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Intradetrusor injections of onabotulinumtoxinA are efficacious for the treatment of overactive bladder with urgency urinary incontinence in adults refractory to or intolerant of anticholinergics. Delivery of onabotulinumtoxinA via instillation would reduce the need for intradetrusor injections. The objective of this trial was to assess the efficacy and safety of intravesical instillation of an onabotulinumtoxinA + hydrogel admixture.After review of a stage 1 safety phase by an independent committee, participants were recruited into stage 2 and randomized to either onabotulinumtoxinA 100, 300, 400, or 500 U, or placebo, all with hydrogel admixture. End points included change from baseline to week 12 in the number of urinary incontinence episodes (primary); micturition, urgency urinary, and nocturia episodes/day; volume voided per micturition; proportion of participants with a ≥50% decrease from baseline in urinary incontinence episodes/day; and Overactive Bladder Questionnaire total score. Adverse events were reported.Change from baseline to week 12 in number of urinary incontinence episodes was -2.72 with placebo and ranged from -0.89 to -1.85 in the onabotulinumtoxinA + hydrogel treatment groups. No difference from placebo was observed for any efficacy end point. The proportions of participants with treatment-emergent adverse events were similar among all groups, with asymptomatic bacteriuria the highest reported (6.7%-15.5%). There were no reports of urinary retention or elevated post-void residual volume.Intravesical instillation of an onabotulinumtoxinA + hydrogel admixture for the treatment of refractory overactive bladder was well tolerated, but it showed no improvement over placebo.

AimThe aim of this study was to examine how new technologies in late-stage clinical trials might address unmet patient, practitioner or caregiver need for faecal incontinence (FI) over the next 5 years.MethodsHorizon scanning techniques were used to provide insights into the current landscape of emerging health technologies. A search was performed across clinical trial registries using the National Institute for Health Research Innovation Observatory’s ScanMedicine database (scanmedicine.com) to identify new, emerging interventions or health technologies (drugs, medical devices or diagnostics) that were addressing or investigating FI. Trials were then screened for relevance to FI in a non-blinded duplicate manner.Results1163 records were identified through searching ScanMedicine, and 136 trials were included in the final data extraction and mapping process. The most frequently investigated FI intervention topics were complementary therapies (n=17, 12.4%); electrical stimulation (n=13, 9.5%); pelvic floor muscle training/biofeedback/sphincter exercises (n=13, 9.5%) and implanted sacral nerve stimulation (n=12, 8.7%). There was little evidence of new pharmaceutical technologies in development. Existing drugs are, however, being repurposed and trialled for the treatment of FI (eg, linaclotide, colesevelam). Such repurposed drugs often have lower development costs, shorter timelines and report lower failure rates compared with new pharmaceutical products.ConclusionOverall, the innovation space as indicated by late-stage clinical trials related to FI, is relatively stagnant. Patients, carers and healthcare professionals are demanding more effective treatment and containment options; however, these are unlikely to come to market in the immediate future.

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.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.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.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.

There is limited data addressing the value of vaginal biofeedback (VBF) on fecal incontinence (FI) symptoms. The objective of this pilot study was to evaluate whether use of a motion-based VBF device and app was effective for at-home treatment of women with FI. We hypothesized that VBF would result in improvement in FI symptoms.A single-arm 10-week prospective pilot trial in women with FI was conducted using the VBF device. The primary outcome was change in St. Mark's score from baseline to week 10. Secondary outcomes included change in 2-week bowel diary and FI quality of life (FIQoL). Statistical analysis included paired t test and Wilcoxon's signed-rank test.Of 29 enrolled women, 27 had data available for analysis. Mean (±SD) age was 60.9 (±14.4). 63% (17) subjects were White, 33% (9) were Black. Mean St. Mark's score was 14.6 (±4.4) at baseline and 11.6 (±5.1) at 10-weeks (p = 0.005). Changes in the total FIQol, and three of four subsets of the FIQoL scores were also significantly improved (p 0.001). Bowel diary showed decrease in FI episodes, baseline 8.4 (±8.73) to 10 weeks 4.8 (±3.79), (p = 0.052).In this pilot study, there was significant improvement in FI symptom-specific severity and quality of life using a vaginal, motion-based device for biofeedback. A larger study is needed to better understand the value of this device, which may be useful for women who prefer a vaginal device, which can be utilized at home compared with standard anal biofeedback for treatment of FI in the clinical setting.

