatively with Ovestin cream and office based trimming if required; 3 % underwent surgical revision. Conclusions: The mesh extrusion rates are consistent with other studies. The long interval between implantation and first mesh extrusion highlights the need for long term follow up. The mesh extrusion rates in short term studies are likely underestimated.

Our data suggests a significant increase in Perigee mesh extrusion in women with previous anterior repair (p0 0.03); this raises the possibility of a causal relationship of devascularisation and scarring from previous surgery to mesh extrusion in the anterior compartment. Extrusion rates in our study are significantly lower with Intepro Lite, but follow up needs to be extended to confirm this. The overall mesh extrusion rates for Perigee and Apogee were significantly different at 9.6 % and 20 % respectively (p00.03; 95%CI 5–27 %). This difference of extrusion rates by mesh site is unexpected and more research is needed to confirm the finding.

Table 1. Background characteristics by mesh extrusion outcomes Perigee %(n) Age at Implantation Parity median (IQR) BM median (IQR) Diabetic Current Smoker Pessary use pre-op Previous Hysterectomy Previous same compartment repair Concurrent Surgery Synthetic Mesh in other compartment Biomesh in other compartment Vaginal hysterectomy Sacrospinous fixation Native tissue repair in other compartment Midurethralsing

Apogee

Extrusion (n=12)

No Extrusion (n=113)

p-value

Extrusion (n=16)

No Extrusion (n=64)

p-value

68 (8) 3 (2.5, 5) 30 (26, 33) 8% 0% 4 (33.3 %) 75 % (9) 75 % (9)

67 (10) 3 (2,4) 29 (26,32) 10 % 5% 32 (27.9 %) 51.4 % (57) 30 % (33)

68 (10) 3 (2,4) 29 (27,32) 6% 1 (6 %) 4 (25 %) 44 % 25 %

67 (9) 3 (2,4) 29 (26, 32) 16 % 2 (3 %) 21 (33 %) 75 % 38 %

58.3 % (7) 0% 0% 16.7 % (2) 0% 33.3 % (4)

41.5 % (47) 4.4 % (5) 8.8 % (10) 23.0 % (26) 16.8 % (19) 8.8 % (10)

0.73 0.78** 0.74** 0.73* 0.81 0.72 0.11 0.003* 0.07

87.5 % (14) 0% 0% 6.25 % (1) 6.25 % (1) 6.3 % (1)

71.9 % (46) 0% 4.7 % (3) 14.1 % (9) 0% 4.7 % (3)

0.82 0.82** 0.95** >0.90* 0.25 0.55 0.008 0.37* n/a

*Md-Por fisher exact test, the rest of the categorical variables are chisquare test **Median two sample test, the rest of continuous variable used two sample t test n/a insufficient number for statistical analysis Figure 1. Mesh extrusion by mesh material implanted

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Figure 2. Mesh extrusion by size, symtoms, timing and position

S. Lin: None. L. Hayward: None. J. Smalldridge: None.

54 V I S C E R A L I N J U R I E S D U R I N G VA G I N A L PROSTHETIC SURGERY A. Cornille 1, R. De Tayrac 2, P. Debodinance 3, M. Cosson1; 1 CHU Lille, Lille, France, 2CHU Nimes, Nimes, France, 3 CH Dunkerque, Dunkerque, France. Introduction: Rectal and bladder injuries during vaginal prosthetic surgery are rare events in experienced teams. Their management is not consensual and there are few data in the literature on this topic. Background: To describe the experience of three centers for the management of visceral wounds occurring during vaginal prosthetic surgery. Methods: This is a descriptive, retrospective and multicentric study conducted from 2005 to 2011, concerning patients operated for vaginal prolapse (cystocele and/or rectocele) with the use of polypropylene meshes. Results: 1547 procedures were performed: 418 anterior meshes, 289 posterior meshes and 840 anterior and posterior meshes. There were 22 visceral wounds on a total of 1547 interventions (1.42 %): 16 bladder injuries on 1258 anterior interventions (1.27 %) and 6 rectal injuries on 1129 posterior interventions (0.53 %). Visceral wounds were made by a junior surgeon in 31.8 % of cases and by a senior surgeon in 68.2 % of cases. Only one posterior mesh was placed during a rectal injury. This injury occurred at the end of the procedure whereas the mesh was already fixed and was

very distal. The patient developed a rectovaginal fistula, which was reoperated several times (with colostomy). The other patients with rectal injury did not received mesh and we observed no complication. In case of bladder injuries, a mesh was placed in 62.5 % of cases. No complications were diagnosed for 14 of 16 cases (one case of persistent back pain and one ureteral fistula diagnosed at day 3 with ureteral reimplantation by laparotomy). Cystoscopy was performed in 43.75 % of cases. Double J ureteral stents were placed by urologists in 3 patients for complex wounds. One Bladder suture had to be performed by laparotomy because of multiple wounds. The urinary catheter was maintained 10.1 days (± 3.3). Conclusion: If the management of rectal injuries seems to be consensual among the three teams (no placement of mesh), that one of bladder injuries is not. Indeed, in one team meshes are never placed, while for others a distinction is made: in case of simple wounds (single wound, away from ureteral meatus, easily sutured vaginally) the mesh is placed. In case of complex wounds (multiple, large, close to ureteral meatus) the mesh is not placed. It is important to diagnose intra-operative visceral wounds, with a bladder methylene blue test if there is any doubt, and with a systematic digital rectal exam at the end of interventions. Postoperative outcomes are most of the time favorable, including when a mesh is placed. However, we recommend a routine cystoscopy for every bladder injury to detect more severe lesions (ureteral). A. Cornille: None. R. de TAYRAC: Consultant; Boston scientific. P. Debodinance: Consultant; Ethicon. M. Cosson: Consultant; Ethicon, AMS.

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55 FOLLOW UP OF MESH COMPLICATIONS USING THE ICS/IUGA CTS CODING CLASSIFICATION H. Bontje, G. Van De Pol, M. Scheltes, W. A. Spaans Gelre Ziekenhuis Apeldoorn, Apeldoorn, Netherlands. Objective: Providing insight in complications of 5 year prolapse repair using trocar-guided polyprolylene mesh in a peripheral hospital. Assessing applicability of the ICS/ IUGA CTS coding in describing mesh complications. Background: Transvaginal mesh in pelvic prolapse surgery has been introduced in 2005. In recent years, it became clear that mesh can cause serious complications, leading to FDA warnings to protect overcourageous patients and doctors. The ICS and IUGA have developed a complication classification CTS code (C category, T time, and S site) to facilitate international comparison and to improve understanding of these complications. This system was applied to review and analyze operated cases over the past 5 years and report reoperation rates. Methods: Patients who underwent vaginal prolapse repair using trocar-guided polypropylene mesh between 2006 and 2010 in a peripheral hospital in the Netherlands were included. Questionnaires and physical examination were completed pre-operatively, 6 weeks after operation and at secondary follow-up between 2010 and 2011. If indicated, a concomitant procedure was performed. The mesh was inserted according to kit protocol. Complications were classified using the ICS/IUGA CTS codes. Results: Of the 107 women included, 92 patients (86 %) had previous pelvic surgery, of whom 66 underwent previous hysterectomy. Six women (6 %) had peri-operative complications, including haemorrhage and bladder perforation (category 6 and 7); in two of them the surgeon decided not to use the mesh and one of them needed reoperation relieving a hematoma. In the period before the secondary follow up two patients (2 %) were re-operated because of symptomatic mesh exposure (category 2 and 3) and in one patient the arm of the prosthesis was cut because of local pain (code 1BcT4S3). The secondary follow up rate was 76 % (n081) at average of 36 months (range 11–64). At this follow up another 6 % (n0 5) was diagnosed with mesh exposure (category 2 and 3), being symptomatic (division B) in three women, for which one woman underwent partial mesh excision and closure. Fifty-two women (64 %) had no complication at follow up. In 23 (28 %) women some kind of wrinkling or shrinkage of the mesh was found (category 1). Most of them had no complaints or only pain on provocation (code 1Aa or 1Bb). Five of them (6 %) had complaints in daily activities or dyspareunia (code 1Bc/d/e). Eleven women (14 %) needed tension free vaginal tape for stress urinary incontinence and seven patients (9 %) needed further surgery for prolapse in other compartiments (not included in the complication code).

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Conclusions: This observational study collected data on complications and re-operation rates after transvaginal trocar-guided polypropylene mesh for prolapse using the ICS/IUGA CTS coding. Perioperative complication rate was 6 %. The long term mesh exposure rate was 9 % of which 43 % was treated with local excision and closure and 57 % was treated conservatively. Complaints in daily activities and dyspareunia due to mesh was 6 %. The ICS/IUGA CTS code was a useful tool in describing mesh complications. A supplemental category covering re-operations like excision of mesh exposure, treatment of prolapse in another compartment or treatment of stress urinary incontinence could improve CTS coding. H. Bontje: None. G. van de Pol: None. M. Scheltes: None. W.A. Spaans: None.

56 THIRD GENERATION VAGINAL MESH IN PROLAPSE SURGERY—SHORT TERM COMPLICATIONS A. Lam 1, P. Patel 1, O. Daly 2, C. Benness2 1 Ctr. for Advanced Reproductive Endosurgery, Sydney, Australia, 2Royal Prince Alfred Hosp., Sydney, Australia. Objective: To assess the short term complications associated with a third generation vaginal mesh procedure in the management of pelvic organ prolapse Background: Polypropylene mesh kits are often used in the surgical management of pelvic organ prolapse (POP) with the aim of decreasing prolapse recurrence. However, the use of mesh remains controversial with the FDA recently warning pelvic surgeons about possible complications. Mesh characteristics have changed considerably over the past two decades with the latest products utilising much lighter weight mesh with the addition of level 1 support to the sacrospinous ligaments. Theoretically the newer meshes, and improved surgical techniques (such as full thickness skin dissection), may result in fewer related mesh complications. Method: A prospective cohort study of 250 consecutive women having POP surgery with the use of a low density polypropylene mesh (anterior or posterior ‘Elevate’—American Medical Systems) to the anterior or posterior compartments or both. The Elevate systems incorporate bilateral fixation of the graft to the sacrospinous ligaments with low profile self-fixating tips, with the Anterior Elevate also having bilateral fixation into the obturator internus muscles. The procedures were performed by three surgeons at two tertiary referral centres between December 2009 and March 2012. Patients were reviewed at 6 weeks and 6 months following surgery. Results: A total of 250 women with POP and a mean age of 63 years (range 48–90 year), underwent surgical treatment with polypropylene mesh to either anterior or posterior

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compartments or both. Ninety nine (39.6 %) had a Posterior Elevate procedure, 74 (29.6 %) had an Anterior Elevate procedure and 77 (30.8 %) had both an anterior and a posterior Elevate procedure. The median POP-Q stage was 3 and over one third had recurrent prolapse. Eight women (3.2 %) had a concomitant hysterectomy, 45 (18 %) had a concomitant continence procedure (midurethral sling), and 100(40 %) had concomitant prolapse surgery, usually a colporrhaphy, to the opposite compartment. The mean time of follow-up was 8 months.

Conclusions: Considering that POP surgery utilising mesh is usually performed in complex patients, often having had previous pelvic surgery, and often requiring concomitant continence surgery and surgery in multiple compartments, the post-operative rate of significant complications of around 6 % found in this study would seem acceptable. The low mesh erosion rate of 2.5 % may indicate improving mesh design and possibly better surgical techniques. A. Lam: Consultant; AMS. P. Patel: None. O. Daly: None. C. Benness: None.

Table 1. Intra-operative complications Complication Bleeding (>500 mls)

n 13

% 5.2 %

Bladder perforation Inability to complete procedure

2 7

1.3 % 4.4 %

Intraoperative complications are shown in Table 1 and consisted of 13 cases (5.2 %) of bleeding (> 500mls) and two (1.3 %) bladder perforations with the Anterior Elevate procedure. These cystotomies were both noted at cystoscopy and rectified, and the planned procedure completed. Seven (4.4 %) of the planned 158 Anterior Elevate procedures could not be performed due to difficulty reaching the sacrospinous ligaments or bleeding from paravesical venous plexuses. Table 2. Post-operative complications Complications Mesh erosion Bleeding/haematoma Blood transfusion Urinary Cystitis/UTI Voiding dysfunction

n 6 6 1

% 2.5 % 2.4 % 0.4 %

6 10

2.4 % 4%

Hydronephrosis De Novo stress UI Pulmonary embolus Dyspareunia Vaginal stenosis

1 30 1 18 1

0.4 % 12.5 % 0.4 % 8.6 % 0.4 %

Post-operative complications (Table 2) included 6 (2.4 %) cases of cystitis, 6 (2.4 %) cases of post-operative bleeding or haematoma (one of which required transfusion), 10 cases (4 %) of transient voiding dysfunction. One patient had a post-operative finding of a unilateral mild hydronephrosis which resolved after ureteric stenting for 1 month. There was one post-operative pulmonary embolus. De Novo stress urinary incontinence occurred in 30 women (12.5 %), while dyspareunia occurred in 18 (8.6 %). Mesh erosion occurred in 6 women (2.5 %) with two (0.8 %) of these requiring surgical treatment. Vaginal stenosis was encountered in one patient and was managed conservatively with dilators.

57 A COHORT STUDY TO DETERMINE THE OUTCOME AND COMPLICATION RATE AND TO CLASSIFY COMPLICATIONS USING IUGA/ICS TERMINOLOGY FOLLOWING VAGINAL MESH FOR PELVIC ORGAN PROLAPSE SURGERY D. R. Avery Pelvic Floor, Southern Hlth., Melbourne, Victoria, Australia. Objective: To determine objective and subjective outcomes and the complication rate following vaginal mesh surgery following 12–48 month follow up. To discover factors associated with mesh complications including comparing different types of mesh and classify the complications using the IUGA/ICS classification system (1). Background: The reported complication rate following the use of vaginal mesh varies and most studies have only had short term follow up or included only one type of mesh. (2). This study includes several different types of mesh, heavy and light, kit and non-kit., trocar and non-trocar and allows comparison regarding complication rate and type. The IUGA/ICS classification provides a framework for classifying complications. Methods: All women who had pelvic floor surgery using vaginal mesh at 3 centres from June 2006 until December 2011 were included. The choice of conventional pelvic organ prolapse surgery or the use and type of vaginal mesh surgery was at the discretion of the surgeon. Outcomes were assessed by POP-Q score on clinical exam and telephone interview where PGII (patient global impression of improvement) and the presence of pelvic organ prolapse symptoms was ascertained by using the Queensland Female Pelvic Floor Questionnaire Q27, Q31. Details on patient characteristics, operative techniques and operative complications were discovered by chart review Results: 137 women aged 38–90 (mean 66±10) underwent operations using synthetic vaginal mesh from June 2006– December 2011. A range of mesh was used, (total mesh used 0140 as several women had 2 mesh types) Trocar, non-trocar, light<25–30 g (n0103). Heavy 30–60 g (n037) (Table 1). Median parity was 3 (0–11), mean BMI 28.7±6.8 (20–42.6). Clinic follow up ranged from 1.2 to 18.4 months (mean 4.7+ −4.1). Telephone follow up ranged from 6.7 to

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69 months (mean 26.0+ −15.7). The three leading points of POPq (Ba, C, Bp) improved (Ba 1.6±2.2, −2±1.1; C 0±4.9, −5±5.0; Bp 0±2.6, −2±1.1; preoperative and post-operative respectively. Anatomical success defined by POP-Q leading point of prolapse greater than point -1 was Ba 71.5 % (98/ 137), C 76.6 % (105/137), Bp 74.5 % (102/137). 72/137 women were successfully contacted for telephone follow up; of these women 68.1 % (49/72) reported a global impression of improvement of prolapse condition following surgery. A similar number of women 65.3 % (47/72) reported the lack of vaginal bulge whereas 79.2 % (57/72) reported no bother in regards to pop symptoms. 15/137 (10.9 %) complications were recorded using the IUGA classification. 9/15 (60 %) were in category A, asymptomatic. The other complications were spread throughout the IUGA/ICS categories (Figure 1)

Those patients who had had heavy mesh had a higher complication rate than light mesh, 8/53 (15.1 %) vs. 7/18 (vs. 38.9 %,) p value (Fischer exact, two tailed) 00.046. Smoking and BMI was not associated with an increase rate of complication. 8.8 % (12/137) patients have had repeat operations with 13 reoperations in total. 3.7 % (5/137) patients were returned to theatre for excision of mesh. There have been 7 (5.1 %) repeat prolapse operations. Conclusions: In this cohort of patients who underwent mesh surgery from 2006 to 2011 success as defined by anatomical and subjective outcomes was shown to be 71–79. Complication rate of 10.9 % classified using the IUGA/ICS terminology. The use of heavy mesh, 30–60 g was associated with a higher complication rate than the light, <25–30 g mesh.

Figure. 1 Complication percentage in each IUGA/ICS category

Table 1 Mesh Ultrapro Uphold/Pinnacle Elevate Perigee Apogee Prolift Gynemesh Prosima

Number 21 22 62 17 3 11 2 2

References: 1. Int Urogynecol J (2011) 22:3–15 DOI 10.1007/s00192010-1324-9 2. Obstet Gynecol 2011;118:629–36Figure. 1 Complication percentage in each IUGA/ICS category D.R. Avery: None.

58 SURGICAL COMPLICATION RATES FOLLOWING VAGINAL SYNTHETIC MESH REPAIR WITH APOGEE® AND PERIGEE® MESH KITS— A 7-YEAR REVIEW S. Lin, J. Smalldridge, L. Hayward; Middlemore Hosp., Auckland, New Zealand. Objective: To evaluate the complication rates of vaginal synthetic mesh kits, Apogee® and Perigee® (AMS Minnetonka). Background: Mesh kits have been developed to promote a minimally invasive alternative to pelvic organ prolapse surgery. These procedures seem intuitive in replacing or reinforcing damaged endopelvic fascia, however there is an ongoing paucity of quality data reflecting long term outcomes. Methods: A retrospective review of complication outcomes in all patients who had vaginal prolapse surgery with Perigee and/or Apogee synthetic mesh kits at our institution from February 2005 to December 2011.

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Results: 125 Perigee and 80 Apogee synthetic mesh kits were used in a total of 147 patients over the 7-year period with a median follow-up period of 99 weeks and 133 weeks respectively. 57 patients had both Apogee and Perigee at the index surgery. Overall Perigee and Apogee mesh extrusion rates were 9.6 % and 20.0 % with a mean time between surgery to mesh extrusion of 76 and 84 weeks respectively. Only 3 % of mesh extrusion overall required surgical excision. There has been no reported cases of fistula formation nor immediate trochar injury in our series to date. Recurrent compartmental prolapse rates are 4.8 % and 1.3 % following the Perigee and Apogee repair respectively, with an overall rate of re-operation of 5.2 % for either recurrent or de novo compartmental prolapse. There is a 12.0 % rate of de novo stress incontinence following synthetic Perigee mesh repair; 9 out of these 15 patients underwent subsequent incontinence surgery (see Table 1).

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12.1 % of patients following Apogee synthetic mesh repair required colorectal referral for evaluation of ongoing bowel symptoms; out of these 8 patients, 3 patients underwent anterior DeLormes procedure, 1 required banding for rectal prolapse (see Table 2). Conclusions: Our complication rates compare favourably to other shorter term studies with an overall 16.7 % of patients requiring subsequent related surgery under general anaesthesia after the index surgery. Our data will provide surgeons with the long term devicerelated complication rates to counsel women on. Further research addressing long term functional outcomes and quality of life improvement is needed to evaluate the role of synthetic mesh kit repair. Re-operation following synthetic Perigee repair (Total Perigee n0125)

Table 1. Re-operation following synthetic Perigee repair (Total Perigee n0125)

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Table 2. Re-operation following synthetic Apogee repair (Total Apogee n080)

S. Lin: None. J. Smalldridge: None. L. Hayward: None.

59 PRESENTATION AND MANAGEMENT OF IATROGENIC LOWER URINARY TRACT INJURY AFTER MINIMALLY INVASIVE SURGERY: A CASE SERIES J. M. Evans1, A. Mahdy 2, M. Karram 1 1 The Christ Hosp./Univ. of Cincinnati, Cincinnati, OH, 2 Univ. of Cincinnati, Cincinnati, OH. Objective: To report a series of lower urinary tract injuries that occurred after minimally invasive gynecologic procedures. Methods: After Institutional Review Board approval was obtained, we reviewed the medical records of sixteen women who were referred for evaluation of urologic injuries between February 2009 and January 2012 after a gynecologic laparoscopic or robotic pro-

cedure. Demographics, type of gynecologic procedure in which injury occurred, time of presentation for diagnosis, surgical management chosen for fistula repair, and perioperative and postoperative complications were recorded. Results: 16 patient records were reviewed with ages ranging from 32 to 67 years of age (mean age 47). Twelve subjects underwent initial robotic procedures, 3 traditional laparoscopies, and 1 was a single port laparoscopy. Time to presentation with symptoms ranged from 2 days to 9 months postoperatively. Four patients had robotic procedures for a malignant indication (27 %). Six patients presented with vesicovaginal fistulas (34 %), eight had ureterovaginal fistulas (50 %), one developed a large urinoma after ureteral transection, and one patient had a cervicovesical fistula after supracervical hysterectomy. Five of six vesicovaginal fistulas were repaired vaginally, whereas one healed spontaneously with constant foley catheter drainage. Of the subjects with ureterovaginal fistulas, 50 % were repaired

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with ureteral reimplantation and 50 % were conservatively managed with double-J stent placement. The subject with the urinoma had a nephrostomy tube placed and delayed reimplantation of the right ureter. The vesicocervical fistula was repaired abdominally with an associated trachelectomy. Two patients reported previous attempts at repair by an outside physician prior to referral. No patients had any documented serious complications of fistula repair. Discussion: Laparoscopic and robotic procedures are increasing in the gynecologic setting. Although these procedures are minimally invasive with theoretically shorter recovery and hospital times, they can have unique morbidities. The use of special energy sources for cautery and cutting of tissues minimizes blood loss and the need for sharp dissection, but also has the potential to increase intraoperative and postoperative thermal injuries such as insults to bowel, bladder, vascular structures, and the ureters. Excessive magnification of the field may also contribute to positional disorientation of the instruments. This series of urogenital injuries highlights the unique and often complex nature of urologic and urogynecologic surgical repairs. In addition, this series raises some questions regarding the cause of urologic injury during minimally invasive procedures. Although several of the cases in our study may have resulted from direct surgical trauma, the majority suggest delayed injury due to cautery sources with the exception of one robotic sacral colpopexy in which severe vaginal atrophy 9 months postop resulted in mesh erosion into the vagina and bladder. Past studies have shown that excessive cautery at the vaginal cuff can result in increased rates of cuff dehiscence. Current literature suggests that a steep learning curve, lack of appropriate anatomic vigilance, and potentially excessive confidence with relatively new and unproven instruments may result in significant gynecologic postoperative complications. Additionally, early recognition of injury to the urologic organs is key for early intervention. J.M. Evans: None. A. Mahdy: None. M. Karram: Consultant; AMS.

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60 A RETROSPECTIVE COMPARISON OF DEFECATORY SYMPTOMS IN SUBJECTS WITH A POSTERIOR VAGINAL WALL DEFECT IDENTIFIED BY POPQ SCORES VERSUS DIGITAL RECTAL EXAM D. Zoorob, M. South, J. Evans, C. Sanan, R. Maxwell The Christ Hosp./Univ. of Cincinnati, Cincinnati, OH. Objective: The purpose of this retrospective cohort study was to compare the prevalence of defecatory symptoms in subjects utilizing two different diagnostic methods for identifying posterior wall defects. Posterior vaginal wall defects identified with traditional POPQ (Pelvic Organ Prolapse Quantitative) scores (Ap and Bp ≥ -2) were compared with defects found on digital rectal exams but normal posterior wall POPQ scores. Study design: We included all subjects who underwent pelvic examination with documented POPQ scores between September 2008 and December 2011. Data on defecatory symptoms including daily bowel movements, fecal incontinence, constipation, splinting with defecation, incomplete rectal emptying, vaginal protrusion and pressure were sytematically collected in all subjects. Objective findings of a posterior wall defect were noted on POPQ exam or digital rectal exam. Subjects were divided into two groups; Group 1 included all subjects with POPQ scores suggesting a posterior wall defect and Group 2 included all subjects who did not have evidence of posterior wall prolapse on POPQ measurements but did have a defect noted on digital rectal exam. The rate of surgical repair (i.e. posterior colporrhaphy) between Group 1 and Group 2 was also compared. Statistical analysis included Student t-test and Fisher’s exact test (SPSS; Version 18.0, Somers, NY). Results: A total of 664 subjects were evaluated with 254 subjects noted to have evidence of posterior wall defects on examination. As part of their routine examination, all subjects underwent digital rectal exam

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regardless of defecatory symptoms or POPQ scores. Of the 254 subjects, 205 (81 %) were noted to have findings suggestive of posterior wall prolapse based on POP-Q (Ap and Bp≥-2) and were assigned to Group 1. An additional 49 (19 %) subjects had evidence of a posterior wall defect based solely on digital rectal examination and were assigned to Group 2. No difference in demographics between Group 1 and Group 2 were noted including age (61.0 years vs. 58.0 years), BMI (29.2 vs. 29.6), parity, or route of delivery. In addition, both groups experienced defecatory symptoms in equal distribution. More than 50 % of subjects in both groups reported symptoms of protrusion and pressure followed by ~35 % of all subjects reporting constipation and the sensation of incomplete emptying. Twenty-six percent of subjects in Group 1 and 20 % in Group 2 proceeded to colporrhaphy. Among those who underwent surgical repair, the distribution and prevalence of symptoms were similar. Conclusion: In patients with normal posterior wall POPQ scores, the use of digital rectal examination helps identify additional patients who may benefit from surgical correction with posterior colporrhaphy. D. Zoorob: None. M. South: None. J. Evans: None. C. Sanan: None. R. Maxwell: None.

61 PREDICTORS OF RESPONSE TO INTRAVESICAL D I M E T H Y L S U L F O X I D E I N PAT I E N T S WITH INTERSTITIAL CYSTITIS K. Stav, A. Lindner, D. Leibovici; Assaf Harofeh Med. Ctr., Zeriffin, Israel. Objective: to identify predictors of treatment failure of dimethyl-sulfoxide (DMSO) “cocktail” for patients with interstitial cystitis (IC). Background: to date, no curative treatment is available for ICor its closely related clinical variant of painful bladder syndrome (PBS). However, palliation has been accomplished

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in some patients using intravesical instillations of Dimethylsulfoxide [1] either alone or combination with other drugs [2– 3]. Methods: 51 IC patients received weekly intravesical instillations of “cocktail” comprising of 50 % DMSO (50 mL), 100 mg of hydrocortisone (5 mL), 10,000units of heparin sulfate (10 ml) and 0.5 % bupivacaine (10 mL) for 12 weeks. A reduction from baseline in the O’Leary-Sant questionnaire score of more than 30 % was considered as a response. Patients were evaluated every 3 weeks during the treatment course and at 1, 3, 6, 9 and 12 months subsequently. In addition, patients filled in a 3-days bladder-diary and 0–10 visual analogue scale (VAS) for pain. Responders and nonresponders were compared and predictors of treatment failure were identified using univariate analysis and multiple logistic regression. Results: 31 patients (61 %) were responders. A significant decrease from base-line in the mean questionnaire’s score (27.2 ±2.8 vs. 18.8± 2.0, p00.0001) was noted in the responders group. Improvements in the mean daily number of micturitions (16.7± 3.6 vs. 14.8 ± 2.8, p00.003) and in the mean VAS (7.6± 1.6 vs. 3.6 ± 1.0, p 00.0001) were noted, as well. In the nonresponders group, none of these variables improved significantly. Patient age, menopausal state, body mass index, diabetes mellitus, cystometric and anesthetic capacities were all associated with response. However, the only an anesthetic bladder capacity <675 ml independently predicted treatment failure (OR 83, 95 % CI 9714, p<0.0001). Figure 1 describes the comparison of the measu rement tools between responders and non-respon ders during the treatment and follow-up periods. It shows that the response curves become divergent at 3 weeks, and follow a coherent course thereafter. However, the treatment effect was transient, and 12 months after treatment all parameters reverted to baseline levels.

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Conclusions: Intravesical cocktail for IC patients is associated with a 61 % response rate. A small anesthetic bladder capacity predicts treatment failure. References: 1. Urology 1987; 29 (Suppl):17–21. 2. World J Urol 1993; 11:178–182. 3. Urology 1997; 49(5A suppl):105–107. K. Stav: None. A. Lindner: None. D. Leibovici: None.

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62 BLADDER AND BOWEL FUNCTION FOLLOWING TREATMENT OF DEEPLY INFILTRATING ENDOMETRIOSIS: A ROLE FOR A NERVE SPARING APPROACH? S. Krishnan, Y. Li, B. De Vries, C. Benness, J. O. Daly, A. Korda Royal Prince Alfred Hosp., Camperdown, Australia.

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Objective: To compare bladder and bowel function outcomes following standard laparoscopic techniques for excision of Deeply Infiltrating Endometriosis (DIE) involving the inferior hypogastric plexus, with outcomes following excision of endometriosis from other sites Background: Laparoscopic excision of Deeply Infiltrating Endometriosis (DIE) involving the rectovaginal septum and uterosacral ligaments, may adversely affect voiding function due to iatrogenic injury to the inferior hypogastric plexus (1). Recently, a nerve sparing approach has been described for women with deep infiltrating endometriosis (2), with the aim of decreasing pelvic floor dysfunction. These nerve-sparing techniques require a high level of expertise and such an investment requires evidence of benefit. This study will demonstrate whether there is an increase in bowl and bladder voiding dysfunction, in our population of women having had exicision of DIE, necessitating further research into nervesparing techniques. Methods: A retrospective cohort study was performed. Patients aged 20 to 50, who underwent excision of endometriosis, conducted by two level 6 laparoscopists within our centre, in the last 5 years were eligible for the study. Patients with a history of a forceps delivery or pelvic floor repair were excluded. A validated questionnaire examining four domains of bowel and bladder function was developed and mailed to eligible patients. The primary outcomes were symptom scores for urinary voiding and stool evacuation. The secondary outcomes were urinary stress and urge incontinence, and a global score for urinary and bowel symptoms. Independent t-tests were used to compare means of normally distributed data. The Wilcoxon rank sum test was used to analyse non-normally distributed data and was described using medians and interquartile ranges (IQR). Chi-squared and Fisher exact tests were used to compare frequencies. Results: Of 252 questionnaires mailed, 15 were returned to sender and 84 were completed for a response rate of

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35.2 %. 55 respondents had excision of DIE and 33 had excision of endometriosis from other sites in the pelvis. As seen in Table 1, those in the DIE group were significantly older however similar in parity and time since surgery. There was no difference in the primary outcomes of voiding dysfunction or stool evacuation scores. In the secondary outcomes, there was a significant increase in the urinary stress score in the DIE group, but no difference in urinary urgency as seen in Table 2. The global scores for urinary and bowel symptoms demonstrated a significant improvement, 25 % vs 3 % (p<0.01) and 39 % vs 3 % (p<0.01), respectively, as seen in Figure 1. Table 1. Demographic characteristics

Age Mean +/- (SD) Years since surgery (IQR) Nulliparity

DIE (n051) 40.1 (7.5) 3.3–5.2#

Other Endo Sites (n033) 35.4 (7.0) 3.6–4.1

Test statistic (p value) t 82 02.87 (0.005)* 1.75**

55 %##

55 %###

X2 00.001 (0.97)

* Statistically significant **Wilcoxon Rank Sum Test #n0 49 ## n028 ### n023 Table 2. Comparison of outcomes Comparison

Voiding dysfunction score Stool evacuation score Urinary stress score Urinary urgency score Global Urinary Symptoms Global Bowel Symptoms

DIE group Median score (IQR*) 1.0 (3.0)

Control group median ( IQR*) 2.0 (4.0)

Wilcoxon Rank sum test: z score (p value) 1.05 (0.30)

3.0 (3.0) 1.0 (3.0) 1.0 (3.0) 2.0 (1.0)

4.0 0.0 0.0 2.0

0.56 2.01 0.54 2.37

2.0 (1.0)

2.0 (0.0)

(3.0) (2.0) (3.0) (0.0)

(0.57) (0.047)** (0.59) (0.018)**

3.06 (0.002)**

* Interquartile range **Statistically significant

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Conclusion: In our population, global subjective bowel and urinary function significantly improved in patients treated for DIE with standard excision techniques, without adversely affecting urinary or bladder voiding function. The im-

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provement most likely reflects effective treatment of endometriosis and subsequent reductions in pain-mediated symptoms, rather than change in bladder/bowel storage or voiding function.

Figure 1. Reported change in bowel and urinary symtoms since index surgery (<20worse, 20no change, >20improved). *Deep infiltrating endometriosis

References: (1) J Am Coll Surg 2005 December;201(6):913–7 (2) J Minim Invasive Gynecol 2008 March; 15(2):235– 40

S. Krishnan: None. Y. Li: None. B. De Vries: None. C. Benness: None. J.O. Daly: None. A. Korda: None.

63 EARLY HOME FEEDBACK PHYSIOTHERAPY COMPARED WITH PELVIC FLOOR EXERCISES SOON AFTER THIRD DEGREE PERINEAL TEAR: A RANDOMISED TRIAL C. O’herlihy UCD Sch. of Med. and Med. Sci., Dublin, Ireland. Objective: This study aims to compare postnatal continence scores and anal manometry in women receiving home biofeedback physiotherapy (BFP) within 3 months of sustaining an obstetric third degree tear (3DT) compared with women who received standard advice concerning pelvic floor physiotherapy (PFE) in the same interval following 3DT.

Background: Women who sustain 3DT are at an increased risk of developing subsequent faecal incontinence. Optimal treatment following immediate 3DT repair remains unknown, although pelvic floor exercises (PFE) have represented standard advice in given hitherto. Methods: Women were randomised following 3DT to postpartum home physiotherapy (n 030) or to conventional PFE’s (n090). Continence assessment was performed at 3 months postpartum in a dedicated Perineal Clinic. Results: Resting anal pressures (39+/−13 mmHg BFP versus 430/−17 mmHg PFE; P00.12) and anal squeeze pressures (64+/ −17mmhg BFP vs 620/−23 PFE; P00.68) were not signicantly different at 3 months postpartum between the home BFP and the traditional PFE groups. Continence symtpoms scores and quality of life assessments were also similar between the groups. Conclusions: Early BFP appears not to had an advantage following 3DT to standard BFP, although reduced patient compliance may have influenced results. Biofeedback physiotherapy should remain and first line early treatment option for women after 3DT, especially for those with ongoing or worsening continence symptoms. References (optional): C. O’Herlihy: Consultant; P Ronan O’Connell, Cliona Murphy, Myra Fitzpatrick, Leslie Daly. Employee (full or part time); Colin Peirce, Mary Cassidy.

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64 MECHANO-GROWTH FACTOR (MGF), A SMOOTH MUSCLE REGENERATION MECHANISM PRESENT IN HEALTHY AND PATHOLOGICAL HUMAN BLADDER TISSUE. E. Cortes1, E. C. Chin-Smith 2, J. Freeman 3, A. Chandra 4, C. Kelleher 5, R. M. Tribe 6 1 Div. of Women’s Hlth., Guy’s & St Thomas’ Hosp., London, United Kingdom, 2Div. of Women’s Hlth., King’s Coll. London and King’s Hlth. Partners, London, United Kingdom, 3Dept. of Histopathology, GSTS Pathology, London, United Kingdom, 4 Dept. of histopathology. Guy’s & St Thomas’ Hosp., London, United Kingdom, 5Div. of Women’s Hlth.. Guy’s & St Thomas’ Hosp., London, United Kingdom, 6Div. of Women’s Hlth., King’s Coll. London and King’s Hlth. Partners, London, United Kingdom. Objectives: The purpose of the present study conducted in the human bladder was to a) identify where MGF is expressed; b) assess whether MGF promotes smooth muscle cell proliferation; c) quantify IGF-1 splice variants expression in women with different bladder conditions. Introduction: Recent studies have demonstrated the expression of two insulin-like growth factor (IGF-1) splice variants, IGF-1Ec (known as MGF) and IGF-1Ea in the human bladder(1). Previous research in skeletal muscle indicated that following muscle distension, MGF promotes myogenesis by differentiation of muscle progenitor cells into myotubes. This process is completed at a later stage by IGF-1Ea which stimulates anabolic growth forming myofibers. Whether this newly identified repair mechanism plays a role in the healthy and pathological bladder remains to be ascertained. Methods: Patients were recruited from a urogynaecology clinic. Groups studied included: asymptomatic women for urinary conditions (controls) and patients with overactive bladder (OAB), urodynamic stress incontinence (USI) or recurrent urinary tract infections (RUTI). All participants underwent saline cystoscopy and bladder biopsies using cold cup biopsy forceps. Immunohistochemestry: In order to localise MGF protein expression in the human bladder, three control samples and two pathological samples (RUTI and refractory OAB on botulinum A injections) were used for immunolocalisation using a MGF polyclonal antibody, as previously described(2). Tissue incubation: Four control samples, two OAB samples, three USI and four RUTI samples were incubated at 37 °C for 24 h in phosphate buffered saline containing 0, 25 or 100 ng/ml human MGF. MGF effect on detrusor muscle proliferation was assessed using western blot for alphasmooth muscle actin (α-SMA) protein expression. Q-PCR: MGF and IGF-1Ea mRNA expression in tissues from controls and women with different bladder conditions, was quantified using qPCR. Data were collected from controls (n0

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9) and patients with USI (n014), OAB (n019), and RUTI (n0 10). Ten out of the 19 OAB patients were on anticholinergics. Data were expressed as mean (±SE) copy number normalized to GAPDH (most stable housekeeper out of a panel of three). Mann Whitney test was used for statistical analysis with values of p<0.05 considered statistically significant Results: Immunohistochemistry: MGF protein was detected in control samples in both urothelium and detrusor muscle (DM) when compared to a paired negative control. MGF protein expression in the detrusor muscle was limited/negative in comparison with the RUTI and refractory OAB samples. Tissue incubation: There was no significant difference in αSMA protein expression in tissues from the pathological groups compared with controls at baseline (p00.4177). Incubation with MGF gave inconsistent results with 2 out of 4 control samples, 1/2 OAB, and 1/3 SI samples demonstrating an increase in α- SMA expression. Interestingly, both pathological samples that responded to MGF were from women on antimuscarinic therapy. None of the RUTI samples demonstrated an increase in α-SMA expression. Q-PCR: MGF and IGF-1Ea expression was not significantly different between controls and three of the pathological groups studied (USI, RUTI and OAB not on antimuscarinic therapy). However, when compared with controls, OAB patients on antimuscarinic therapy showed significantly higher MGF concentrations (p00.03) (Table 1). Discussion: Previous studies have demonstrated an association between bladder distension and DM regeneration(3). This novel demonstration that MGF protein is localised in DM and in the urothelium could also reflect a neuroprotective role within the urothelium as mediator of mechanosensitive signals in the bladder. To our knowledge, this is also the first demonstration of cell proliferation properties of MGF in human bladder. Our preliminary findings lead to us to hypothesise that therapies aimed at increasing bladder volume capacity in patients with OAB such as bladder retraining or antimuscarinic therapy have the capacity to impact on this detrusor muscle regeneration mechanism. Table 1. MGF mRNA expression using q-PCR. *0copy numbers relative to GAPDH. Controls

OABOAB+Ach Ach 0.002246 0.012661

USI

RUTI

MGF* 0.003071 0.003553 0.002815 (mean± 0.00211357 0.000822 0.005772745 0.0005670 0.00155988 SE) P value 0.1081 0.033 0.2155 0.4512

References: 1. Int. Urogynecol. J. (2011) 22 (Suppl 1); S1–S195 2. Am J Obstet Gynecol. 2005; 193:64–70. 3. Am J Physiol Renal Physiol. 2002; 283:F1192–9.

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E. Cortes: Grant /Research Support; Rosetrees Trust Grant. E.C. Chin-Smith: Grant /Research Support; Rosetrees Trust Grant. J. Freeman: None. A. Chandra: None. C. Kelleher: Consultant; Pfizer, Astellas, J&J. R.M. Tribe: Grant /Research Support; Rosetrees Trust grant.

65 EXPERIMENTAL VAGINAL SURGERY IN SHEEP AND VARIABLES DETERMINING GRAFT RELATED COMPLICATIONS S. Manodoro 1, P. Uvin 1, M. Albersen 1, M. Endo 1, J. Vláčil 1, P. Meier 2, A. Engels 1, A. Feola 1, D. De Ridder 1, J. Deprest1 1 KULeuven, Dept of Dev. and Regeneration, Pelvic Floor Unit, Leuven, Belgium, 2Women’s Hlth.& Urology R&D, Ethicon GmbH, Norderstedt, Germany. Background: Vaginal insertion of implants leads to a higher number of Graft Related Complications (GRC) than abdominal insertion. Vaginal surgery in sheep has been described with 20*20 mm polypropylene(PP) mesh. Reproducibility has not been confirmed and small mesh size precludes biaxial measurements. Objective: We aimed to study the relationship of surgical variables with the occurrence of GRC in a sheep model for vaginal surgery. Materials and methods: 20 adult parous Texel sheep underwent mesh implantation under general anaesthesia, 1500 mg metronidazole prophylaxis in sterile conditions. Through a single incision the rectovaginal septum was dissected to accommodate a flat 50*50 (n010) or 35*35 mm (n010) mesh (Gynemesh M, Ethicon, PP (32 g/m²) and resorbable polyglecaprone) with its stiffest axis along the body axis. The mesh was fixed with 3/0 PP at its four corners and midway along mesh borders (Figure 1A). The incision was closed with a running 2/0 Vicryl (Ethicon). A 50*50 mm Gynemesh M was laid over a full thickness 40 mm longitudinal abdominal wall fascial incision that was primarily repaired with a running 1 polydioxanone (PDSII, Ethicon). Sheep were sacrificed at 60 (n010) and 90 days (n05; 5 ongoing), and the presence of GRC was noted. We determined contraction and biomechanical properties on explants (mesh and surrounding tissues). Contraction was defined as (surface mesh at implantation— surface at sacrifice)/surface at implantation X 100 (%). Biaxial tensiometry was done with a 500-N Zwicki tensiometer (Zwick, Ulm, Germany) with a 200-N load cell and a spherical 18 mm plunger (aperture: 20*20 mm, compression rings 30*30 mm) at a speed of 20 mm/min until disruption (Konerding, Med Eng Phys 2011). The travel (mm) and the corresponding force (Newton) were recorded, including their maximum at rupture. We defined two regions in the forcetravel diagram, corresponding to the comfort and stress zone in uniaxial measurements (Ozog, IUGJ 2011). Then we

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determined the Young’s modulus within these zones and the length of the comfort zone. Results: 20 ewes were used (mean weight: 68±3.5 kg). At necropsy, all 50*50 mm vaginal meshes showed remarkable contraction (−50 %), 80 % had folding, and in 3/10 animals there was exposure (figure 1B). Abdominal implants contracted less, with very limited folding (n01) neither showed exposure. Because the insertion and fixation of that large size mesh in sheep vagina may be partly responsible for the GRC, we implanted a second batch of 10 sheep with smaller 35*35 mm implants. Those explanted at 60d did have less folding neither became exposed; the unfolded meshes contracted by 7 %. The 90da animals are still not explanted, though no exposures have yet been observed. It is cautious to disregard biomechanical measurements in the presence of GRC (50*50 mm). In the 35*35 mm group, there was no difference in Young’s modulus, or length of the comfort zone between vaginal and abdominal implants. The disruption level was never reached at 200 N for any specimen. Gynemesh M dimensions Sacrifice at day: Abdominal explants Contraction (%) Exposure Folding (n) Modulus (comfort)

50*50 mm

50*50 mm

35*35 mm

60 (n05)

90 (n05)

60 (n05)

16 ±21,69 % * 0/5 (0 %) 0/5 (0 %) 0,47±0,41

11±13,44 % * 0/5 (0 %) 1/5 (20 %) + 0,49±0,15

1±6,47 % 0/5 (0 %) 0/5 (0 %) 0,74±0,18

Comfort zone length Modulus (stress) Vaginal explants Vaginal exposure Contraction

6,79±1,40 6,04±0,35 * 6,98±1,30 47,05±18,85 41,93±15,42 26,15±7,52 * 2/5 (40 %) 51±11,19 %

1/5 (20 %) 0/5 (0 %) 55±16,95 % 15±26,37 % **

Folding (n) Modulus (comfort) Comfort zone length Modulus (stress)

5/5 (100 %) 0,52±0,38 9,17±1,51 47,18±5,65

3/5 (60 %) 0,38±0,12 7,87±1,20 * 57,68±10,08

1/5 (20 %) 0,79±0,45 18,59±58,35 41,72±8,76 *

+ : over less than 10 % of the surface. * p<0,05 (compared to vaginal value) ** In the absence of GRC it is 7 %, which is comparable to that in abdominal meshes. Discussion: In sheep, vaginal mesh insertion leads increases the risk for GRC, mainly contraction but also exposure. Insertion of 50*50 mm vaginal 32 g/m² mesh lead to 100 % GRC (80 % folding; 30 % exposure). Reduction to 35*35 mm dramatically reduced this to 20 % folding and no exposures. Smaller yet 41 g/m² PP implants cause exposure in ~20 %, questioning if it is size or weight leading to GRC (de Tayrac, IUGJ, 2007). Biomechanical measurements on unfolded vaginal explants were no different

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from abdominal explants. It seems that vaginal complications are better studied in sheep. Figure 1. a Vaginal surgery in adult sheep, flat mesh being inserted. b Palpable contraction of the mesh after 60d, which becomes obvious by distortion of the orientation stripes on the mesh.

References: S. Manodoro: None. P. Uvin: None. M. Albersen: None. M. Endo: None. J. Vláčil: None. P. Meier: None. A. Engels: None. A. Feola: None. D. De ridder: Consultant; AMS, ASTELLAS. Grant /Research Support; ETHICON, DYNAMESH, BARD, AMS, ASTELLAS. J. Deprest: Consultant; ETHICON,. Grant /Research Support; ETHICON, BARD, DYNAMESH, AMS.

66 VAGINAL FIBROBLAST INFLAMMATION BY IN VITRO EXPOSURE TO POLYPROPYLENE TYPE I MESH: AN INERT MATERIAL? J. A. Pizarro-Berdichevsky1, S. Katto 2, A. Delpiano 2, M. L. Bravo 2, G. Galleguillos 1, R. Cuevas 1, M. Aramayo 1, B. Blümel 1, A. Pattillo 1, S. Barba 1, J. A. Ortiz 1, M. Cuello 2; 1 Complejo Asistencial Hosp. Dr. Sotero del Rio, Santiago, Chile, 2 Centro Investigaciones Medicas Facultad de Med. Pontificia Univ. Catolica de Chile, Santiago, Chile. Introduction: Prosthetic meshes are a good alternative, improving anatomical and functional outcomes of pelvic floor surgeries. Meshes must behave as an inert material, unable to induce an abnormal inflammatory response affecting healing process. Polypropylene type-I mesh is considered the best one and the unique synthetic mesh that must be used in pelvic floor repair. Concerns have arisen about safety, based on increased infection and extrusion rates. Few studies have been conducted to explore meshes effects in cellular healing process. Objective: To investigate mesh effects on stromal vaginal fibroblasts (VF), a cellular component participating in inflammatory response during vaginal healing. Material

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and Methods: Stromal VF were isolated from vaginal mucosa from postmenopausal patients undergoing surgery for stage III/IV pelvic organ prolapse. Tissue was minced and subjected to enzymatic digestion in a Hank’s solution with collagenase (2 mg/ml) and hiluronidase (1 mg/ml). VF obtained were culture in DMEM/F12 media with 10 % SBF. VF were exposed to 4×4 cm polypropylene mesh at 4, 8, 16 and 24 h., with corresponding controls. After incubation, VF were harvested to measured mRNA levels of markers involved in inflammation cascade (IL-6, Prostaglandin E syntethase (PGES), scavenger receptor CD36) by RT-PCR with GAPDH like a housekeeping and COX-2 mRNA levels by real time PCR with HPRT1 as a housekeeping. The results were standardized under respective housekeeping and expressed as a ratio between mesh exposure VF and their control. Results: Upon mesh exposure there was increase in mRNA levels of IL-6 in VF at 4 and 8 h followed by a decrease level at 16 and 24 h. No significant change or expression pattern was identified in CD36 mRNA levels. Changes in mRNA levels of PGES were only observed upon long mesh exposure (a 2.6 fold increase was observed at 24 h, as shown in Figure 1). There was an exponential increase in mRNA levels of COX 2 in meshexposed VF compared to controls, reaching a maximum of 26.9 fold at 24 h (as shown in Figure 2). Calculated ratios for all the genes studied are summarized in table 1. Conclusions: Our preliminary results show that the exposure to a polypropylene type I mesh induces mRNA expression of genes involved in inflammatory cascade in VF isolated from vaginal stroma. These results support the fact that the polypropylene mesh would not be an inert material, at least, for this cellular component participating in healing process. In this in vitro model, the mesh seems to induce a progressive inflammatory response of VF over time. Taken in account these findings, new strategies should be explored to reduce the inflammatory response induced by these socalled ‘inert meshes’. (This work was supported by Fondecyt grant nº 1080163). Table 1 Gen

Method

4 Hrs

8Hrs 16 Hrs

24 Hrs

IL6 CD 36 PGES COX 2

RT-PCR RT-PCR RT-PCR Real Time PCR

1,16 1,35 1,13 1,12

1,42 0,88 0,73 2,28

0,96 2,21 0,87 5,21

0,52 0,16 2,60 26,92

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Values are ratios between Mesh Exposure and unexposed arbitrary measures

J.A. Pizarro-Berdichevsky: None. S. Katto: None. A. DelPiano: None. M.L. Bravo: None. G. Galleguillos: None. R. Cuevas: None. M. Aramayo: None. B. Blümel: None. A. Pattillo: None. S. Barba: None. J.A. Ortiz: None. M. Cuello: None.

67 MUSCLE FIBER DIRECTION OF THE LEVATOR ANI AND EXTERNAL ANAL SPHINCTER MUSCLE IN MRI C. Betschart1, K. Jinyong 2, J. A. Ashton-Miller 2, J. O. Delancey 1 1 Gynecology, Univ. Hosp. Michigan, Ann Arbor, MI, 2 Mechanical Engineering, Univ. of Michigan, Ann Arbor, MI. Objective: The aim of this study was to map fiber direction and quantify the orientation of the different parts of the LA and external anal sphincter (EAS) in living women, including visualization of the findings in the 3-dimensional space. Background: Understanding the mechanical function of muscle requires knowledge of the muscle fiber orientation. Within the levator ani muscle (LA), many fiber

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directions have been described both by anatomical dissection and imaging (1,2), although without angle measurements as yet. The aim of this study was to map fiber direction and quantify the orientation of the different parts of the LA and external anal sphincter (EAS) in living women, including visualization of the findings in the 3-dimensional space. Methods: Fiber-tracing by insertion-origins pairs of LA fibrils in resting 3T-MRI on the sagittal slides was performed in 6 healthy women with normal muscles and no pelvic organ prolapse (POP) (Fig 1). Muscles fibers were traced in the three parts of the pubovisceral muscle (PVM), namely the pubovaginalis (PVaM), puboperinealis (PPM), and puboanalis (PAM), as well as the puborectalis (PRM), iliococcygeus (ICM) and external anal sphincter muscle (EAS). The angle of the LA fiber tracings relative to the sacrococcygeal-inferior pubic point (SCIPP) line was then measured using Matlab software (Ver. R2012a, MathWorks) as shown in Fig. 1b. For visualization purposes, the sagittal MR images and fiber tracings were also imported to Rhinoceros software (Ver. 4, Robert McNeel & Associates) to create a 3-D LA surface model with fiber mapping. Mean±standard error (SE) angle values were calculated, and ANOVA and post-hoc two-sided t-tests were used to make pair-wise comparisons between the muscle groups using using SPSS (Ver. 19, IBM Corp.). Results: Demographical and clinical data of the women were: age 41 ±14 years, BMI 25.8± 4.0 kg/m2, parity 2 ± 1.3, vaginal deliveries 1.7 ± 0.8, Caucasian with no hysterectomies. For each muscle the number of fibers counted ranged as follows: PVM: 44 to 72, PRM: 13 to 35, ICM: 29 to 68, and EAS: 7 to 30. The muscle fiber angle of the PVM, ICM, PRM and EAS were normally distributed. The PVM was inclined a mean± SE angle of 71.7±3.8 ° [PVaM: 65.0±4.1 °, PPM: 77.0±2.4 °, PAM: 77.9±3.0 °], the PRM was 23.8±6.5 °, the ICM was 60.8± 3.1 °, and the EAS was 10.9±3.5 ° relative to SCIPP line of each patient (Fig. 2). The fiber directions for the PVM, PRM, ICM and EAS muscles were statistically different (p<0.005, ANOVA). Only the PVM and the ICM had similar fiber directions (p00.599). Discussion: In living women without prolapse the difference in fiber angles between the PVM and the PRM is almost 50°, and between the PVM and EAS is 60°. Even with this modest sample size, these significantly different lines-of-action suggest different muscle functions. References: 1) Am J Obstet Gynecol 2008;199:686.e1–686.e6 2) Eur Radiol 2011;21:1243–49

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Fig. 1. Sample LA and EAS model with muscle fiber orientations: a Regular parasagittal MR image through; b muscle fibers were traced using different colors (blue0PVaM, violet0PPM, orange0PAM, green0PRM, yellow0ICM, turquois0coccygeus muscle). Note that angular representation of the fibers is with respect to SCIPP line (dash-dot line); c 3-D LA and EAS surfaces were created by patching traced lines; d Muscle fibers were projected onto 3-D LA and EAS surfaces.

C. Betschart: Grant /Research Support; NIH Grant, Swiss Research Foundation Grant. K. Jinyong: Grant / Research Support; NIH-Grant. J.A. Ashton-Miller: Grant /Research Support; NIH-Grant, Group research support from AMS, Kimberly-Clark, Proctor&Gamble. J.O. DeLancey: Grant /Research Support; NIH-Grant, Group research support from AMS, Johnson&Johnson, Kimberly-Clark, Proctor&Gamble.

Fig. 2. Average muscle fiber angles (with standard error bars) for the six women. **denotes significant difference between muscle groups (p<0.005, ANOVA).

68 ON THE ANATOMY OF THE SITE OF VAGINAL BIRTH-RELATED INJURY TO THE LEVATOR ANI J. Kim1, R. Ramanah 2, C. Betschart 1, J. A. Ashton-Miller 1 , J. O. Delancey 1 1 Univ. of Michigan, Ann Arbor, MI, 2Besançon Univ. Med. Ctr., Besançon, France.

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Objective: To establish the gross and microscopic anatomy of the normal structure of the pubic origin of the levator ani (LA) that is injured at birth. Background: The LA injury associated with vaginal birth seen in MRI [1] occurs in a characteristic site of injury on the inner surface of the pubic bone (PB) at the attachment point of the pubovisceral muscle (PVM). Details of the macroscopic and microscopic nature of the muscle’s attachment to the pubis that fails has not previously been described [2]. Methods: Ten female pelvises (ages 30 to 98 years) were dissected, with eight being used for histological analysis. The combination of targeted feature sampling and sequential sampling, where each specimen was cut sequentially in approximately 5 mm thick slices apart yet keeping the area of known LA injury, was applied in the ventral LA attachment sites, which runs from the arcus tendineus fascia pelvis origin to the arcus tendineus levator ani (ATLA) origin (Fig. 1a). Histological sections were stained with Masson’s trichrome. Results: The origin of the LA is transparent and thin as it attaches tangentially to the pubic periosteum (Fig. 1b & c), with its morphology changing from medial to lateral regions (Fig. 2). Medially, fibers of the thick muscle belly coalesce towards several narrow aponeurotic attachments and extend within 1 mm of the pubic periosteum. In the intermediate portion the aponeurosis is wider (~3 mm), creating a larger separation between the muscle fascicles and bone. Laterally, the angle of the LA fibers abruptly changes at the ATLA origin where the PVM to the iliococcygeous muscle (ICM) transition occurs. Finally, the ATLA, whose thickness is less than 1 mm, forms the lateral most margin of the LA attachment to the pelvic sidewall. Conclusions: 1) At its medial margin, the muscle originates by multiple slips from the pubic periosteum. 2) The PVM has an aponeurotic origin from the pubic periosteum, whose width increases from medial to lateral. 3) Laterally, at the

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transition to the ICM, origin shifts from the pubic periosteum to the ATLA.

Fig. 1. (a) Superior view of a pelvis for after removal of bladder, upper vagina and rectum indicating area for histological sampling. (b, c) Medial (b) and lateral (c) view of LA attachment. Note how thin the semitransparent aponeurosis (arrow) is (i.e. (b) clamp and (c)tip of thumb visible) as it attaches to the superior pubic ramus. (ATFP, arcus tendineus fascia pelvis; ATLA, arcus tendineus levator ani; LA, levator ani muscle; PS, pubic symphysis; SPR, superior pubic ramus; U, urethra; V, vagina; R: rectum)

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Fig. 2. Images from two specimens (a, b) showing LA pubic origin, from medial (1) to lateral (3). (1) The medial LA fibers originate from multiple slips attaching to the pubis. (2) Intermediate portion originates from the SPR in a single aponeurotic attachment (arrow). References: [1] Obstet Gynecol (2006) 107:1064–9 [2] Ann R Coll Surg Engl (1974) 54:244–52

J. Kim: None. R. Ramanah: None. C. Betschart: Grant / Research Support; Swiss National Research Foundation. J.A. Ashton-Miller: Grant /Research Support; American Medical Systems Inc, Johnson & Johnson, KimberlyClark Corp, Procter & Gamble Co. J.O. DeLancey: Grant /Research Support; American Medical Systems Inc, Johnson & Johnson, Kimberly-Clark Corp, Procter & Gamble Co.

69 A STRENGTH COMPARISON OF IMMEDIATE AND DELAYED EXTRACTION FORCES OF FIVE DIFFERENT SINGLE-INCISION SLINGS ANCHOR TYPES: AN ANIMAL MODEL E. Kocjancic1, A. Sedlar 2 1 Univ. of Illinois at Chicago, Chicago, IL, 2Univ. Med. Ctr. Ljubljana, Ljubljana, Slovenia. Objective: In this study we compare the physical characteristics and force required to insert anchors from five different anchor-based single-incision slings, as well as the force needed to extract anchors immediately after implantation

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and 30 days post-implantation in a rabbit rectus femoris model. Background: Synthetic mid-urethral slings became the new “gold standard” for surgical therapy of female stress urinary incontinence. Single-incision slings, also named minislings, are the most recent evolution of mid-urethral sling. Single-incision sling is comprised of a polypropylene mesh, with the ends of the mesh being secured to the tissue with one of these methods: – – –

“Velcro-style” secure tip (TVT Secur™), Needleless™ fascial pocket, Anchor.

Anchors secure the ends of sling into the obturator internus muscles. Anchors and their performance is critical in the immediate postoperative phase prior to the beginning of the maturation phase of wound healing and fibrosis securing the mesh in place. Methods: The following slings were used: 1. 2. 3. 4. 5.

AMS Miniarc® Boston Scientific Solyx™ Promedon Ophira™ Bard Ajust™ Coloplast Altis®

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Results:

Table 1. Anchor characteristics.

Anchor Anchor Anchor Anchor Anchor

Width at barbs opposing extraction (mm) 4.9 4.55 3.85 9.76 6.47

Table 2. Percentage difference in force between insertion to extraction. Anchor Anchor Anchor Anchor Anchor

1 2 3 4 5

Immediate −13 % −62 % −73 % +44 % +200 %

30-day +16 % −61 % +21 % +>311 % +>445 %

Conclusions: Insertion forces of all anchors are similar –

Mean insertion forces range from 7.3 to 13.2 N (not statistically different when compared by paired t-tests)

Immediate extraction forces vary between anchors –

Measurements of each anchor were recorded. One anchor of each type was implanted into the rectus femoris muscle of a 6-month old New Zealand white rabbit. After 30 days, anchors were extracted by applying steadily increasing force to the mesh perpendicular to the muscle. Anchors were also implanted with immediate extraction for comparison. Paired t-tests was used to compare insertion forces of all anchors.

1 2 3 4 5

Length of anchor (mm) 7.25 9.2 26.5 5.5 4.4

–

Anchors 2 and 3 have the lowest mean immediate extraction forces Anchors 4 and 5 have the highest mean immediate extraction forces

Delayed extraction forces vary between anchors – –

Anchor 2 has the lowest 30-day extraction force Anchors 4 and 5 have the highest 30-day extraction forces

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Figure 1. Anchor insertion and extraction forces. (#—anchor unable to be extracted at 40 N, the force at which the mesh failed)

#

40.0

#

Force (N)

35.0 30.0 25.0 20.0 15.0 10.0 5.0 0.0 Anchor 1 Anchor 2 Anchor 3 Insertion Force Immediate Extraction Force

Variation in insertion and extraction forces can be attributed to differences in anchor characteristics The shape, orientation, number and size of the barbs: considerable differences in the design of each studied anchor may contribute to the differences in insertion and extraction forces Anchors 4 and 5 have the highest surface area to counteract extraction, hence having the highest extraction forces Anchor extraction forces much higher than physiologic forces experienced by sling – – –

[1] showed that in vivo tension exerted on proximal urethral slings during cough ranges from 0.42 and 0.48 N These forces are much lower than any of the immediate extraction forces found in this study (3.5 to 22 N) We can infer that it would be extremely difficult to dislodge a properly placed anchor with physiological cough or Valsalva

References (optional): 1. J Urol 2005; 173: 894–897. E. Kocjancic: Consultant; BARD, Coloplas, AMS. A. Sedlar: None.

70 MUSCLE-DERIVED STEM CELLS THERAPY FOR INJURED URETHRA OF FEMALE RATS M. Z. Ipólito, M. A. Bortolini, R. C. Souza, I. D. Silva, M. G. Sartori, M. J. Girão, R. A. Castro Federal Univ. of São Paulo, São Paulo, Brazil. Objective: We aimed to assess the effect of injections of muscle-derived stem cells (MDSCs) on the urethra of female rats after prolonged vaginal trauma.

Anchor 4 30-day Extraction Force

Anchor 5

Background: Stress urinary incontinence (SUI) is the complaint of involuntary leakage on effort or exertion, or on sneezing or coughing. Pelvic floor trauma followed by vaginal delivery is the main risk factor for SUI development by causing urethral damage. Thus we hypothesize that (1) vaginal distension (VD) changes the histological composition and organization of the urethra; and (2) heterologous MDSCs therapy may act to recover the injuries and restore the urethral structure of female rats after VD. Methods: In these experiments, we analyzed the urethras of three groups of Wistar female rats: control, vaginal distention (VD) and VD receiving stem cell therapy. The balloon was inserted intravaginally in the groups of rats and inflated with 3 ml of water for 12 h intermittently. In vitro cultures were used for MDSCs characterization and proliferation from healthy female rats expressing green fluorescent protein (GFP) before the treatment. GFP cells were checked for authenticity and presented positive staining for mesenchymal stem cells markers CD73, CD90, CD105, while negative staining for the CD34, CD45 and CD31. MDSCs differentiated into adipocytes, chondroblasts and osteoblasts. After 72 h of injury, we injected stem cells into the tail vein of the traumatized rats. GFP cells localization as well as urethral tissue morphologies were checked at days 7, 14, 21 and 28 after injection using immunofluorescence. Results: VD rats had their smooth and striated muscle layers disorganized and thinner than the control rats, confirming our animal model of pelvic trauma that originated a persistent urethral injury in a long term. We have noted the early presence of MDSCs in the urethral muscular layers of the rats after 7 days of therapy. The cells showed GFP staining up to 28 days of follow-up, with phenotypes compatible with smooth and striated muscle fibers. Differently from what seen in VD rats, VD rats treated with stem cells

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presented partial structural muscle layers reorganization, similar to what found in control animals. However, urethral lumen of the treated animals was found to be wider than the ones in the control group. Conclusion: We have developed an animal model of urethral injury throughout VD that persists to 28 days. Alterations in the components and structure of the damaged urethra after cellular therapy suggest that stem cells are a potential source for muscle tissue repair and regeneration. These findings may encourage additional studies addressing the potential role of stem cell therapy in SUI. M.Z. Ipólito: Grant /Research Support; Coordenação de Aperfeiçoamento de Pessoal de Nível Superior—CAPES. M.A. Bortolini: None. R.C. Souza: None. I.D. Silva: None. M.G. Sartori: None. M.J. Girão: None. R.A. Castro: Grant /Research Support; National Counsel of Technological and Scientific Development—CNPq.

71 NOVEL FLUORESCENT STAINING METHODS FOR DETECTION OF ADHERENT AND INTRACELLULAR BACTERIA IN UROTHELIAL CELLS FROM PATIENTS WITH REFRACTORY URGENCY Y. Cheng1, K. J. Mansfield 2, M. A. Schembri 3, K. H. Moore 1; 1 St George Hosp., Kogarah, Australia, 2Univ. of Wollongong, Wollongong, Australia, 3Univ. of Queensland, Brisbane, Australia. 1. Objective: The aim was to investigate whether testing urothelial cells isolated from bladder fluid using a variety of staining procedures may reveal evidence of bacterial colonisation that is not detected on routine microbiological testing. 2. Background: Escherichia coli (E. coli) is the organism responsible for about 80 % of all community-acquired urinary tract infections (UTI). However, routine microbiology testing methods such as culturing of urine samples on horse blood agar plates may not be sensitive enough to detect cases of clinically important bacteriuria, which might contribute to lower urinary tract dysfunction, such as refractory detrusor overactivity [1]. 3. Methods: Urothelial cells were isolated from urine or urodynamic fluid from 14 women who presented with symptoms of urgency, i.e they had either refractory detrusor overactivity, longstanding small capacity bladder (previously called sensory urgency, now painful bladder syndrome) or recurrent UTI with urgency. Urothelial cells were concentrated and fixed, then cytocentrifuged onto slides. Urine samples were also sent for routine microbiology testing. Bacterial cultures at ≥104 CFU/ml was considered as positive for UTI according to current accepted methodologies. UTI was also

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detected following examination of isolated urothelial cells using: 1) immunofluorescence microscopy employing Escherichia coli antibodies; 2) light microscopy in combination with Wright-Giemsa staining; and 3) immunofluorescence microscopy in combination with DAPI, a fluorescent stain that can permeate intact cell membranes and label bacterial and eukaryotic DNA. 4. Results: To date six of the 14 patients had positive growth by traditional microbiology culture methods (Table 1). In two of these patients E. coli was isolated by bacterial culture. This was confirmed by immunofluorescence microscopy employing E. coli antibodies (Table 1). In all six patients positive by traditional culture methods bacterial DNA was visible following DAPI staining (Table 1). Wright-Giemsa staining of urothelial cells also demonstrated the presence of bacteria in samples from all patients who were positive by traditional methods (Table 1). In the 8 patients who were negative for UTI by traditional microbiology culture methods, four samples were positive for bacteria using immunofluorescence microscopy employing E. coli antibodies (Table 1) and five samples were positive for bacteria following Giemsa-Wright staining and DAPI staining (Table 1). Table 1. Comparison of four different UTI detection protocols Traditional Microbiology culture 6+ve

8 -ve

Bacteria cultured

Staining technique

IF (antiE.coli) 2 x E. coli 2 of 2 +ve 1 x Enterococcus 1 of 1 ve 3 x Mixed perineal 3 of 3 and bowel flora +ve 4 of 8 +ve

DAPI Light microscopy 2 of 2 2 of 2+ve +ve 1 of 1 1 of 1+ve +ve 3 of 3 3 of 3+ve +ve 5 of 8 5 of 8+ve +ve

5. Conclusions:Our results indicate the combination of immunofluorescence microscopy employing specific antibodies, Wright-Giemsa staining and DAPI staining of bacterial DNA in urothelial cells should be considered for the detection of adherent and intracellular bacteria where routine microbiology culture tests are negative. Bacteria were detected in 10 out of 14 patients suffering from refractory urgency, including four patients with negative microbiology culture results. Patient recruitment is ongoing. This new approach to examine urothelial cells for evidence of bacterial colonisation will likely shed further light upon the concept that a subset of patients with refractory detrusor overactivity may have heretofore unrecognised chronic bacterial colonisation associated with the presence of intracellular bacterial communities [2].

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6. References: 1. Neurourol Urodyn (2011) 30:32–37 2. PLoS Med. (2007) 4(12):e329 Y. Cheng: None. K.J. Mansfield: None. M.A. Schembri: None. K.H. Moore: None.

72 EXPERIMENTAL MRI-CONTRAST IMAGING BY LOADING Fe3O4 NANO-PARTICLES IN CONSTITUTING POLYMERS - IN VIVO EVALUATION OF IMPLANT CONTRACTION IN A RABBIT ABDOMINAL WALL RECONSTRUCTION MODEL S. Manodoro 1, F. Claus 2, A. Engels 3, M. Endo 1, J. Vláčil 1, D. De Ridder 1, J. Deprest1 1 KULeuven, Dept. of Dev. and Regeneration, Pelvic Floor Unit, Leuven, Belgium, 2Univ. Hosp. Leuven, Dept. of Radiology, Leuven, Belgium, 3KULeuven, Ctr. for Surgical Technologies, Leuven, Belgium. Background: Alloplastic materials may cause graft related complications (GRC), including contraction, dyspareunia and pain. In vivo imaging of mesh repairs may be helpful in understanding and managing recurrence GRC. Depth and tissue contrast resolution are limiting ultrasound. Polivinylidenefluoride (PVDF) sutures or meshes have improved biomechanical features, and incorporation of Fe3O4 microparticles allows “visualization” on specific MRI sequences. Objective: To determine feasibility of in vivo measurement of implant contracture following primary overlay repair of a full thickness abdominal wall defect in rabbits. Matherials and Methods: Six New Zealand female rabbits (mean weight: 3,3 kg) were randomly divided into two groups of three. Under general anaesthesia, two fullthickness 25*30 mm midline defects were created in the upper respectively lower part of the anterior abdominal wall. They were primarily overlaid by 35*40 mm implants, one with a PVDF- mesh (Dynamesh, FEG Textiltechnik, Aachen, Germany; total n06), and one with polypropylene (PP)-mesh (lightweight Gynemesh M; 32 gr/m², Ethicon (n03) or Marlex (90 gr/m², Bard, n03)). To fix meshes purpose manufactured 3/0 PVDF sutures were used, at the corners and subsequently at the borders (inter-run distance: 5 mm). Constituting PVDF fibers contained 1 mg/g Fe3O microparticles. Animals were longitudinally followed up and underwent MRI imaging at 2, 30 and 90 days, and then sacrificed. Primary outcome measure was the change in dimensions as measured by MRI. Anatomic high resolution T2 images were taken under sedation in the prone position in a 3 T MRI device (Siemens, Erlangen, Germany) with spinal coil (slice thickness: 1 mm, inter-slice distance: 0 mm, resolution TE 102 ms, TR 3890 ms, field of view 100 mm, bandwidth 256 Hz/pixel) for measuring implant

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dimensions and geometrical changes using OsiriX-DICOM 32-bit viewer software (Figure 1). At necropsy implant dimensions were noted again. First, we correlated actual implant dimensions at insertion with that in vivo at d2, and explantation versus d90. Second we plotted the course of the surface by MRI during the entire experiment (d2, 30, 90). Results are reported as means and standard deviations and normal distribution was tested. Linear correlation and Mann-Whitney U test was performed. Results: PVDF meshes and sutures could be adequately “visualized” using MRI (figure 1). Dimensions measured prior to implantation and at 2 days (mean -3,67±5,77 %) were marginally different, and actual measurements at explantation and on MRI at 90 days also correlated well (R00,1022). Therefore we used MRI as a tool for non-invasive longitudinal measurement of flat mesh contraction (table). There was a trend for contraction of implants over the 90 days period (figure 2), when using actual measurements and that was significant for PVDF. There were discrepancies in actual and MRI measurements in Gynemesh M. Conclusion: We demonstrated that using PVDF filaments with Fe3O4 microparticles allows “visualization” of the mesh in vivo. We used this feature to measure longitudinal dimensional changes of implants. Progressive but not significant contraction was observed on MRI in all implants,

Fig. 1 MRI image of the anterior abdominal wall, below the PVDF mesh and at the top PVDF sutures marking the mesh contour.

Fig. 2 Plot of MRI measured mesh dimensions over the observation period.

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Mesh area (mm2) PVDF (n06) Gynemesh M (n03) Bard Mesh (n03)

Implant 1400±0,00 * 1400±0,00 1400±0,00

MRI 2 d 1375±106,19 (−1,8 %) + 1378±72,25 (−1,6 %) 1346±24,76 (−3,9 %)

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MRI 30 d 1082±156,0 (−22,7 %) 1438±32,01 (+2,7 %) 1258±85,26 (−10,1 %)

MRI 90 d 1246±122,51 (−11,0 %) 1193±200,36 (−14,8 %) 1227±35,72 (−12,4 %)

Explant 1095±172,00 (−21,8 %) 1100±111,36 (−21,4 %) 1282±136,31 (−8,4 %)

*p<0,05 comparison of actual measurements of implant & explant - + p<0,05 comparison MRI at 2 and 90 d

which was significant ex vivo for PVDF meshes. Additional experiments will have to determine whether indirect determination of the mesh contours by suturing is providing enough geometrical insight and accuracy. Overall incorporating of Fe 3 O 4 is an elegant method for visualizing implants, which allows non-invasive assessment of the implant. The inflammatory changes induced by PVDF loaded polymers are now being determined. S. Manodoro: None. F. Claus: None. A. Engels: None. M. Endo: None. J. Vláčil: None. D. De Ridder: Consultant; AMS, ASTELLAS. Grant /Research Support; ETHICON, BARD, DYNAMESH, AMS, ASTELLAS. J. Deprest: Consultant; ETHICON. Grant /Research Support; ETHICON, BARD, DYNAMESH, AMS.

