Percutaneous Tibial Nerve Stimulation vs Sham Stimulation for Fecal Incontinence in Women: NeurOmodulaTion for Accidental Bowel Leakage Randomized Clinical Trial.

INTRODUCTION: To determine whether percutaneous tibial nerve stimulation (PTNS) is superior to sham stimulation for the treatment of fecal incontinence (FI) in women refractory to first-line treatments. METHODS: Women aged 18 years or older with ≥3 months of moderate-to-severe FI that persisted after a 4-week run-in phase were randomized 2:1 (PTNS:sham stimulation) to 12 weekly 30-minute sessions in this multicenter, single-masked, controlled superiority trial. The primary outcome was change from baseline FI severity measured by St. Mark score after 12 weeks of treatment (range 0-24; minimal important difference, 3-5 points). The secondary outcomes included electronic bowel diary events and quality of life. The groups were compared using an adjusted general linear mixed model. RESULTS: Of 199 women who entered the run-in period, 166 (of 170 eligible) were randomized, (111 in PTNS group and 55 in sham group); the mean (SD) age was 63.6 (11.6) years; baseline St. Mark score was 17.4 (2.7); and recording was 6.6 (5.5) FI episodes per week. There was no difference in improvement from baseline in St. Mark scores in the PTNS group when compared with the sham group (-5.3 vs -3.9 points, adjusted difference [95% confidence interval] -1.3 [-2.8 to 0.2]). The groups did not differ in reduction in weekly FI episodes (-2.1 vs -1.9 episodes, adjusted difference [95% confidence interval] -0.26 [-1.85 to 1.33]). Condition-specific quality of life measures did not indicate a benefit of PTNS over sham stimulation. Serious adverse events occurred in 4% of each group. DISCUSSION: Although symptom reduction after 12 weeks of PTNS met a threshold of clinical importance, it did not differ from sham stimulation. These data do not support the use of PTNS as conducted for the treatment of FI in women.

Predicting outcomes after intradetrusor onabotulinumtoxina for non-neurogenic urgency incontinence in women.

AIMS: Develop models to predict outcomes after intradetrusor injection of 100 or 200 units of onabotulinumtoxinA in women with non-neurogenic urgency urinary incontinence (UUI). METHODS: Models were developed using 307 women from two randomized trials assessing efficacy of onabotulinumtoxinA for non-neurogenic UUI. Cox, linear and logistic regression models were fit using: (1) time to recurrence over 12 months, (2) change from baseline daily UUI episodes (UUIE) at 6 months, and (3) need for self-catheterization over 6 months. Model discrimination of Cox and logistic regression models was calculated using c-index. Mean absolute error determined accuracy of the linear model. Calibration was demonstrated using calibration curves. All models were internally validated using bootstrapping. RESULTS: Median time to recurrence was 6 (interquartile range [IQR]: 2-12) months. Increasing age, 200 units of onabotulinumtoxinA, higher body mass index (BMI) and baseline UUIE were associated with decreased time to recurrence. The c-index was 0.63 (95% confidence interval [CI]: 0.59, 0.67). Median change in daily UUIE from baseline at 6 months was -3.5 (IQR: -5.0, -2.3). Increasing age, lower baseline UUIE, 200 units of onabotulinumtoxinA, higher BMI and IIQ-SF were associated with less improvement in UUIE. The mean absolute error predicting change in UUIE was accurate to 1.6 (95% CI: 1.5, 1.7) UUI episodes. The overall rate of self-catheterization was 17.6% (95% CI: 13.6%-22.4%). Lower BMI, 200 units of onabotulinumtoxinA, increased baseline postvoid residual and maximum capacity were associated with higher risk of self-catheterization. The c-index was 0.66 (95% CI: 0.61, 0.76). The three calculators are available at http://riskcalc.duke.edu. CONCLUSIONS: After external validation, these models will assist clinicians in providing more accurate estimates of expected treatment outcomes after onabotulinumtoxinA for non-neurogenic UUI in women.

Effect of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse: 5-year results of a randomized clinical trial.

