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Introduction and hypothesis: In randomized trials both percutaneous tibial nerve stimulation (PTNS) and sham result in clinically significant improvements in accidental bowel leakage (ABL). We aimed to identify subgroups who may preferentially benefit from PTNS in women enrolled in a multicenter randomized trial. Methods: This planned secondary analysis explored factors associated with success for PTNS vs sham using various definitions: treatment responder using three cutoff points for St. Mark's score (≥3-, ≥4-, and ≥5-point reduction); Patient Global Impression of Improvement (PGI-I) of ≥ much better; and ≥50% reduction in fecal incontinence episodes (FIEs). Backward logistic regression models were generated using elements with significance of p<0.2 for each definition and interaction terms assessed differential effects of PTNS vs sham. Results: Of 166 women randomized, 160 provided data for at least one success definition. Overall, success rates were 65% (102 out of 158), 57% (90 out of 158), and 46% (73 out of 158) for ≥3-, ≥4-, and ≥5-point St Mark's reduction respectively; 43% (68 out of 157) for PGI-I; and 48% (70 out of 145) for ≥50% FIEs. Of those providing data for all definitions of success, 77% (109 out of 142) met one success criterion, 43% (61 out of 142) two, and 29% (41 out of 142) all three success criteria. No reliable or consistent factors were associated with improved outcomes with PTNS over sham regardless of definition. Conclusions: Despite exploring diverse success outcomes, no subgroups of women with ABL differentially responded to PTNS over sham. Success results varied widely across subjective and objective definitions. Further investigation of ABL treatment success definitions that consistently and accurately capture patient symptom burden and improvement are needed. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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 ideally1 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, and5 include cost-effectiveness analyses to justify any increased cost by showing improvement in efficacy or reduction in side effects. Neurourol. Urodynam. 35:288-292, 2016. © 2016 Wiley Periodicals, Inc. [ABSTRACT FROM AUTHOR]

We compared maternal morbidity between planned vaginal and planned cesarean delivery. A university hospital's database was queried for delivery outcomes. Between 1995 and 2005, 26,356 deliveries occurred. Subjects were divided into two groups: planned vaginal and planned cesarean delivery. This was based on intent to deliver vaginally or by cesarean, despite actual route of delivery. Planned vaginal delivery included successful vaginal delivery and labored cesarean delivery intended for vaginal delivery. Planned cesarean delivery included unlabored and labored cesarean delivery and vaginal delivery intended for cesarean. Chart abstraction confirmed the delivery plan. Primary outcomes were chorioamnionitis, postpartum hemorrhage, and transfusion. Secondary outcomes were also measured. A subanalysis compared actual vaginal delivery, labored cesarean delivery, and unlabored cesarean delivery. There were 3868 planned vaginal deliveries and 180 planned cesarean deliveries. Planned cesarean delivery had less chorioamnionitis (2.2% versus 17.2%), postpartum hemorrhage (1.1% versus 6.0%), uterine atony (0.6% versus 6.4%), and prolonged rupture of membranes (2.2% versus 17.5%) but a longer hospital stay (3.2 versus 2.6 days). There were no differences in transfusion rates. For healthy primiparous women, planned cesarean delivery decreases certain morbidities. Labored cesarean delivery had increased risks compared with both vaginal delivery and unlabored cesarean delivery. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To identify risk factors for postpartum FI and UI. METHODS: Secondary analysis of data from the CAPS study, which estimated the prevalence of postpartum FI and UI in primiparous women with clinically recognized anal sphincter tears after vaginal delivery, compared with women who delivered vaginally without recognized tears or by cesarean before labor. A total of 921 women were enrolled while in the hospital and 759 (82%) were interviewed by telephone 6 months postpartum. FI was assessed using the FISI and UI using the Medical, Epidemiological, and Social Aspects of Aging Questionnaire. FI risk factor analyses were conducted within each group, because of higher prevalence in the tear group. UI analyses were conducted with the groups combined. RESULTS: In women with sphincter tears, FI at 6 months was associated with white race (OR 6.1, 95% CI 1.3–29.4), antenatal UI (OR 2.2, CI 1.1–4.3), 4th versus 3rd degree tear (OR 2.0, CI 1.0–4.0), older age at delivery (OR 1.6 per 5 yr, CI 1.2–2.1), and higher body mass index (BMI) (OR 1.3 per 5 kg/m2, CI 1.0–1.7). No factors were associated with FI in the vaginal or cesarean control groups. Across all groups, risk factors for postpartum UI were antenatal UI (OR 3.5, CI 2.4–5.2), less education (OR 2.0, CI 1.4–2.8), and higher BMI (OR 1.2 per 5 kg/m2, CI 1.1–1.4); cesarean delivery was protective (OR 0.5, CI 0.3–0.9). CONCLUSIONS: Postpartum FI and UI are associated with few modifiable risk factors. However, the presence of antenatal UI and high BMI may help clinicians target at-risk women for early intervention. [ABSTRACT FROM AUTHOR]

PURPOSE: To date, no measures of fecal incontinence severity or its impact on quality of life have been validated for telephone interview. This study was designed to 1) compare responses of a self-administered and a telephone- administered Fecal Incontinence Severity Index; 2) compare a self-administered Fecal Incontinence Quality of Life Scale to the Manchester Health Questionnaire after modifying the latter for telephone administration and American English (Modified Manchester Health Questionnaire); 3) assess test-retest reliability of the telephone-administered Modified Manchester Health Questionnaire; and 4) assess the internal consistency of the Modified Manchester Health Questionnaire subscales. METHODS: Consecutive, English-speaking, nonpregnant females known to have fecal incontinence were invited to participate. Two validated paper questionnaires accompanied the letter informing them of the study: Fecal Incontinence Severity Index and Fecal Incontinence Quality of Life Scale. Consenting patients were contacted for the initial telephone administration of the Modified Manchester Health Questionnaire, and patients who agreed to continue the study were contacted for a repeat telephone administration of the Modified Manchester Health Questionnaire two to four weeks after completing the first interview. RESULTS: Fifty-one females were invited to participate in the study; however, 13 declined or were ineligible. Thirty females, aged 49.3 ± 10.3 years, returned self-administered questionnaires and completed the first telephone interview, and 21 completed a second telephone interview after an average interval of 23 days. The telephone-administered Fecal Incontinence Severity Index scores were significantly lower than those yielded by the self-administered Fecal Incontinence Severity Index, (6.19 vs. 9.85; P < 0.001), but the telephone and written administrations were significantly correlated (r = 0.5; P c 0.02). Correlations between the Modified Manchester Health Questionnaire quality of life subscales and the paper Fecal Incontinence Quality of Life subscales ranged from 0.6 to 0.9 (median, r = 0.81). The correlation between the total score for the Fecal Incontinence Quality of Life and the total score for the Modified Manchester Health Questionnaire quality of life scales was 0.93 (P < 0.00 1). Test-retest reliability for the eight Modified Manchester Health Questionnaire subscales ranged from 0.55 to 0.98 (median, r = 0.83), and test-retest reliability for the two telephone administrations of the Fecal Incontinence Severity Index was r = 0.75. Cronbach's alpha for the eight Modified Manchester Health Questionnaire subscales ranged from 0.79 to 0.92 (median, alpha = 0.85). CONCLUSIONS: Telephone-administered versions of the Modified Manchester Health Questionnaire showed good-to-excellent validity, internal consistency, and test-retest reliability. The telephone-administered Fecal Incontinence Severity Index yielded lower severity scores than the written Fecal Incontinence Severity Index; however, the difference (3.66 units) was not clinically significant. [ABSTRACT FROM AUTHOR]