Objectives There does not currently exist a complication scale to evaluate pelvic reconstructive surgery (PRS) that takes in account patient-centered outcomes. The purpose of this study was to characterize and compare patient and surgeon responses to a simplified, patient-centered version of the previously described Pelvic Floor Complication Scale (PFCS). Methods This is a multicenter (4 female pelvic medicine and reconstructive surgery practices) cross-sectional study of patients and surgeons. Using focus groups and telephone surveys, the original PFCS questionnaire was simplified. One hundred and twenty-four patients were recruited 6-12 months after PRS. Fifty-seven surgeons were recruited via electronic questionnaires. Surgeons and patients were asked to rank the severity and bother of each complication on a scale of 0 to 5 (0, none; 1, mild; 3, moderate; 5, major). Results Patients rated bother higher than severity for 36 of 38 complications (all differences ≤0.5 points). For statistical analysis, the highest response to patient bother/severity was chosen to weigh in favor of the patient. Patient bother/severity scores were significantly different (±0.5 points) for 27 of 38 complications compared with surgeon responses. Surgeon scores were higher for 5 complications (0.5-1.9 point differences) related to major injury requiring repair and wound breakdown. Patient scores were higher for 22 complications with the highest differences related to dyspareunia, constipation, or new/persistent urinary incontinence. Conclusions This mixed methods investigation revealed key differences between how patients and surgeons value PRS complications. Surgeons scored major surgical injuries higher than patients, whereas patients rated issues that many surgeons consider quality-of-life outcomes higher due to potential long-term bother. These data will be used to create a simplified, patient-centered PFCS.

Fecal incontinence is a highly prevalent and debilitating condition that negatively impacts quality of life. The etiology is often multifactorial and treatment can be hindered by lack of understanding of its mechanisms and available treatment options. This article reviews the evidence-based update for the management of fecal incontinence.

OBJECTIVE: To evaluate characteristics associated with treatment failure 1 year after midurethral sling in women with mixed urinary incontinence. METHODS: Four-hundred three women who participated in a randomized trial that compared midurethral sling and behavioral and pelvic floor muscle therapy (combined group) compared with midurethral sling alone for mixed incontinence with 1-year follow-up data were eligible for this planned secondary analysis. Overall treatment failure was defined as meeting criteria for subjective or objective failure or both. Subjective failure was defined as not meeting the minimal clinical important difference for improvement on the UDI (Urogenital Distress Inventory) total score (26.1 points). Objective failure was defined as not achieving 70% improvement on mean incontinence episodes of any type per day or having undergone any additional treatment for persistent urinary symptoms at 12 months postoperative. Logistic regression models for treatment failure were constructed. Independent variables included site and treatment group, and clinical and demographic variables based on bivariate comparisons (P

To assess whether immediate or delayed pushing in the second-stage results in higher risk of pelvic floor morbidity.This study was a planned secondary aim of a multicenter randomized clinical trial that included nulliparous patients at 37 weeks of gestation or greater in labor with neuraxial analgesia. Participants were randomized in the second stage to initiate pushing immediately or wait 60 minutes before pushing. Participants had pelvic floor assessments at 1-5 days postpartum, 6 weeks postpartum, and 6 months postpartum. Rates of perineal lacerations, pelvic organ prolapse quantification (POP-Q) measures, and scores on validated symptom-specific distress and quality-of-life questionnaires (PFDI-20 [Pelvic Floor Distress Inventory], PFIQ [Pelvic Floor Impact Questionnaire], FISI [Fecal Incontinence Severity Index], and MMHQ [Modified Manchester Health Questionnaire]) were compared. It was estimated that 630 participants would provide more than 80% power to detect a 40% difference in second-degree or greater perineal lacerations and approximately 80% power to detect a 40% difference in stage 2 or greater pelvic organ prolapse (POP).Among 2,414 participants in the primary trial conducted between May 19, 2014, and December 16, 2017, 941 (39%) had pelvic floor assessments: 452 immediate pushing and 489 delayed pushing. The mean age was 24.8 years, and 93.4% had vaginal delivery. There were no significant differences in perineal lacerations at delivery and POP at 6 weeks and 6 months postpartum. Changes from baseline in total and subscale scores for the PFDI-20, the PFIQ, and the MMHQ were not significantly different at 6 weeks postpartum and 6 months postpartum. The change in FISI score was higher in the immediate pushing group at 6 months (2.9±5.7 vs 2.0±4.5, difference 0.9, P=.01), but less than the minimum important difference of 4.Among nulliparous patients in the second stage with neuraxial analgesia, immediate pushing, compared with delayed pushing, did not increase perineal lacerations, POP-Q measures, or patient-reported pelvic floor symptoms at 6 weeks and 6 months postpartum.ClinicalTrials.gov, NCT02137200.