BACKGROUND: Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Sacrospinous hysteropexy with graft (vaginal mesh hysteropexy) is an alternative, although in 2019 the Food and Drug Administration removed this mesh product from the United States market. OBJECTIVE: Our objective was to compare the efficacy and adverse events of these 2 procedures. STUDY DESIGN: At 9 clinical sites in the United States National Institutes of Health and National Institute of Child Health and Human Development Pelvic Floor Disorders Network, 183 postmenopausal women requesting vaginal surgery for symptomatic uterovaginal prolapse were enrolled in a multisite randomized superiority clinical trial, comparing a sacrospinous hysteropexy with graft (hysteropexy) with a vaginal hysterectomy with uterosacral ligament suspension (hysterectomy). Participants consented to remain masked to treatment assignment for the study duration. Study visits were conducted at 6-month intervals through 60 months. The primary treatment failure composite outcome (retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival modeling. Secondary outcomes included complications or adverse events, individual anatomic measures of the pelvic organ prolapse quantification examination, and presence, severity, and impact and bother of prolapse, urinary, bowel, and pain symptoms as measured by validated questionnaires. The 3-year published results suggested better primary outcomes with sacrospinous hysteropexy with graft, but the differences were not statistically significant (P=.06). This study reports the 5-year outcomes. RESULTS: A total of 183 women with a mean age of 66 years were randomized between April 2013 and February 2015; 93 were randomized to hysteropexy and 90 were randomized to hysterectomy. Notably, 175 were included in the trial, and 156 (89%) completed the 5-year follow-up. The primary outcome showed fewer failures for hysteropexy than hysterectomy through 5 years (adjusted hazard ratio, 0.58; 95% confidence interval, 0.36-0.94; P=.03), with failure rates of 37% vs 54%, respectively, resulting in a difference of -18% (95% confidence interval, -33% to -3%) at 5 years. With the exception of the Urogenital Distress Inventory, no group differences were demonstrated in patient-reported pelvic floor symptoms, prolapse symptoms, bowel function symptoms, general quality of life, body image, or pelvic pain. At their last visit through 5 years, 70% of participants (129 of 183) reported they remained masked to their treatment with no difference in masking between groups. Adverse events for hysteropexy vs hysterectomy included mesh exposure (8% vs 0%), granulation tissue after 12 weeks (1% vs 12%), and suture exposure after 12 weeks (3% vs 21%), respectively. CONCLUSION: Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, sacrospinous hysteropexy with graft resulted in a lower composite failure rate than vaginal hysterectomy through 5 years. There were no meaningful differences in patient-reported outcomes between groups. Our results suggest that this vaginal mesh hysteropexy procedure should be made available to patients.

Assessing pelvic organ prolapse recurrence after minimally invasive sacrocolpopexy: does mesh weight matter?

INTRODUCTION AND HYPOTHESIS: There has been a trend toward the use of ultra-lightweight mesh types for minimally invasive sacrocolpopexy. We hypothesized that ultra-lightweight mesh would have a greater proportion of composite anatomical pelvic organ prolapse recurrence than lightweight mesh. METHODS: Retrospective cohort study of minimally invasive sacrocolpopexies at two academic institutions from 2009 to 2016. Our primary outcome was composite anatomical prolapse recurrence, defined as prolapse beyond the hymen or retreatment with pessary or surgery, compared between ultra-lightweight (≤21 g/m2 [range 19-21]) and lightweight (>21 g/m2 [range 35-50]) mesh types. We assessed time to prolapse recurrence using Kaplan-Meier and Cox regression. RESULTS: The cohort consisted of 1,272 laparoscopic (n = 530, 41.7%) and robotic-assisted sacrocolpopexies (n = 742, 58.4%). Lightweight mesh was used in 745 procedures (58.6%) and ultra-lightweight mesh in 527 (41.4%). The lightweight mesh had longer median follow-up than the ultra-lightweight group (344 [IQR 50-670] vs 143 days [IQR 44-379], p < 0.01). There was no difference in composite anatomical prolapse recurrence between lightweight and ultra-lightweight mesh (54 [7.2%] vs 35 [6.6%], p = 0.68). Ultra-lightweight mesh demonstrated a shorter time to prolapse recurrence (p < 0.01), which remained significant on multivariate Cox regression (HR 2.38 [95% CI 1.47-3.87]). The lightweight mesh had significantly more mesh complications (43 [5.8%] vs 7 [1.3%], p < 0.01). CONCLUSIONS: Ultra-lightweight mesh for minimally invasive sacrocolpopexy was not associated with a higher proportion of composite anatomical prolapse recurrence; however, it was associated with a shorter time to recurrence. Longer follow-up is needed to assess the clinical importance of this finding, particularly given the trade-off of more complications with lightweight mesh.

Performance, acceptability, and validation of a phone application bowel diary.

AIMS: To assess performance, acceptability, external validity, and reliability of a phone application electronic bowel diary (PFDN Bowel eDiary). METHODS: Women reporting refractory accidental bowel leakage (ABL) were enrolled in a randomized, crossover trial evaluating paper versus eDiary documentation of bowel movements (BM) and fecal incontinence episodes (FIE). Events were characterized by the presence or absence of urgency and Bristol stool scale consistency. The eDiary entries were date/time stamped and prompted by twice-daily phone notifications. Women were randomized to complete up to three consecutive 14-day diaries in two sequences. Diary events were compared between formats using the Pearson correlation. System usability scale (SUS) assessed eDiary usability. The eDiary test-retest reliability was assessed with intraclass correlations (ICCs). RESULTS: Paired diary data were available from 60/69 (87%) women 63.8 ± 9.8 years old with mean 13.2 BM per week and 6.5 FIE per week (nearly half with urgency). Among those providing diaries, adherence did not differ by paper or eDiary (93.3% vs. 95.0%). Notifications prompted 29.6% of eDiary entries, improving adherence from 70% to 95%. Paper and eDiaries were moderate to-strongly correlated for BMs per week (r = .61), urgency BMs per week (r = .76), FIE per week (r = .66), urgency FIE per week (r = .72). Test-retest reliability was good (ICC = .81 BMs per week, .79 urgency BMs per week, .74 FIE per week, and .62 urgency FIE per week). The mean SUS score was high, 82.3 ± 17.5 (range, 0-100) with 91.4% rating it easy to use, and 75.9% preferring the eDiary over paper. CONCLUSION: The PFDN Bowel eDiary correlated well with paper diary was considered easy to use, preferred to paper diaries, had high rates of confirmed real-time diary completion that obviated staff data entry.