73 IDENTIFYING URINARY INCONTINENCE: PRIMARY CARE PHYSICIANS, A MULTI-SPECIALITY INTEGRATED HEALTH CARE SYSTEM, AND AN ENTERPRISE DATA WAREHOUSE K. E. Jirschele1, R. Ross 2, A. Gafni-Kane 1, J. Letko 2, J. Lakeman 1, P. K. Sand 2, S. M. Botros 2; 1 Univ. of Chicago/NorthShore Univ., Evanston, IL, 2 Univeristy of Chicago/NorthShore Univ., Evanston, IL. Objective: The purpose of our study is to determine the frequency with which primary care physicians (PCPs) identify urinary incontinence (UI) and associated urinary complaints in an integrated multi-specialty health care system using objective data from our institution’s enterprise data warehouse (EDW). Background: The prevalence of urinary UI among women in the U.S. approaches 30 %; however, fewer than 50 % of these women seek help for their symptoms (1). Research of help seeking behaviors focuses primarily on barriers to care from patient perspectives. Few studies address physician barriers to screening for UI; and, to our knowledge, none have done so in an objective manner. Our institution is ideal for this data collection because of the following system characteristics. All PCP’s queried are members of the medical group, their patients are part of our integrated multispecialty health care system, and the information relating to those patients is included in our electronic medical record (EMR) and captured for inclusion within our

EDW. Our institution’s EDW is a vast information repository which includes extensive administrative, clinical, and pharmacy data and captures some 12,000 unique encounters daily. In addition, the institution has well-established female pelvic medicine and reconstructive surgery (FPMRS) and urology practices, and a strong focus on creating a closed referral system. Patients within our system already have access to physicians and medical care, removing these as potential patient barriers to care. Methods: Queries of PCP encounters for UI and associated urinary complaints using ICD-9 codes were made from the EDW from 1/1/2006 to 12/31/2011. PCPs were defined as physicians in family medicine, internal medicine, and Ob/Gyn (excluding FPMRS). Unique PCP encounters for urinary complaints were tallied and frequencies were calculated from patient totals. Subsequent referrals made to general Ob/Gyn, FPMRS, and urology were identified and tallied. Descriptive statistics were used to evaluate the referral and physician characteristics. Results: 190 PCPs saw 145,592 unique female patients ages 18–99 for an office encounter. A unique ICD-9 code for urinary complaints was entered in the EMR for 13,414 patients (9.2 %). Any patient with multiple ICD-9 codes or multiple visits for the same ICD-9 code was tallied once. Of the patients identified with urinary complaints, 2,009 (15.0 %) were referred for further management: 72 % to FPMRS, 19 % to urology, 9 % to Ob/Gyn. 86 % (164) of PCPs identified urinary complaints and 71 % (135) made a referral. More than 50 % of the 13,414 patients with urinary complaints were identified by 18 % (35) of the PCPs. The greatest percentage of total referrals were made by internal medicine (55 %), followed by family medicine (29 %) and Ob/Gyn (16 %) physicians. Conclusions: Our results indicate a suboptimal identification rate of UI and urinary complaints within our institution despite access to care for existing patients, a closed medical group that encourages internal referrals, and an established FPMRS group. Our data also suggests that a relatively small number of physicians are identifying urinary complaints and making the majority of the referrals, which is an interesting consideration for future understanding of physician barriers to identification and referral. Identifying these physician barriers and educating PCPs about screening for UI and urinary complaints could

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improve the rate of identifying the condition. Future work involves further elucidation of physician barriers and consideration of streamlined institution guidelines for UI screening. References (optional): 1. J Womens Health 2003;12:687–97 K.E. Jirschele: None. R. Ross: None. A. Gafni-Kane: None. J. Letko: None. J. Lakeman: None. P.K. Sand: None. S.M. Botros: None.

74 IMPACT OF ROBOTIC OPERATIVE EFFICIENCY ON PROFITABILITY E. J. Geller 1, J. M. Bowling 2, C. A. Matthews1 1 UNC-Chapel Hill Urogynecology, Chapel Hill, NC, 2 UNC-Chapel Hill Gillings Sch. of Intl. Publ. Hlth., Chapel Hill, NC. Objective: To determine the effect of robotic operative efficiency on profitability. Secondary aims include comparison of surgical subspecialties and assessing the impact of payer mix on profitability. Background: The introduction of the robotic surgery has provided another minimally-invasive resource for surgeons to perform a variety of procedures. Surgical efficiency is important in robotic-assisted procedures, as it can play a vital role in reduction of operative cost. Both laparoscopic and robotic sacrocolpopexy are significantly more expensive than the abdominal route, based on an analysis of direct operating room costs.1 A cost-minimization analysis of sacrocolpopexy comparing robotic-assisted, laparoscopic, and

Correlations for profitability Total Operating Income FY 10 Total Operating Income FY 11

Total Surgical Volume 1.0 0.8

open routes found that the two minimally-invasive approaches would be cost equivalent when robotic time was reduced to 149 min.2 Mean published surgical times for robotic sacrocolpopexy, all of which include concomitant urogynecologic procedures, range from 186 to 328 min.3,4 Methods: This is a retrospective analysis of 1,295 robotic surgical cases performed at one academic medical center. A de-identified database was used to assess financial data for women and men undergoing robotic surgery. All associated costs, charges, assigned overhead, and total reimbursements were collected for all robotic cases performed for fiscal years 2010 (FY10) and 2011 (FY11). Participating subspecialties included Urogynecology, Gynecologic Oncology, Advanced Gynecologic Laparoscopy, General Gynecology, Urology, Gastrointestinal Surgery, Otolaryngology, Surgical Oncology, and Pediatric Surgery. Total number of cases (case volume), direct variable contribution margin, operating income, case performance times, and insurance payer mix were evaluated. Profitability was defined as a positive operating income. Analyses were performed for in-patient, out-patient, and total charges. Results: From July 2009 through June 2011, 1,295 robotic cases were performed by all surgical subspecialties, with an increase in surgical volume from FY 10 to FY 11. (Figure 1) Over both fiscal years, robotic surgery was profitable, with a total operating income of $386,735 in FY10 and $843,407 in FY 11. For FY 10, Urogynecology and Pediatric Surgery were the only unprofitable subspecialties; and in FY 11 they became profitable. This transition to profitability was associated with

Total Case Time 0.8 1.0

BCBS 1.0 0.9

Managed Care 0.8 0.9

Medicaid 1.0 0.7

Medicare 1.0 0.8

Self Pay 0.8 1.0

SHP 1.0 0.4

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an improvement in average case performance times, with Urogynecology (specifically robotic sacrocolpopexy and concurrent procedures) decreasing from 220 to 179 min (p00.012) and Pediatric Surgery decreasing from 418 to 258 min (p0 0.019) Profitability was highly correlated with total surgical volume, case performance time, and payer mix. (Table 1) Conclusions: Robotic operative efficiency and surgical volume have a large impact on overall profitability regardless of surgical specialty. These results highlight the need for robotic training programs designed to improve surgical performance times in order to create and maintain a profitable robotic surgical program. References (optional): 1. Int Urogynecol J Pelvic Floor Dysfunct 2009;20:223–8. 2. J Minim Invasive Gynecol 2010;17:493–9. 3. Urol Int 2011;86:414–8. 4. Obstet Gynecol 2008;112:1201–6. E.J. Geller: Consultant; Intuitive Surgical, Inc.. J.M. Bowling: None. C.A. Matthews: Consultant; Intuitive Surgical, Inc.. 75 CLINCAL RELEVANCE OF OSTEOPOROSIS IN WOMEN W I T H S E V E R E P E LV I C O R G A N PROLAPSE , THE SECOND REPORT H. Abe1, R. Kimura 1, W. Doi 1, Y. Fukaya 1, S. Takenaka 1, T. Inamoto 2, H. Azuma 2, M. Takeyama 3 1 Shizuoka saiseikai general Hosp., Shizuoka, Japan, 2Osaka Med. Coll., Osaka, Japan, 3Senboku Fujii Hosp., Osaka, Japan. Objective: Incidence of pelvic organ prolapse (POP) and osteoporosis are both increased in elderly women after menopause. We evaluated whether there is an association between POP and osteoporosis. Furthermore, among those patients, we examined risk factors of osteoporosis. Patients and methods: The patients consisted of 281 females. They underwent Tension-free vaginal mesh (TVM) operations, who were at POP-Q (quantification) stage3 or over between 2008 and 2012 in our hospital. (Table 1) Bone mineral density (BMD), which is available from indirect estimates using X-ray absorptiometry, was used to evaluate osterporosis. For this purpose, we used dual-energy X-ray absorptiometry (DXA) measurements of lumbar spine and femoral trochanter. BMD was converted into young adult mean (YAM)—an established score for Japanese elderly with osteoporosis. We defined less than 70 % of YAM as osteoporosis, 70 % through 80 % or less as osteopenia, others as normal in

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accordance with guideline of the Japanese Society for Bone and Mineral Research (JSBMR). (Fig.1) We evaluated association between independent variables of interest, ie, aging and YAM, duration of illness and YAM, BMI and YAM, parity and YAM and POP stage and YAM. They were explored by univariate analyses. We evaluated age, height, weight, BMI (Body Mass Index), duration of illness, parity, age of menopause, history of hypertension, hyperlipidemia, diabetes mellitus and osteoporosis between two groups consisting of group A who suffering from osteoporosis and group B with normal YAM by logistic regression statistical analysis. Results: Of 281 POP patients, 44 % (121/281) were osteoporosis and 24 % (68/281) were osteopenia. (Fig.2) Osteoporosis and osteopenia were estimated in the classification by age. (Fig.3, Fig.4) Among the patients aged 70 years or over, 57.8 % (85/147) were estimated as osteoporosis, 25.9 % (38/147) as osteopenia. Hence, 83.7 % of elderly were virtually deemed as in need of treatment. Multivariate logistic regression statistical analysis confirmed that higher age (P 0 0.0267) was prone to be osteoporosis for the patients with severe POP. Since,muscle,tendon and bone include collagen type1 that support each organs. We form a hypothesis that collagen type1 decreasing set in from menopause, associate loss of mechanical stability of the pelvic floor and the bone strength. Conclusions: We conclude that patients with severe POP were associated with osteoporosis. At this point, concise mechanisms, along with clinical impact of osteoporosis in POP patients remains unclear. We speculate that decreased estrogen influence bone and pelvic organ su'spension in postmenopausal women.

Selected baseline characteristics Variable Age(y) POP-Q 3 4 Duration (m) BMI (kg/m2) Age at menopause(y) History of osteoporosis History of hyperthyroidism History of hypothyroidism hysterectomy

mean±SD 69.5±8.37 (46–89) – – 47.7±6.16 (0.3–468) 23.24±3.23 (16.58–38.20) 50.8±2.3(42–59) – – – –

n 281 123 158 259 280 278 46 3 4 40

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Fig. 1 Evaluate Osteoporosis in accordance with guidance of the Japanese Society for Bone and Mineral Research (JSBMR).

Fig. 2 Morbidity of osteoporosis in 281 severe POP.

Fig. 3 The morbidity of osteoporosis in severe POP in classification by age.

Fig. 4 The morbidity of osteopenia+osteoporosis in severe POP in classification by age.

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H. Abe: None. R. Kimura: None. W. Doi: None. Y. Fukaya: None. S. Takenaka: None. T. Inamoto: None. H. Azuma: None. M. Takeyama: None.

76 A DECISION ANALYTIC MARKOV MODEL TO COMPARE THE COST UTILITY OF ANTERIOR REPAIR AUGMENTED WITH SYNTHETIC MESH COMPARED TO NON-MESH REPAIR IN WOMEN WITH SURGICALLY TREATED PROLAPSE J. Duckett 1, M. Basu2 1 Medway Maritime Hosp., Gillingham, Kent, United Kingdom, 2 St. George’s Hosp., London, United Kingdom. Objective: The objective of this study was to assess whether the use of mesh in primary anterior vaginal wall repair is cost-effective using an advisory £20,000 cost per QALY threshold as suggested by the UK National Institute of Health and Clinical Excellence (NICE). Background: Mesh augmented repairs aim to reduce the rate of recurrent prolapse. However, there are extra costs associated with purchasing the mesh, with longer operating times and managing complications caused by mesh. Balancing the extra risks of mesh surgery against the benefits is therefore an important issue. Methods: A decision analytic Markov model, developed in TreeAge Pro 2007®, was used to compare the cost-utility of mesh and non mesh anterior vaginal wall repairs. The base case analysis was based on a 5-year follow-up period from commencement of surgical treatment and the costing was undertaken from an NHS perspective. Sensitivity analysis was used to assess the impact of different scenarios and assumptions on the model’s results. Recurrence rates for mesh and non-mesh anterior repair, as well as mesh erosion rates were identified from meta-analysis data from the literature for use in the model. Costing inputs for the model were derived from NHS and Personal Social Services perspectives, including the cost of the initial surgery as well as any downstream costs related to surgical or mesh complications, or repeat surgery for recurrent prolapse. There was no data in the literature pertaining to health state utility gain or loss for vaginal prolapse surgery, or from the incidence of complications arising from vaginal prolapse surgery. A default value was therefore estimated using data from urinary incontinence treatments. Health outcomes were expressed in terms of quality-adjusted life years (QALYs). Results: Under base case assumptions at 5 years, the incremental cost-effectiveness ratio (ICER) for mesh augmented anterior repairs was £15.5 million per QALY. Non mesh surgery was cost-effective with an ICER of £9,496 per QALY. Sensitivity analysis found no plausible model inputs that could make a mesh repair cost effective by conventional criteria. This was mostly due to the

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extra costs associated with the price of the mesh, and treating mesh erosion There was also difficulty finding data for the model supporting a lower reoperation rate for mesh anterior wall repairs or superior outcomes. An analysis using theoretical “best case” inputs for mesh repair demonstrated an ICER of £207817 per QALY for mesh repair versus £6187 per QALY for non-mesh repair Conclusions: The results suggest that the use of synthetic mesh for anterior repair in women is unlikely to be a cost effective procedure when judged by conventional willingness to pay for QALY improvement. Mesh surgery may be indicated but only if patients likely to have high recurrence rates are targeted, whilst limiting the cost of mesh surgery. J. Duckett: None. M. Basu: None.

77 A ONE YEAR PROSPECTIVE COMPARISON OF VAGINAL PESSARIES AND SURGERY IN THE TREATMENT OF PELVIC ORGAN PROLAPSE USING THE VALIDATED ICIQ-VS QUESTIONNAIRE. F. Lone, R. Thakar, A. Sultan Croydon Univ. Hosp., London, United Kingdom. Objective: To compare the effectiveness of pessaries and surgery in women with symptomatic pelvic organ prolapse (POP) using the validated ICIQ Vaginal Symptoms (ICIQVS) questionnaire. Background: POP affects approximately 50 % of parous women over the age of 50 years [1]. Although surgery is frequently performed for POP, nearly two-thirds of women with symptomatic POP choose a vaginal pessary as the initial treatment [2]. The long-term use of vaginal pessaries have been evaluated using lengthy questionnaires most of which are not validated. This is the first study to prospectively evaluate the comparative outcomes of vaginal pessaries and surgery using the ICIQ-VS questionnaire which is a validated, comprehensive, robust and simple tool to use. [3] Methods: Women attending Urogynaecology clinics with symptomatic POP between August 2009 to December 2010 were recruited. A detailed history was taken and demographic data was collected. All women had pelvic organ prolapse quantification (POPQ) and were treated with either a vaginal pessary or surgery. Outcomes were evaluated and then compared at 1 year using the validated ICIQ-VS questionnaire. Results: 287 women with symptomatic prolapse completed ICIQ-VS questionnaire. The mean (± SD) age was significantly higher in the pessary group compared to the surgery group (62.3±11.04 vs 55.8± 10.36) years with no difference in parity (median parity was 3). In the pessary group, 27 women were sexually active

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compared to 48 women in surgery group. Pessaries used were: 107 ring, 23 (17.25 %) gellhorn, 2 (1.5 %) cubes and 1 (0.75 %) donut. In the surgery group, 40 (26 %) had anterior colporrhaphy , 22 (14 %) posterior colporrhaphy, 11 (7 %) anterior and posterior colporrhaphy, 47 (30.5 %) vaginal hysterectomy and anterior colporrhaphy, 20 (13 %) vaginal hysterectomy, 9 (6 %) sacrocolpopexy and 5(3.5 %) sacrospinous fixation. The mean (± SD) time interval for the questionnaires response for the surgery and pessary groups were 14 (± 5.96) and 13 (± 3.9), months respectively. ICIQ-VS questionnaire was completed at baseline by 116 (87 %) and 153 (99 %) women who opted for pessary use and surgery respectively. At 1 year compared to baseline, there was a significant improvement in all symptoms and related bother except faecal evacuation and symptoms related to sex in the pessary group [Table 1 and 2]. In the surgery group, there was significant improvement and related bother was in all vaginal and sex symptoms except faecal evacuation and tight vagina [Tables 1 and 2]. There was no significant difference between the two groups at 1 year. Conclusions: Using the validated ICIQ VS questionnaire, 1 year after treatment, women with symptomatic POP report significant improvement in vaginal symptoms and quality of life scores irrespective of treatment with pessary or surgery. As there was no significant difference between the two treatment groups, pessaries should be offered as a first line treatment for POP. Table 1. Change of vaginal symptoms from baseline to 1 year after pessary and surgery use. Pessary

Surgery

n080

N0109

Symptoms Change in score a Dragging −2.08* Soreness −0.4 ↓Sensation −1.2* Loose −1.9* vagina Lump felt −6.9* Lump −5.2* seen Dry −1.4* vagina Faecal −4.6* evacuation Tight −3.7* vagina Vaginal −7* score a

MannWhitney U

Change in bother a −3* 1* −3* −2.5*

Change in score a −6 * −5.1* −2.4* −5.2*

Change in bother a −4* −2* −2* −4*

p-value

−6 * −3*

−8* −7.2*

−8* −8*

0.156 0.493

−1 *

−4.4*

−3*

0.122

1

−2.1*

−3

0.441

2*

−1.2

−2*

0.382

–

−3.6*

–

0.118

0.769 0.997 0.785 0.113

Wilcoxon signed rank test score (*0p-value<0.05)

Table 2. Change of sex and quality of life symptoms from baseline to 1 year after pessary and surgery use. Pessary

Surgery

n080

N0109

Symptoms

Change in score Interfere with −1.4 sex life b −1.2 Affect relationship

a

Change in Change bother a in score –1 −2.89*

MannWhitney U a

Change in p-value bother a −3* 0.930

−1

−2.45*

−3*

0.345

Sex life spoilt −1.3

−1

−2.6*

−2*

0.342

Interference with daily life Sex score QOL score

−5.5*

−2 *

−6.8*

−4*

0.629

−1 −5.5*

– –

−8 * −12.7*

– –

0.245 0.362

b b

a b

Wilcoxon signed rank test score (*0p-value<0.05) data for sexually active patients

References: 1: Cochrane Database Syst Rev 2006 ; (4):CD003882. 2: Int Urogynecol J Pelvic Floor Dysfunct 2010 ; 21(1):27– 31. 3: BJOG 2006 ;113(6):700–12 F. Lone: None. R. Thakar: None. A. Sultan: None.

78 A COMPARISON OF TWO DIFFERENT FORMS OF MESH FIXATION V. Wong1, K. Shek 2, J. Lee 3, A. Rosamilia 4, A. Rane 5, J. Iyer 5, H. P. Dietz 2 1 St George Hosp., Sydney, Australia, 2Univ. of Sydney, Penrith, Australia, 3Mercy Hosp. for Women, Melbourne, Australia, 4Monash Med. Ctr., Melbourne, Australia, 5James Cook Univ., Townsville, Australia. Objective: To assess subjective and objective measures of prolapse recurrence after Anterior Elevate and Perigee mesh kit surgery. Background: Anterior colporrhaphy (AC) with mesh has become popular, with two main methods used: transobturator fixation (e.g. Perigee) and mesh suspension to the sacrospinous ligament (e.g. Anterior Elevate). In this study we compared these two forms of mesh surgery to provide pilot data for power calculations for a future RCT.

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Methods: Surgical audits of patients following AC with mesh (Perigee or Anterior Elevate) were undertaken at three Urogynaecological centres. All patients had an interview, ICS POPQ and 4D translabial ultrasound at maximum valsalva, after voiding (1). Recurrence was defined as 1) symptoms of prolapse (lump or drag), 2) ICS POPQ≥Stage 2, and

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3) sonographically as bladder descent ≥10 mm below the symphysis pubis(2) on Valsalva. Offline analysis was undertaken using proprietary software, blinded against clinical data. Mesh coordinates and organ descent on Valsalva were determined relative to the inferior symphyseal margin (Fig 1).

Fig. 1 Mesh imaging on translabial ultrasound at rest (a) and on Valsalva (b). The dotted line marks the mesh. Mesh position is measured against the reference of the inferoposterior symphyseal margin. The vertical lines show the lowest positions of cranial and caudal mesh aspects. S0symphysis, B0bladder, U0urethra, R0rectum.

Results: 229 patients with anterior compartment mesh (138 Perigee, 91 Elevate) were assessed at a median follow-up of 1.6 years (0.3–5.6). Mean age was 65 year (32–88), mean BMI 28 (17–43) and mean vaginal parity 3(0–10). 94 (41 %) patients had had a previous prolapse repair, 116 (51 %) a previous hysterectomy and 11 (5 %) previous anti-incontinence surgery. 11 % (n026) had a concomitant hysterectomy, 11 % (n025) a vault suspension, 39 % (n090) a posterior repair, 11 % (n0 24) an Apogee, and 3 % (n07) a Posterior Elevate. 24 % (n055) had symptoms of prolapse, 46 % (n0 106) had a clinical recurrence (ICS POPQ≥Stage 2), and 45 % (n0102) a recurrent cystocele on US. Avulsions were found in 43 % (n099). Mean hiatal area was 34.1 cm2. On univariate analysis, a comparison between Perigee and Anterior Elevate for symptoms of prolapse, objective prolapse on clinical exam and cystocele on US favoured the Perigee (Table 1). Anterior Elevate meshes seemed to descend to a substantially lower position on Valsalva. There were no differences between groups for satisfaction and subjective cure/ improvement.

Table 1. Comparison of subjective and objective outcome measures between groups; *measurement below SP on maximal valsalva. Symptoms Mean of prolapse Ba Perigee 37/138 (n0138) (26.8 Elevate 18/91 (n091) (19.8 P value 0.22

ICS POPQ≥ stage 2 −1.8 46/138 %) (SD 1.3) (33.3 %) −0.9 60/88 %) (SD 1.1) (68.2 %) <0.0001 <0.0001

Bladder descent on US* (mm) −3.5 −12.0 <0.0001

Lowest mesh position on US* (mm) −7.8 (SD 9.0) −14.8 (SD 7.7) <0.0001

On multivariate analysis of mesh type vs. subjective and objective outcome measures, adjusting for potential confounders of prolapse recurrence (age, length of follow-up, previous anti-incontinence/prolapse repair, previous hysterectomy, levator avulsion and hiatal ballooning) we found that the difference in outcomes between Anterior Elevate and Perigee remained highly significant (P<0.0001 for clinical and ultrasound measures of prolapse recurrence). Of 52 sonographic failures in the Anterior Elevate group, 50 seemed to

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involve a high degree of apical mesh mobility, implying insufficient cranial anchoring. Conclusions: This retrospective analysis of three audit projects conducted at tertiary urogynaecological centres suggests that apical anchoring as in the Anterior Elevate mesh system does not necessarily confer any advantage over the original transobturator mesh fixation technique for anterior compartment reconstruction. References: 1. IUGJ 2011:22;1221–1232 2. UOG 2007; 29: 688–691 V. Wong: None. K. Shek: None. J. Lee: Consultant; AMS, Boston Scientific. Grant /Research Support; AMS. A. Rosamilia: Consultant; AMS, Boston Scientific. Grant /Research Support; AMS. A. Rane: Consultant; AMS for surgeon training and education. J. Iyer: None. H.P. Dietz: Grant /Research Support; GE Medical.

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Results: The combined surgery strategy is least effective and most costly strategy; the most cost-effective strategy is preoperative screening with urodynamics (Graph 1). Conclusions: Based on currently available data, combined surgery strategy is clearly inferior to others in terms of both cost and effectiveness. The best strategy is preoperative testing. Current data are insufficient to conclude which screening test is superior. Further studies need to be done to compare the effectiveness of each screening test; patient satisfaction & quality of life with different strategies.

79 COST-EFFECTIVENESS ANALYSIS OF CLINICAL STRATEGIES USED TO MANAGE STRESS URINARY INCONTINENCE AT THE TIME OF REPAIR OF PELVIC ORGAN PROLAPSE IN WOMEN. V. Raizada, E. E. Duecy, J. G. Dolan Univ. of Rochester, Rochester, NY. Objective: The primary objective was to identify the most cost-effective strategy for evaluating & treating occult SUI in women undergoing surgical repair of POP. A clinical decision tree of commonly used management options is outlined in figure 1. Background: Surgeons are faced with the problem of deciding whether and how to evaluate for occult stress urinary incontinence (SUI) in women undergoing surgical repair of pelvic organ prolapse (POP). Failure to address this may either result in unnecessary surgery with additional risks and costs or avoidance of a surgery for bothersome SUI. Cost effectiveness analysis (CEA) is a technique comparing the relative benefits and costs of alternative approaches to management. Methods: Our target population was women with POP and no symptoms of SUI at baseline. Commonly used surgical approaches compared were: 1) Combined surgery (POP repair+prophylactic surgery for SUI); 2) POP repair alone; & 3) Preoperative screening for occult SUI with either urodynamics, simple cystometry, or basic office exam. Parameter estimates and confidence intervals were derived from literature review. Clinical judgment was used to derive utilities for outcomes. The CEA was performed from the payor’s perspective. Estimates of costs were obtained from 2010 Medicare reimbursements for Upstate New York; cost resources used in our practice and published literature. Analysis was performed using TreeAge software.

Fig. 1 Clinical decision model depicting strategies for managenet of SUI during POP repair. (UDYN: Urodynamics, BOE: Basic office exam, SCYSTO: Simple Cystometry).

Graph. 1 Cost effectiveness analysis shows that the combined approach of treating POP and SUI is most costly and least effective. Cost is expressed in Dollars. Rx: Treatment

V. Raizada: None. E.E. Duecy: None. J.G. Dolan: None.

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80 ASSESSING PUBOVISCERAL AVULSION SEVERITY BASED ON COMMONLY ACQUIRED GYNECOLOGICAL VARIABLES K. Lammers, J. J. Fütterer, M. Prokop, M. E. Vierhout, K. B. KLUIVERS Radboud Univ. Nijmegen Med. Ctr., Nijmegen, Netherlands. Objective: The aim of this study was to identify variables that were associated with higher or lower odds of more severe pubovisceral avulsions in women with complaints of pelvic floor dysfunction. Background: Imaging is becoming increasingly important as a diagnostic tool in pelvic floor dysfunctions, such as pelvic organ prolapse (POP). Avulsion injury of the pubovisceral muscle of the levator ani is one of the contributing factors in both POP development and recurrence of POP after surgery. These pubovisceral avulsions can be visualized using magnetic resonance (MR) imaging. Medical professionals seem little aware of this type of birth injury and only a small number of urogynecology subspecialists have mastered the skill of detecting avulsion injury on imaging. Methods: This was an observational cohort study of data obtained at a tertiary urogynecology clinic in the period 2005–2011. Patients underwent pelvic floor MR imaging as part of routine clinical workup in case of recurrent POP or when the patients’ complaints did not correlate with clinical findings. Women were included in case they had additionally returned the following questionnaires: urinary distress inventory (UDI), incontinence impact questionnaire (IIQ), and defecatory distress inventory (DDI). Baseline characteristics, data on surgical and obstetric history and pelvic organ prolapse quantification (POP-Q) measurements were obtained. All MR images were evaluated for pubovisceral avulsions by two independent observers and in case of disagreement, MR images were reviewed jointly to reach consensus. Women were classified as having no defect, or a minor or major pubovisceral avulsion based on the levator avulsion defect scoring system. To identify differences between groups, Fisher’s Exact test and ANOVA test with post-hoc LSD testing for intergroup comparison were used, as appropriate. All parameters with a p value <.20 on univariable logistic regression were entered in a multivariable ordinal logistic regression analysis. Odds ratios (OR) were hereby calculated with pubovisceral avulsion severity as outcome variable. Results: Of the 194 women included, major and minor pubovisceral avulsions were diagnosed in 83 (43 %) and 50 (26 %) women, respectively, while 61 (31 %) women had no visible trauma of the pubovisceral muscle.

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The three groups were comparable with regard to age, BMI, and previous hysterectomy and urinary incontinence surgery. Statistically significant differences were predominantly observed between the groups “no defect” and “major pubovisceral avulsion”. Twenty variables were entered in the multivariable regression analysis. Table 1 outlines the variables that were associated with a higher or lower OR of more severe pubovisceral avulsions. Both the crude and adjusted ORs are presented. Four predictors had a OR larger than 1 indicating that with increasing values of these variables, the likelihood of larger scores on pubovisceral avulsion severity increased. The OR below 1 for the variable DDI “obstructive defecation” indicates a lower likelihood of higher scores on pubovisceral avulsion severity. The model had an adjusted R2 of 40 %. Conclusions: We identified episiotomy, previous POP surgery of the anterior compartment and more severe prolapse as factors that were associated with an increased likelihood of more severe pubovisceral avulsions. Symptoms of obstructive defecation were associated with less severe pubovisceral avulsions.

Table 3. The crude and adjusted odds ratios with 95 % confidence intervals for pubovisceral avulsion severity in three ordered categories using multivariable ordinal logistic regression Variable

Crude OR (95 % CI)

Obstetric history - Episiotomy 3.24 (1.76–5.97) Surgical POP history - Anterior 4.48 (2.54–7.90) compartment POP-Q measurements -C 1.21 (1.09–1.35) UDI

Adjusted OR (95 % CI)

p value

3.77 (1.80–7.89)

<.001

3.23 (1.60–6.77)

.001

1.18 (1.04–1.34)

.01

- Genital prolapse 1.02 (1.007–1.024) 1.01 (1.002–1.023) .02 DDI - Obstructive 0.98 (0.97–0.99) 0.97 (0.96–0.99) <.001 defecation

OR 95%CI, odds ratio with 95 % confidence interval. POP(-Q), pelvic organ prolapse (quantification). C, most descended edge of cervix, in centimeters relative to the hymen. UDI, urogenital distress inventory. DDI, defecatory distress inventory. The estimates for the intercepts of the lower and middle outcome categories were -.770 and .833, respectively. K. Lammers: None. J.J. Fütterer: None. M. Prokop: None. M.E. Vierhout: None. K.B. Kluivers: None.

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81 MEDIUM-TERM CLINICAL OUTCOMES FOLLOWING TROCAR-GUIDED MESH REPAIR OF VAGINAL PROLAPSE USING PARTIALLY ABSORBABLE MESH A. L. Milani1, P. Hinoul 2, J. Gauld 3, P. C. Jones 3, C. Reisenauer 4, K. Lobodasch 5, M. Cosson 6, S. Khandwala 7, D. Van Drie 8, V. Lucente 9, For The Prolift+m Investigators 1 Dept of Obstetrics and Gynaecology, Reinier de Graaf Group, Delft, Netherlands, 2Med. Affairs, ETHICON, Inc., Somerville, NJ, 3Clinical Dev., ETHICON, Inc., Livingston, United Kingdom, 4Univ.tsklinik Tubingen, Tubingen, Germany, 5DRK Krankenhaus Chemnitz-Rabenstein, Chemintz, Germany, 6Chirurgie Gynécologique, CHRU de Lille, Hôpital Jeanne De Flandre, Lille, France, 7Advanced Urogynecology of Michigan, Dearborn, MI, 8Women’s Hlth.Ctr. of West Michigan, Grand Rapids, MI, 9The Inst. for Female Pelvic Med. and Reconstructive Surgery, Allentown, PA. Objectives: To evaluate anatomic and functional outcomes at 3 years following trocar-guided transvaginal prolapse repair using a partially absorbable mesh. Background: Recent Level I evidence indicates that standardized transvaginal mesh kit resulted in significantly higher rates of anatomic and symptomatic success compared to native tissue repair for anterior vaginal prolapse1. However, it was associated with higher rates of adverse events. In order to generate further evidence on the clinical outcomes following mesh repair, longer-term follow-up is required. In 2008, a partially absorbable mesh was introduced into the trocar-guided system, which provided increased elasticity in the longitudinal direction and less permanent mesh. Here, we report medium-term results which assess the durability of the repair and safety profile of this mesh repair at 3 years. Methods: Prospective multicentre cohort study at 11 international sites. 128 subjects with Pelvic Organ Prolapse Quantification (POP-Q) Stage≥III were enrolled. Concurrent hysterectomies and/or perineal repairs were allowed; exclusion criteria included other surgical repair of prolapse and previous prolapse repair using mesh. Subjects underwent transvaginal mesh placement using a partially absorbable implant (Gynecare Prolift+M Pelvic Floor Repair System, Ethicon, NJ). Evaluations were at 3 months, 1, 2 and 3 years post-surgery. The primary outcome measure was defined as anatomical success, POP-Q Stage 0-I, in the treated compartment. Subjects requiring reintervention for prolapse in the treated compartment were considered failures. Secondary outcome measures included an alternative anatomical measure defined as leading edge above the hymen (i.e. all POP-Q values <0 cm) in the treated compartment and subjective outcome assessed by validated scores such as PFDI-20, PFIQ-7, PISQ-12 and Patients Global Impression of Change (PGI-C). Post-operative complications were recorded (peri-operative complications were described previously)2.

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Results: Of the original 128 subjects undergoing surgery, 109 (85 %) provided 3 year follow up data. At 3 years, anatomical success, defined as POP-Q stage≤I in the treated vaginal compartments, was 75.9 % (95%CI 66.7% to 83.6 %, ClopperPearson method). Leading vaginal edge above the hymen in the treated compartment side was achieved in 88.0 % (95%CI 80.3% to 93.4 %) of subjects. 6 subjects required reintervention for recurrent prolapse in the treated compartment. The Quality of Life (QOL) measures including pelvic symptoms and sexual function improved significantly from baseline (p<0.001) and are presented in Table 1. 96.9 % subjects responded much better or a little better in the PGI-C. Mesh exposure was observed in 19 subjects over 3 years (14.8 %); 14 (10.9 %) occurred within the first 12 months post surgery. 10 of 19 exposures were at the apex, the majority following a total repair; 15 resolved on partial mesh excision (10 in-office and 5 excised in the OR) while 4 subjects had ongoing mesh exposure at 3 years (≤1 cm in size), being treated conservatively. Incidence of mesh exposure varied between sites (0–20 %). At 3 years, no subjects had de novo pelvic pain; 3 (2.8 %) had pain only on mesh palpation during pelvic examination. Resolution of pre-existing pelvic pain occurred in 7 (5.5 %) subjects. De novo dyspareunia was observed in 3/33 subjects (9 %); the causes were vaginal atrophy; uterine prolapse and 1 unknown. None of these subjects had mesh exposures. Preexisting dyspareunia resolved in 6/18 (33 %) subjects. Conclusions: These medium term results indicate that this standardized transvaginal mesh repair with a partially absorbable mesh yields sustained anatomic and functional results. No major safety concerns were identified, and the low incidence of pain and dyspareunia are encouraging. Table 1. Patient reported outcomes Baseline N0128 PFDI-20 98.9 (52.0) PFIQ-7 74.5 (70.5) PISQ-12 33.4 (7.8); n058 PGI-C Much better A little better About the same A little worse Much worse

1 year N0125 25.9 (28.0)* 9.5 (23.4)* 39.3 (4.1)*; n054 86.6 % 9.2 % 2.5 % 0.8 % 0.8 %

2 years N0123 28.8 (29.2)* 12.5 (30.3)* 39.1 (4.5)*; n049 88.4 % 7.1 % 3.6 % 0.9 % –

3 years N0109 28.0 (33.5)* 9.5 (24.1)* 39.8 (4.2)*; n038 89.8 % 7.1 % 3.1 % – –

Differences from baseline: probability values denoted as * for p<0.001. Data presented as mean (± SD) except for PGIC which is reported as %. PFDI-20 and PFIQ-7 scores range from 0 (best score) to 300 (worst score); sub-scales score range from 0 (best score) to 100 (worst score). PISQ-12 scores range from 0 (worst score) to 48 (best score). PISQ12 was only collected for subjects who were sexually active (n060). Missing data were excluded.

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References: 1. N Engl J Med 2011;364:1826–36 2. Am J Obstet Gynecol 2011; 204:74.e1–8 A.L. Milani: None. P. Hinoul: Employee (full or part time); full time. J. Gauld: Employee (full or part time); full time. P.C. Jones: Consultant; Consultant. C. Reisenauer: None. K. Lobodasch: None. M. Cosson: None. S. Khandwala: None. D. Van Drie: None. V. Lucente: Consultant; Consultant, Research, Speaker.

82 HIATAL BALLOONING IS AN INDEPENDENT RISK FACTOR FOR PROLAPSE RECURRENCE N. Rodrigo, K. Shek, V. L. Wong, A. Martin, H. Dietz; Univ. of Sydney, Penrith, Australia. Objective: To determine whether the size of the levator hiatus is an independent predictor of prolapse recurrence after Anterior Colporrhaphy (AC) +/−mesh. Background: Female pelvic organ prolapse is a common condition, and recurrence after surgery a significant clinical issue. In this study we used audit data to determine whether the size of the levator hiatus is an independent risk factor for recurrence. Methods: This study utilizes data obtained in four clinical audit projects after AC +/−mesh. Appointments consisted of a standardised interview, an ICS POP-Q clinical examination and 4D translabial ultrasound (1). Recurrence was defined as: 1.) recurrent symptoms of a vaginal lump / dragging sensation, 2.) Ba0-1 or lower on ICS POP-Q, and 3.) a cystocele reaching to at least 10 mm below the symphysis pubis on Valsalva. Ultrasound (US) analysis was performed on a PC, blinded against all clinical data. Levator avulsion was diagnosed on tomographic US as previously described(2). Hiatal dimensions were determined in the plane of minimal dimensions, using rendered volumes of 2 cm thickness (3). We tested potential predictors of recurrence (age, BMI, follow- up interval, previous surgery, pre-operative prolapse grading, avulsion and ballooning) against subjective and objective recurrence using logistic regression modelling. Results: 334 women were seen at 3 months to 6.4 (mean 2.51) years after AC +/−mesh. 87 had had a traditional AC, 143 a Perigee, 67 an Anterior Prolift, and 37 an Anterior Elevate mesh. 86/334 patients (26 %) complained of recurrent symptoms of prolapse. Evidence of recurrence on clinical examination was seen in 141 (42 %); on US in 113/334 (34 %) women. Table 1 gives results for the prediction of cystocele recurrence on US.

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Table 1. Univariate and multivariate analysis of risk of recurrence on US examination after AC +/−mesh (n0334) at an average follow-up of 2.51 years). Variable Mesh Age (years) BMI Previous hysterectomy Prev. incontinence/ prolapse surgery Follow-up in years Levator avulsion Hiatal area on Valsalva

Univariate OR (95 % CI) P 0.59 (0.36–0.99) 0.044 1.00 (0.98–1.02) 0.969 1.00 (0.95–1.04) 0.85 1.09 (0.69–1.72) 0.715 1.11 (0.32–3.8)

Multivariate OR (95 % CI) P 0.41 0.003 (0.23–0.75)

0.87

0.90 (0.79–1.03) 0.11 3.45 (2.15–5.53) <0.001 2.95 (1.77–4.91) 1.08 (1.05–1.11) <0.001 1.07 (1.04–1.11)

<0.001 <0.001

None of the tested predictors were predictive of recurrent prolapse symptoms. Mesh, avulsion, and hiatal area were significant univariate predictors of anatomical recurrence, and remained significant in multivariate models for clinical and US recurrence, with receiver operator characteristics showing an area under the curve of 0.65 (clinical recurrence) and 0.73 (sonographic recurrence) respectively. We included a term for the interaction between avulsion and mesh in a secondary analysis, on the basis of weak

Figure Risk of prolapse recurrence 2.5 years after AC +/−mesh in women with avulsion (a) and intact pelvic floor (b).

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evidence in this dataset (p00.087) that mesh may be more effective in women with avulsion. The predicted probability of recurrence with respect to hiatal area, avulsion status, and mesh use based on this secondary analysis is shown in Figure 1. Interpretation of results: In this series of 334 patients on average 2.5 years after cystocele repair, avulsion was associated with an odds ratio of 2.95 for recurrence, whilst hiatal area on valsalva conveyed an additional 7 % per cm2 for the likelihood of recurrence. This effect of ballooning seems largely independent of the risk conveyed by avulsion. Both factors in combination may effectively distinguish patients in whom conventional surgery is likely to fail. Concluding message: Recurrence risk after Anterior Colporrhaphy is largely determined by the state of the patient’s pelvic floor. The likelihood of recurrence may vary from 12 % to 95 % in a patient with a given degree of cystocele, depending on avulsion and hiatal ballooning. Both should be determined prior to prolapse surgery, especially if mesh use is contemplated. References: 1) Int Urogynecol J 2011; 22: 1221–1232 2) Int Urogynecol J2011; 22: 699–705 3) Aust NZ J Obstet Gynaecol 2011; 51: 540–543 N. Rodrigo: None. K. Shek: None. V.L. Wong: None. A. Martin: None. H. Dietz: Consultant; Materna Inc. (2010). Grant /Research Support; Educational grant (AUD 9000) in 2012, General Electric.

83 A PROSPECTIVE MULTI-CENTER CLINICAL TRIAL EVALUATING ELEVATE ANTERIOR AND APICAL IN THE TREATMENT OF PELVIC ORGAN PROLAPSE: TWO-YEAR FOLLOW-UP E. J. Stanford1, R. D. Moore 2, J. W. Roovers 3, C. Courtieu 4, R. Beyer 5, J. C. Lukban 6, E. Bataller 7, S. E. Sutherland 8 1 Auburn Regional Med. Ctr., Auburn, WA, 2Atlanta Med. Res. Inst., Atlanta, GA, 3Academic Med. Ctr. Univ. of Amsterdam, Amsterdam, Netherlands, 4CMC Beausoleil, Montpellier, France, 5Women’s Hlth. Care Specialists, PC, Kalamazoo, MI, 6Eastern Virginia Med. Sch., Div. of Urogynecology, Norfolk, VA, 7Hosp. Clínic i Provincial de Barcelona, Univ. de Barcelona, Barcelona, Spain, 8 Metro Urology, Ctr.s for Female Urology, Minneapolis, MN. Table of Contents & Objective & Methods & Results & Conclusion

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Objective: To assess safety and efficacy of the Elevate® Anterior and Apical (EAA) with IntePro® Lite™ support system (American Medical Systems, Minnesota, USA) in the repair of pelvic organ prolapse (POP). We present twoyear post procedure data. Methods: One hundred and forty-two women (age 63.9 ±9.8 years) were enrolled at 16 investigational sites (10 US, 6 EU) of which 124 (87.3 %) completed 24-month follow-up. The primary outcome was surgical treatment success using 2 definitions: 1) Objective anatomic success defined as≤Stage I POP-Q during follow-up using the Last Observation Carried Forward (LOCF) method. The LOCF method carries forward a patient’s objective failure at previous visits if their 24-month results were missing. It also considers subjects to be failures if they were re-operated for recurrent prolapse in the anterior or apical segments within 24 months from the initial implant regardless of their POP-Q test results. Subjects who had a concomitant Elevate Apical and Posterior repair were excluded from the apical efficacy analysis. 2) Subjective cure defined as the absence of bulge symptoms (negative response to Pelvic Floor Distress Inventory (PFDI) questions ‘Do you usually have a sensation of bulging or protrusion from the vaginal area?’ (Q4) and ‘Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?’ (Q5)). Wilcoxon signed rank test and paired t-test were used to compare continuous measurements from baseline through 24 months as appropriate. The exact 95 % confidence interval of the anatomic success rates was calculated using the binomial method. Statistical significance was assessed at p-value<0.05. Results: The objective anatomic success rate for the anterior compartment was 81.6 % (102/125, 95 % CI 73.7–88.0 %). Of the 23 subjects considered failure per LOCF, none complained of bulging on the PFDI. The anatomic success rate for the apical compartment was 95.9 % (71/74, 95 % CI 88.6–99.2 %). Of the 3 subjects who presented with apical anatomic failure only one complained of bulge symptoms and one subject had her study device removed due to recurrence of cystocele. Table 1 lists POP-Q measurement results. There were 8 (5.6 %) mesh extrusions all resolved but one (subject was lost to follow up). Treatment included trimming in the office (3/8), excision in the operating room (3/8), topical estrogen (1/8), and resolution without treatment (1/8). Other related adverse events reported at >2 % were urinary tract infection (8; 5.6 %), dyspareunia (7; 4.9 %), de novo urinary stress incontinence (6; 4.2 %), transient buttock pain (5; 3.5 %), new prolapse (5, 3.5 %), urinary retention (5; 3.5 %), granuloma formation (4; 2.8 %), hematoma (3; 2.1 %) and urinary urgency (3, 2.1 %). Satisfaction scores revealed that 120 (96.8 %) felt

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they were some or a lot improved and 116 (93.5 %) were moderately, very, or extremely satisfied. Conclusion: Two year data show that the Elevate Anterior and Apical support procedure completed through a single vaginal incision and no external needle passes yields objective and subjective improvement with few complications. It also demonstrates low mesh extrusion rates and high patient satisfaction.

POP-Q Point Aa Ba C* Total Vaginal Length

Baseline (n0122) Mean±sd

24 month (n0122) 95 % CI Mean±sd 95 % CI

P-value (Wilcoxon)

1.2 ±1.3 2.7 ±1.9 −0.3±3.7 8.5 ±1.1

0.9–1.4 2.3–3.0 −1.0–0.4 8.3–8.7

<0.001 <0.001 <0.001** 0.839

−2.2 ±1.0 −2.2 ±1.0 −7.2±1.8 8.5 ±1.1

−2.4–−2.0 −2.3–−2.0 −7.4–−6.7 8.3–8.7

* n0110, subjects who had a concomitant Elevate Apical and Posterior were not included in the analysis ** paired t-test E.J. Stanford: Consultant; American Medical Systems Inc. Grant /Research Support; American Medical Systems Inc. R. D. Moore: Consultant; American Medical Systems Inc. Grant /Research Support; American Medical Systems Inc. J. W. Roovers: Consultant; American Medical Systems Inc. Grant /Research Support; American Medical Systems Inc. C. Courtieu: Consultant; American Medical Systems Inc. Grant /Research Support; American Medical Systems Inc. R. Beyer: Consultant; American Medical Systems Inc. Grant /Research Support; American Medical Systems Inc. J. C. Lukban: Consultant; American Medical Systems Inc. Grant /Research Support; American Medical Systems Inc. E. Bataller: Consultant; American Medical Systems Inc. Grant /Research Support; American Medical Systems Inc. S. E. Sutherland: Consultant; American Medical Systems Inc. Grant /Research Support; American Medical Systems Inc.

84 EFFECTS OF TOPICAL ANTISEPTIC AGENT ON VAGINAL SYMPTOMS, PH AND INFECTION IN POSTMENOPAUSAL WOMEN USING PESSARY FOR PELVIC ORGAN PROLAPSE S . Vir a v a i d y a , J . M a n o n a i , S . S a r i t - A p i r a k , R . Wattanayingcharoenchai Faculty of Med. Ramathibodi Hosp., Bangkok, Thailand. Objective: To compare the effect of topical antiseptic gel and placebo on vaginal symptoms, pH and infection in

postmenopausal women using pessary for pelvic organ prolapse. Background: With an aging population, there has been an increasing of interest in using pessaries for the management of pelvic organ prolapse. These devices are apropriate for elderly patients as they are noninvasive with minimal risk, provide immediate relief of symptoms, and are cost-effective compared with surgery. A commonly experienced symptom of pessary use is vaginal discharge and foul odor. A study comparing pessary users with nonusers found that the presence of a foreign body increased the risk for bacterial vaginosis. Vaginal estrogen is generally recommended to postmenopausal women who at the time of their initial fitting or at subsequent follow-up are noted to have vaginal atrophy or ulceration or abrasions from pessary use. Despite the routine use of vaginal estrogen, it was seen that the frequency of removing the pessary or the dissatisfaction degree due to foul-odor discharge was rather high. A topical antiseptic gel, containing Chamomile and Thyme extract, and lactic acid, demonstrated effective antiinflammatory, decongestant, lenitive and emollient activity with a neutral pH. It might be useful to add this antiseptic gel for daily intimate hygiene in postmenopausal women. Methods: This was a double-blinded, randomized placebo-controlled trial. Postmenopausal women, using pessary for pelvic organ prolapse, were asked to participate in this study. All had been using pessaries for at least 1 week and vaginal estrogen cream 0.5 g was applied three times per week regularly. Subjects were randomly assigned into two groups and instructed to use few drops of topical antiseptic gel or identical placebo twice a day for hygiene of the external genital region for 14 days. A questionnaire was applied at baseline and the second visit regarding: 1) demographic data; 2) vaginal symptoms; 3) satisfaction with gel; and 4) adverse events. Total symptom score (TSC) of vaginal symptoms was calculated as the sum of the individual score (0–3) for discharge, pruritus and burning. Vaginal pH was measured directly from upper one third of lateral vaginal wall using an indicator paper. The samples of vaginal secretion were obtained with two dry cotton-tipped swabs from vaginal fornices. Then these specimens were cultured and evaluated for aerobic and anaerobic colonies. Results: Forty-four women initiated the use of a topical antiseptic gel or placebo at visit 1. At visit 2, there were 42 women available for evaluation. Demographic and baseline characteristics of the study and control groups were comparable (Table 1).

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Table 1. Subjects’ characteristics (n044) Topical antiseptic group Placebo group Age, years (mean±SD) Year since menopause, years (mean±SD) Parity, median (range) BMI, kg/m2 (mean±SD)

(n022) 68.1±6.4 18.6±6.7

(n022) 65.8±8.4 16.4±8.8

3 (1–6) 28.9±9.9

3 (1–9) 25.7±4.6

Mean total symptom scores did not change after 2 weeks of treatment in both groups; from 4.9 to 5.6 in the study group and from 5.1 to 5.3 in the control group (p>0.05). The mean vaginal pH in the study group was significantly lower than in the control group (Table 2). The median vaginal pH in the study group significantly decreased from 6.0 to 5.0, while it did not change in the control group (from 6.0 to 5.5). Table 2. Vaginal symptoms score and pH at baseline and week 2 (mean±SD) Scores/pH

Topical antiseptic group (n022)

Placebo group (n022)

Baseline Total symptom score - discharge - pruritus - burning Vaginal pH

Week 2 4.9±0.5 1.4±0.5 1.4±0.5 1.9±0.3 5.9±0.5

Week 2 5.1±0.5 1.4±0.5 1.6±0.5 2.0±0.0 5.8±0.5

Baseline 5.6±0.5 1.8±0.4 1.8±0.4 1.8±0.0 5.0±0.3*

5.3±0.6 1.7±0.5 1.6±0.5 1.9±0.2 5.6±0.5

*P<0.05 When compared with baseline and the control group. Conclusions: A 2-week course of topical antiseptic gel, containing Chamomile and Thyme extract, showed a positive clinical effect favouring the reduction of vaginal pH in postmenopausal women using pessary and vaginal estrogen for pelvic organ prolapse. S. Viravaidya: None. J. Manonai: None. S. Sarit-apirak: None. R. Wattanayingcharoenchai: None. 85 VAGINAL MESH REPAIR SYSTEMS FOR PELVIC ORGAN PROLAPSE: ANATOMICAL STUDY COMPARING OUTSIDE-IN VS INSIDE-OUTTECHNIQUES G. CAMPAGNA1, P. GADONNEIX 2, V. DELMAS 3, R. VILLET 2, A. LANZONE 1, M. GUIDO 1 1 Dept. of Obstetrics and Gynaecology. Università Cattolica del Sacro Cuore, Rome, Italy, 2Dept. of Visceral and Gynaecologic Surgery, Diaconesses Hosp., Paris, France, 3Inst. of Anatomy, Université Paris Descartes, Paris, France. Objective: the aim of present study was to compare the anatomic landmarks of two pelvic floor repair systems, in

order to identify the potential neurovascular lesions related to different mesh fixation techniques. Background: In the context of a university research protocol, we performed pelvic and perineal dissections of 10 fresh cadavers after prolapse surgery using outside-in vs inside-out- techniques. Methods: The anterior and posterior outside-in pelvic floor repair were applied on 5 corpses and 5 inside-out anterior and posterior prolapse repair were applied on five other specimens. All the procedures were performed according to the manufacturer’s instructions for use guide. Results during out-in anterior repair, the superficial mesh’s arm passed 2,5±0,6 cm medially to the obturator pedicle; the deep arm passed 2,1±0,4 cm cranially to the ischial spine. In three cases we observed that the deep cannula-guide, during its way, tore the obturator membrane descending caudally, near the posterior edge of obturator foramen. This portion of foramen is traversed by the posterior branch of obturator artery, which originates at the level of obturator canal and anastomoses with the anterior branch that crosses the anterior edge of obturator foramen. During in-out anterior repair the distance between the obturator pedicle and the mesh’s arm was 2,3±0,7. The vessels and the pudendal nerve passed posteriorly to the sacrospinous ligament, medially and caudally to the ischial spine (0.4,±0,5). The medium length of the sacrospinous ligament was measured 4,1 ± 0,4 cm. The sacrotuberous ligament passed in arrears to the ischial spine up to its connection with the ischial tuberosity. During the dissections, the inferior gluteal artery was identified in the space between the sacrospinous and sacro-tuberous ligaments and it represented the main vessel at this level. During out-in posterior repair the distance between the mesh’s arm and the pudendal pedicle was 1,7± 0,5 cm. During in-out posterior repair it was 2,3±0,4. Conclusions: the two techniques have the same level of reliability concerning to the fixation of superficial out-in and the anterior in-out mesh’s arm. During posterior out-in repair, if the posterior cannula-guide is placed in the sacrospinous ligament 3 cm medially and 2 cm lower of the ischial spine, the risk of pudendal lesions will be minimal. Nevertheless, the distance between the ischio-anal fossa and the sacrospinous ligament represents a way that could rule against the correct needle positioning. Another problem is the transgressing of entire sacrospinous ligament thickness by cannula-guide that could increase the injury risk of pudendal vessels. Contrary, the in-out technique, offers an easier access to the sacrospinous ligament avoiding to completely pass through the sacrospinous ligament and consequently pudendal lesions.

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References: Obstet Gynecol 1999; 94:973–7. Int Urogynecol J Pelvic Floor Dysfunct. 2008;19:1617–22. Int Urogynecol J Pelvic Floor Dysfunct. 2009; 20:103–1 G. Campagna: None. P. Gadonneix: None. V. Delmas: None. R. Villet: None. A. Lanzone: None. M. Guido: None.

86 POST-OPERATIVE MORBIDITY FOLLOWING LAPAROSCOPIC SACROCOLPOPEXY IN WOMEN ABOVE AND UNDER 65 YEARS K. Haest, F. Claerhout, E. Werbrouck, J. Verguts, J. Veldman, F. Van Der Aa, M. Vanhasselt, G. Coremans, D. De Ridder, J. Deprest KULeuven, Dept of Dev. and Regeneration, Pelvic Floor Unit, Leuven, Belgium. Background: Abdominal sacrocolpopexy offers better anatomical results than sacrospinous fixation (SSPF), however at the expense of increased morbidity [1]. For that reason, vaginal SSPF rather than abdominal apical

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suspension is often suggested for elder or frail women. Given sacrocolpopexy can be effectively performed by laparoscopy [2], we have not fixed an age limit for offering the procedure, so also perform this procedure in patients above 65 years. Objective: Herein we aimed to compare the immediate postoperative morbidity following laparoscopic sacrocolpopexy (LSC). Materials and methods: This is a prospective study on 365 consecutive patients scheduled for LSC, n 0201 above 65 years and 164 under 65 years of age. All were reevaluated within 3 months after the procedure. LSC was performed for symptomatic vault prolapse (stage 2 or higher). Principal outcome measures were occurrence of postoperative complications and anatomical outcome within three months, success being defined as anatomical cure (Stage I or 0 at the vault, and for any compartment). Additional outcomes were need for conversion, blood loss, occurrence and nature of postoperative complications as displayed in the table below. Statistical analysis was done with SPSS 17 and data are reported as mean (SD) or number and (%). Student t-test and Pearson chi square were used to compare continuous and categorical data between groups.

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Table 1. Outcome measures as per two age categories. Last column displays significant p value. * some patients may have more than one complication, therefore total may be different than sum of the listed complications. Preoperative data

<65 (n0164)

>65 (n0201)

Mean/n SD/%

Mean/n SD%

Age 56.3 Parity 2.63 BMI 25.78 Previous prolapse surgery 140 Previous abdominal surgery 61 Intraoperative data and hospital stay Intraoperative complication 3

7.2 1.36 3.59 85.9 % 37 %

72.5 2.89 26.47 182 71

1.8 %

- Epigastric bleeding - Urinary tract lesion - Bowel lesion Conversion to laparotomy Operation time (min) Blood loss (mL) Total postoperative days Major complications Thromboembolic events Spondylodiscitis Reintervention - Exposure/early mesh revision - Bleeding - Ureteral trauma - Early recurrence - Bowel problems - Pulmonary edema Minor complications - Urinary tract infection - Pneumonia - Vaginal infection - Paralytic ileus - Paresthesis - Transfusion - Urine retention Short term outcome (3 m) - Failure at the vault

0 3 0 7 189.3 180.75 5.1 7 2 1 4 0

0% 1.8 % 0% 4.3 % 47.9 105 1.0 4.3 % 1.2 % 0.6 % 2.4 % 0%

1 1 1 1 0 15 6 0 3 0 3 0 3

0.6 % 0.6 % 0.6 % 0.6 % 0% 9.1 % 3.6 % 0% 1.8 % 0% 1.8 % 0% 1.8 %

2 0 0 2 1 13 4 1 1 2 1 2 2

1.0 % 0% 0 1% 0.5 % 6.5 % 2.0 % 1.0 % 0.5 % 1.0 % 0.5 % 1.0 % 1%

p

4.8 1.82 3.9 90.1 % 35 %

* ns ns ns ns

4

2%

ns

1 2 1 8 180 133.6 5.1 8 3 0 5 1

0.5 % 1.0 % 0.5 % 4.0 % 45.9 86.1 1.0 4% 1.5 % 0% 2.5 % 0.5 %

ns ns 0.005 ns ns

87 THE CORRELATION OF PELVIC ORGAN PROLAPSE SEVERITY WITH LOWER URINARY TRACT SYMPTOMS, SEXUAL DYSFUNCTION AND QUALITY OF LIFE SCORES ASSESSED BY VALIDATED QUESTIONNAIRES E. S. Cetinkaya, O. Dai, F. Dokmeci Ankara Univ. Faculty of Med., Ankara, Turkey.

ns 2

1.2 %

0

groups. The major and minor complications were comparable and as listed in the table. Conclusions: Essential perioperative outcome parameters of patients undergoing LSC are similar for patients above 65 years compared to those being younger. Anatomical outcomes after 1 year or higher are also comparable, with around 3 % reoperations. There were less graft related complications, but there may be a bias as patients at elder age were less frequently sexually active and/or may complain less. References: 1. Maher, C., et al., Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev, 2010(4): p. CD004014. 2. Claerhout, F., et al., Implementation of laparoscopic sacrocolpopexy–a single centre’s experience. Int Urogynecol J Pelvic Floor Dysfunct, 2009. 20(9): p. 1119–25. K. Haest: None. F. Claerhout: None. E. Werbrouck: None. J. Verguts: None. J. Veldman: None. F. Van der Aa: None. M. Vanhasselt: None. G. Coremans: None. D. De Ridder: Consultant; AMS, ASTELLAS. Grant / Research Support; ETHICON, DYNAMESH, BARD, AMS, ASTELLAS. J. Deprest: Consultant; ETHICON. Grant /Research Support; ETHICON, BARD, DYNAMESH, AMS.

0%

Results: Parity, BMI, clinical presentation and stage, as well as previous surgical history were comparable. Intraoperative parameters were also comparable apart from a lesser estimated blood loss in those above 65 years. There was 1 immediate reintervention which was finally again revised by open surgery because the mesh released from the tackers used. Postoperative hospital stay was 5.1 days in both

Objective: The aim of this study was to evaluate the relationship between POP severity, clinical findings, lower urinary tract symptoms (LUTS), sexual dysfunction and quality of life (QOL) using validated questionnaires. Background: Pelvic organ prolapse (POP) may present with a wide range of symptoms and often requires surgery. The symptoms are largely subjective in nature, and contradictory results have been reported regarding the association of POP with LUTS and sexual dysfunction. Success of surgical outcome has usually been described as the improvement in anatomical support. However, pelvic reconstructive surgery does not always provide functional improvement and patient satisfaction. To determine the patients’ needs and expectations correctly, it is important to evaluate their perception of the condition and its reflection on QOL. Thus, in addition to objective and anatomical measures, validated questionnaires should be used to make a complete clinical

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decision plan, meeting both the goals of the patient and physician. Various instruments have evolved for the assessment of the functional aspects of pelvic floor disorders validated in different languages; still, the results may be affected by cultural differences. Methods: This is a cross-sectional observational study of women attending the Urogynecolgy Department of a University Hospital. Data of baseline characteristics, clinical examination and questionnaires assessing pelvic floor dysfunction and QOL were analyzed. Clinical findings included the Q-tip test, stress test, postvoid residual (PVR) and POP staging (performed using the POP-Q system). Lower urinary tract symptoms, sexual dysfunction and QOL were evaluated using validated versions of UDI-6, IIQ-7, OAB-V8, PISQ-12 and Wagner questionnaires. Baseline characteristics and clinical findings were compared with the Kruskal Wallis test. Spearman correlation analysis was used to evaluate the correlation of POP with pelvic floor dysfunction related symptom severity and QOL. Results: A total of 388 women were enrolled; 108 patients had stage 0 (group 1) (28.3 %), 83 (21.5 %) had stage 1 (group 2), 151 (38.5 %) had stage 2 (group 3) and 46 (11.5 %) had stage 3 and 4 prolapse (group 4). Patients in group 1 were older than group 2 and 3 (p00.02); mean age was similar in groups 1 and 4 (p00.73). Menopausal status was similar in group 1 and 4 (p00.84). Parity, previous pelvic surgery, chronic obstructive lung disease were similar among all stages. Clinical findings showed significant differences among POP stages (p<0.05) (Table 1). The Q-tip test, stress test and PVR were positively correlated with POP severity (r0 0.425, r00.117, r00.163 respectively; p<0.05). Total scores for UDI-6, IIQ-7, OAB-V8, PISQ-12 and Wagner questionnaires did not differ among the POP stages. However, irritative, stress and obstructive subscales of UDI-6; physical, travel and emotional subscales of IIQ-7 showed significant differences among the groups (Tables 2 and 3). Correlation analysis showed a significant positive relationship between POP severity and total scores of UDI-6, subscale scores of UDI-6 and IIQ-7 (Table 4).

Conclusions: The correlation of lower urinary tract dysfunction and POP severity were shown to be best represented by clinical findings and scores of UDI-6 and IIQ-7. Table 1. Clinical examination findings with regard to POP stage Clinical findings

Group 1 (Stage 0)

Positive Q-tip 21(%19.8) n (%) Positivestress 29(%26.2) test n (%) PVR*(ml) 25(0–270)

Group 2 (Stage 1)

Group 3 (Stage 2)

Group 4 (Stage 3–4)

p

43(%51.8)

99(%65.6)

38(%82.6)

0.00

44(%53)

77(%51)

17(%37)

0.00

30(0–250)

45(0–700)

50(0–350)

0.047

*median (min–max) PVR: Post-voidresidual Table 2. Comparison of scores of UDI-6 according to POP stages POPQ stages UDI-6*

0 1 2 3–4 p

Irritative

Stress

Obstructive/voidingdifficulty

50(0–100) 50(0–100) 67(0–100) 67(0–100) 0.005

33(0–100) 33(0–100) 50(0–100) 50(0–100) 0.009

17(0–100) 17(0–100) 17(0–100 33(0–100) 0.05

*median,min–max Table 3. Comparison of scores of IIQ-7 according to POP stages POPQ stages IIQ-7* Physicalactivity Travel

Social/relationship Emotionalhealth

0

0(0–100)

0(0–100)

0(0–100)

0(0–100)

1

17(0–100)

33(0–100)

33(0–100)

17(0–100)

2

50(0–100)

33(0–100)

36(0–100)

17(0–100)

3–4

67(0–100)

50(0–100)

50(0–100)

67(0–100)

p

0.001

0.031

0.116

0.006

*median,min–max

Table 4. Correlation of POP severity with scores of LUTS and QOL questionnaires UDI-6 Scores Total

IIQ-7 Scores Irritative

Stress

Obstructive Total

Physical

Travel

Social

Emotional

POP-Q stage 0.148 (0.009) 0.198 (0.000) 0.192 (0.001) 0.146 (0.01) 0.054 (0.384) 0.223 (0.000) 0.154 (0.008) 0.120 (0.039) 0.171 (0.003) Spearman correlation, r (p)

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E.S. Cetİnkaya: None. O. Dai: None. F. Dokmeci: None.