Objectives High-level evidence for second-line noninvasive treatments for fecal incontinence in women is limited. We present the rationale for and design of the NeuromOdulaTion for Accidental Bowel Leakage trial, a randomized controlled trial of percutaneous tibial nerve stimulation (PTNS) and validated sham stimulation in women with refractory accidental bowel leakage. Methods The rationale and goals for a 2-part study with a run-in phase, use of a generic pulse generator for PTNS and sham stimulation, masking, participant inclusion, primary and secondary outcome measures, and adverse event collection are described. A superiority design will be used to compare change from baseline in St. Mark's score after 12 weekly stimulation sessions between PTNS and sham. Responders to initial treatment (PTNS or sham) will be assigned to scheduled or "as needed" intervention for up to 1 year. Secondary outcome measures include incontinence episodes and other bowel events recorded in a 14-day electronic bowel diary, general and condition-specific quality of life instruments, adaptive behavior, global impression of improvement, symptom control, and sexual function. Results Sample size calculations determined that 165 participants (110 PTNS and 55 sham) would provide 90% power to detect greater than or equal to 4-point difference between PTNS and sham in change from baseline in St. Mark's score at 12 weeks. Conclusions The methods for the NeuromOdulaTion for Accidental Bowel Leakage trial will provide high-level evidence of the effectiveness and optimal maintenance therapy schedule of a low-cost PTNS protocol in community-dwelling women seeking second-line intervention for refractory accidental bowel leakage.

OBJECTIVE To determine whether use of an intravaginal motion-based digital therapeutic device for pelvic floor muscle training (PFMT) was superior to PFMT alone in women with stress-predominant urinary incontinence (SUI). METHODS A multicenter, randomized-controlled trial was conducted where women with SUI or SUI-predominant mixed urinary incontinence were treated with either PFMT using the device (intervention group) or PFMT alone (control group). Primary outcomes, measured at 8 weeks, included change in Urinary Distress Inventory, short-version and improvement in the Patient Global Impression of Improvement, defined as "much better" or "very much better." Participants also completed Pelvic Organ Prolapse and Colorectal-anal Distress Inventories, Pelvic-Floor-Impact Questionnaire and a 3-day bladder diary. Primary analysis used a modified intention-to-treat approach. Statistical analysis used Student t test and χ2 test. The trial was prematurely halted due to device technical considerations. RESULTS Seventy-seven women were randomized, and final analysis included 61 participants: 29 in intervention and 32 in control group. There was no statistical difference in Urinary Distress Inventory, short-version scores between the intervention (-13.7 ± 18.7) and the control group (-8.7 ± 21.8; P = 0.85), or in Patient Global Impression of Improvement (intervention 51.7% and control group 40.6%; P = 0.47). Pelvic Organ Prolapse and Colorectal-anal Distress Inventories and Pelvic-Floor-Impact Questionnaire scores improved significantly more in the intervention group than the control group (all P < 0.05). Median number of SUI episodes decreased from baseline to 8 weeks by -1.7 per-day [(-3)-0] in the intervention group and -0.7[(-1)-0] in the control group, (P = 0.047). CONCLUSIONS In this prematurely terminated trial, there were no statistically significant differences in primary outcomes; however, PFMT with this digital therapeutic device resulted in significantly fewer SUI episodes and greater improvement in symptom-specific quality of life outcomes. A larger powered trial is underway.