Outcomes of native tissue transvaginal apical approaches in women with advanced pelvic organ prolapse and stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: Limited data exist comparing different surgical approaches in women with advanced vaginal prolapse. This study compared 2-year surgical outcomes of uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) in women with advanced prolapse (stage III-IV) and stress urinary incontinence. METHODS: This was a secondary analysis of a multicenter 2 × 2 factorial randomized trial comparing (1) ULS versus SSLF and (2) behavioral therapy with pelvic floor muscle training versus usual care. Of 374 subjects, 117/188 (62.7%) in the ULS and 113/186 (60.7%) in the SSLF group had advanced prolapse. Two-year surgical success was defined by the absence of (1) apical descent > 1/3 into the vaginal canal, (2) anterior/posterior wall descent beyond the hymen, (3) bothersome bulge symptoms, and (4) retreatment for prolapse. Secondary outcomes included individual success outcome components, symptom severity measured by the Pelvic Organ Prolapse Distress Inventory, and adverse events. Outcomes were also compared in women with advanced prolapse versus stage II prolapse. RESULTS: Success did not differ between groups (ULS: 58.2% [57/117] versus SSLF: 58.5% [55/113], aOR 1.0 [0.5-1.8]). No differences were detected in individual success components (p > 0.05 for all components). Prolapse symptom severity scores improved in both interventions with no intergroup differences (p = 0.82). Serious adverse events did not differ (ULS: 19.7% versus SSLF: 16.8%, aOR 1.2 [0.6-2.4]). Success was lower in women with advanced prolapse compared with stage II (58.3% versus 73.2%, aOR 0.5 [0.3-0.9]), with no retreatment in stage II. CONCLUSIONS: Surgical success, symptom severity, and overall serious adverse events did not differ between ULS and SSLF in women with advanced prolapse. ClinicalTrials.gov Identifier: NCT01166373.

Responsiveness and minimally important difference of SF-6D and EQ-5D utility scores for the treatment of pelvic organ prolapse.

BACKGROUND: Utility preference scores are standardized, generic, health-related quality of life (HRQOL) measures that quantify disease severity and burden and summarize morbidity on a scale from 0 (death) to 1 (optimal health). Utility scores are widely used to measure HRQOL and in cost-effectiveness research. OBJECTIVE: To determine the responsiveness, validity properties, and minimal important difference (MID) of utility scores, as measured by the Short Form 6D (SF-6D) and EuroQol (EQ-5D), in women undergoing surgery for pelvic organ prolapse (POP). MATERIALS AND METHODS: This study combined data from 4 large, U.S., multicenter surgical trials enrolling 1321 women with pelvic organ prolapse. We collected condition-specific quality of life data using the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). A subset of women completed the SF6D; women in 2 trials also completed the EQ5D. Mean utility scores were compared from baseline to 12 months after surgery. Responsiveness was assessed using effect size (ES) and standardized response mean (SRM). Validity properties were assessed by (1) comparing changes in utility scores at 12 months between surgical successes and failures as defined in each study, and (2) correlating changes in utility scores with changes in the PFDI and PFIQ. MID was estimated using both anchor-based (SF-36 general health global rating scale "somewhat better" vs "no change") and distribution-based methods. RESULTS: The mean SF-6D score improved 0.050, from 0.705 ± 0.126 at baseline to 0.761 ± 0.131 at 12 months (P < .01). The mean EQ-5D score improved 0.060, from 0.810 ± 0.15 at baseline to 0.868 ± 0.15 at 12 months (P < .01). The ES (0.13-0.61) and SRM (0.13-0.57) were in the small-to-moderate range, demonstrating the responsiveness of the SF-6D and EQ-5D similar to other conditions. SF-6D and EQ-5D scores improved more for prolapse reconstructive surgical successes than for failures. The SF-6D and EQ-5D scores correlated with each other (r = 0.41; n = 645) and with condition-specific instruments. Correlations with the PFDI and PFIQ and their prolapse subscales were in the low to moderate range (r = 0.09-0.38), similar to other studies. Using the anchor-based method, the MID was 0.026 for SF-6D and 0.025 for EQ-5D, within the range of MIDs reported in other populations and for other conditions. These findings were supported by distribution-based estimates. CONCLUSION: The SF-6D and EQ-5D have good validity properties and are responsive, preference-based, utility and general HRQOL measures for women undergoing surgical treatment for prolapse. The MIDs for SF-6D and EQ-5D are similar and within the range found for other medical conditions.