88 A SYSTEMATIC REVIEW AND META-ANALYSIS OF SURGICAL TREATMENT OF WOMEN WITH RECURRENT STRESS URINARY INCONTINENCE W. AGUR1, M. RIAD 2, S. SECCO 3, H. LITMAN 4, P. MADHUVRATA 5, G. NOVARA 3, M. ABDEL-FATTAH 6, Scottish Pelvic Floor Network 1 NHS Ayrshire & Arran, Kilmarnock, United Kingdom, 2 Worcestershire NHS Trust, Worcester, United Kingdom, 3 Univ. of Padua, Padua, Italy, 4New England Res. Inst.s, Watertown, MA, 5Sheffield Hosp. NHS Trust, Sheffield, United Kingdom, 6Univ. of Aberdeen, Aberdeen, United Kingdom. Objective: To assess the current evidence of effectiveness and complications of the various surgical procedures used for treatment of women with recurrent stress urinary incontinence (R-SUI). Background: The current evidence in medical literature is limited to a number of small observational studies and very few, if any, RCTs with limited populations. This is a systematic review, and meta-analysis when possible, of subgroups of women with R-SUI within larger RCTs comparing surgical treatments for women with SUI. Methods: A prospective, peer-reviewed protocol was prepared a priori. A systematic literature review of all published RCTs comparing any two surgical procedures for treatment of SUI was performed in accordance with PRISMA. Studies were identified through MEDLINE, EMBASE, Cochrane library, clinicaltrials.gov, and Web of Science Library as well as IUGA/ICS conference abstract databases. Literature search was performed in July 2011 independently by two authors and updated in March 2012. There were no language restrictions. Authors of RCTs for surgical treatment of R-SUI and those of RCTs for surgical treatment of SUI who had included a subgroup of patients with R-SUI, were contacted to provide further data. Two authors independently extracted data and controversies were resolved by discussions with senior authors. The primary outcome was the clinical cure/improvement (both patient-reported and objective outcomes) of incontinence for procedure A versus procedure B at 6– 24 month follow-up. The secondary outcomes were: intra-operative complications (such as major vascular injury, bladder, urethra or bowel perforation); postoperative complications (such as voiding dysfunction, erosion to vagina/ bladder or urethra); and impact on women’s quality of life and sexual function. Data was

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analysed using Rev-Man 5. Meta-analysis was performed using the fixed effect model and heterogeneity calculated using I2 estimate. Results: Out of 45 RCTs with confirmed subgroups of patients with R-SUI in their populations, complete data were available from 9 RCTs (n0309) towards our pre-specified 4 different comparisons: (a) retropubic tension-free vaginal tape (RP-TVT) vs. transobturator tape (TO-TVT): 5 RCTs, n0135; (b) RP-TVT vs autologous fascial sling (AFS): 2 studies; n035; (c) Burch colposuspension vs. AFS: 1 study, n093; and (d) inside-out vs. outside-in TO-TVT: 1 study, n046. Meta-analysis was possible only for comparisons (a) and (b). There was no evidence of statistically significant difference between RP-TVT and TO-TVT in either the patientreported (OR 0.84 95%CI 0.41, 1.69) or the objective cure/ improvement (OR 1.75 95%CI 0.86, 3.54). However, there was a higher risk of bladder/urethral injury with RP-TVT although not statistically significant (OR 0.27 95%CI 0.06, 1.20, p00.09). Similarly, there was no significant difference between AFS and RP-TVT in the patient-reported (OR 2.10 95%CI 0.48, 9.11) or objective cure/improvement (OR 1.43 95%CI 0.22, 9.26). Meta-analysis and estimates of effects were not possible in the other 2 comparisons of surgical techniques as data were available from only one study in each comparison. There was no significant difference between AFS and Burch colposuspension (one study) in the cure/improvement rate (OR 0.62 95%CI 0.27, 1.41). However, in comparison (d) between inside-out and outside-in TO-TVT, there was a trend towards higher rate of patient-reported cure/improvement (OR 3.00 95%CI 0.85, 10.57, p00.09) and objective cure/ improvement (OR 3.32 95%CI 0.96, 11.41, p00.06) in favour of the inside-out route, but this did not reach statistical significance (one study). The TO-TVT (and preferably the inside-out approach) may prove to be the favoured procedure in this context to reduce the risk of lower urinary tract injuries which can be a specifically high risk in these patients. The results of this study are unique as no previous metaanalysis was performed for R-SUI; however, they are limited by the small number of RCT’s and women included in the analysis. Conclusions: TO-TVT has similar patient-reported and objective cure/improvement rates when compared to the RPTVT in the surgical treatment of women with recurrent SUI. There was a trend towards higher success rate with the inside-out TO-TVT when compared to the outside-in approach. Similarly, there was no significant difference between AFS and RP-TVT in the patient-reported and objective cure/improvement rates. The results should be

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interpreted with caution as evidence in this field is quite limited and is of low quality. Further primary research is urgently needed to guide clinicians and patients towards the best surgical treatment of this increasingly prevalent and distressing condition. W. Agur: None. M. Riad: None. S. Secco: None. H. Litman: None. P. Madhuvrata: None. G. Novara: None. M. Abdel-Fattah: None. 89 A S Y S T E M AT I C R E V I E W O F TR E ATM E N T OPTIONS FOR THE SURGICAL MANAGEMENT OF RECURRENT STRESS URINARY INCONTINENCE K. NIKOLOPOULOS, S. K. DOUMOUCHTSIS St George’s NHS Trust, St George’s Univ. of London, London, United Kingdom. Objective: To systematically review the current evidence on the effectiveness of different surgical interventions for the management of recurrent stress urinary incontinence (SUI). Background: The reported prevalence of SUI can be as high as one in four adult women, and approximately half of all incontinent women are affected by this type of incontinence. Success rates of the currently available continence procedures appear high, but in spite of the wide spectrum of interventions, treatment of SUI fails in 10–20 % of patients. In the United States alone, about 120,000 women undergo surgery for UI each year. Since the tension-free vaginal tape (TVT) procedure was introduced, (1995) more than 1,200,000 cases have been performed worldwide, so the expected absolute numbers of women with failures and recurrences as well as recurrent procedures are high. Methods: We performed a systematic review to identify studies evaluating the success rates of treatments for recurrent SUI. We included studies reporting on at least 5 cases. All searches were performed independently by 2 researchers and updated in February 2012. Failure of management was defined as ongoing stress incontinence based on the different studies’ outcome measures, and/or the need to proceed to a surgical intervention. Studies from 1950 were selected from PubMed, Google, Google Scholar, Cochrane, as well as Embase (from 1980). Keywords used in combinations were: ‘stress urinary incontinence’, ‘recurrence’, ‘treatment’, ‘failure’. Searches were limited to humans and female patients. After the initial yield, studies were selected following title screening and then abstract and full text scrutiny. The selected studies were analyzed with a focus on their

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outcome measures, methodical quality and time of follow-up. The initial search yielded 338 studies and 34 of them were finally included. Results: Three identified studies evaluated Burch colposuspension (n01), or midurethral tape (MUT, n02) as treatment options after failed Burch colposuspension. The majority of studies on midurethral tapes show higher success rates but also a wide variation depending on the outcome measures (table 1). Eight cohort studies reporting on repeat MUT were included. They have varying success rates (40–100 %), but those of the transobturator approach appear lower than those of the retropubic procedures. Other studies evaluated laparoscopic as well as open colposuspension after failed MUT (n03). Colposuspension procedures are more invasive, and objective cure rates vary from 54% to 78 %. However they are associated with higher complication rates. Periurethral bulking injections after MUT have 77 % satisfaction rates and MUT after bulking injections 81–100 % subjective cure rates. Four cohort studies on artificial urinary sphincter showed success rates of 70–90 % with few minor complications, but not all included patients had previously had anti incontinence surgery. Re-adjustment of an adjustable tape and tape fixation procedures are not commonly used. Studies show more complications and similar success rates to the secondary procedures. Conclusion: The causes of treatment failure can be different from patient to patient and there is a wide spectrum of surgical interventions reported for secondary or tertiary treatment. The significant heterogeneity of the identified studies requires interpretation of findings and especially of pooled results with caution. The definition of criteria for cure and improvement of SUI differs between studies varying from subjective to objective and including use of diagnostic tools ranging from self reported questionnaires to pad tests. Complications have been inconsistently reported and may not represent the actual prevalence. The success rates, complications, and patient characteristics, must be considered by the surgeon and the patient for the expected outcome. The choice of treatment should also be based on urodynamic evaluation. Patient consultation should always include assessment of patient expectations. Randomized controlled trials of the various treatment options, as well as long term follow up studies are therefore required. J Obstet Gynaecol Res, 2010. 36(3): p. 467–73 J Urol, 2010. 183(1): p. 241–6 J Urol, 2007. 178(4 Pt 1): p. 1370–4

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PROCEDURE

NUMBER OF TOTAL OUTCOMES INCLUDED CASES (n) STUDIES

COMPLICATIONS (n0number of patients)

Burch colposuspension for recurrent SUI

1

•Bladder laceration 1 patient

Repeat Burch colposuspension MUT after failed Burch colposuspension

1 2

MUT for recurrent stress urinary incontinence

3 (any primary 184 incontinence procedure)

26

60 53

•81 % success following 1 continence procedure (any) •25 % following 2 continence procedures (any) •0 % after 3 continence procedures (any)

•Intraoperative hemorrhage (blood loss >1000 mL) 2 (4 %) •Urinary tract infection: 1 patient •Detrusor overactivity 2 (8 %) 69 % mean satisfaction rate None reported 57,1 %–70,8 % overall success rate •Bladder injuries (n06) •Urinary tract infection (n08) •De novo urge urinary incontinence (n05) •Urinary retention (n01) •TVT migrated (n01) 66 %–69,6 % objective cure •Intraoperative hemorrhage: (n011) 89 %–96 % subjective cure •Urinary tract infection (n08) •Obstructive voiding dysfunction necessitating prolonged CISC(n05) •Mesh exposure necessitating excision (n02) •Detrusor overactivity:(n01)

Repeat MUT

8

278

40 %–100 % cure (subjective)

Laparoscopic Burch colposuspension after failed MUT Open colposuspension after failed MUT

1

16

54 % cure (objective)

2

65

77 %–78 % cure (objective)

23 18 316

77 % (subjective) 81 %–100 % cure (subjective) 47 %–84 % cure (no necessity of pad usage)

Bulking injections after MUT 1 MUT after bulking injections 2 Re-adjustment tape for recurrent 5 SUI after any primary procedure (not specified)

•vaginal perforation(n05) •bladder injury (n01) •urethral injury(n01) •bladder perforation: (n04 ) •significant bleeding from the retropubic space: (n01) •de novo urge incontinence: (n021) •urgency (n035) •dysuria: (n05) •incomplete bladder emptying (n08) •urinary infection: (n02) Voiding difficulties (n01) •bladder injuries (n03) •rectus muscle tear which required repair (n01) •voiding difficulties which required clean intermittent self-catheterisation (n08) 4 patients required CISC for <3 days. nil •port erosion (n019) •balloon migration(n014) •balloon erosion (n011) •perforation at implant (n09), •worsening incontinence or no change (3.4 %), •procedure failure (n07) •pain/discomfort (n02)

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Table 1 (continued) PROCEDURE

NUMBER OF TOTAL INCLUDED CASES STUDIES (n)

Tape fixation / shortening / loosen 2 or tighten

18

Spiral sling for recurrent SUI after any primary procedure (not specified)

74

2

Artificial urinary sphincter for 4 recurrent SUI after any primary procedure (not specified)

374

OUTCOMES

COMPLICATIONS (n0number of patients)

•device failure infection and withdrawal (n021) 60 %–75 % Cure (absence of any 1 woman, had a second TVT-O for rupture episode of involuntary urine of the pre-implanted mesh during the leakage adjustment 72 %–75,6 % improvement ( patient •One patient had a vaginal extrusion of report on questionnaires) the spiral sling on 1 side •De novo urge incontinence(n05) •Unilateral vesical perforation (n03) 70 %–87,5 % satisfaction (pad •Pain (n025) use≤2 per day) •Hematoma (n015) •UTI (n055) •Hematuria (n03) •Urinary retention (n050) •Unable to wean from bladder catheter (n095) •Vaginal injuries (n03) •Ureteral injuries (n02) •Enteroplasty dissection (n01)

NUMBER OF STUDIES / TOTAL CASES / OUTCOMES / COMPLICATIONS (table 1) K. Nikolopoulos: None. S. K. Doumouchtsis: Grant / Research Support; Ethicon. 90 LONG-TERM RESULTS OF PELVIC FLOOR MUSCLE TRAINING OR MIDURETHRAL SLING SURGERY FOR FEMALE MODEREATE TO SEVERE PREDOMINANT STRESS URINARY INCONTINENCE: A RANDOMISED CONTROLLED TRIAL J. LABRIE1, L. C. BERGHMANS 2, K. FISCHER 1, A. L. LAGRO-JANSSEN 3, C. H. VAN DER VAART 1, The Portret Study Group 1 Univ. Med. Ctr. Utrecht, Utrecht, Netherlands, 2Univ. Med. Ctr. Maastricht, Maastricht, Netherlands, 3Univ. Med. Ctr. Nijmegen, Nijmegen, Netherlands. Objective: The objective of this RCT was to compare the effect of pelvic floor muscle training (PFMT) or midurethral synthetic sling surgery for the subjective cure of stress urinary incontinence (SUI) symptoms in women with moderate to severe symptomatic predominant stress urinary incontinence. Background: PFMT is advocated in international guidelines to be the first-line treatment for SUI. When PFMT is unsuccessful, a midurethral synthetic sling procedure is the next option. These two treatment options have never been compared directly as primary treatment options in a

randomised study. This abstract will focus on the 12 month outcomes of both interventions for SUI symptoms. Methods: From March 2008 till May 2010 patient inclusion for a multi-center RCT (24 centers) was conducted in the Netherlands. Subjects were women with moderate to severe predominant symptomatic SUI as measured with the Sandvik index1. They were treatment naïve or had not had specialised PFMT for at least six months prior to inclusion. Women were randomised for either PMFT by specialised physiotherapists (once weekly, including biofeedback, according to the national guidelines, up to 9–18 sessions) or midurethral synthetic sling procedure (retropubic or transobturator). At baseline and 12 months follow-up subjective symptoms were assed with the patient global impression of severity and improvement index (PGI-S, PGI-I)2. This simple, one question outcome measure is commonly used in incontinence research. The PGI-S was dichotomised into no complaints and mild, moderate or severe symptoms and the PGI-I into improvement or no improvement (including worse symptoms). The presence or absence of subjective SUI symptoms was assessed with a question from the UDI. Objective cure was assessed with a standardised urinary stress-cough test. Sample size calculation was based on an expected difference in subjective cure of 15 % and resulted in 200 women for each arm to detect a difference with a power of 0.9 at an alpha of <5 %. We expected a lost to follow-up of 15 % and therefore we aimed to include 460 women in the study. Analyses were performed on intention-to treat basis. Data of chi-square statistics are presented in 2×2 tables with treatment effects (percentage

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point differences) and 95 % confidence intervals. Original data are presented and outcomes were checked in after missing data were imputed. Results: Two hundred thirty-one women were randomised for surgery and 231 for PFMT. At 12 months follow up 99 patients (49 %) in the PFMT group were operated after PFMT. In table 1 and 2 the PGI-S and PGI-I results, objective and subjective cure at 12 months follow up are presented. At 12 months follow-up significantly more women in the surgery group (90.8 %) reported to be (very) much improved compared to women in the PFMT group (64.4 %). Furthermore significantly more women in the surgery group (85.6 %) than women in the PFMT group (65.5 %) reported their complaints to be not severe. Subjective and objective cure of SUI occurred significantly more often in the surgery group compared to the PFMT group. Conclusions: At 12 months follow-up, women with moderate to severe SUI who underwent primary surgery were significantly more likely to experience symptomrelief, improvement of symptoms, and subjective cure from SUI compared to women that were allocated to primary PFMT. Table 1. Subjective outcome measures at 12 months follow up 12 months follow-up

PGI-I (improved) PGI-S (not severe)

MUSS

PFMT

Treatment effect ([95 %] CI)

P-value

177/195 (90.8 %) 167/195 (85.6 %)

112/174 (64.4 %) 114/174 (65.5 %)

26.4 (18.1–34.5)

<0.001

20.1 (11.4–28.6)

<0.001

Table 2. Subjective and objective cure at 12 months follow up 12 months follow-up

Objective cure Subjective cure*

MUSS

PFMT

Treatment effect ([95 %] CI)

P-value

140/183 (76.5 %) 167/196 (85.2 %)

94/160 (58.8 %) 93/174 (53.4 %)

17.8 (7.9–27.3)

0.001

31.8 (22.6–40.3)

<0.001

* “Do you experience urine leakage related to physical activity, coughing, or sneezing?” References: 1. J Epidemiol Community Health. 1993 Dec;47(6):497–9 2. Am J Obst Gynecol, 189(1), 98–101 J. Labrie: None. L. C. Berghmans: None. K. Fischer: None. A. L. Lagro-Janssen: None. C. H. van der Vaart: None.

91 WHO WILL UNDERGO MIDURETHRAL SLING SURGERY AFTER INITIAL PELVIC FLOOR MUSCLE TRAINING FOR MODERATE TO SEVERE PREDOMINANT STRESS URINARY INCONTINENCE J. LABRIE1, A. L. LAGRO-JANSSEN 2, K. FISCHER 1, L. C. BERGHMANS 3 , C. H. VAN DER VAART 1 , The Portret Study Group 1 Univ. Med. Ctr. Utrecht, Utrecht, Netherlands, 2Univ. Med. Ctr. Nijmegen, Nijmegen, Netherlands, 3Univ. Med. Ctr. Maastricht, Maastricht, Netherlands. Objective: We developed a prediction rule to predict the chance of additional midurethral sling surgery after pelvic floor muscle training for women with predominant symptomatic moderate to severe stress urinary incontinence treated with primary pelvic floor muscle training (PFMT). Background: After treatment with PFMT 5 % to 49 % of women with stress urinary incontinence (SUI) will be objectively cured compared to 57–92 % of women treated with midurethral sling surgery (MUSS). After 3–15 years followup, up to 50 % of women primarily treated with PFMT will proceed to MUSS. This abstract will focus on the possible predictors for MUSS after PFMT. Furthermore a prediction rule was developed to predict the chance of MUSS after completing primary PFMT. Methods: Data for this study were collected as part of a randomised controlled trial comparing primary PFMT or MUSS for SUI. From March 2008 till May 2010 patient inclusion for this trial was conducted. Data from women allocated to primary PFMT were used. Supervised PFMT was conducted according to national guidelines. PFMT was not continued when the woman and physiotherapist both decided further treatment was not effective. Demographic and incontinence related data obtained at baseline were used for constructing the prediction rule. The main endpoint was MUSS before 12 months follow up. All possible predictors, with P-values≤0.20 in univariate analyses, were simultaneously entered in a multivariable regression model with a stepwise backward selection procedure to construct the prediction rule for the chance of MUSS after PFMT. Regression coefficients were shrunk to reduce overfitting of the model. A prediction rule was designed based on the shrunk regression coefficients. The agreement between predicted probabilities and the observed frequencies of surgery was tested with the Hosmer-Lemeshow test (calibration). The area under the receiver operating curve was calculated for the model. Specificity, sensitivity negative and positive predicted values were calculated for several cut off points of the score.

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Results: The primary PFMT treatment arm consisted originally of 231 women and 202 women were eligible for analysis, 38 women were lost to follow up, however information on operation status after PFMT was collected. A total of 99 (49 %) women in the PFMT group received additional MUSS after ceasing PFMT. The results of multivariable analysis are presented in table 1. The calibration of the model was good (Hosmer-Lemshow test P00.883) A simplified prediction rule was constructed: (4*age<55)+(2*Sandvik-severe)+(4*higher educational level)+(0.1*UDI-score on incontinence domain)+(-9*(higher educational level*age<55)). A discriminative ability for the risk score of 0.71 was calculated with the area under the curve of the ROC curve. In table 2, sensitivity, specificity, positive and negative predictive values for different score cut-off points are presented. Conclusions: Women under the age of 55 with a higher level of education and more severe stress urinary incontinence complaints before start of treatment are more likely to undergo midurethral sling surgery after initial treatment with pelvic floor muscle training. Our prediction rule could be a helpful tool in counseling women in the treatment of their SUI complaints. Table 1. Results of multivariable analysis after selection of possible predictors Characteristic

Multivariable analysis

Age <55 HEL Sandvik (severe) UDI Incontinence HEL*Age<55 Contant

Score

OR (95 % CI)

P value

β

2.86 (1.30–6.32) 3.28 (0.80–13.47) 1.76 (0.95–3.29) 1.03 (1.01–1.05) 0.86 (0.02–0.46) 0.12

0.01 0.10 0.08 0.02 0.04 0.00

1.052 1.187 0.566 0.028 −2.448 −2.120

4 4 2 0.1 −9

HEL; Higher Educational Level Table 2. Absolute number of patients and patients with midurethral sling surgery before 12 months follow up according to score calculated with the prediction rule Score No. of No. of patients patients with operation <12 months FU

Sensitivity Specificity PPV NPV

>7 >8

113 71

71 46

0.73 0.47

0.58 0.75

0.63 0.69 0.65 0.60

>9 >10 >11

60 35 24

41 27 18

0.42 0.28 0.19

0.81 0.92 0.94

0.68 0.59 0.77 0.57 0.75 0.55

PPV: Positive predictive value; NPV: Negative predictive value J. Labrie: None. A. L. Lagro-Janssen: None. K. Fischer: None. L. C. Berghmans: None. C. H. van der Vaart: None.

92 A RANDOMISED TRIAL OF THE MINIARC SINGLE INCISION SLING VERSUS A RETROPUBIC TVT IN THE MANAGEMENT OF WOMEN WITH STRESS URINARY INCONTINENCE- THREE YEAR FOLLOW UP M. BASU, J. DUCKETT Medway Maritime Hosp., Gillingham, Kent, United Kingdom. Objective: To evaluate the long term efficacy of a single incision sling versus a retropubic tension free vaginal tape (TVT) for the surgical management of stress urinary incontinence (SUI). Background: The TVT is a minimally invasive and effective treatment for SUI. A randomised study comparing the TVT to the colposuspension found similar efficacy rates, but with fewer post-operative complications, recovery time and hospital stay in the TVT group1. Long term follow up studies have found efficacy to persist in the longer term. More recently a third generation of mid-urethral slings has been developed using a single vaginal incision and shorter tape. The aim of single incision slings is to further reduce morbidity. These slings require less dissection and have the potential to be used in a true out patient setting (local anaesthetic without sedation). Much of the existing data on single incision slings in the literature is from non-randomized cohort studies, with conflicting results. The small number of published randomized studies report short term follow up data only (up to 1 year), with no long term data. These studies have reported a lower short term cure rate for stress incontinence in women undergoing a single incision sling2,3. Here we report the outcome of a 3 year follow up of women entered into a randomized trial of the Miniarc single incision sling versus the Advantage TVT. The 6 week and 6 month objective and subjective data have been previously reported. Methods: This was a single centre, prospective, randomised trial. A 90 % power and significance level of 0.05 gave a sample size of 64 (32 in each arm) to show equivalence between the TVT and the Miniarc single incision sling. Women with SUI resistant to conservative therapy, together with objective evidence of urodynamic stress incontinence (USI) were eligible for entry to the trial. Exclusion criteria included previous continence surgery, pelvic organ prolapse of stage 2 or above, voiding dysfunction and recurrent urinary tract infections. A total of 71 patients were randomised to undergo retropubic TVT or Miniarc insertion upon entry to the study, and were followed up by questionnaire at 3 years post-operatively. The primary outcome measure was persistent stress urinary incontinence as indicated by the symptom domain of the King’s Health Questionnaire (KHQ). Secondary outcome measures were the incidence

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of secondary continence procedures and quality of life scores. All participants were given written information on the study and procedures and gave informed consent. Approval for this study was granted by the local Research Ethics Committee. Results: 3 year questionnaires were received from 35/38 women in the minisling group and 26/33 in the TVT group. There were no baseline demographic or clinical differences between the two study groups. At 3 years’ follow up, 8/38 (21.1 %) of patients in the minisling group and none in the TVT group had undergone a second continence procedure for persistent SUI. Of the remaining patients in the single incision sling group, 11/30 had persistent SUI, giving an overall 3 year failure rate of 19/38 in the single incision sling group versus 3/33 in the TVT group (OR 10.0, 95 % confidence interval 2.6 to 38.4). There was a significant difference in KHQ domain scores between the single incision sling and TVT groups, with lower quality of life scores in the single incision sling group. There were no late adverse events identified at this 3 year follow up. Conclusions: At 3 years’ follow up, the failure rate for the Miniarc single incision sling was significantly higher than in the TVT group. The re-operation rate for persistent SUI for the single incision sling group in this study was 21 %. There is a need for reporting of further long term outcome data, in order to fully evaluate the place of single incision slings in the management of women with SUI. These data suggest that they should be used with caution. References: 1. BMJ 2002; 325: 67 2. BJOG 2010; 117: 730–735 3. J Urol 2011; 185: 1356–1362 M. Basu: None. J. Duckett: Grant /Research Support; American Medical Systems, Boston Scientific.

93 MINIARC AND MONARC SUBURETHRAL SLING IN WOMEN WITH STRESS URINARY INCONTINENCE —A RANDOMISED CONTROLLED TRIAL J. LEE1, A. ROSAMILIA 2, P. DWYER 3, Y. N. LIM 3, E. THOMAS 3, C. MURRAY 3, E. FITZGERALD 2, A. LEITCH 2, A. POLYAKOV 2, L. SCHIERLITZ 3 1 Mercy Hosp. for Women, Monash Moorabbin, Melbourne, Australia, 2Monash Moorabbin, Melbourne, Australia, 3 Mercy Hosp. for Women, Melbourne, Australia. Objective: to assess and compare objective, subjective and functional outcomes following Miniarc or Monarc suburethral sling in women with stress urinary incontinence (SUI) at 6 m. Background: Midurethral slings (MUS) had become the most common surgery for women with SUI. Single incision slings, such as Miniarc, were introduced to reduce post

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operative pain, and improve recovery. We set out to examine if Miniarc had at least equivalent objective cure rates against Monarc at 6 m. Methods: Women, referred to tertiary urogynaecology centres, who had SUI or urodynamic stress incontinence (USI) were randomised, in a 1:1 ratio, to receive either Miniarc or Monarc. Women with intrinsic sphincter deficiency, previous MUS, untreated detrusor overactivity or significant voiding dysfunction were excluded. Assuming an objective cure rate of 85 % for Monarc, this RCT was powered (80 %) to detect a clinical difference of 15 %, and allows for an attrition of 15 % with a sample size of 220, using a one sided α of 0.05. Computer generated random allocation was concealed and stratified to centre. Surgeons or patients were not blinded once allocation was revealed. Patients were seen at 6w and 6 m with a clinical examination. Standardised proformas together with validated tools, including ICIQ UI SF, ICIQ OAB, PISQ12, IIQ7, PGII and 24 pad weigh, were used to facilitate prospective collection of data to evaluate objective and subjective outcomes following surgery. Objective cure was defined as negative urodynamic stress or cough stress test (CST) at follow up. Subjective cure was defined as absence of patient reported SUI at follow up. Surgeries were performed, according to manufacturer’s instructions, by surgeons had already performed at least 10 Miniarc, which was tensioned to snug. Urodynamic studies were performed pre operatively and 6 m post operatively. Definitions, outcome measures and standardised reporting adhered to IUGA/ICS terminology, IUGA & CONSORT guidelines. Institution ethics approval was obtained and the trial was registered with the ANZCTR (ACTRN12608000624381). Outcomes were compared with Pearson χ2 or Fischer Exact test for categorical data and Student t test or Wilcoxon rank-sum for continuous data as appropriate. Results: 271 women were assessed for eligibility, of which 31 declined participation, 2 indicated a preference to Miniarc (refused randomisation), and 14 were excluded post randomisation (3 did not meet criteria, 10 withdrawn from surgery, 1 unfit). 224 women aged 31–81 (52.9±9.9) received Miniarc (112) or Monarc (112). Median parity was 2 (0–6), mean BMI 27.8±5.8 (15–46). Table 1 showed a balanced baseline characteristic. Perioperative results from Table 2 showed the Monarc arm has more trocar repass, took longer (sling only), had a higher proportion of women requiring more than 1 day of catheters and required more analgesia usage. Table 3 demonstrated no statistically significant difference in the subjective (absence of SUI) or objective (absence of USI or CST) cure rates between Miniarc and Monarc at 6 m. Within both Miniarc and Monarc groups, there was a statistically significant improvement at 6 m for ICIQ UI, ICIQ OAB, PISQ12, IIQ7, PGII scores and 24 h pad weigh but no statistically significant difference

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between both arms at 6 m, including proportion of antimuscarinic use, except a higher PISQ12 score for Monarc, as detailed. At latest follow up, 3 in Miniarc and 2 in Monarc group underwent repeat surgery for SUI (TVT). There was 7 reported groin pain (not bothersome) and 3 detected paraurethral prominence (asymptomatic) in the Monarc arm, but none in the Miniarc arm. There were no sling divisions in both arms. Conclusions: Patients who had Miniarc sling only, needed less analgesia and had less groin pain compared to those who have Monarc sling only. At this short term follow up, efficacy of Miniarc appears comparable to Monarc.

Table 1 (continued) Monarc (n0112) Miniarc (n0112) P value (C / V) LPP M±sd Ba M±sd Bp M±sd C M±sd Concomitant POP Vag Hyst±A/P or AP repair (Ant) Mesh kit or ASC Posterior repair only±Mesh

110±51.8 −1±1 6±2 −1±1 53 33

107±29 −1±1 6±2 −1±1 44 25

0.5933 1.0 1.0 1.0 0.2249 0.6786

5 15

7 12

0.3690 1.0

Table 1. Baseline characteristics—MiniMo Table 2. Perioperative results—MiniMo Monarc (n0112) Miniarc (n0112) P value Age (y) M±sd Parity # BMI M±sd Menopause (%) Prev Hysterectomy Previous POP surgery Previous SUI Surgery Chest Neuro DM CT ICIQ UI SF # Antimuscarinic use ICIQ OAB # PISQ 12 # Not Sexually active

52.27±9.69 2 (2,3) 27.96±5.66 49 21 5 1 17 14 (11,16) 15 5 (4,8) 34 (29,38) 23/110

53.56±10.22 2 (2,3) 27.58±5.92 46 21 7 4 16 13 (10,16) 16 5 (3,8) 33 (28,37) 20/110

0.3362 0.9492 0.6238 0.685 1.0 0.5529 0.1748 0.8505 0.2745 0.8466 0.927 0.9528 0.7341

IIQ 7 # PGI S # 24 h pad M±sd USI DO MUCP M±sd

9 (5,12) 3 (3,3) 35±45 102 5 48.8±21

9 (5,13) 3 (2,3) 25±35 102 10 45.5±17.1

0.6704 0.0279 0.0647 1.0 0.1814 0.1985

Monarc (n0112)

Miniarc (n0112) P value

Trocar repass Groin pain Groin pain≤1w Groin pain >1w Catheter≤2d Catheter 2–4d Catheter 4–7d hematoma

12 (9 L 3R) 34 27 7 19 1 1 0

wound infection Qmax <15, <10th Centile PVR >100

3 (antibiotics only) 1 VH Ant Elevate: V333 Q11, PVR 100 Monarc (n059) 10.95±5.37 4 5.5±8.2

3 (1R, 2 L) 10 7 3 2 1 1 2 (1 packing, 1 drainage) 0 1 miniArc only: V428 Q8, PVR100 Miniarc (n068) 8.82±5.16 1 1.5±2.6

(Sling only) Time (min) catheter>1d panadeine Use

0.0161 0.0001 0.0005 0.34 0.0001 1.0 1.0 0.4978 0.25

0.0028 0.1747 〈0.0001

Table 3. 6 m cure rates and functional outcomes—MiniMo

(#Median (25 %,75 %)

Subj Cure Obj Cure Sling only Subj Cure Sling only Obj Cure ICIQ UI SF # OAB Meds ICIQ OAB # PISQ 12 #

Monarc Baseline

Monarc 6m

14 (11,16) 15/112 5 (4,8) 34 (29,38)

94/105 77/87 50/56 40/46 4 (0,6) 12/112 3 (2,5) 39 (33,41)

Miniarc Baseline

Miniarc 6m

P value Between groups 6 m vs 6 m

13 (10,16) 16/112 5 (3,8) 33 (28,37)

92/100 73/83 58/64 49/55 4 (0,7) 10/112 3 (2,5) 37 (33,40)

0.5411 0.9108 0.8073 0.7413 0.6323 0.6534 0.6138 0.045

P value Within group 0 m vs 6 m Monarc

P value Within group 0 m vs 6 m Miniarc

〈0.0001 0.5381 〈0.0001 〈0.0001

〈0.0001 0.2107 〈0.0001 0.0051

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Table 1 (continued) (#Median (25 %,75 %)

Not Sexually active IIQ 7 # PGI I # 24 h Pad M±sd

Monarc Baseline

Monarc 23/110 9 (5,12) 3 (3,3) 35±45

Monarc 6m

Miniarc Baseline

Monarc 28/99 0 (0,3) 1 (1,2) 8.3±23

Miniarc 20/110 9 (5,13) 3 (2,3) 25±35

J. Lee: Grant /Research Support; AMS. A. Rosamilia: Grant /Research Support; AMS. P. Dwyer: Grant /Research Support; AMS. Y. N. Lim: Grant /Research Support; AMS External Research Grant. E. Thomas: None. C. Murray: None. E. Fitzgerald: None. A. Leitch: None. A. Polyakov: None. L. Schierlitz: None. 94 DOSE INDEPENDENT EFFECT OF INTRASPHINCTERIC IMPLANTATION OF AUTOLOGOUS MYOBLASTS FOR THE TREATMENT OF STRESS URINARY INCONTINENCE IN WOMEN A. ROSE1, M. JU 2, C. REHME 1, H. RÜBBEN 1 1 Univ. Hosp. of Essen, Essen, Germany, 2Praxisklinik Urologie Rhein/Ruhr, Mülheim, Germany. Objective: Purpose of this phase IIb study was, to find the optimal dosage for treatment of stress urinary incontinence by implantation of autologous skeletal muscle-derived cells into the urethral sphincter and to assess efficacy and safety. Background: This study addressed women aged 18 to 75 years with proven stress urinary incontinence. Each patient had a history of failed or refused pelvic floor muscle training and no previous anti incontinence surgery. Methods: Between 06/2010 and 06/2011 263 women were randomized and 217 patients were evaluable for efficacy. Urodynamic studies were done prior to randomization to exclude patients with detrusor overactivity. Patients were randomized in an open manner to cell implantation or control groups and in a double-blind manner to either high (10×106) or low (0.2×106) cell count implantation or to placebo or duloxetine treatment (ratio 2:2:2:1). Duloxetine (max. 80 mg/ d) was included in the study to blind the placebo. Patients in the cell implantation arms received a muscle biopsy from the pectoralis or biceps muscle under local anaesthesia. Autologous satellite cells were isolated, brought into culture and expanded up to the desired cell number. Transurethral injection of cells was done under general anaesthesia with a device enabling a standardized ultrasound-directed implantation of

Miniarc 6m

Miniarc 23/97 0 (0,4) 1 (1,2) 6.4±11

P value Between groups 6 m vs 6 m

P value Within group 0 m vs 6 m Monarc

P value 0.5167 0.927 0.9943 0.455

P value 0.2594 〈0.0001 〈0.0001 〈0.0001

P value Within group 0 m vs 6 m Miniarc P value 0.3914 〈0.0001 〈0.0001 〈0.0001

cells into the external urethral sphincter with high precision. Afterwards all treatment and control groups performed electrical stimulation of the pelvic floor for 12 weeks. Primary efficacy endpoint of the study was the change from baseline in the IEF score 12 weeks after treatment. Therefore patients had to document incontinence episodes in a diary over 1 week prior to each visit. Secondary endpoints reported here were changes in the I-QoL score and the 1 h pad test. For safety evaluation all adverse events were analyzed. Results: For safety evaluation 120 patients treated with cell implantation were evaluated. No treatment related serious adverse events were reported for the cell implantation groups. The most common adverse events with at least possible relation to treatment were urethral or post procedural hemorrhage with a frequency of 7 episodes of mild intensity in both cell groups. Urgency or frequency Symptoms were observed in 3 and urinary tract infections in 2 cases of mild intensity. Regarding frequency and severity there were no significant differences between both cell implantation groups. The evaluation of the primary efficacy variable revealed a reduction in the mean IEF score in all groups (Table 1). Superiority of cell implantation over placebo was observed for low cell count (p00.0019) as well as high cell count (p0 0.002) but there was no significant difference between both cell implantation groups. Table 1. Pre-post comparison 12 weeks after treatment, IEF: Incontinence episode frequency N

Low cell count

61 IEF [Episodes/w] Pre-treatment 25.2 mean Post-treatment 8.8 mean Difference mean −16.4 (13.3) (SD)

High cell count

Placebo

Duloxetine

56

68

32

28.6

25.1

26.8

10.2

16.1

15.4

−18.4 (18.6) −9.0 (13.1) −11.4 (18.2)

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One of the secondary efficacy variables was the change in the pad weight from baseline. A decrease in pad weight was observed in all groups. Mean decrease in the pad weight was: 10.9 g (low cell count), 11.3 g (high cell count), 6.7 g (placebo) and 6.8 g (duloxetine). Whereas both cell concentrations were equally effective, cell implantation showed superiority of the low and high cell count groups over placebo treatment (p00.0005, p<0.0001 respectively) and duloxetine treatment (p00.0051, p00.0023 respectively). Measures of Quality of life evaluated with the I-QoL questionnaire showed a mean increase of I-QoL score in all groups: 31.3 (low cell count), 32.3 (high cell count), 13.8 (placebo) and 20.2 (duloxetine). The increase in Quality of life observed in the high cell count group was significantly superior vs. placebo and duloxetine (p < 0.0001, p 00.0094 respectively) which was also true for the low cell count group (p 00.0002, p0 0.0438 respectively). Also this analysis showed equivalence of both cell implantation groups. Conclusions: In this study we evaluated safety and efficacy of implantation of autologous myoblasts into the urethral sphincter in stress urinary incontinent women. For this purpose we used two different concentrations of 0.2×106 and 10×106 cells respectively. The equivalence of both cell doses, with regard to efficacy and safety, was confirmed for all primary and secondary parameters. Treatment related adverse events were of mild intensity and easily treated which leads us to the assumption, that cell therapy for stress urinary incontinence is safe. Regarding the reduction of IEF, we could demonstrate significant superiority vs. placebo for both cell concentrations. For the secondary efficacy criteria we also observed a superiority of cell therapy vs. duloxetine treatment. A. Rose: None. M. Ju: None. C. Rehme: None. H. Rübben: None.

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birth-associated injury mechanisms responsible for increased pelvic floor dysfunction remain to be elucidated [2, 3]. Methods: A 3-D finite element model was created from magnetic resonance (MR) images of a healthy nulliparous woman; an improved representation of the injury-prone pubic origin of the LA was developed) and LS-DYNA (v. 971 R5) (Fig. 1). The LA was modeled using 1,576 brick elements. The arcus tendineus levator ani (ATLA) was represented as a catenary supporting the posterior LA between the pubic ramus and ischial spine. LA fiber anisotropy was measured from MR images and incorporated into the model. Ripened soft tissue properties were taken from human tissues. A spherical molded fetal head was passed through the birth canal at constant velocity to represent the 2nd stage of labor. Results: Two foci of concentrated stress and strain were identified during the birth: the pubic origins of the arcus tendineus levator ani (ATLAo) and the pubovisceral muscle enthesis (PVMe). The ATLAo was placed under greater stress and strain than the PVMe particularly at the early 2nd stage (Fig. 2a). As the fetal head further descends and fully engage the LA, the PVMe also becomes the region of concentrated stress (Fig. 2b). More specifically, a localized stress and strain concentration characteristically occurs at the inferior obtuse corner of the PVMe. Conclusions: The pubic origins of both the ATLA and PVM are at risk for injury due to excessive stress and strain, with the former being stressed earlier during the 2nd stage than the latter. This is the first biomechanical explanation of why it is the pubic origins of these structures that can be injured during vaginal birth.

95 WHY IS THE LEVATOR ANI INJURED AT ITS PUBIC ORIGIN DURING VAGINAL BIRTH? A BIOMECHANICAL ANALYSIS J . K I M , C . B E T S C H A RT, J . O . D E L A N C E Y, J. A. ASHTON-MILLER Univ. of Michigan, Ann Arbor, MI. Objective: To develop a biomechanical computer model to better understand how, when and why injuries occur at the pubic origin of the levator ani muscle (LA) during the 2nd stage of vaginal birth. Background: Vaginal birth is the single largest modifiable risk factor for pelvic floor dysfunction, including genital prolapse and incontinence [1]. However, details of the

Fig. 1. 3-D pelvic floor FE model. Top view with the pubic bone (PB) for orientation. Lateral edges of the levator ani (LA) are supported by the arcus tendineus levator ani (ATLA), a catenary structure from the ischial spine (IS) to the anterior PB. (PVM: pubovisceral muscle; P: perineum; R: rectum)

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Johnson & Johnson, Kimberly-Clark Corp, Procter & Gamble Co.

96 NUMERICAL MODEL OF THE PERINEUM WITH AND WITHOUT MANUAL PERINEAL PROTECTION M. JANSOVA 1 , V. KALIS 2 , L. LOBOVSKY 3 , R. ZEMCIK 1, Z. RUSAVY 2, K. LAINE 4 1 European Ctr. of Excellence NTIS—New Technologies for Information Society, Faculty of Applied Sci., Univ. of West Bohemia, Pilsen, Czech Republic, 2Dept. of Obstetrics and Gynecology, Univ. Hosp., Faculty of Med., Charles Univ., Pilsen, Czech Republic, 3Mechanical and BioMed. Engineering, Coll. of Engineering and Informatics, Natl. Univ. of Ireland, Galway, Ireland, 4Dept. of Obstetrics, Oslo Univ. Hosp., Oslo, Norway.

Fig. 2. LA principal stress contours in the early (a) and the late (b) 2nd-stage of labor. Note stress concentrations at the ATLAo before the fetal head fully interacts with the levator ani (LA). As delivery progresses, the PVMe also exhibits a stress concentration, especially at the inferior obtuse attachment to the pubic bone References: [1] Obstet Gynecol (2006) 107:144–9 [2] Obstet Gynecol (2004) 103:31–40 [3] J Biomech (2012) 45:455–60 J. Kim: None. C. Betschart: Grant /Research Support; Swiss National Research Foundation. J. O. DeLancey: Grant /Research Support; American Medical Systems Inc, Johnson & Johnson, Kimberly-Clark Corp, Procter & Gamble Co. J. A. Ashton-Miller: Grant / Research Support; American Medical Systems Inc,

Objective: Using a computerized numerical biomechanical model to analyze tension of the perineum during vaginal delivery comparing ,,hands-on“ and ,,hands-off” techniques. Background: The main principle for reducing perineal tension at its acutest point is to disperse it over a wider surface area. It is difficult to prove significance of manual perineal protection (MPP) and results in recent studies are conflicting. MPP is categorized into: “hands-on”, “hands-poised” or “hands-off” techniques. To our knowledge, this is the first study exploring manual perineal protection from the perspective of biomechanics. The aim of this study is to quantify the tension of the perineum during the final part of the delivery with finite element model(s) of the perineum and to evaluate whether MPP can reduce this tension throughout the entire thickness of the perineal body and thus, minimize perineal trauma. Methods: A novel finite element model was developed to show the effect of MPP, as such a model of the perineum did not exist. This model allows for the depiction of the stretching and movement of the perineal tissue around the fetal head during the simulation of a vaginal delivery. To define this model of the perineum, available data from literature with regards to anatomy were collected. I.e. the location and dimensions of the perineal structures (pubis, subpubic angle, inferior pubic ramus, genital hiatus, perineal body, anus), fetal head, trajectory of the passage of the fetal head, location of the fingers on the perineal surface, area of contact between fingers and the perineum, pressure between fingers and finger trajectory. Stereophotogrammetry during the second stage of labor was used to adjust the geometry of the model to correspond more accurately to biomechanical changes in perineal anatomy during the final part of labor.

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The materials for the evaluated structures used in the model are chosen with respect to the available data. Boundary conditions are set with respect to the anatomy. The vaginal delivery is simulated with the model. The stretching and movements of the perineal tissue around the fetal head were recorded for both “hands-on” and “hands-off” techniques of delivery during a videosimulation. Results: The stress distribution with “hands-off” technique shows the highest tension in the midline at the fourchette. The stress distribution with “hands-on” shows the same location of the highest tension, while using MPP the peak of stress was decreased by 23 % compared to the “handsoff”. The cross-sections through the midline of the perineal body (see Figures) revealed that in ,,hands-off“ the area of the tissue tension above 20, 40 and 60 units of stress is 2.2, 1.7 and 2.7-times larger compared to the “handson” technique. Conclusions: In a biomechanical assessment with a finite element model of vaginal delivery, appropriate application of fingers on the surface of the perineum during the second stage of delivery significantly reduces the tissue tension throughout the entire thickness of the perineum and thus, this intervention might be beneficial in reducing the rate and/or degree of obstetric perineal trauma.

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M. Jansova: Grant /Research Support; European Regional Development Fund (ERDF), project European Centre of Excellence, NTIS—New Technologies for Information Society, CZ.1.05/1.1.00/02.0090. V. Kalis: None. L. Lobovsky: None. R. Zemcik: Grant /Research Support; European Regional Development Fund (ERDF), project European Centre of Excellence, NTIS—New Technologies for Information Society, CZ.1.05/1.1.00/02.0090. Z. Rusavy: None. K. Laine: None.

97 EFFECT OF TIME INTERVAL BETWEEN REPEAT TRANSECTION ON RECOVERY OF EXTERNAL ANAL SPHINCTER CONTRACTILE FUNCTION IN AN ANIMAL MODEL S. BALGOBIN, J. F. ACEVEDO, T. I. MONTOYA, R. A. WORD, C. Y. WAI Univ. of Texas Southwestern Med. Ctr., Dallas, TX. Objective: To evaluate the effect of the time interval between repeat transection on the contractile properties of the external anal sphincter (EAS). Background: Although mechanical disruption of the anal sphincter complex that occurs during vaginal delivery is thought to be a major cause of anal incontinence in women,

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the exact mechanism of postpartum anal incontinence is unclear, and many questions remain unanswered. One of these is the effect of recurrent injury of the anal sphincter on longterm function and whether recovery of physiologic function occurs with time. Even though our prior data suggests that recovery eventually occurs after primary injury, the effects of repeat sphincter transection with repair and the timing of this second injury on the recovery process are unknown. Methods: 80 young female rats underwent anal sphincter transection and repair. After a 90-day interval, animals underwent a second operation, randomized to either repeat sphincter transection (Inj-Inj, n040) or sham operation (i.e., superficial vaginal incision without sphincter involvement, Inj-Sham, n0 40). Thereafter, the anal sphincter complex was dissected, mounted, and analyzed for contractile function 7, 21, 90 or 180 days after the second operation. Contractile function was also determined in 40 age-matched unoperated controls, (n0 10 for each time point). Results from this study were compared with those from a previous concurrently designed and conducted study in which the interval between repeat sphincter transection was 7 d. Statistical analysis was performed using ANOVA with Tukey-Kramer adjustment for multiple testing, with P≤0.05 considered significant. Results: Although single injury (Inj-Sham) resulted in modest compromise of sphincter function, repeat injury (Inj-Inj) resulted in profound impairment of twitch tension, maximal tetanic responses, and maximal electrical field stimulation (EFS) induced force generation 7 d after repeat injury (Table). Repeat injury also resulted in significant reduction of frequency- and voltage-response curves compared with controls or Inj-Sham. After single injury, parameters of contractile function returned to baseline uninjured levels by 21 days. In contrast, sphincter function remained impaired 21 days after repeat injury. Fatigue, an indicator of denervation, did not change among groups, reaffirming that compromised function of the EAS after transection was likely due to muscular trauma rather than denervation. Contractile function of sphincters from both Inj-Sham and Inj-Inj animals fully recovered by 90 days and were maintained at 180 days. Interestingly, contractile properties of animals with the 90 days time interval between repeat sphincter transections used in this study were less impaired compared with data from a previous study in which the interval was shorter (7 days). Inj-Inj animals with the shorter interval between transections had the greatest amount of impairment across all treatment groups. Nevertheless, Inj-Inj animals ultimately recovered by 90 days regardless of the time interval between sphincter transection. Conclusions: In this animal model, repeat injury to the external anal sphincter resulted in prolonged compromise of EAS function compared with single injury. It appears that the longer the time interval between sphincter transection &

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repair, the less severe is the impairment. Nevertheless, under optimal repair conditions contractile function of the doubleinjured sphincter fully recovered with time resulting in no long term impairment, regardless of time interval between transections. *Supported by a research grant from the International Urogynecologic Association (IUGA) Table. (*P≤0.02, compared with controls) 7 days after 2nd surgery

21 days after 2nd surgery

Contractile Control Inj-Sham parameter (n010) (n010) (g/sphincter)

Inj-Inj (n010)

Control Inj-Sham Inj-Inj (n010) (n010) (n010)

Twitch tension Max tetanic tension Max EFS

1.2±0.2*

2.0±0.2

2.3±0.2

1.8±0.3*

1.7±0.4

1.3±0.2*

15.8±0.5 13.5±1.5* 10.9±0.7* 14.7±0.8 12.9±1.1 10.9±1.0* 13.4±0.6 11.0±1.1* 9.0±0.5*

10.7±0.9 10.5±0.8 9.2±1.0*

S. Balgobin: Grant /Research Support; International Urogynecological Association. J. F. Acevedo: None. T. I. Montoya: None. R. A. Word: None. C. Y. Wai: None.

98 “MIXED GROWTH OF DOUBTFUL SIGNIFICANCE” IS EXTREMELY SIGNIFICANT IN PATIENTS WITH LOWER URINARY TRACT SYMPTOMS S . S AT H I A N A N T H A M O O RT H Y, S . S WA M Y, A. S. KUPELIAN, H. HORSLEY, K. GILL, L. COLLINS, J. MALONE-LEE UCL Div. of Med., London, United Kingdom. Hypothesis: The assessment of patients with lower urinary tract symptoms (LUTS) commences with the exclusion of

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urinary tract infection (UTI). This is subordinated to the culture of a clean-catch, midstream urine sample (MSU), with a threshold of 105 colony forming units (cfu) ml−1, of a single species of a known urinary pathogen. Kass et al described this criterion in 1957 (1), but the proposition rested on a study of 74 women with acute pyelonephritis, and 337 asymptomatic controls. Nevertheless, this threshold has been accepted as gold standard. Some have questioned the widespread adoption of a single dichotomous threshold for the diagnosis of UTI, but they have had little influence. In recent times there has been further dissent (2, 3), Kass’ insistence on a single species of a known urinary pathogen has no basis in research evidence and yet it is commonplace for mixed growths to be dismissed as of “doubtful significance”. This is worrying as surrogate markers, such as urinary dipsticks, are calibrated to this standard. A Darwinian perspective insists that the adaptability of living organisms, especially bacteria, should cause us to expect polymicrobial infections rather than the dominance of a single species. This study re-examined the significance of a mixed growth culture result obtained from MSU samples collected from patients with non-acute LUTS, by comparison against symptoms, inflammatory markers: pyuria and uroepithelial cell shedding, and urinary dipstick. Methods: Normal controls and patients with non-acute LUTS had symptoms measured and an MSU cultured. Fresh urine specimens were examined microscopically to quantify pyuria and uroepithelial cells and analysed using a urinary dipstick. Four groups were compared: normal controls, LUTS no growth, LUTS mixed growth and LUTS positive culture. The data were checked for normality using Q–Q plots and satisfied the criteria for parametric analysis so ANOVA was used to test the between-group differences (alpha 0.05), with post-hoc analysis using Bonferroni’s method (alpha 0.01). Results: 43 control subjects (M010, F033, Mean age 41 sd015) and 6208 LUTS patients (M0590 F05618, Mean age 56, sd017) provided data. The symptom distribution was as follows: storage symptoms 58 % (stress urinary incontinence 16 %); voiding dysfunction 20 %; nondysuric pain symptoms 28 %. The log pyuria count differed markedly between: “Normal controls”; “LUTS no growth”; “LUTS mixed growth”; and LUTS positive culture” (F0110; p<.0001; df03). The figure shows how “mixed growth” and “positive culture” discriminate from other groups. Similar between-group differences were identified in measures of frequency and incontinence, in symptoms of urgency, stress incontinence,

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voiding dysfunction and dysaesthesia, and additionally in the amount of uroepithelial cell shedding. In all cases “LUTS mixed growth” differed markedly from “normal controls” and “LUTS no growth” behaving similarly to the “LUTS positive culture” group. Urinary dipstick data were comparably distributed so that for leucocyte esterase the following proportions proved positive: “Normal controls” 4 %; “LUTS no growth” 26 %; “LUTS mixed growth” 40 %; “LUTS positive culture” 36 %, and for nitrite: “Normal controls” 0 %; “LUTS no growth” 1 %; “LUTS mixed growth” 11 %; “LUTS positive culture” 9 %. These data have scrutinised this problem from several different perspectives and examined symptom complexes, evidence of inflammatory reaction, urothelial reactivity and nitrite conversion. Every analysis points to a significant pathological state coinciding with “mixed growth of doubtful significance”. Conclusion: These data imply that it is no longer tenable to dismiss “mixed growth of doubtful significance” as implying no disease. We need re-examine many previous assumptions in order to achieve a proper perspective on the pathophysiology of all LUTS. References: 1. Arch Intern Med, 100:709–14, 1957 2. NEJM, 19; 307(8):463–8, 1982 3. J Urol, 17:183(5):1843–7, 2010 Figure: Comparison of the log pyuria count by the different MSU culture result groups

S. Sathiananthamoorthy: None. S. Swamy: None. A.S. Kupelian: None. H. Horsley: None. K. Gill: None. L. Collins: None. J. Malone-Lee: None.

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99 WHAT DO WOMEN WITH OR WITHOUT LOWER URINARY TRACT SYMPTOMS (LUTS) CONSIDER AS NORMAL BLADDER FUNCTION? A MULTICENTRE QUESTIONNAIRE SURVEY. A. Derpapas1, A. G. Digesu 1, G. Vijaya 1, P. Gallo 1, C. Dell’utri 1, C. Hendricken 1, P. Robshaw 1, M. Torella 2 , P. Pifarotti 3, R. Fernando 1, V. Khullar 1 1 St Mary’s Hosp., Imperial Coll. Hlth.care NHS Trust, London, United Kingdom, 2Seconda Univ. Degli Studi di Napoli, Napoli, Italy, 3 IRCCS Fondazione Policlinico Mangiagalli Milano, Milan, Italy. Objective: To assess what women with or without lower urinary tract symptoms (LUTS) consider as normal regarding bladder function. Background: The high prevalence of storage and voiding bladder symptoms in women produces a negative impact on quality of life.1 Understanding the burden of LUTS has important implications for public health and clinical practice. Various tools, like Patient Perception of Bladder Condition (PPBC), have been used in research and clinical practice to identify patients’ perception of LUTS, surprisingly the perceived impact on the patient as assessed by the clinician is very different. Furthermore, evaluation of treatment success is based on knowing when a patient has achieved what they consider asymptomatic or not bothersome. These definitions might also differ amongst patients, clinicians and researchers.2 Methods: This is a population-based, cross-sectional questionnaire survey conducted in three urogynaecological centres in the U.K and Italy, between February– September 2011. A specially designed questionnaire to assess patients’ perspective about their bladder function was distributed to both symptomatic and asymptomatic subjects for LUTS presenting in Urogynaecology and General Medicine outpatient clinics. The questionnaire was divided into three sections: the first composed of questions about demographics and level of education, the second assessed patients’ bladder symptomatology, if present, and the third comprised questions about what the patients considered normal with regards to frequency of micturition, nocturia, urgency, incontinence and frequency of urinary tract infection in accordance with the International Continence Society (ICS) standardisation of terminology in lower urinary tract function3 . Women were considered symptomatic if they had frequency of micturition ≥8 times a day, nocturia ≥1 at night, unable to defer the desire to void for more than 10 min and ≥1 episode of leakage per week. Statistical analysis was performed with Kruskal-Wallis H test (level of significance P<0.05) following confirmation of a non-normal data distribution with Q–Q plot test.

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Results: Six-hundred and forty-one women were recruited across the three centres. The mean age±SD of the studied population was 48±12 years. Two-hundred and ninety-three patients (46 %) were of higher educational status, whereas 348 patients (54 %) were educated to school level (p< 0.001). Tables 1–3 show the main results regarding patients’ perception of normality of bladder condition among women with and without reported bladder symptoms. Table 1. Perception of normality of frequency of micturition (number of voids per day) among patients with and without reported increased frequency <3

4–7

8–10 11–12 >13

frequency Symptomatic 6 % 45 % 37 % 8 % Asymptomatic 11 % 64 % 21 % 2 %

4 % P<0.001 1%

Table 2. Perception of normality of urgency (minutes of deferment of voiding) among patients with and without symptoms of urgency.

urgency

symptomatic asymptomatic

<10 59 % 26 %

10–30 30 % 51 %

>30 11 % 23 %

P<0.001

Table 3. Perception of normality of quantity of leakage among women with and without reported stress urinary incontinence and urge urinary incontinence. Never Few drops SUI Symptomatic 37 % 42 % Asymptomatic 74 % 20 % UUI Symptomatic 49 % 42 % Asymptomatic 68 % 29 %

Tea spoon 16 % 3% 9% 2%

Table spoon 4% 2% 0% 1%

Large amount 1% P<0.001 0% 0% P<0.001 0%

Table of Contents &

Table 3. Perception of normality of quantity of leakage among women with and without reported stress urinary incontinence and urge urinary incontinence.

Conclusions: There are significant differences in the perception of normality of frequency, urgency and amount of leakage between women with and without lower urinary tract symptoms. These differences reflect on the degree of impact of bladder dysfunction on patients’ quality of life and seem to be independent of their social and educational status. It is important to recognise that patients consider symptoms including leakage to be normal and this may have an impact on their view of the outcome of successful treatment. Understanding what women with and without LUTS consider as normal bladder condition could help set realistic goals for individualised treatment of such a challenging and often debilitating condition.

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References: 1. BJU Int. 2009 Aug;104(3):352–60 2. BJU Int. 2008 Jun;101(11):1381–7 3. Urology. 2003 Jan;61(1):37–49. A. Derpapas: None. A.G. Digesu: None. G. Vijaya: None. P. Gallo: None. C. Dell’utri: None. C. Hendricken: None. P. Robshaw: None. M. Torella: None. P. Pifarotti: None. R. Fernando: None. V. Khullar: None. 100 OSTEOPOROSIS AND PELVIC ORGAN PROLAPSE IN AUSTRALIAN WOMEN: A LONGITUDINAL ANALYSIS. P. Chiarelli, D. Sibbritt; Univ. of Newcastle, Callaghan, Australia. Objective: This study aimed to longitudinally explore associations between diagnosis of osteoporosis in relation to self reported pelvic organ prolapse surgery in Australian women. Background: In women, urinary incontinence, pelvic organ prolapse and osteoporosis are prevalent, progressive disorders. Osteoporosis is characterised by compromised bone strength resulting in vertebral fractures, the most prevalent female osteoporotic fractures. Such fractures are strongly cor-

related with spinal deformity, and height loss hypothesised to increase intraabdominal pressure. Height loss inherent with osteoporosis is significantly associated with female urinary incontinence [1] which is also significantly associated with pelvic organ prolapse Methods: In the first survey (1996), women were asked if they had “ever been told by a doctor that you had osteoporosis”. In subsequent surveys were asked “in the last 2 years have you been diagnosed or treated for osteoporosis”. Mid aged women were asked if they had repair of prolapse of the uterus, bladder or bowel in the previous 3 years in each survey while women in the ‘older’ group were asked in each if they had ever been told by a doctor they had POP in the first three surveys only. Responses were analysed from 10,951 mid-aged women (aged 45–50 years in 1966) across 5 surveys and 8847 elderly women (aged 70–75 in 1996) across 4 surveys in the Australian Longitudinal Study on Women’s Health. After adjusting for confounders, crude and adjusted odds ratios for osteoporosis were obtained using longitudinal generalized estimating equation models, predicting pelvic organ prolapsed for both cohorts. Results: Statistically significant associations were found between osteoporosis and pelvic organ prolapse (OR0 1.46; 95 % CI: 1.13, 1.89) in mid-age women.

Table 1. Osteoporosis status by POP for women in the 1946–1951 and 1921–1926 cohorts Cohort 1946–1951

POP yes POP No 1921–1926 Cohort

POP yes POP No

Survey 1 1996 Osteoporosis Yes No (n0338) (n010613) % % 15 8 85 92

Survey 2 1998 Osteoporosis Yes No (n0428) (n011298) % % 3 1 97 92

Survey 3 2001 Osteoporosis Yes No (n0543) (n09759) % % 3 2 97 98

Survey 4 2004 Osteoporosis Yes No (n0708) (n08595) % % 2 2 98 98

Survey 5 2007 Osteoporosis Yes No (n0866) (n08548) % % 4 3 96 97

Survey 1 Survey 2 1996 1999 Osteoporosis Yes No (n01627) (n07220)

Survey 3 Survey 4 2002 2005 Osteoporosis Yes No (n02005) (n07799)

Survey 5 2008 Osteoporosis Yes No (n02239) (n05869)

Not questioned

Osteoporosis Yes No (n02053) (n03196)

% 25 75

% 5 95

% 5 95

% 16 84

% 4 96

% 4 96

_ – –

% 5 95

% 4 96

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Table 2. Crude and adjusted odds ratios for osteoporosis, obtained from longitudinal Generalized Estimating Equation (GEE) models, predicting POP for the 1946–1951 cohort Dependent variable0POP

Osteoporosis No (ref) Yes

Crude Odds Ratio

95 % C.I.

1.00

–

1.52

(1.22, 1.88)

p

Adjusted

p

Odds 95 % C.I. Ratio 0.0001 1.00 1.46

– (1.13, 1.89) 0.0039

Table 3. Crude and adjusted odds ratios for osteoporosis, obtained from longitudinal Generalized Estimating Equation (GEE) models with time lag, POP) for the 1921–1926 cohort. Dependent variable0POP

Crude*

Osteoporosis No (ref) Yes

Adjusted†

Odds 95 % C.I. Ratio

p

Odds 95 % C.I. Ratio

1.00

–

<0.0001 1.00

1.50

(1.35, 1.67)

1.44

p

– (1.27, 1.64) <0.0001

Conclusion: Mid-aged and older women diagnosed with osteoporosis are at increased risk of developing organ prolapse suggesting that on diagnosis of osteoporosis, women be screened for and informed about their increased risk of developing pelvic organ prolapse. References: Berecki-Gisolf J, Spallek M, Hockey R, Dobson A. Height loss in elderly women is preceded by osteoporosis and is associated with digestive problems and urinary incontinence. Osteoporos Int. 2010;21:479–85. P. Chiarelli: None. D. Sibbritt: None. 101 A REVISED MEASURE OF SEXUAL FUNCTION IN WOMEN WITH PELVIC FLOOR DISORDERS (PFD); THE PELVIC ORGAN PROLAPSE INCONTINENCE SEXUAL QUESTIONNAIRE, IUGA-REVISED (PISQ IR) R. G. Rogers1, T. Rockwood 2, R. Thakar 3, Pisq Ir Working Group 1 Univ. of New Mexico, Albuquerque, NM, 2Univ. of Minnesota, Minneapolis, MN, 3Croydon Univ. Hosp., Croydon, Surrey, United Kingdom.

Objective: To create a valid, reliable and responsive sexual function measure in women with PFDs for both sexually active (SA) and inactive (SI) women. Background: Accurate measure of sexual function is integral to the care of women with pelvic floor dysfunction. The original PISQ, the only condition-specific sexual function questionnaire for women with PFDs (1), did not include women who were not sexually active and had not been validated in women with anal incontinence. We sought to improve on prior measures and create a questionnaire that was designed specifically for international validation. Methods: Current measures were reviewed by 23 experts to identify concept gaps and generate items which were then evaluated with cognitive interviews. Women recruited from 12 US and 5 UK sites gave data including POPQ measurements, and, in addition to the PISQ IR, completed the Incontinence Severity Index (ISI), a prolapse question from the Epidemiology of Prolapse and Incontinence Questionnaire (EPIQ Q35), the Pelvic Floor Distress Inventory-20 (PFDI-20) and the Female Sexual Function Index (FSFI). Clinicians indicated PFD diagnoses based on physical exam and clinical data. Principle components and orthogonal varimax rotation and principle factor analysis with oblique rotation (promax, Harris-Kaiser) identified item grouping. If items met a .6/.4 factor loading or a .20 loading difference between scales we deemed factor scaling robust; internal consistency was measured with Cronbach’s alpha. PISQ IR condition-specific factor correlations with PFD measures and FSFI scores were used for criterion validation. Comparison of PISQ IR factor change scores to change scores in the PFDI-20, ISI, EPIQ Q35, FSFI scores as well as correlation of mean change scores in women who underwent surgery at 3– 5 months following treatment evaluated responsiveness. Sub-analyses of women with anal incontinence (AI) were performed. Results: After expert review and cognitive interviews, 42 items were created or modified for testing. 589 women gave baseline data, 200 returned surveys after treatment and 147 provided test-retest data. Most women were married (76 %), middle-aged (55 +/−12.1 years), and Caucasian (77 %); 68 % were SA. Most women had UI and/or POP; 11 % had AI. For SA women, 3 scales each in 2 domains (17 items) and for SI women, 2 scales in each of 2 domains (12 items) emerged with robust psychometric properties. Cronbach’s alpha ranged from

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.63 to .90 for all scales. For SA women, significant correlations were observed in the anticipated direction with baseline PFDI-20 (r0.34 and .39), ISI (r0.29 and .12) and FSFI subscale scores (r range 0.29 to.79) (all p <.05). POPQ exams (r0.17) and EPIQ Q35 responses (r0.40) were also significantly correlated in one domain (all p<.05). For responsiveness testing, PFDI-20, ISI, and FSFI subscale change scores were positively correlated with PISQ IR factor change scores (range r0.26–.55, all p<.05) and with mean change scores in women who underwent surgery (r 0.35 and .40, all p<.05). For SI women, baseline correlation with PFDI20 scores were significant in the anticipated direction (r 0.34 and .6, p < .05) and one factor demonstrated correlation with the EPIQ Q35 (r 0.76, p < .05). For responsiveness testing, ISI change scores (r0.37, p<.05) and change scores in women who underwent surgery were correlated with PISQ IR factor change scores (r 0.50, p < .05). Subanalyses for women with AI revealed similar findings. No items demonstrated significant differences between test and retest (all p ≥ .05), indicating repeatability. Conclusions: The PISQ IR is a 29-item valid, reliable and responsive measure of sexual function in both sexually active and inactive women with PFDs. References (optional): (1) Am J Obstet Gynecol. 2001 Mar;184(4):552–58 R.G. Rogers: None. T. Rockwood: None. R. Thakar: None. 102 ICS-IUGA CLASSIFICATION OF SURGERY COMPLICATIONS OF MESHES: A NEW AND USEFUL TOOL TO BE MASSIFIED K. Briceño, R. Cuevas, M. Aramayo, G. Galleguillos, S. Gonzalez, B. Blümel, A. Pattillo, J. Alvo, A. Majerson, J. A. Ortiz, J. A. Pizarro-Berdichevsky Complejo Asistencial Hosp. Dr. Sotero del Rio, Santiago, Chile. Introduction: The explosive use of prosthetic materials used in pelvic floor surgeries has determined the appearance of unique and complex complications. It is essential to know the types of complications in effort to reduce them and give proper advice to patients. The ICS-IUGA published a new classification system. Complications are divided into categories (vaginal no epithelial separation, extrusion <1 cm, extrusion >1 cm, urinary tract, rectum or bowel, skin and musculoskeletal, patient compromise, that including hematoma or systemic involvement), time (up to 48 h after surgery, between 48 h and 2 months, between 2 and 12 months, more than 12 months) and site (vaginal suture line,

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away from vaginal suture line, passage of the trocar, other skin or musculoskeletal, or abdominal). Also there is a subcategory to report pain. The online calculator facilitates the appropriate classification (http://icsoffice.org/ complication). Objective: Analyze the urogynecological mesh surgery complications using the new ICS-IUGA classification. Methods: This study is a retrospective and prospective analysis (from January 2011) of the pelvic floor surgery complications in which prosthetic materials was used performed by our urogynecology unit. Our unit has a web based standardized record that includes the new ICS-IUGA classification of complications. We conducted a search of all implanted prosthesis and its complications. Results: 430 urogynecological surgeries were performed using mesh between January 2008 and August 2011. Of them, 138 patients (32 %) had some type of complication according to the ICS-IUGA classification, 15 had two or more complications. 44 surgeries were TOT or TVT, 72 TVM, 17 sacrocolpopexy (SCP) and 5 combined surgeries. Mean follow up was 15.8 ± 9.9 months, average age 58.6 ± 9.3 years, average parity 3.5 ± 3.1 and greater weight of NB was 3809 ± 583 g. Category: There were 151 CATEGORY complications. Of them 72 were vaginal no epithelial separation (47.6 %), 16 extrusion <1 cm (10.6 %), 7 extrusion >1 cm (4.6 %), 22 urinary tract involvement (14.5 %), 3 rectal or bowel compromise (1.9 %), 20 skin or musculoskeletal (13.2 %), 11 patient compromise (7.2 %) See Table 1. Time: There were 159 TIME complications. Of them 28 were from 0 to 48 h after surgery (17.8 %), 47 between 48 h and 2 months (29.9 %), 61 between 2 and 12 months (38.8 %), 23 over 12 months (14.6 %). See Table 2. Site: There were 146 SITE complications. Of them 56 were Vaginal in the suture line (38.3 %), 52 vaginal suture line away from (35.6 %), 16 passage of the trochar (10.9 %), 12 skin or musculoskeletal (7.5 %), 11 intra-abdominal (7.5 %). See table 3. Conclusion: Complications are common and transversal to the different techniques. The distribution of the category complication varies between the different techniques. The ICS-IUGA classification is applicable to most mesh surgeries. The online calculator facilitates the classification and applicability. The classification enables to standardize and compare the analysis. The usage of this tool is useful to proper patient information. It allow to compare local realities between different techniques. This classification must be used prospectively by urogynecology units allowing compartment local and international complications.

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Table 1. CATEGORY description of complications. Values are numbers (percentage) of complications n0138 patients

No epithelial separation: 72 (47.6 %)

Extrusion: 23 (15.2 %)

Urinary tract involvement: 22 (14.5 %)

Rectal or bowel Skin or musculoskeletal: compromise: 20 (13.2 %) 3 (1.9 %)

Patient compromise: 11 (7.2 %)

TOTAL0151

14 (63.6 %)

0

3 (27.2 %)

46 (30.4 %)

<1 cm

>1 cm

Sling (TVT or 25 (34.7 %) TOT) TVM 41 (56.9 %)

0

0

15 (65 %)

7 (30 %)

7 (31.8 %)

2 (66.6 %)

4 (20 %)

6 (54.5 %)

82 (54.3 %)

SCP

3 (4.1 %)

0

0

0

1 (33.3 %)

11 (55 %)

2 (18.1 %)

17 (11.2 %)

Combined Surgery TOTAL

3 (4.1 %)

1 (4.3 %)

0

1 (4.5 %)

0

0

0

6 (3.9 %)

72

16

7

22

3

20

11

151

4 (20 %)

Table 2. TIME description of complications. Values are numbers (percentage) of complications n0138 patients

0–48 hrs: 28 (17.8 %) 48 hrs–2 month: 47 (29.9 %) 2–12 month: 61 (38.8 %) >12 month: 23 (14.6 %) TOTAL0159

Sling (TVT or TOT) TVM SCP Combined Surgery TOTAL

13 (46.4 %) 11 (39.2 %) 4 (14.2 %) 0 28

11 (23.4 %) 27 (57.4 %) 7 (14.8 %) 2 (4.2 %) 47

15 (24.5 %) 39 (63.9 %) 3 (4.9 %) 4 (6.5 %) 61

6 (26 %) 13 (56.5 %) 4 (17.3 %) 0 23

45 (28.3 %) 90 (56.6 %) 18 (11.3 %) 6 (3.7 %) 159

Table 3. SITE description of complications. Values are numbers (percentage) of complications n0138 patients

Suture Line: 56 (38.3 %)

Away from suture line: 52 (35.6 %)

Trochar passage: 16 (10.9 %)

Skin or Musculoskeletal: 11 (7.5 %)

Intra-Abdominal: 11 (7.5 %)

TOTAL0146

Sling (TVT or TOT) TVM SCP Combined Surgery

20 (35.7 %) 32 (57.1 %) 1 (1.7 %) 3 (5.3 %)

14 (26.9 %) 34 (65.3 %) 2 (3.8 %) 2 (3.8 %)

9 (56.2 %) 7 (43.7 %) 0 0

1 (9 %) 0 10 (91 %) 0

2 (18.1 %) 5 (45.4 %) 4 (36.3 %) 0

46 (31.5 %) 78 (53.4 %) 17 (11.6 %) 5 (3.4 %)

TOTAL

56

52

16

11

11

146

K. Briceño: None. R. Cuevas: None. M. Aramayo: None. G. Galleguillos: None. S. Gonzalez: None. B. Blümel: None. A. Pattillo: None. J. Alvo: None. A. Majerson: None. J.A. Ortiz: None. J.A. Pizarro-Berdichevsky: None. 103 HOW COMMON IS FIXATION FAILURE AFTER MESH KIT SURGERY? K. Shek1, V. L. Wong 2, A. Rane 3, J. Goh 4, H. Krause 5, J. Lee 6, A. Rosamilia 7, H. Dietz 1 1 Univ. of Sydney, Penrith, Australia, 2St George Hosp., Kogarah, Australia, 3 James Cook Univ., Townsville,

Australia, 4Griffith Univ., Brisbane, Australia, 5Greenslopes Hosp., Brisbane, Australia, 6Mercy Hosp. for Women, Melbourne, Australia, 7Monash Med. Ctr., Melbourne, Australia. Objective: To define the incidence of failure of mesh fixation after Anterior Coloporrhaphy (AC) with mesh. Background: Mesh implants are commonly used to augment AC. Anterior compartment mesh seems to reduce recurrence rates(1), especially in women with levator avulsion(2) and hiatal ballooning. However, cystocele recurs even after mesh augmentation, and this may result in unusual, hitherto undocumented anatomical situations.

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Methods: This is a retrospective study using data obtained in 4 audit projects. Patients after AC+mesh were invited to a follow up including a questionnaire, ICS POPQ and 3D/4D translabial ultrasound (US), supine after voiding, at rest and on Valsalva. Offline analysis of stored ultrasound data was done blinded to other data. Cystocele recurrence was defined as ICS POPQ≥stage 2 or on US as a bladder > 0 10 mm below the symphysis pubis on Valsalva (3). Tomographic imaging (TUI) was used to diagnose avulsion (3), and

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hiatal area on Valsalva was measured in the axial plane (3). In patients with prolapse recurrence on US we defined: 1) Anterior failure: Cystocele ventral and caudal to well supported mesh; 2.) Apical failure: Cystocele/ anterior enterocele/ uterine prolapse dorsal and caudal to mesh with high mobility of the cranial mesh aspect; 3.) Global failure: Cystocele with high mobility of cranial and caudal mesh aspects on Valsalva (see Fig.). A test retest series (n 050) on failure typing yielded a kappa of 0.75 (CI 0.60–0.91)

Figure: Anterior (a), apical (b) and global (c) recurrence after AC+mesh. SP0symphysis pubis, B0bladder, U0urethra, R0rectum, A0anal canal

Results: We saw 301 patients ≥3 months after AC +mesh surgery. 5 were excluded due to missing data, leaving 296. Mean follow-up was 1.8 years (0.3–5.6). 139 had a Perigee, 66 an Anterior Prolift, and 91 an Anterior Elevate. Mean age was 65 years (32–88). Mean BMI was 28 (17–49). 148 (50 %) had had a previous hysterectomy, 111 (37 %) incontinence or prolapse surgery. Concomitant procedures were carried out in 217 patients (73 %). 242 (82 %) were satisfied with the outcome, 275 (93 %) considered themselves cured/improved. Recurrent prolapse symptoms (lump/ drag) were reported in 65 (22 %). Recurrent cystocele was noted in 128 (43 %) clinically and 105 (35 %) on US. Mean Ba was −1.6 (−3 to +2). Mean cystocele descent was 5.1 mm below the pubis (+21.8 to−44 mm). Avulsion was diagnosed in 117 patients (39.5 %). Mean hiatal area on Valsalva was 33.3 cm2. A failure of mesh fixation was diagnosed in 112 (38 %). It was a global failure in 81, apical failure in 23 and anterior failure in 8 patients. Cystocele recurrence was significantly associated with hiatal area (37.38 vs 30.8 cm2, P<0.001) and avulsion (46 % vs 32 %, P00.017). Apical and global mesh failure were also significantly associated with these parameters (Table 1) but this was not the case for anterior failure.

Table: Hiatal area and avulsion in women with / without mesh failure. P values for comparison between failure groups vs. no recurrence.

Hiatal area on Valsalva P value Avulsion P value No mesh failure 30.81 34 % (n0184) Global failure (n081) 37.26 <0.001 44 % 0.114 Apical failure (n023) 41.01

<0.001 65 %

0.004

Anterior failure (n08) 28.59

0.226

0.849

38 %

Conclusion: In this retrospective series we have observed a failure of mesh fixation in 38 % of patients at a mean of 1.8 years after AC with mesh. Most were global or apical failures, implying dislodgment of lateral and/or apical anchors or fixation. A small minority were anterior failures, implying dislodgment of the mesh from the bladder base, likely due to suboptimal surgical technique. Global and apical failures were associated with hiatal area. It is plausible that a larger hiatus subjects anchoring structures to greater loads, increasing recurrence risk. Future studies should focus on improving implant design as well as on means to normalise levator morphobiometry.

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1. NEJM 2011; 364: 1826–1836 2. Neurourol Urodyn 2011: 30;879–880 3. IUGJ 2011:22;1221–1232 K. Shek: None. V.L. Wong: None. A. Rane: Consultant; AMS. J. Goh: None. H. Krause: None. J. Lee: Consultant; AMS, Boston Scientific. Grant /Research Support; AMS. A. Rosamilia: Consultant; AMS, Boston Scientific. Grant /Research Support; AMS. H. Dietz: Grant /Research Support; GE Medical.

104 HIGH NUMBER OF COMPLICATIONS FOLLOWING INSERTION OF THE PINNACLE PELVIC FLOOR REPAIR KIT: A CAUSE FOR CONCERN K. J. Brouard, S. Jeffery Groote Schuur Hosp. and Univ. of Cape Town, Cape Town, South Africa. Objective: The assess the extent and severity of the postoperative complications associated with the Pinnacle Pelvic Floor Repair Kit (Boston Scientific). Background: The Pinnacle Pelvic Floor Repair Kit is a single incision trocar-free prolapse repair mesh device. This system ensures apical support by securing the mesh arms to the sacrospinous ligament and arcus tendinious fascia pelvis. Compared to the trocar-based systems, there may be an increased risk of nerve injury and pain associated with increased tension and more extensive fixation of the mesh within the pelvis. There is as yet no published data on this device. In this study we report on a disturbingly high number of complications associated with the use of this system. Methods: We performed 23 prolapse repair procedures using either the anterior or posterior Pinnacle kit. The surgeons were experienced in pelvic floor reconstruction and had received adequate training in vaginal mesh procedures. This is a retrospective descriptive analysis of the complications associated with the use of the Pinnacle Kit. All the complications were classified according to the joint International Urogynaecology Association and International Continence Society system for the classification of complications related directly to the insertion of meshes (1). In addition, we recorded de novo incontinence and symptomatic recurrence of prolapse. Results: Our analysis includes 19 anterior and four posterior Pinnacle Repair Kits. Four patients had a concomitant midurethral tape. Seven patients that had an anterior Pinnacle repair had a concomitant posterior fascial plication. Seventy percent (N016) of the women in our cohort experienced at least one complication. (Table 1) All,

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except one, were following an anterior Pinnacle. A high proportion of these patients had varying degrees of pain. Ten patients (43 %) had a tender vaginal mesh prominence or contraction anteriorly or at the vaginal apex. Of these, four (16 %) complained of associated buttock, groin or vaginal pain, while the tenderness was only detected during vaginal examination in the other six (26 %) patients. Three (13 %) patients required extensive vaginal mesh excision for severe pain; one patient required a second procedure. Three patients (13 %) had vaginal mesh exposure diagnosed between 10 and 21 days post operatively. One exposure resolved on Estrogen cream therapy and the other two required excision. One patient had a small(<1 cm) mesh extrusion diagnosed at 6 weeks which was successfully excised at 24 weeks as it was associated with tender prominent vaginal mesh arms. We also noted a high incidence of de novo urinary incontinence in our cohort (Table 2). Five (22 %) women reported de novo stress urinary incontinence. One patient had de novo urge urinary incontinence which resolved on treatment with oxybutynin. Two additional women experienced de novo mixed urinary incontinence. Three patients (13 %) developed post-operative voiding dysfunction that necessitated prolonged catheterisation, ranging from 13 to 90 days. Two of these patients required a suprapubic catheter and the third patient was treated with a transurethral catheter. None of these patients had a concomitant midurethral tape at the primary surgery. One had had a posterior Pinnacle with concomitant enterocoele repair. Two patients (8 %) have developed a symptomatic recurrent prolapse. The prolapse recurrence in the one patient developed following a mesh excision due to a large mesh exposure. The other patient had recurrent anterior compartment prolapsed above and below a tender contracted anterior vaginal mesh. Conclusions: The Pinnacle Prolapse Repair Kit is assoctaed with a high incidence of post-operative complications in our small cohort of 23 women. This included pelvic pain and de novo urinary incontinence. Since these complications are higher than those reported with other mesh devices, we would advise against the further use of the Pinnacle in prolapse surgery. References: 1. Haylen BT et al. An International Urogynecological Association (IUGA) / International Continence Society (ICS) joint terminology and classification of the complications related directly to the insertion of prostheses & grafts in female pelvic floor surgery (2011) Int Urogynecol J 22(1):3–15

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Table 1. Description of complications in individual patients Patient Description of complication (ICS/IUGA)

ICS/IUGA codes

Description of complications—other

1

7AT1S1 3CT2S1 4BT2S2

Symptomatic recurrent mid-compartment prolapse seen at 30 weeks. Declined sacrocolpopexy.