The objective was to determine the relationship between the preoperative D-point and apical outcomes at 24 months, using the Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) dataset. This was a secondary analysis of the OPTIMAL trial, a randomized multi-centered study comparing outcomes of sacrospinous ligament fixation and transvaginal uterosacral ligament suspension (USLS). The 2-year dataset utilized included women undergoing USLS with concomitant hysterectomy. The primary outcome was the relationship between preoperative D-point and apical outcomes at 24 months. Secondary objectives were to determine the relationship between preoperative D-point and anatomical, composite and subjective outcomes, and to determine a D-point cut-off that could be used to predict success in each of these categories. Of the 186 women in the USLS arm, 120 were available for analysis of anatomical failure at 24 months. A higher preoperative D-point correlated with improved apical outcome (C-point) at 24 months (r = 0.34; p value = 0.0002). Using ROC curves, a moderate association was found between the preoperative D-point and apical and anatomical success, (AUC 0.689 and 0.662). There was no relationship between preoperative D-point and composite or subjective success (AUC 0.577 and 0.458). Based on the ROC curves, a “cut-off” D-point value of −4.25 cm (sensitivity = 0.58, specificity = 0.67) was determined to be a predictor of postoperative anatomical success at 2 years. Preoperative D-point correlates with postoperative anatomical and apical support, but is less successful at predicting subjective outcomes. The strongest predictive D-point cut-off for anatomical and apical success at 24 months was −4.25 cm.

Groundwater is a critical resource not only for human communities but also for many terrestrial, riparian, and aquatic ecosystems and species. Yet groundwater planning and management decisions frequently ignore or inadequately address the needs of these natural systems. As a consequence, ecosystems dependent on groundwater have been threatened, degraded, or eliminated, especially in arid regions. There is growing acknowledgment that governmental protections for these ecological resources are necessary, but current legal, regulatory and voluntary provisions are often inadequate. Groundwater management premised on “safe yield,” which aims to balance human withdrawals with natural recharge rates, typically provides little to no consideration for water needed by ecosystems. Alternatively, the “sustainable yield” concept aims to integrate social, economic and environmental needs for groundwater, but the complexity of groundwater systems creates substantial uncertainty about the impact that current or future groundwater withdrawals will have on ecosystems. Regardless of the legal or regulatory framework, guidance is needed to help ensure environmental water needs will be met, especially in the face of pressure to increase human uses of groundwater resources. In this paper, we describe minimum provisions for planning, managing, and monitoring groundwater that collectively can lower the risk of harm to groundwater‐dependent ecosystems and species, with a special emphasis on arid systems, where ecosystems and species may be especially reliant upon and sensitive to groundwater dynamics., Article impact statement: Using our model, one can evaluate the inflow to a tunnel and estimate the pumping rate and location of nearby well(s) to dewater the tunnel.

OBJECTIVES: The primary objective of this study is to compare patient versus physician rankings of adverse event (AE) and adverse symptom (AS) severity after pelvic reconstructive surgery. Secondary objectives include to estimate the association between patient rankings of AEs/ASs with decision-making and quality-of-life outcomes and to determine whether patient perspective about AE/AS changes over time. METHODS: This is a supplementary study, Patient-Perspectives in Adverse Event Reporting (PPAR), to the index trial, ASPIRe (Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design). During the trial, AEs/ASs will be assessed by physicians longitudinally every 6 months, which includes a determination of the AE/AS grade severity. For PPAR, additional patient perspective will be measured for 19 predetermined AEs/ASs at the time of identification and again at 12 and 36 months post-operatively. Decision-making and quality-of-life questionnaires will be collected at these time points. The primary outcome, the overall interrater agreement between patient and physician rankings for AE/AS severity, will be determined using a repeated-measures concordance correlation coefficient. RESULTS: To date, the index trial has completed enrollment, and follow-up is ongoing. CONCLUSIONS: The PPAR methods for incorporating patient perspective in the measurement of AEs/ASs to determine their agreement with physician ranking, long-term relevance, and impact on treatment decision making and quality of life are described. This will contribute to improved measurements of AEs/ASs in future research with the goal of improving patient counseling and informing expectations and treatment decision making.