Effect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse: A Randomized Clinical Trial.

Importance: Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Transvaginal mesh hysteropexy is an alternative option. Objective: To compare the efficacy and adverse events of vaginal hysterectomy with suture apical suspension and transvaginal mesh hysteropexy. Design, Setting, Participants: At 9 clinical sites in the US Pelvic Floor Disorders Network, 183 postmenopausal women with symptomatic uterovaginal prolapse were enrolled in a randomized superiority clinical trial between April 2013 and February 2015. The study was designed for primary analysis when the last randomized participant reached 3 years of follow-up in February 2018. Interventions: Ninety-three women were randomized to undergo vaginal mesh hysteropexy and 90 were randomized to undergo vaginal hysterectomy with uterosacral ligament suspension. Main Outcomes and Measures: The primary treatment failure composite outcome (re-treatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival models. Secondary outcomes included operative outcomes and adverse events, and were evaluated with longitudinal models or contingency tables as appropriate. Results: A total of 183 participants (mean age, 66 years) were randomized, 175 were included in the trial, and 169 (97%) completed the 3-year follow-up. The primary outcome was not significantly different among women who underwent hysteropexy vs hysterectomy through 48 months (adjusted hazard ratio, 0.62 [95% CI, 0.38-1.02]; P = .06; 36-month adjusted failure incidence, 26% vs 38%). Mean (SD) operative time was lower in the hysteropexy group vs the hysterectomy group (111.5 [39.7] min vs 156.7 [43.9] min; difference, -45.2 [95% CI, -57.7 to -32.7]; P = <.001). Adverse events in the hysteropexy vs hysterectomy groups included mesh exposure (8% vs 0%), ureteral kinking managed intraoperatively (0% vs 7%), granulation tissue after 12 weeks (1% vs 11%), and suture exposure after 12 weeks (3% vs 21%). Conclusions and Relevance: Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, vaginal mesh hysteropexy compared with vaginal hysterectomy with uterosacral ligament suspension did not result in a significantly lower rate of the composite prolapse outcome after 3 years. However, imprecision in study results precludes a definitive conclusion, and further research is needed to assess whether vaginal mesh hysteropexy is more effective than vaginal hysterectomy with uterosacral ligament suspension. Trial Registration: ClinicalTrials.gov Identifier: NCT01802281.

Robotic-assisted sacrocolpopexy: early postoperative outcomes after surgical reduction of enlarged genital hiatus.

BACKGROUND: Currently, the decision to perform a concurrent posterior repair/perineoplasty at the time of robotic-assisted sacrocolpopexy is not standardized. OBJECTIVE: We sought to compare anatomic failure after robotic-assisted sacrocolpopexy among 3 groups of patients categorized by their preoperative and postoperative genital hiatus size. STUDY DESIGN: We performed a retrospective cohort study of women who underwent robotic-assisted sacrocolpopexy, from January 2013 through September 2016. We defined a wide genital hiatus as ≥4 cm and a normal genital hiatus as <4 cm. We compared 3 groups: (1) wide preoperative and postoperative genital hiatus (persistently wide); (2) wide preoperative and normal postoperative genital hiatus (improved); and (3) normal preoperative and postoperative genital hiatus (stably normal). Our primary outcome was composite anatomic failure defined as either recurrent prolapse in any compartment past the hymen or retreatment for prolapse with either surgery or pessary. Our data were analyzed using 1-way analysis of variance and χ2 test. Logistic regression was performed to evaluate for independent risk factors for anatomic failure among the 3 groups. P < .05 was considered significant. RESULTS: Our study population consisted of 452 women with a mean age of 59.3 ± 10.0 years and a mean body mass index of 27.8 ± 5.3 kg/m2. Of the women with reported race, 394/447 (88.1%) were white. The genital hiatus groups were distributed as follows: 57 (12.6%) were persistently wide, 296 (65.5%) were improved, and 99 (21.9%) were stably normal. The stably normal group had less advanced preoperative prolapse (stage ≥3) than the other groups (P < .01). A similar percentage of patients among groups had a concomitant posterior repair/perineoplasty (P = .09) with a total of 84 (18.6%) women undergoing this procedure. There was a statistically significant difference in overall composite anatomic failure among the groups (P = .03). There was an increase in failure in the persistently wide group (14.0%) compared to the improved group (5.7%, P = .04) and compared to the stably normal group (4.0%, P = .03). In a logistic regression model, controlling for number of vaginal deliveries and posterior repair/perineoplasty, there was a 5.3-fold increased odds of composite anatomic failure in the persistently wide group (adjusted odds ratio, 5.3; 95% confidence interval, 1.4-19.1; P = .01) compared to the stably normal group. In a subanalysis of failure by compartment, there was an increase in failure of the posterior compartment in the persistently wide group compared to the improved group (8.8% vs 2.0%, P < .01), but not the stably normal group (3.0%, P = .12). There was not a statistically significant difference in failure of the combined apical and anterior compartments among groups (P = .29). CONCLUSION: Surgical reduction of an enlarged preoperative genital hiatus decreases early composite anatomic failure, after robotic sacrocolpopexy, specifically related to the posterior compartment. Studies investigating the correlation of intraoperative measurement of genital hiatus to postoperative genital hiatus are needed to help clinicians determine who may benefit from a concomitant posterior repair/perineoplasty at the time of robotic-assisted sacrocolpopexy.