2

3

4

5 6 7 8 9 10

11

Prolonged difficult surgery with estimated blood loss >1000 ml. Large (>2 cm) midline anterior vaginal mesh exposure day 21 postoperatively, associated with postoperative vaginal infection. Infection treated, mesh excised 24 weeks post operatively. Voiding dysfunction requiring prolonged suprapubic catherisation (28 days). Associated with E Coli urinary tract infection. Small midline posterior vaginal mesh exposure associated with postoperative vaginal infection day 11 post operatively. Treated with antibiotics and vaginal oestrogen cream. Mesh exposure resolved at 6 weeks. Voiding dysfunction requiring prolonged transurethral catherisation (13 days). Associated with E Coli urinary tract infection. Mesh exposure seen day 10 post operatively—associated with vaginal infection. Treated with antibiotics and topical oestrogen. Mesh excised 12 weeks post operatively. Prolonged suprapubic catheterisation (90 days) due to voiding dysfunction postoperatively. Delayed trial of void due to co-incidental cervical spine fracture during catheterisation period. Small (<1 cm) mesh extrusion noticed at 6 weeks. Bilateral tender prominent vaginal mesh arms. Mesh excised 24 weeks postoperatively. Lost to follow-up—metastatic breast carcinoma.

Tender prominent vaginal mesh ridge palpated anteriorly at 10 weeks. No pain reported. Not sexually active. Tender prominent mesh ridge palpated at vaginal apex at 6 weeks. Associated with buttocks pain near coccyx. No dysparunia. Tender prominent vaginal mesh ridge palpated anteriorly at 8 weeks, still present at 20 weeks. Associated pelvic and groin pain. No dysparunia. Tender prominent mesh ridge palpated at vaginal apex at 6 weeks. No pain reported. Not sexually active. Tender prominent vaginal apical mesh arms palpated at 6 weeks, still present at 24 weeks. No pain reported. Not sexually active. Recurrent symptomatic (vaginal bulge) grade 3 cystocoele 20 months post operatively. Cystocoele rolled over and under the prominent non tender vaginal mesh contraction. Tender prominent vaginal vault mesh ridge palpated at 6 weeks—associated with vaginal pain. Not sexually active. Mesh partially excised 40 weeks postoperatively. Ongoing intermittent suprapubic and vulval pain. Referred to pain clinic.

2CT2S1 4BT2S2

3CT2S1 4BT2S2

3AaT2S1 3BbT2S2

De novo stress and urge urinary incontinence at 6 weeks. Treated with oxybutynin. Urge urinary incontinence resolved, but stress urinary incontinence persisted. Trans-obturator tension free vaginal tape placed, but stress leakage continued. Booked for retropubic tape. Lost to follow-up.

1BbT3S2 1BeT2S2 1BeT3S2

De novo urge urinary incontinence—responded to oxybutynin.

1BbT2S2

De novo stress urinary incontinence reported at 6 week. Resolved by 24 week follow-up.

1BbT2S2 1AaT4S2

Symptomatic recurrent grade 3 cystocoele seen 20 month post operatively. Booked for laparoscopic hysterectomy and sacrocolpopexy.

1BeT2S2

De novo urge and stress urinary incontinence 6 weeks. Transobturator tension free vaginal tape placed 20 weeks postoperativly. Developed voiding dysfunction. Tape initially unsuccessfully cut 4 weeks later. Tape successfully cut 24 weeks after initial placement.

Table 2. Description of complications in individual patients: urinary tract related Patient Description of complication (ICS/IUGA) 12 Small breach in bladder mucosa superior to left ureteric orifice, not full thickness, ureters clear—catheterised for 10 days. Tenderness in region of left ischial spine adjacent to left vaginal apical mesh arm at 6 weeks—associated with spontaneous left iliac fossa pain. Not sexually active 13 Full thickness bladder injury noticed intra-operatively, ureters clear, repaired vaginally—catheterised for

ICS/IUGA codes 4AT1S2 1BeT2S2

4AT1S2 1BeT2S2

Description of complications—other De novo stress urinary incontinence, declined surgery.

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Patient Description of complication (ICS/IUGA) ICS/IUGA codes 10 days. Tender prominent anterior/apical vaginal mesh ridge at 6 weeks—associated with spontaneous perineal pain and dysparunia. Required mesh excision twice. 14

Description of complications—other

15

16

K.J. Brouard: None. S. Jeffery: Grant /Research Support; Bard, Johnson and Johnson, AMS, Boston Scientific. 105 RISK FACTORS FOR IATROGENIC LOWER URINARY TRACT INJURY IN PELVIC RECONSTRUCTIVE SURGERY: DOES A HISTORY OF PREVIOUS PELVIC SURGERY MATTER? D. Saguan, O. Chinthakanan, C. Hudson, G. Northington, D. Karp Emory Univ., Atlanta, GA. Objectives: Though gynecologic surgery is the most common cause of iatrogenic injury to the lower urinary tract (LUT), little data exists on potential factors that may heighten this risk in pelvic reconstructive surgery (PRS). The objective of this study was to evaluate whether previous pelvic surgery is associated with LUT injury at the time of PRS. Background: Iatrogenic injury to the lower urinary tract is estimated to be 4.3 % after benign hysterectomy1, and up to 5.1 % ureteral injury after vaginal surgery for pelvic organ prolapse and urinary incontinence.2 Previous pelvic surgery has been shown to increase the risk of urinary tract injuries with benign hysterectomy but there is little information on the influence of previous pelvic surgery and lower urinary tract injury with pelvic reconstructive surgery.3 Methods: A retrospective analysis of patients undergoing PRS surgery between January 1, 2006 through December 30, 2011 at a single institution was performed. Patients were excluded if they had previous iatrogenic LUT injury. Patients undergoing previous pelvic surgery including hysterectomy, adnexectomy, surgery for endometriosis, adhesiolysis, pelvic reconstruction, Cesarean delivery, and nongynecologic pelvic surgery such as appendectomy and colon surgery were included. Using the electronic medical record, demographic and clinical factors, including a history of endometriosis and pelvic inflammatory disease, were abstracted. Based on a 4 % rate of lower urinary tract injury, a sample size of 360 cases was needed to detect a three-fold

De novo stress urinary incontinence at 6 weeks. Declined midurethral tape as symptoms not bothersome. De novo stress urinary incontinence at 32 weeks. Retropubic tension free vaginal tape placed with resolution of symptoms. De novo stress urinary incontinence at 6 weeks. Trans-obturator tension free vaginal tape placed with resolution of symptoms.

difference in lower urinary tract injury between women with and without prior pelvic surgery. Associations between previous pelvic surgery and iatrogenic lower urinary tract injury were then assessed with univariate and multivariate analysis. A logistic regression model was constructed in order to isolate independent factors associated with lower urinary tract injury. Results: 448 patients were included in the analysis–323 (72.1 %) with and 125 (27.9 %) without prior pelvic surgery. Mean age was 61 (SD±14.3). 77.2 % were Caucasian and 18.9 % were African American. A significantly larger proportion of patients with previous pelvic surgery were older (>60 years old) compared to those without previous pelvic surgery (p00.015). Estimated blood loss for the current PRS was significantly higher in those who did not have previous pelvic surgery (p00.021). The overall lower urinary tract injury rate was 5.12 % (n023). Of the injuries, 10 (43.5 %) were cystotomies, 9 (39.1 %) were ureteric obstructions, 3 (13 %) were suture perforations, and 1 (4.4 %) was a urethral injury. Previous pelvic surgery did not significantly affect the rate of lower urinary tract injury (OR 2.61, 95 % CI 0.733– 9.29). Previous hysterectomy, urogynecologic surgery, and lower abdominal surgery were not individually significantly associated with lower urinary tract injury (all p≥0.099). Of those who sustained a LUT injury, 87 % (n020) had a history of previous pelvic surgery. Other clinical risk factors such as endometriosis and PID did not significantly affect the rate of lower urinary tract injury (all p≥0.353). PRS for a primary indication of pelvic organ prolapse was significantly associated with an increased risk of lower urinary tract injury (OR 4.87, 95 % CI 1.13–21.02). However in the adjusted model when controlling for age, history of previous pelvic surgery, and anterior and apical vaginal surgery, statistical significance was not achieved (AOR 6.16, 95 % CI 0.88–42.88). The association between LUT injury and prior pelvic surgery remained non-significant in the adjusted model (AOR 1.72, 95 % CI 0.62–4.75). Conclusions: Prior pelvic surgery does not seem to affect the rate of injury in current PRS cases. However, because

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the incidence of lower urinary tract injury at the time of PRS is low, a large observational study may be required to definitively determine the relationship between prior pelvic surgery and lower urinary tract injury. References: 1. Obstet Gynecol. 2009 Jan;113(1):6–10. 2. Am J of Obstet Gynecol 2006; 194:1478–1985. 3. Int Urogynecol J Pelvic Floor Dysfunct. 2006 Jun;17 (4):360–4. D. Saguan: None. O. Chinthakanan: None. C. Hudson: None. G. Northington: None. D. Karp: None. 106 MORBI-MORTALITY REGISTRY AFTER POP SURGICAL TREATMENT AMONG FRENCH GYNECOLOGIST SURGEONS. UPDATE ON THE FIRST 3327 PROCEDURES R. De Tayrac1, G. Eglin 2, P. Debodinance 3, T. Perez 4, J. Marty 5, J. Faillie 1, B. Jacquetin 6 1 Nimes Univ. Hosp., Nimes, France, 2Beziers Hosp., Beziers, France, 3Dunkerque Hosp., Dunkerque, France, 4Aubagne Hosp., Aubagne, France, 5Gynerisq, Toulouse, France, 6 Clermont-Ferrand Univ. Hosp., Clermont-Ferrand, France. Objective: The main objective of this study was to evaluate morbidity after POP surgical treatment, involving all surgical techniques, in both private and public French hospitals during 2 years. The secondary objective was to describe current surgical practice, including vaginal mesh surgery, among French Gynecologist surgeons. Background: If many surgical techniques for POP reconstructive surgery have been described, robust comparative data between abdominal and vaginal surgery are still lacking. Furthermore, comparative studies, even randomized controlled trials, are not always transposable to clinical practice. Registries are of great interest for clinical practice. Methods: A web-registry on POP surgical treatment was put online in may 2010. That registry was included in the Gynerisq website, mainly available for physicians practicing private Obstetrics and Gynecology, but also open to public hospitals. To motivate physicians, declarations were followed by a reduced rate of insurances. Inclusions are still ongoing and follow-up of one-year is scheduled. That registry obtained the required acceptance of the National Commission of Informatics and Liberty (CNIL), the French Health Authority (HAS) and the French College of Obstetrician and Gynecologist (CNGOF). Results: During 20 months (May 2010–December 2011), 3327 surgical procedures were recorded among 276 surgeons. 2563 procedures were done vaginally (77.2 %) versus 764 abdominally. Among abdominal procedures, 610 (79.8 %) were done laparoscopically, including 58/610 assisted robotic procedures (9.5 %). Technically, polypropylene meshes were

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preferred to polyester in 62.6 %, sutures were preferred to staples in 89.1 % and a posterior mesh fixed on the levator ani muscles were associated in 69.7 % of cases. Associated hysterectomy and SUI surgical treatment were done in 40.4 % and 25.7 %, respectively. Among vaginal procedures, 2055 anterior repairs, 1456 apical suspensions, and 1208 posterior repairs were recorded. Synthetic meshes were used in 49.8 % anterior repair and 32.1 % posterior repair. The transobturator technique was preferred for anterior mesh in 83.4 % of cases. Apical suspensions were done by sacrospinous suspension, posterior tape and high uterosacral ligament fixation in 57.8 %, 22.5 % and 18.9 %, respectively. Intra-operative and post-operative complications are summarized in Tables 1 and 2. The rate of reoperation was 2.7 % vs 3.4 % after vaginal and abdominal surgery, respectively (p00.3). Table 1. Intra-operative complications occurred in 194/3327 patients (5.8 %). Vaginal Surgery n02563

Abdominal Surgery n0764

p

Overall intraop complications Major complications

154 (6.0)

40 (5.2)

0.4

63 (2.5)

18 (2.4)

0.9

Bladder injuries

30 (1.2)

10 (1.3)

0.8

Rectal injuries

9 (0.4)

3 (0.4)

1

Vascular injuries

4 (0.2)

3 (0.4)

0.4

Hemorrhage

20 (0.8)

2 (0.3)

0.1

n(%) Table 2. Post-operative complications, with a follow-up up to 12 months, occurred in 858/3327 patients (25.8 %). Vaginal Surgery n02563

Abdominal Surgery n0764

p

Overall postop complications Major complications

675 (26.3 %)

183 (24 %)

0.2

132 (5.2)

52 (6.8)

0.09

Hematomas

54 (2.1)

10 (1.3)

0.2

Vaginal erosions

36 (2.6)

8 (1.1)

0.01 0.01

Visceral erosions

0

3 (0.4)

Chronic pains

25 (1)

12 (1.6)

0.2

Bowel occlusions

0

12 (1.6)

<.001

Pelvic abscess

9 (0.4)

3 (0.4)

1

Fistula

6 (0.2)

1 (0.1)

0.6

Spondylodicitis

0

1 (0.1)

0.1

Pulmonary embolism

1 (0.04)

1 (0.1)

0.5

Death

1 (0.04)

1 (0.1)

0.5

n(%) Conclusions: Morbi-mortality could occur after both vaginal and abdominal reconstructive surgery for POP. The

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knowledge of complication rates in routine surgical practice is important for preoperative inform consent. R. De tayrac: Consultant; Boston Scientific. Grant /Research Support; Boston Scientific, Sofradim-Covidien. G. Eglin: Grant /Research Support; Sofradim-Covidien. P. Debodinance: Consultant; Ethicon. T. Perez: None. J. Marty: None. J. Faillie: None. B. Jacquetin: Consultant; Ethicon. 107 DOUBLE TROUBLE? THE INCIDENCE OF BOWEL SYMPTOMS IN WOMEN ATTENDING A TERTIARY REFERRAL ONE-STOP URODYNAMICS CLINIC H. Mastoroudes, I. Giarenis, S. Srikrishna, K. Adams, L. Cardozo, D. Robinson, S. Papagrigoriades King’s Coll. Hosp., London, United Kingdom. Objective: The purpose of this study was to determine the prevalence of coexistent lower urinary tract symptoms (LUTS) and colorectal symptoms (CRS) in our female population, attending a one-stop urodynamics clinic. This was performed to optimise the detection of unreported bowel pathology and improve the patient care pathway. CRS were defined as the presence of anal incontinence (AI) and/or constipation. Background: Colorectal symptoms are known to commonly coexist with lower urinary tract symptoms. Both systems originate from the embryological cloaca and have similar function. AI is the involuntary loss of flatus, liquid and solid stool which is socially debilitating and that can significantly impair quality of life (1). It is an embarrassing condition, which affects 17–54 % of women presenting to a urogynaecology clinic but is unfortunately under-reported (2). Constipation is also a common clinical complaint and affects 20–50 % of women with pelvic floor dysfunction (3). Materials and methods: This was a prospective study of women with LUTS who attended a one-stop urodynamics clinic. All patients were asked to complete a patient perception questionnaire (PPQ) and the validated Cleveland Clinic Faecal Incontinence and Constipation Questionnaires. A urodynamic diagnosis was made according to the ICS/IUGA guidelines. All analyses were performed using SPSS version 17.0 (SPSS Inc., Chicago, Ill., USA). Frequencies, percentages of different responses in addition to the statistical difference were analysed using Chi squared and Fischer’s exact test. Multiple logistic regression analysis was used to find an association between demographic data and CRS. Results: We recruited 150 women with a mean age of 50.3 years (range 18–80) and median parity 2 (range 1–6). Half of the women were postmenopausal. Age, menopausal status and parity were not found to be linked to AI or constipation on multiple logistic regression analysis.

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The overall prevalence of CRS (according to the Cleveland Clinic Faecal Incontinence and Constipation Questionnaires) was 26 % but (according to the PPQ) a significantly higher number perceived they had additional CRS (p0<0.05) (Table 1). Table 1. Prevalence of CRS Prevalence of CRS according to Cleveland Clinic 26 % (39/150) Incontinence & Constipation Questionnaires Prevalence of CRS according to Patient 36 % (54/150) Perception Questionnaire Request for further referral to Department 32 % (48/150) of Colorectal Surgery

There was no significant difference in the prevalence of AI in those with a urodynamic diagnosis of urodynamic stress incontinence, detrusor overactivity incontinence or mixed incontinence (p00.187). There was no association between the likelihood of urinary incontinence and AI being coexistent, and the type of urinary incontinence did not alter this. Over half of the patients had pelvic organ prolapse (POP). The association between POP and CRS can be seen in Table 2. There was a significantly higher incidence of AI in POP and posterior compartment prolapse. Increasing grade of POP and the presence of posterior compartment prolapse were significantly associated with AI (p00.03,p00.02). Table 2. Pelvic organ prolapse and CRS p value Pelvic organ prolapse (POP) POP and anal incontinence (AI) Posterior compartment prolapse Posterior compartment prolapse and AI Prolapse and constipation Posterior compartment prolapse and constipation

58.7 %(88/150) 27.3 %(24/88) 42 %(63/150) 30.2 %(19/63) 7.9 %(7/88) 9.5 %(6/63)

0.021 0.013 0.954 0.928

POP grade and posterior compartment prolapse were not related to constipation. The only item on the Cleveland Clinic Constipation Score more likely to be reported with posterior compartment prolapse was the feeling of incomplete bowel emptying (p00.010). Conclusion: This study confirms that women with LUTS have a high prevalence of CRS. It supports the value of a multidisciplinary approach to assessing women with pelvic floor dysfunction. A thorough bowel function history should be taken from all urogynaecology patients, as the prevalence of CRS is high. An integrated approach, across specialties, should lead to improved patient care.

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References: 1. Am J Obstet Gynecol. 2003 Jul;189(1):127–9 2. Obstet Gynecol 2002;100:719–23 3. Am J Obstet Gynecol. 2005 Dec;193(6):2105–11 H. Mas toroudes: N o n e . I . G i a re n i s : None . S . sRIKRISHNA: None. K. adams: None. L. cARDOZO: Consultant; Astellas, Pfizer, Gynecare, Uroplasty, advamed, ethicon, merck. Grant /Research Support; pfizer, boston scientific. D. rOBINSON: Consultant; astellas, Pfizer, Gynecare, Uroplasty, ferring, recordati, novo-nordisc. Grant /Research Support; astellas, pfizer, boston scientific. S. papagrigoriades: None. 108 POSTVOID RESIDUAL URINE IN WOMEN WITH PELVIC FLOOR DYSFUNCTION K. Aimjirakul, R. Wattanayingcharoenchai, J. Manonai Mahidol Univ., Ratchathewi, Thailand. Objective: To evaluate the postvoid residual volume and study the correlation between postvoid residual urine (PVR) and urinary tract infection (UTI) in women with pelvic floor dysfunction. Background: Traditional measures of PVR volume include urethral catheterization and ultrasonography. Urethral catheterization is the method of measuring PVR volume but might cause complication by trauma, discomfort and its potential to induce infection. Transvaginal ultrasonographic PVR measurement might be equivalent to urethral catheterized techniques [1]. Normal value for PVR volume measurement has not been cleared. Volumes less than 50 ml indicate adequate bladder emptying, and volumes greater than 200 ml can be considered inadequate emptying. Clinical judgement must be exercised in interpreting the significance of PVR volumes, especially in the intermediate range of 50 to 200 ml. Elevated PVR and urinary tract infections (UTI) are quite common in women with pelvic floor dysfunction. The aim of this study was to evaluate the correlation between PVR volume and UTI. Methods: A retrospective chart review was carried out of all new patients to our urogynecology clinic. Questions asked were about demographic data (age, parity, menopausal status, history of hysterectomy), symptoms of urinary incontinence and pelvic organ prolapse. After a comprehensive history, a full examination was performed. We routinely measure PVR volume by transvaginal ultrasonographic within 5 min of a spontaneous, private void in the restroom. Measurement of depth (D) and height (H) in sagittal plane and width (W) in transversal plane, then PVR volume (ml) is (0.7) x (D x H x W) [2]. Patients were included in the study if they had symptoms of urinary incontinence and/or pelvic organ prolapse, and a PVR had been obtained during their initial visit. UTI was diagnosed by urine culture in woman as growth of more

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than 100,000 colony forming units (CFU)/ml of the uropathogenic bacteria. This definition for UTI is in accordance with the definition as proposed by the Centers for Disease Control and Prevention (CDC). We used Chi-square or Fisher exact test to explore the correlation between PVR volume and UTI. Results: Two hundred and forty (82 %) of 290 medical record were completed. The mean patient age was 55±12.4 years (range 23–86) and the median parity was 2 (range 0–16). A hundred and forty-nine (62 %) were postmenopausal and twenty-four (10 %) were nulliparous. The median PVR volume was 8 ml (range 0–310); the mean PVR volume was 20±39 ml. The overall percentage of PVR was 82.9 % at 0–30 ml, 7.1 % at 31– 50 ml, 7.5 % at 51–100 ml and 2.5 % at more than 100 ml. The percentages of UTI were 27.1 %, 35.3 %, 11.1 % and 33.3 % for PVR at 0–30 ml, 31–50 ml, 51–100 ml and more than 100 ml, respectively. No association was found between elevated PVR and UTI (P>0.05). There was no significant relationship between the PVR volume more than 30 ml and either age (P00.721) or parity (P00.963). The increasing age was not associated with PVR volume more than 30 ml. And there was no significant correlation between the PVR volume more than 30 ml and either prior hysterectomy (P00.508) or postmenopausal women (P00.386). The percentage of women who had PVR volume more than 30 ml were 29 % and 6 % in pelvic organ prolapse with stress urinary incontinence (SUI) and SUI alone group, respectively. As a result, there was a statistically significant increase in the percentage of PVR more than 30 ml with patients who had pelvic organ prolapsed (P00.048). Conclusions: Eighty-two percent women with pelvic floor dysfunction had PVR of 30 ml or less. Women with POP and SUI tended to have higher PVR (more than 30 ml) compared to women who had SUI alone. Elevated PVR was not associated with UTI. References (optional): 1. Int Urogynecol J (2008) 19: 603–606 2. J Urol (1981) 125: 174–176 K. Aimjirakul: None. R. Wattanayingcharoenchai: None. J. Manonai: None. 109 VASCULARITY OF THE URETHRA IN URINARY CONTINENT WOMEN USING COLOUR DOPPLER HIGH-FREQUENCY ENDOVAGINAL ULTRASONOGRAPHY (EVUS) F. Lone, A. Sultan, R. Thakar, A. Stankiewicz Croydon Univ. Hosp., London, United Kingdom. Objective: To assess the urethral vascularity in continent nulliparous and multiparous women using colour doppler high frequency endovaginal ultrasonography (3D-EVUS). Background: The vascularity within the urethral submucosa contributes to the normal tension of the urethral mucosal wall [1]. Although transperineal ultrasound (TPUS) has been used in the assessment of urethral vascularity [1], interpretation

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was limited by low-frequency transducers (4–8 MHz) and artefacts created by transducer pressure on the urethra. 3DEVUS eliminates these limitations and allows video recordings for off-line analysis using Pixel Flux software [2]. Although this method is reliable in assessing vascularity of kidneys and lymph nodes [2] it has not been used to compare vascularity of the female urethra in nulliparous and multiparous women. Our hypothesis was that there is no difference in vascularity between continent nulliparous and multiparous women. Methods: We recruited 61 asymptomatic women attending gynaecology clinics between July and October 2009. Exclusion criteria included symptoms of urinary incontinence, voiding dysfunction, pelvic organ prolapse or urinary tract infection. The participants underwent 3DEVUS using high frequency (12 MHz) biplane transducer (Type 8848 BK Medical), according to a standardised protocol [3]. The transducer was placed vaginally at the level of the mid-urethra. The vascular parameters recorded on video (10 s) were: flow velocity, area of the vessels, intensity of vascularity, pulsatility index and resistance index [Fig 1]. Results: There were 30 nulliparous (49.2 %) women and 31 multiparous women (50.8 %) with a mean (± SD) age of 32 (± 4) and 46 (± 6) years in nulliparous and multiparous group respectively. 9 (14.75 %) women were para 1 and9 were para 2, 5 (8.2 %), 4 (6.6 %), 3 (4.9 %) and 1 (1.6 %) were para 3, 4, 5 and 7 respectively. Statistically significant differences were observed in the vascularity between nulliparous and multiparous women in all measured variables (Table 1). Cronbach alpha was used to assess correlations between vascularity parameters and parity. The correlation between all vascular parameters and parity was moderate (Cronbach’s alpha 0.44). Cronbach’s alpha decreased to 0.12 when expressed only for vascular parameters, indicating that number of deliveries is an important factor while assessing urethral vascularity. Conclusions: Compared to continent nulliparous women, continent multiparous women demonstrated a significant reduction in the vascularity parameters in all measured variables when parity was accounted for. Therefore, parity must be taken into consideration in research studies involving Doppler assessment of the urethra. This study can now form the basis of further research in incontinent women. References: 1: Ann NY Acad Sci 2007; 1101:266–296 2: Transplantation 2006; 81(5):751–755 3: Int Urogynecol J Pelvic Floor Dysfunct 2009; 20 (10):1213–1222. Table 1. Vascular parameters in the midurethra in axial and sagittal planes in nulliparous and multiparous patients. Fig. 1 Colour Doppler of midurethra in axial and sagittal plane usingb endovaginal ultrasound

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Vascular parameters

Nulliparous mean (SD)

Multiparous mean (SD)

p-value*

Midurethral Axial V mix

0.37(0.16)

0.18 (0.09)

<0.001

A mix

0.05 (0.05)

0.02 (0.02)

<0.001 <0.001

I mix

0.02 (0.02)

0.005 (0.01)

RI mix

0.89 (0.15)

0.98 (0.05)

<0.005

PI mix

2.34 (1.18)

3.18 (1.47)

00.01

V mix

0.41 (0.1)

0.18 (0.08)

<0.001

A mix

0.1 (0.06)

0.02 (0.02)

<0.001

I mix

0.01 (0.01)

0.01 (0.01)

00.01

RI mix

0.62 (0.24)

0.99 (0.04)

<0.001

PI mix

1.04 (0.62)

2.86 (1.29)

<0.001

Rhabdosphinter sagittal

* Statistically significant differences were assumed at p<0.05 ‘V’ denotes flow velocity, ‘A’ area of the vessels, ‘I’ intensity of vascularity, ‘PI’ pulsatility index and ‘RI’ resistance index

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F. Lone: None. A. Sultan: None. R. Thakar: None. A. Stankiewicz: None. 110 HOW MUCH LEVATOR MUSCLE DEFECT IS ASSOCIATED WITH FEMALE PELVIC ORGAN PROLAPSE? S. Shobeiri, G. Rostaminia, D. White, A. Hegde, M. Mukati, L. Quiroz The Univ. of Oklahoma, Oklahoma City, OK. Objective: The objective of this study was to determine if there is a levator ani muscle bulk threshold below which pelvic organ prolapse occurs. Background: Levator ani (LA) muscle injury occurs in 13– 36 % of parous women. Our previous studies, along with the MRI studies,1,3 divides the LA into 3 muscle groups: the puborectalis, puboanalis, and iliococcygeus / pubococcygeus muscles. 3D endovaginal ultrasonography (3D EVUS) has been used successfully to visualize these muscles with good reliability3 and to score each subdivision separately to assess their integrity. The objective of this study was to determine if there is a muscle bulk threshold below which pelvic organ prolapse occurs. Methods: We reviewed the 3D EVUS of patients. Each LA muscle subdivision was individually scored (00no defect, 10minimal or 50 % defect, 30total absence of the muscle)2 on each side based on thickness of the muscle and detachment from the pubic bone. A cumulative score was calculated for each subject and categorized as mild, moderate, and severe defect (score 0–6 0mild; 7–100moderate; >100severe). The individual and cumulative scores were correlated with stage of prolapse on POP-Q examination. Summary statistics were calculated. Correlation of stage of prolapse with total LA score was assessed using Spearman’s rank correlation coefficient. Logistic regression was used to assess the relationship between stage of prolapse and LA score. Kruskal-Wallis Test was used to determine if the distribution of scores differed by stage of prolapse. A p value of <0.05 was considered significant. Results: 300 3D EVUS of women, who were admitted to our tertiary urogynecology clinic with pelvic floor symptoms, were available. 197 subjects met the inclusion criteria, had a documented POP-Q exam near the time of ultrasound imaging, and were included in the analysis. The mean age was 54 (23–88) and median parity was 2. The mean LA score was 8.88 (±5.38). 55 (28 %) subjects had no prolapse on examination, 51 (26 %) had stage 1, 60 (31 %) had stage 2, 26 (13 %) had stage 3, and 5 (3 %) had stage 4 prolapse. A moderate positive correlation was demonstrated between LA score category and stage of prolapse (r s 00.44, p<0.0001)(Table 1). For each score category, the odds of

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worsening stage increased by 3.32 (95 % CI 2.28, 4.84). No subjects with stage 3 prolapse had a LA score lower than 6. No subjects with stage 4 prolapse had a LA score lower than 9 (Figure 1). By Kruskal-Wallis Test the distribution of scores significantly differed by stage of prolapse (p < 0.0001). However, 22 % of women with stage 0, 27 % of women with stage 1, 56 % of women with stage 2, 69 % of women with stage 3 and 80%of women with stage 4 had severe LA defect (Table 2). Conclusions: Increasing LA score as an indicator of LA abnormality is associated with worsening stage of prolapse. Women with severe prolapse should be evaluated for the presence of LA defects. However, while most patients with severe prolapse have LA muscle defects, many patients with sonographically visualized defects do not have clinically significant prolapse. Thus, it is likely that factors other than LA abnormalities also play a significant role in the pathogenesis of pelvic organ prolapse. Table 1. Disturbution of different levator scores in different stages of prolapse.

Stage Stage Stage Stage Stage

0 1 2 3 4

All subjects (n, %) 55 (27.92) 51 (25.89) 60 (30.46) 26 (13.20) 5 (2.54)

Low LA Moderate LA Score (n, %) Score (n, %)

High LA Score (n, %)

36 (48.00) 18 (24.00) 16 (21.33) 5 (6.67) 0 (0.00)

10 (14.29) 12 (17.14) 28 (40.00) 16 (22.86) 4 (5.71)

9 (17.31) 21 (40.38) 16 (30.77) 5 (9.62) 1 (1.92)

Table 2. prolapse stage zero and levator scores.

Total stage 0 Total Frequency Percent Cumulative Frequency 0 13 23.64 13 1 1 1.82 14 2 7 12.73 21 3 1 1.82 22 4 2 3.64 24 6 12 21.82 36 8 7 12.73 43 10 2 3.64 45 11 2 3.64 47 12 2 3.64 49 14 1 1.82 50 15 1 1.82 51 16 1 1.82 52 17 1 1.82 53

Cumulative Percent 23.64 25.45 38.18 40.00 43.64 65.45 78.18 81.82 85.45 89.09 90.91 92.73 94.55 96.36

18

100.00

2

3.64

55

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References (optional):$$MISSING OR BAD GRAPHIC SPECIFICATION ({EF20B4EF-23E4-490 F- , -87E1D26BC2936}) $$

S. Shobeiri: None. G. Rostaminia: None. D. White: None. A. Hegde: None. M. Mukati: None. L. Quiroz: None. 111 URINARY LACTOFERRIN AS A PROMISING, NEW, IMPROVED MARKER FOR URINARY TRACT INFECTION K. Gill, J. Malone-Lee, T. Brenton, A. S. Kupelian, H. Horsley, S. Sathiananthamoorthy, L. Collins UCL, London, United Kingdom. Objective: To investigate if urinary lactoferrin has potential as a promising surrogate marker for urinary tract infection. Background: There is growing evidence to incriminate chronic cystitis as an important aetiological factor in the development of lower urinary tract symptoms (LUTS), particularly storage (OAB), voiding and painful LUTS. There is a problem with the 1957 Kass criteria (1) for diagnosing urinary tract infection using culture of a midstream urine sample (MSU). The threshold of 105 colony forming units (cfu) ml−1, of a single species of a known urinary pathogen, was drawn from a small experiment applying only to pyelonephritis in pregnancy. The validation of urinary leucocyte esterase and nitrite tests was not only extremely deficient, but used the Kass criteria as the gold standard. Recently dipstick analysis and routine culture have attracted harsh criticisms for being very misleading. (2)

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All available data confirm that the best surrogate marker of urinary infection is the microscopy of a fresh unspun specimen of urine in a haemocytometer in order to count the white cells (2). This is not an option in many clinics and delayed analysis results in an underestimate. We need a reliable alternative to the dipstick test that can reflect the true pyuria levels. Immune proteins present very attractive options because of modern proteomics. Lactoferrin is an iron binding glycoprotein expressed in the distal collecting tubules and can be found associated with the luminal surface. It is released in response to mucosal pathogenic invasion and prevents bacterial access to iron which is essential for bacterial growth and development. Lactoferrin damages microbes both by chelation of iron and by affecting membrane integrity and has been detected in abundance in patients with acute UTI (3). . Method: Patients presenting with LUTS were recruited from incontinence clinics and clean-catch midstream urine samples obtained. Healthy control volunteers were recruited from hospital staff. Storage, voiding, and pain symptoms were collected using a fixed protocol and recorded into a bespoke database. Light microscopy was performed on fresh urine for leucocytes and urothelial cell counts. The urine was cultured on selective chromogenic agar media and aliquots of spun urine frozen at −80 °C. These were then analysed for urinary lactoferrin using a sandwich ELISA. Results: There were 65 patients (F059 M06, mean age0 62.3; sd016.99. The control group consisted of 14 healthy control volunteers (F09 M05, mean age053.6; sd 016.98). Symptom analysis showed that mean 24 h frequency within the patient group was 11.4 and total 24 h incontinence episodes were 1.2. 81 % of patients had urgency symptoms, 31 % complained of stress symptoms, 17.2 % complained of voiding symptoms and 36.2 % complained of pain symptoms. A Q–Q plot was used to confirm a normal distribution for log lactoferrin and parametric tests were used for analysis. A quadratic regression model was fitted to the log pyuria data, with log lactoferrin as the dependent variable; R was calculated at 0.8 (p<0.001; df02 and 76)—see figure. The log lactoferrin was raised in patients compared to controls (t04.8, df077, mean diff01.5, 95 % CI 2.0 to 0.9, p< 0.001). The regression model implied that this difference related to the presence of inflammation. It was noted that 72 % of patients had negative routine urine cultures. Conclusions: These data demonstrated that urinary lactoferrin levels discriminate successfully between patients with LUTS and controls. There is evidence that the lactoferrin reflects the pyuria status quantitatively with a high effect size of R00.8. Lactoferrin appears to be a remarkably strong candidate for replacing point-of-contact urinary microscopy with a potential for promoting a considerable improvement in patient diagnosis and management.

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References: 1. Arch.Intern.Med., 1957, 100; 709, 714. 2. J.Urol., 17-3-2010, 183; 1843, 1847. 3. Eur.J Clin.Invest, 2008, 38 Suppl 2; 29, 38.

K. Gill: None. J. Malone-Lee: None. T. Brenton: None. A.S. Kupelian: None. H. Horsley: None. S. Sathiananthamoorthy: None. L. Collins: None. 112 3 DIMENSIONAL ULTRASOUND MULTI COMPARTMENT SCANNING: A RELIABLE TOOL FOR THE DIAGNOSIS OF UREHTRAL DIVERTICULUM A. Hegde1, A. Shobeiri 2, E. Mueller 3, P. Wieczoreck 4, V. Aguilar 1, G. Davila 1 1 Cleveland Clinic Florida, Weston, FL, 2Univ. of Oklahoma Hlth.Sci. Ctr., Oklahoma City, OK, 3Loyola Univ., Stritch Sch. of Med., Chicago, IL, 4Med. Univ., Children’s Teaching Hosp., Lublin, Poland. Objective: To investigate the utility of 3-dimensional endovaginal ultrasonography (3D EVUS) in the assessment of urethral diverticula. Background: Magnetic resonance imaging has become the imaging method of choice for the diagnosis of urethral diverticula (1). Disadvantages of MRI include increased cost and limited availability in certain settings. A recent study discovered a 24 % error rate between MRI and surgical findings (27). The utility of ultrasonography in the evaluation of the internal anatomy of the female pelvis is

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well established, but little has been reported on the characterization of urethral diverticula. Recent advances in 3D ultrasound encourage the application of this technique to the diagnosis of urethral diverticula. Multicompartment scanning of the pelvis can be performed to obtain 3D cubes that can be manipulated in any plane to obtain precise information on the location and complexity of the diverticulum in relation to the urethral anatomy including identifying the ostia. Materials and methods: A retrospective review of all patients at four institutions, who underwent 3D EVUS during evaluation for urethral diverticulum between July 2008 until March 2012, was conducted. Each patient’s history was reviewed to determine whether any other imaging modality had been used for comparison, whether surgery was performed and what the surgical or pathologic findings were. The findings on 3D EVUS were correlated with those obtained with MRI and/or surgical pathology. The scans were reviewed by two reviewers and interrater agreement was established. Results: 25 patients with urethral diverticulum had undergone 3D EVUS. Endovaginal ultrasound was performed using the 8848 (Figure 1) or the 2052 BK (Figure 2) transducers. Median age of the patients was 46 (range 19–72). Urethral diverticulum was clinically diagnosed in 7 (28 %) of the patients. All patients were diagnosed to have diverticulum by 3D EVUS. The location of the diverticulum, its 3 dimensional extent and ostial opening could be determined by 3D EVUS in all patients. The diagnosis was confirmed in 40 % of the patients by MRI and in all patients at the time of surgery. Interrater agreement was 100 % for 3D EVUS findings. Conclusion: 3D ultrasound is a reliable tool for the preoperative assessment of patients with urethral diverticulum. References: 1. Female Pelvic Medicine & Reconstructive Surgery 2011; 17(6): 264–271. 2. J Urol 2010; 183(6):2265Y2269. Figure 1. Anterior compartment scan: urethral diverticulum

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Figure 2. 360 ° Scan: Urethral Diverticulum

A. Hegde: None. A. Shobeiri: None. E. Mueller: None. P. Wieczoreck: None. V. Aguilar: None. G. Davila: None.

113 CORRELATION BETWEEN CLINICAL AND URODYNAMIC FINDINGS AND BLADDER TRABECULATION IN WOMEN WITH SEVERE PELVIC ORGAN PROLAPSE C. Liang, Y. Chang, Y. Lin, L. Tseng, T. Lo Chang Gung Mem. Hosp., Linkou Med. Ctr., Taoyuan, Taiwan. Objective: To investigate the relationship between clinical manifestation, urodynamic findings and bladder trabeculation in women with advanced pelvic organ prolapse (POP) Background: Because of distortion of the lower urinary tract, advanced POP may cause urethral obstruction. Bladder trabeculation is the secondary result of a bladder outlet obstruction (BOO), and is caused by morphological and histological changes due to hypertrophy of the bladder muscle. It is not clear about the significance of bladder trabeculation in women with advanced POP. Methods: Between January 2005 and 2011, 308 patients with ICS stage 3 and 4 POP who underwent pelvic reconstructive surgeries were recruited for analyses. The protocol of preoperative evaluation included urodynamic studies and cystoscopy before surgery, and a structured questionnaire with regard to lower urinary tract and pelvic symptoms that was completed at entry. The following parameters were compared between patients with and without bladder trabeculation, including patients’ demographics, lower urinary tract symptom presentations, pelvic symptoms, and urodynamic findings. Results: One hundred sixty nine patients had bladder trabeculation and 139 did not. Between these two groups, there was no significant difference in history of pregnancy, menopausal

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status, diabetes mellitus, and severity of prolapse. However, the mean age was significantly higher in the group with bladder trabeculation (66.4±10.5 versus 61.6±9.3, p<0.001). Comparison of urinary and pelvic symptoms in the two groups showed that the incidences of urgency, urge incontinence, voiding difficulty and backache were significantly higher in patients with trabeculation than without trabeculation. The parameters of the urodynamic study, however, were not significantly different between the two groups, although preoperative detrusor overactivity and residual volume beyond 100 ml were more significantly increased in the group with trabeculation than in the group without. Comparison of the two groups showed that the incidence of BOO was higher in patients with trabeculation than without trabeculation, but the result was not significantly different (15.4 % vs 9.4 %, p00.095). Conclusions: Over half of women with advanced POP have bladder trabeculation detected by cystoscopy, which when compared with patients without trabeculation, indicated higher incidences of urgency, urge incontinence and voiding difficulty symptoms, and detrusor overactivity and urinary retention in urodynamic testing. References (optional): Table. Clinical and urodynamic manifestation of patients with or without bladder trabeculation Trabeculation (n0169)

No trabeculation (n0139)

P value

Age

66.4±10.5

61.6±9.3

<0.001

Residual volume >100 ml

47.9 % (n081)

38.2 % (n042)

0.001

Bladder outlet obstruction

15.4 % (n026)

9.4 % (n013)

0.095

Detrusor overactivity

13.1 % (n022)

3.6 % (n05)

0.004

Urgency

56.8 % (n096)

35.3 % (n049)

<0.001

Urge incontinence

34.9 % (n059)

15.1 % (n021)

<0.001

Difficult to void

42.6 % (n072)

32.4 % (n045)

0.044

48.9 % (n068)

33.1 % (n056)

0.009

Lower urinary tract symptoms

Pelvic symptoms Backache

C. Liang: None. Y. Chang: None. Y. Lin: None. L. Tseng: None. T. Lo: None. 114 WHAT IS “CURE” AFTER SURGERY FOR PROLAPSE: A SURVEY AMONG THE OBSTETRICIANS AND GYNAECOLOGISTS M. Naidu, S. Srikrishna, D. Robinson, L. Cardozo King’s Coll. Hosp. NHS Fndn. Trust, London, United Kingdom. Objectives: 1. To Investigate consensus opinion amongst UK practising gynaecologists on the best definition of “cure” following surgery for urogenital prolapse

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2. To Investigate consensus opinion amongst UK practising gynaecologists on the ideal outcome measure to quantify “success” following surgery for urogenital prolapse. 3. To Establish whether there are significant differences in the above two goals and postoperative follow up based on individual practice as a generalist / generalist with special interest in urogynaecology / urogynaecologists Background: Urogenital prolapse is a common, distressing condition for women with a prevalence of stage 3–4 prolapse in the range of 2–11 %[i]. In addition, there is an 11 % lifetime risk of needing surgical correction of urogenital prolapse with a third of these women requiring further surgery in the future. [ii]. The lack of standardised definitions for surgical success following pelvic organ prolapse (POP) surgery has resulted in highly variable estimates of success. The primary aim of our survey was to establish a consensus definition of surgical cure based on the expert opinion of all practising UK based gynaecologists. Methodology: A questionnaire was designed to elicit peer opinion on the “best-fit” definition of cure following surgery for pelvic organ prolapse (POP). A pilot study was carried out by asking open-ended questions to identify all the contentious issues in the definition of “cure” following surgical management of urogenital prolapse among the consultant gynaecologists and urogynaecologists in our institution. The questionnaire devised on the basis of this pilot study was then subjected to a test-retest validity analysis by asking the respondents to fill it in twice, 2 weeks apart. The testretest reliability of the questionnaire was found to be good based on Cronbach’s alpha analysis of responses [0.82]. An online survey was designed and sent to 1402 practicing consultant obstetricians and gynaecologists in the UK identified from the Royal College of Obstetricians and Gynaecologists members database. Non-responders were sent a reminder email to complete the survey 2 weeks later.

Results: The total response rate was 15 %. At 1st mailing, 112(8 %) and at 2nd mailing, 100(7.13 %) consultant obstetricians and gynaecologists responded to the survey. 82 (48.81 %) were generalists, 70(41.67 %) were generalists with special interest in urogynaecology and 16(9.52 %) were urogynaecologists. 40 surveys were excluded, as they were either incomplete or from retired practitioners. We found the majority (96 %) of the clinician’s primary goal was to cure symptoms and/or provide better QoL. Most (75.58 %) of the respondents would follow-up the patients in a hospital outpatient clinic irrespective of whether or not they experienced post-operative problems. Routine hospital consultant led follow up continues to be the norm for the majority (64.71 %) where all patients are examined irrespective of residual POP symptoms. Unsurprisingly, when considering an ideal definition of cure, we found (35.46 %) ranked the highest for improving QoL (Table: 1). Eleven of the consultants ranked all the subjective definitions together as ideal. To determine success, (38.3 %) ranked patient goal achievement the highest as their ideal outcome measure (Table: 2). Five consultants ranked all the subjective outcome measures together to determine success of the surgery as ideal. Conclusion: This survey demonstrates the lack of standardised definition of cure and the outcome measure to determine success following surgery for prolapse. Interestingly, we have shown a definite move from traditional anatomical measures of success towards more subjective outcomes. Majority of the consultants define cure based mainly on patient’s self reported improvement of symptoms after their surgery for prolapse. It may be that any definition will need to encompass several parameters in order to define cure. There is however an urgent need to develop a consensus on what constitutes cure and the best outcome measures to determine success of the surgery. Endnotes i (2005)Am J Obstet Gynecol 192:795–806 ii (1997)Obstet Gynecol;89:501–6

Table 1. Ideal definition of cure ranking Ranking n Restore (%) anatomy 1 17(9.8) 2 14(8.0) 3 16(9.2) 4 14(8.0) 5 106(61.2)

Bladder and/or bowel and/or sexual function 37(21.3) 36(20.8) 25(14.4) 65(37.5) 9(5.2)

Improving Quality of Life 61(35.2) 41(23.6) 48(27.7) 14(8.0) 9(5.2)

Achievement of patient centered goals 57(32.9) 42(24.2) 32(18.4) 29(16.7) 12(6.9)

Patient’s impression of improvement 53(30.6) 37(21.3) 39(22.5) 25(14.4) 18(10.4)

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Table 2. Ideal outcome measure ranking Ranking n(%)

POP-Q [Pelvic Organ Prolapse Quantification System]

QoL questionnaire [Quality of life]

Patient goal achievement

PGI-I [Patient global impression of improvement]

1 2 3 4

23(13.2) 20(11.5) 20(11.5) 89(51.4)

44(25.5) 45(26) 52(30) 15(8.6)

66(38.3) 44(25.4) 24(13.8) 18(10.4)

51(29.4) 55(31.7) 38(21.9) 15(8.6)

M. Naidu: None. S. Srikrishna: None. D. Robinson: None. L. Cardozo: None. 115 THE ASSOCIATION BETWEEN HIATAL DIMENSIONS AND ANTERIOR COMPARTMENT DESCENT E. Kasikova1, K. L. Shek 2, H. P. Dietz 2 1 INSTITUTION FOR THE CARE OF MOTHER AND CHILD, PRAGUE, Czech Republic, 2SYDNEY Med. SCHOOL NEPEAN, SYDNEY, Australia. Objective: To determine the mathematical association between bladder descent and dimensions of the levator hiatus

Background: There is a strong association between female pelvic organ prolapse and hiatal dimensions, both on imaging (1) and clinically (2). In order to assist with modeling of pelvic floor dysfunction we undertook a study to define the mathematical nature of this relationship. Methods: We analysed data of 628 primiparous women. Ultrasound volume datasets obtained on Valsalva were analyzed with proprietary software. Hiatal biometry and pelvic organ descent were determined as previously described (3). Pearson’s correlations were used for analysis, together with regression modeling to visualize the relationship between pelvic organ descent and hiatal dimensions.

Figure 1. Determination of hiatal dimensions and pelvic organ descent on ultrasound. Illustrated is measurement of bladder descent (a) and hiatal area / hiatal diameter (b)

Results: Of 628 women seen on average 0,42 (0.19–1.8) months after a term birth, 326 ( 52 %) had had normal vaginal deliveries, 76 (12 %) a Vacuum and 38 ( 6 %) a Forceps. 187 ( 29 %) had been delivered by Caesarean section. Women reported sypmtoms of prolapse (2.5 %), stress incontinence (26 %), urge incontinence (8 %), frequency ( 24 %) and nocturia (8 %). Mean bladder neck descent was 25.33 (SD 11.28) mm, mean lowest bladder position 4.16 (SD 12.07) mm above the symphysis (SP). The mean uterine position on Valsalva was 25.4

(SD 16.08) mm above the SP. Levator hiatal area on Valsalva measured 21.58 (SD 7.11) cm2, hiatal circumference 17.2 (SD 2.78) cm and the midsagittal hiatal diameter 5.99 (SD 1.11) cm. We found statistically highly significant associations (all P< 0.001 on Pearson’s correlation) between all tested parameters of pelvic organ descent (bladder neck descent, cystocele descent, uterine descent on the one hand and hiatal area, hiatal diameter and hiatal circumference on Valsalva on the other hand). The association is most linear between organ descent and circumference (see Fig 2).

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Fig. 2 Fitted Line plots (quadratic regression) of maximal bladder descent vs. hiatal circumference (left, R2 0.52) and area (right, R2 0.55) on Valsalva. The association on the left is more nearly linear.

Conclusions: There is a strong association between anterior and central compartment descent on the one hand and the dimensions of the levator hiatus on the other hand. This relationship seems to be almost linear with circumference. This is consistent with a model that considers the pelvic floor as a membrane suspended to the perimeter of the levator hiatus, since forces acting on the membrane perimeter are proportional to circumference rather than area of the membrane. We speculate that a reduction in hiatal circumference should reduce forces acting on anchoring structures within the levator hiatus. Such a reduction would be expected to be in a linear relationship with hiatal circumference. A procedure that reduces hiatal circumference should protect against prolapse recurrence. References: 1. Ultrasound Obstet Gynecol 2008, 31, 676–680 2. Neurol Urodyn 2003, 22, 513–514 3. BJOG 2010, 117, 1485–92 E. Kasikova: None. K.L. Shek: None. H.P. Dietz: None. 116 IS PELVIC FLOOR ULTRASONOGRAPHY USEFUL WHEN COMBINED WITH CLINICAL ASSESSMENT? F. Lone, A. Sultan, R. Thakar, A. Stankiewicz Croydon Univ. Hosp., London, United Kingdom. Objective: To establish if preoperative pelvic floor ultrasonography in urogynaecology patients can complement clinical findings and contribute to additional management strategies. Background: Comprehensive assessment of the pelvic floor provides information which affects operative decisions [1]. Pelvic organ prolapse quantification (POPQ) has been approved by the International Continence Society as a standardised system for assessment of pelvic organ prolapse (POP) [2]. Ultrasound is increasingly being used in the assessment of the pelvic floor. Diagnosis of coexisting

abnormalities may be important when planning pelvic floor reconstructive procedures. Methods: Women were recruited from the urogynaecology and gynaecology clinics between July and October 2009. 106 women had POP and 54 asymptomatic women were included as controls. A history was taken and demographic data was collected. All patients had a POPQ assessment in the dorsal position [2] by an independent examiner. The measurements of POPQ points Ba, Bp and C were used as they describe the maximum descent of the anterior, posterior and middle compartment respectively. For ultrasound assessment, no patient preparation was required, no rectal or vaginal contrast was used and the patients were scanned in the supine position [3]. To perform comprehensive PFUS, we used 6 MHz convex transducer (B-K Type 8802, ProFocus Ultraview) 2D-transperineal ultrasound (2D-TPUS, 9–16 MHz endovaginal ultrasound (EVUS) with a 360° rotational probe and 5–12 MHz biplane endovaginal transducer with linear and transverse arrays. The clinician performing pelvic floor ultrasound (PFUS) was blinded to POPQ results. POPQ and PFUS were repeated at 1 year. Results: 158 of 160 women had a POPQ and PFU. The mean (± SD) age was 49.5 (± 14.1) years, BMI 29.3 (± 6.5) kg/m2 and median (range) parity of 2 (0–6). Two clinicians analysed the PFUS independently and found good to excellent agreement [Lin’s correlation r2 00.77–0.93 (95 % CI 0.71–0.95)]. Additional ultrasound diagnoses at baseline and at 1 year are demonstrated in Fig 1. At baseline assessment, using 2D-TPUS in combination with EVUS, detected 11 enteroceles, 4 intussusceptions, 2 urethral diverticulae, 4 bladder calcifications, 6 vaginal cysts and 1 combined enterocele and intussusception. However, when 2D-TPUS was used in isolation, 2 intussusceptions and 1 combined enterocele and intussusception were not identified at baseline and 2 enteroceles, 2 intussusceptions and 1 combined enterocele and intussusception were not identified at 1 year (Fig 1) . None of the additional diagnoses were picked up on clinical examination except urethral diverticulae. Details of these

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additional occurrences and interventions are shown in Table 1. None of these women with missed diagnoses on POPQ and TPUS needed any surgical intervention for these diagnoses. Conclusions: Pelvic floor ultrasonography identifies additional conditions to that diagnosed during clinical assessment. However, at 1 year follow-up, it does not appear that

additional pre-operative information obtained by pelvic floor ultrasound would have been clinically useful in the management. Longer term follow-up is now underway. References: 1: Ultrasound Obstet Gynecol 2006 ; 28 :629–634. 2: Am J Obstet Gyneco 1996 ; 175(1):10–17. 3: Ultrasound Obstet Gynecol 2011 ; 37(4):381–96.

Table 1. Additional diagnoses at baseline and at 1 year follow up with events and interventions during study period. Additional diagnoses Enterocele n median(range) mm Intussusception n median(range) mm Urethral diverticulum Bladder calcification Vaginal cysts Enterocele+Intussusception

At baseline

a

At baseline b

Event/ Intervention

At 1 year a

At 1 year

b

1 recurrent prolpase 2

9

12

16

10 (7–13) 1 (5)

10 (−9–16) 3 10 (5–15)

1 STARR

−10 (−20–6) 2 7 (5–10)

9 (−16–16) 7 −5 (−12–8)

1 1 4 0

1 3 2 1

1 diverticulec-tomy – – –

1 1 4 0

0 2 2 2

a

0controls 0prolapse STARR refers to Stapled Transanal Rectal Resection

b

F. Lone: None. A. Sultan: None. R. Thakar: None. A. Stankiewicz: None. 117 DOES THE VISUALIZATION OF PELVIC FLOOR STRUCTURES CHANGE WITH AGING? D. E. White, G. Rostaminia, L. H. Quiroz, S. Shobeiri OUHSC, Oklahoma City, OK.

Fig. 1 Additional diagnoses at baseline and 1 year using POPQ, TPUS and EVUS

Objectives: To evaluate the anterior and posterior pelvic floor compartments in nulliparous women ages 21–80 using 3-dimensional endovaginal ultrasound (3D EVUS). Background: Pelvic floor disorders are an important part of women’s healthcare, affecting millions of women worldwide. Despite the prevalence of these disorders, they continue to be poorly understood. Age and parity are considered the dominating risk factors for developing pelvic floor disorders.1 Age has not consistently been associated with deterioration in pelvic organ support, urethral support, or levator function, but most studies have not controlled for parity when assessing these associations. Furthermore, imaging the pelvic floor to enhance studies related to pelvic anatomy has been limited by technology that is expensive

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and produces images that require substantial expertise to interpret. 3D EVUS has been validated as a reliable method of imaging pelvic floor structures in young nulliparous women.2 In this study, we aim to assess the anterior and posterior compartment pelvic floor anatomy in a community-based cohort of nulliparous women to determine if the visualization of these structures changes with aging. Materials and Methods: This is a sub-analysis of a study aimed at assessing age-related changes of the pelvic floor in nulliparous women using 3D EVUS. Imaging of the anterior and posterior compartments was obtained at the time of the primary study. Two observers independently read all images, looking anteriorly for the vesical trigone (VT), trigonal ring (TR), trigonal plate (TP), striated urogenital sphincter (SUG), compressor urethra (CU), and the longitudinal and circular smooth muscle (LCM). Posterior structures included the superficial external anal sphincter (EASsq), main external anal sphincter (EAS-m), internal anal sphincter (IAS), and the rectovaginal septum (RVS). Structures were rated as “present” or “not present”. Urethral, RVS, and anal sphincter measurements were recorded. Summary statistics were calculated for the study population. Spearman’s rank correlation was used to evaluate the association between urethral and anal sphincter measurements and age. Logistic regression was used to evaluate the association between age and the presence of anterior or posterior compartment structures. Inter-observer reliability was determined with Cohen’s kappa statistic. P value of <0.05 was considered significant. Results: 77 community dwelling nulliparous women underwent 3D EVUS imaging of the anterior and posterior compartments. The majority of the subjects were Caucasian (81 %). The median age was 47 (range 22, 70). 30 % of the subjects were postmenopausal; 10 % were on hormone replacement therapy at the time of 3D EVUS imaging. The majority of subjects had stage 0–1 anterior or posterior compartment prolapse on exam. The median measurements are as follows: urethral length 3.68 cm (range 1.67, 6.84), IAS length 2.60 cm (range 1.74, 4.12), IAS width 0.32 cm (range 0.17, 0.63), and RVS length 3.02 cm (range 2.15, 3.98). Increasing age was not associated with the measurement of any structure. Also, increasing age was not associated with the visualization of anterior or posterior compartment structures on 3D EVUS. Inter-observer agreement for visualization of structures is shown in Table 1. Conclusions: 3D EVUS can identify anterior and posterior compartment structures with good to excellent interobserver reliability. Increasing age was not associated with decreasing visualization or measurement of anterior or posterior compartment structures in nulliparous women. References: Obstet Gynecol. 2009 May;113(5):1089–97. Int Urogynecol J. 2012 Mar 9.

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Table 1. Inter-observer analysis of visualizing anterior or posterior compartments Structure VT TR TP LCM SUG CU RVS IAS EAS-sq EAS-m

Agreement (n, %) 70/75 (93.33) 67/77 (87.01) 73/75 (97.33) 76/77 (98.70) 76/77 (98.70) 72/77 (93.51) 70/74 (94.59) 74/75 (98.67) 67/75 (89.33) 72/75 (94.67)

k 0.806 0.696 0.937 0.794 0.794 0.724 0.854 0.957 0.718 0.878

95 % CI 0.643, 0.969 0.537, 0.854 0.852, 1.000 0.400, 1.000 0.400, 1.000 0.496, 0.953 0.716, 0.992 0.874, 1.000 0.536, 0.901 0.743, 1.000

D. E. White: None. G. Rostaminia: None. L.H. Quiroz: None. S. Shobeiri: Grant /Research Support; BK Medical. 118 SAFETY OF VIDEO-URODYNAMICS. HOW CAN WE MINIMISE RADIATION EXPOSURE? I. Giarenis, J. Phillips, H. Mastoroudes, S. Srikrishna, D. Robinson, C. Lewis, L. Cardozo King’s Coll. Hosp., London, United Kingdom. Objective: To calculate the total radiation exposure and specific organ absorbed dose during video-urodynamics (VUDS) in women. Background: VUDS offers the most comprehensive means of assessment of lower urinary tract dysfunction, adding high-resolution anatomic details to the urodynamic data¹. Despite concerns regarding the radiation dose during VUDS there is limited evidence in the literature to estimate the extent of radiation exposure in the adult female population. Methods: Consecutive women attending for VUDS in a tertiary referral urogynaecology unit were included in the study. Multichannel videourodynamics were performed by urodynamicists following a standardised protocol, in line with the ICS good urodynamic practice guidelines. Filling cystometry was performed in the supine position with a contrast medium (Omnipaque TM, Ioxehol). When the cystometric capacity was reached the X-ray table was rotated to a standing position and fluoroscopy of the lower and upper abdomen in a posteroanterior view was performed. Urodynamic Stress Incontinence (USI) was detected by simultaneous fluoroscopy of the bladder neck in a semi-oblique plane during a series of coughs with maximal effort. The urethral shape and outline were assessed during voiding by intermittent fluoroscopy of the urethra in the same oblique plane.

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Then, the bladder was imaged with fluoroscopy during an isometric contraction to detect vesico-ureteric reflux. The fluoroscopy unit was a Siemens Axiom Sireskop SD configured with 0.2 mm of copper filtration and a 3.6 mm of aluminium filtration. In order to facilitate the dose calculations, video playbacks of 60 examinations were analysed by two medical physicists in order to determine a typical examination. The Monte-Carlo simulation programme PCXMC (version 2.0), a reliable simulation software², was utilised to calculate normalised entrance skin exposure doses for the radiosensitive organs T. The effective dose was calculated using the equation effective dose0Σ WT x HT, where WT is the tissue weighting factor for organ T and HT is the absorbed dose to organ T. Multivariable linear model regression analyses on the data were performed using SPSS (V17, Chicago, Illinois). Results: 345 consecutive VUDS, performed by five different operators, were reviewed. 264 studies that followed the standardised protocol were included in the study. The mean age was 51.59 years (SD: 14.29), the mean BMI was 27.31 (SD: 5.95) and 53 % were postmenopausal. The indications for VUDS are summarised in table 1. The majority of the studies (60 %) were performed for patients with complex pathology such as co-existence of significant pelvic organ prolapse (POPQ stage≥2), previous continence surgery and recurrent urinary tract infection. Table 1. VUDS indications Indication Urinary incontinence Significant pelvic organ prolapse Previous continence surgery Recurrent urinary tract infection

N (%) 106 (40.15) 76 (28.79) 30 (11.36) 29 (10.98)

Neurogenic bladder Voiding difficulties Suspected vesicovaginal fistula

11 (4.17) 9 (3.41) 3 (1.14)

General radiation data are presented in table 2. The mean calculated effective dose was 0.34 mSv (SD: 0.15). Table 2. Radiation exposure Mean Mean Mean Mean

fluoroscopic time (sec) tube potential (kV) dose area product (cGycm²) effective dose (mSv)

63.15 (SD:21.81) 95.84 (SD:8.97) 163.76 (SD:82.14) 0.34 (SD:0.15)

The mean absorbed doses to specific organs are shown in table 3. Unsurprisingly, the bladder and uterus received the highest absorbed doses.

Table 3. Organ absorbed dose Organ Bladder Uterus Colon Ovaries Kidneys Bone marrow

Mean absorbed dose (mGy) 1.57 1.39 0.70 0.70 0.50 0.32

Skeleton Liver

0.28 0.09

Multivariable linear regression analysis showed that BMI (p00.009) and fluoroscopy time (p<0.001) were the only statistically significant factors. The operator (p00.178) and the indication of the VUDS (p00.187) did not appear to have a statistically significant impact on the effective dose. The final linear regression model for the estimation of the effective dose was Eff. Dose (mSv)00.049+0.003·BMI (kg/ m²)+0.004·fluoroscopy time (sec). Conclusion: This study shows that VDUS in adult women are associated with a very low exposure and radiation risk. This dose is comparable to the dose of an abdominal X-ray (0.4 mSv) and much lower than that reported in the literature (4.3 mSv)³. The use of a standardised protocol without image acquisition, but only fluoroscopy, minimises exposure to a level consistent with the ‘as low as reasonably achievable’ radiological principle. References: 1. Neurourol Urodyn 8: 447–449 2. Radiat Protect Dosim 1998; 80: 213–219 3. Urology 2006; 67: 269–274 I. Giarenis: None. J. Phillips: None. H. Mastoroudes: None. S. Srikrishna: None. D. Robinson: Consultant; Astellas, Ferring, Gynaecare, Pfizer. Grant /Research Support; Astellas, Pfizer. C. Lewis: None. L. Cardozo: Consultant; Allergan, Astellas, Ethicon, Merck, Pfizer, Teva. Grant /Research Support; Pfizer. 119 HAVE OUR AMBULATORY PROTOCOL (AND PATIENTS!) BEEN AROUND FOR TOO LONG? A. M. Rantell, L. Cardozo, D. Robinson, S. Srikrishna; King’s Coll. Hosp., London, United Kingdom. Objective: The aim of this study was to evaluate new ambulatory urodynamics technology in the diagnosis of detrusor overactivity (DO), and thereby streamline our standard protocol to increase the cost effectiveness of the test. Background: Ambulatory urodynamics monitoring (AUM) is a functional test of lower urinary tract function, performed outside the clinical setting1. It adopts a

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more physiological approach to bladder filling and allows the patient to recreate everyday activities2. Our department ambulatory protocol has been in place for almost 20 years, advocating a 4 h test. During this time the women perform various provocative manoeuvres and complete a written diary listing symptoms and sensations. Although previously the traces could be seen in real time when the ambulatory recorder was connected to the computer, the trace could not be reviewed until the recording had been stopped and downloaded. There is now software available which allows the trace to be reviewed contemporaneously via a Bluetooth connection and enables markers to be placed directly onto the trace to document patient’s symptoms. Consequently, once the woman feels that her symptoms have been replicated, the trace can be reviewed and if a diagnosis can be made, the test can be terminated early. Following acquisition of new ambulatory equipment, it was necessary to adapt the department protocol. Thus we have undertaken this evaluation of the revised protocol. Methods: This was a pilot study of 100 consecutive patients undergoing AUM. All had previously had equivocal or normal video urodynamics (VCU) findings which did not concur with their symptoms. The MMS Luna ambulatory recorder was used to perform the tests and reviews were undertaken every hour during the recording. All tests were performed by the nurse specialists in the department who have received training in AUM in line with the National Guidelines3 and followed the standard 4 h department protocol. Results: Of the 100 women who underwent AUM, seventy two complained of urinary urgency. All the AUM diagnoses are shown in table 1. Table 1 AUM Diagnosis Detrusor Overactivity Mixed Incontinence Stress Incontinence Voiding Difficulties Normal Urodynamics Post Micturition Dribble Unconscious Leakage

No. Of Women (%) 25 11 44 4 12 2 2

The traces for the women found to have detrusor overactivity or mixed incontinence were then reviewed to determine the time point in the test they experienced their first detrusor contraction. The average time to the first detrusor contraction was 71mins (range 9–204 min) (Figure 1). Within 2 h and 10 min 93 % of cases of DO had been diagnosed.

Conclusions: In the majority of women shown to have DO, the test could be significantly shortened. This can improve cost effectiveness of the test by halving nursing time and saving the hospital approximately £54 per test. It may also reduce patient discomfort and potentially improve patient satisfaction. This study demonstrates that new equipment allowing real time interpretation of AUM traces, can improve our service in terms of patient acceptability and cost effectiveness. It also highlights the importance of reviewing protocols and auditing our service when introducing new technology. References (optional): 1. Int Urogynaecology J (2010) 21: 5–26. 2. Neurourol.Urodyn (2000) 19:113–125 3. UKCS (2009) A.M. Rantell: Grant /Research Support; Pfizer. L. Cardozo: Consultant; AdvaMed, Astellas, Ethicon, Merck, Pfizer, Teva. D. Robinson: Consultant; Astellas, Ferring, Gynaecoare, Uroplasty, Pfizer, Recordati. S. Srikrishna: None. 120 IS OBESTIY ASSOCIATED WITH URODYNAMIC STRESS INCONTINENCE? F. Puccini 1, A. Tubaro 2, G. A. Digesu 1, A. A. Bhide1, C. Hendricken 1, R. Fernando 1, V. Khullar 1 1 Imperial Coll. London, London, United Kingdom, 2 Ospedale Sant’Andrea, Rome, Italy. Objective: To assess whether an increased body mass index (BMI) is associated with urodynamic stress incontinence and/or detrusor overactivity. Background: Obesity has been widely studied as an independent risk factor for urinary incontinence (UI) in women. Epidemiological and experimental studies indicated a strong relationship between increased BMI and UI. Surgical or behavioural weight loss has been shown to significantly improve urinary incontinence symptoms. Other authors have also demonstrated that a 5% to 10 % reduction in weight is sufficient to reduce the frequency of incontinence episodes. However the relationship between increased body weight and urodynamic diagnosis is still unknown. Methods: Women with lower urinary tract symptoms (LUTS) were recruited from a urodynamics clinic. All eligible women completed a 3 day frequency-volume chart and underwent urodynamics using a standardised protocol according to ICS guidelines. Dual channel cystometry was performed with each woman supine and the bladder filled through a 10 F filling catheter using room temperature saline; a fluid-filled 4.5 F catheter was used to measure the

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intravesical and abdominal pressures. The filling catheter was removed when the patient developed a strong desire to void or 500 mL had been infused into the bladder. Provocative manoeuvres were used with each woman in a standing position. Women were asked to cough 1, 3, and 5 times with maximal effort and then listen to running water and wash their hands in cold water. Finally, they were seated for a pressure-flow study conducted in private. BMI was defined as weight (in kilograms) divided by height (in meters squared). The relationship between BMI and urodynamic diagnosis was assessed. A chi square test and version 19.0 SPSS software were used for the statistical analysis. Results: A total of 272 women were studied. The mean age was 51 years old, range 25–75. 152 women had a BMI of equal or greater than 30 whereas 120 had a BMI of less than 30. 130 (48 %) had a diagnosis of detrusor overactivity (DO), 49 (18 %) had a diagnosis of urodynamic stress incontinence (USI), 78 (29 %) had a mixed urodynamic diagnosis of DO and USI and 15 (5 %) of women had inconclusive urodynamics. Women with a BMI≥30 are more likely to have DO (both DO and mixed urodynamic diagnosis) rather than USI (p value 0.02). A BMI≥ 30 was not associated with an increased incidence of USI. Conclusions: A raised body mass index is associated with increased incidence of detrusor overactivity as a single diagnosis or as mixed urinary incontinence. Surprisingly there was no such association with urodynamic stress incontinence. F. Puccini: None. A. Tubaro: None. G. A. Digesu: None. A. A. Bhide: None. C. Hendricken: None. R. Fernando: None. V. Khullar: None. 121 DOES CESAREAN DELIVERY PROTECT AGAINST PELVIC FLOOR DYSFUNCTION AT 6 MONTHS POSTPARTUM? R. G. Rogers, L. Leeman, N. Borders, C. Qualls, A. Fullilove, D. Teaf, R. J. Hall, L. L. Albers; Univ. of New Mexico, Albuquerque, NM. Objective: To compare pelvic floor function at 6 months postpartum between women who gave vaginal birth (VB) and those who delivered by cesarean (C/S) without entering the 2nd stage of labor. Background: Prior comparisons of women who deliver by C/S and those who deliver vaginally have included large numbers of women who undergo episiotomy and operative VB; known risk factors for postpartum pelvic floor dysfunction. We sought to compare 6 month pelvic floor function between nulliparous women giving VB with low rates of these interventions to women delivered by C/S who did not enter the 2nd stage of labor.