Objective: To evaluate physical performance measures of mobility and functional impairments and assess their association with urinary incontinence (UI) severity and impact on quality of life among older women with UI. Methods: In a cross-sectional pilot study, 20 women aged ≥ 70 years with UI completed UI questionnaires (Global Impression of Severity, Incontinence Impact Questionnaire (IIQ-7)) and functional status evaluation. Functional status evaluation included the Modified Physical Performance Test (MPPT; range 0–36), Short Physical Performance Battery (SPPB; range 0–12), and other physical performance measures (e.g., Timed Up and Go [TUG]). MPPT and SPPB scores 0.05) with UI measures. Conclusions: Mobility and functional impairments are common among older women with UI. Associations between MPPT score, TUG performance with UI impact on quality of life suggest these physical performance measures could be markers of mobility and functional impairments in future research on UI in older women., Brief Summary: Further research in utility of physical performance measures as markers of mobility and functional impairments in older women with urinary incontinence is warranted.

AIMS: To characterize symptom specific distress and impact on quality of life among women with urge, passive and combined urge/passive fecal incontinence (FI) phenotypes. A secondary aim was to characterize FI symptom specific distress and impact in women with a novel fourth phenotype, stress FI. METHODS: Women with at least monthly FI from 2003 to 2017 were included. Participants completed the Modified Manchester Health Questionnaire (MMHQ) including Manchester Health Questionnaire (MHQ) and Fecal Incontinence Severity Index (FISI). Anorectal manometry (ARM) and endoanal ultrasound (EAUS) testing was performed. Total MHQ and FISI scores were compared across FI subtypes controlling for pertinent baseline covariates. RESULTS: The cohort included 404 subjects, 220 meeting criteria for urge FI, 67 passive FI and 117 combined urge/passive FI. On MHQ, women with combined urge/passive FI were most impacted (p0.05). 29 subjects were identified with stress FI. There was no difference in overall MHQ or FISI scores or anal sphincter evaluation among the urge, passive and stress FI groups (all p>0.05). CONCLUSIONS: Women with combined urge/passive FI have higher symptom distress and impact on quality of life than urge or passive FI alone. Further research is needed to determine the significance of stress FI as a subtype and response to treatment.

Author(s): Zyczynski, Halina M; Richter, Holly E; Sung, Vivian W; Arya, Lily A; Lukacz, Emily S; Visco, Anthony G; Rahn, David D; Carper, Benjamin; Mazloomdoost, Donna; Gantz, Marie G; NICHD Pelvic Floor Disorders Network | Abstract: AimsTo assess performance, acceptability, external validity, and reliability of a phone application electronic bowel diary (PFDN Bowel eDiary).MethodsWomen 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).ResultsPaired 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.ConclusionThe 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.

INTRODUCTION AND HYPOTHESIS: The protocol and analysis methods for the Defining Mechanisms of Anterior Vaginal Wall Descent (DEMAND) study are presented. DEMAND was designed to identify mechanisms and contributors of prolapse recurrence after two transvaginal apical suspension procedures for uterovaginal prolapse. METHODS: DEMAND is a supplementary cohort study of a clinical trial in which women with uterovaginal prolapse randomized to (1) vaginal hysterectomy with uterosacral ligament suspension or (2) vaginal mesh hysteropexy underwent pelvic magnetic resonance imaging (MRI) at 30-42 months post-surgery. Standardized protocols have been developed to systematize MRI examinations across multiple sites and to improve reliability of MRI measurements. Anatomical failure, based on MRI, is defined as prolapse beyond the hymen. Anatomic measures from co-registered rest, maximal strain, and post-strain rest (recovery) sequences are obtained from the “true midsagittal” plane defined by a 3D pelvic coordinate system. The primary outcome is the mechanism of failure (apical descent versus anterior vaginal wall elongation). Secondary outcomes include displacement of the vaginal apex and perineal body, and elongation of the anterior wall, posterior wall, perimeter, and introitus of the vagina between (1) rest and strain and (2) rest and recovery. RESULTS: Recruitment and MRI trials of 94 participants were completed by May 2018. CONCLUSIONS: Methods papers which detail studies designed to evaluate anatomic outcomes of prolapse surgeries are few. We describe a systematic, standardized approach to define and quantitatively assess mechanisms of anatomic failure following prolapse repair. This study will provide a better understanding of how apical prolapse repairs fail anatomically.