Correlation of Virtual Reality Simulation and Dry Lab Robotic Technical Skills.

STUDY OBJECTIVE: To examine whether a set of virtual reality (VR) surgical simulation drills have correlative validity when compared with the validated Robotic Objective Structured Assessment of Technical Skills (R-OSATS) dry lab drills. DESIGN: A prospective methods comparison study (Canadian Task Force classification II-2). SETTING: A teaching hospital. PARTICIPANTS: Thirty current residents, fellows, and faculty from the Departments of Obstetrics and Gynecology, Urology, and General Surgery. INTERVENTIONS: Participants completed 5 VR drills on the da Vinci Skills Simulator and 5 dry lab drills. Participants were randomized to the order of completion. MEASUREMENTS AND MAIN RESULTS: VR drills were scored automatically by the simulator. Dry lab drills were recorded, reviewed by 3 blinded experts, and scored using the R-OSATS assessment tool. Spearman correlation coefficients were calculated comparing simulator scores and R-OSATS scores for the same surgeon. The correlation for overall summary scores between VR and dry lab drills was strong (r = 0.83; p < .01). Each of the 5 VR drills was also found to have a statistically significant correlation to its corresponding dry lab drill, with correlation coefficients ranging from r = 0.49 to 0.73 (p < .01 for all). The performance on VR drills also confirmed construct validity. Faculty and fellows had consistently higher overall scores than residents (median VR scores: 458 for faculty, 425 for fellows, 339 for residents; p < .01). CONCLUSION: We selected a core set of VR drills that reliably correlate with validated dry lab R-OSATS drills. Because dry lab drills require significant time and effort on the part of the trainees and the evaluators, this set of VR drills could serve as an ancillary method of determining trainee competence.

What is the role of combination drug therapy in the treatment of overactive bladder? ICI-RS 2014.

AIMS AND METHODS: The role of combination therapy using oral antimuscarinic medications for the treatment of overactive bladder was proposed at the 2014 International Consultation on Incontinence-Research Society in Bristol, UK to identify key factors to consider when making clinical decisions and to guide future research design. RESULTS: Combination therapy is justified if monotherapy is associated with suboptimal efficacy or bothersome side effects. Combination therapy has the potential to improve efficacy with fewer side effects than monotherapy. Two Phase 2 studies comparing combination therapy that included an antimuscarinic demonstrated improvement in mean voided volume, the primary outcome chosen, with some combinations showing improved micturition frequency and quality of life. The two studies found no evidence of an increased safety risk with combination therapy compared to monotherapy. Future studies should use clinically meaningful or patient reported outcomes such as incontinence episodes when comparing efficacy. If surrogate measures are used, a clear justification should be provided. Cost analyses should be planned for clinical research trials evaluating combination drug therapy. CONCLUSIONS: Combination therapy is reasonable when monotherapy has suboptimal efficacy or bothersome side effects. Future research studies evaluating combination therapy for urgency urinary incontinence should ideally(1) be performed as part of a randomized clinical trial,(2) evaluate non-responders to monotherapy,(3) evaluate combination therapy using medications with different mechanisms of action,(4) include clinically meaningful and patient reported outcomes when evaluating efficacy, and(5) include cost-effectiveness analyses to justify any increased cost by showing improvement in efficacy or reduction in side effects.

Anticholinergic therapy vs. onabotulinumtoxina for urgency urinary incontinence.