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Methods: We recruited midwifery (MW) patients during pregnancy and an additional cohort of women who underwent C/S without entering the 2nd stage of labor at birth. Physical exam and functional data were assessed during pregnancy and at 6 months postpartum for MW patients; the C/S cohort gave functional data at birth and functional and physical exam data again at 6 months postpartum. MW patients who underwent C/S without entering the 2nd stage of labor were included in the C/S group for analyses; all other MW patients were in the vaginal birth (VB) group. Physical exam data included Pelvic Floor Quantification Exams (POPQ); in addition, women completed the Incontinence Severity Index (ISI), the Questionnaire for Urinary Incontinence Diagnosis (QUID), the Pelvic Floor Impact Questionnaire (PFIQ-20), the Wexner Fecal Incontinence Scale (W), the Present Pain Intensity Scale (PPI) and the Female Sexual Function Index (FSFI). All women underwent 3D perineal U/S to assess the anal sphincter complex at 6 months. Multivariate analyses controlled for differences in patient and baseline characteristics between groups. Significance was set at p<.05. Results: We recruited 672 women who met inclusion criteria for these analyses; 331/448(74 %) VB and 138/224(62 %) C/S women followed up at 6 months postpartum. Eight women (2 %) underwent episiotomy, one woman had a forceps delivery and 25(6 %) a vacuum delivery. Women who followed up at 6 months were older (24.0 +/−5.3 vs 25.2 +/−5.5, p0.005), more educated (13.1 +/−2.7 vs 14.1 +/−2.8, p<.001) and were less likely to have fecal incontinence (FI) at baseline (22 vs 15 %, p0.04). Follow up groups did not differ in rates of urinary incontinence (UI) or sexual activity, BMI, or race/ ethnicity. As expected, the C/S group was older (26.6 +/−6.1 vs 23.9 +/−4.9 years, p<.001), more overweight/obese (58 vs 38 % obese, p<.001) than the VB group; however, baseline functional measures did not vary between VB and C/S groups (all p≥.05). At 6 months, VB women were more likely to have≥Stage 2 prolapse (22 vs 15 %, p0.008); these differences were confined to the anterior vaginal wall (data not shown). At 6 months, women who underwent C/S were as likely to be sexually active (92 vs 88 %, p0.18) but reported slightly poorer FSFI scores (26.6 +/−6.3 vs 28.5 +/−5.4, p0.004) than the VB group. At 6 months, presence of any UI (46 vs 55 % ISI>0, p0.10) or FI (13 vs 8 % FI on W, p0.12) were not different between groups; severity or type of incontinence and PFIQ-20 scores also did not differ (data not shown). The majority of women reported no perineal pain (94 vs 92 %, C/S vs VB, p0.27) at 6 months. On 3D transperineal U/S, 34(8 %) internal and 4(<1 %) external defects were noted, with no differences between groups. Multivariate analyses controlling for education, BMI and age differences between groups did not change conclusions.

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Conclusions: VB resulted in measurable changes in prolapse, but did not result in more UI, FI, decreased sexual activity, perineal pain or changes in PFIQ-20 scores at 6 months postpartum compared to women who delivered by C/S who did not enter the 2nd stage of labor. References (optional): R. G. Rogers: None. L. Leeman: None. N. Borders: None. C. Qualls: None. A. Fullilove: None. D. Teaf: None. R.J. Hall: None. L.L. Albers: None. 122 PELVIC FLOOR TRAUMA: DOES THE SECOND BABY MATTER? T. A. Horak1, R. Guzman Rojas 2, K. Shek 2, H. Dietz 2 1 Univ. of Cape Town, Cape Town, South Africa, 2Univ. of Sydney, Penrith, Australia. Objective: To determine the impact of a second pregnancy and delivery on pelvic floor structure and function. Background: Pelvic floor trauma is commonly detected in women who have delivered vaginally. Mathematical modelling suggests that most such trauma is due to the first baby, but epidemiological data shows that subsequent deliveries are associated with an increased risk of prolapse.

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Methods: This is a retrospective analysis of data obtained in 2 perinatal imaging studies. Women were invited for antenatal and two postnatal appointments. All had undergone a standardized questionnaire, clinical examination and translabial 4D ultrasound. Ultrasound volumes were acquired at rest, on Valsalva and pelvic floor muscle contraction (PFMC) and analyzed by postprocessing on a PC, blinded against all other data. Avulsion was diagnosed on tomographic ultrasound imaging (TUI). This study reports data obtained in those women who were delivered of a second child between the first and second postnatal assessments. Results: Out of 715 participants seen at an average gestation of 36+5, 529 returned for their first postnatal assessment at a median follow-up time of 4.2 (2.3–22.1) months postpartum. Of those, 227 were again seen for a second postnatal appointment, and 94 of them seen at an average of 2.7 (1.43–4.21) years after their first delivery reported a second birth. This had occurred at a mean gestation of 39.4 (33,5– 42) weeks with a birth weight of 3512 (1844–4800) grams. 65 (69 %) had a vaginal delivery (NVD 58 [62 %], vacuum 4, [4 %]; forceps 3 [3 %]), and 29 (31 %) a caesarean section (prelabour CS 24 [26 %]; 1st stage CS 5 [5 %]). There were 9 VBAC attempts, of which 6 were successful (2 NVD, 3 Vacuum, 1 FD).

Figure 1. Tomographic imaging of the m. puborectalis 4.5 months after a first delivery by 2nd stage C/S (a) and 1.8 years later, 9 months after a second birth by Vacuum (b). A right-sided avulsion is indicated by (*) in slices 2–8.

When we analyzed ultrasound findings before and after a second delivery, there was a trend towards increased bladder neck descent, with no significant change observed to cystocele descent and hiatal area on valsalva. Levator avulsion was diagnosed in 6 patients (6 %). Table 1 shows a comparison of findings after first ( 3–6 months follow up) and second birth.

Table 1. Comparison of bladder neck descent, cystocele descent, hiatal area on valsava and avulsion after 1st and 2nd birth (n094) Parameter BND (mm)

After first delivery After second delivery Change 24.4 (SD 10.6) 24.2 (SD 10.5) −0.24 (ns)

Cystocele descent (mm) 4.1 (SD 11.4)

5.5 (11.5)

Hiatal area (cm2)

21.3 (SD 7.3)

22.0 (SD 7.8)

−1.4 (ns) +0.67 (ns)

Avulsion

6/94

6/94

1 “healed”,1 new

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Delivery mode of the second birth seemed to have little effect on changes observed between follow ups, although there was a trend towards increased bladder neck descent in women after vaginal delivery (Table 2). Table 2. Changes in bladder neck descent, hiatal area on valsava and avulsion after a second vaginal and abdominal birth. Parameter Change in BND (mm) (n088) Cystocele descent Change in hiatal area (cm2) New avulsion

Vaginal birth + 1.4 (10.1) −2.4 (10.4 +0.14 (5.6) 1

C/S delivery −2.67 (8.8) +0.3 (7.7) +1.67 (6.5) 0

P0 0.057 0.19 n.s.

On reviewing patients who were diagnosed with avulsion at their 2–3 year visit and comparing them with findings at the first follow up, we found identical normal findings in 87. In 5 there was an unchanged avulsion. In one case findings had improved from complete to partial avulsion—after a second NVD. There was one new avulsion in a patient who had delivered her first baby by emergency C/S, and her second by Vacuum (see Figure 1). Conclusions: A second pregnancy and delivery do not seem to have a major effect on bladder support and/ or levator function. However, we have documented a case of major levator trauma after Vaginal Birth after Caesarean. The issue of pelvic floor trauma after VBAC may have to be investigated further. T.A. Horak: None. R. Guzman Rojas: None. K. Shek: None. H. Dietz: Grant /Research Support; AUD 9000 educational grant, GE Medical 2012. 123 DO LEVATOR HIATUS DIMENSIONS AND THE ABILITY TO STRETCH THE PUBOVISCERAL MUSCLE IN LATE PREGNANCY INFLUENCE DELIVERY OUTCOME? -A 3/4D TRANSPERINEAL ULTRASOUND STUDY F. Richter 1 , J. Stær-Jensen 2 , G. Hilde 3 , K. Bø 3 , M. Eellström Engh 1 1 Univ. of Oslo, Faculty Div. Akershus Univ. Hosp., Oslo, Lørenskog, Norway, 2 Akershus Univ. Hosp., Oslo, Lørenskog, Norway, 3Norwegian Sch. of Sport Sci., Dept. of Sports Med., Oslo, Norway. Objective: The aim of the study was to determine if levator hiatus (LH) dimensions at rest and on Valsalva and the ability to stretch the pubovisceral muscle (PVM) in late pregnancy impacted on duration of active and passive second stage of delivery and delivery mode. Background: Factors leading up to normal vaginal delivery (NVD) are complex. It has been hypothesized that anatomy and biomechanical properties of the pelvic floor muscles may

influence progress of labour (1). The PVM, the most medial part of the levator ani complex bordering on the LH, has to extend up to 250 % to allow the passage of the fetal head (2).This marked increase in length is achieved by the forces acting on the muscle during delivery, but may also depend on the adaptability of the PVM. We wanted to study the influence of LH dimensions and the ability to stretch the PVM in late pregnancy on duration of second stage of delivery and delivery mode. Methods: In this cohort study, 88 pregnant nulliparous women were examined using 3/4D transperineal ultrasound at rest and on maximal Valsalva at 37 weeks of gestation. The ultrasound examinations were performed by two trained investigators, blinded to the women’s obstetric history, using a GE Voluson E8 system (GE Medical Systems, Zipf Austria). The ultrasound volumes were determined in the axial plane in render mode off-line using the 4D View (v 10.0). LH dimensions including anterior-posterior (LHap), transverse (LHrl) diameter and area (LHarea) were measured. To compute the stretch of the PVM (percentual increase in PVM length on Valsalva) the ratio of PVM length on Valsalva to resting state was calculated (3). The women`s obstetrical data were collected from the hospital’s electronic medical records. Duration of passive and active second stage was calculated in women with normal and instrumental vaginal delivery. Passive second stage is defined as the interval between full cervical dilatation and commencement of active pushing. Active second stage is defined as time of active pushing. Mean values and standard deviation (SD) for demographic data and LH measurements at week 37 were computed. Differences in LH measurements and PVM stretch between women with NVD and women with instrumental delivery, including caesarean section (ID) were given as mean differences with 95 % confidence interval (95 % CI) and were analysed using independent-sample t-test or Mann-Whitney U Test. Pearson Correlation was used to analyse associations between passive and active second stage and LH measurements and stretch of PVM. P values < 0.05 were considered significant. Results: The mean age of the 88 included women was 29.5 years (SD 4.1), pre-pregnancy body mass index (BMI) 24.1 kg/m2 (SD 4.4) and mean gestational age at ultrasound examination 37.2 weeks (SD 0.5). Four women underwent prelabour caesarean section and were excluded from further analysis. Of the 84 women who went into labour, 62 (73.8 %) had NVD and 22 (26.2 %) ID (vacuum n013, forceps n01, emergency caesarean deliveries n=8). Maternal age, BMI, mean birth weight and head circumference at gestation did not differ between women with NVD and ID. Significant moderate inverse correlation could be estimated for LHrl and LHarea at rest and active second stage (r = -0.39, p0 0.001), (r0 -0.39, p0 0.01) respectively. There was also significant weak inverse correlation between LHap at rest (r0 -0.29, p0 0.01), LHrl on Valsalva (r0 -0.26, p0 0.02) and LHarea on Valsalva (r0 -0.26,

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= 0.02) and duration of active second stage. No correlation was found between LH dimensions at rest and on Valsalva and passive second stage. This was also true for stretch of PVM on Valsalva and duration of active and passive second stage. Women with NVD had significantly larger LHrl (3.81 cm, SD 0.4) at rest compared with women with ID (3.59 cm, SD 0.3) (mean difference= 0.22; 95 % CI 0.04 / 0.41). LH area was 1 cm2 larger in women with NVD as compared with women with ID at rest (14.26 cm2, SD 3.2 vs 13.20 cm2, SD 2.6) and on Valsalva (19.09 cm2, SD 5.6 vs 18.06 cm2 SD 5.1), but none of the differences were significant. LHap did not differ between groups. Women with ID had greater stretch of PVM on Valsalva (23.9 %, SD 24.9) than women with NVD (20.1 % SD 19.1) (mean difference= -0.04; 95 % CI -0.14 / 0.06). Conclusions: In the present study we found, that LH dimensions at rest, rather than LH dimensions on Valsalva impacted on duration of active second stage in women who delivered vaginally. As for NVD compared with ID, larger LHrl at rest seemed to facilitate NVD. Women in late pregnancy were able to voluntarily stretch the PVM between 20 and 24%, which is not much in comparison with the involuntary stretch of the PVM during delivery. The clinical importance of these findings needs further studies. References: (1) Neurol Urodyn.200, 19: 508-509 (2) Am J Obstet Gynecol (2008) 199:198e1-5 (3) Ultrasound Obstet Gynecol (2008), 31: 201-205 124 EVALUATION OF PELVIC FLOOR AND SEXUAL FUNCTION IN WOMEN WITH SECOND STAGE ARREST WHO UNDERWENT OPERATIVE VAGINAL DELIVERY VERSUS CESAREAN DELIVERY A. K. Crane 1, E. J. Geller 1, H. Bane 2, R. JU 1, E. Myers 1, C. A. Matthews1 1 The Univ. of North Carolina at Chapel Hill, Chapel Hill, NC, 2Carolinas Med. Ctr., Charlotte, NC. Objective: To compare the prevalence and severity of pelvic floor disorders and sexual dysfunction at 1 year postpartum in women who underwent operative vaginal delivery (OVD) versus cesarean delivery (CD) for second stage arrest. Background: The optimal management of second stage arrest of labor, a condition that occurs in 11 % percent of nulliparous women, presents a challenge to most obstetricians1. The relative risks and benefits of maternal and fetal outcomes for a trial of OVD versus CD are not clearly defined. While operative vaginal delivery has been shown to have a negative impact on urinary incontinence, fecal incontinence, and possibly pelvic organ prolapse compared to spontaneous vaginal delivery, the relative risk of this intervention compared to cesarean section for women with second stage arrest has only been reported in a single

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European trial2. In addition, the impact of OVD versus CD on sexual function needs to be better elucidated. Methods: This was a retrospective cohort study of women with second stage arrest in their index pregnancy who delivered between January 2009 and May 2011. Inclusion criteria were primiparous women ≥18 years, term singleton cephalic delivery, not currently pregnant, and having had second stage arrest (defined as greater than 2 h) in the index pregnancy. Subjects were identified based on ICD-9 codes for second stage arrest in an obstetric database. Pelvic floor and sexual function were measured with the Pelvic Floor Distress Inventory-Short Form (PFDI-20) and the Female Sexual Function Index (FSFI) via telephone interview. Demographics and details of the index delivery were extracted from the electronic medical record. Subjects were divided into two groups: 1) successful OVD or 2) CD. The two groups were also analyzed by intent-to-treat (planned OVD versus planned CD at time of arrest), stratification of vacuum vs forceps for the OVD group, and rates of breastfeeding at 1 year postpartum. Results: Of the 109 women who completed the one-year postpartum assessment, 53 (48.6 %) had a successful OVD, 20 (18.3 %) failed a trial of OVD and underwent CD, and 36 (33 %) underwent CD only. Those with a successful OVD were more likely to have lower birth weight (3394 vs 3651 g, p0 0.015), and shorter length of stay (3.66 vs 5.09 calendar days, p<0.001). Those who underwent CD were more likely to have a non-OA presentation (86.2 % vs, 28.6 %, p<0.001), higher station at time of arrest (57.1 % vs 4.1 %, p<0.001), and chorioamnionitis (29.1 % vs 7.5 %, p00.006). At 1 year postpartum, there were no differences between groups in either pelvic floor function (PFDI: 23.9 vs 20.31, p00.475) or sexual function (FSFI: 23.08 vs 24.97, p00.240). When analyzed by intent-to-treat, pelvic floor symptoms remained similar between groups. However, those in the planned CD group reported higher orgasm scores (4.52 vs 3.73, p00.037) and overall sexual satisfaction scores (4.70 vs 4.10, p00.032). When comparing forceps to vacuum-assisted OVD, there were no differences in the rate of 3rd or 4th degree tears, or urinary and bowel symptoms. However, women that underwent a forceps-assisted OVD had higher rates of pressure and pain in the abdomen and vagina at 1-year postpartum (25 % vs 2.7 %, p00.025). The rate of breastfeeding was not different between OVD and CD groups, but those with greater than 6 months of breastfeeding had less dyspareunia at one-year postpartum (p00.044). Conclusions: In this sample of primiparous women with second stage arrest, overall pelvic floor function was good, but mild sexual dysfunction was reported at 1 year postpartum. There were no differences in pelvic floor symptoms between OVD and CD. However, women who underwent CD only had higher orgasm and sexual satisfaction scores. These findings may be useful when counseling women with second stage arrest.

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References (optional): 1. Am J Obstet Gynecol 1995; 173: 906–12. 2. Am J Obstet Gynecol 2004; 191: 4–10. A.K. Crane: None. E.J. Geller: None. H. Bane: None. R. Ju: None. E. Myers: None. C.A. Matthews: None. 125 DISTRIBUTION OF INNERVATION ZONES OF THE EXTERNAL ANAL SPHINCTER CHANGE AFTER VAGINAL DELIVERY WITH EPISIOTOMY K. Baessler1, C. Cescon 2, R. Merletti 3, Tasi-technologies For Anal Sphincter Analysis AndIncontinence; 1 Charité Univ. Hosp., Berlin, Germany, 2LISIN, Torino, Italy, 3Lab. for Engineering of the Neuromuscular System (LISiN), Torino, Italy. Distribution of innervation zones of the external anal sphincter changes after vaginal delivery with episiotomy— Final results of a prospective study Objective: The aim of this study was to evaluate the distribution of the innervation zones and the effect of delivery related trauma on the innervation of the EAS employing surface electromyography (EMG). Background: Recent studies demonstrated that there is a significant correlation between anal sphincter damage during vaginal birth, with or without episiotomy, and subsequent development of anal incontinence in women. Knowledge of the location of the innervation zones (IZs) of the external anal sphincter (EAS) would allow better protection of the innervation. Avoiding the innervation zones during episiotomy could presumably significantly reduce the incidence of sphincter dysfunction. Methods: This is a multicenter study from eight European Centres. Thirty primiparous women concluded the experimental protocol up to date. Measurements were performed during the third trimester of pregnancy and 6–8 weeks after the delivery. Included were only nulliparous women older than 18 years. Measurements were performed with a disposable rectal probe including 16 silver electrodes (see Figure 1). The time shift of the EMG signals from these electrodes reveal the innervation of active motor units and how the action potentials propagate along the fibers. For each of the two investigations, surface EMG signals were amplified in single differential configuration using an EMGUSB amplifier (LISiN OT-Bioelettronica, Torino, Italy), sampled at 2048 Hz, and stored on a PC after 12bit A/D conversion. Slow signals produced by active smooth muscles (if any) were rejected because of the high pass filter at 10 Hz. Women were asked to perform a maximal voluntary contraction (MVC) of the EAS for 10s. EMG signals were acquired for 50s including 10s and 20s of rest before and after the MVC contraction. Signals were divided in epochs of 0. 5 s. For each channel and epoch ARV was computed.

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The ARV values were averaged along the epochs in order to have one value for each channel and extract the ARV map. The activity of single motor units was identified by means of a surface EMG decomposition algorithm. Fig. 1 Disposable rectal probe with 16-electrodes (code: DRP1x16-05MC). Diameter 14 mm. B) Example of multichannel surface EMG signals detected on the external anal sphincter. Black circles indicate the innervation zone location of the active motor units and straight lines indicate the propagation of the potentials. Results: The high quality signals of 249 women were interpreted. Thirty-two women (13 %) had a vaginal delivery without any laceration, 82 (33 %) had an episiotomy, 75 (30 %) had a spontaneous perineal laceration and 60 (24 %) were delivered by caesarean section. Only in women with episiotomy, there was a significant change in the distribution of IZs. Fig. 2 illustrates an example of a woman with a right-sided episiotomy. Fig. 2 Conclusion: Episiotomy causes a significant decrease of the number of innervation zones in the right-ventral quadrant of the EAS quantified between 0.21 and 1.03 innervations zones. Nno other significant decrease or increase is observed for other quadrants and other type of deliveries. K. Baessler: None. C. Cescon: Grant /Research Support; Compagnia di San Paolo and the Else Kroner Fresenius Stiftung. R. Merletti: Grant /Research Support; Compagnia di San Paolo and the Else Kroner Fresenius Stiftung. 126 TOO TIGHT TO GIVE BIRTH? K. Bø1, G. Hilde 1, J. Stær-Jensen 2, F. Richter 3, M. Ellström Engh 2 1 Norwegian Sch. of Sport Sci., Oslo, Norway, 2Akershus Univ. Hosp., Lørenskog, Norway, 3Univ. of Oslo, Faculty Div. Akershus Univ. Hosp., Oslo, Norway. Objective: The purpose of the present study was to investigate the influence of mid pregnancy vaginal resting pressure (VRP), maximum voluntary contraction (MVC) and endurance of the pelvic floor muscles (PFM) on delivery outcomes. Background: One existing myth of the PFM is that a strong pelvic floor might obstruct labor and result in perineal trauma and instrumental delivery. Some studies have concluded that there is no increased risk of prolonged labor or operative deliveries after antenatal PFMT (1,2,3). However, none of these studies reported any data from assessment of VRP, pelvic floor muscle MVC or endurance. Methods: Three hundred nulliparous pregnant women were included in the present prospective cohort study. Inclusion criteria were being in their first ongoing pregnancy and able

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to understand the native speaking language. Exclusion criteria were multiple pregnancy, premature birth <32 weeks and prior miscarriages after gestational week 16. VRP (cm H2O), pelvic floor muscle MVC (cmH2O) and endurance (area under curve for 10 s; cmH2Osec) were measured at mid pregnancy with a vaginal balloon connected to a fiberoptic microtip transducer (Camtech AS). Delivery data was collected from electronic birth records. Differences between VRP, MVC and endurance at mid pregnancy in women with and without acute cesarean section, induction, prolonged 2nd stage (>1.5 h), instrumental vaginal delivery, 3rd and 4th degree perineal tear and episiotomy are reported as mean differences with 95 % CI and analyzed by use of MannWhitney or Independent Sample T-test. Pearson Correlation was used to analyze association between mother’s age and BMI and VRP, MVC and duration. P-value was set to ≤0.05. Results: Twenty-three of 300 participants (7.7 %) were lost to follow up, mostly because they gave birth at another hospital, leaving 277 women with delivery data. Mean age of the study population was 28.7 years (SD 4.3) and pre-pregnancy BMI 23.8 kg/m2 (SD 3.9). Mean VRP, MVC and endurance for the whole study group at gestational week 22 was 42.7 cm H2O (SD 9.6), 35.4 cmH2O (SD 18.1) and 245.5 cm H2Osec (SD 134.0), respectively. There were no statistically significant differences in VRP, MVC or endurance at mid-pregnancy in women delivering with or without acute cesarean section (−1.6 (−6.6–3.4), 0.2 (−7.3–7.3),−7.2 (−61.0–46.6)), induction (0.3 (−2.6–3.2), 0.6 (−5.0–6.2), 3.8 (−37.3–45.9)), instrumental delivery (−2.5 (−5.5–0.4), 0.5 (−5.4–6.5), 0.4 (−43.7–44.6)), prolonged 2nd stage of labor (1.9 (−0.6–4.5), 2.8 (−2.3–7.9),16.0 (−21.7– 53.5)), 3rd and 4th degree perineal tear (4.3 (−2.1–10.7),−1.2 (−13.3–10.9), 12.6 (−77.0–102.2)) or episiotomy (−0.8 (−3.4– 1.8), 0.8 (−5.7–4.1), 1.4 (−35.0–37.5)). There was no significant correlation between mother’s age and VRP (r0.024, p0.696), a borderline significant weak correlation between age and MVC (r0.115, p0.056) and a significant weak correlation between age and PFM duration (r0.128, p0.033). No significant correlations were found between the mother’s prepregnancy BMI and VRP (r0-.053, p0.384), MVC (r0-.021, p0.722) or duration (r0-.078, p0.198). Conclusions: Vaginal resting pressure, maximum voluntary PFM contraction and endurance at mid-pregnancy did not affect delivery outcomes in primiparous women. VRP may be considered the most important factor as it reflects the involuntary state of the PFM and is closely related to the levator hiatus area. Neither mothers’ age nor prepregnancy BMI were correlated to VRP, though this needs further research in samples with greater variation in age and BMI. The myth that strong or firm pelvic floor muscles will negatively affect labor and birth was not supported by the present study. References (optional): 1.BMJ, 329: 378–80, 2004. 2.Int Urogynecol J, 19: 85–88, 2008. 3.Obstet Gynecol, 113,6:1279–84, 2009

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K. Bø: None. G. Hilde: None. J. Stær-Jensen: None. F. Richter: None. M. Ellström Engh: None. 127 HOW WELL CAN PELVIC FLOOR MUSCLES WITH MAJOR DEFECTS CONTRACT? A cross-sectional study 6 weeks post partum using 3D/ 4D diagnostic ultrasound and manometer G. Hilde1, J. Stær-Jensen 2, F. Richter 3, K. Gjestland 2, M. Ellström Engh 2, K. Bø 1 1 Norwegian Sch. of Sport Sci., Dept. of Sports Med., Oslo, Norway, 2Akershus Univ. Hosp., Dept. of Obstetrics and Gynaecology, Lørenskog, Norway, 3Univ. of Oslo, Faculty Div. Akershus Univ. Hosp., Oslo, Norway. Objective: The purpose of the present study was to evaluate pelvic floor muscle (PFM) function 6 weeks after vaginal delivery in primiparous women with and without major defects of the most medial part of the PFM, the pubovisceral muscle (PVM). PFM function was evaluated in terms of ability to contract, vaginal resting pressure (VPR), PFM maximum voluntary contraction (MVC) and endurance. Background: Recent ultrasound and MRI studies have shown major defects of the PVM among primiparous women within in the range of 10–25 % (1), but there is still scant knowledge on how these injuries influence VPR, MVC and endurance of the PFM. Methods: This is a cross-sectional study comparing PFM function in women with and without major PVM defects 6 weeks post partum. Inclusion criteria were primiparous women delivering a healthy singleton baby vaginally after more than 32 weeks of gestation and being able to speak and understand the native speaking language. Women who had a prior abortion/still birth after gestational week 16, or a perineal tear graded 3b, 3c or 4 during delivery were excluded. Major PVM defects were clinically assessed by 3D/4D transperineal ultrasound at maximal PFM contraction. By tomography imaging, major defects were defined when an unilateral or bilateral abnormal muscle insertion of PVM toward the pubic bone was present in three slices; at the plane of minimal dimension and 2.5 mm and 5.0 mm cranially to it (2). Clinical assessments of ability to contract the PFM were done by observation and vaginal palpation. VRP, MVC and endurance was measured by manometry using a vaginal balloon connected to a pressure transducer (Camtech AS). The method has been found to be reliable and valid if used with simultaneous observation of inward movement of the perineum/catheter (3). Data on obstetric factors were collected from the hospital’s electronic medical records. Background and descriptive variables are presented as frequencies and means with standard deviations (SD). Between groups comparisons were analysed by independent-samples t-test. P-values<0.05 were considered significant.

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Results: 175 primiparous women with mean age of 30 years (SD 4.1) and pre-pregnancy body mass index (BMI) of 23.8 kg/m2 (SD 4.0) were included at 6.1 weeks post partum (SD 0.9). Major PVM defects were diagnosed in 55 of 175 women (31.4 %). After thorough instruction, feedback and practice on how to contract correctly, 7 of 175 women (4 %) were not able to contract the PFM correctly. Four of these women had major PVM defects. Women with major defects had significantly lower MVC and endurance when compared to women without major defects. No difference was found regarding VRP (Table 1). Table 1. Pelvic floor muscle function in terms of vaginal resting pressure (VRP), maximum voluntary contraction (MVC) and endurance 6 weeks post partum in primiparous women with and without major defects of the pubovisceral muscle (PVM). Values within groups are given as mean with standard deviation (SD) and between groups as mean difference with 95 % confidence intervals (CI). 2: Major 1 vs. 2 defects of PVM, n055 28.7 (9.3) 0.5 (−1.8–2.9)

0.670

MVC(cmH2O) 16.0 (11.0)

8.4 (5.2)

7.7 (5.1–10.0)

<0.001

110.3 (80.0) Endurance* (cmH2Osec)

58.1 (42.4)

52.1 (33.8–70.4) <0.001

VRP(cmH2O)

1: No major defects of PVM, n0120 29.2 (6.4)

1 vs. 2 P-value

* PFM endurance is reported after one attempt of sustained maximal contraction quantified during 10 s Conclusions: Women with major PVM defects after vaginally delivery had pronounced lower PFM strength and endurance than women without major defect. However, most women with major PVM defects were able to contract the PFM. This indicates a potential capacity by non injured muscle fibres to compensate for loss in muscle strength even at this early stage after delivery. Early active rehabilitation is standard treatment after muscle-skeletal injury within sports medicine, and training is believed to be important in speeding up tissue healing. The success of PFMT in women with major muscle defects in the pelvic floor is still not known, and needs to be addressed in future randomized controlled trials of high interventional and methodological quality. References: 1. Obstet Gynecol 2006; 107:144–49 2. Int Urogynecol J. 2011; 22(6):699–704 3. Neurourol Urodyn 1990; 9:479–87 G. Hilde: Grant /Research Support; Norwegian Research Council. J. Stær-Jensen: Grant /Research Support; South-Eastern Norway Regional Health Authority. F. Richter: Grant /Research Support; South-Eastern Norway Regional Health Authority. K. Gjestland: Grant /Research Support; Norwegian Research Council. M. Ellström Engh: None. K. Bø: None.

128 A PROSPECTIVE STUDY OF SEXUAL WELL BEING AT 6 MONTHS POSTPARTUM. DOES MODE OF DELIVERY MATTER? A. De souza1, P. L. Dwyer 1, M. Charity 2, E. Thomas 1, L. Schierlitz 1 1 Mercy Hosp. for Women, Melbourne, Australia, 2Univ. of Melbourne, Melbourne, Australia. Objective: To prospectively determine the effect of mode of delivery and perineal trauma on sexual function at 6 months postpartum. Background: In order to preserve vaginal and sexual function, women are considering caesarean section for delivery. Several studies have shown a decline in sexual function during the postpartum period however a lack of prospective data exists addressing how mode of delivery and perineal trauma affects sexual well being. Methods: This was a prospective questionnaire based cohort study. Ethics approval was obtained. English literate primigravidas in the first trimester were recruited and completed 4 validated questionnaires: Female Sexual Function Index (FSFI), Urinary Distress Inventory Short Form (UDI6), Incontinence Impact Questionnaire Short form (IIQ-7) and Prolapse Incontinence Sexual Questionnaire Short form (PISQ-12). All questionnaires were repeated at 6 months post partum and women also completed an Edinburgh postnatal depression scale (EPDS) and mode of feeding survey. Birthing outcome and demographic data were obtained from the hospital database. 440 patients were required to determine a statistical difference in sexual function between patients undergoing a caesarean section (CS) versus vaginal delivery with 80 % power and alpha <0.05 assuming 30 % CS rate and drop out of 30 %. Significance testing of FSFI, PISQ, UDI and IIQ between timepoints was undertaken using Wilcoxon Signed Rank tests. Significance testing for additional variables on the four measures was carried out using Mann Whitney or Kruskal Wallis tests depending on the number of levels of the independent variable. Non-parametric tests were used due to outliers in the sample. Results: 440 women were recruited in the first trimester of pregnancy. At 6 months post delivery, 299 (68.0 %) women completed all surveys and formed the analysis group. In the analysis group there were 148 (50.3 %) normal vaginal deliveries (NVD), 43 (14.6 %) forceps, 24 (8.2 %) vacuums and 79 (26.9 %) CS. Of those women delivering vaginally, 44.5 % had an intact perineum. There were 39.7 % episiotomies, 3.4 % 1st degree, 9.3 % 2nd degree and 3.1 % third degree tears. There were no 4th degree tears. 92 % of women were sexually active at 6 months postpartum. There was no statistical difference in total FSFI (p00.217), FSFI domains or PISQ score (p00.165) between vaginal

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delivery, including normal and instrumental delivery, and CS at 6 months post partum. When CS was compared to intact deliveries and perineal trauma, the episiotomy group showed a significantly lower FSFI (p00.009) and PISQ score (p00.036) than other groups. Lubrication (p00.020) and orgasm (p00.008) FSFI domains were significantly decreased and pain (p00.001) was increased. Women who underwent CS had a significantly lower UDI (p00.011) and IIQ score (p00.030) post partum compared to women undergoing either a NVD or instrumental delivery. When NVD, forceps and vacuum delivery were compared to each other independent of perineal trauma, there were no significant differences detected in FSFI or PISQ. Women with a NVD had a significantly higher IIQ score (p00.043) at 6 months than other delivery types. Women with an intact perineum had a significantly higher total FSFI score (p00.021) and PISQ score (p0 0.032) than those with any perineal injury. This group also had higher domains scores for orgasm (p00.015) and lower pain scores (p 00.011). No difference was detected in the domains of desire, arousal, lubrication or satisfaction. Women with episiotomies had significantly lower total FSFI (p<0.001) and lower PISQ (p00.012) scores when compared to women without episiotomy. In addition, these women experienced lower arousal (p00.004) decreased lubrication (p<0.001), decreased orgasm (p00.001) and increased pain (p<0.001). No change to desire or satisfaction was noted. Women with 3rd degree tears had significantly lower (p00.019) UDI scores than other types of trauma. There were no other statistical differences noted in the 3rd degree tear group. Conclusions: At 6 months post partum in our study, there was no difference in sexual function between women who had a vaginal delivery with an intact perineum or spontaneous tear compared to CS. Women who had an episiotomy had worse sexual function than women having a CS at 6 months post partum. Women with an intact perineum had improved sexual function including improved orgasm and decreased pain compared to women with other types of perineal injury. Women who had an episiotomy experienced significantly more sexual dysfunction than those women who were intact or had spontaneous tears. Women having a CS had less symptoms of urinary bother than those having any type of vaginal birth. When counseling women about the effect of mode of delivery on sexual function, the potential for perineal trauma particulary episiotomy with vaginal birth should be considered.

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A. De Souza: Grant /Research Support; Medical Research Foundation for Women and Babies. P.L. Dwyer: None. M. Charity: None. E. Thomas: None. L. Schierlitz: None. 129 PROLAPSE AND INCONTINENCE SURGERY: WOMEN’S SEXUAL CONCERNS UNRAVELLED A. Roos1, R. Thakar 1, A. H. Sultan 1, A. T. Paulus 2 1 Croydon Univ. Hosp., Croydon, United Kingdom, 2 Maastricht Univ., Maastricht, Netherlands. Objective: To establish what factors matter most to women in terms of sexual functioning, prior to and after surgery for pelvic floor dysfunction (PFD). Background: PFD has been shown to be associated with sexual dysfunction [1]. However, successful surgery, based on objective measurements, does not guarantee an improvement in sexual satisfaction. Methods: This is a mixed quantitative and qualitative study. Women were seen prior to and at 3 months after pelvic floor surgery. At both visits women completed the Pelvic organ prolapse/urinary Incontinence Sexual function Questionnaire (PISQ) [2] and a semi-structured face-to-face interview was administered. The PISQ calculates a total score as well as 3 domain scores, with higher scores indicating better sexual function. Wilcoxon Signed Ranks Test was used to compare PISQ scores before and after surgery. The qualitative interviews were transcribed verbatim and analysed systematically using data matrices. Results: We included 37 women and 30 came for follow up at a mean (SD) of 18 (8) weeks after surgery. Fifteen (50 %) had pelvic organ prolapse (POP) surgery, 6 (20 %) antiincontinence surgery, 8 (27 %) combined surgery, and 1 (3 %) anal sphincter repair. The median age was 49 years (range 36–64). At follow up 28 women completed the PISQ as 2 were not sexually active. Total PISQ scores improved after surgery (p00.001) as did the Physical (p<0.001) and Partner-Related (p00.001) domains. There was no improvement in the Behavioural/Emotive domain (p00.118). Qualitative results: Body image/confidence played a central role and was affected by PFD in the vast majority of women. Women with POP had a negative image of their vagina describing it as: “not normal”, “ugly”, or “dirty”. They felt insecure about their partner’s sexual satisfaction, as he might feel or see the prolapse during sexual activity, or as a result of loss of tightness. Although this did not commonly affect the women’s ‘drive’, i.e. spontaneous sexual interest, their

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‘motivation’, or willingness to engage in sexual activity, was diminished. Furthermore, worrying about “not being normal” and their partner’s sexual experience made it difficult to arouse and consequently to climax. Additionally, genital sensations could be diminished which affected the ability to reach an orgasm or its intensity. In women with incontinence, ‘motivation’, but not ‘drive’ was reduced, predominantly due to the presence, or fear, of coital incontinence. Body image/confidence was diminished as women felt embarrassed about not being able to control this basic bodily function. Other body image issues such as fear of smelling of urine and feeling dirty further reduced their ‘motivation’. A third effect on ‘motivation’ was from a lack of spontaneity, because of the need to void or wash prior to sexual activity. During sexual activity the fear of incontinence made it difficult to relax which affected arousal and reaching an orgasm. To avoid coital incontinence, some tried to hurry through intercourse which affected their arousal, while others prevented themselves climaxing. Dyspareunia occurred mostly in relation to POP. Discomfort, obstruction, and fear of damaging the prolapse also affected the women’s motivation to be sexually active. Following surgery women described an improved sex life as having sex was ‘easier’ and they felt more relaxed during it; they didn’t have to worry about the presence of POP and how that would affect their partner, and didn’t fear the occurrence of coital incontinence. Furthermore, discomfort associated with POP had resolved. Consequently they were more motivated to be sexually active. Despite this, some negative effects were mentioned. Resuming sexual activity could be delayed by a prolonged healing time, fear of pain, partner’s fear of causing pain, or worries about dislodging the tape (anti-incontinence) or mesh (POP) during penetration which would undo the success of surgery. Once sexually activity was resumed lasting dyspareunia, new symptoms such as faecal urgency, an unsatisfactory result of POP surgery, or being used to not having sex, could negatively effect the evaluation of sex life. Other factors affecting sexual function before and after surgery were older age, menopause, lifestyle, relationship duration, male sexual dysfunction, and relationship problems. Conclusions: This is the first prospective study using both qualitative and quantitative methods to analyse sexual function in relation to PFD and surgery. We found body image/confidence plays a key role in the

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sexual functioning of these women especially in their ‘motivation’. The distinction between ‘drive’ and ‘motivation’ is important and not commonly addressed in sexual function questionnaires. Women need to be reassured that tapes and meshes are unlikely to dislodge during sexual intercourse. References: 1: Obstet Gynecol 2008; 111:1045–52 2: Am J Obstet Gynecol 2001; 184: 552–8 A. Roos: None. R. Thakar: None. A.H. Sultan: None. A.T. Paulus: None. 130 SEX AFTER THE FIRST PREGNANCY S. Botelho1, F. K. Alves 2, K. J. Vieira 1, J. M. Pereira 3, D. B. Adami 4, L. C. Pereira 2, J. Marques 2, A. B. Lanza 2, P. Palma 2, C. Riccetto 2 1 Federal Univ. of Alfenas—UNIFAL-MG and State Univ. of Campinas—UNICAMP Brazil, Alfenas, Brazil, 2State Univ. of Campinas—UNICAMP Brazil, Campinas, Brazil, 3 Pontifical Catholic Univ. of Minas Gerais—PUC MINAS Brazil, Pocos de Caldas, Brazil, 4Pontifical Catholic Univ. of Minas Gerais—PUC MINAS and State Univ. of Campinas—UNICAMP Brazil, Pocos de Caldas, Brazil. Objective: The aim of this study was to evaluate the sexual function of primiparous women with 5 to 12 months of postpartum and to verify the influence of demographic, personal and obstetric risk factors. Background: The gestation process triggers a series of physical, hormonal, psychological, social and cultural adaptations in the life of women, who may also be influenced by mode of delivery, number of successive gestations, physical and psychological preparation, as well as the environment in which they live. Puerperium is considered a period of readjustments to the prior conditions, however, many women experience significant changes, whether temporary or permanent. Despite the important advances in maternal and fetal care, there is still restricted care to female sexual function in the postpartum period, since many people consider it “normal” for these women to present some complaints at this stage, justifying that “soon everything will become as it was before”⋯ Methods: This is a clinical, prospective and controlled study that recruited 78 primiparous women, with mean age of 24.46 (±6,53) years, within 5 to12 months after delivery (mean of 8.19 ±2.38 months), being 37 vaginal delivery women and 41 cesarean delivery women (25 elective cesarean and 16 urgency cesarean). Demographic, personal and obstetric factors as well as the continence status and sexual

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function were investigated. A validated Female Sexual Function Index—FSFI questionnaire of the Portuguese language was used. FSFI is a multidimensional, selfadministered questionnaire, consisting of 19 items that propose to evaluate the female sexual function, through six domains: sexual desire, sexual excitation, vaginal arousal, orgasm, sexual satisfaction and pain/discomfort. The total score as well as the individual score of each domain were considered for analysis of the results. The points obtained in each correspondent question, multiplied by the correction factor represent the score of each domain and they are added in order to obtain the total score. For obtained the points of each domain adds points number of the correspondent question multiply of the correction factor. Domains with values lower than three are considered to be compromised (dysfunction), except for the pain/discomfort domain, which changes starting from values greater or equal to three. The total score is obtained adding the scores of the domains, and it presents a variation ranging from 2 to 36. The lower the score the worse is the sexual function. A total score less than or equal to 26 suggests sexual dysfunction. The findings were submitted to statistic tests (Linear Regression Analysis as well as Univariant and Multivariate Logistic with Stepwise criterion) to determine the risk factors for sexual dysfunction. The significance level was 5 %. Results: Regarding the demographic profile, the majority of women were Caucasian (65.38 %), with high school education degree (54.55 %), family income from one to two minimum wages (62.34 %), married or living in stable condition with a partner (66.67 %). Among the relevant personal characteristics of the women there were : body mass index of 23.86 (±4.31), weight of newborn (NB) 3.15 (±0.57), sedentary (84.42 %), reporting not having returned to the body weight prior to gestation (56.58 %), intestinal frequency less than three times per week (56.41 %), continents (83.12 %). Most women (93.51 %) reported never having received any orientation about the practice of pelvic floor muscle training. When investigating sexual function it was observed that 43.59 % of the women had IFSF total score less than or equal to 26 (mean 24.24±8.91). We found that marital status was the variable that significantly influenced sexual function, in other words, single or divorced women had five times greater risk of developing sexual dysfunction compared to those married or in stable relationship (OR 1.63 95 % CI-14.98, p00.005). Analyzing the six domains separately, we found that four of them (excitation-p < 0001; lubrication-p 00.07; orgasm-p 00.016 and satisfaction-p 00.022) showed to be significantly dependent on marital status. The birth weight (p 00.026) and educational level (p 00.014)

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showed to have a significant joint relationship in triggering sexual pain/discomfort among the studied women. The weight of the newborn also presented a risk factor for the lubrication (p00.031) and orgasm domains (p00.041). The body weight gain presented risk to the content domain (p00.043). Conclusions: Sexual dysfunction may be present among primiparous women in the period of 5–12 months after delivery. Risk factors can be social (marital status), physical (weight gain during pregnancy) and/or obstetric care (birth weight), which emphasize the need to an appropriate professional’s accompaniment. References (optional): S. Botelho: None. F.K. Alves: None. K.J. Vieira: None. J.M. Pereira: None. D.B. Adami: None. L.C. Pereira: None. J. Marques: None. A.B. Lanza: None. P. Palma: None. C. Riccetto: None. 131 D O W O M E N N O T I C E T H E I M PA C T O F CHILDBIRTH-RELATED LEVATOR TRAUMA ON PELVIC FLOOR AND SEXUAL FUNCTION? S. Thibault-Gagnon1, S. Yusuf 2, S. Langer 2, V. L. Wong 2, K. Shek 2, H. Dietz 2 1 Queen’s Univ., Kingston, Canada, 2Univ. of Sydney, Penrith, Australia. Objective: To determine associations between childbirthrelated levator trauma and women’s reports of pelvic floor and sexual function after a first delivery. Background: In 10–30 % of women, vaginal delivery results in macroscopic tearing of the levator ani (‘avulsion’), while microscopic damage or traumatic overdistension of the levator occurs independently of avulsion in about 30 % of vaginally parous women after a first delivery [1]. Women seem to notice a reduction in pelvic floor muscle strength after vaginal childbirth, and this reduction is associated with levator trauma [2]. To date there is no literature on the impact of delivery-related levator trauma on female sexual function. Methods: 421 women with a singleton pregnancy were assessed by 4D translabial ultrasound imaging, at 36– 39 weeks’ gestation and at 3–6 months following delivery. All women were imaged in the supine position after bladder emptying, at rest, on maximal Valsalva maneuver, and on pelvic floor muscle contraction (PFMC). On follow-up, women also answered a questionnaire on pelvic floor and sexual function following childbirth, which has been validated in our unit. The diagnosis of levator avulsion was made on tomographic ultrasound, in postpartum volumes obtained on PFMC. The participant was rated as positive for avulsion if all three central slices (the plane of minimal levator hiatal

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dimensions, as well as slices 2.5 and 5 mm cranial to this plane) showed an abnormal insertion, see Figure 1 [3]. The area of the levator hiatus on Valsalva maneuver

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was measured in ante- and postpartum volumes, and microtrauma was diagnosed if an increase of >20 % in hiatal area was found postpartum.

Figure 1. Tomographic imaging of a typical right- sided avulsion. Defects are marked with (*).

Patients answered questions using a 5-point Likert scale. A score of 1 represented the most negative response and a score of 5 represented the most positive response, with regards to changes in pelvic floor and sexual function since giving birth. Mean questionnaire scores were computed for each of the 5 questionnaire domains (see Table 1). Levator avulsion and levator microtrauma were analyzed against questionnaire responses using separate one-way ANOVAs. Results: 421 women with a mean age of 30.4 years (range 18.8–45.3) were seen antenatally between 33+1 and 40+ 5 weeks of gestation (mean 36). 320 (76 %) women returned for their postnatal follow-up a median of 4.6 months after delivery (range 2.3–30.9). Antenatal and postnatal ultrasound datasets and questionnaire data were available for 294 women. Analyses pertain to these 294 women. Levator avulsion was diagnosed in 14 % (n042, 25 unilateral, 17 bilateral) of women. Levator microtrauma was assessed only in women without levator avulsion (n0252), and was diagnosed in 26 % (n064) of these women. Levator avulsion was significantly associated with scores for the Pelvic floor integrity & function domain of the questionnaire (P<0.0005), whereby avulsion was associated with more negative scores, but was not associated with any of the other domains. Microtrauma was not associated with

scores for any of the questionnaire domains (see Table 1 for ANOVA results) Questionnaire domain

Avulsion (none/ unilateral/bilateral) ANOVA (n0249–288)

Microtrauma (yes/no) ANOVA (n0218–251)

Sexual activity Sensation on intercourse Sexual arousal & orgasm Pelvic organ prolapse symptoms Pelvic floor integrity & function

P00.125 P00.462 P00.931 P00.710 P<0.0005 2.8 [SD 0.5] vs 2.6 [0.4] vs 2.3 [0.5]

P00.460 P00.953 P00.803 P00.546 P00.347

Conclusions: The effect of levator trauma on sexual function 3–6 months after childbirth seems to be limited to a perception of reduced integrity and function of the pelvic floor muscles. Future work should aim to replicate this work with a longer-term follow-up. References: 1. Obstet Gynecol. 2005;106:707–712. 2. Int Urogynecol J. 2011;22(S1):S66–67. 3. Int Urogynecol J. 2011; 22(6):699–704.

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S. Thibault-Gagnon: None. S. Yusuf: None. S. Langer: None. V.L. Wong: None. K. Shek: None. H. Dietz: Grant /Research Support; General Electric, A$ 9000 for educational grant. 132 VAGINAL AND SEXUAL MATTERS SYMPTOMS A F T E R S U R G E R Y F O R P E LV I C O R G A N PROLAPSE (POP) D. Ulrich 1, P. Dwyer 2, A. Rosamilia 1, Y. Lim 1, J. Lee1 1 Monash Med. Ctr. Moorabbin, Melbourne, Australia, 2 Mercy Hosp. for Women, Melbourne, Australia. Objective: To investigate the post-operative anatomical, subjective prolapse and sexual function outcomes following different prolapse surgeries using the ICIQ-VS questionnaire in a prospective observational series. Background: Goals in female pelvic floor surgery include not only anatomical restoration, but also improvement in urinary, bowel and sexual symptoms. Changes in the quality of life and in sexual function are one of the main concerns following vaginal surgery. The ICIQ-VS is a validated 14 item psychometrically questionnaire that has been validated to measure the presence, severity, and impact of vaginal symptoms and associated sexual matters on quality of life and outcome of treatment [1]. Methods: For this prospective study consecutive women undergoing surgical management for POP between 2009 and 2010 were offered to participate in this study. The ICIQ questionnaire was completed prior to surgery as well as 6 and 12 months postoperatively. The questionnaire assesses the presence and the severity of the symptoms by a 3 or 4 tailed scale ranging from 0 to 53 points for the vaginal symptom score and 0–58 for the sexual matters score. Worsening of vaginal or sexual matter symptoms is accompanied by an increase in the score. Native tissue female pelvic floor reconstructive surgery as well as vaginal and laparoscopic mesh operations were performed. Women with stress urinary incontinence received a concomitant midurethral sling including TVT, Advantage®, Monarc® and Miniarc®. Statistical analysis was performed using analysis of variance. Based on the vaginal matters score as the primary outcome of interest with a power of 80 % and an α level of 0.05 we estimated that 24 subjects were necessary in each group to detect a difference of 10 points in the total score between women with and without pelvic organ prolapse. Results: 102 women aged 32–84 years (mean: 61± 11) participated in the study; 84 (82 %) returned the 6 month questionnaire and 87 (84 %) the 12 month questionnaire. Mean BMI was 26.8 (±4.7), median parity was 2 (1–3). 41 women (40 %) were sexually active preoperatively, 49 (48 %) 6 months post-operatively, 43 (44 %) 12 months postoperatively. 2 women who were not sexually active

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preoperatively resumed intercourse after surgical intervention. The mean vaginal-symptom score was 23 (±9) preoperatively, 6 months after surgery it decreased significantly to 7 (±8) and 12 months after surgery to 7 (±7) (p<0.001) with no significant differences between mesh vs. native surgery. The mean sexual matters score was 22 (±19) preoperatively, 6 months postoperatively it decreased significantly to 12 (±18), 12 months after surgery to 10 (± 14) (p<0.05) with no significant differences between the surgical procedures. Dyspareunia rates increased from 20 % preoperatively to 47 % and 44 % after 6 and 12 months, respectively. No significant differences for any of the scores were noted between women assigned to anatomical success and failure with success defined as the anterior and posterior compartment better than -1. Three of the measured points of the POP Q exam representative of each compartment improved significantly after 6 and 12 months (Ba: 0±2, −2±1, −2±1, C:2±3, −5.4±2.1, −5.6±1.5, Bp: 0±1.5, −2.6±0.6, −2.6±0.6; preoperatively, 6 months and 12 months postoperatively, respectively, p<0.01). Only 2 % of the patients had surgical failure if success is defined as Ba or Bp 0 and lower 6 and 12 months after surgery. Conclusions: Surgical intervention for POP improved the vaginal symptom and the sexual matters score as well as the POP Q at 6 and 12 months post-operatively independent of the anatomical success. References: 1. Price, N., et al., Development and psychometric evaluation of the ICIQ Vaginal Symptoms Questionnaire: the ICIQ-VS. Bjog-an International Journal of Obstetrics and Gynaecology, 2006. 113(6): p. 700–712. D. Ulrich: None. P. Dwyer: None. A. Rosamilia: None. Y. Lim: None. J. Lee: None. 133 THE EXPRESSION OF CYTOKINES IN THE OVERACTIVE BLADDER I. Offiah1, J. Dawes 2, S. Mcmahon 2, B. A. O’reilly 1 1 Cork Univ. Maternity Hosp., Co. Cork, Ireland, 2Wolfson Ctr. for Age Related Disease, London, United Kingdom. Objective: We propose to sample human bladder with detrusor overactivity and compare these to controls with stable bladders. We will focus on the role of cytokines, chemokines, and growth factors, which may be upregulated in the overactive bladder pathology compared to the controls. Background: Little is known about the pathophysiology of the OAB. The precise role of cytokines and sensory neurons remains unclear. Are there correlations with pain and overactivity, or is OAB driven by abnormal sensory activity? Methods: We carried out a prospective observational study of 20 female patients with detrusor overactivity and 20 age matched controls. Both patient groups had urodynamics

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preformed, the overactive group with detrusor overactivity, and the controls with Urodynamic proven stress incontinence. Biospies from above the bladder trigone were acquired from each patient with detrusor overactivity during cystoscopy to outrule any other pathology and biopsies were taken from the control patients during cystoscopy following anti-incontinence procedures for stress urinary incontinence. Following RNA isolation custom-made PCR array cards were used to measure the relative expression levels of inflammatory mediators, namely cytokines and chemokines, in tissue samples from OAB and control patients. The expression changes were normalised against the geometric mean of 3 housekeeping genes (18 s, GAPDH and Beta-Actin) and displayed as the fold change relative to control samples. Results: The results of our pilot study included 10 DO patients and 10 age matched controls. A number of genes had a greater than 2 fold increase in their expression levels in OAB patients when compared to controls. These included the chemokine ligands CCL18 and 21, the cytokines Interleukin 12b, 17a and 21 and the enzyme Inducible Nitric oxide synthase. The overexpression of CCL18 in the study group biopsies was particularly evident with a fold change of 6.5. Of uncertain significance is the downregulation of certain factors, such as IL23a, 18 and CCL7 in the overactive bladder biopsies. These cytokines are consistently underexpressed in disease versus control tissue, raising the question of a protective role in the disease process. Conclusions: Our pilot study findings identified biologically relevant increased levels of certain chemokines and cytokines, which are overexpressed in the overactive bladder patients compared to controls. These inflammatory mediators, most notably CCL18, are possibly responsible for driving the pathology behind the overactive bladder and presents itself as a novel therapeutic target for the treatment of the overactive bladder. I. Offiah: Grant /Research Support; Department of Urogynaecology Research fund. J. Dawes: None. S. McMahon: None. B.A. O’Reilly: None.

DO is simply missed by laboratory urodynamics as ambulatory UDS has a much higher sensitivity for detecting DO¹. However, it has been suggested that patients with DO may have a greater degree of bladder dysfunction². Methods: This was a cross-sectional study in a tertiary referral Urogynaecology Unit. Consecutive women attending a one-stop urodynamic assessment clinic with OAB symptoms were included in the study. All women were asked to complete a King’s Health Questionnaire (KHQ) and 3-day bladder diary incorporating the Patient’s Perception of Intensity of Urgency Scale (PPIUS)³, before attending the urodynamic clinic. They then underwent multichannel urodynamics according to the recommendations of the ICS, using a Laborie Aquarius Triton machine. Filing cystometry was performed in the supine position at a rate of 100 mls / min. Filing was stopped when the patient developed a strong desire to void or 500 ml of fluid had been infused into the bladder, whichever occurred first. The patient was then moved to the standing position and provocative manoeuvres (coughing, running water and hand-washing) were performed. Women, whose symptoms of urgency were not reproduced during the laboratory test, underwent a 4-hour ambulatory urodynamics test, following a standardised protocol. SPSS (V 17 Chicago, Illinois) was used for statistical analysis and p≤0.05 was considered as statistically significant. The Student’st-test and the Mann-Whitney U-test were used for comparison of numerical variables. The Pearson chisquare test was used for comparison of categorical variables. Ethical approval was obtained. Results: 556 women with OAB were included in the study. The mean age was 52.1 years (SD: 14.8), the mean BMI was 28.1 (SD: 6.0) and 53 % of them were postmenopausal. 39 women (7 %) underwent an ambulatory test. 43 % of the patients were diagnosed with DO either by laboratory (227/ 556) or ambulatory urodynamics(11/39). Baseline characteristics are presented in table 1. There was no difference between the groups in age, BMI, menopausal status and presence of prolapse (POPQ ordinal stage).

134 IS THERE A DIFFERENCE BETWEEN WOMEN WITH OR WITHOUT DETRUSOR OVERACTIVITY COMPLAINING OF SYMPTOMS OF OVERACTIVE BLADDER? I. Giarenis, H. Mastoroudes, S. Srikrishna, D. Robinson, L. Cardozo; King’s Coll. Hosp., London, United Kingdom.

Table 1. (Baseline characteristics)

Objective: To determine if there are differences between female overactive bladder (OAB) patients with and without urodynamic detrusor overactivity (DO). Background: The association between OAB and the urodynamic diagnosis of DO is not very clear. It is possible that

Patients with DO had smaller maximum functional capacity (p<0.001), greater urgency episode frequency (p<0.001) and larger maximum and mean urgency rating (p<0.001). However, there was no difference in daytime or nocturnal micturitions between the groups (table 2).

Age [mean(SD)] BMI [mean(SD)] Postmenopausal Ordinal POPQ [median(range)]

DO 51.79 (16.19) 28.75 (6.30) 55.1 % Stage 1 (0–4)

No DO 52.39 (13.59) 27.71 (5.77) 49.5 % Stage 1 (0–4)

P-value 0.602 0.052 0.141 0.308

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Cardozo: Consultant; Allergan, Astellas, Ethicon, Merck, Pfizer, Teva. Grant /Research Support; Pfizer.

Table 2. (Bladder diary variables) Bladder diary variables

DO Mean (SD)

No DO Mean (SD)

P-value

Daytime micturitions / 24 h

8.43 (2.71)

8.49 (2.82)

0.812

Nocturnal micturitions / 24 h 1.30 (1.22)

1.09 (1.03)

0.072

Functional capacity

374.12 (149.44) 453.90 (170.50) <0.001

Maximum urgency rating

3.68 (0.64)

3.24 (0.79)

<0.001

Mean urgency rating

2.51 (0.65)

1.95 (0.67)

<0.001

Severe urgency episodes / 24 h

4.94 (3.05)

2.77 (2.85)

<0.001

The presence of DO had a more negative impact on the quality of life. There was a statistically significant difference between the groups in six of the domains of the KHQ (Incontinence Impact, Role Limitations, Social Limitations, Emotions, Sleep / Energy and Severity Measures). The scores of the different domains of the KHQ are summarised in table 3. Table 3. (KHQ domains) KHQ domains

DO Mean (SD)

No DO Mean (SD)

P-value

GHP II

38.66 (25.21) 78.46 (26.24)

36.51 (22.27) 73.24 (27.94)

0.299 0.026

RL PL SL PR E SE SM

55.95 56.57 42.28 49.40 56.85 52.49 57.97

50.39 55.00 33.86 46.70 49.41 46.99 49.48

0.047 0.588 0.004 0.530 0.012 0.031 <0.001

(32.26) (34.69) (35.03) (40.57) (34.10) (28.86) (27.75)

(32.36) (32.96) (32.92) (36.76) (34.26) (30.21) (28.00)

GHP: General Health perception, II: Incontinence Impact, RL: Role Limitations, PL: Physical Limitations, SL: Social Limitations, PR: Personal Relationships, E: Emotions, SE: Sleep/Energy, SM: Severity Measures Conclusion: Our study detects objective differences between female OAB patients with and without DO. Women with DO experience a more significant impairment on their quality of life and have a greater degree of bladder dysfunction. The identification of these subjective and objective differences may have a significant impact on the design of future studies involving OAB patients. References: 1. J Urol 2001; 166: 2253–2258 2. Int Urogynecol J 2010; 21: 325–329 3. BJU Int 2011; 107: 1612–1617 I. Giarenis: None. H. Mastoroudes: None. S. Srikrishna: None. D. Robinson: Consultant; Astellas, Ferring, Gynaecare, Pfizer. Grant /Research Support; Astellas, Pfizer. L.

135 ONSET OF ACTION OF EFFICACY OF THE POTENT AND SELECTIVE BETA-3-ADRENOCEPTOR AGONIST, MIRABEGRON, FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) IN A 12-WEEK, MULTICENTRE, RANDOMISED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO- AND TOLTERODINE SLOW RELEASE (SR)-CONTROLLED STUDY IN OAB PATIENTS V. Khullar1, J. Cambronero 2, J. Angulo 3, M. Wooning 4, M. Blauwet 5, E. Siddiqui 6, C. Dorrepaal 4 1 St Mary’s Hosp., London, United Kingdom, 2Infanta Leonor Hosp., Madrid, Spain, 3 Hosp. Univ.rio De Getafe, Madrid, Spain, 4Astellas Pharma Global Dev., Leiderdorp, Netherlands, 5Astellas Pharma Global Dev., Deerfield, IL, 6Astellas Pharma Europe Ltd, Staines, United Kingdom. Objective: The efficacy and safety of mirabegron for the treatment of overactive bladder (OAB) has been demonstrated in two separate 12-week, Phase III studies (NCT00662909 and NCT00689104) in patients with OAB. This analysis utilized the efficacy endpoints at earlier timepoints to assess the onset of action for efficacy of mirabegron in one of the Phase III studies (NCT00689104). Background: Oral antimuscarinic agents are currently the mainstay of pharmacotherapy for the treatment of OAB. In the absence of an alternative therapeutic class of agent, patients who have a suboptimal response to antimuscarinic agents or find that antimuscarinic therapy is limited by associated adverse events (AEs; e.g. dry mouth and constipation) [1], either persist with an unsatisfactory treatment or discontinue therapy. Mirabegron, a potent and selective β3adrenoceptor agonist has been developed for the treatment of OAB and may provide an alternative therapeutic option in these patients. Methods: This multicentre, randomised, double-blind, parallel-group, placebo- and tolterodine SR-controlled trial enrolled patients (≥18 years of age) with symptoms of OAB for at least 3 months into a 2-week, single-blind, placebo run-in period. Patients with ≥8 micturitions/24 h and ≥3 urgency episodes during a 3-day micturition diary, were randomised to receive once-daily placebo, mirabegron 50 mg or 100 mg, or tolterodine slow release (SR) 4 mg for 12 weeks. The co-primary efficacy endpoints were change from baseline to Final Visit in the mean number of micturitions/24 h based on the Full Analysis Set (FAS; all randomised patients who took ≥1 dose of study drug and had baseline and ≥1 post-baseline micturition measurement) and mean number of incontinence episodes/24 h based on

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the Full Analysis Set-Incontinence (FAS-I; FAS patients with ≥1 incontinence episode recorded in the baseline 3-day micturition diary). Efficacy was assessed according to patient micturition diaries at Weeks 4, 8 and Final Visit (end of treatment). Safety was assessed in the Safety Analysis Set (SAF; all randomised patients who took ≥1 dose of study drug); assessments included AE reporting, physical examinations, vital signs, ECG, and laboratory tests. Results: Patients were randomised to receive placebo (n0 494), mirabegron 50 mg (n0493), mirabegron 100 mg (n0 496), or tolterodine SR 4 mg (n0495). Of the patients who received study drug (n01978; mean age 59.1 years, 72.2 % female) 39.5 % had urgency incontinence, 37.8 % had frequency without incontinence and 22.7 % had mixed stress/urgency incontinence with predominant urgency at baseline. When compared with placebo at Final Visit, both 50 mg and 100 mg mirabegron groups demonstrated statistically significant improvements from baseline in both coprimary endpoints. However, although numerical improvements in both co-primary endpoints were also observed with tolterodine SR, these did not reach statistical significance versus placebo (Table). Statistically significant improvements in these co-primary efficacy measures were observed

for both mirabegron doses versus placebo at the first measured time point (Week 4) and significance was maintained at all time points to Final Visit. Efficacy of tolterodine SR was only significant versus placebo at the Week 4 timepoint. The incidence of treatment-emergent AEs was similar across the placebo, mirabegron 50 mg, 100 mg, and tolterodine SR groups (43.3, 42.8, 40.1 and 46.7 %, respectively). The most common AEs were hypertension (7.7, 5.9, 5.4 and 8.1 %), dry mouth (2.6, 2.8, 2.8 and 10.1 %), headache (2.8, 3.7, 1.8 and 3.6 %), and nasopharyngitis (1.6, 2.8, 2.8 and 2.8 %). The incidence of dry mouth, the most common AE associated with the use of oral antimuscarinic agents [1], was similar in placebo and mirabegron groups, and markedly lower than observed in patients receiving tolterodine SR. Conclusions: Mirabegron at doses of 50 mg and 100 mg once-daily over 12 weeks demonstrated superior efficacy compared with placebo for key symptoms of OAB. Furthermore, the efficacy of mirabegron was evident as early as Week 4 and remained significant versus placebo at all time points through to Final Visit. Mirabegron was well tolerated in patients with OAB and exhibited a low incidence of treatment-emergent AEs. Mirabegron may provide a therapeutic alternative to antimuscarinic agents for the treatment of OAB.

Table: Mean change from baseline to each visit in the number of incontinence episodes and micturitions/24 h Placebo

Mirabegron

–

50 mg

100 mg

4 mg

Endpoints: adjusted mean (standard error) change from baseline Co-primary Endpoint–FAS-I N0291 Incontinence episodes/24 h at Final Visit −1.17 (0.113) Incontinence episodes/24 h at Week 4 −0.65 (0.118) Incontinence episodes/24 h at Week 8 −1.00 (0.126) Incontinence episodes/24 h at Week 12 −1.18 (0.115) Co-primary Endpoint - FAS N0480 Number of micturitions/24 h at Final Visit −1.34 (0.110) Number of micturitions/24 h at Week 4 −0.77 (0.096)

N0293 −1.57* (0.113) −1.04 (0.118) † −1.29 (0.127) † −1.61 (0.115) † N0473 −1.93* (0.111) −1.16 (0.097) †

N0281 −1.46* (0.115) −1.03† (0.120) −1.40† (0.129) −1.47† (0.117) N0478 −1.77* (0.110) −1.29† (0.096)

N0300 −1.27NS (0.112) −1.00† (0.117) −1.03NS (0.124) −1.28NS (0.114) N0475 −1.59NS (0.110) −1.10† (0.096)

Number of micturitions/24 h at Week 8 Number of micturitions/24 h at Week 12

−1.63 (0.106) † −2.00 (0.113) †

−1.65† (0.106) −1.80† (0.112)

−1.44NS (0.106) −1.61NS (0.113)

−1.14 (0.105) −1.36 (0.112)

Tolterodine SR

Data are least-squares means, adjusted for baseline, sex and geographical region; *statistically significantly superior compared with placebo at the 0.05 level with multiplicity adjustment; † statistically significantly superior compared with placebo at the 0.05 level without multiplicity adjustment; NS, not statistically significantly superior compared with placebo; multiplicity adjustment was only performed in the comparison between mirabegron and placebo

References: 1. Eur Urol. 2008; 54:543–62. V. Khullar: Consultant; Astellas. J. Cambronero: Consultant; Astellas. J. Angulo: Consultant; Astellas. M.

Wooning: Employee (full or part time); Astellas. M. Blauwet: Employee (full or part time); Astellas. E. Siddiqui: Employee (full or part time); Astellas. C. Dorrepaal: Employee (full or part time); Astellas.

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136 COST-EFFECTIVENESS ANALYSIS OF SACRAL NEUROMODULATION IN REFRACTORY OVERACTIVE BLADDER : A CANADIAN PERSPECTIVE L. Tu1, M. M. Hassouna 2, J. Gajewski 3, M. Robert 4, G. J. Grey 5, N. E. Dwyer 6, J. Corcos 7, H. Sadri 8 1 Ctr. Hosp.ier universitaire de Sherbrooke, Sherbrooke, Canada, 2Toronto Western Hosp., Toronto, Canada, 3Queen Elizabeth II Hosp., Halifax, Canada, 4Foothills Hosp., Calgary, Canada, 5Royal Hosp., Edmonton, Canada, 6Moncton Hosp., Moncton, Canada, 7Jewish Gen. Hosp., Montreal, Canada, 8Medtronic of Canada Ltd., Brampton, Canada. Objective: The goal of this study was to estimate the costeffectiveness of sacral neuromodulation (SNM) vs. optimized medical therapy (OMT) and onabotulinumtoxin-A (BoNT-A). Introduction: A substantial number of refractory overactive bladder patients fail conservative treatment with OMT and may benefit from minimally invasive procedures including SNM or BoNT-A injection. Currently, the safety, efficacy and effectiveness are conventional hurdles for patient access. With the evolving treatment options actually available, the efficiency evaluation of a treatment modality which is considered in the health economic analysis should be implemented with the affordability issue through budget impact analysis. Methods: An economic Markov model with Monte Carlo simulation was used to assess the incremental cost-effectiveness ratio (ICER) of SNM vs. BoNT-A and OMT. The model calculated the ICER in deterministic (base-case) and

probabilistic (sensitivity) analysis from a Canadian provincial payer’s perspective over a 10-year time horizon with 9month Markov cycles. The Willingness-To-Pay or acceptability curve for ICER calculation was assumed at $50,000. Clinical data, healthcare resource utilization and utility scores were acquired from recent publications and an expert panel of 7 Canadian surgeons. Cost data (2011-Dollars) were derived from provincial health insurance policy, drug benefit formulary, and hospital data. All cost and outcomes were discounted at 3 % rate. Results: The annual incremental cost of SNM vs. BoNT-A was $7,237 in year-1 and -$9,402 in year-10 and was respectively between $8,878 to −$11,447 vs. OMT. In the base-case deterministic analysis, the ICER for SNM vs. BoNT-A and OMT were within the acceptable range ($44,837 and $15,130 respectively) at the second year of treatment, with SNM being dominant in the consequent years (Table 1). Furthermore, the probability of ICER obtained from the base-case deterministic analysis of being below the acceptability curve was >94.4 % for SNM vs. BoNT-A at year 4 and >99.9 % for SNM vs. OMT at year 2 (Table 2). Finally, graphs 1 and 2 showed the cost-effectiveness of SNM when compared to BoNT-A and OMT modalities at year 5. Conclusion: SNM is a cost-effective treatment option for the management of patients with refractory overactive bladder when compared to either BoNT-A or OMT. From a Canadian payers’ perspective, SNM should be considered as first line treatment option in patients with refractory overactive bladder.

Table 1. Deterministic analysis

INTERSTIM Incr. cost vs BoNT-A mean

Incr. cost Incr. cost Incr. QALY Incr. QALY Incr. QALY C/QALY low range high range mean low range high range mean

C/QALY low range

1 year 2 years 4 years

7,237$ 4,318$ −651$

7,574$ 4,884$ 277$

6,709$ 3,591$ −1,691$

0,05 0,09 0,19

0,05 0,09 0,19

0,05 0,09 0,19

150,769$ 50,708$ 1,436$

5 years

−2,275$

−1,701$

−3,941$

0,24

0,24

0,24

10 years

−9,402$

−7,698$

−11,129$

0,51

0,51

0,51

144,067$ 44,837$ INTERSTIM DOMINANT INTERSTIM DOMINANT INTERSTIM DOMINANT

INTERSTIM vs OMT 1 year 2 years 4 years 5 years

8,878$ 5,888$ 348$ −2,233$

8,812$ 5,847$ 335$ −2,236$

9,008$ 6,029$ 523$ −2,039$

0,19 0,38 0,76 0,94

0,19 0,38 0,76 0,94

0,19 0,38 0,76 0,94

10 years

−11,447$ −11,347$

−11,246$

1,76

1,76

1,76

45,999$ 15,130$ 455$ INTERSTIM DOMINANT INTERSTIM DOMINANT

45,655$ 15,024$ 438$ INTERSTIM DOMINANT INTERSTIM DOMINANT

C/QALY high range

133,558$ 37,288$ INTERSTIM DOMINANT INTERSTIM INTERSTIM DOMINANT DOMINANT INTERSTIM INTERSTIM DOMINANT DOMINANT

46,672$ 15,491$ 684$ INTERSTIM DOMINANT INTERSTIM DOMINANT

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Table 2. Probabilistic analysis (Willingness-to-Pay050,000$) INTERSTIM vs BoNT-A 1 year 2 years 4 years 5 years 10 years INTERSTIM vs OMT 1 year 2 years 4 years 5 years 10 years

%
0,10 % 21,60 % 95,60 % 94,60 % 88,60 %

0,40 % 48,60 % 93,90 % 89,40 % 77,70 %

17,90 99,90 99,60 99,60 64,70

22,00 99,80 99,60 99,60 61,40

9,40 % 100,00 % 100,00 % 100,00 % 78,00 %

% % % % %

%
% % % % %

L. Tu: Consultant; Medtronic of Canada Ltd. M.M. Hassouna: Consultant; Medtronic of Canada Ltd. J. Gajewski: Consultant; Medtronic of Canada Ltd. M. Robert: Consultant; Medtronic of Canada Ltd.. G.J. Grey: None. N.E. Dwyer: Consultant; Medtronic of Canada Ltd. J. Corcos: Consultant; Medtronic of Canada Ltd. H. Sadri: Employee (full or part time); Medtronic of Canada Ltd.. 137 MIDURETHRAL SLINGS FOR WOMEN WITH URODYNAMIC MIXED INCONTINENCE: WHAT TO EXPECT? S. Athanasiou, T. Grigoriadis, G. Giannoulis, A. Protopapas, A. Antsaklis 1st Obstetrics & Gynecology Univ. Clinic, Alexandra Hosp., Athens, Greece. Objective: We assessed efficacy of retropubic and transobturator midurethral slings (MUS) on women with urodynamically proven mixed incontinence (UMI). Background: Surgical management of women with UMI represents a challenging task for the clinicians. Initially, concerns have been expressed that anti-incontinence procedures may fail to treat or even aggravate the pre-existing incontinence and/or overactive bladder (OAB) symptoms. However, during the last few years, evidence has been gathered regarding the use of MUS for women with mixed urinary incontinence1, 2.