BACKGROUND: Anticholinergic medications and onabotulinumtoxinA are used to treat urgency urinary incontinence, but data directly comparing the two types of therapy are needed. METHODS: We performed a double-blind, double-placebo-controlled, randomized trial involving women with idiopathic urgency urinary incontinence who had five or more episodes of urgency urinary incontinence per 3-day period, as recorded in a diary. For a 6-month period, participants were randomly assigned to daily oral anticholinergic medication (solifenacin, 5 mg initially, with possible escalation to 10 mg and, if necessary, subsequent switch to trospium XR, 60 mg) plus one intradetrusor injection of saline or one intradetrusor injection of 100 U of onabotulinumtoxinA plus daily oral placebo. The primary outcome was the reduction from baseline in mean episodes of urgency urinary incontinence per day over the 6-month period, as recorded in 3-day diaries submitted monthly. Secondary outcomes included complete resolution of urgency urinary incontinence, quality of life, use of catheters, and adverse events. RESULTS: Of 249 women who underwent randomization, 247 were treated, and 241 had data available for the primary outcome analyses. The mean reduction in episodes of urgency urinary incontinence per day over the course of 6 months, from a baseline average of 5.0 per day, was 3.4 in the anticholinergic group and 3.3 in the onabotulinumtoxinA group (P=0.81). Complete resolution of urgency urinary incontinence was reported by 13% and 27% of the women, respectively (P=0.003). Quality of life improved in both groups, without significant between-group differences. The anticholinergic group had a higher rate of dry mouth (46% vs. 31%, P=0.02) but lower rates of catheter use at 2 months (0% vs. 5%, P=0.01) and urinary tract infections (13% vs. 33%, P<0.001). CONCLUSIONS: Oral anticholinergic therapy and onabotulinumtoxinA by injection were associated with similar reductions in the frequency of daily episodes of urgency urinary incontinence. The group receiving onabotulinumtoxinA was less likely to have dry mouth and more likely to have complete resolution of urgency urinary incontinence but had higher rates of transient urinary retention and urinary tract infections. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women's Health; ClinicalTrials.gov number, NCT01166438.).

The female urinary microbiome in urgency urinary incontinence.

OBJECTIVE: The purpose of this study was to characterize the urinary microbiota in women who are planning treatment for urgency urinary incontinence and to describe clinical associations with urinary symptoms, urinary tract infection, and treatment outcomes. STUDY DESIGN: Catheterized urine samples were collected from multisite randomized trial participants who had no clinical evidence of urinary tract infection; 16S ribosomal RNA gene sequencing was used to dichotomize participants as either DNA sequence-positive or sequence-negative. Associations with demographics, urinary symptoms, urinary tract infection risk, and treatment outcomes were determined. In sequence-positive samples, microbiotas were characterized on the basis of their dominant microorganisms. RESULTS: More than one-half (51.1%; 93/182) of the participants' urine samples were sequence-positive. Sequence-positive participants were younger (55.8 vs 61.3 years old; P = .0007), had a higher body mass index (33.7 vs 30.1 kg/m(2); P = .0009), had a higher mean baseline daily urgency urinary incontinence episodes (5.7 vs 4.2 episodes; P < .0001), responded better to treatment (decrease in urgency urinary incontinence episodes, -4.4 vs -3.3; P = .0013), and were less likely to experience urinary tract infection (9% vs 27%; P = .0011). In sequence-positive samples, 8 major bacterial clusters were identified; 7 clusters were dominated not only by a single genus, most commonly Lactobacillus (45%) or Gardnerella (17%), but also by other taxa (25%). The remaining cluster had no dominant genus (13%). CONCLUSION: DNA sequencing confirmed urinary bacterial DNA in many women with urgency urinary incontinence who had no signs of infection. Sequence status was associated with baseline urgency urinary incontinence episodes, treatment response, and posttreatment urinary tract infection risk.

Role of salpingectomy at the time of urogynecologic surgery.

PURPOSE OF REVIEW: This article reviews the current literature about prophylactic bilateral salpingectomy and provides guidelines for clinicians in regard to the inclusion of salpingectomy at the time of urogynecologic surgery. RECENT FINDINGS: After the Nurses' Health Study showed that all-cause mortality was increased in women undergoing oophorectomy at the time of hysterectomy for benign indications, there was a shift in focus toward ovarian conservation at the time of gynecologic surgery. As there has been continued interest in the fallopian tube as the origin of ovarian cancer, a move toward prophylactic salpingectomy has occurred. This strategy has become widely accepted in high-risk women, but is not universal in either premenopausal or postmenopausal women who are primarily served by the urogynecologic community. SUMMARY: Current literature supports that, if easily accessible, the fallopian tubes should be removed at the time of urogynecologic surgery. In premenopausal women, salpingectomy does not likely affect ovarian reserve, but this possibility should be discussed with patients. If inaccessible (i.e., at the time of a midurethral sling), there should not be additional surgery performed to access the fallopian tubes. In addition, the pathologic evaluation of the fallopian tubes should include complete examination of the fimbriae and a representative section of the nonfimbriated portion.

Vaginal native tissue repair versus transvaginal mesh repair for apical prolapse: how utilizing different methods of analysis affects the estimated trade-off between reoperation for mesh exposure/erosion and reoperation for recurrent prolapse.