Methods: Prospective study of women with UMI i.e. coexistence of urodynamic stress incontinence (USI) and detrusor overactivity (DO) on multichannel urodynamics (UDS), who failed conservative treatment and underwent MUS between January 2005 and December 2010. Pre- and postoperative assessment included: completion of the validated ICIQFLUTS questionnaire, POP-Q examination and UDS. The MUS used were the retropubic TVTTM and the inside-out transobturator TVT-OTM. The choice of the MUS depended by the regional health authority which alternated the provision of the the kits on a monthly basis. The primary outcome was the assessment of incontinence symptoms reported by the patient 12 months postoperatively, based on the ICIQ-FLUTS questionnaire. We particularly focused on OAB symptoms such as frequency of micturition (Freq), nocturia (Noc), urgency (U), urge incontinence (UUI) and the symptom of stress urinary incontinence (SUI). Secondary outcomes included assessment of postoperative UDS findings and evaluation of differences of reported symptoms and UDS diagnosis between women who underwent TVT and TVT-O. Results: Eighty-five women were included; 44(49.2 %) underwent TVT and 41(51.8 %) underwent TVT-O. At 12 months follow-up there was a statistically significant reduction of SUI (p<0.001), UUI (p<0.001), urgency (p0 0.021) and frequency (p00.014) with more patients reporting improvement compared to those reporting deterioration of symptoms. However, depending on the symptom, 30.6– 41.2 % of women reported no change of the urge component

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while 16.6–18.8 % stated deterioration of symptoms (Table 1). UDS at 12 months revealed cure of USI in 82,4 % of patients and no evidence of DO in 35,3 %. No differences of reported symptoms were found between the TVT and TVT-O group. Assessment of postoperative UDS between the two groups showed no significant differences with regard to USI. However, the number of DO-free patients was significantly different (p00.014) between the two groups: 20/44 (48.48 %) of patients who underwent TVT and 10/41(22.7 %) of patients who underwent TVT-O showed no postoperative evidence of DO. Conclusions: Placement of MUS was found to be effective for alleviating incontinence and OAB symptoms in patients with UMI. TVT causes similar subjective improvement to TVT-O but resulted in higher resolution of DO. Our study provides data that could be helpful in informing patients preoperatively of the potential impact that the MUS may have on each individual symptom separately, including the likelihood of symptom deterioration. Table 1. Postoperative symptom change Symptom Freq Noc Urg UUI SUI

Decreasea 37 (42.4 %) 33 (38.8 %) 38 (44.7 %) 50 (58.8 %) 63 (74.1 %)

Stablea 35 (41.2 31 (36.5 31 (36.5 26 (30.6 10 (11.8

%) %) %) %) %)

Increasea 14 (16.5 %) 21 (24.7 %) 16 (18.8 %) 9 (10.6 %) 12 (14.1 %)

p 0.026 0.134 0.003 <0.001 <0.001

a

n (%) References: 1. Int Urogynecol J. 2010 ;21(7):763–6 2. Int Urogynecol J. 2011;22(8):923–32 S. Athanasiou: None. T. Grigoriadis: None. G. Giannoulis: None. A. Protopapas: None. A. Antsaklis: None. 138 ONABOTULINUMTOXINA IMPROVES HEALTHRELATED QUALITY OF LIFE IN PATIENTS WITH OVERACTIVE BLADDER WITH URINARY INCONTINENCE P. K. Sand1, K. M. Khalaf 2, X. Yan 2, D. Globe 2 1 Evanston Continence Ctr., Univ. of Chicago, Evanston, IL, 2 Allergan, Inc., Irvine, CA. Objective: To evaluate the impact of onabotulinumtoxinA compared with placebo on health-related quality of life (HRQOL) in patients with overactive bladder syndrome (OAB) with urinary incontinence (UI) who have had an inadequate response or experienced intolerable side effects with anticholinergic therapy. Background: Anticholinergic medications are the mainstay first line pharmacotherapy to treat OAB, however, for many patients anticholinergics provide limited or no benefit and

side effects are common, resulting in poor patient treatment compliance and cessation of treatment by physicians. There exists a significant unmet medical need for an acceptable, effective and safe treatment option to bridge the gap in the treatment algorithm between failed anticholinergic pharmacotherapy and surgical interventions. OnabotulinumtoxinA has been investigated as a potential therapy for OAB in two pivotal, phase 3, randomized trials. Methods: In this study, a component of one of the doubleblind, randomized, placebo-controlled, pivotal phase 3 trials, eligible patients had idiopathic OAB with ≥3 urgency UI episodes over a 3-day period, and an average of ≥8 micturitions/ day. All had been inadequately managed by prior anticholinergic therapy. Patients were randomized 1:1 to receive onabotulinumtoxinA 100 U or placebo, administered cystoscopically as 20 intradetrusor injections of 0.5 mL, sparing the trigone. The primary time point was week 12. Co-primary efficacy variables were the mean change from baseline in daily number of UI episodes and the proportion of patients with a positive treatment response on the Treatment Benefit Scale. Secondary efficacy variables included the mean change from baseline in the Incontinence Quality of Life (I-QOL) total summary score and the King’s Health Questionnaire (KHQ) Role Limitations and Social Limitations domain scores. Responder analyses were conducted for all domains to compare the proportion of patients with a clinically important change at week 12 (minimally important difference [MID] defined as a 10 point increase for the IQOL, and a 5 point decrease for the KHQ). General health status was measured via the Short Form-12 health survey (SF12) as change from baseline in Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. Results: A total of 557 patients were randomized (280 and 277 in the onabotulinumtoxinA and placebo groups, respectively). There were no significant differences between treatment groups with respect to demographic parameters (including age, race, and weight) or mean baseline HRQOL scores. The mean age of the patients was 61.3 years (range 19– 88 years), and 89.2 % (n0497) of the sample was female. At week 12, significant improvements from baseline above the MIDs were observed in the onabotulinumtoxinA group compared to placebo in all of the secondary HRQOL measures: IQOL total summary score and KHQ Role Limitations and Social Limitations domains (p<0.001 for all). A significantly higher proportion of patients treated with onabotulinumtoxinA achieved clinically meaningful thresholds compared to placebo on I-QOL total summary scores (60.2 % compared to 34.1 %, respectively, p<0.001) as well as on KHQ Role Limitations (63.3 % compared to 37.4 %, respectively, p<0.001) and Social Limitations domains (57.6 % compared to 42.1 %, respectively, p<0.001). The same responder result was noted in all individual I-QOL domains (p<0.001) and all remaining KHQ domains (p<0.001) except for the General Health Perception domain (p00.391). Furthermore, the MCS score of the SF12

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showed a significant mean change from baseline improvement in the onabotulinumtoxinA group compared with placebo (p00.002). Improvements from baseline in the PCS score of the SF12 were not significantly different between onabotulinumtoxinA and placebo groups. Conclusions: Treatment with onabotulinumtoxinA 100U for OAB with UI resulted in significant HRQOL improvement across all disease-specific patient-reported outcomes that reached clinically meaningful responder thresholds. P.K. Sand: Consultant; Allergan, Astellas, Pfizer, Teva, Watson, Ferring, Uroplasty. Grant /Research Support; Boston Scientific, Allergan, Bioform, Contura, Ferring, EMKinetics. K.M. Khalaf: Employee (full or part time); Allergan, Inc. X. Yan: Employee (full or part time); Allergan, Inc. D. Globe: Employee (full or part time); Allergan, Inc. 139 PELVIC FLOOR DYSFUNCTION IN WOMEN WITH BENIGN JOINT HYPERMOBILITY SYNDROME . A CASE-CONTROL STUDY Objective: The aim of this case-control study was to determine whether urinary incontinence (UI), pelvic organ prolapse (POP) and sexual dysfunction are more severe in women with Benign Joint Hypermobility Syndrome(BJHS) than in the normal population. Background: BJHS also known as Ehlers Danlos III is a hereditary connective tissue (HDCT) disorder causing hypermobility of joints. BJHS is under-recognised by lay people and medical professionals and therefore poorly managed (1). The ratio of type III to type I collagen is increased in the skin of a hypermobile population (2). The high collagen content in the pelvic floor can lead to pelvic floor problems in women with this condition, such as pelvic organ prolapse and urinary incontinence Methods: Women referred to a tertiary referral hypermobility clinic and diagnosed with BJHS according to the Brighton criteria (3) were invited to participate. Control subjects were recruited from hospital personnel who did not have BJHS. Study and control participants were asked to complete the King’s Health Questionnaire (KHQ), Prolapse Quality of life Questionnaire (P-QOL) and the Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaires (PISQ-12) all of which have been validated. Objective assessment of POP was undertaken using the Pelvic Organ Prolapse Quantification System (POP-Q). The scores for KHQ, P-QOL,PISQ-12 and the POP-Q were compared between study and control groups. All analyses were performed using SPSS version 17.0. Frequencies, percentages in addition to the statistical difference were analysed using Chi squared test. Comparison of QOL scores was performed with Wilcoxon SignedRanked Test. Paired t-test was used to compare the POP-Q measurements.

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Results: 120 subjects (60 Study, 60 Controls) were recruited. All patients were matched with healthy members according to age, parity and ethnicity. The overall mean age was 39.4 years and median parity was 1. The overall prevalence of UI was significantly higher in those with BJHS [Table 1]. Table 1. Prevalence of incontinence

Urinary Incontinence Urgency Incontinence Stress Incontinence

Study Group 73.3 % 62 % 63.3 %

Control Group 48.3 % 38.3 % 36.7 %

p value 0.009 0.017 0.141

There was a significant difference between study and control groups in most of the urinary specific symptoms of the KHQ/P-QOL [Table 2a, 2b]. Table 2a. Urinary specific symptoms KHQ

Frequency Nocturia Urgency Nocturnal enuresis Intercourse incontinence Urinary tract infections Bladder pain

Study Group 80 % 78.3 % 73.3 % 40 % 30 % 56.7 % 58.3 %

Control Group 48.3 % 60 % 35 % 13.3 % 16.7 % 23.3 % 20 %

p value 0.001 0.04 <0.001 0.002 0.130 <0.001 <0.001

Table 2b. Urinary specific symptoms P-QOL Study Group Straining 48.3 % Poor stream 38.3 % Incomplete bladder emptying 63.3 %

Control Group 13.3 % 8.3 % 23.3 %

p value <0.001 <0.001 <0.001

Significantly more women with BJHS felt that POP interfered with sex and defaecation compared to the control group [Table 3]. Table 3. Symptom specific P-QOL questions

Feeling of ‘Bulge’ in vagina Bulge interfering with sex Vaginal bulge interfering with bowel emptying Straining to open bowels Incomplete bowel emptying Digitation

Study group Control group p value 25 % 13.3 % >0.05 27 % 10 % 0.032 23 % 5% 0.007 61.7 % 63.3 % 33.3 %

26.7 % 26.7 % 8.3 %

<0.001 <0.001 0.001

The impact of UI on QoL was statistically different in all 9 domains of the KHQ, and the impact of prolapse symptoms in most of the P-QOL domains.

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There was a statistically significant difference(p<0.001)between points Aa, Ba, Ap, Bp and C in study and control groups showing that prolapse is objectively more severe in those with BJHS Conclusion: To our knowledge this is the largest case control study looking at the relationship between BJHS and prolapse, urinary incontinence and sexual function to date. A large number of women with BJHS have lower urinary tract and prolapse symptoms, which significantly affects their Qol. Under-diagnosis of these may be in part due to patient underreporting of their symptoms to their physicians and also in part due to a failure by GPs and rheumatologists to routinely screen for these symptoms. It is important to identify women who are symptomatic. The addition of a systematic active case-finding approach may be more effective in identifying these cases. References: (1) Rheumatology,2001,40:559–62 (2) Jof Rheu,1986,13: 239–46 (3) JRheumatology,2000,27(7):1777–1779 H. Mastoroudes: None. I. Giarenis: None. S. srIKRISHNA: None. H. kAZKAZ: None. R. Grahame: None. D. rOBINSON: Consultant; astellas, Pfizer, Gynecare, Uroplasty, ferring, recordati, novo-nordisc. Grant /Research Support; astellas, pfizer, boston scientific. L. Cardozo: Consultant; astellas, Pfizer, Gynecare, Uroplasty, advamed, ethicon, merck. Grant /Research Support; pfizer, boston scientific 140 T R E AT M E N T O F A D VA N C E D P R O L A P S E IN THE ELDERLY POPULATION S. Zebede, A. L. Smith, A. Hegde, V. Aguilar, G. Davila Cleveland Clinic Florida, Weston, FL. Objective: To compare pelvic reconstructive vaginal surgery with obliterative surgery for the treatment of post hysterectomy vault prolapse in the elderly. Background: With an aging population, it is likely that elderly women with posthysterectomy vault prolapse will increasingly seek treatment and that 36 per 10,000 a year will undergo surgery for their prolapse.1 Additionally approximately 80 % of older adults are afflicted with one chronic medical condition, and 50 % two, making this a high risk surgical population2. Because of these factors, many clinicians avoid surgical treatment of prolapse in this population. Methods: This was a retrospective cohort study comparing patients who underwent reconstructive vs. obliterative surgery for the management of prolapse from May 2005 until December 2010. Reconstructive procedures included apical suspension with transvaginal kit, vaginal enterocele repair, anterior colporrhaphy and posterior colporrhapy as necessary, while obliterative procedures consisted of colpocleisis with perineoplasty.

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Inclusion criteria included age 70 years or older, POP-Q stage 2 or greater prolapse and history of previous hysterectomy. All patients with less than 6 month follow-up were excluded. The primary outcome measure was prolapse recurrence defined as POP-Q stage 2 or greater prolapse in any compartment. Secondary outcomes include POP-Q points, operative time, estimated blood loss, perioperative complications and patient satisfaction. Patients reported satisfaction at every follow-up visit using a 5-poing global satisfaction scale (“cure”, “great improvement”, “some improvement”, “not improved” or “worsened”) Statistical analysis included student’s t-test, wilcoxon signed rank test, and Chi-square/Fisher exact test as appropriate. Results: During the study period, 131 elderly women underwent surgical repair of their prolapse. A colpocleisis was performed in 44 (34 %) patients and 87 (66 %) underwent reconstructive surgery. The majority of patients in both groups presented with prolapse≥stage 3; 39 (88 %) patients in the obliterative group and 71 (82 %) patient in the reconstructive group. As seen in Table 1 patients in the obliterative group were significantly older, presented with more advanced pelvic organ prolapse and were less sexually active. Concomitant procedures are illustrated in Table 1. Surgery was performed with spinal anesthesia in 35 (80 %) patients in the colpocleisis group and 68 (78 %) in the reconstructive. Colpocleisis resulted in shorter operative times, less blood loss, and fewer complications when compared to pelvic reconstructive surgery (Table 1). There were no significant operative complications in the colpocleisis group, however in the reconstructive surgery group, 4 (4.6 %) patients required a blood transfusion due to surgical blood loss. There was no difference in mean postoperative follow-up time between the between groups (73.1±60.7 week and 87.2±67 week, p00.07) respectively. There was a statistically significant difference in the primary outcome with zero colpocleisis patients vs. 14 (16 %) reconstructive patients developing anatomic recurrence (p < 0.01). Of the 14 patients with recurrent prolapse, 7 (50 %) were symptomatic. Repeat POP surgery was performed in 4 patients and 3 chose conservative management with a pessary. Among the recurrences, failure of the anterior compartment was seen most commonly (n 011). Two patients in the reconstructive group developed postoperative complications, one mesh exposure and one rectovaginal fistula. Following colpocleisis, patients were highly satisfied with 33 (73.3 %) reporting “cure” or “great improvement on a global patient satisfaction scale vs. 51 (58.7 %) following reconstructive POP surgery, however this was not statistically significant (p00.13). Conclusion: For the treatment of vault prolapse in the elderly, obliterative procedures result in improved anatomic success with less associated perioperative morbidity than vaginal reconstructive procedures. Colpocleisis results in high patient

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satisfaction and should remain a feasible surgical option for the treatment of prolapse in this population. Variable

Group A (obliterative) N044

Group B (reconstructive) N087

P Value

Age (y)* BMI (kg/m2)^ Gravidity^ Parity^ Pessary Sexually active Prolapse≥Stage 3 Concomitant procedures •Colporrhaphy •Grafted Anterior Repair •Incontinence Surgery Operative Variables •Operative Time (min)* •Blood loss (mL)* Complications

81.1±3.3 25.58 (5.61) 2.5 (2) 2 (1.75) 20 (46 %) 0 39 (88 %)

74 (6) 25.42 (5.14) 3 (2) 3 (1) 25 (29 %) 21 (24.1) 71 (82 %)

0.00 0.2 0.2 0.6 0.06 < 0.001 0.3

N/A N/A 34 (77 %)

45 (52 %) 10 (11 %) 61 (70 %)

81.2±17 111.4±54 0

107.1±24 208±175 6

<0.001 <0.0001

*Mean (SD; 95 % CI). ^Median (Interquartile range) References: 1. Epidemiology of genital prolapse: observations from the Oxford family planning association study. BJOG (1997);104:579–85. 2. Effect of patient age on increasing morbidity and mortality following uroginecologic surgery. AJOG (2006); 194:1411–7. S. Zebede: None. A.L. Smith: None. A. Hegde: None. V. Aguilar: None. G. Davila: Consultant; astellas, AMS, coloplast, CL Medical, Teva pharmaceuticals, Israel Biomedical Innovations. 141 GENITAL PROLAPSE: RANDOMIZED, MULTICENTER TRIAL OF SURGICAL ASSESSMENT FOR FASCIAL REPAIR VERSUS SYNTHETIC POLYPROPYLENE MESH REPAIR S. B. Silveira1, A. P. Auge 2, Z. I. Jarmy-Di Bella 3, F. Nastri 4, M. G. Kawabata 1, S. Carramao 2, C. A. Rodrigues 3, J. M. Haddad 4, E. C. Baracat 1 1 Hosp. Univ.rio da Univ.e de Sao Paulo, Sao Paulo, Brazil, 2 Santa Casa de Misericordia de Sao Paulo, Sao Paulo, Brazil, 3Sao Paulo Federal Univ., Sao Paulo, Brazil, 4Hosp. das Clinicas da Faculdade de Med. da Univ.e de Sao Paulo, Sao Paulo, Brazil. Objective: The aim of the study was to compare fascial and synthetic polypropylene mesh repair to treat severe genital prolapse

Background: Despite of it presents better rates of cure; the use of synthetic material brought us new complications. The relevance of this study is the efficacy and security criterious evaluation of the use of synthetic meshes when compared to the fascial repair Methods: multicenter and randomized study that included 172 women with genital prolapse S3 or S4 by POP-Q. The women were randomized by a software to surgical treatment using fascial repair (Group F- 82) or synthetic mesh, Prolift® (Group M- 90). Twelve cases were excluded due to the follow-up loss. The fascial repair surgery was performed according to site-specific defects. We performed sacrospinal ligament fixation with non-absorbable sutures for correcting the apical defects. The Prolift® was conducted according to the technique recommended by the manufacturer. Hysterectomy was performed in cases of uterine prolapse, and the passage of the anterior mesh was through the same incision, without performing “T” incision. The primary outcomes were considered the evaluation of POP-Q and the questionnaire of quality of life (P-QoL validated for idiom). The secondary outcomes were considered the complication during and after surgeries. The anatomic cure was considered S <2. This study is ongoing and we presented the 6 months results. Data were allocated in programm with double entry into two identical databases. It was used association statistical tests and comparison according to the nature of the variables. Alpha risk ≤5 %. The amostral data were calculated considering failure between techniques 15 % Results: Both groups were homogeneous regarding age (mean F065,1; M066,3), obstetric history, hemoglobin level, hematocrit, quality of live (total score mean F050,8; M048,3–p0 0,450), stage and type of prolapse—Anterior (mean F02,6; M02,8–p00,114) Apical (mean F01,9; M02,1–p00,478) and Posterior (mean F01,8; M02,0–p00,323). No significant differences were observed between the two groups at the time of surgery (mean: F0110.7 min and M0106.0–p00,447). The anatomic cure rate was 32.9 % in group F and 53.3 % in M (p0 0.007). Comparing the groups regarding the POP-Q points after 6 months we obtained a significant difference in point Ba (mean F0-0,3 and M0-1,2–p00,003). For other points the result was: C (mean F0-4,2 and M0-5,3–p00,225); Bp (mean F0-2,0 and M0-2,4–p00,115) and TVL (F07,2 and M06,9– p00,118). There was recurrence of apical prolapse beyond E2 in 8 cases in F and 4 in M. Comparing pre-and post-operative POP-Q points: C was from 0.8 to −4.2 in F and from 1.0 to −5.3 in M; Ba was from 3.3 to 0.3 in the F and from 3.6 to −1.2 in M; Bp was from 1.3 to −2.0 in F and 2.0 to −2.4 in M; TVL was form 8.5 to 7.2 in F and the M from 8.4 to 6.9 (all these changes with p<0.001). Intraoperative complications included bleeding with blood transfusion (F02 and M01–p00.606), bowel perforation (M01–p01,000), and bladder injury (F01 and M 03–p00,622). Post-operative complication was exposure (M016). Other complications did not present relevant

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differences and were described as: dysuria (F00 and M03–p0 0,247), bleeding (F01 and M02–p01,000), pain (F05 and M012–p00,112), dyspareunia (F02 and M06–p00,282), miccional dysfunction (F01 and M03–p00,622), difficult defecation (F04 and M04–p01,000) and infection (F01 and M04–p00,370). Regarding to quality of life the total score between the groups was F013,8 and M013,5–p00,478) Conclusions: This study is ongoing and showed that the anatomical success in the mesh group was better than fascial group only regarding anterior prolapse for 6 months post-operative period. The patients presented similar and significant improvement on quality of life in both groups and the main complication was exposure that occurred in a significant part of group M. S.B. Silveira: Consultant; eventually presentations. A.P. Auge: None. Z.I. Jarmy-di bella: Consultant; eventually presentations. F. Nastri: None. M.G. Kawabata: None. S. Carramao: None. C.A. Rodrigues: None. J.M. Haddad: None. E.C. Baracat: None. 142 OUTLET CONSTIPATION ONE YEAR AFTER ROBOTIC SACROCOLPOPEXY WITH AND WITHOUT CONCOMITANT DISTAL POSTERIOR REPAIR A. K. Crane, E. J. Geller, C. A. Matthews The Univ. of North Carolina at Chapel Hill, Chapel Hill, NC. Objective: To evaluate outlet constipation at 1 year after robotic sacrocolpopexy (RSCP) with and without a concomitant distal posterior repair (PR). Background: Outlet constipation is described when a patient has incomplete bowel emptying and has to either strain excessively or splint to complete defecation1. Postoperative prevalence rates of outlet constipation following abdominal sacrocolpopexy have been reported in 22–38 % of cases1–2. De novo constipation has been observed in 22.9 % of patient who underwent laparoscopic sacrocolpopexy2. It has been hypothesized that dissection of the levator ani and the posterior vaginal vault could lead to denervation that result in rectoplegia and subsequently constipation1–2. Even though RSCP has demonstrated durable improvement in pelvic floor function including bowel symptoms3, outlet constipation has not been specifically described in the RSCP population. Methods: This was a cohort study of women who underwent RSCP between November 2007 and February 2011 at an academic center. Subjects completed validated questionnaires including the Pelvic Floor Distress Inventory (PFDI-20) and Pelvic Floor Impact Questionnaire (PFIQ-7) both preoperatively and one-year postoperatively. The CRADI-8 subscale of the PFDI-20 was used to assess bowel symptoms. Pre- and postoperative posterior vaginal wall support was evaluated using the pelvic organ prolapse quantification system (POP-Q), in addition to digital rectal examination (DRE). Bowel symptoms were compared between women who underwent RSCP only

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and those who also had a concomitant PR and/or perineoplasty. Subsequent primary and repeat PR was also assessed. Results: Of the 77 women who underwent RSCP, 21 (27 %) had a concomitant distal PR. Overall there was significant improvement in pelvic floor function (PFDI-20: p00.009 and PFIQ: p00.029) at 1 year after surgery when compared to preoperative scores. There was no significant difference in the CRADI-8 subscale (27.5 vs 13.6, p00.094). Preoperatively, outlet constipation was present in 59.5 % of those that had RSCP only and in 53.3 % of those with concomitant PR. Postoperatively, 50 % of all preoperative outlet constipation resolved and 50 % persisted (p00.008). The rate of postoperative de novo outlet constipation was 13.6 %. The breakdown for each group is illustrated in Figure 1. Those that had a concomitant PR had less posterior prolapse preoperatively (Bp0-2 vs -1, p00.033) and postoperatively (Bp0-3 vs -2.5, p00.002), with no differences in preoperative and postoperative DRE, preoperative CRADI-8 (25.4 vs 28.2, p00.658), and postoperative CRADI (16.5 vs 16.0, p00.91). At 1 year after RSCP, 18.2 % of patients had symptomatic posterior prolapse, with no difference between both groups (p00.746). Overall, 11.7 % underwent a subsequent PR, but none of the women who underwent reoperation had concomitant PR at initial surgery (p0.104). Women who underwent reoperation had no difference in preoperative Bp or CRADI-8 scores compared to those who did not undergo reoperation. Conclusions: In women who underwent RSCP, 50 % reported persistent outlet constipation and 13.6 % reported de novo outlet constipation at 1 year after surgery. Concomitant PR did not affect bowel symptoms at 1 year after RSCP, but none of the women opting for reoperation for symptomatic posterior prolapse had undergone a concomitant PR at initial surgery. This information may be useful in counseling women regarding the effect of RSCP with and without PR on outlet constipation. References (optional): 1. Obstet Gynecol 2001; 97:678–684. 2. Hippokratia 2008; 13:101–105. 3. J Minim Invasive Gynecol 2011; 18: 322–7.

A.K. Crane: None. E.J. Geller: Grant /Research Support; Intuitive Surgical. C.A. Matthews: Grant /Research Support; Intuitive Surgical.

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143 EXPRESSION OF MODULATORS OF COLLAGEN AND ELASTIN REMODELLING IN VAGINAL TISSUE OF PREMENOPAUSAL WOMEN WITH SEVERE PELVIC ORGAN PROLAPSE H. Kufaishi 1, O. Shynlova 1, M. Alarab2 1 Samuel Lunenfeld Res. Inst., Toronto, Canada, 2Mount Sinai Hosp., Toronto, Canada. Objective: We aimed to examine the expression of proteins involved in elastin and collagen biogenesis, namely ADAMTS-2, −3 and −14; the extracellular procollagen-N-proteinases that cleave the N-propeptides of procollagens I, II, III, in vaginal tissue biopsies of premenopausal women with advanced POP and asymptomatic healthy controls in the secretory and the proliferative phase of the menstrual cycle. We also examined the expression of LOX, LOXL1-4 and MMP1,2,7,9,12,14 in the secretory phase of the menstrual cycle. Background: Evidence suggests that abnormalities of connective tissue structure or its repair mechanism may predispose women to Pelvic Organ Prolapse (POP). We reported earlier that the Lysyl oxidase (LOX) family gene and protein expression involved in the maturation of collagen and elastin was decreased in the vaginal tissue of premenopausal women with severe POP in the proliferative phase of the menstrual cycle.[i] ADAMTS-2, −3 and −14 are extracellular procollagenN-proteinases that cleave the N-propeptides of procollagens I, II, III in vivo, which is necessary for the proper assembly of collagen fibrils. Ehlers-Danlos syndrome (EDS) type VIIC, or dermatosparactic type, is a recessively inherited connective tissue disorder characterized by extreme skin fragility , joint hypermobility and skin laxity resulting from mutations inactivating ADAMTS-2. Women with EDS have a higher incidence of POP.[ii]Methods: Premenopausal Caucasian women undergoing total hysterectomy for benign conditions were recruited as controls (POP-Q 00) while women with advanced POP (POP-Q stage ≥ 3) were recruited as patients. Phase of the menstrual cycle was confirmed by histology report. Exclusion criteria: steroids therapy, malignancy, previous pelvic surgery, connective tissue diseases. During surgery, 1 cm2 of full thickness vaginal tissue was obtained; total RNA and protein were extracted and analyzed by RT-PCR and Western Immunoblot respectively. Mann-Whitney test (p< 0.05) was used for statistical analysis. Results: We recruited 40 Caucasian premenopausal women (20 patients and 20 controls). ADAMTS-2, but not ADAMTS-3 and ADAMTS-14, mRNA was expressed in all vaginal biopsies and was significantly increased in all patients

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with POP compared to controls. Four bands corresponding to pro and mature forms of the two major isoforms of ADAMTS2 (active and inactive) were detected on Immunoblot: 132 kDa, 107 kDa, 58 kDa and 34.5 kDa. The 58 kDa protein was significantly increased in patients compared to controls in both the secretory (p00.043) and the proliferative (p0 0.025) phases of the menstrual cycle. 18 women were in the secretory phase of the menstrual cycle (8 patients and 10 controls). LOX, LOXL1-4 gene were expressed in vaginal tissue biopsies, however only LOX was significantly increased (p00.0028). We detected a significant increase in MMP2 and MMP14 mRNA levels in patients with POP compared to controls (p00.029, p 00.008 respectively). Immunoblot analysis for LOX indicated a significant increase of the 35 kDa form of LOX in vaginal tissue of patients compared to controls (p 00.04). MMP-2 and -9 gelatinase activities were significantly increased in vaginal biopsy samples of patients compared to controls. Conclusions:We identified differential expression of proteins that may contribute to altered collagen and elastin biogenesis and subsequent defective assembly of pelvic tissues in patients with severe POP. References (optional): [i] International Urogynecology Journal, 21(11), p.1397–1404. [ii]Am J Obstet Gynecol.2000;182:1021–3. H. Kufaishi: None. O. Shynlova: None. M. Alarab: None. 144 THE STUDY ON THE RELATIONSHIP BETWEEN THE SERUM RELAXIN LEVELS AND THE PELVIC FLOOR PROLAPSE Q. Wu, Y. Zhou, L. Luo SHANGHAI JIAOTONG Univ. AFFILIATED 6TH Hosp., SHANGHAI, China. Objective: The relationships between the serum relaxin levels and the pelvic floor prolapse (POP) were investigated in this paper. Background: Pelvic floor prolapse refers to a wide range of issues that occur when muscles of the pelvic floor are weak, tight, or there is an impairment of the sacroiliac joint, lower back, coccyx, or hip joints. Tissues surrounding the pelvic organs may have increased or decreased sensitivity or irritation resulting in pelvic pain. Many times, the underlying cause of pelvic pain is difficult to determine. Serum Relaxin (RLX) levels could promote growth of the mammary gland, inhibit uterine contractile activity, and dilate and soften the cervix uteri. RLX is now considered a hormone with more than reproductive functions: it has antifibrotic, vasodilator, and pro-angiogenic properties; it controls

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pituitary hormone release, interacts with cerebral cortical receptors, and increases ovarian apoptosis. Methods: 39 POP patients (POP group) and 39 normal women (normal group) were enrolled to this study between Oct 2010 and Apr. 2011. The relationships between women pelvic organ prolapse and serum Relaxin levels were analysed. Results: The serum relaxin levels in POP group was 406.7 ± 311.2 ng/L,higher than the normal group (199.4 ± 208.7 ng/L), there was significant difference between two groups (P < 0.05); The serum relaxin levels of menopausal women was 172.0 ± 197.5 ng/L, lower than non-menopausal women (587.5 ± 716.8 ng/L), the data was with statistical significance (P < 0.05); The serum relaxin levels of menopausal women in POP group was 226.2 ± 178.8 ng/L, the serum relaxin levels of menopausal women in the normal group was 108.4 ± 98.7 ng/L, there was significant difference between two groups (P < 0.05); The serum relaxin levels of non-menopausal women in POP group was 1870.2 ± 264.4 ng/L, the serum relaxin levels of non-menopausal women in the normal group was 373.7 ± 370.4 ng/L, there was significant difference between two groups (P < 0.001). Conclusions: Elevation of serum Relaxin level might be the cause of female pelvic organ prolapse. References (optional): Q. Wu: None. Y. Zhou: None. L. Luo: None. 145 DURABILITY AND COMPLICATIONS OF AN ULTRA L I G H T W E I G H T T R A N S VA G I N A L M E S H IN THE TREATMENT OF PELVIC ORGAN PROLAPSE R. M. Alinsod1, M. P. Patel 2, T. B. Erickson 3 1 South Coast Urogynecology, Laguna Beach, CA, 2Piedmont Urology Associates, PA, Gastonia, NC, 3Rosemark WomenCare Specialists, Idaho Falls, ID. Objective: To assess the anatomic durability and complications of a synthetic non-absorbable ultra lightweight mesh (Restorelle® Smartmesh®, Coloplast Corp, Minneapolis, Minnesota, USA) placed transvaginally for the treatment of pelvic organ prolapse (POP). Background: Data have shown that the rate of vaginal mesh exposure may decrease with a reduction in polypropylene mesh density, without compromise in tissue support.1,2 Mesh material with a surface density below 50–60 g/m2 and a pore size larger than 1.2 mm are considered to be of low weight and high porosity.3 Restorelle is a type I polypropylene mesh, considered to be ultra lightweight and of high porosity, as it possesses a density of 19 g/m2and a pore size between 1.6 and 2.0 mm.

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Methods: A retrospective chart review was conducted at 3 sites in the United States. Women who received Restorelle for anterior and/or posterior prolapse at least 6 months prior were included in the analysis. Primary endpoint was anatomic durability assessed by the Pelvic Organ Prolapse Quantification System (POP-Q) or the Baden-Walker halfway scoring system (B-W), with success defined by POP-Q Stage < 0 I or B-W Grade < 0 I; and absence of retreatment for POP. Secondary endpoints included mesh-related complications. Exposures, dyspareunia, and pain were coded using the International Urogynecological Association (IUGA)—International Continence Society (ICS) classification system. Anatomic durability was analyzed using Kaplan-Meier curves. Complication rates and 95 % Exact Confidence Intervals (CI) were based on number of mesh units placed, overall and by compartment. Results: 481 subjects were ≥180 days post implant with Restorelle. 247 had clinical follow-up at or beyond 180 days (mean 532±355 days; range 181 to 1989), comprising the sub-set of patients we chose to analyze (Cohort 1). 234 subjects had clinical follow-up <180 days (Cohort 2). Baseline characteristics are summarized in Table 1. As the only significant differences between Cohorts were gravidity, parity, and previous hysterectomy, we would expect the groups to have similar outcomes. In Cohort 1, mesh was placed in the anterior compartment in 62 patients, posterior compartment in 68, and in both compartments in 117, for a total of 366 mesh implants (181 anterior and 185 posterior). Anterior success rate was 95.5 % and posterior success rate was 97.8 %. Anterior success rates for baseline stages 2, 3, and 4 were 94.5 %, 96.4 %, and 95.2 %, respectively. Posterior success rates for baseline stages 1, 2, 3, and 4 were 100 %, 97.5 %, 97.8 %, and 100 %, respectively. Anatomic durability is shown in Figure 1. Five complications were reported among five study subjects, with 4 exhibiting exposure and 1 dyspareunia. The total mesh complication rate (5/366) was 1.4 % (95 % CI: 0.5 %–3.2 %). The anterior mesh complication rate (4/181) was 2.2 % (95 % CI: 0.6 %–5.6 %), and the posterior mesh complication rate (1/185) was 0.5 % (95 % CI: 0.01 %–3.0 %). Table 2 summarizes IUGA/ICS codes and event details, all of which were resolved. There were no reported erosions into viscus or explants. Conclusions: Ultra lightweight transvaginal mesh appears to be durable with low rates of mesh related complications. References: 1 J Gynecol Obstet Biol Reprod 2004;33:577–88 2 Int Urogynecol J 2012. Epub April 3 Int Urogynecol J 2010;21:261–270

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Table 1. Baseline characteristics Long-term Follow-up (N0247) Cohort 1 mean±standard deviation (N) / % (N)

Short-term Follow-up (N0234) Cohort 2 mean±standard deviation (N) / % (N)

Wilcoxon /Chi-Square P-value

Age (years) Gravidity Parity Body Mass Index (BMI) Height (inches) Weight (lbs)

61.4±12.4 (247) 2.9±1.7 (225) 2.5±1.4 (225) 27.1±5.8 (233) 64.2±2.8 (234) 157.8±30.6 (242)

59.5±12.6 (234) 3.6±2.0 (215) 3.1±1.8 (214) 27.2±5.5 (196) 64.4±2.8 (203) 160.6±33.4 (211)

0.053 <0.001 0.007 0.690 0.234 0.337

Previous Hysterectomy Previous Incontinence Surgery Previous POP Surgery Pre-implant estrogen—Yes Post-implant estrogen—Yes Baseline Grading/POP-Q Staging Anterior Procedures 1 2 3 4 Missing Posterior Procedures 1 2 3 4 Missing

47.8 % (118) 10.5 % (26) 1.2 % (3) 45.8 % (104/227) 86.6 % (201/232)

38.5 % (90) 6.8 % (16) 2.1 % (5) 45.5 % (85/187) 86.1 % (174/202)

0.039 0.152 0.429 0.942 0.880

N0179 0 % (0) 40.8 % (73) 46.9 % (84) 11.7 % (21) 0.6 % (1) N0185 1.6 % (3) 42.7 % (79) 48.1 % (89) 6.5 % (12) 1.1 % (2)

N0174 1.2 % (2) 39.1 % (68) 42.0 % (73) 13.8 % (24) 4.0 % (7) N0189 1.1 % (2) 40.2 % (76) 43.9 % (83) 7.4 % (14) 7.4 % (14)

0.424

0. 931

Table 2. Complication codes and details for mesh-related events Subject Complication Category Pain

Compartment Complication Code Time to Onset

1

Anterior

2 3 4

5

Exposure Vaginal: ≤ 1 cm exposure Exposure Vaginal: ≤ 1 cm exposure De novo dyspareunia Vaginal: no epithelial separation Exposure Vaginal: ≤ 1 cm exposure

Exposure Vaginal: ≤ 1 cm exposure

No

Yes, provoked Posterior on exam Yes, with Anterior intercourse

2A/T3/S1 2Ab/T3/S1 1Bc/T3/S2

No

Anterior

2A/T3/S1

No

Anterior

2B/T3/S1

Resolution

2–12 months (132 days) Resolved in office with mesh trim 2–12 months (292 days) Resolved in office with mesh trim 2–12 months (134 days) Resolved with use of medical dilator

Number of Visits 1 1 1

2–12 months (141 days) Treated initially with 2 estradiol cream; resolved with mesh excision in operating room 2–12 months (210 days) Resolved with mesh 2 trim and use of estradiol

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Figure 1. Anatomic durability

R.M. Alinsod: Consultant; Coloplast Corp, Ellman International, Cooper Surgical. M.P. Patel: Consultant; Coloplast Corp, Medtronic, Astellas. T.B. Erickson: Consultant; Coloplast Corp, American Medical Systems, Ethicon. Grant /Research Support; Coloplast Corp. 146 NATURAL PROGRESSION OF PELVIC ORGAN PROLAPSE USING DYNAMIC 2D TRANSPERINEAL ULTRASONOGRAPHY: A ONE YEAR PROSPECTIVE STUDY F. Lone, A. Sultan, R. Thakar, A. Stankiewicz Croydon Univ. Hosp., London, United Kingdom. Objective: To prospectively establish the natural history of progression of pelvic organ prolapse (POP) over 1 year using pelvic organ prolapse quantification (POPQ) and dynamic 2D- transperineal ultrasound (TPUS). Background: POPQ staging is a clinically validated tool for staging pelvic organ prolapse (POP) [1] and TPUS assessment of prolapse provides objective quantification of POP [2]. As both techniques allow for evaluation of anatomical outcome after surgical treatment, prospective studies allow for the evaluation of the stage of prolapse over time. Methods: Women with symptomatic prolapse attending urogynaecology clinics between July to October 2009 were recruited. A detailed history was taken and demographic data was collected. For ultrasound assessment, no patient

preparation was required, no rectal or vaginal contrast was used. 2D-TPUS was performed using a 6 MHz convex transducer (B-K Medical Type 8802, ProFocus Ultraview). The patients were scanned with a comfortable volume of urine in the bladder and with the patient in the supine position. Images were taken at rest and then at three maximum valsalva efforts. The descent of prolapse was measured offline on the image demonstrating maximum descent. A reference line was drawn parallel to the infero-posterior margin of pubic symphysis perpendicular to which the leading edge of descent was measured [Fig 1]. POPQ and TPUS were repeated at 1 year . Wilcoxon Signed Rank test was used to study the change at 1 year from baseline within the groups. Results: 89 women were included. The mean (± SD) age was 49.5 ( ± 14.1) years, BMI was 29.3 (± 6.5) kg/m2 and median parity was 2 (range 0–6). Twelve scans (13 %) were not analysable (12 poor quality images, 1 missing). The flow diagram of study participants is demonstrated in Figure 2. A significant reduction (p-value <0.05) in POPQ and TPUS measurements at 1 year in comparison to baseline was demonstrated in women who underwent surgery. However the reduction in POP measurements was not significant in women who opted for no treatment or pessary use [Table 1]. Conclusions: This is the first long term prospective study assessing the natural history of POP using POPQ and TPU. Surgical correction leads to a reduction in prolapse measurements. However, no treatment or pessary use does not alter the measurements at 1 year. This on-going prospective study

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demonstrates that at 1 year, prolapse does not worsen in women who have not undergone surgery and provides a basis for longer term follow-up.

References: 1: Am J Obstet Gynecol; 1996:175(1):10–17. 2: Ultrasound Obstet Gynecol. 2001; 18: 511–514.

Table 1. POPQ and TPUS at 1 year compared to baseline. Surgery

Anterior TPU Point Ba

Posterior TPU Point Bp

Middle TPU Point C

Pessary

No treatment

Median change

p-value

Median change

p-value

Median change

p-value

n028 −4.623 −4.963 n09 −2.666 −2.975 n021 −3.980 −2.636

<0.001 <0.001

n09 −1.955 −1.841 n09 −1.481 −1.869 n07 −0.845 −4.16

0.051 0.064

n030 −1.574 −1.732 n033 −6.88 −1.811 n020 −0.22 −1.732

0.116 0.082

0.008 0.003 <0.001 0.008

0.139 0.062 0.398 0.677

0.491 0.070 0.983 0.080

p-value<0.05 was taken as significant

Figure 1. Reference line from infero-posterior margin of symphysis pubis and cystocele measurement

F. Lone: None. A. Sultan: None. R. Thakar: None. A. Stankiewicz: None. 147 OUTCOMES OF ROBOTIC SACROCOLPOPEXY: A SYSTEMATIC REVIEW AND META-ANALYSIS C. O. Hudson, G. M. Northington, D. R. Karp Emory Univ., Atlanta, GA.

Figure 2. Flow diagram of study participants

Objective: The aim of this study was to systematically review the current published literature on robotic-assisted laparoscopic sacrocolpopexy and analyze the results with a focus on >6 month anatomic outcomes. Background: Sacrocolpopexy is the current gold standard for surgical management of apical prolapse with high success rates and long-term durability. With the advent of robotic surgery, pelvic reconstructive surgeons have quickly incorporated robotic-assisted sacrocolpopexy into their practice. Methods: A MEDLINE search was performed using the terms “robot* AND sacrocolpopexy”, “robot* AND sacral colpopexy”, and “robot* AND promontofixation.” Sixty one English language articles were identified, and the abstracts were reviewed. All studies that assessed postoperative outcomes after robotic sacrocolpopexy were eligible for selection. Studies were excluded if the patient cohort was less than 15 or if the mean follow-up period was less than 6 months. Demographic data, perioperative information and postoperative outcomes were abstracted by 2 separate reviewers blinded to each other’s results. Abstracted data included age, BMI, length of follow-up, preoperative

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and postoperative prolapse stage, estimated blood loss, conversion rates, concomitant procedures, complication rates, reoperation rates, satisfaction, and postoperative dyspareunia. The weighted means and weighted standard deviations were calculated for selected outcomes. Results: Six articles met criteria for review. Three additional articles were included after reviewing the references of the selected articles. A total of 9 studies involving 294 women were included in the review including 1 randomized controlled trial, 3 prospective, and 5 retrospective studies. The weighted mean patient age was 62.7±3.1 years. Mean BMI ranged from 24.7 to 29.5 kg/m². The weighted mean rate of conversion to open or laparoscopic procedure was 3.7±3.1 %. Anti-incontinence procedures were the most common concomitantly performed procedures with a weighted mean rate of 48.3±26.9 %. The most common intraoperative complication was incidental cystotomy with a weighted mean rate of

3.4±3.3 %. Weighted mean rate of mesh erosion was 3.2± 4.2 %. Seven out of nine studies used the POP-Q staging system to report apical anatomic outcome. The weighted mean anatomic cure rate, defined as postoperative apical prolapse≤POP-Q Stage 1, was 96.9±3.9 % at a weighted mean followup of 23.4±18.2 months ranging from 7 to 59 months. The weighted mean rate of reoperation for prolapse was 1.4± 2.0 %, while the total reoperation weighted mean rate was 8.3±9.0 %. Conclusions: Despite the rapid incorporation of roboticassisted laparoscopic sacrocolpopexy into surgical practice, there is a paucity of objective long-term data on the procedure. The limited objective data available suggests that robotic-assisted sacrocolpopexy is a safe and effective alternative to the open abdominal approach. However, additional long-term prospective studies are needed to adequately assess postoperative outcomes.

Table 1. Pooled data from selected studies (Weighted means±weighted standard deviations) N

Age (years)

Follow-up Conversion Anti-incontinence Mesh erosion Cystotomy Anatomic Total reoperation Recurrent prolapse (months) rate (%) procedure rate (%) rate (%) rate (%) success rate (%) rate (%) reoperation rate (%) (pop-q stage≤1)

294 62.7±3.1 23.4±18.2 3.7±3.1

48.3±26.9

3.2±4.2

C.O. Hudson: None. G.M. Northington: None. D.R. Karp: None. 148 EVALUATING THE EARLY IMPACT OF THE FOOD AND DRUG ADMINISTRATION (FDA) SAFETY COMMUNICATION ON USE OF SURGICAL MESH E. M. MYERS, A. K. CRANE, E. J. GELLER, B. L. ROBINSON, C. A. MATTHEWS Univ. of North Carolina at Chapel Hill, Chapel Hill, NC. Objective: To evaluate the impact of the 2011 United States FDA Mesh Safety Communication on surgical practice patterns of gynecologic surgeons managing pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Background: POP and SUI are common disorders among women, resulting in an 11 % lifetime risk of surgical repair.1 Of women managed surgically, approximately 30 % will undergo reoperation for recurrent symptoms and will face potentially increased morbidity from repeat operations.1,2 In an effort to decrease this anatomic failure rate, various types of mesh have been introduced for prolapse and incontinence repair. Based on protocol for Class II devices, transvaginal mesh use for SUI (FDA approved in 1996) and POP (FDA approved in 2002) preceded clinical verifying long term efficacy and safety.3 In 2008 the FDA reported over 1,000

3.4±3.3

96.9±3.9

8.3±9.0

1.4±2.0

complications over the preceding 3 years with vaginal mesh use: vaginal mesh erosion, recurrent prolapse, pain, infection, bowel, bladder, or blood vessel perforation, vaginal scaring, discomfort and pain, specifically dyspareunia and incontinence. In response, providers were encouraged to obtain specific training for each mesh kit used, explain the risks associated with permanent mesh, and cautiously monitor for adverse intraoperative and postoperative outcomes. In July 2011, after a 3-year query of the FDA’s Manufacturer and User Device Experience (MAUDE), the FDA issued a warning regarding vaginal mesh products that highlighted a five-fold increase in mesh-associated complications since 2008, totaling 2,874 cases. In addition to the previously reported outcomes, there were now reports of neuromuscular problems, vaginal scarring or shrinkage, and three deaths directly related to mesh placement. The new announcement stated that surgical placement of vaginal mesh is associated with considerable risks without conclusively improving clinical outcomes over traditional repair. Providers were reminded that mesh is not necessary to effectively treat POP, and many patients can be managed with a native tissue repair or with non-surgical options, thus avoiding potential mesh complications all together.3 Methods: A cross-sectional study was performed by administering a mesh usage survey to physicians attending a United States national gynecology conference. Respondents included surgeons in General Gynecology (OB/GYN),

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Minimally Invasive Gynecologic Surgery (MIGS), Female Pelvic Medicine and Reconstructive Surgery (FPMRS), and Urology. The survey assessed level of training, number of years in practice, and practice type. Surgical practice patterns were assessed regarding primary and recurrent anterior, posterior, and apical POP and SUI, before and after the FDA Safety Communication. For each of the listed procedures respondents were asked if they performed native tissue repair, vaginal mesh repair, or abdominal mesh repair, and/or other procedures. Surgical counseling methods pre and postFDA Safety Communication were also assessed. Results: Of the 827 physicians attending the opening session of the conference, 281(34 %) completed the survey, 202(72 %) of whom reported performing surgery for POP and/or SUI. The majority of respondents were attending physicians (84.1 %) with at least 10 years experience (66.9 %), who identified themselves as General OB/GYN 136(72.7 %), FPMRS 29(15.5 %), MIGS 13(7 %), and Urology 3(1.6 %). When comparing generalists to all specialists, specialists were more likely to use mesh for abdominal POP repair (86 % vs 56.3 %, p<.001) and vaginal POP repair (65.9 % vs 37.2 %, p0.001). Specialists used more mesh for: anterior compartment (50 % vs 28.3 %, p0.01), posterior compartment (36.4 % vs 12.5 %, p 0.001), anterior/apical compartment (43.2 % vs 13.3 %, p < .001), posterior/apical compartment (22.7 % vs 10.8 %, p0.052), and total vaginal mesh kits (13.6 % vs 1.7 %, p0.005). All respondents reported an increase in the use of mesh for primary abdominal POP repair (82 vs 92, p0.013), and a decrease in mesh use for recurrent vaginal POP repair (99 vs 75, p<.001), with more surgeons opting against mesh for recurrent prolapse (49 vs 74, p<.001). Overall, 23 % reported intent to decrease mesh use, with 20.7 % using vaginal mesh only for recurrent prolapse, 5.9 % not using any vaginal mesh, and 7.7 % referring patients to a different provider. In terms of patient counseling, 53.7 % of providers reported changing their counseling methods to include more mesh-specific counseling. Conclusions: In a sample of varied gynecologic and urology practitioners, an early impact of the 2011 FDA Safety Communication was seen, with changes in not only surgical use of mesh but also referral and counseling patterns. References (optional): 1. Obstet Gynecol 1997;89:501–6. 2. Am J Obstet Gynecol 2003;189:1261–7. 3. FDA;2011. ttp://www.fda.gov/MedicalDevices/Safety/ AlertsandNotices/ucm262435.htm. E.M. Myers: None. A.K. Crane: None. E.J. Geller: Grant /Research Support; Intuitive Surgical. B.L. Robinson: None. C.A. Matthews: Grant /Research Support; Intuitive Surgical.

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149 SUBOPTIMAL SUSPENSION EFFECT OF THE PROSIMATM PROCEDURE FOR SEVERE ANTERIOR VAGINAL WALL PROLAPSE M. Hung, C. TSAI Taichung Veterans Gen. Hosp., Taichung, Taiwan. Objective: ProsimaTM (Ethicon, Somerville, NJ) is a novel procedure for treatment of pelvic organ prolapse (POP) with non-anchored mesh and vaginal support device. However, mesh non-fixation may limit its efficacy. In order to further understand the indication and limitation of the ProsimaTM procedure, a Data and Safety Monitoring Plan study was conducted at 3month follow-up in this Institutional Review Board-approved prospective clinical trial. The information obtained may therefore contribute to the proper preoperative planning on consideration of using the ProsimaTM procedure for a POP repair. Background: The ProsimaTM procedure was thought to provide true tension-free support for POP repair. Absence of fixation of mesh through the pelvic floor muscles was thought to result in less vaginal distortion or band formation because of excessive tensioning. However, mesh non-fixation may also cause a suboptimal suspension effect of the procedure. According to the recent results reported in the literatures, the anatomic success rates (stage 0–1) of POP repair were 76.9 % and 69.1 % at one- and two-year followup, respectively [1, 2]. These rates were obviously inferior to those achieved by using armed vaginal mesh kits with fixation at longer follow-up intervals [3]. Methods: Patients with POP ≧ stage 2, who underwent the ProsimaTM procedure, were enrolled consecutively in this study. Each patient underwent a baseline and 3-month follow-up interview with a validated symptom and quality-oflife questionnaire, a pelvic examination, a cough stress test with comfortably full bladder and a multi-channel urodynamic study. The follow-up urodynamic study was not routinely performed but was done if indicated by urinary symptoms or a positive cough stress test. Results: Fifty (96 %) of the first 52 patients completed the baseline and postoperative assessment. Demographic data was presented in Table 1. Surgical results were summarized in Table 2. 42 (84 %) of the 50 patients were cured of POP (stage 0). The other eight (16 %) patients had stage 1–2 recurrent anterior vaginal wall prolapse, although most (5/8) of them remained asymptomatic. After a statistical analysis, the recurrence was found to be significantly (p<0.05) associated with a “preoperative Ba≧4 cm” (odds ratio020.57), “conservation of prolapsed uterus” (odds ratio010.56) and a “concomitant midurethral sling” (odds ratio00.076), respectively. Conclusions: ProsimaTM seems to have limitation in managing severe anterior vaginal wall prolapse. Meanwhile, concurrent procedures may have further positive or negative impacts on its effectiveness.

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References: 1. Am J Obstet Gynecol. 2010 Dec;203(6):587.e1–8. 2. Int Urogynecol J. 2012 Apr;23(4):487–493. 3. Int Urogynecol J. 2011 Nov;22(11):1445–57. Table 1. Demographic data (n050) Patient characteristics Mean age (year)

Value Range 60.5±9.3 (38–78)

Median parity Mean body mass index (kg/m2) % with menopause % with prior prolapse surgery % with prior hysterectomy % with urodynamic stress incontinence % with diabetes mellitus % with chronic constipation % with professional/recreational heavy lifting

3 24.9±2.9 88 8 18 38 18 22 22

(1–6) (20.0–31.1) (44/50) (4/50) (9/50) (19/50) (9/50) (11/50) (11/50)

Table 2. Surgical results (n050) Parameters Basic clinical data

Value

Range

Mean days hospital stay

5.3±1.1

(4–9)

Mean days Foley drainage

3.4±1.1

(3–8)

Mean minutes total operation time

134±25.7

(90–190)

Mean milliliters estimated blood loss

100±150.6

(50–800)

VTH with McCall culdoplasty

51.2 %

(21/41)

McCall culdoplasty with/without trachelectomy

48.8 %

(20/41)

Optimal result (stage 0)

84 %

(42/50)

Satisfactory result (asymptomatic stage 1–2)

10 %

(5/50)

Unsatisfactory result

6%

(3/50)

Re-operation rate

2%

(1/50)

Cured

89.5 %

(17/19)

Persisted

10.5 %

(2/19)

2%

(1/50)

Ctr. for Advanced Reproductive Endosurgery (CARE), St. Leonards, NSW, Australia. Objective: To evaluate and compare the outcomes of three different transvaginal mesh (TVM) procedures for pelvic organ prolapse. Background: While the 2011 U.S. Food and Drug Administration’s (FDA) Public Health Notice has thrust the controversy surrounding the role of transvaginally implanted mesh to new heights, it has also reminded clinicians that continued audit and review of outcomes is essential for it continued use in clinical practice. Over the years, the range of surgical meshes and mesh kits available for transvaginal prolapse repair have changed and increased dramatically. Our center began using TVM 10 years ago, primarily in complex, recurrent and/or severe Level II defects, where the native endopelvic fascia was thought to be too deficient, or the risk of vaginal shortening or stenosis too high to recommend native tissue repair. Methods: A retrospective cohort study was conducted on all consecutive women who underwent: –

–

Concurrent procedures for prolapsed uterus

Treatment outcome of POP

Treatment outcome of USI

Surgical complications Retropubic hematoma De novo stress urinary incontinence

5.4 %

(2/37)

De novo urgency urinary incontinence

4.7 %

(2/43)

Vaginal mesh exposure

8%

(4/50)

VTH: vaginal total hysterectomy; POP: pelvic organ prolapse; USI: urodynamic stress incontinence 1 M. Hung: None. C. Tsai: None. 150 TRANSVAGINAL MESH FOR PELVIC ORGAN PROLAPSE: 10-YEAR EXPERIENCE WITH 627 PROCEDURES P. Patel, A. Lam

–

an anterior and/or posterior vaginal repair with a surgeonfashioned inlay of Gynemesh® (Ethicon, Inc., a knitted, large-pore, monofilament polypropylene mesh of 41 g/m2 density), with or without concurrent SSF using 0-Prolene suture (referred to as the ‘Gynemesh’ group hereafter), an anterior, posterior or total Prolift®, (Ethicon, Inc., a kit utilizing Gynemesh® in a trocar-based delivery system, with 4 exits anteriorly and 2 exits posteriorly, providing apical support via bilateral sacrospinous ligament fixation (SSF) with the posterior and total systems, the ‘Prolift’ group), or an anterior and/or posterior Elevate® (American Medical Systems, Inc., a kit using IntePro® Lite™ mesh, a polypropylene mesh of 25 g/m2 density, in a trocar-less, no exit system, designed with self-fixating tips, allowing bilateral SSF with both the anterior as well as the posterior systems, the ‘Elevate’ group).

at our university-affiliated tertiary referral center between January 2002 and April 2012. All procedures were performed by or under the direct supervision of a single surgeon. Postoperative follow-up included scheduled visits at 1, 12, and 60 months. Success was evaluated subjectively based on patients’ answers to standardized questions regarding bowel, bladder and sexual function, and objectively using the pelvic organ prolapse quantification (POP-Q) scale (defined as a POPQ stage of ≤1 in the treated compartment(s) at final follow-up). Results: A total of 627 TVM procedures were performed during the study period: 76 with Gynemesh, 299 with Prolift, and 248 with Elevate. The average age of patients was 61.2 years (31–87). The Elevate group had fewer hysterectomized patients (32.4 % vs. 51.3 %, P<0.001), recurrent

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prolapses (25.9 % vs. 46.9 %, P<0.001), or POP-Q Stage≥3 at presentation (70.0 % vs. 84.5 %, P<0.001). Concurrent continence procedures were performed more commonly in the Elevate group (25.9 % vs. 12.6 %, p00.001). The Prolift group took longer (mean difference 15 min, P<0.001), and had greater number of intra-operative bleeding complications (defined as an estimated blood loss of ≥500 cc, a hemoglobin drop of ≥30 g/L, or the need for a blood transfusion, 15.3 % vs. 7.4 %, p00.009) compared to the other two groups. The only visceral injuries were cystotomies: 4 in the Prolift and 1 in the Elevate group. In the immediate post-operative period, UTIs and transient voiding dysfunction resulted in 5.1 % and 2.7 % of the patients respectively. The Prolift group suffered more febrile episodes (5.4 % vs. 1.2 %, p00.014), and exit-site cellulitis (3.0 % vs. 0 %, p00.008). The only mesh infection requiring surgical debridement and removal of the mesh implant, occurred in the Gynemesh group. Eight patients were lost to follow-up; the remaining had an average follow-up of 17.4 months. The objective anatomical cure rate per procedure was similar in the Prolift and Elevate groups (85.7 %), and significantly lower in the Gynemesh group (70.7 %, p00.002). Mesh complications, such as erosion, contraction causing stenosis, and prominence, were all lower in the Elevate group (1.6 % vs. 14.2 %, P<0.001, 0.6 % vs. 4.0 %, p00.036, and 1.6 % vs. 6.2 %, p00.008 respectively). De novo stress urinary incontinence, urge incontinence, and dyspareunia occurred in 13.1 %, 6.4 % and 12.1 % of the patients respectively. Conclusion: This study suggests that while the Elevate® and Prolift® TVM kits are associated with improved anatomical cure rates over the surgeon-fashioned Gynemesh® inlay, –

the trocar-based system, which requires greater dissection and has exit sites, is associated with greater operative morbidity, andcomplications such as mesh erosion and contraction appear to be related to the specific mesh used, indicating that differences in mesh properties, such as density, could account for differences in these complication rates.

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Objective: The aims were to: 1. Compare the retention rates to a randomised controlled trial (RCT) between 2 methods of recruitment (‘indirect’ and ‘direct’), 2. Compare the reasons for withdrawals by recruitment method, 3. Compare differences in trial outcomes by recruitment method sub-analysed by treatment group allocation. Background: Recruitment of eligible participants referred from gynaecology outpatient clinics (indirect methods) during a pelvic organ prolapse RCT was found to be slower than anticipated. Alternative ‘direct’ methods were tried to increase recruitment (1). These ‘direct’ methods, which included social media, resulted in accelerated recruitment and a reduction in recruitment costs. With completion of the trial, retention and outcomes between recruitment methods can be examined. Methods: This was an observational study, embedded in an existing RCT investigating the effect of pelvic floor muscle training (PFMT) for women with symptomatic Stage I, II or III pelvic organ prolapse (POP). Participants were randomly assigned to either a ‘PFMT plus lifestyle advice’ group, or ‘Lifestyle advice alone’ group. Primary outcomes of the trial were a Pelvic Organ Prolapse Symptom Score (POP-SS) (2), PFM strength and POP-Q stage. Data collection time points were baseline, 6 and 12 months. Retention to the trial was measured by collection of full data-sets by 12 months; withdrawals were considered as loss of data-sets before either 6 or 12 months. Retention data were analysed by a chi-squared test. Regression with an interaction between recruitment method and treatment group tested whether results differed by recruitment method. All models included baseline as a covariate. Results: 168 participants were recruited to the RCT (Table 1). Table 1. Trial entry by recruitment method.

P. Patel: Grant /Research Support; Stryker. A. Lam: Consultant; American Medical Systems. Grant /Research Support; American Medical Systems, Ethicon, Stryker, BBraun.

Participants

Total N0477 (100 %)

Indirect N0253 (100 %)

Direct N0224 (100 %)

151 DOES E-RECRUITMENT AFFECT RETENTION AND OUTCOMES IN A CLINICAL TRIAL? H. C. Frawley1, L. Y. Whitburn 1, P. Herbison 2, M. P. Galea 1 1 The Univ. of Melbourne, Parkville, Australia, 2Univ. of Otago, Dunedin, New Zealand.

Assessed for eligibility Excluded Pre-randomisation withdrawals Randomised Trial group allocation

477 297 (62 %) 10 (2 %)

253 149 (59 %) 10 (4 %)

224 150 (67 %) 0 (0 %)

168 (35 %) PFMT*: 84 Lifestyle: 84

94 (37 %) PFMT: 44 Lifestyle: 50

74 (33 %) PFMT: 40 Lifestyle: 34

Does e-recruitment affect retention and outcomes in a clinical trial?

*PFMT0Pelvic floor muscle training

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Retention and withdrawal rates are shown in Table 2. Participants recruited via indirect methods were less likely to provide full data-sets at 6 months (69 % of indirect vs 76 % of direct, p00.35) and at 12 months (49 % vs 68 % respec-

tively, p00.02). Twenty-one participants had withdrawn by 6 months (15 % indirect vs 9 % direct, p00.29). A further 20 participants withdrew between 6 and 12 months (18 % indirect, vs 9 % direct, p00.18).

Table 2. Retention and withdrawal of trial participants. Data retention

Full data-sets: -PFMT -Lifestyle Withdrawals: -PFMT -Lifestyle

6 month Assessments

12 month Assessments

Total N0168 (100 %)

Indirect N094 (100 %)

Direct N074 (100 %)

Total N0147 (100 %)

Indirect N080 (100 %)

Direct N067 (100 %)

121 (72 %) 63 (38 %) 58 (35 %) 21 (13 %) 12 (7 %) 9 (5 %)

65 (69 %) 32 33 14 (15 %) 7 7

56 (76 %) 31 25 7 (9 %) 5 2

97 (66 %) 50 (34 %) 47 (32 %) 20 (14 %) 4 (3 %) 16 (11 %)

46 (58 %) 24 23 14 (18 %) 3 11

50 (74 %) 26 24 6 (9 %) 1 5

The most frequently cited reason for complete withdrawal from the trial was decision to have POP surgery, which was more common in the indirect than the direct group at 6 months (50 % vs 29 % respectively, p00.057) and significantly so 12 months (64 % vs 17 %, p00.000). There were no differences in the key outcome measures of this trial according to method of recruitment sub-analysed by treatment group: POP-SS (p 00.74 at 6 months, p 00.41 at 12 months); POP-Q (p00.16, p00.60); PFM strength (p0 0.45, p00.59). Conclusions: Direct methods of recruitment resulted in significantly higher rates of retention to the trial than indirect methods. Significantly more participants in the indirect group withdrew from the trial to undergo POP surgery, which may be explained by their referral to gynaecology outpatients, usually with “a view to surgery”, and the short waiting lists for surgery in this country. Self-referred or directly-recruited participants were not seeking surgical treatment for their prolapse. As participants recruited via either method did not differ in any of the key trial outcome measures, there did not appear to be a predictive effect or bias from either method of recruitment. Researchers may consider the benefits of targeted, direct recruitment to RCTs, for efficiencies of time to achieve recruitment numbers, and importantly, retention to the trial. Participants who respond to social media methods of advertising may

have higher self-efficacy or motivation to remain adherent to a research protocol (3). Higher rates of retention to a trial are critical for the validity of the findings. References: 1. Neurourology and Urodynamics 2011, 30(6): 811–812. 2. BJOG: An International Journal of Obstetrics and Gynaecology 2009, 116(1): 25–31. 3. Journal of Women’s Health 2010, 19 (5): 855–862. H.C. Frawley: None. L.Y. Whitburn: None. P. Herbison: None. M.P. Galea: None. 152 ROBOTIC SACROCOLPOPEXY: A SINGLE CENTER EXPERIENCE ON OUR FIRST 65 CASES L. Dutto, S. Khalid, S. O’sullivan, W. E. Babiker, B. O’reilly Cork Uiversity Maternity Hosp., Cork, Ireland. Objective: To report outcomes of robotically assisted laparoscopic sacrocolpopexy (RASC) in a high volume center. Background: Laparoscopic sacorocolpopexy (LSC) has established itself in the last two decades and has shown to produce similar results to abdominal sacrocolpopexy (ASC). RASC seems promising, but literature on this topic is still scarce.

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Methods: We performed a retrospective analysis on 65 consecutive patients operated between August 2008 and January 2012. Two surgeons performed the procedures (fellow mentoring was included in the last 20 cases). Besides demographic information, we recorded intra-, peri- and postoperative variables like operative time, complications, and concomitant procedures. Objective success (defined as POP-Q stage≤1), subjective success (satisfaction with surgery), pre- and postoperative symptoms, postoperative pain (VAS scale 0–10: 00no pain, 100unbearable pain) and time to return to normal activities were assessed. Follow up visits were done at 6 weeks, 6 months, 1 year, then yearly. Results: Mean age was 61 years (39–80), mean parity 3,5 (0–8), mean BMI 25,2 (37,3–20). All patients had undergone previous hysterectomy, 49,2 % had previous POP repair and 32,3 % had previous laparotomic surgery. All patients had prolapse stage ≥2 (A≥2071 %, B ≥ 2046 %, C≥ 2 098 %). Operating time -excluding docking and undocking- was 130 (208–75) minutes, mean hospital stay was 1, 7 days (1–10) and mean pain on postoperative day 1 was 2,4 (0–7). We recorded 5 conversions, 3 to open surgery and 2 to vaginal repair. Additional procedures were performed in 30 % of cases and perioperative complications occurred in 11 patients (16,9 %). Five patients were lost to follow up. Objective success (defined as POP-Q ≤1) at 6 weeks was: 96,3 % at vault and 79,6 % at any point, while at mean follow (11,9 months, range 1,5–39) success at the vaginal vault was 89,8 % and 67,4 % for any POP-Q point. Reoperations for recurrence were necessary in 5/54 patients (9,25 %), while 1 patient had developed lumbar discitis, which required mesh removal. No mesh erosions were recorded. Satisfaction with surgery was 81,6 %, with 31 patients being very satisfied and 9 moderately satisfied. The incidence of any POP-related symptom decreased from 100 % preoperatively to 46,9 % at follow up. Conclusions: Our experience with RASC is the second largest series on this topic available in literature. RASC produces good objective and subjective results for POP repair, with reasonable complication and recurrence rates. L. Dutto: Grant /Research Support; recipient of intuitive surgical fellowship grant (period July ‘11-July ’12). S. Khalid: None. S. O’sullivan: None. W.E. Babiker: None. B. O’reilly: None.

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153 INCIDENCE OF DE NOVO STRESS URINARY INCONTINENCE (SUI) FOLLOWING APICAL PROLAPSE REPAIR AND ITS RELATION TO PATIENT SATISFACTION. A PROSPECTIVE OBSERVATIONAL STUDY. D. H. El-Hamamsy, A. M. FAYYAD Luton and Dunstable Hosp., Luton, United Kingdom. Objectives: To assess the incidence of de novo stress urinary incontinence (SUI) following apical prolapse repair and its effect on patient satisfaction. Background: The exact incidence of de novo stress urinary incontinence following apical prolapse repair is unknown, and hence the need for anti-continence procedure at the time of apical prolapse repair is controversial1,2 Methods: One hundred and twenty two women with symptomatic apical prolapse who underwent surgical correction between February 2010 and August 2011 were prospectively recruited to the study. Patients were followed up 3 and 6 months after surgery. Those who had symptomatic stress urinary incontinence and underwent a concomitant continence procedure at the time of prolapse repair were excluded. All subjects filled the King’s Health Questionnaire, Prolapse Quality of Life Questionnaire (P-QOL) and were examined using the pelvic organ prolapse quantification system (POP-Q) preoperatively and at follow up visits. All women filled the Patient Global Impression of Improvement Questionnaire (P-GII) at follow up. Statistical analysis was preformed using t test and Chi squared test as appropriate. Results: The mean age of patients was 64 years with mean body mass index of 27 kg/m2. Postoperatively, point C was at stage 0/1 in 89.9 % with 77.3 % reporting feeling either “much better” or “very much better”. Fifty-five women (46 %) reported postoperative SUI, with 29 women (24.4 %) describing it as moderate/severe (severe: 12.6 %) (figure 1). Six women (5 %) found their incontinence bothersome and underwent a subsequent incontinence procedure (5: retro pubic vaginal tape, 1: bulkamid injection). All incontinence procedures were performed within the first 6 months following apical prolapse repair. There were no differences in patient global impression of improvement between women who developed de novo stress urinary incontinence and those who did not (figure 2). Conclusions: The incidence of de novo SUI following apical prolapse repair was 46 %, with 24.4 % being moderate/severe. It did not affect the patient’s global impression of improvement. Subsequent continence procedure was performed in 5 % of patients. These findings can help counselling of women regarding the outcome of apical prolapse surgery.

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References: 1. N Engl J Med. 2006 Apr 13;354(15):1557–66. 2. J Urol. 2011 Jun;185(6):2236–40. Epub 2011 Apr 16. D.H. El-Hamamsy: None. A.M. Fayyad: None. 154 OBESE PATIENTS HAVE LESS FUNCTIONAL IMPROVEMENTS THAN NORMAL WEIGHT AFTER VAGINAL PROLAPSE SURGERY Y. Tan, T. Lo, A. Krishna Dass, S. Khanuengkitkong Chang Gung Mem. Hosp., Tao-Yuan, Taiwan. Objective: The aim is to study the relationship between body mass index and surgery for advanced pelvic organ prolapse. Background: Obesity is on the rise and not only predisposes women to pelvic organ prolapse but it may also affect the success of surgical treatment. Limited knowledge is available on the functional status post optimal surgical correction in these women. This may result in inadequate counseling and inappropriate planning for surgical treatment of advanced pelvic organ prolapse. Methods: A prospective prolapse surgery study on 217 patients with POP-Q stage III or IV pelvic organ prolapse was carried out. The common vaginal route sacrospinous ligament fixation was performed together with anterior mesh repair as the later may reduce risk of recurrent cystocoele. POP-Q Stage I or less was objective cure. Subjective cure was based on POPDI-6

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feedback. All patients in addition, prior to surgery and post prolapse surgery had completed questionnaires UDI-6, IIQ-7, POPDI-6 and PISQ-12. Outcome measures were observed according to three category of Asian body mass index, BMI (normal weight 18.5 to 23.0 kg/m2, overweight >23.0 to 27.5 kg/m2 and obese ≥27.5 kg/m2). Student paired t-test was used to examined the outcomes and a p value of <0.05 was considered significant. A post hoc sample size calculation of 62 subjects was needed to detect differences in failure rate of 10 %, with a confidence level of 95 %, and statistical power of 80 %. Results: Postoperative data were available for 208 patients with an overall mean follow-up of 38.29 ± 18.08 months. Objective cure of for the normal weight, overweight and obese were 93.3 %(56 out of 60), 92.0 % and 94.2 % respectively. Only 91.4 % obese patient achieved subjective cure compared to 93.8 % overweight and 95 % normal weight patients. All patients had significant improvements in anatomical outcomes after prolapse surgery (p < 0.05) and none had recurrence requiring further surgery. Within each category, significant improvements of UDI-6, IIQ-7, POPDI-6 and PISQ-12 after surgery were noted. However, the obese category has a significantly less improvement in POPDI-6 and PISQ-12 when compared to normal weight (p< 0.05). There were no differences in the duration of procedure, intra-operative blood loss and hospital stay for overweight or obese compared to

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normal weight. In total 8 patients had vaginal mesh exposure (3.8 %) and the overall infection rate was 0.4 % (1 out of 208). Conclusions: BMI has no effect on the anatomical outcomes of prolapse surgery. However, obese patients had less functional related improvements compared to normal weight patients after surgical correction of advanced pelvic organ prolapse. This is an important aspect to consider when counseling patients for prolapse surgery based upon BMI. Y. Tan: None. T. Lo: None. A. Krishna dass: None. S. Khanuengkitkong: None. 155 MESH CONTRACTION AS A PREDICTOR OF POSTOPERATIVE PAIN AND OVERACTIVE BLADDER SYMPTOMS AFTER PELVIC ORGAN PROLAPSE SURGERY A. Rogowski 1, A. Tosiak 1, E. Chudy 1, P. Bienkowski 2, W. Baranowski1 1 Military Inst. of Med.; Dept. of Gynecology and Oncological Gynecology, Warsaw, Poland, 2Inst. of Psychiatry and Neurology; Dept. of Pharmacology, Warsaw, Poland. Objective: The aim of this retrospective analysis was to evaluate a relationship between ultrasound-assessed mesh contraction after Prolift anterior implantation and complications related to the insertion of mesh, including de novo stress urinary incontinence (SUI), de novo overactive bladder symptoms (OAB) and postoperative vaginal pain. Background: The use of alloplastic materials for transvaginal repair of pelvic organ prolapse (POP) has become widespread. Although the use of Prolift mesh in POP surgery seems to be effective, it has been reported that implantation of polypropylene mesh may be associated with various complications, including: vaginal pain, extrusion, infections, OAB, and SUI. Recently it has been hypothesized that mesh-associated complications may be related to the degree of mesh contraction. Methods: The study group included 49 women (mean age: 64.5±9.7 year, Body Mass Index: 27.5±4.4) with cystocoele, stages III and IV based on the Pelvic Organ Prolapse Quantification (POPQ) system who underwent the standardized transvaginal mesh placement (Gynaecare Prolift Pelvic Floor Repair System, Ethicon, NJ, USA). None of the patients suffered from preoperative SUI or OAB. A vaginal ultrasound examination was performed 6 to 8 months after pelvic floor surgery to measure the length of Prolift mesh in the midsagittal

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plane. All the women were also examined for de novo SUI and OAB symptoms with the aid of the cough stress test and a 3-day bladder diary, respectively. Anatomic outcomes were quantified using the POPQ staging system. Postoperative pain was assessed with a grading system for the assessment of mesh-related pain in females undergoing pelvic floor surgery based on the recently introduced IUGA/ICS guidelines. Results: 47 patients (95.9 %) had objective improvement at stage I or less at 6–8 months’ follow-up. The mean length of mesh at follow up was 45.4 mm (range: 27–76 mm). An inter-rater reliability for the ultrasound measurement of the mesh length was very high (R00.96, P<0.001). At the follow-up, any vaginal pain was found in 14 (28.5 %) patients, de novo OAB symptoms in 11 (22.4 %) patients, and de novo SUI in 13 (26.5 %) patients. Five women with de novo SUI required subsequent TVT procedure. A significant correlation was observed between mesh contraction and the severity of vaginal pain (R 00.51, P <0.01). Similarly, a significant correlation was found between mesh contraction and the number of strong urge episodes per day (R 00.70, P <0.05). A trend towards a larger mesh contraction in the subgroup of patients with de novo SUI symptoms was also noted (P 00.08). In contrast, no correlation was found between mesh contraction and preoperative or postoperative POPQ staging, age, BMI, and the history of gynecological surgery (P values>0.1). Conclusions: 1. A significant mesh contraction is observed at 6– 8 months after POP surgery. 2. The degree of mesh contraction may be associated with: i) postoperative pain, ii) the severity of OAB symptoms after POP surgery. 3. Further studies are needed to evaluate possible associations between mesh contraction and urinary symptoms after POP surgery. References: 1. Haylen BT. et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint terminology and classification of the complications related directly to the insertion of prostheses (meshes, implants, tapes) & grafts in female pelvic floor surgery. Int Urogynecol J. 2011;22(1):3–15. 2. Skala C. et al. The IUGA/ICS classification of complications of prosthesis and graft insertion. A comparative experience in incontinence and prolapse surgery. Int Urogynecol J (2011) 22:1429–1435.