INTRODUCTION AND HYPOTHESIS: Informed decision-making about optimal surgical repair of apical prolapse with vaginal native tissue (NT) versus transvaginal mesh (TVM) requires understanding the balance between the potential "harm" of mesh-related complications and the potential "benefit" of reducing prolapse recurrence. Synthesis of data from observational studies is required and the current literature shows that the average follow-up for NT repair is significantly longer than for TVM repair. We examined this harm/benefit balance. We hypothesized that using different methods of analysis to incorporate follow-up time would affect the balance of outcomes. METHODS: We used a Markov state transition model to estimate the cumulative 24-month probabilities of reoperation for mesh exposure/erosion or for recurrent prolapse after either NT or TVM repair. We used four different analytic approaches to estimate probability distributions ranging from simple pooled proportions to a random effects meta-analysis using study-specific events per patient-time. RESULTS: As variability in follow-up time was accounted for better, the balance of outcomes became more uncertain. For TVM repair, the incremental ratio of number of operations for mesh exposure/erosion per single reoperation for recurrent prolapse prevented increased progressively from 1.4 to over 100 with more rigorous analysis methods. The most rigorous analysis showed a 70% probability that TVM would result in more operations for recurrent prolapse repair than NT. CONCLUSIONS: Based on the best available evidence, there is considerable uncertainty about the harm/benefit trade-off between NT and TVM for apical prolapse repair. Future studies should incorporate time-to-event analyses, with greater standardization of reporting, in order to better inform decision-making.

Trends in use of surgical mesh for pelvic organ prolapse.

OBJECTIVE: Limited data exist on the rates of pelvic organ prolapse procedures utilizing mesh. The objective of this study was to examine trends in vaginal mesh prolapse procedures (VMs), abdominal sacrocolpopexy (ASC), and minimally invasive sacrocolpopexy (MISC) from 2005 to 2010. STUDY DESIGN: We utilized deidentified, adjudicated health care claims data from across the United States from 2005 to 2010. Among women 18 years old or older, we identified all mesh prolapse procedures based on current procedural terminology codes (57267 for VM, 57280 for ASC, and 57425 for MISC). VM procedures included all vaginal prolapse surgeries in which mesh was placed, whether in the anterior, apical, or posterior compartment. We estimated rates per 100,000 person-years (100,000 py) and 95% confidence intervals (CIs). RESULTS: During 78.5 million person-years of observation, we identified 60,152 mesh prolapse procedures, for a rate of 76.0 per 100,000 py (95% CI, 73.6-78.5). Overall, VMs comprised 74.9% of these surgeries for an overall rate of 56.9 per 100,000 py (95% CI, 55.0-58.9). Rates of ASC and MISC were considerably lower at 12.0 per 100,000 py (95% CI, 11.6-12.5) and 9.5 per 100,000 py (95% CI, 9.2-9.9), respectively. Among sacrocolpopexies, ASC was more common than MISC in 2005-2007; however, since 2007, the rate of MISC has increased, whereas the rate of ASC has decreased. Regarding trends by age, VM was considerably more common than sacrocolpopexies at all ages, and ASC was more common than MISC in women older than 50 years. CONCLUSION: From 2005 to 2010, the rate of mesh prolapse procedures has increased, with vaginal mesh surgeries constituting the vast majority.

Comparing the risk of urethrolysis for the treatment of voiding dysfunction between two retropubic mesh slings: a case-control study.

INTRODUCTION AND HYPOTHESIS: Long-term outcome data exist with Gynecare TVT tension-free support for incontinence (TVT), yet few comparisons have been made to newer retropubic sling delivery systems, especially with regards to urethrolysis for postoperative voiding dysfunction. Our objective was to compare the odds of urethrolysis for the treatment of voiding dysfunction between two retropubic sling systems. METHODS: We performed a case-control study comparing the risk of urethrolysis between TVT versus the Bard ALIGN Urethral Support System (Bard Align). We identified surgical procedures described as urethrolysis, sling revision, loosening, or lysis performed for the treatment of voiding dysfunction by urogynecologists at Duke University between January 2007 and June 2011. Slings placed at outside institutions were excluded. Controls were matched for both concomitant prolapse procedures and academic year. RESULTS: Of 818 total slings placed during the study period, there were 28 (3.4 %) urethrolysis cases, which were matched to 84 controls. Among urethrolysis cases, 6/28 (21.4 %) had received TVT, while 22/28 (78.6 %) had received Bard Align slings. Of the 84 matched controls, 30/84 (35.7 %) had undergone TVT and 54/84 (64.3 %) had undergone Bard Align. There was no significant difference in the odds of urethrolysis following the use of TVT or Bard Align [odds ratio (OR) 2.00, 95 % confidence interval (CI) 0.74-5.50]. In a conditional logistic regression model, which adjusted for age, body mass index, prior anti-incontinence or prolapse surgery, and postvoid residual, there remained no significant difference in odds of urethrolysis between the two sling types (OR 1.50, 95 % CI 0.42-5.33). CONCLUSIONS: Despite different instrument designs, there was no significant difference in the risk of urethrolysis following TVT or Bard Align retropubic sling.