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3. Svabik K. et al. Ultrasound appearances after mesh implantation—evidence of mesh contraction or folding? Int Urogynecol J (2011) 22:529–533. A. Rogowski: None. A. Tosiak: None. E. Chudy: None. P. Bienkowski: None. W. Baranowski: None. 156 DOES THE GRADE OF VAGINAL WALL PROLAPSE CORRELATE WITH THE PELVIC ORGAN PROLAPSE DISTRESS INVENTORY (POPDI) SCORES? R. El Haddad, K. Svabik, J. Masata, P. Hubka, A. Martan; 1st Faculty of Med., Charles Univ. and Gen. Univ. Hosp., Prague, Czech Republic. Objective: The purpose of this study was to determine the correlation between the most prolapsed portions of the anterior (Ba), apical (C) and posterior vaginal wall (Bp) according to pelvic organ prolapse quantification (POP-Q) system with the pelvic distress symptoms assessed by the condition-specific pelvic organ prolapse distress inventory (POPDI) questionnaire [1]. Background: Women with symptomatic pelvic organ prolapse (POP) present a high diversity of distress symptoms of prolapse or/and urinary or/and bowel dysfunction. The POPDI questionnaire (16 items) was introduced in 2001 with a significant correlation with the stage of prolapse, but in other study women with stage II prolapse and prior pelvic surgery reported more symptoms than those with more advanced prolapse [2]. Methods: We analyze the preoperative data of women participating in a prospective randomized interventional trial of two standard surgical procedures for post-hysterectomy vaginal vault prolapse. All eligible patients attended our unit from 5/2008 to 12/2010. They were with symptomatic stage II or greater prolapse of at least two compartments and were diagnosed by 4D ultrasound with avulsion injury. The POPQ classification for prolapse was used and the diagnosis of avulsion injury was performed by 4D ultrasound tomographic imaging. All patients completed the 16 items of the conditionspecific quality of life POPDI questionnaire. Data was computed and the association between POPDI and the most prolapsed points of prolapse was provided. The correlation between Ba, C and Bp with the POPDI scores was analyzed with Spearman’s correlation coefficient. P values <0.05 were considered statistically significant. Results: 70 consecutive women were included in the analysis. Their demographic data, surgical history, clinical measurements and mean POPDI score are shown in table 1.

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Table 1. characteristics of women included in this study (n070) Age (years) Height (cm) Weight (kg) BMI (kg/m²) Parity

62.80 (43–85) 163.62 (150–177) 74.58 (56–95) 27.88 (21.45–39.55) 2.16 (1–5)

Caucasian Hysterectomy Avulsion injury Ba (cm) C (cm) Bp (cm) POPDI score

70 70 70 4.03 (−1-+9) 1.98 (−4-+9) 2.77 (−2-+9) 65.25 (3,57–200)

The relationship between POPDI scores and the most prolapsed POP-Q points is shown in table 2. Table 2. Spearman’s correlation between POPDI and Ba, C and Bp. Variables POPDI and Ba POPDI and C POPDI and Bp

N 70 70 70

Spearman’s rho 0.039700 −0.072335 −0.157989

p 0.759330 0.576361 0.220044

Conclusions: In a cohort of women with symptomatic POP after hysterectomy, the POPDI scores do not correlate with the most prolapsed portions of the anterior (Ba), apical (C) and posterior vaginal wall (Bp). This finding raises question about appropriate assessment criteria of postoperative follow-up. Most of the inclusion criteria for prolapse surgery are anatomical staging and not subjective criteria according to condition specific questionnaires scoring. Postoperatively we would expect similar symptoms variability that may not correlate with objective POP-Q measurements. References: 1. Am J Obstet Gynecol 2001 Dec;185(6):1388–95 2. Int J Gynaecol Obstet.2007 Jul;98(1):24–8 R. El Haddad: Grant /Research Support; This work was supported by the Grant Agency of the Ministry of Health of the Czech Republic, grant NT12147-4. K. Svabik: None. J. Masata: None. P. Hubka: None. A. Martan: Consultant; for Ethicon Women’s Health and Urology, Astellas and Bard.

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157 TRENDS IN SURGICAL MANAGEMENT OF UTEROVAGINAL PROLAPSE AND UTERINE DESCENT IN THE NETHERLANDS 1997–2009 R. J. Detollenaere1, J. Den Boon 1, K. B. Kluivers 2, M. E. Vierhout 2, H. W. Van Eijndhoven 1 1 Isala klinieken, Zwolle, Netherlands, 2Radboud Univ. Nijmegen Med. Ctr., Nijmegen, Netherlands. Objective: To analyze trends in surgical treatment of pelvic organ prolapse (POP) and to evaluate whether there were changes with regard to uterus preserving techniques in the Netherlands during the last decade. Background: Hysterectomy may cause nerve supply damage and disrupt supportive structures of the pelvic floor therefore introducing a risk of incontinence1. Uterus preserving techniques have furthermore been associated with less morbidity, shorter hospital stay and earlier resumption of activities2. These new insights may have resulted in a changed policy with regard to uterus preserving techniques in case of surgical management of uterine descent. Methods: Using a nationwide registry from the Netherlands (LMR), we assessed the number of hospital admissions and the number and type of surgical procedures performed for POP between 1997 and 2009. Between 1986 and 2005, all Dutch hospitals participated in the LMR. After 2005 a representativity formula was used to correct for missing data of hospitals that have stopped registration because of the introduction of a new financial

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declaration system. For this analysis, the total number of POP procedures was identified using all registries linked to the primary diagnosis genital prolapse ICD-9-CM code 618 (International Classification of Diseases, 9th Revision, Clinical Modification) . POP procedures for uterine descent (ICD-9-CM 618.1 to 618.4) were identified as subgroup. POP procedures in the registry were grouped into seven categories (table 1). The registry did not allow to differentiate between specific techniques in the group ‘other POP procedures without hysterectomy’. Results: Table 1 shows that the total number of hospital admissions due to uterovaginal prolapse increased from 7.784 to 12.910 (+65%) and the number of hospital admissions due to uterine descent increased from 4.121 to 5.373 (+30%). Figure 1 shows that the number of POP procedures because of uterovaginal prolapse increased from 8.151 in 1997 to 17.376 in 2009 (+113%). In 1997, vaginal hysterectomy for uterine descent was responsible for 73% (n03164) of the surgical procedures performed. In 2009 this percentage had dropped to 43% (n03649). Conclusions: This study demonstrated that there was a major increase in hospital admissions due to uterovaginal prolapse and POP procedures between 1997 and 2009 in the Netherlands. The number of vaginal hysterectomies performed due to uterine descent did not follow this change, which reflects a trend to preserve the uterus. References: 1. Lancet. 2007;370:1494-9 2. Nat Rev Urol. 2010;7:626-33

Table 1. Hospital admissions and POP procedures performed in the Netherlands because of uterovaginal prolapse (A) and uterine descent (B) in 1997 and 2009 A. Uterovaginal prolapse

B. Uterine descent

Hospital admissions POP procedures

1997 7.794 n (% of total)

2009 12.910 n (% of total)

1997 4.121 n (% of total)

2009 5.373 n (% of total)

Vaginal hysterectomy with/without anterior and/or posterior repair Abdominal hysterectomy with/without anterior and/or posterior repair Anterior and/or posterior repair without hysterectomy Cervical amputation with/without concomitant repair Other pelvic organ prolapse procedures without hysterectomy Rectopexy

3.799 (46,6) 346 (4,2) 2.543 (31,2) 301 (3,7) 1.050 (12,9) 62 (0,8)

4.438 (25,5) 165 (0,9) 7.417 (42,7) 834 (4,8) 4.206 (24,2) 161 (0,9)

3.164 (72,5) 250 (5,7) 422 (9,7) 127 (2,9) 379 (8,7) 6 (0,1)

3.649 (43,1) 115 (1,4) 2.022 (23,9) 557 (6,6) 2.023 (23,9) 25 (0,3)

Repair vulva and/or perineum Total POP procedures

50 (0,6) 8.151

155 (0,9) 17.376

18 (0,4) 4.366

72 (0,9) 8.462

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Figure 1. Registered POP procedures performed because of uterovaginal prolapse from 1997 to 2009 in the Netherlands

R.J. Detollenaere: None. J. den Boon: None. K.B. Kluivers: None. M.E. Vierhout: None. H.W. van Eijndhoven: None. 2012-A-136-IUGA 158 A COST-UTILITY ANALYSIS OF STRATEGIES FOR MANAGING STRESS CONTINENT WOMEN WHO WILL UNDERGO SURGERY FOR REPAIR OF PELVIC ORGAN PROLAPSE. A. M. Johnson, A. Hadpawat, P. Dramitinos, F. Strube, A. Leegant, K. Downing Albert Einstein Coll. of Med. Montefiore Med. Ctr., Bronx, NY. Objectives: Stress continent women who undergo pelvic organ prolapse (POP) repair surgery are at risk for developing post-operative stress urinary incontinence (SUI). Our goal is to determine the cost-utility of three commonly used strategies for managing these patients.

Methods: A decision analysis model was constructed from a societal perspective over a 1 year period. Our analysis was based on a three arm decision tree: Arm 1) No mid-urethral sling (MUS) placement; Arm 2) MUS placement in patients with occult SUI detected on urodynamic (URD) screening with prolapse reduced; Arm 3) MUS placement in all patients. Costs were estimated based on Medicare reimbursement data and current literature. Utility estimations were based on published information regarding the following health states: stress continent versus stress incontinent, and surgery with major, minor or no complications. We then determined incidence rates of SUI after POP repair surgery, complications from MUS placement, and the sensitivity of URD screening for occult SUI by review of the current literature. Sensitivity analyses were performed for the multiple variables included in our model. Our main outcome measures were costs estimated in 2008 US dollars and quality adjusted life years. Results: Based on our model, Arm 1 (no MUS placement) was the least costly ($2282 per case), most effective strategy (0.86). Arm 2 (MUS placement based on URD screening for

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occult SUI) was more costly ($5623 per case) and decreased the quality of life compared to Arm 1 (0.83). Arm 3 (MUS placement in all patients) was the most costly treatment strategy ($6692 per case) and was associated with the lowest overall quality of life (0.81). Sensitivity analyses did not alter the global cost-effectiveness of each strategy. Conclusions: No MUS placement is the dominant strategy for managing stress continent women who will undergo POP repair surgery. Placing a MUS based on URD screening for occult SUI was more cost-effective than placing a MUS in all patients. The placement of a MUS in all patients is the most costly, least effective strategy due to complications that result in re-operations and/or additional follow up office visits. For prophylactic MUS placement to be more cost-effective improved screening for patients at risk for post-operative SUI and decreased surgical complications are necessary. A.M. Johnson: None. A. Hadpawat: None. P. Dramitinos: None. F. Strube: None. A. Leegant: None. K. Downing: None. 159 EFFICACY OF OPHIRA MINI SLING SYSTEM FOR STRESS URINARY INCONTINENCE: MIDTERM FOLLOW UP OF 124 PATIENTS IN A MULTICENTRE INTERNATIONAL CLINICAL TRIAL P. Palma 1, C. Riccetto 1, E. Bronzatto 1, V. herrmann 1, F. Dalphorno 1, R. Castro 2, S. Altun 3 1State Univ. of Campinas, São Paulo/Campinas, Brazil, 2Federal Univ. of Sao Paulo, São Paulo/Campinas, Brazil, 3Austral Univ., Buenos Aires, Argentina. Objective: The aim of this presentation is to report up to two years follow up results of the use of Ophira Mini Sling System in an open international multicentre prospective trial. Background: Sling procedures have been around for decades in the management of female stress urinary incontinence (SUI), but only in the past decade have they become the preferred technique. The Ophira Mini Sling System is an anatomical approach that involves placing a midurethral low-tension tape anchored to the obturator internus muscles bilaterally at the level of the tendinous arc. A minisling (Ophira Mini Sling System - Promedon), made of polypropylene monofilament mesh, held between two self-anchoring polypropylene columns in a fishbone design connected to two delivering needles was used. Methods: From February 2008 to February 2011, 124 female patients, mean age054.7 years old (SD±9.9) with SUI, underwent treatment with Ophira Mini Sling System. 95/ 124 patients were followed for 24 months and 29/124 for at least 12 months.

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The work-up included history, physical examination, stress test, standardized 1-h pad test, and preoperative urodynamic study. Also, patients were evaluated with two validated questionnaires: International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) and Urogenital Distress Inventory (UDI-6). The procedure was carried under local anesthesia in 87 (73.1 %) patients, using 20 ml of 2 % lydocaine solution, injected at the midurethra towards the vaginal fornix, advancing 2 cm in the obturator internus muscles. Eventually, general in 21 (17.6 %) or regional anesthesia 11 (9.2 %) patients was used, according to the anesthesiologist decision. During the follow-up, patients were reviewed at 12 and 24 months as to urinary incontinence, lower urinary tract symptoms, and dyspareunia. The objective evaluation included 1 h pad test and stress test. For comparative purposes it was considered pad test: cure (<1 g), improvement (loss of 50 % of preoperative). This study was approved by the ethical committee, and all patients signed a written consent. Results: Until February 2011, 124 patients complete at least 12 months follow-up and 95 of those patients have more than 24 months of follow-up. Demographic data are: previous gestation 2.99 (SD±2.0); post menopause 64.5 %; previous anti-incontinence surgery 27.4 %; Body Mass Index 27.9 (SD±4.4); stress test was positive in 100 % of the cases, VLPP preoperative 79.2 cmH2O (SD±26.6). The mean pad test ranged from 12.5 g (SD±16.4) to 2.2 (SD± 9) preoperatively and after 24 months of follow up respectively (p<0.0005). The scores of the ICIQ-UI SF ranged from 15.8 (SD±3.8) to 1.9 (SD±4.3) (p<0.0005) and UDI-6 ranged from 9.2 (SD±3.1) to 1.7 (SD±2.2) (p<0.0005). The mean operative time was 17.0 (SD±7.1) minutes (in to out surgical room). Complications such as infection, severe bleeding or sexual dysfunction were not observed. Three patients presented lydocaine overdose symptoms which were treated conservatively. Mesh exposure was observed in 4 patients (3.2 %). All of them were less than 0.5 cm and they were treated by ambulatory resection of exposed area, of which two patients had been treated with local estrogen. Four patients have urinary retention, solved spontaneous (2 patients), treated with mesh excision (1 patient) and solved within the first week by sling loosening (1 patient). Nine patients (7.3 %) have de novo urge incontinence, all treated with anti-cholinergic. Using the pad test to objectively evaluate the patients after 24 months 81 (85.3 %) patients were dry, 6 (6.3 %) improved, and 8 (8.4 %) was incontinent. The results let us to assume that the multipoint fixation arms provided primary and stable fixation of the sling over the

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time. Otherwise, the most severe adverse events related to the transobturator route, such as infection and post-operative persistent pain were not observed. This can lead us to suppose possible advantages in the clinical setting. Future randomized studies would verify this hypothesis. Conclusion: Ophira Mini Sling System is an effective option for the treatment of SUI, offering reliable fixation and stability of the device and represents a real advance towards an in office procedure. P. Palma: Grant /Research Support; Promedon. C. Riccetto: None. E. Bronzatto: None. V. Herrmann: None. F. Dalphorno: None. R. Castro: None. S. Altun: None. 160 RANDOMIZED CONTROLLED TRIAL: EXTRACORPOREAL MAGNETIC INNERVATION VERSUS PELVIC FLOOR MUSCLE TRAINING IN WOMEN WITH STRESS URINARY INCONTINENCE W. Hayes, J. O’toole, A. Thakkar, E. Karantanis, K. H. Moore; St George Hosp., Sydney, Australia. Objective: We aimed to compare extracorporeal magnetic innervation (ExMI™) using the Neocontrol™ chair treatments to standard pelvic floor muscle training (PFMT) supervised by an experienced pelvic floor physiotherapist for women experiencing stress urinary incontinence (SUI). Background: ExMI comprises a chair whose seat contains a magnetic field generator. Patients sit fully clothed and the rapidly changing magnetic field flux stimulates pelvic floor contraction. Sessions of 20 min, 2–3 times per week for 6 weeks are promoted for women with stress urinary incontinence (SUI). Apart from one published sham-controlled trial1 showing improvement, ExMI has never been prospectively compared to other conservative treatments for SUI, but is potentially costly. Methods: Women with predominant SUI symptoms and no prior continence surgery were recruited. Consenting women were randomized to PFMT or ExMI. The PFMT group attended 5 individual sessions and the ExMI group attended 20 sessions over 12 weeks. The ExMI group also received a pamphlet encouraging pelvic floor exercises. Primary outcome measures were subjective (ICIQ-SF) and objective (24-hour pad test). Cure was defined as an ICIQ-SF score of zero post treatment. For an estimated difference in cure rates between 70 % for PFMT and 38 % for ExMI, a sample size of 19 in each arm was generated (for 80 % power and 5 % alpha error). Secondary outcome measures were pelvic floor muscle (PFM) strength (Modified Oxford score by a single blinded urogynaecologist), the request for further treatment, and the average total cost of each treatment arm.

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Results: Sixty-five women were recruited: 33 in the PFMT group and 32 in the ExMI group, with similar baseline characteristics (Table 1). Table 1. Baseline characteristics (Median and Range)

Age (yrs) BMI 24-h Pad test(g) ICIQ-SF PFM strength

PFMT (n033) 52 (36–75) 28 (18–42) 5 (1–234) 11 (5–18) 3 (1–5)

ExMI (n032) 48 (30–79) 24.5 (23.6–27.2) 3 (0–54) 10 (4–19) 3 (0–5)

(P) 0.174 0.314 0.069 0.233 0.907

Six women (18 %) withdrew from the PFMT group and five (15 %) withdrew from the ExMI group. Two of five withdrawals in the ExMI group were due to pain during treatment. At 3 months, the outcomes for those who completed their treatment were analysed. There were 27 patients in ExMI arm and 23 in PFMT. Table 2. Three-month treatment outcomes

24-h Pad Test (g) ICIQ-SF PFM strength

PFMT (n023) 5 (1–150) 8 (0–16) 3 (2–4)

ExMI (n027) 3 (0–17) 7 (3–15) 4 (1–5)

P 0.111 0.240 0.595

Wanted further treatment Subjective Cure (ICIQ00) Objective Cure (Pad0<2 g)

31.6 % 6% 9%

60 % 0% 24 %

0.058 0.49 0.2

At 3-months follow-up fewer women in the PFMT group wanted further treatment. Patient discussion indicated that women who underwent PFMT were not willing to commit themselves to a further 3 months of ExMI treatment sessions three times per week as they felt equipped to continue with self treatment at home. In contrast ExMI patients felt their condition would decline once treatment was completed and were more likely to opt for supervision with PFMT sessions with a physiotherapist. Six- month data collection is ongoing and will be presented once complete. Assessment of the cost of each treatment approach was based on the Australian Medicare rebate, demonstrating significant cost differences (Table 3). Table 3. Total Cost estimation between PFMT and ExMI. Number treatments Medicare rebate per treatment Total cost PFMT 5 $50.05 $250.25 ExMI 20 $35.90 $718.00

Conclusions: At 3-months post-treatment, there appears to be no significant difference in cure between PFMT and ExMI for women with SUI. However the achieved power

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is low. Fewer women opted for further treatment after undertaking PFMT. Furthermore, PFMT is less costly to women. Six-month data is pending and will assist our understanding of the medium-term benefit of these treatments. Our results differ from the cure rates of most studies of PFMT or ExMI for women with SUI. The difference may be because treatment outcomes of this study have been measured using 24-hour pad tests and the ICIQ-SF questionnaire, rather than stress tests2 used in many other studies which may not be as sensitive. The outcome measures used in this study have also given conservative results for the TVT (38 % ICIQ00) 3. Thus our outcome measures, though validated, may not accurately reflect women’s satisfaction with their improvement following conservative treatment. The request for further treatment may be a better indicator. References: 1. BJU Int. 2009 May;103(10):1386–90 2. Neurourol Urodyn. 2011 Mar;30(3):317–24. 3. ICS Florence 2003. Abstract 85. W. Hayes: None. J. O’Toole: None. A. Thakkar: None. E. Karantanis: None. K.H. Moore: None. 161 EFFECTIVENESS OF A MODIFIED TECHNIQUE FOR THE POSITIONING OF THE TVT-O DEVICE G. A. Tommaselli1, A. D’afiero 2, C. Formisano 1, A. Fabozzi 1, C. Di Carlo 1, C. Nappi 1 1 Univ. of Naples Federico II, Naples, Italy, 2Hosp. S. Maria della Pietà, Casoria, Italy. Objective: To evaluate the impact of a more limited dissection and a more medial trocar trajectory in TVT-O positioning in comparison with the traditional technique on cure rates. Background: TVT-O approach has proven to be as efficient as the retropubic technique and relatively safer (in particular for bladder perforations) (1). One of the most frequent postoperative complication caused by the trans-obturator passage of the sling, is groin and hip pain, that is in most cases transient and self-limiting but can become chronic, with a significant impact on the quality of life (2). For this reason modifications to its positioning technique as well as modification to the tape itself were introduced that seem to limit post-operative pain (3). No definitive data exist on the impact that these modifications have on the efficacy of the TVT-O procedure. Methods: Ninety-seven patients with stress urinary incontinence (SUI) were randomized to undergo TVT-O either with the traditional technique (group A) or a modified procedure (reduced paraurethral dissection and a more medial trocar trajectory) (group B). Inclusion criteria were: SUI as diagnosed by clinical evaluation and urodynamics; age > 30 years; previously failed pelvic floor muscle training. Exclusion criteria were: previous surgery for SUI; isolated

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overactive bladder symptoms; pelvic organ prolapse ≥ stage 2 according to PoP-Q scoring system; neurological diseases; serious contraindications to surgical procedures. All patients underwent a preoperative clinical examination with POP-Q scoring, Q-tip test, challenge stress test (CST) with 250 cc. bladder filling and post-voidal residue (PVR) evaluation and completed I-QoL, PISQ-12, and PGI-S questionnaires. Urodynamic tests, including cystometry and Valsalva leak point pressure evaluation were also performed. Duration of the procedure and intra-operative complications were recorded. Post-operative pain was assessed using a VAS scale from 0 (absence of pain) to 10 (maximum pain possible) 12 and 24 h after the procedure. Analgesics were administered on demand and the total number of vials was recorded. Subjects were controlled 1, 6 and 12 months after the procedure. Definition of cure was the absence of urinary leakage during the filling phase of cistometry with a bladder filling of 250 cc and at CST. Student’s t tests were used to compare I-QoL and PISQ-12 scores between the two groups and within groups. Differences in pain VAS score, number of analgesic vials administered, PGI-S and PGI-I values were evaluated with the Mann-Whitney test, while differences between baseline and post-operative values were evaluated with the Wilcoxon test. Objective cure rates were investigated with the Fisher’s exact test. Results: Objective cure rates 12 months after the procedure were 92.3 % in group A (48 patients cured) and 88.8 % in group B (40 patients cured) (p0NS). No patient in either group showed PVR>100 cc. at follow-up visits. No intra-operative complications were reported. Two patients experienced mild post-operative urinary retention (PVR≈150 cc.) that spontaneously resolved in 48 h. No other complication was observed intra-operatively and at the follow-up visits. No differences between the groups were observed at the first pain evaluation 12 h from the procedure and at 1 month follow-up, while pain VAS score was significantly lower in group B in comparison with group A 24 h after surgery (p00.01). Pain significantly declined from 12 h to 24 h post-operatively in both groups (p <0.01). On months after the procedure, pain VAS score was significantly lower in comparison with both post-operative values (12 and 24 h) in both groups (p<0.001). No significant differences were observed in the number of analgesic vials administered in the post-operative period between the two groups. No difference was observed in all questionnaires between the two groups at baseline. PGI-S and I-QoL scores were significantly improved 12 months after surgery in both groups (p<0.001). PGI-I score was similar in the two groups at the 6 months follow-up. PISQ-12 score showed no significant changes in both groups. Conclusions: A limited dissection and a more medial trocar trajectory seem to reduce post-operative groin pain, apparently with no detrimental effects on cure rates 12 months after the procedure.

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References: 1. Eur Urol 2010; 58: 218–38. 2. Int Urogynecol J Pelvic Floor Dysfunct 2009; 20: 337–48. 3. Int Urogynecol J Pelvic Floor Dysfunct 2011; 22: 145–56. G.A. Tommaselli: None. A. D’Afiero: Consultant; Ethicon Women’s Health and Urology. C. Formisano: None. A. Fabozzi: None. C. Di Carlo: None. C. Nappi: None. 162 SYSTEMATIC REVIEW: ADJUSTABLE SLINGS S. H. Almeida, F. Czap, F. S. Pesente Univ.e Estadual de Londrina, Londrina, Brazil. Objective: The aim is identify and evaluate the evidence in the literature on adjustable slings. Background: The sling surgery is considered the “gold standard” for treatment of female stress urinary incontinence, but there is a percentage of patients who present postoperative voiding dysfunction. Thus, the idea of a sling that can be adjusted, it is very interesting. Methods: A systematic review of the literature according to the the Cochrane Library. There was no limit as to language research and the search was conducted from 2001 to March 2011. Was used to search databases: Medline, Embase and Lilacs. The terms used in the search were: failure sling, sadjustable or readjustable sling, readjustment. After the identification of specific articles, we obtained the articles that was grouped according to relevance and discarded by three examiners. Results: We identified 80 articles, written in English, Spanish, Portuguese, French and Italian. Review articles case reports were discarded. Three systems of synthetic slings were identified: REMEEX system, TOA (adjustable transobturator tape) and Safyre. The three systems showed cure rates (80–86 %) and similar complications (in percentages similar to those slings not adjustable). Only one study compared a adjustable technique with another not adjustable (1). Sixty-three patients underwent TOA and 40 others were treated with Transobturator sling. In the third month follow-up, 90 % of patients with TOA and 85.7 % of TOT were continents. Four patients required a relaxation of the mesh or increase the tension in the first postoperative day. There was no difficulty in adjusting. As for Safyre and REMEEX, there are only multicenter studies with 126 and 30 patients, followed for 36 and 60 months respectively (2,3). Conclusions: The REMEEX and TOA propose adjustments in the first postoperative day after stress test, while for Safyre there wasn’t a standardization of the adjustment. Also, the techniques cannot be compared, by different patient selection, time adjustment, follow up, definition of objective and subjective success. There are a low level of evidence on the effectiveness in the medium and long term follow up.

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References (optional): 1- Korean J Urol 2010;51:544–549 2- BJU Int. 2005 Feb;95(3):341–5 3- BJU Int 2011, 108: 1140–1144 S.H. Almeida: None. F. Czap: None. F.S. Pesente: None. 163 LONG TERM FOLLOW UP OF THE OUTCOME OF THE MONARC MIDURETHRAL SLING FOR URODYNAMIC STRESS URINARY INCONTINENCE C. R. Dowling1, J. K. Lee 2, E. Fitzgerald 2, A. Polyakov 2, A. Rosamilia 2 1 Dept. of Surgery, Monash Univ., Melbourne, Australia, 2 Dept. of Obstetrics and Gynaecology, Monash Univ., Melbourne, Australia. Objective: In 2003 a prospective register of cases for an outside-in TOT approach (Monarc™, AMS) was commenced. Between May 2003 and September 2005, 241 women who underwent the procedure were entered. Five year follow up data was collected to assess the durability of the TOT based system, using a subjective analysis based on validated patient questionnaires and patient satisfaction scores. Background: Transobturator midurethral slings for stress urinary incontinence (SUI) were described in 2001 (Prog Urol 2001;11:1306–1313) with an aim to improve the safety of the approach compared with the retropubic sling, however there is less established long term data on the durability of this method compared with the retropubic sling. Methods: All women completed an initial assessment including POPQ examination, voiding diary, urodynamic assessment, pad weigh test and validated questionnaires including the Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire (IIQ7). The examination, pad weigh test, UDI-6 and IIQ7 were repeated at 6 months and the questionnaires at 12 months and thereafter annually. The overall subjective satisfaction score (VAS) was obtained at 6 weeks, 6 months, 12 months and annually. These results have been previously reported. At the 5 year follow up patients were recontacted and asked to complete the UDI-6, IIQ7 and 3 indices of patient satisfaction, including the Patient Global Impression of Improvement (PGI-I) and the VAS. Patients with a urodynamic diagnosis of intrinsic sphincter deficiency (ISD) were excluded on the basis of reported lower success in the ISD group with the transobturator tape. Statistical analysis was performed. Results: Demographic data and LUTS at baseline as measured by the UDI-6 and IIQ7 for the entire cohort, and for those who completed 5 years follow up was balanced. There were no major complications of the surgery. Overall, a reoperation rate of 6/241 or 2 % was found. All reoperations had occurred by the 2 year follow up. Surgery for complications consisted of excision of 3 vaginal mesh exposures, 2

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sling divisions and 1 early sling loosening from 241 surgeries. Patient reported outcomes (Table 1a) demonstrated a reduction in SUI to 5 years. Between 6 months and 5 years there was a significant difference found in scores suggesting some deterioration in both SUI and urge urinary incontinence (UUI). The IIQ7 did not change during this period. De novo urge as defined as an increase in UDI-6 Qu2 increased over time (Table 1b). Graph 1 demonstrates success, defined as VAS≥70, over time in total, by surgeon experience, by presence of concomitant procedure and pre operative urgency. Success reduced irrespective of these parameters (p>0.0001). 5 year patient global impression of improvement remained high at 93 % (PGII>4). The reduction in overall VAS may reflect an increase in denovo UUI. Conclusions: At 5 years, there was a sustained reduction in subjective SUI , with an equivalent sustained improvement in incontinence impact. Despite a reduction in UUI to 9 % that persisted at this low rate, there was an increase in denovo UUI at 5 years leading to a reduction in overall VAS score. While there are issues with loss to follow up, a similar subjective cure rate in those who are lost has been demonstrated (Obstet Gynaecol. 2010; 50(2):173–8). In a “last record carried forward model” a higher success rate of 77 % would be expected. Table 1a Table 1b Graph 1: %VAS score over time in total and relative to experience, concomitant procedure and pre-operative urgency C.R. Dowling: None. J.K. Lee: Consultant; Boston Scientific, AMS. E. Fitzgerald: None. A. Polyakov: None. A. Rosamilia: Consultant; Boston Scientific, AMS. 164 RANDOMISED TRIAL OF TVT-O AND TVT-S FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. A. H. Bianchi, Z. I. Jarmy-Di-Bella, R. A. Castro, M. G. Sartori, M. J. Girão UNIFESP (Federal Univ. of São Paulo—Brazil), São Paulo, Brazil. Objective: The objective of this study is to compare the efficacy and complications of TVT-O and TVT-S midurethral tapes as surgical treatment for stress urimary incontinence. Background: Single incision slings were developed to reduce complications of retropubic and transobturator approaches, nevertheless there are still few studies about efficacy and complications of these thecnics. Methods: This is an ongoing prospective randomized study. Women with urinary stress incontinence, without detrusor overactivity and no concomitant prolapse stage ≥2 (POP-Q) were elligible. All patients underwent pre-operatory clinical evaluation with pad-test and urodynamic test. Quality of life was also evaluated

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through the King’s Health Questionnarie (KHQ). After signing an informed consent patients were randomized to have either TVT-O™ (56) or TVT-Secur™ (66) procedure. The procedures were performed either under local anaesthesia and sedation or raquianesthesia according to published techniques. Clinical evaluation, pad-test and the KHQ were again performed 30, 90, 180 days annually after the procedure. Urodynamic test was again performed 6 months and 1 year after the procedure. Statistical analysis were performed by using Statistical Package for Social Sciences ( SPSS v18.0). Statistical significance reached when p<0.05. 4. Results: The two groups are similar regarding to demographic and clinical pre-operatory parameters (table 1) Continuous variables are expressed in mean±standard deviation. Table 1. Pre-operatory data TVT-O

TVT-S

Number of patient Age (y)

56 52,13 (±8,79)

66 54,05 (±11,37) 0,305

BMI (kg/m2 )

30,02 (±4,69)

29,84 (±5,35)

Parity

3,64 (±2,26)

4,05 (±2,65)

0,302

20 (30.3)

0.183

Previous Surgery for SUI—n (%) 15 (26.8)

p

0,847

Mean value pre-op pad-test (g)

19,87 (±25,39) 19,9 (±22,85)

0,909

Mean value pre-op VLPP (cm H2O)

85,34 (±36,43) 79,39(±27,7)

0,404

T Student, Qui2,Mann-Whitney Table 2. Post operatory results

Number of patients

TVT-O 56

TVT-S 66

Mean Follow up (m)

24 (12–36)

24 (12–36)

47/56 (83.9 %) Objective cured (Negative post -op 45/56 pad test and negative VLPP) (80.3 %)

53/66 (80.3 %) 48/66 (72.3 %)

Continent patient (subjective)

p

0.643 0.395

Fisher Table 3. Post-Operatoty complications

Number of patients Mean Follow up (m) Vaginal MucosaTransfixation Urinary Retention Urinary Infection Thigh Pain Tape Exposure De novo Urgency

Fisher

TVT-O 56 24 (12–36) 4 (7.1 %) 2 (3.5 %) 4 (7.1 %) 15 (26.7 %) 1 (2.7 %) 2 (3.5 %)

TVT-S 66 18 (12–36) 3 (4.5 %) 2 (3.0 %) 3 (4.5 %) 1 (1.5 %) 2 (3.0 %) 1 (1.5 %)

p

0.702 1.00 0.702 <0.001* 0.946 0.946

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5. Conclusions: We have observed that both techniques have had similar results in 24 months mean post operatory follow-up . The two groups have had similar subjective and objective continence rates, without statistical difference (table 2). Only minor complications (table 3) have been observed: urinary retention up to 5 days, uncomplicated urinary infection, tight pain up to 10 days, assintomatic tape exposure and lower rates of de novo urgency. This study is still underway in order to have a longer follow-up. A.H. Bianchi: None. Z.I. Jarmy-di-bella: None. R.A. Castro: None. M.G. Sartori: None. M.J. Girão: None. 165 EVALUATION OF EXPERIENCE WITH MINIARC AND AJUST SYSTEM MINI-SLING ANTI-INCONTINENCE PROCEDURES, CONSIDERING CHANGES IN THE CURE RATE OVER TIME A. Martan 1, J. Masata 1, K. Svabik 1, M. Halaska 2, R. Zachoval 3, L. Horcicka 4, J. Krhut 5; 1 1st Faculty of Med., Charles Univ. and Gen. Univ. Hosp., Prague, Czech Republic, 2Dpt. of Obstet. Gynecol., Faculty Hosp., Bulovka,, Prague, Czech Republic, 3Dpt. of Urology, Thomayer Hosp., Prague, Czech Republic, 4GONA, Prague, Czech Republic, 5Dpt. of Urology, Univ. Hosp.,, Ostrava, Czech Republic. Objective: The objective of this study was to evaluate the efficacy of the MiniArc and AJUST system mini-sling antiincontinence procedures for female stress urinary incontinence (SUI). The hypothesis was that the cure effect of the MiniArc and AJUST procedures may slowly decrease, and that changes in the cure rate may be in correlation with the time that elapses after the operation. Background: This clinical study included 66 women with previously untreated SUI, and 63 patients completed the study. These women were randomly divided by the envelope method into two groups; the first group of patients underwent operations using the MiniArc (n033) technique, while the second group were treated with the AJUST (n033) technique. The efficacy of AJUST and MiniArc procedure (n031/32) was evaluated 3 months (±1 week) and an average of 28/ 29 months after the procedures had been performed. Methods: We briefly present the subjective and objective outcomes of these procedures from the 5 hospitals which participated in the study. Subjective assessment of the cure rate and the leakage of urine was based on the five-point Likert scale and on the International Consultation on Incontinence Questionnaire—Short form (ICIQ-UI SF) filled in before and 3 months (±1 week) and—on average 28/29 months (minimum— 24 months)—after the surgery (mean number of days after AJUST/MiniArc operation was 843/873). Improvement in urinary incontinence by ICIQ-UI SF was defined as a drop in the score of more than 50 %. The evaluation of the five-point Likert

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scale was: 5-cured; 4-improved; 3-no change to preoperative status; 2-worsened; 1-significantly worsened). Objective assessment of leakage of urine was assessed by the cough test. Ethical committee approval was obtained, and all subjects gave written consent to participate in the study. Data were processed and statistical analysis performed by Number Cruncher Statistical System (NCSS). Changes in time and differences between groups were assessed using t-tests, Wilcoxon tests or Fischer exact test; the level of significance was set to 0.05. Results: The patients’ mean age before the operation was 59 years in the AJUST group and 60.2 years in the MiniArc group. Mean BMI was 29.1/28.6 in the AJUST/MiniArc group, and mean parity was 2.06/2.25. We did not find statistically significant differences between these two groups. Objective assessment by cough test showed that 30/31(96.8 %)/29/32 (90.6 %) of patients had negative results for this test 3 months and 29/31(93.5 %)/26/32(81.3 %) 28/29 months after AJUST/ MiniArc operation. The difference in time is not statistically significant in any group (p01.0000/p00.4758). Subjective assessment by the ICIQ-UI SF questionnaire showed that 30/31 (96.8 %)/ 32/32 (100 %) of patients were dry or improved 3 months after the AJUST/MiniArc operation and 29/31 (93.5 %)/ 31/32 (96.9 %) 28/29 months after the operation. The difference in time is not statistically significant in any group (p01.0000/p01.0000). ICIQ-UI SF questionnaire showed that 26/31(83.9 %)/24/32 (75 %) of our patients were completely dry 3 months after operation and 21/31(67.7 %)/20/32(62.5 %) patients 28/29 months after AJUST/MiniArc operation. The difference in time is not statistically significant in any group (p00.2351/p00.4190). The ICIQ-UI SF mean score before the AJUST/MiniArc operation was 15.26 (SD 3.43)/15.56 (3.35); 3 months after the operation it was 1.26 (SD 3.48)/1.13(SD 2.11); and 28/29 months after the operation it was 2.94 (SD 5.45)/2.53 (SD 4.33). The changes in the score 3 months and 28/29 months after operation are not statistically significant (p0 0.2048/p00.0631). The mean Likert score 3 months after operation was 4.84(SD 0.37)/ 4.78(SD 0.66) and 28/29 months after operation was 4.42 SD1.20)/4.46(SD 1.07). The comparison of the differences between the cure effect 28/29 months and 3 months after surgery between the AJUST/MiniArc groups is not statistical significant (p00.7630). Conclusions: Our initial experience with AJUST and MiniArc procedures are positive. From the results 3 months (±1 week) and—on average 28/29 months after surgery we can conclude that the cure effect of AJUST and MiniArc is similar. The hypothesis that the cure rates of AJUST and MiniArc procedure may slowly statistical significant decrease as time passes after the operation was not confirmed. References (optional): A. Martan: Consultant; For Astelas, Bard, Ethicon Women’s Health and Urology. Employee (full or part time); 1st Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic. Grant /Research

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Support; This work was supported by the Grant Agency of the Ministry of Health of the Czech Republic, grant NT121474. Shareholder; J.MASATA, K.SVABIK, 1st Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic. J. Masata: Employee (full or part time); 1st Faculty of Medicine, Charles University and General University Hospital. Grant /Research Support; This work was supported by the Grant Agency of the Ministry of Health of the Czech Republic, grant NT12147-4. Shareholder; A. Martan, K. Svabik, 1st Faculty of Medicine, Charles University and General University Hospital. K. Svabik: Employee (full or part time); 1st Faculty of Medicine, Charles University and General University Hospital. Grant /Research Support; This work was supported by the Grant Agency of the Ministry of Health of the Czech Republic, grant NT12147-4. Shareholder; A. Martan, J. Masata, 1st Faculty of Medicine, Charles University and General University Hospital. M. Halaska: None. R. Zachoval: None. L. Horcicka: None. J. Krhut: None.

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urgency, urgeincontinenece and the KHQ parameters were still found, but no significant results were reached for stress urinary incontionence and the use of daily pads. When comparing the treatment group versus placebo a difference (p<0.05) was found on urinary leakage, use of daily pads, urgency and KHQ domains, with 29 % versus 0 % of dry patients (p00.03) and 83 % versus 33 % of patients without urgency (p00.01). Conclusions: The pelvic floor electromagnetic stimulation is an effective therapeutic tool in treating patients with urinary incontinence with a probable mild or moderate neuromodulator effect, which allows the management of symptoms related to overactive bladder. Am J Obstet Gynecol 1995; 173:72–9. Urology 1999; 53:1108–11. BJU Int 2004; 93:539–42. V.I. Manriquez: None. R. Valdevenito: None. C.D. Sandoval: None. M. Naser: None. R. Guzman: None. J. Lecannelier: None. A. Aguilera: None.

166 EXTRACORPOREAL MAGNETIC STIMULATION VERSUS SHAM STIMULATION IN WOMEN WITH URINARY INCONTINENCE V. I. Manriquez, R. Valdevenito, C. D. Sandoval, M. Naser, R. Guzman, J. Lecannelier, A. Aguilera Hosp. Clinico Univ. de Chile, Santiago, Chile.

167 SLING REVISION AFTER SUBURETHRAL TAPE TREATMENT FOR FEMALE STRESS URINARY INCONTINENCE—A 6-YEAR RETROSPECTIVE ANALYSIS S. B. Albrich, R. M. Laterza, K. Rommens, C. Skala, G. Naumann, H. Koelbl Univ. Med. center Mainz, Mainz, Germany.

Introduction: Urinary incontinence is a prevalent disease that affects the quality of life of patients suffering from it. The use of magnetic fields employing simple physical principles and high technology to stimulate muscular and nerve structures produces clinical effects in patients with urinary incontinence. Materials and methods: This research was designed as a prospective, randomized, placebo-controlled study, in magnetic stimulation of the pelvic floor of women with mild to moderate urinary incontinence score according to Sandvik. Thirty three patients were randomized to receive magnetic stimulation or simulation therapy with 20 min sessions, twice a week, for 6 weeks, using the stimulation parameters suggested by the manufacturer. (Neotonus Inc. Marrietta, GA, USA). Therapeutic effectiveness was assessed using a 72-hour voiding diary, quality of life survey (KHQ) and the Sandvik severity index and simple cystometry at baseline, 8 weeks post-term and end of the intervention. The statistical analysis of data utilized was mainly t-test, considering a significance of 0.05. Data was analyzed with the version 9 STATA program. Results: Prior to the intervention both groups were comparable regarding the severity index and the presence of urinary urgency. The patients in the treatment group improved (p<0.05) in the following parameters: stress urinary incontinence, urgency, urgeincontinence, daily use of pads, and all domains of the KHQ post treatment. At the 8 week of evaluation, effects on

Objective: The aim of our study was to retrospectively analyze all cases of sling revision after suburethral sling treatment in respect to type of sling, mode of sling correction, interval of sling insertion to revision and indication for revision. Background: Today suburethral slings have become the gold standard treatment for stress urinary incontinence in women. Although the success rate is very high, some patients remain incontinent and others encounter complications such as de-novo OAB-symptoms, voiding dysfunction, erosions and dyspareunia. Methods: We performed a retrospective analysis of all patients’ charts undergoing sling correction surgery over a 6year period. Results: A total of 116 patients underwent tape revision between 2006 and 2011. In a preliminary evaluation 84 (72.4 %) charts could be analyzed. Among these cases there were 59 retropubic slings (70.2 %), 19 transobturator slings (22.6 %) and 7 mini-slings (8.3 %) (one patient with retropubic and transobturator sling). Sling revision was indicated for de-novo urge-symptoms in 53 cases, for voiding dysfunction in 42 cases, pain and dyspareunia in 13 cases, recurrent urinary tract infections in 12 cases and healing problems in 8 cases. The time interval from insertion of tape to correction varied from 1 to 120 months with a mean of 32 months. The mean

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interval was 23 months for symptoms of voiding dysfunction, 28 months due to pain/ dyspareunia, 31 months for urge-symptoms and 44 months due to healing problems. Eighteen of the 84 patients had more than one revision procedure (21.4 %). We performed a loosening of the tape twice, a cut in midline in 20 patients, a partial suburethral removal in 62 cases and an abdominal plus vaginal subtotal resection twice. After retropubic slings the mean interval to correction was 35 months, the main indication for re-intervention was urgesymptoms (66.1 %), followed by voiding dysfunction (55.9 %), pain/ dyspareunia (11.8 %) and healing problems (6.8 %). Revision interventions after transobturator slings were performed after a mean interval of 23 months. The main indications were urge-symptoms (57.9 %) followed by voiding dysfunction (36.8 %), pain/ dyspareunia (31.6 %) and healing difficulties (15.8 %). The mean interval for correction surgery after mini-slings was 6 months. The main reason for revision after minislings were urge-symptoms (57.1 %), voiding dysfunction (42.9 %) and healing difficulties (14.3 %). Conclusions: Suburethral slings are a highly efficacious intervention for the treatment of female stress urinary incontinence. Our data show that the main reasons for revision after sling treatment are OAB symptoms, voiding dysfunction and pain. S.B. Albrich: None. R.M. Laterza: None. K. Rommens: None. C. Skala: None. G. Naumann: None. H. Koelbl: None. 168 WHICH MECHANISMS KEEP US CONTINENT?—THE ROLE OF PELVIC FLOOR MUSCLES, BLADDER NECK SUPPORT AND MOTOR CONTROL K. Baessler, B. Junginger Pelvic Floor Ctr., Charité Univ. Hosp., Berlin, Germany. Which mechanisms keep us continent?—The role of pelvic floor muscles, bladder neck support and motor control Objective: The aim of this study was to assess known continence mechanisms (maximum urethral closure pressure0UCP, bladder neck support0BNsupp, pelvic floor pre-contraction0PFpreC) and their chronological interaction during functional tasks (coughing, nose blow, lift a weight) in standing healthy continent women who have not had vaginal deliveries. Background: We know that the pelvic floor muscle (PFM) co-contracts with the transverse abdominus muscle and also pre-contracts before the intraabdominal pressure (IAP) increases (1). We also know that incontinent women might have lost the PFpreC (2). Furthermore, it is established that both maximal UCP and BNsupp are important factors that maintain continence resulting in bladder neck “stiffness” (3). However, continence mechanisms have not been assessed concurrently and during functional tasks.

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Methods: Ten continent premenopausal women (6 nulliparous, 4 caesarean section) were recruited. Surface EMG electrodes were placed to measure activity of the oblique and transverse as well as rectus abdominis muscles. One electrode attached to a small sponge was placed intravaginally at the level of the puborectalis muscle. Microtip transducers were inserted rectally to measure IAP and urethrally (orientated laterally) to measure urethral and vesical pressures. Perineal ultrasound was performed to assess bladder neck and puborectalis muscle movements. Ventrocranial changes in position were labelled as a positive vector, dorsocaudal displacements as negative. Positions at rest were measured from a horizontal line with the dorsal edge of the pubic symphysis as the reference point. All measurements were taken with a comfortably full bladder at 300 ml and assembled on one screen with one timeline (Noraxon Tele Myo software). EMG signals were band pass filtered between 30 and 1000 Hz. For pre-contraction measurements, the beginning of the increase and the peak of the IAP was marked. Raw EMG signals were amplified and the moment of increase in PF-EMG activity determined and the length of time measured until the increase in IAP started. With the subjects standing, all measurements were taken at rest, during coughing, nose blow and isometric resistance lifting. Results: All women demonstrated a PFpreC before the increase of the IAP during coughing, nose blow and lifting. UCP did not increase and the bladder neck was not elevated with this PFpreC. EMG signals of abdominal wall muscles increased concurrently with IAP augmentation. The IAP and UCP peaked concomitantly. UCP always exceeded IAP. Table 1 summarises measurements at rest, during coughing, nose blowing and lifting. Whereas the puborectalis muscle usually demonstrated a contraction during all tasks, the BN descended in most women. The BN descent was greatest during a cough compared to nose blow and lifting (p00.028). Table 1. Displayed are means and range

PFpreC before IAP increase (ms) IAP rise (cmH2O) UCP at IAP peak (cmH2O)

Cough 62.9

Nose blow 64.8

Lifting 82.6

36–91

30–120

50–130

77.6

57.4

20.5

57–102

42–80

7–50

78

75.4

49.9

9–161

19–153

14–111

BN support

–

3.6 (n01)

2.9 (n03)

Elevation mm (n) Descent mm (n)

−6.01 (n010)

−4.6 (n09)

−4.2 (n07)

Puborectalis muscle

4.4 (n09)

3.7

4.3 (n08)

Elevation mm (n) Descent mm (n)

−4.8 (n01)

–

−3.45 (n02)

Conclusions: In continent women, motor control provides a pelvic floor muscle pre-contraction approximately 63 ms before intraabdominal muscle increase which results in bladder

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neck support and resistance. Thereby the urethra is compressed by the IAP against the supportive layer and the urethral closure pressure increases simultaneously with the IAP peak. The peak of the urethral closure pressure during a cough e.g. does not seem to be result of a PFC as EMG measurements did not increase accordingly. Therefore, our measurements validate the “hammock hypothesis” although the pelvic floor muscle and its supportive connective tissue structures act rather as a trampoline and seem paramount to urinary continence. References: 1 Int Urogynecol J. 2010 Jan;21(1):69–77 2 Int Urogynecol J Pelvic Floor Dysfunct. 2007 Aug;18 (8):901–11. Epub 2006 Dec 1. 3 Obstet Gynecol. 2000 Apr;95(4):535–40. K. Baessler: Grant /Research Support; Deutsche Forschungsgemeinschaft. B. Junginger: None.

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169 RELATIONSHIP BETWEEN DEVICES AND ANATOMIC STRUCTURES IN SURGERIES FOR URINARY INCONTINENCE IN FRESH CADAVERS J. M. Haddad 1, L. R. Fiorelli1, T. L. Takami 1, S. Hwang 1, T. Peterson 1, S. H. Coletti 1, E. C. Baracat 2 1 Urogynecology Div. of Obstetrics and Gynecology Dept. at the São Paulo Univ. Med. Sch.., Sao Paulo, Brazil, 2Gynecology Discipline of Obstetrics and Gynecology Dept. at the São Paulo Univ. Med. Sch.., Sao Paulo, Brazil.

Objective: To evaluate the relationship between devices for stress urinary incontinence (SUI) surgeries and pelvic structures in fresh cadavers. Background: Tension-free-vaginal tape (TVT), transobturator TVT (TVT-O) and TVT- Seccur (TVT-S) surgeries have blinded steps and this study demonstrates its correlation with anatomical structures. Methods: TVT (Figure 1), TVT-O and TVT-S were perfomed in ten fresh cadavers followed by dissection of pelvis and abdominal cavity. It was approved by Research Ethics Committee at University of São Paulo. Results: Mean age of cadavers was 76,4 (±8,15) years; weight was 58,94 kg (±10,61) with 22,92 kg/m2 (±4,6) of body mass index. Mean distance from needle to bowel in TVT was 5 cm (±1,1) (Figure 2) and 8,55 cm (±1,59) to iliac vessels. In TVT-O, mean distance from needle to obturator vessels was 2,25 cm (±0,34) (Figure 3). Needle of TVT-S was located at intern obturator muscle in all cadavers without reaching obturator membrane (Figure 4). Conclusion: Profound knowledge of surgical techniques and anatomical structures in SUI surgeries is essential to avoid injuries to the patients. Studies with more fresh cadavers dissection are needed to minimize anatomical differences. References: J Urol. 2005 Apr;173(4):1223–8. Am J Obstet Gynecol. 2006 Dec;195(6):1809–13. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jun;20(6):681–8. Epub 2009 Feb 13.

J.M. Haddad: Consultant; Jonhson and Jonhson. L.R. Fiorelli: None. T.L. Takami: None. S. Hwang: None.

T. Peterson: None. S.H. Coletti: None. E.C. Baracat: None.

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170 A NOVEL METHOD OF PREDICTING PATIENT USE OF ANTIMUSCARINIC MEDICATION FOR THE TREATMENT OF OVERACTIVE BLADDER: THE NECESSITY-CONCERN DIFFERENTIAL. R. K. Basra1, V. Khullar 2, C. J. Kelleher 3 1 Guys & St Thomas’ NHS Fndn. trust, Herts, United Kingdom, 2Imperial Hlth.care, London, United Kingdom, 3Guys & St Thomas’ NHS Fndn. trust, London, United Kingdom. Objective: Success of multimodality management of overactive bladder (OAB) may be limited by poor persistence and adherence to antimuscarinic medication. Interventions to support patients who have been prescribed medication as part of their treatment package include pharma sponsored help lines, patient information leaflets and online resources, and bladder master-classes with nursing and physiotherapy input alongside follow-up with their primary care or hospital clinician. These interventions are costly and may not be utilised by all patients. A simple way of assessing patients’ intention to try and persist with antimuscarinic medication is by assessing their personal beliefs about the possible benefits and risks of taking the tablet they have been prescribed. The aim of this study was to assess patients’ cost-benefit analysis of antimuscarinic medication and its influence on the use of medication in patients with idiopathic OAB. Background: The Beliefs about Medicines Questionnaire (BMQ) consists of two parts; the first assesses how patients’ feel about their doctors’ prescribing practices. The second part assesses how necessary patients’ believe their antimuscarinic medication is to maintain good health, and the concerns they have about using it. The necessity concern differential (NCD) which is calculated by subtracting the concern score from the necessity score has been shown to be predictive of adherence to medication in chronic conditions such as asthma, renal and cardiac disease. Methods: Women with idiopathic OAB referred to two tertiary urogynaecology centres were recruited into a prospective study investigating the management of OAB in clinical practice. After a baseline and 6 week visit, patients were invited for follow-up at three monthly intervals for 12–24 months. All patients were offered conservative/lifestyle advice and antimuscarinic medication unless there were contraindications to its use. Patients also completed validated questionnaires to measure adherence to antimuscarinic medication, and health related quality of life. Results: 133 patients were recruited into a prospective longitudinal study of the real world management of OAB and completed 1 year of follow-up. 68 patients completed 2 year followup. 96 % of patients were prescribed antimuscarinic medication. Analysis of the BMQ showed that the mean necessity and concern scores ranged from 12 to 15 and 12–14 out of a possible 25 respectively, at each of the follow-up visits. The majority of

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patients did not report strong feelings about the necessity of antimuscarinic medication to maintain good health, or strong concerns about their medication. Self reported adherence was lower in patients reporting high concerns about using antimuscarinic medication. Conversely, higher perceived necessity of antimuscarinic medication was associated with better adherence. Patients who reported good adherence to medication (i.e. >88 % adherence to treatment at follow-up visits) also reported a positive NCD. This association was statistically significant at 5 of the 8 follow-up visits (P<0.05). Analysis of health related quality of life data showed that patients who reported a negative NCD were more likely to report that treatment had little effect on their bladder symptoms compared with patients reporting a positive NCD which was associated with significant improvement in their condition. Conclusions: This study using the NCD analysed whether patients’ perceived balance of treatment benefits and risks was associated with adherence to medication. Patients reporting a positive NCD indicating that their perceptions about the necessity of medication were greater than concerns about treatment reported better adherence to treatment than women whose concerns about treatment exceeded the benefits. The NCD is a useful objective tool for assessing patients’ feelings about using antimuscarinic medication and is related to adherence to treatment. Using the results of a patient’s NCD may allow a more personalised and effective management plan for this chronic condition, which may include an emphasis on conservative/lifestyle measures in preference to antimuscarinic medication. References (optional): 1. J Psychosom Res 1999 Dec;47(6):555–67. 2. J Psychosom Res 1999 Dec;47(6):491–5. R.K. Basra: None. V. Khullar: Consultant; Pfizer, Allergan, Astellas. C.J. Kelleher: Consultant; Astellas, pfizer. 171 THE DIAGNOSTIC CATEGORISATION OF LOWER URINARY TRACT SYMPTOMS: IS OAB A DINSTINCT CLINICAL CONDITION? J. Malone-Lee, A. S. Kupelian, H. Horsley, T. Dacheva, K. Gill, S. Sathiananthamoorthy, L. Collins Univ. Coll. London, London, United Kingdom. Objective: This study used cluster analysis to scrutinise the relationships between common lower urinary tract symptoms (LUTS). The purpose was to determine whether natural clustering could be found to justify the use of common diagnostic categories including the overactive bladder (OAB), stress urinary incontinence (SUI), voiding symptoms, and lower urinary tract pain symptoms. Background: As clinicians, we typically take diagnostic categorisation for granted, without considering the strength of our assumptions, or the potential for generating error.

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Immanuel Kant warned of the illusion of categorisation: “Do not confuse the thought of things [categories] as things in themselves”; more recently, Dawkins has criticised “The tyranny of the discontinuous mind” (1). Nature is inimical to categorisation, and its use in clinical science may distort our understanding of disease. Cluster analysis is a tool designed to reveal natural groupings within datasets. Objects are grouped, characterised by similarities in the properties of constituent members. The mathematics hinges on calculating distances between variables, and grouping them by defining the distance ranges that should delineate group membership. Methods: Recruitment and data collection were undertaken in a single, specialist service in the UK (2002–2011). Patients presenting with one or more LUTS underwent a complete symptom assessment undertaken by one researcher using a fixed protocol. The diagnostic groups included storage symptoms, subdivided into (1) OAB and (2) SUI; (3) voiding symptoms (including postmicturition symptoms); and (4) lower urinary tract pain symptoms. ICS terminology was adhered to (2). Symptom assessment used 37 individual questions; responses were Boolean Yes/No outcomes. For the analysis, all of these symptoms were ungrouped and randomly ordered. The SPSS Two Step Cluster Analysis procedure was used to identify clusters based on a distance measure assuming independence and a multinomial distribution. Results: 2642 patients (F02312, M0330; mean age056; sd0 31) with LUTS, underwent symptom assessment over 17 242 consultations; the dataset comprised 568,986 individual symptom elements. Various Cluster analyses showed poor silhouette measures of cohesion and separation until OAB symptoms were removed. When the analysis was repeated with OAB symptoms excluded, the remaining symptom groups formed clusters with some overlap. The figure, its core consisting of a three-variable Venn diagram, demonstrates the relationship between SUI, voiding symptoms, and pain symptoms. It has been constructed to reflect the expression of these symptoms in the study population precisely. These three groups were identified successfully by the cluster analysis. A fourth variable, representing OAB symptoms, has been added to this diagram. OAB symptoms were not found to cluster, other than through the property that their removal from the dataset permitted the other clusters to be circumscribed. The problem caused by OAB symptoms, illustrated in the figure, resulted from OAB being scattered throughout the entire dataset, failing to cluster. Conclusions: This analysis provides evidence that OAB does not form a distinct categorical clinical group. It implies that we may conjecture properties about OAB that are not founded in nature. The expression of LUTS demonstrates substantial overlap, with elements exerting different influences amongst individual patients. These interactions raise important questions relating our understanding of LUTS. Large populationbased, symptom prevalence studies have already reported significant symptom multiplicity and overlap in patients with

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OAB (3). This study challenges categorisation as a means of understanding, studying, and treating LUTS, whilst demonstrating natural clustering of some elements. References: (1) ISBN-10: 0753819961 (2) Neurourol Urodyn 2002; 21 (2): 167–78. (3) BJU Int 2008; 101(11):1381–7.

J. Malone-Lee: None. A.S. Kupelian: None. H. Horsley: None. T. Dacheva: None. K. Gill: None. S. Sathiananthamoorthy: None. L. Collins: None. 172 SURGICAL TREATMENT OF FEMALE STRESS URINARY INCONTINENCE THROUGH YEARS 2007–2010; REPORT OF NATIONAL REGISTRY O. Sottner1, L. Horcicka 2, M. Halaska 3, A. Martan 4, J. Masata 4, L. Krofta 5, I. Huvar 6, J. Feyereisl 5, J. Zmrhal 7, P. Krahulec 8, K. Maxova 3, D. Kolarik 9 1 i) Dept. of OB/Gyn, Hosp. Na Bulovce, First Faculty of Med., Charles Univ. in Prague; ii) OB/GYN & Urogynae Clinic in Polna and Brtnice, Prague, Czech Republic, 2 Gona, spol. s r.o., Prague, Czech Republic, 3Dept. of OB/ Gyn, Hosp. Na Bulovce, First Faculty of Med., Charles Univ. in Prague, Prague, Czech Republic, 4Dept. of OB/ Gyn, Gen. Univ. Hosp., First Faculty of Med., Charles Univ. in Prague, Prague, Czech Republic, 5Inst. for the Care of Mother and Child, Third Faculty of Med., Charles Univ. in Prague, Prague, Czech Republic, 6Hosp. Milosrdnych Bratri, Brno, Brno, Czech Republic, 7Dept. of OB/Gyn, Univ. Hosp. Kralovske Vinohrady, Third Faculty of Med., Charles Univ. in Prague, Prague, Czech Republic, 8MUDr. Pavel Krahulec, CSc., OB/GYN & Urogynae Clinic in Brno, Brno, Czech Republic, 9i) Dept. of OB/Gyn, Hosp. Na Bulovce, First Faculty of Med., Charles Univ. in Prague; ii) Hosp. Nymburk, Prague, Czech Republic.

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Objective: The aim of this project is to report the outcomes of the National Registry in the field of urogynecological procedures involving implant intended to treat female stress urinary incontinence in our country. We set two main objectives—to map a spectrum of used implants and to study complication rates. Background: New urogynecological mesh implantation techniques gained very quickly their popularity arising probably from an extreme success of Tension Free Vaginal Tape (TVT). Uncontrolled implantation of many different kinds and modifications of original TVT, and moreover, implantation of disparate meshes in order to treat pelvic organ prolapse brings urgent need of feedback. Methods: Methods are determined by the design of the Registry and correspond to a retrospective registry analysis. We submit outcomes of the national registry of the years 2007–2010 established in our 10 million population country. This Registry is designed to cover all urogynecological procedures involving implantation of the artificial material. It has been kept by the National Urogynecological Association. Cooperation with the Registry is not mandatory by law in our country but we ask all Centers involved in Urogynecology for cooperation every year. Results: 27 centers reported their year 2010 results to our registry—2409 implants were used to treat female stress urinary incontinence. We seem to cover at least

two thirds of all implants intended to treat female stress urinary incontinence. Predominant implant for female stress urinary incontinence was midurethral sling— 2325 midurethral slings versus 84 periurethral implants (bulking agents) implantations. Midurethral slings were mainly transobturator tapes; retropubic trajectory was used just in 125 cases (i.e. 5,2 % of all tapes), transobturator way was chosen in 1929 females (i.e. 80,1 %) and 271 patients underwent single incision sling (i.e. 11,3 %). All 27 centers were implanting transobturator tapes during the year 2010; on the other hand just 9 centers were using retropubic trajectory and 13 centers included single incision slings into their armamentarium. In comparison with previous years 2007, 2008 and 2009 this represents a steady rule of transobturator tape trajectory. But there are some significant changes in popularity of retropubic tape, single incision slings and periurethral implants during these years. Periurethral implants were not virtually used during the years 2007–2008 and their popularity arose in years 2009 and 2010 (sharing 3,5 % of all anti-incontinence implants in 2010). Both retropubic tapes and single incision slings went through the decrease period followed by comeback. In case of single incision slings this was probably due to the disillusion from the first kind of single incision sling followed by restoration of confidence thanks to the newly designed single incision slings.

Table 1. Share of different kinds of anti-incontinence implants through the years 2007–2010 Year

Total number of anti-incontinence procedures involving implant

Retropubic midurethral slings

Transobturator midurethral slings

Single incision slings

Periurethral implants (bulking agents)

2007 2008 2009 2010

2232 1536 2033 2409

179 (8,02 %) 97 (6,32 %) 70 (3,44 %) 125 (5,19 %)

1701 1325 1715 1929

346 (15,50 %) 114 (7,42 %) 192 (9,44 %) 271 (11,25 %)

6 (0,27 %) 7 (0,46 %) 56 (2,75 %) 84 (3,49 %)

(100 (100 (100 (100

%) %) %) %)

Complication rate reported by cooperating centers is surprisingly low compared to the generally accepted numbers of complication rates but this is a fate of all registers. No death was reported. Declared intra-operative complication rate was around 1 % in all the reported years, most often due to excessive bleeding. Early post-operative complications always comprise mainly of delayed spontaneous micturition restoration and urinary tract infections—altogether representing between 2,5 % and 5,0 % of all cases. Long term post-operative complications were declared in between 3,9 % and 6,8 % of all operated cases—most commonly reported are failure to treat, vaginal protrusions of mesh and de novo urgencies.

(76,21 (86,26 (84,36 (80,07

%) %) %) %)

Conclusions: Transobturator tape remains local mainstay of urogynecological implants intended to treat female stress urinary incontinence. Complication rate reported by cooperating centers is considerably low but this is a usual bias of all registers, especially in their early years. Nevertheless, we still do think Registries are very valuable source of medical knowledge and their sense is undoubted, mainly in the task of newly introduced treatment methods. O. Sottner: None. L. Horcicka: None. M. Halaska: None. A. Martan: None. J. Masata: None. L. Krofta: None. I. Huvar: None. J. Feyereisl: None. J. Zmrhal: None. P. Krahulec: None. K. Maxova: None. D. Kolarik: None.

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out interstitial cystitis. Standardised criteria for histopathological diagnoses were used as previously described. The findings on histology reports included presence of chronic or active cystitis, lymphoid follicles, cystitis cystica, glandular cystitis, interstitial cystitis, von Brunn’s nests, and tumour. Both cystoscopy and histological findings were compared to assess the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of cystoscopy findings for chronic cystitis. Results: 106 women aged 22–91 years were studied. 6 women presented with haematuria. Histopathology showed chronic cystitis in 94 women, follicular cystitis in 3, acute and chronic cystitis in 2, transitional cell carcinoma in 6 and no abnormality in 1 woman. Trabeculations and increased vascularity were the most common cystoscopy findings seen in 71 % and 72 % respectively. On cystoscopy haemorrhages were seen in 11 women (10.4 %) on first filling and 15 women (14 %) on refilling respectively. 7 women had a space-occupying lesion on cystoscopy which was confirmed to be a bladder tumour only in 71 % of the cases (5/7). One woman out of six, who was diagnosed with bladder tumour, did not have space-occupying lesion on cystoscopy. Histology confirmed a bladder tumour only in 33 % of these cases (2/6) whereas 67 % (4/6) of women with bladder tumour did not have haematuria. Table 1 shows the comparison of cystoscopy and histology findings. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of cystoscopy findings for chronic cystitis are shown in Table 2. Conclusions: More than 90 % of women with refractory OAB have chronic cystitis on histopathology thus we can speculate that antibiotic/anti-inflammatory therapy in those women might be beneficial prior to starting anticholinergics. Further larger randomised controlled trials are mandatory to confirm our hypothesis. Cystoscopy is an important investigation of refractory overactive bladder as 6 % of women have a bladder tumour.

173 WHY WOMEN WITH REFRACTORY OVERACTIVE BLADDER(OAB)SYMPTOMS MUST UNDERGO CYSTOSCOPY AND BLADDER BIOPSY A. Digesu, F. Puccini, A. Tubero, R. Fernando, A. A. Bhide, V. Gopalan, V. Khullar Imperial Coll. London, London, United Kingdom Objectives: The aim of this study was to evaluate the diagnostic accuracy of cystoscopy and the clinical value of bladder biopsy in the assessment of women with non-neurogenic refractory overactive bladder (OAB) symptoms. Background: There is some evidence showing that cystitis might play a role in the pathogenesis of OAB and detrusor overactivity (DO). Recent animal studies have also demonstrated that tolterodine produced no effect on DO in rats with chronic chemical cystitis compared to the sham group. Cystoscopy is a useful tool to evaluate urethral and vesical pathology that can clinically present with OAB. However, it is unclear if an underlying pathology may be missed if bladder biopsy is not performed. Therefore, the role of cystoscopy and bladder biopsy in refractory OAB assessment is still controversial. Methods: Women with lower urinary tract symptoms (LUTS) were recruited from an urogynaecology outpatient clinic. All women studied had vaginal assessment using a pelvic organ prolapse quantification system (POP-Q), bladder diary, urinalysis, Kings Health questionnaire, urodynamics and pelvic, kidney-ureter-bladder ultrasound scans as per unit protocol. Women with OAB symptoms and urodynamic diagnosis of detrusor overactivity resistant to conservative management and two or more anticholinergics were included in the study. Urinalysis and MSU were sent off for all women. Women with urinary tract infection (UTI), pelvic organ prolapse≥2 and/or neurological diseases were excluded. All women were further investigated with rigid cystoscopy, hydro distension and bladder biopsy under general anaesthesia to rule Table 1. Comparison of cystoscopy and histology findings. Cystoscopy

Histology Active cystitis

Chronic cystitis

Lymphoid follicles

Cystits cystica

Glandular cystitis

von Brunn’s nests

Tumour

Interstitial cystitis

Trabeculation Increased vascularity Haem 1st filling Haem refilling Space occupying lesion

1 1 0 0 0

62 62 9 12 3

5 5 4 3 0

3 2 0 0 0

1 0 0 0 0

3 0 1 0 2

0 2 0 0 5

2 2 2 2 2

Haematuria

1

3

1

0

0

0

2

0

Values expressed as numbers

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Table 2. Sensitivity, specificity, PPV and NPV of cystoscopic findings for chronic cystitis

Trabeculation Increased vascularity Haem on 1st filling Haem on refilling

Sensitivity 77.5 77.5 11.2 15

Specificity 55.6 50 88.9 83.3

PPV 88.5 87.3 81.8 80

NPV 35.7 33.3 18.4 18.1

Values expressed as percentage A. Digesu: None. F. Puccini: None. A. Tubero: None. R. Fernando: None. A.A. Bhide: None. V. Gopalan: None. V. Khullar: None. 174 LOWER URINARY TRACT SYMPTOMS IN WOMEN WITH AUTONOMIC DYSFUNCTION: IMPACT ON QUALITY OF LIFE G. Vijaya, F. Puccini, V. Iodice, A. Digesu, R. Fernando, C. Mathias, V. Khullar I M P E R I A L C o l l . H E A LT H C A R E N H S T R U S T, LONDON, United Kingdom Objective: To assess the prevalence of lower urinary tract symptoms (LUTS) and their impact on quality of life in women with autonomic dysfunction Background: The lower urinary tract and genitalia are largely innervated by autonomic fibres and consequently detrusor overactivity, voiding dysfunction, sphincter incompetence and impaired sexual responses can either be presenting symptoms of autonomic nervous system failure or occur as troublesome problems in patients with established disease. In one study 8 % of patients with autonomic dysfunction displayed voiding symptoms severe enough to warrant urologic referral [1]. So far the impact of urinary symptoms on patient’s quality of life has not been explored in these group of patients Methods: Women with symptoms of autonomic dysfunction were recruited from the neurovascular unit. Ethical approval was obtained from the local REC committee prior to recruitment. All women had abnormal autonomic

function tests which included tilt table, blood pressure and pulse changes with posture. King’s health questionnaires were completed postally to assess the presence of urinary symptoms and the impact of these symptoms on their quality of life. Questionnaires were resent to patients who had not responded to the first request. King’s health questionnaire is a condition specific questionnaire for the assessment of patients with lower urinary tract symptoms and quality of life. The assessment is made in 9 different domains including the general health perception, impact of bladder problems on life, role limitation, physical/social limitation, impact on personal relationship, emotions, sleep /energy and degree of severity measures. The score for each domain is then calculated, the maximum score for each domain being 100. The higher the score ,the greater the quality of life impairment. Results: In total one hundred and fifteen King’s health questionnaires were sent to women with autonomic dysfunction. Eighty questionnaires were resent to patients who had not responded to the first request. Fifty-seven questionnaires were returned. Of these 43 [76 %] women reported urinary symptoms. Five women [9 %] were known to the urogynaecology department and were undergoing treatment for their urinary symptoms. The remaining 67 % of women did report urinary symptoms but were not undergoing treatment for them. The mean age group of the symptomatic patients were 48 years [age range 19–72]. 15 % of these patients had autonomic failure, 76 % had Postural orthostatic tachycardia syndrome, 6.5 % had vasovagal syncope and 30 % had Ehlers Danlos syndrome [type three]. The mean total KHQ score was 351 [range 83–776] and 30 % of women had a mean score of more than 450 which is half of the total maximum score. The mean scores for each domain is listed in table 1 and nearly 60 % of the symptomatic group had bladder symptoms, which had an impact on their life. Interestingly 70 % of patients reported moderate to severe urinary symptoms such as daytime frequency, urinary urgency, urgency urinary incontinence, stress urinary incontinence, nocturnal enuresis, urinary infections and bladder pain.

Table 1. The mean score for each domain in King’s health questionnaire and the % of patients with a mean score of≥50 in each domain

Mean score [maximum 100] % of patients with a mean score of ≥ 50

General health perception

Incontinence Impact

Role limitation

Physical limitation

Social Limitations

Impact on personal relationship

Impact on emotions

Impact on sleep/energy

Severity measures

60.5

57.8

30.7

37.7

24.5

19.8

27.4

42

32.3

84%

54%

26%

40%

21%

21%

23%

40%

28%

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Conclusion: LUTS is common in women with autonomic dysfunction. Nearly 70 % of women were experiencing LUTS with 70 % of them perceiving their symptoms to be moderate or severe. About 60 % of the symptomatic group felt that their symptoms had an impact on their quality of life. Women with autonomic dysfunction have a high rate of lower urinary tract symptoms and this suggests a possible aetiological cause. Multidisciplinary management and early referral to the respected specialities can help in improving the patient’s quality of life References: Abstract no.35- ICS 2009 G. Vijaya: None. F. Puccini: None. V. Iodice: None. A. Digesu: None. R. Fernando: None. C. Mathias: None. V. Khullar: None. 175 VESICOURETERAL REFLUX IN WOMEN WITH IDIOPATHIC HIGH PRESSURE DETRUSOR OVERACTIVITY A. Gafni-Kane, J. Letko, K. Jirschele, P. K. Sand NorthShore Univ. Hlth.System, Univ. of Chicago Pritzker Sch. of Med., Evanston, IL, IL Objective: To characterize bladder function in women with idiopathic high pressure detrusor overactivity (IHPDO) and to assess the prevalence of vesicoureteral reflux (VUR). Background: Pediatric patients with myelodysplasia have a hypertonic, areflexic response to bladder filling with an inability to affect urethral relaxation. The results of these physiologic abnormalities are high incidences of vesicoureteral reflux (VUR) and upper urinary tract damage. McGuire et al.[1] showed that 68 % of myelodysplastic children with intravesical pressures >40 cm H2O at the time of urine leakage had VUR and that 81 % of those patients had ureteral dilatation. In contrast, they demonstrated that no patients with intravesical pressures <40 cm H2O had VUR. Similarly, others have shown that pediatric patients with myelodysplasia are at significantly greater risk for upper urinary tract damage in the form of ureteral dilatation, hydronephrosis, and renal scarring if they have intravesical pressures >40 cm H2O either at the time of urinary leakage or with bladder filling [2,3]. What is not known is whether women with IHPDO are at risk for such complications. Methods: We conducted a retrospective study of women diagnosed with IHPDO at our center between 2007 and 2010 who were assessed for VUR by x-ray voiding cystourethrogram (VCUG). HPDO was defined as involuntary bladder contractions >40 cm H2O. The upper urinary tract was evaluated with retroperitoneal ultrasound, pelvic CT, or creatinine clearance calculation if VUR was present. For each patient, maximum cystometric capacity, DO volume, DO pressure, and maximum urinary flow rate were

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reviewed. DO volume and volume instilled at VCUG were compared with a Wilcoxon signed-rank test. Results: Ninety-eight women were diagnosed with IHPDO. VCUG was ordered for each patient, 73 underwent VCUG (mean age 58.8±17.4). HPDO diagnoses were made with single-channel cystometrography (n023) and multichannel urodynamics (n050). Maximum cystometric capacity, DO volume, DO pressure, and maximum flow rate were explored (see table). Six patients had VUR on VCUG (4 with grade I VUR and 2 with grade II VUR). None had signs of upper urinary tract deterioration. On urodynamic pressure flow studies, no patients had urethral pressure increases with voiding. Seventeen voided with increased perianal EMG activity, 15 with and 2 without urethral relaxation. Twentynine voided with urethral and perianal relaxation. There was no difference between median DO volume (257 mL) and median volume instilled at VCUG (325 mL) (p00.08). Conclusions: IHPDO in adult women does not carry as great a risk for VUR or upper urinary tract damage as for children with myelodysplasia. This may be so because patients with IHPDO are subject to episodic rather than constant elevations in intravesical pressure. Despite voiding obstructively, detrusor contractions in many of these patients occur with both urethral and pelvic floor relaxation suggesting that IHPDO is not occurring against a closed outlet. A receiver operating characteristic could not be performed to establish a threshold pressure associated with increased risk of VUR. An insufficient number of patients with VUR were identified in the 3-year period during which our center performed VCUGs for IHPDO. A post hoc analysis showed that a sample size of 366 women with IHPDO is needed to identify the 30 subjects with VUR necessary for a 0.80 ROC curve area within±0.10 for a 95 % CI. We ceased performing VCUGs as our clinical management of IHPDO was not altered by the presence of VUR. References (optional): 1. J Urol 1981;126:205–209. 2. J Urol 1994;152:1574–1577. 3. Pediatr Nephrol 2007;22:1891–1896. A. Gafni-Kane: None. J. Letko: None. K. Jirschele: None. P.K. Sand: None. 176 THE PREVALENCE OF ANAL SPHINCTER INJURY IN PRIMIPAROUS WOMEN R. A. Guzman Rojas, K. Shek, S. Langer, H. Dietz Nepean Clinical Sch., Univ. of Sydney, Penrith, Australia Objective: To determine the prevalence of obstetric anal sphincter injuries (OASIS) in primiparous women. Background: OASIS are common and associated with anal incontinence. It has been suggested that a significant number of OASIS remain undiagnosed during delivery, either due to a missed diagnosis, or due to trauma that is clinically occult.

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Methods: This is a retrospective analysis of ultrasound datasets of 320 primiparous women seen 3-6 months postpartum with a questionnaire, clinical examination and translabial 4D Ultrasound. Volumes were acquired at rest, on Valsalva and pelvic floor muscle contraction (PFMC)(1). Volume datasets were analysed later, using proprietary software, blinded against all other data. Tomographic ultrasound imaging

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(TUI) was used to evaluate the external anal sphincter (EAS) (2). We bracketed the EAS by placing one slice cranial and another caudad to the EAS, leaving 6 to demonstrate the muscle (Figure 1). A residual defect was diagnosed if 4/6 slices showed a defect of =>30º (3). TUI was also used to diagnose levator avulsion (1). Potential demographic and obstetric predictors of sphincter injury were analyzed.

Figure 1 A: Normal anal sphincter (A) after NVD with intact perineum; B: residual defect 3 months after NVD with 2nd degree perineal tear; C: Large residual defect after 3rd degree tear

Results: A test re-test of 47 patients showed good repeatability of the diagnosis of EAS defects (k=0.68, CI 0.57- 0.78). Of 343 women seen on average 5.2 months (2.3-22.4) after childbirth, 23 were excluded for various reasons, leaving 320. 73 women (23 %) had a Caesarean Section (CS) and 247 (77 %) a vaginal delivery (NVD 54 %; vacuum 16%; Forceps 7 %). 130 patients (53 % of vaginally parous women) had suffered perineal trauma (1st degree tear 13 %, 2nd degree tear 31%, and 3rd degree tear 5%). An episiotomy was performed in 65 (26%). Postnatally, 3.4% reported fecal incontinence. A levator avulsion was diagnosed in 44 (13.8%), residual EAS defects on TUI in 69 patients (21.6%); 6 were complete (1,9%). Nine had been diagnosed with a 3rd degree, 29 with a 2nd degree and 2 with a 1st degree tear; 3 had an intact perineum. 31 had an episiotomy (5 extended to 3rd degree tear.) In 60 women (87%) with residual defects there was no evidence of sphincter damage in labour ward. Of 12 diagnosed with a 3rd degree tear, 2 had a complete defect (all 6 slices) at follow-up, 7 a residual defect, 2 minor abnormalities; one was rated normal. In women with residual EAS defects we found a levator avulsion in 25%, compared to 15% in those with normal EAS (P= 0.08 on x2). Table 1 shows the association between residual defects and potential predictors. There was only a

weak trend towards more fecal incontinence in those with residual defects (4/69 vs. 7/251, P= 0.2). Parameter

Age (years)

Residual EAS P Value defect (OR, CI) Univariate analysis

1.06 (1.00 1.12) BMI 0.973 (0.91 1.04) Gestational age 1.026 (0.81 (weeks) 1.29) Length of 2nd 1.003 (0.99 stage (mins) 1.01) Birthweight 1.0 (0.99 (grams) 1.0) Forceps 5.69 (2.2514.40)* Vacuum delivery 2.671 (1.375.20)* Syntocinon use 1.72 (0.983.01) Epidural use 2.09 (1.193.68) Episiotomy 3.46 (1.896.32) Avulsion 1.83 (0.923.62)

Residual EAS P Value defect (OR,CI) multivariate analysis. #

0.038 0.41 0.83 0.12 0.84 0.0002 0.0034 0.06

3.45 (1.1810.1) 1.98 (0.914.34)

0.024

2.03 (0.9454.34)

0.07

0.086

0.011 <0.001 0.084

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Table 1: Association between residual EAS defects and predictive variables in vaginally parous women (n=247). (*reference NVD); #backward elimination strategy Conclusions: In this cohort of 320 primiparous singleton term deliveries, 28% of women after vaginal delivery showed significant EAS defects. Most EAS trauma had not been detected intrapartum; three women had been diagnosed with intact perineum. This may imply truly occult trauma. In addition, we documented two episiotomies and two second degree tears with unrecognised complete EAS trauma. There seems to be a need for better education of staff in the recognition of major perineal tears, since 1/4 of OASIS were missed. However, there may be truly ‘occult’ EAS defects, ie., tears masked by intact skin / fascia. The significance of such defects remains doubtful. References 1. Int Urogynecol J (2011) 22:1221–1232. 2. Ultrasound Obstet Gynecol (2012) 39:83–90. 3. Ultrasound Obstet Gynecol (2010) 36: 368–374. 177 A PROSPECTIVE STUDY OF SEXUAL WELL BEING DURING PREGNANCY AND THE EFFECTS OF BREASTFEEDING, DEPRESSION AND MATERNAL BMI 6 MONTHS POSTPARTUM A. De Souza1, P. L. Dwyer 1, M. Charity 2, E. Thomas 1, L. Schierlitz 1 1 Mercy Hosp. for Women, Melbourne, Australia, 2Univ. of Melbourne, Melbourne, Australia Objective: To prospectively determine sexual well being during pregnancy and the effect of breastfeeding, depression and maternal BMI at 6 months post partum. Background: Requests for caesarean section in primigravidas have risen due to the belief that vaginal and sexual function may be preserved. There is a lack of prospective data addressing how perineal trauma and variables including breastfeeding, postnatal depression and maternal BMI affect sexual function. Methods: This was a prospective questionnaire based cohort study. Ethics approval was obtained. English literate primigravidas in the first trimester completed 4 validated questionnaires: Female Sexual Function Index (FSFI), Urinary Distress Inventory Short Form (UDI-6), Incontinence Impact Questionnaire Short form (IIQ-7) and Prolapse Incontinence Sexual Questionnaire Short form (PISQ-12). All questionnaires were repeated at 6 months post partum in addition to an Edinburgh postnatal depression scale (EPDS) and mode of feeding survey. Birthing outcome and demographic data were obtained from the hospital database. This study had 80 % power with alpha <0.05 to detect a statistical difference in sexual function between vaginal delivery and caesarean section (CS). Secondary outcomes of sexual function within pregnancy, breastfeeding, postnatal depression, and BMI were then analyzed.

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Significance testing of FSFI, PISQ, UDI and IIQ between time-points was undertaken using Wilcoxon Signed Rank tests. Significance testing for the effect of additional variables on the four measures was carried out using Mann Whitney or Kruskal Wallis tests depending on the number of levels of the independent variable. Non-parametric tests were used due to outliers in the sample. Results: 440 women were recruited. At 28 weeks gestation 344 (78.2 %) had completed all 4 questionnaires. Total FSFI scores were not statistically significant between the first and third trimesters of pregnancy (p00.237). There was no difference in the individual domains of the FSFI including no significant change in desire, arousal, lubrication, pain or satisfaction. In contrast, total PISQ scores were significantly decreased (p<0.001) between first and third trimesters. Individual analysis of the 12 questions showed a decrease in orgasm and orgasmic intensity, decreased arousal and satisfaction, increased fear of leakage, coital incontinence and negative emotions. At 28 weeks gestation, total UDI and IIQ scores were significantly increased (p<0.001 for both scores) with urge incontinence (p00.002), stress incontinence (p< 0.001), small urinary loss (p<0.001) and voiding difficulty (p<0.001) all increasing between first and third trimesters. At 6 months post partum, 299 (68.0 %) women completed all surveys. The mode of delivery was 79 (26.9 %) CS, 148 (50.3 %) normal vaginal deliveries (NVD), 43 (14.6 %) forceps and 24 (8.2 %) vacuum deliveries. 92 % of women were sexually active at 6 months. At discharge from hospital 89.2 % of women were exclusively breastfeeding reducing to 38.5 % at 6 months. 4.0 % of women were exclusively formula feeding increasing to 42.0 %. The remainder of patients were complementing breast milk with formula feeding. Women who were exclusively formula feeding at 6 months had a significantly higher FSFI (p00.001) and higher PISQ score (p00.033) at 6 months post delivery. 25.1 % of responders had EDPS scores>010 and were possibly depressed. These patients had lower total FSFI (p<0.001) and PISQ (p<0.001) scores and higher UDI (p00.001) and IIQ (p<0.001) scores at 6 months. There was no statistical significance between the number of women with possible depression and mode of feeding. Numbers were too small to identify an association between perineal injury and depression. 44.3 % of responders had a normal BMI. 25.2 % were overweight and 20.6 % were obese or morbidly obese. The women in the latter category had significantly higher FSFI (p00.016) and PISQ (p00.040) scores and a higher UDI score (p00.040) at 6 months. Conclusions: In our study there was no statistically significant decrease in sexual function between the first and third trimesters of pregnancy in the FSFI. PISQ score was significantly less between first and third trimesters however PISQ has not been validated for use in pregnancy. Quality of life

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related to urinary function was found to significantly decline between first and third trimesters. An increase in urinary symptoms including urge incontinence, stress incontinence, voiding difficulty and coital incontinence were noted. Exclusive formula feeding at 6 months post partum was associated with improved sexual function compared to breastfeeding. Women with postnatal depression risk had decreased sexual function and increased urinary symptoms affecting quality of life. Obese women appear to have better sexual function despite higher symptoms of urinary bother 6 months after birth. A. De Souza: Grant /Research Support; Medical Research Foundation for Women and Babies. P.L. Dwyer: None. M. Charity: None. E. Thomas: None. L. Schierlitz: None.

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rotated using the anterior margin of the symphysis pubis as a fulcrum. The angle was measured when the full length of the pubic rami was visualised (see Figure 1). All measurements were performed in triplicate, with the average used for further analysis. Logistic regression was used to model the association between the binary outcomes (vaginal delivery yes-no) and the SPAA. Cox proportional hazards model was used to examine the association between duration of second stage of labour and SPAA. The study was approved by the local IRB. Figure: Determination of SPAA on translabial ultrasound, using an adjusted axial plane. SP0symphysis pubis, PR0pubic rami, U0urethra, V0vagina, R0rectum, L0levator ani, SPAA0subpubic arch angle.

178 CAN VAGINAL BIRTH BE PREDICTED BYANTENATAL MEASUREMENT OF THE SUBPUBIC ARCH ANGLE BY 3D TRANSLABIAL ULTRASOUND? S. B. Albrich1, K. L. Shek 2, H. P. Dietz 3 1 Univ. Med. center Mainz, Mainz, Germany, 2Sydney Med. Sch. Nepean, Penrith, Sydney, Australia, 3Sydney Med. Sch. Nepean, Penrith/ Australia, Australia Objective: Vaginal birth is considered to be influenced by the interaction of bony pelvis and fetal head dimensions. In the past, the shape of the bony pelvis was considered the main determinant of vaginal delivery. One of the parameters that can relatively easily be assessed with imaging is the subpubic arch, the angle formed by the inferior rami of the os pubis. The aim of this study was to test whether measurement of the subpubic arch angle (SPAA) as a parameter of the bony pelvic outlet could predict vaginal delivery. Background: A large proportion of first-time parturients aim for a normal vaginal delivery, only to then require emergency operative delivery during labour. Prediction of delivery mode would have major benefits, enabling optimal streaming of patients towards low-risk versus high-risk services. To date, the SPAA has not been investigated as a predictor of delivery mode. Methods: Between 1/07 and 6/11, 625 nulliparous women with a singleton pregnancy were recruited from antenatal clinic in the context of two perinatal trials. This study constitutes a secondary analysis of datasets obtained in those trials. Patients were seen between 33 and 38 weeks’ gestation for an interview and 4D translabial ultrasound. Volume ultrasound data was saved for later offline analysis by the first author on a PC, using the software 4D View v10 (GE Kretz, Zipf, Austria), blinded against all other data. To quantify the SPAA, the hyperechogenic inferior rami of the pubic bone were identified in an axial plane close to the plane of minimal hiatal dimensions(1). The axial plane was

Results: An interobserver test-retest series (n020) yielded an ICC of 0.797 (95 % CI 0.50–0.919), demonstrating good repeatability. 625 women were seen at an average gestation of 36.3 weeks (33.6–38.3). They all carried singleton pregnancies and were aiming for a vaginal delivery. Mean age was 29.1 (18.1–45.3) years. Body mass index was on average 29.6 (20.9–56.5) kg/ m2. Sixteen ultrasound data files could not be retrieved, likely due to clerical error during data archiving, leaving 609 for measurement of SPAA. Patients had been delivered on average at a gestation of 39.9 (range 35.6 to 42.6) weeks. 468 (76.8 %) of Patients had been delivered vaginally (336 NVD [55.2 %], 92 Vacuum [15.2 %] and 40 Forceps [6.6 %]). There were 25 prelabour C/S (4.1 %), 89 C/S in first stage (14.6 %), and 27 C/S in 2nd stage (4.4 %). The subpubic arch angle was measured at a mean of 109.36° (SD 8.94) degrees, and this data was normally distributed. There was no association between SPAA and the odds of vaginal delivery (OR 1.005; CI 0.942–1.071; P 00.89). However, there was evidence of an association between SPAA and the duration of 2nd stage within the subgroup

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of women who delivered vaginally (Hazard Ratio HR 1.013; CI 1.002–1.023; P00.019). Conclusions: The subpubic arch angle is not useful for predicting vaginal delivery in a modern Caucasian population. Hence, the utility of this parameter in contemporary affluent developed societies seems very limited. However, the theoretical role of the subpubic arch angle in delivery mechanics is supported by our finding of a correlation between this parameter and the length of the second stage of labour in vaginal deliveries. References: 1. Ultrasound Obstet Gynaecol 2005; 25 (6): 580–585 S.B. Albrich: None. K.L. Shek: None. H.P. Dietz: Grant / Research Support; Educational grant, GE Medical. 179 OBSTETRIC ANAL SPHINCTER INJURIES: RISK FACTORS AND IMPACTS OF INCONTINENCE S. Dilgir St. George Hosp., Sydney, Australia Objective: To determine predictive factors for obstetric anal sphincter injury (OASI) by comparing prospectively collected data of primiparous women who sustained an OASI to a control population. Furthermore, to determine the likelihood of both urinary and faecal incontinence in these women at 6 weeks post-partum using the ICIQ-SF and St. Marks score respectively, and compare these to controls. Background: Sparse information is available to characterize risk factors for OASI in the Australian population, and in a multi-ethnic setting. Few studies assess risk factors for OASI in the context of controls. Further understanding of risk factors leading to OASI is required in order to consider preventative measures for this common problem. Methods: A proforma was completed by midwifery and medical staff when a primiparous woman sustained an OASI. The pro-forma explored details of the delivery and repair. These women were seen at a dedicated multidisciplinary clinic at 6 weeks post-partum including a urogynaecologist, physiotherapist, with colorectal support and subsequent anorectal physiology testing. At 6 weeks postpartum, fecal and urinary symptoms were reviewed using the St. Marks score and ICIQ-SF respectively. A control population was studied consisting of women who were primiparous (or multiparous if they had a LSCS previously) and delivered vaginally but did not sustain a 3rd or 4th degree tear. After obtaining informed consent, information on detail of the delivery was completed. A research nurse contacted these women by phone at 6 weeks post-partum to assess for symptoms incontinence and quality of life measures. Ethics approval was obtained. Variables analysed included patient and partners racial background. Details of labour onset, progression and delivery

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were recorded, including gestation, gender, birth weight and head circumference. The severity of anal sphincter injury was classified, and repair methods were explored. At the 6-week follow-up the ICIQ-SF was used to determine the degree of urinary incontinence and the St. Marks score was used to determine degree of fecal incontinence. Quality of life was assessed with questions on sexual activity, breastfeeding and desire for future children. The data was entered into SPSS version 18 database for analysis. Descriptive statistics were performed and a significance level of 0.05 was used. Results: At present, 222 women with OASI have been compared to 65 controls. Data collection is ongoing. Compared to controls, women with OASI were more likely to: – – –

Be of Indian and Asian origin (p0.000). Have an instrumental delivery (p0.009) Deliver in a an occipito-posterior position (p0.002)

Factors that were not associated with OASI compared to controls were: – – – – –

Maternal age (p0.0738) Episiotomy (p0.818) Epidural usage (p0.738) Mean duration of pushing (p0.797) Birth weight (p00.892)

At 6-weeks post partum, the mean ICIQ-SF score was surprisingly higher in the control group (p00.017). Furthermore there was no statistical difference in the St. Marks scores of women who sustained OASI compared to controls. (p00.582). However, the incidence of St Marks scores greater than 6 was 5.4 % in the OASI group, versus 6.2 % in controls (p0.318) At 6- weeks post partum, women sustaining OASI were less likely to have commenced intercourse (p .030), and were more likely to want no future pregnancies compared to controls (p0.001) Conclusions: Our study has identified independent risk factors for OASI in an Australian setting. These include Indian and Asian ethnicity, instrumental delivery and persistent occipitoposterior position at delivery. Women not sustaining OASI may also develop faecal incontinence symptoms and may be similar in severity to women with OASI. Surprisingly, subjective urinary incontinence severity is higher in women who do not sustain OASI. S. Dilgir: Consultant; Emmanuel Karantanis. 180 RISK FACTORS FOR SEVERE OBSTETRIC LACERATIONS: MODERN OBSTETRICS AT A TEACHING INSTITUTION L. H. Quiroz, D. Deschamps, M. Brinlee, R. Wild, E. Crouse, S. Shobeiri The Univ. of Oklahoma, Oklahoma City, OK

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Objective: To evaluate current risk factors for severe obstetric perineal lacerations at a single university-affiliated hospital. Background: Methods: A case control study was designed by reviewing the clinical records of all vaginal deliveries between September 2009 and March 2012. Cases of a severe perineal laceration were defined as women with 3rd or 4th degree laceration and controls were defined as any patient who did not have a 3rd or 4th degree laceration. Controls were matched by month of delivery. Four controls were randomly selected for each case of a severe perineal laceration. Obstetric and maternal characteristics were analyzed and compared between cases and controls for the given study period. Continuous variables were compared with t-tests or Wilcoxon Rank Sum test. Proportions were compared with Fischer’s exact test or Chi squared where appropriate. Univariate analysis was used to identify significant variables, which were then entered into a multivariate logistic regression model to identify independent risk factors. P value of <0.05 was considered significant. Results: 9,143 vaginal deliveries were identified during the study period. Mean age was 26.5 (± 5.89 SD). 38 % were Caucasian, 37 % Hispanics and 18 % were African American. Over the study period, only 1.8 % underwent an instrumented vaginal delivery with either vacuum or forceps and 0.8 % had episiotomies. Perineal laceration rates did not vary significantly by month of delivery. 160 cases of a severe perineal laceration were identified during the study period, and 640 controls were randomly chosen, matched by month of delivery. Of the various maternal factors, primiparity, Asian ethnicity and heavier maternal weight were more common among cases with a severe perineal laceration. Gestational age, prolonged 2nd stage, episiotomy, instrumented delivery, birth weight >4000 g and head circumference >35.5 cm were more common in cases with a severe perineal laceration, while epidural analgesia and oxytocin use were not. Multivariate logistic regression showed episiotomy (OR 13.14, 95 % CI 6.7, 46.8), primiparity (OR 4.5, 95 % CI 2.9, 7.2), instrumented delivery (OR 3.5, 95%CI 1.6, 7.8), prolonged second stage (OR 2.1, 95 % CI 1.2, 3.8), and baby heavier than 4,000 g (OR 3.2, 95 % CI 1.6, 6.1) to be associated with increased odds of having a severe perineal laceration. Conclusions: Risk factors for severe perineal lacerations, include episiotomy, primiparity, instrumented delivery, prolonged second stage and heavier birth weight. Low rates of episiotomy and instrumented delivery are reflective of current obstetric practices at this teaching institution. In spite of recent high rates of cesarean sections, risk factors for severe perineal lacerations remain unchanged. References (optional): L.H. Quiroz: None. D. Deschamps: None. M. Brinlee: None. R. Wild: None. E. Crouse: None. S. Shobeiri: None.

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181 PERIPARTUM BLADDER CARE IN HIGH RISK OBSTETRIC CASES A. Obloza, J. D. Gandhi Hull NHS Trust Hosp., Hull, United Kingdom. Objective: The aim of this study was to assess the level of compliance with NICE (National Institute of Clinical Excellence), RCOG (Royal College of Obstetricians and Gynaecologists) and Trust Guidelines for intrapartum and postpartum bladder care. Background: Intrapartum and postnatal bladder care are pivotal in preventing postpartum urinary retention which occurs in 4–17 % women (1). Unrecognised postnatal bladder overdistention may cause irreversible damage to the detrusor muscle that presents as recurrent urinary tract infections and permanent voiding difficulties (2). Studies have shown that normal bladder sensation is impaired up to 8 h following last epidural top up; during this stage postpartum bladder is susceptible to overdistention (3). Methods: Retrospective study comparing 183 selected cases of high risk patients (trial of instrumental delivery, full dilatation caesarean section, 3rd or 4th degree tear, manual removal of retained placenta) between March and September 2011. In line with the local protocol following were evaluated: timing and volume of the 1st postpartum void, assessment of postpartum micturition delay beyond 6 h, indwelling and intermittent self-catheterisation, and specialist continence services involvement. Data was collected from case notes and analysed using Excel Basic statistic package. Results: Catheterisation of high risk patients shortens 1st postnatal voiding interval (p<0.0001) (fig: 1). Seventy five per cent of catheterised patients passed 1st postpartum void within 6 h vs. only 39 % of non-catheterised postpartum women. Women who had postpartum catheter between 8 and 12 h, voided sooner than patients who did not have postpartum catheter (280 min vs. 500 min) (fig: 2). Catheterisation reduced 1st postnatal voiding time in patients with perineal trauma (360 min vs. 480 min), shoulder dystocia (180 min vs. 394 min), prolonged 2nd stage of labour (380 min vs. 550 min), obesity (290 min vs. 500 min), postpartum haemorrhage >500 ml, and history of pre-pregnancy voiding difficulties when compared with non catheterised patients. Intrapartum time record of bladder emptying at the beginning of 2nd stage of labour was achieved in 50.5 % cases. Record of bladder emptying prior to instrumental delivery reached 96 %. Poor record keeping of 1st postnatal voiding time and volume were observed (8.3 %). Conclusions: This study demonstrated that high risk obstetric patients, who were catheterised, voided within 6 h after catheter removal. Patients who were not catheterised took 8 h before their 1st postpartum void. This may be

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due to more staff awareness regarding bladder care following catheter removal rather than physical / obstetric cause. Patients who were catheterised for 8–12 h postpartum voided sooner than those who had catheter removal in less than 8 h, or more than 12 h after the delivery. First postpartum void documentation should be an integral part of the postnatal bladder care. References: 1. Aust N ZJ Obstet Gynaecol 2002; 42:365–8. 2. International Journal of Gynaecology and Obstetrics 2005; 91: 71–2 3. Neurourol Urodyn 993; 89:424–5.

A. Obloza: None. J.D. Gandhi: Consultant; AMERICAN MEDICAL SYSTEM. 182 PELVIC FLOOR MUSCLES AND PELVIC ORGAN SUPPORT ARE ALTERED BY THE FIRST THREE VAGINAL DELIVERIES IN A COHORT OF SQUIRREL MONKEY FEMALES USING NONINVASIVE SERIAL MAGNETIC RESONANCE IMAGING EXAMINATIONS J. N. Bracken, M. Reyes, J. M. Gendron, V. M. Runge, B. L. Shull, T. J. Kuehl Scott & White Hlth.care and Texas A&M Hlth.Sci. Ctr. Coll. of Med., Temple, TX.

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Objective: Serial magnetic resonance imaging (MRI) examinations were used to test whether pelvic muscle volumes and pelvic organ support are altered by parturition and recovery in squirrel monkeys undergoing their first three pregnancies and deliveries. Background: Vaginal delivery and number of pregnancies are established risk factors in pelvic floor dysfunction. We have previously noted changes in the pelvic floor associated with one pregnancy and parturition in the squirrel monkey, a species with a human-like pattern of spontaneous age and parity associated pelvic organ prolapse. We now extend these studies to follow a cohort of females through multiple pregnancies with the hypothesis that serial pregnancies leading the births of large developing fetuses will contribute to progressing changes in the pelvic support and pelvic floor muscles. Only a serial noninvasive technology such as MRI allows such observations with sufficient resolution to quantify these changes. Methods: Levator ani (LA), obturator internus (OI), and coccygeus (COC) muscle volumes were obtained from serial gradient echo axial images of 5 females prior to pregnancy, 3 days after first delivery, and 3 months post-partum followed subsequently by examinations 3 days after the second and third delivery, and 3 months post-partum after the second and third deliveries during a 4 year time frame. MRI was performed on anesthetized animals using an 8channel wrist coil and Siemens 3 T Trios. Position of the bladder neck relative to bone landmarks was measured at each session using a dynamic MRI with abdominal squeezing using a neonatal blood pressure cuff. Positions and muscle volumes were compared using analysis of variance with repeated measures and Duncan’s post-hoc test with p< 0.05 taken as significant. Results: Five females delivered 15 infants at 149±2 (mean with SD) days gestation without a difference (p00.61) related to parity. Infants weighed 116±15 g in females weighing between 700 and 900 g without (p00.31) effect of parity. Infants delivered mentum anterior with presenting face having a circumference of 10.6±0.8 cm without (p0 0.57) effect of parity. In the presence of this similar challenge, LA and OI volumes also did not vary (p>0.12), while COC volumes increased after the second (p00.002) and third (p00.0004) deliveries. In general COC volumes were greater immediately after parturition, then decrease after a recovery interval of 3 to 4 months (Figure). Percent of COC accumulating contrast agent increased (p<0.0008) during the study interval from 0 % to 39 %, 51 %, and 60 % immediately after the 1st, 2nd, and 3rd deliveries, respectively, and was only partially corrected to 19 %, 24 %, and 32 % by 3 to 4 months postpartum before the next pregnancy. Bladder neck position with abdominal pressure was seen as descended (p<0.0001) at 4 months after the first delivery, but did not differ with the effects of 2 additional deliveries (Figure).

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Conclusions: In the squirrel monkeys, the COC muscles demonstrated changes related to pregnancy and parturition, and the bladder neck descent seen after the first pregnancy and delivery continues, but does not worsen with two additional pregnancies.

J.N. Bracken: None. M. Reyes: None. J.M. Gendron: None. V.M. Runge: None. B.L. Shull: None. T.J. Kuehl: None. 183 WEB VS PAPER-BASED COMPLETION OF THE EPIDEMIOLOGY OF PROLAPSE AND INCONTINENCE QUESTIONNAIRE (EPIQ) M. J. Egger 1, E. S. Lukacz2, M. E. Newhouse 3, J. Wang 1, I. E. Nygaard 1 1 Univ. of Utah, Salt Lake City, UT, 2Univ. of California San Diego, La Jolla, CA, 3Univ. of Utah, Salt Lake City, UT Objective: To examine the validity and reliability of a webbased version of the Epidemiology of Prolapse and Incontinence Questionnaire (EPIQ) compared to the standard paper-based EPIQ. 1 Background: The EPIQ is a validated, paper based, questionnaire designed to identify the presence of bothersome pelvic floor disorders in community dwelling women. It includes domains for stress urinary incontinence (SUI), overactive bladder (OAB), pelvic organ prolapse (POP) and anal incontinence (AI). With increasing use of electronic and web based questionnaires in research, it is important that the instruments maintain their validity. Methods: Participants included 876, non-pregnant women, ages 38 to 65, not seeking care for pelvic floor disorders, recruited from primary care clinics in the Salt Lake Valley for an ongoing cross-sectional study about lifetime physical activity and it’s relationship to prolapse and stress incontinence. Women completed either a single web or paper based version, and a subset was recruited to repeat the same or opposite method (with order randomized) of questionnaire

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at 2 separate time points. Factor analysis of the 22 EPIQ items related to PFD symptoms was performed using principal components analysis and varimax rotation to assess subscales for the web-based version. Internal consistency was assessed using coefficient alpha. Test-retest and intermethod reliability were assessed using intraclass correlation coefficients (ICC[2,1]) for mean domain scores. Correlations above 0.70 were considered acceptable. Results: Overall, 384 women completed the web and 492 completed the paper administration of the EPIQ and 93 % were Caucasian with mean age of 50±7 years. Of these, 63 completed web-web, 57 web-paper, 47 paper-web and 109 paper-paper test-retest. Overall, factor analyses were consistent with the 7 domains of the original EPIQ (data not shown). Cronbach’s alpha for the 4 symptomatic PFD domains (defined using original EPIQ subscales) and range of test-retest reliability for the various administration methods are shown in Table 1. All domains were similarly consistent and reliable save for POP in the web administrations: however, only 1 woman in the web-web group, 1 in web-paper, and 0 in paperweb were characterized by the EPIQ as having symptomatic POP, which is insufficient to estimate reliability. Conclusions: Overall, web administration of the EPIQ has similar psychometric properties with comparable internal consistency and test-retest reliability when administered in the same modality. Reliability between both methods of administration is acceptable for SUI, OAB and AI. Interpretation of results related to POP diagnosis using web administration may need further assessment in a larger, more diverse population of women with and without PFD. PFD Domain N SUI OAB Overall prevalence (%) 876 12.1 % 7.3 % of symptomatic PFD ** Internal Consistency (Cronbach’s alpha) 294 0.85 0.89 Original 2005 EPIQ1 validation study Web administration 384 0.81 0.84 Paper administration 492 0.84 0.84 Test Retest Reliability (intraclass correlation) Web-web administration 63 0.88 0.85 (mean interval 61±61 days) Paper-paper administration 109 0.89 0.90 (mean interval 69±58 days) Intermethod Reliability (intraclass correlation) Web vs. Paper administration 57 0.79 0.82 (mean interval 51±39 days) Paper vs. Web administration 47 0.81 0.90 (mean interval 71±57 days)

POP* AI 4.2 % 18.3 %

NA

0.58

NA NA

0.51 0.61

NR

0.68

0.85

0.85

NR

0.82

NR

0.76

*NA0not applicable, single item scale; NR0not reported, small numbers. **using 1st completed EPIQ and determined by original EPIQ subscales 1. Int Urogynecol J Pelvic Floor Dysfunct. 2005; 16(4): 272–84.

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M.J. Egger: None. E.S. Lukacz: Consultant; Pfizer, Ethicon/Johnson & Johnson. Grant /Research Support; Renew Medical, Ethicon/Johnson & Johnson. M.E. Newhouse: None. J. Wang: None. I.E. Nygaard: None. 184 PREVALENCE OF LEVATOR DEFECTS DETECTED B Y 3 D P E R I N E A L U LT R A S O U N D A N D I T S CORRELATION WITH CLINICAL PALPATION IN A UROGYNECOLOGICAL COHORT S. B. Albrich, E. Haberer, K. Rommens, R. M. Laterza, C. Skala, G. Naumann, H. Koelbl Univ. Med. center Mainz, Mainz, Germany Objective: Perineal sonography today plays an indispensable role in imaging of the pelvic floor in urogynecology. Introduction of the c-plane by 3D/ 4D ultrasound technology enables us to detect defects of the puborectalis sling of the levator ani muscle at the insertion to the pubic bone. The aim of this study was to describe the prevalence major levator defects by 3D/4D perineal ultrasound and its correlation with palpation in a cohort of urogynecological patients. Background: Major levator defects seem to fill the pathophysiological gap between trauma by vaginal childbirth and urogynecological symptoms in later life. Several studies have demonstrated the correlation of levator avulsion with pelvic organ prolapse of the anterior and central compartment. Furthermore there seems to be a risk for prolapse recurrence after surgery for patients with major levator defects. Methods: We performed a retrospective analysis on patients referred to our tertiary urogynecological unit. Only patients, on whom a 3D/ 4D perineal ultrasound was obtained between March 2011 and March 2012 were included in the analysis. The clinical assessments consisted of an interview, a speculum examination, a palpation of the levator ani and 4D perineal ultrasound. Volume ultrasound data was obtained in the dorsal lithotomy position at rest, on maximal Valsalva and on pelvic floor muscle contraction after emptying of the bladder. All data was saved for later analysis using the software 4D View v10 (GE Kretz, Zipf, Austria), blinded against all other data. Evaluation of the pelvic floor muscle by palpation consisted of an Oxford-Score (0–5) and presence or absence of muscle tissue at the site of insertion at the pubic bone bilaterally. Ultrasound analysis was carried out at a later stage by the same examiner blinded to all other data. Evaluation of levator ani integrity was performed in a standardized way at maximum pelvic floor muscle contraction using tomographic ultrasound imaging as described by several research groups. Three groups were formed according to patients symptoms: stress incontinence symptoms, ovar-active-bladder (OAB) symptoms and pelvic oran prolapse symptoms. Results: After interim analysis 146 out of a total of 327 patients were evaluated. There were 76 patients complaining

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of stress urinary incontinence, 101 with OAB symptoms and 76 patients with symptoms of pelvic organ prolapse. By clinical palpation a unilateral or bilateral levator defect was detected in 16 (11.2 %) cases (8 cases each for unilateral and bilateral defects). Any major levator defect was found by ultrasound in 22 (15.4 %) cases. With the use of ultrasound we found 11 (14.5 %) cases of levator defects within the group of stress incontinence, 14 (13.9 %) cases in the OAB-group and 17 (25.4 %) in the prolapse-group. Therefore the ovaer-all correlation for the assessment of levator status by palpation and 3D ultrasound was 91.6 %. The correlation for patients with symptoms of stress incontinence and OAB-symptoms was 92.1 % and 86.6 % for patients complaining with symptoms of pelvic organ prolapse. Conclusions: The prevalence of levator defects in a cohort of urogynecological patients was 15.4 % detected by 3D ultrasound and 14.2 % by clinical palpation. In women with pelvic organ prolapse the prevalence was highest (25 %). Overall our study revealed a high correlation of palpation with 3D ultrasound.

S.B. Albrich: None. E. Haberer: None. K. Rommens: None. R.M. Laterza: None. C. Skala: None. G. Naumann: None. H. Koelbl: None. 185 ASSESSING QUALITY OF LIFE IN UROGYNAECOLOGY— A COMPARISON OF PAPER AND ELECTRONIC QUESTIONNAIRES L. A. Linehan1, O. E. O’sullivan2, E. Babiker2, A. S. Khashan3, B. A. O’reilly2, S. O’sullivan 2 1 Univ. Coll. Cork, Cork, Ireland, 2Cork Univ. Maternity Hosp., Cork, Ireland, 3Anu Res. Ctr., Cork, Ireland.

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Objective: The aim of this study was to compare the electronic personal assessment pelvic floor questionnaire, ePAQ-PF, to the paper-based Queensland pelvic floor questionnaire. The QQ-10 was used as a comparative measure of the Value and Burden of use of these questionnaires. The study also sought to examine the acceptability of the questionnaires to older women and to compare the completion rates of the sexual function sections. Background: It is well recognised that urogynaecological symptoms can have a detrimental effect on patient quality of life. Multiple questionnaires have been designed to capture this effect. Two recently developed comparable specific instruments are the Queensland Pelvic Floor Questionnaire [1] and the Electronic Pelvic Floor Symptoms Assessment Questionnaire (ePAQPF) [2]. Both assess all pelvic floor complaints, including bladder, bowel and sexual function and prolapse symptoms. They also estimate the impact of these symptoms on patients quality of life. The QQ10 is a ten-item questionnaire that was originally designed to measure the face validity of ePAQ-PF [3]. It comprises a series of positive(Value) and negative (Burden) statements relating to patients experience of questionnaire use, each with a five point Likert response scale relating to their agreement with these statements[3] Methods: Over a 6 month period,186 women attending Urogynaecology clinics in CUMH were asked to participate. Women were selected based on symptomatology from their GP referral letters and sent a Queensland questionnaire and QQ-10 to complete at home. In clinic, they completed ePAQ-PF and a second QQ-10. The Burden and Value scores of the QQ-10 from each questionnaire were calculated and median scores compared using Wilcoxon matched-pairs signed-rank test. The scores were then evaluated according to age. The completion rate of the sexual function domain in these groups was also analysed, and Pearson’s chi-squared test calculated. Results: One hundred women participated. The average age of respondents was 55 years (range 29–91). A statistically significant difference existed between the Value medians, with a p-value of 0.0036. Women aged 40–91 were more likely to find ePAQ-PF of most Value, with a p-value of 0.001. There was no statistically significant difference found between the Burden scores. There was a significant relationship between age and completion of the sexual function sections (χ2(1)037.5693, p 0 <0.0001). Women were more likely to complete the sexual function section on Queensland than ePAQ-PF (61% vs. 56%).

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Conclusion: In conclusion, either form of quality of life questionnaire appears acceptable and could be integrated into routine clinical assessment or employed for research. Surprisingly, our population seemed to adapt well to the computer-based questionnaire, but this may have been due to the presence of an assistant to offer instruction, whereas the paper based questionnaire had to be completed at home. This greater Value must also be balanced against the greater response rate to the sexual function section in Queensland, which may have been due to the increased privacy afforded by completion at home, and the cost involved in using electronic equipment. References: 1. BJOG(2004) Vols. 111:33–36. 2. Int Urogynaecol J.(2010) Vol 21: 163–172 3. Int Urogynaecol J,(2009) Vol. 20. 3: S293–S94, L.A. Linehan: None. O.E. O’Sullivan: None. E. Babiker: None. A.S. Khashan: None. B.A. O’Reilly: None. S. O’Sullivan: None. 186 QUALITY OF LIFE AFTER VAGINAL VAULT PROLAPSE OPERATION M. HALASKA Dept. of Obstetrics and Gynecology, Charles Univ. in Prague, 1st Med. Faculty and Faculty Hosp. Na Bulovce, Prague, Czech Republic. Objective: To compare the impact on QoL after sacrospinous fixation and prolene mesh in the treatment of posthysterectomy vaginal vault prolapse Background: Recently the use of mesh for POP repair has spread, but it is unclear whether it results in better outcomes than traditional sacrospinous fixation. Methods: Patients undergoing the operation were randomized into classical way ( Sacrospinous fixation0group SSF) or using polypropylen total mesh (total mesh0group PT). In 3 years lasting multicentre prospective randomized comparative study we evaluated questionnaires ( UIQ- Urinary Impact Questionnaire, POPIQ- Pelvic Organ Prolapse Impact Questionnaire, CRAIQ -Colo Rectal Anal Impact Questionnaire, PISQ-12 -Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire) of 141 patiens. Data were collected at 3 months and 1 year postoperatively. The inclusion criteria were: women older 18 years, POP of vaginal vault stage II and signed informed consent. Results: 141 patient were enrolled, 60 % completed all the questionnaires at 12 months. The PISQ-12 and the three scales UIQ, CRAIQ and POPIQ exhibited statistically significant improvements after the surgery without significant differences between groups. (UIQ SSF 115.97/54.33/31.48

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vs. PT 103.22/59.12/32.8 ; CRAIQ SSF 35.97/19.7/13.17 vs. PT 37.86/15.92/4.59 ; POPIQ SSF 74.38/27.27/9.13 vs. PT 76.72/16.21/11.55 ; PISQ-12 SSF 29.8/33.63/36.53 vs. PT 30.89/33.02/33.44). Conclusions: The results of our study have shown that sacrospinous fixation and polypropylen total mesh are comparable concerning QoL. References (optional): Fatton B, Savary D, Velemir L, Amblard J, Accoceberry M, Jacquetin B.: Sexual outcome after pelvic reconstructive surgery. Gynecol Obstet Fertil. 2009 Feb;37(2):140–59.

187 THE DIAGNOSTIC ACCURACY OF REAL-TIME ENDOSONOGRAPHIC ELASTOGRAPHY FOR DETECTING ANAL SPHINCTER DEFECTS IN WOMEN A. A. Bhide1, G. A. Digesu 1, S. Dutta 2, V. Khullar 1, R. Fernando 1 1 Imperial Coll. London, London, United Kingdom, 2 Imperial NHS Trust, London, United Kingdom.

M. Halaska: Consultant; Oldrich Sottner, Katerina Maxova, Ladislav Krofta, Kamil Svabik, Michal Krcmar, Alois Martan, Zdenek Adamik.

Objective: To compare the diagnostic accuracy of Real-time Endosonographic Elastography (RTE) with Endoanal ultrasound (EAUS) in diagnosing anal sphincter defects in women. Background: EAUS is reported as the gold standard for diagnosing anal sphincter defects in women after obstetric anal sphincter injury (OASIS)1. RTE is a new imaging technique which detects differences in radiofrequency signals following endogenous and exogenous compression due to different elastic properties of tissues2. Tissues are compressed producing strain depending on the elasticity of the tissues. Strain is lower in harder tissues and appear as blue and higher in softer tissues and appears as red on RTE. Diseased, damaged or fibrosed tissue is considered to be less elastic, produce less strain and therefore appear blue on imaging3. Figure 1 below shows RTE images of an intact anal sphincter complex.

Methods: Women attending a pelvic floor clinic who sustained OASIS during childbirth underwent EAUS and RTE with Hitachi EUB 7500 scanner using the R54 12 mm rectal probe. First EAUS was performed identifying puborectalis

(PR), deep, superficial and subcutaneous External Anal Sphincter (EAS) and Internal Anal Sphincter (IAS). Then RTE was performed using the technique described by the manufacturer at the same levels of the anal sphincter

Group SSF UIQ CRAIQ POPIQ PISQ-12 Group PT UIQ CRAIQ POPIQ PISQ-12

0 months

3 months

12 months

115.97 35.97 74.38 29.8

54.33 19.7 27.27 33.63

31.48 13.17 9.13 36.53

103.22 37.86 76.72 30.89

59.12 15.92 16.21 33.02

32.8 4.59 11.55 33.44

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complex. All images were saved in the hospital Picture Archive and Communication System (PACS). The EAUS and RTE images were separately analysed by the same experienced clinician and presence or absence of defects of the anal sphincter complex were compared. In the RTE images Blue areas were interpreted as defects/scar tissue, Red or Green areas were interpreted as normal sphincter and areas without colour were interpreted as uninterpretable. Areas with no continuous colour were interpreted as fragmented.

Results: Thirty eight women were recruited from the pelvic floor clinic with a mean age of 33 years (range 22–42 years). Twenty eight women were para 1 and 10 were para >2. All women had either a spontaneous vaginal delivery or assisted vaginal delivery. Eighteen patients had 3A tears, 10 had 3B tears, 7 had 3C tears and 3 had 4th degree tears. All tears had been identified and repaired at the time of delivery as per the recommended guidelines. Thirty four out of 38 images were available in the PACS for offline analysis. The findings of the analysis are in table 1.

Table 1. EAUS and RTE findings of the anal sphincter complex EAUS (n034)

PR IAS Deep EAS Superficial EAS Subcut EAS

RTE (n034)

No defect n (%)

Defect n (%)

Fragmented n (%)

Uninterpretable n (%)

No defect (Red/ Green) n (%)

Defect/ Scar tissue (Blue) n (%)

Fragmented (No continuous Colour) n (%)

Uninterpretable (Without colour) n (%)

34(100) 26 (76) 25(74) 24(70) 29(85)

0 8(24) 9(26) 10(30) 5(15)

0 0 0 0 0

0 0 0 0 0

30(88) 12(35) 17(50) 13(38) 11(32)

1(3) 5(15) 9(26) 14(41) 3(9)

0 10(30) 2(6) 2(6) 5(15)

3(9) 7(20) 6(18) 5(15) 15(44)

Twenty per cent of RTE images of the IAS and up to 44 % of EAS images were uninterpretable compared to none in the EAUS group. Conclusions: This study has demonstrated that the present technique of imaging the anal sphincter complex by RTE is not comparable with the gold standard EAUS. Further studies are needed to improve the technique and interpretation of RTE and also to relate the RTE image findings with symptoms and anal manometry findings. References: 1 Br.J.Surg.81, 463–465.1994. 2. Scand J Gastroenterol.;45(1):30–8. 2010. 3. Ultrason Imaging 1991 Apr;13(2):111–34. A.A. Bhide: None. G.A. Digesu: None. S. Dutta: None. V. Khullar: None. R. Fernando: None.

188 HAEMATOMAS MAY MASQUERADE AS LEVATOR ANI MUSCLE DEFECTS K. Van Delft1, A. Shobeiri 2, A. H. Sultan 1, R. Thakar 1 1 Croydon Univ. Hosp., Croydon, United Kingdom, 2Univ. of Oklahoma Hlth.Sci. Ctr., Oklahoma City, OK. Objective: To investigate whether levator ani muscle detachment can be detected within hours of delivery, using Endovaginal Ultrasonography (EVUS). Background: Levator avulsion is the disconnection of the muscle from its insertion on the inferior pubic ramus and the pelvic side wall, whereas tears may occur in any part of the muscle1. Avulsion is a common consequence of overstretching of the levator ani

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muscle during the second stage of labour and occurs in 10–36 % of women usually during their first vaginal delivery1. This trauma is associated with female pelvic organ prolapse later in life. Such trauma was initially thought to be occult, until it was shown to be visible in a patient who suffered a large vaginal tear at the time of delivery2. Although EVUS has been used to evaluate levator ani muscle attachment to the pubic bone 1 , it has not been described in the immediate postpartum period. Methods: All patients were recruited as part of a prospective longitudinal study in which women were seen antenatally, within 3 days of delivery and 3 months postpartum. All women underwent clinical examination and EVUS (BK Medical 9–16 MHz, 360° rotational probe). Levator ani attachment was assessed by placing the index finger laterally in the lower third of the vagina parallel to the urethra and palpating the pubococcygeus muscle at rest and during contraction3. All scans were analysed by two independent investigators to check whether the levator ani muscle was attached to the pubic bone in the plane of the minimal hiatal dimensions. Results: 83 scans were performed at a median of 13 h (range 1–92) following term delivery and 75 scans were performed 3 months following delivery. The mean age was 33.7 (SD±9.2) years and mean BMI was 23 kg/m 2 (SD±4.2). A haematoma appears well delineated hypoechoic (Fig 1). There were no haematomas in the caesarean section group (n 025). Of the 58 (69.9 %) women who had a vaginal delivery, 21 (36.2 %) were found to have haematomas on EVUS (10 bilateral, 9 right, 2 left). There was 100 % agreement in interpretation of haematomas on the scans between the two investigators. Two bilateral defects were identifiable clinically at the time of delivery. There were 19 right haematomas within 3 days of delivery of which 21 % (4/19) were seen as a defect 3 months

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postpartum. On the left there were 12 haematomas within 3 days of delivery of which 25 % (3/12) were seen as a defect 3 months postpartum (Fig 2). Conclusions: One third of primigravid women delivering vaginally develop levator ani haematomas within hours of delivery. Most of these haematomas resolve within 3 months. Therefore, in order to avoid overdiagnosis, caution is required in interpreting sonographic postpartum levator defects as they are more likely to be a haematoma. Figure 1. Bilateral haematomas. PB0pubic bone, U0urethra, LAM0levator ani muscle, V0vagian, A0anal canal, *0haematoma

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Figure 2. Flow chart of haematomas and defects. v20visit within 3 days of delivery, v30three months postpartum

References: 1. Ultrasound Obstet Gynecol 2011;37:381–96 2. Aust N Z J Obstet Gynecol 2007;47:341–4 3. Int Urogynecol J 2008;19:1097–101 K. van Delft: None. A. Shobeiri: None. A.H. Sultan: None. R. Thakar: None. 189 COMPARISON OF 3D ENDOVAGINAL ULTRASOUND TO MAGNETIC RESONANCE IMAGING OF THE PELVIC FLOOR MUSCULATURE D. E. White, J. North, G. Rostaminia, M. Mukati, L. H. Quiroz, S. Shobeiri The Univ. of Oklahoma, Oklahoma City, OK. Objectives: To directly compare the use of 3-dimensional endovaginal ultrasound (3D EVUS) and magnetic resonance imaging (MRI) of levator ani (LA) muscle abnormalities.

Background: Much of the understanding we currently have of pelvic floor anatomy is based on cadaveric and MRI data. Until recently, MRI has been the only available option for adequately visualizing many of the structures in the pelvic floor such as the LA muscles. Correlative studies using MRI in patients with pelvic floor disorders have demonstrated structural abnormalities1; however, the use of MRI in the evaluation of pelvic floor disorders has been limited by expense and lack of individuals with appropriate expertise in interpreting the images. 3D EVUS has been shown to reliably visualize the LA anatomy2, but a direct comparison of the two techniques has not yet been published in the literature. We aim to compare these imaging modalities in the evaluation of LA defects in women with pelvic floor disorders. Materials and Methods: This was a retrospective cohort study. We included women who underwent magnetic resonance imaging (MRI) for evaluation of the pelvic floor at the Women’s Pelvic and Bladder Health clinic at the University

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of Oklahoma Health Sciences Center. These patients were contacted and invited to undergo a 3D EVUS. Institutional Review Board approval was obtained. A radiologist, fellowship-trained in body imaging with special expertise in pelvic floor imaging interpretation, reviewed all MRI images, evaluating the following structures: puborectalis (PR), puboanalis (PA), puboperinealis (PP), and iliococcygeus (IC). The right and left portions of each muscle were evaluated independently. All structures were classified according to the following categories: seen and normal, seen but abnormal, seen but unable to fully evaluate (poor quality), and not seen. For additional analysis, structures were also categorized as binary data (seen/not seen). Utilizing the same categories, two evaluators trained in interpretation of 3D EVUS images of the pelvic floor, blinded to the results of the MRI readings, independently reviewed the 3D rendered data cubes. Descriptive statistics were computed using standard methods. Absolute agreements between imaging modalities are listed as percentages. Paired data was analyzed with McNemar’s test. A p value of 0.05 was considered significant. Results: The MRI and 3D EVUS images of 28 patients were reviewed. 86 % of the patients were Caucasian. The mean age was 51 (±18.23 SD), median BMI was 29.75

(range 20.67, 47.29). The most common indication for MRI was defecatory dysfunction (32 %) followed by pelvic pain (18 %). No patient had pelvic surgery in the time between MRI and 3D EVUS. Exact agreement by imaging modality were: 79 % for left PP, 75 % for right PP, 75 % for left PA, 68 % for right PA, 82 % for left PR, 71 % for right PR, 82 % for left IC, and 19 % for right IC. When unilateral subdivisions were categorized by normal, abnormal, not seen, and poor quality, 3D EVUS more often classified structures as “abnormal” as compared to MRI with the exception of the right PA and right PR (p00.1912 and 0.3340, respectively). When analyzing only those patients with structures visualized on both MRI and 3D EVUS, there was a significant difference in identification of abnormalities between the two techniques for all subdivisions except the right PR (Table 1). When comparing “seen” vs. “not seen”, the right and left IC subdivisions were visualized significantly more often on MRI (p00.0253 and 0.0027, respectively). There was no difference between the visualization of any other structure. Conclusions: 3D EVUS identifies abnormalities in most LA subdivisions more frequently than MRI. References: AJR American Journal of Roentgenology (3):786–791 Obstetrics & Gynecology 114:66–72

Table 1. Comparison of identification of abnormalities in LA subdivisions visualized by both MRI and 3D EVUS Variable Left PP (n, %) Normal Abnormal Right PP (n, %) Normal Abnormal Left PA (n, %) Normal Abnormal Right PA (n, %) Normal Abnormal Left PR (n, %) Normal Abnormal Right PR (n, %) Normal Abnormal Left IC (n, %) Normal Abnormal Right IC (n, %) Normal Abnormal

MRI (n028)

3D EVUS (n028)

Exact agreement (n, %)*

P Value

20 (80.00) 5 (20.00)

5 (26.32) 14 (73.68)

8/18 (44.44)

0.0016

18 (69.23) 8 (30.77)

5 (27.78) 13 (72.22)

8/18 (44.44)

0.0114

18 (85.71) 3 (14.29)

4 (19.05) 17 (80.95)

4/18 (22.22)

0.0013

12 (60.00) 8 (40.00)

4 (20.00) 16 (80.00)

8/16 (50.00)

0.0339

19 (70.37) 8 (29.63)

7 (28.00) 18 (72.00)

13/23 (56.52)

0.0114

11 (45.83) 13 (54.17)

7 (31.81) 15 (68.18)

14/19 (73.68)

0.6547

25 (89.29) 3 (10.71)

6 (26.09) 17 (73.91)

8/23 (34.78)

0.0001

25 (89.29) 3 (10.71)

7 (36.84) 12 (63.16)

9/19 (47.37)

0.0016

*Denominator0number of structures visualized on both MRI and 3D EVUS and included in the McNemar test.

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D.E. White: None. J. North: None. G. Rostaminia: None. M. Mukati: None. L.H. Quiroz: None. S. Shobeiri: Grant /Research Support; BK Medical.

190 ANALYSIS AND IMPLICATION OF DIFFERENT REFERENCE LINES IN MRI PELVIC FLOOR IMAGING C. Betschart1, L. Chen 2, A. Summers 3, J. A. Ashton-Miller 4, J. O. DELANCEY 1 1 Gynecology, Univ. Hosp. Michigan, Ann Arbor, MI, 2 Mechanical Engineering, University of Michigan, Ann Arbor, MI, 3Bloomberg Sch. of Publ. Hlth., John Hopkins University, MD, 4Mechanical Engineering, Ann Arbor, MI. Objective: Assessment of pelvic organ displacements from rest to strain can be measured in MRI (1). This study seeks to quantify the magnitude of changes such as of 1) pelvic inclination in the scanner, 2) the change in angle from rest to strain, and 3) the effect of lines oblique to body axis in making pelvic organ measurements. Background: Pelvic organ prolapse occurs along the gravity and is measured in MRI by different reference lines. Therefore several different axes have been used (1) that can be affected by different factors. Methods: Dynamic MRI from 149 women from a previously published study with and without prolapse were used. The location of the cervix, angle of the sacrococcygeal

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inferior pubic point line (SCIPP), and perineal line (PL) angle to the horizontal scan plane (H-line) were measured in ImageJ 1.44o. Angles were compared using Student’s t Test (significance p < 0.05). For the implication of the oblique line issue, a point correction was taken for the cervix location for the individual SCIPP line angle: Δ v0Δ x* sinθ. Results: Subjects had a mean age of 53.4±12.6 years, parity of 2.7±1.8, BMI of 26.4±4.5 and no prior surgery for POP. Pelvic inclination of the SCIPP line to the H line ranged from −46° to −17° for rest and −48° to −3° for strain, and of the PL from 4° to 44° and 11° to 48°, respectively (Fig. 1a/b). Angles for rest and strain were significantly different for each line (p < 0.005). The effect of measuring to an oblique line (i.e. SCIPP line) is dependent on the angle of the line and ventral-dorsal localization of the organ (Fig 2a). Measuring a distance to a a moving soft tissue line (PL) effects the distance as the reference line is moving during rest and strain (Fig. 2b). Conclusions: Significant variation in pelvic inclination among women and from rest to strain exist that can influence MRI measurements. Soft tissue movement adds further variability. References (optional): Int Urogynecol J 2009;20 (6):721–9 C. Betschart: Grant /Research Support; NIH-Grant, Swiss National Research Foundation. L. Chen: Grant / Research Support; NIH-Grant. A. Summers: Grant /

Figure 1. Determination of hiatal dimensions and pelvic organ descent on ultrasound. Illustrated is measurement of bladder descent (a) and hiatal area / hiatal diameter (b)

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Figure 2. (a) Oblique line issue. Distribution of the cervix location (black dots) at strain (average SCIPP line angle of 29°). Δ×between 5th percentile and 95th percentile is 3.3 cm which will result in Δ y of 1.6 cm. (b) Moving landmark line issue. Cervix distance measured to the PL in rest and strain. PLr0perineal line angle in rest to the H-line. Pls0perineal line angle in strain. Distrain in rest is 4.7 cm (right). As the PL is moving there results only a difference of 5 mm. in fact the cervix moved 2 cm between rest and strain as illustrated by the dotted line in the right MRI.

Research Support; NIH-Grant. J.A. Ashton-Miller: Grant /Research Support; NIH-Grant, Group Research Support from AMS, Kimberly-Clark, Proctor&Gamble. J.O. DeLancey: Grant /Research Support; NIH-Grant, Group research support from AMS, Johnson&Johnson, Kimberly-Clark, Proctor&Gamble.

is a validated questionnaire that assesses self-motivation to perform PFMT for UI (3). The ITMQ consists of 18 items, each item is scored on a likert scale from 1 to 5 (strongly disagree to strongly agree). The items are divided into five domains. Each of which addresses a different area of motivation (Table 1).

191 DOES SELF-MOTIVATION IMPROVE SUCCESS RATES OF PELVIC FLOOR MUSCLE TRAINING (PFMT) IN WOMEN WITH URINARY INCONTINENCE? E. J. Nellist, M. Vella, L. Cardozo, I. Giarenis, H. Mastoroudes Kings Coll. Hosp., London, United Kingdom.

Table 1. Five domains of ITMQ

Objective: This study aims to determine the influence of womens’ self-motivation to perform PFMT on outcome. Background: PFMT is recommended as first line treatment for women with urinary incontinence (UI) (1). However, varying cure rates have been reported. There are many factors including self-motivation that are thought to influence treatment outcome. Motivation expressed by compliance has been shown to be a prognostic factor in the success of PFMT. Thus, the more a patient performs her exercises, the more improvement she can expect. The impact of UI on quality of life has also been acknowledged to influence motivation (2). However, assessment of motivation has received little attention in PFMT and could be an important predictor of successful outcome. The incontinence treatment motivation questionnaire (ITMQ)

MQS1 MQS2 MQS3 MQS4 MQS5

Positive attitudes to treatment Excuses for not doing PFMT Living with incontinence Desire for treatment Incontinence severity affecting PFMT

Methods: Women were recruited between July 2011 and February 2012 from two Urogynaecology Clinics. They were eligible for inclusion if they were over 16 years old and complained of stress or mixed UI. Women were excluded from the study for the following reasons; pregnancy, breastfeeding, symptomatic prolapse, previous surgery for incontinence or prolapse in last 6 months, undiagnosed haematuria, urinary tract infection, bladder or urethral pain or taking anticholinergic medication. Women who met the inclusion criteria and gave informed consent undertook a course of supervised PFMT which consisted of four visits over a 3 month period. They were seen by a specialist Physiotherapist for all visits and digital vaginal examination was performed on visit one to ensure correct technique. Treatment consisted of a home exercise programme of a minimum of 8×3 pelvic floor muscle contractions per day.

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Lifestyle advice was given and “the knack” was also taught if the woman was complaining of stress urinary incontinence. The ITMQ was completed before attending their first physiotherapy appointment. The Patient Global Impression of Improvement questionnaire (PGI-I) was used to assess over-all improvement from PFMT and was scored at the end of treatment. Statistical analysis was carried out using SPSS v13. Spearman’s correlation coefficient was used to assess each domain of the ITMQ to the PGI-I score. Results: Forty out of forty-nine women completed both questionnaires. Their median age was 50.2 years (range 24–75). Results showed that three of the five domains; (MSQ1) positive attitude for treatment, (MSQ3) frustration of living with incontinence and (MSQ4) desire for treatment significantly correlated with outcome. However, (MSQ2) excuses for not doing PFMT and (MSQ5) severity of incontinence affecting PFMT did not significantly correlate with outcome. Results are in Table 2. Table 2. Spearman’s correlation coefficient of ITMQ Domain of ITMQ MQS1 MQS2 MQS3 MQS4 MQS5

Spearman Correlation Coefficient −0.426 0.071 0.383 −0.473 −0.041

P Value 0.007 0.668 0.016 0.002 0.809

Conclusions: Certain aspects of a patients’ motivation including; positive attitudes to treatment and desire for treatment significantly correlated with a good outcome from PFMT. However, frustration of living with urinary incontinence was significantly correlated with a poorer outcome. Self-motivation is an important factor for success of PFMT in women with UI. References (optional): 1. NICE Guidelines on Urinary Incontinence. 2006. 2. British Journal of General Practise. 1991; 41: 445–449 3. International Urogynaecology Journal. 2009; 20:1085– 1093. E.J. Nellist: None. M. Vella: None. L. Cardozo: Consultant; Advamed, Astellas, Ethicon,Merck,Pfizer & Teva. I. Giarenis: None. H. Mastoroudes: None. 192 THE EXPRESSION OF CYTOKINES IN INTERSTITIAL CYSTITIS. I. Offiah1, J. Dawes 2, S. Mcmahon 2, B. O’reilly 1 1 Cork Univ. Maternity Hosp., Co. Cork, Ireland, 2Wolfson Ctr. for Age Related Disease, London, United Kingdom.

Objective: We propose to sample the bladder of patients with interstitial cystitis diagnosed at cystoscopy. We will then compare the expression of inflammatory markers in these disease samples to control bladder biopsies Background: The Painful Bladder Syndrome is a spectrum of urological symptoms characterised by bladder pain. The diagnosis of interstitial cystitis is difficult clinically with little correlation between the clinical picture, cystoscopic findings and histology. The pathophysiology of interstitial cystitis is not well understood. We postulate that this is a peripheral sensory disorder, and there are mediators, eg cytokines and chemokines that activate these sensory pathways and cause the disease. Methods: We recruited patients with symptoms suggestive of the Painful Bladder Syndrome for cystoscopy with or without biopsy. At cystoscopy, if features diagnostic of interstitial cystitis were observed, three 5 mm biopsies were taken from above the bladder trigone from each patient and snap frozen in liquid nitrogen. Women with urodynamic stress incontinence undergoing mid urethral sling surgery were recruited as controls and three biopsies taken in a similar manner. The biopsies were then transferred to the lab, where the RNA was isolated and amplified using custom-made PCR array cards to measure the expression levels of various inflammatory mediators in the tissues. The expression changes were normalised against the geometric mean of 3 housekeeping genes (18 s, GAPDH and Beta-Actin) and displayed as the fold change relative to control samples. Results: The study group consisted of 8 patients with interstitial cystitis and we compared these to 4 controls. Certain genes had a greater than 10 fold increase in their expression levels in the interstitial cystitis samples in comparison to controls. A 2-fold increase is deemed biologically significant. These genes include the chemokine ligands CXCL 1 and 5, CCL 18, 24 and 26 and interleukins 15. The expression of these genes reaches statistical significance with p values of <0.05. However, when the changes are adjusted for multiple testing, only the Macrophage migration inhibitory factor’s adjusted p value is <0.05 (0.0448), with a biologically significant fold change of 4.99. We had no down regulated genes in this our study group. Conclusions: Our study has highlighted several cytokines and chemokines that are upregulated in interstitial cystitis biopsies compared to controls. These inflammatory mediators may be important in the pathophysiology of the disease and presents themselves as therapeutic targets for the treatment of interstitial cystitis. References (optional): I. Offiah: None. J. Dawes: None. S. McMahon: None. B. O’Reilly: None.

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193 IS POLYPROPYLENE MESH COATED WITH ANTIBIOTICS IS EFFICIENT TO PREVENT MESH INFECTION AND CONTRACTION IN AN ANIMAL INFECTIOUS MODEL? V. Letouzey1, S. Huberlant 1, J. Lavigne 2, P. Mares 1, X. Garric 3, R. De Tayrac 1 1 CHU Caremeau, Nimes, France, 2Bacteriological and Microbiol. Dept., Nimes, France, 3Bio Polymer Res. Ctr. IBMM, Montpellier, France. Objective: The present study has tested the hypothesis that antibiotic coating may decrease bacterial mesh colonization in the first month following implantation, with a hypothetic decreased rate subsequent mesh extrusion and contraction. Background: The pelvic floor disorders represent a problem of public health and concern 40 % of women, especially after 50 years. The surgical care of pelvic floor disorders was improved by the use of synthetic mesh, mostly in polypropylene, which establishes a mechanical support of the pelvic floor. However, the rate of complications (erosion or infection), showing itself by shrinkage, connected to the presence of the synthetic device remain high with going rates from 3% to 15 %, for the vaginal access. Subclinical chronic bacterial infection of the mesh interstices is believed to contribute to chronic inflammation, contraction and extrusion erosion of the mesh. Methods: The present study is a randomized double-blind prospective study, performed on 60 Wistar rats, from January to October 2011, on the experimental laboratory of Montpellier-Nimes University, France. Ethical committee approval was obtained for the animal study (Ethical committee approval number CEEA-LR-1063). Twenty Wistar rats, where implanted with a PPL (polypropylene, macro porous, monofilament and knitted) mesh coated with a polymer, , loaded with a double antibiotic (ATB) treatment. The second group of twenty rats was implanted with a mesh coated with a polymer (without antibiotics), which have no anti infective properties. The third group constitutes the witness group with twenty rats implanted with a non coated

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mesh of PPL. The experiments were performed on abdominal localization according to a validated incisional hernia rat model. For every group, 10 rats were infected with a stump of E.Coli and name “infected under group” and 10 others rats represents “non infected under group” The macroscopic data were collected and quantified in term of frequency of erosion and average of apparition by group. Mesh shrinkage was collected (numeric data) before and after implantation and before explantation. At least, we did bacterial and histological analysis. We used a statistical study by using the student’s test for the continuous variables. The p values lower than 0.05 were considered significant. Results: Sixty animals were implanted, watched during 30 days, and then euthanized to analyze the tolerance and the integration of meshes, in double-blind. Considering the rate of E. Coli, in the non coated mesh group and in the coated mesh group (without antibiotics), there is a significant difference between infected and non infected samples. There is no significant difference between infected and non infected on the mesh coated with antibiotics group. Concerning the global percentage of shrinkage, for the non infected rats, there is no significant difference between coated without ATB mesh group and non coated mesh group (p00.28), and between coated mesh group without ATB and coated mesh loaded with antibiotics (p00.76). But for infected groups, there is a significant difference for the rate of shrinkage between non coated mesh group and coated mesh loaded with antibiotics (p00.006). More over, E .Coli is found in 70 % of the non coated infected group Concerning the shrinkage rate of infected animals, there is a significant difference between non coated mesh group and coated mesh loaded with antibiotics (p00.006). Conclusion: This experimental study suggests the interest of an effective antibiotic coating on polypropylene mesh, decreasing bacterial colonization and improving mesh integration. V. Letouzey: None. S. Huberlant: None. J. Lavigne: None. P. Mares: None. X. Garric: None. R. de Tayrac: Consultant; Boston SCI.