Long-term outcomes of vaginal mesh versus native tissue repair for anterior vaginal wall prolapse.

INTRODUCTION AND HYPOTHESIS: To estimate the risk of repeat surgery for recurrent prolapse or mesh removal after vaginal mesh versus native tissue repair for anterior vaginal wall prolapse. METHODS: We utilized longitudinal, adjudicated, healthcare claims from 2005 to 2010 to identify women ≥18 years who underwent an anterior colporrhaphy (CPT 57420) with or without concurrent vaginal mesh (CPT 57267). The primary outcome was repeat surgery for anterior or apical prolapse or for mesh removal/revision; these outcomes were also analyzed separately. We utilized Kaplan-Meier curves to estimate the cumulative risk of each outcome after vaginal mesh versus native tissue repair. Cox proportional hazards models were used to estimate the hazard ratio (HR) for vaginal mesh versus native tissue repair, adjusted for age, concurrent hysterectomy, and concurrent or recent sling. RESULTS: We identified 27,809 anterior prolapse surgeries with 49,658 person-years of follow-up. Of those, 6,871 (24.7%) included vaginal mesh. The 5-year cumulative risk of any repeat surgery was significantly higher for vaginal mesh versus native tissue (15.2 % vs 9.8 %, p <0.0001) with a 5-year risk of mesh revision/removal of 5.9%. The 5-year risk of surgery for recurrent prolapse was similar between vaginal mesh and native tissue groups (10.4 % vs 9.3 %, p = 0.70. The results of the adjusted Cox model were similar (HR 0.93, 95%CI: 0.83, 1.05). CONCLUSIONS: The use of mesh for anterior prolapse was associated with an increased risk of any repeat surgery, which was driven by surgery for mesh removal. Native tissue and vaginal mesh surgery had similar 5-year risks for surgery for recurrent prolapse.

Association Between Enlarged Genital Hiatus and Composite Surgical Failure After Vaginal Hysterectomy With Uterosacral Ligament Suspension.

IMPORTANCE: The impact of a persistently enlarged genital hiatus (GH) after vaginal hysterectomy with uterosacral ligament suspension on prolapse outcomes is currently unclear. OBJECTIVES: This secondary analysis of the Study of Uterine Prolapse Procedures Randomized trial was conducted among participants who underwent vaginal hysterectomy with uterosacral ligament suspension. We hypothesized that women with a persistently enlarged GH size would have a higher proportion of prolapse recurrence. STUDY DESIGN: Women who underwent vaginal hysterectomy with uterosacral ligament suspension as part of the Study of Uterine Prolapse Procedures Randomized trial (NCT01802281) were divided into 3 groups based on change in their preoperative to 4- to 6-week postoperative GH measurements: (1) persistently enlarged GH, 2) improved GH, or (3) stably normal GH. Baseline characteristics and 2-year surgical outcomes were compared across groups. A logistic regression model for composite surgical failure controlling for advanced anterior wall prolapse and GH group was fitted. RESULTS: This secondary analysis included 81 women. The proportion with composite surgical failure was significantly higher among those with a persistently enlarged GH (50%) compared with a stably normal GH (12%) with an unadjusted risk difference of 38% (95% confidence interval, 4%-68%). When adjusted for advanced prolapse in the anterior compartment at baseline, the odds of composite surgical failure was 6 times higher in the persistently enlarged GH group compared with the stably normal group (95% confidence interval, 1.0-37.5; P = 0.06). CONCLUSION: A persistently enlarged GH after vaginal hysterectomy with uterosacral ligament suspension for pelvic organ prolapse may be a risk factor for recurrent prolapse.

Symptomatic and anatomic 1-year outcomes after robotic and abdominal sacrocolpopexy.

OBJECTIVE: The purpose of this study was to compare symptomatic and anatomic outcomes 1 year after robotic vs abdominal sacrocolpopexy. STUDY DESIGN: Our retrospective cohort study compared women who underwent robotic sacrocolpopexy (RSC) with 1 surgeon to those who underwent abdominal sacrocolpopexy (ASC) as part of the Colpopexy and Urinary Reduction Efforts trial. Our primary outcome was a composite measure of vaginal bulge symptoms or repeat surgery for prolapse. RESULTS: We studied 447 women (125 with RSC and 322 with ASC). Baseline characteristics were similar. There were no significant differences in surgical failures 1 year after surgery based on our primary composite outcome (7/86 [8%] vs 12/304 [4%]; P = .16). When we considered anatomic failure, there were also no significant differences between RSC and ASC (4/70 [6%] vs 16/289 [6%]; P = .57). CONCLUSION: One year after sacrocolpopexy, women who underwent RSC have similar symptomatic and anatomic success compared with those women who underwent ASC.