INTRODUCTION AND HYPOTHESIS: The current study aims to assess the continence rate of a “second primary” midurethral sling (MUS) in women with recurrent/persistent stress urinary incontinence (SUI) after sling excision compared to a historical cohort who underwent a repeat MUS. METHODS: A retrospective cohort study of women who underwent excision of a primary MUS and placement of a “second primary” MUS from 2009–2016 compared to a historical cohort who underwent a repeat MUS from 2006–2009. The primary outcome was continence rate, defined as “not at all” or “somewhat” to Urogenital Distress Inventory (UDI-6) SUI subscale questions. Secondary outcomes included assessment of symptom severity (UDI-6), symptom specific quality of life, Incontinence Impact Questionnaire (IIQ-7), Medical and Epidemiologic Aspects of Aging (MESA), and Patient Global Impression of Improvement (PGI-I). RESULTS: Survey responses were available for 23/64 (36%) in the “second primary” MUS group versus 88/135 (65%) in the historical cohort. Mean follow-up in months, second primary: 41.8 ± 26.1 versus repeat: 36.2 ± 14.1, p=0.16 and age (years): 56.4 ± 10.7 versus 59.8 ± 10.8, p=0.19. Continence rates were 48% in “second primary” versus 56% in the repeat group (p=0.50). Both groups had significant improvement in questionnaire scores postoperatively with no intergroup differences. Multivariable analysis demonstrated that odds of success did not differ between groups (adjusted odds ratio: 0.73, 95% confidence interval: 0.27–1.99). CONCLUSIONS: In women with recurrent/persistent SUI, repeat and “second primary” MUS demonstrate similar success outcomes and improvement in UI symptom distress and QOL. Continued research is needed for this increasingly important clinical question.

The primary aim was to compare subjective treatment success among women in short-, mid-, and long-term follow-up after mid-urethral sling (MUS). Symptom severity, condition-specific quality of life (QOL), and patient satisfaction were also examined. Women undergoing a primary MUS between 2001 and 2010 were identified by CPT code. Eligible subjects were mailed the Urogenital Distress Inventory (UDI-6), Pelvic Floor Impact Questionnaire (PFIQ-7), Patient Global Impression of Improvement (PGI-I), and Patient Satisfaction Questionnaire (PSQ). Follow-up intervals were short term (≤ 36 months), mid term (37–70 months), and long term (119–200 months). The primary outcome of treatment success was defined as responses of “not at all” or “somewhat” to both stress urinary incontinence (SUI) subscales on the UDI-6. Of 896 respondents, 361 were assessed in the short-term (23.3 ± 7.2 months), 251 in the mid-term (49.8 ± 9.1 months), and 284 in the long-term group (147.9 ± 20.6 months). Treatment success was 75.4% in the short-, 62.3% in the mid-, and 67.0% in the long-term groups (p

INTRODUCTION AND HYPOTHESIS: The current study aims to characterize the association between pelvic floor disorder symptoms and bone strength reflecting a potential connective tissue pathophysiology in postmenopausal women. METHODS: A cross-sectional study was conducted in postmenopausal women undergoing osteoporosis evaluation from 2007 to 2010. Urinary incontinence (UI) was defined as urinary leakage ≥2–3 times/week. UI types were defined using the 3 Incontinence Questionnaire. Fecal incontinence was defined as stool leakage ≥1/month, and pelvic organ prolapse as a positive response to “Do you have a bulge or something falling out that you can see or feel in your vaginal area?” Bone quality and quantity were assessed by trabecular bone score (TBS) and bone mineral density, respectively; i) bone strength was defined by combined quality/quantity index, low strength being equivalent to moderate-severe fracture risk ii) low quality as TBS≤1.31; iii) low quantity by T-score

Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery in the Vaginal hysterectomy with Native Tissue Vault Suspension vs Sacrospinous Hysteropexy with Graft Suspension (Study for Uterine Prolapse Procedures Randomized Trial) trial, sacrospinous hysteropexy with graft (hysteropexy) resulted in a lower composite surgical failure rate than vaginal hysterectomy with uterosacral suspension over 5 years.This study aimed to identify factors associated with the rate of surgical failure over 5 years among women undergoing sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral suspension for uterovaginal prolapse.This planned secondary analysis of a comparative effectiveness trial of 2 transvaginal apical suspensions (NCT01802281) defined surgical failure as either retreatment of prolapse, recurrence of prolapse beyond the hymen, or bothersome prolapse symptoms. Baseline clinical and sociodemographic factors for eligible participants receiving the randomized surgery (N=173) were compared across categories of failure (≤1 year,1 year, and no failure) with rank-based tests. Factors with adequate prevalence and clinical relevance were assessed for minimally adjusted bivariate associations using piecewise exponential survival models adjusting for randomized apical repair and clinical site. The multivariable model included factors with bivariate P.2, additional clinically important variables, apical repair, and clinical site. Backward selection determined final retained risk factors (P.1) with statistical significance evaluated by Bonferroni correction (P.005). Final factors were assessed for interaction with type of apical repair at P.1. Association is presented by adjusted hazard ratios and further illustrated by categorization of risk factors.In the final multivariable model, body mass index (increase of 5 kg/mObesity and duration of prolapse symptoms have been determined as risk factors associated with surgical failure over 5 years from transvaginal prolapse repair, regardless of approach. Providers and patients should consider these modifiable risk factors when discussing treatment plans for bothersome prolapse.

To evaluate whether pelvic floor muscle training using a motion-based digital intravaginal device is more effective than home pelvic floor muscle training for treatment of stress or stress-predominant mixed urinary incontinence (UI).In a remote, virtually executed 8-week prospective randomized controlled superiority trial, women with stress or stress-predominant mixed UI were randomized to pelvic floor muscle training using a motion-based digital therapeutic device or a home training program using written and narrated instructions. Primary outcomes were change in UDI-6 (Urogenital Distress Inventory, Short Form) score and stress urinary incontinence (SUI) episodes on a 3-day bladder diary. A sample size of 139 per group (n=278) was planned to meet the power analysis requirements for the UDI-6 score (n=278) and the bladder diary (n=78). Prespecified secondary outcomes included quality-of-life surveys and adherence reporting.From September 2020 to March 2021, 5,353 participants were screened, and 363 were randomized: 182 in the intervention and 181 in the control group. There were no baseline clinicodemographic differences between groups. The mean change in UDI-6 score was significantly greater for the intervention group compared with the control group (18.8 vs 14.7, P=.01). The median (interquartile range) number of SUI episodes on the 3-day bladder diary was significantly reduced from 5 (3-8) and 5 (3-8) episodes to 1 (0-3) and 2 (1-4) (P=.005) in the intervention group compared with control group, respectively. A significantly greater number of participants in the intervention group than in the control group reported they were "much improved" or "very much improved" on the PGI-I (Patient Global Impression of Improvement) (63/143 [44.1% vs 45/156 [28.8%], odds ratio 1.94, 95% CI 1.21-3.15). There were no device-related severe adverse events.In this all-remote, virtually conducted trial, pelvic floor muscle training guided by a motion-based digital therapeutic device resulted in significantly improved UI symptoms and reduction of UI episodes compared with a home training program.ClinicalTrials.gov, NCT04508153.Renovia Inc.

Pregnancy and childbirth are known risk factors associated with the development of pelvic organ prolapse; specific intrapartum risk factors are not well characterized.This study aimed to determine intrapartum factors associated with increased risk of pelvic organ prolapse identified after delivery.A planned secondary analysis of a multicenter randomized clinical trial of delayed vs immediate pushing among nulliparous women at ≥37 weeks of gestation in labor with neuraxial analgesia was conducted at 6 academic and community hospitals in the United States. Intrapartum characteristics were identified, and Pelvic Organ Prolapse Quantification assessments at 6 weeks and 6 months after delivery were performed. The primary outcome was pelvic organ prolapse, defined as stage 2 or greater prolapse using the Pelvic Organ Prolapse Quantification assessment at 6 months. Multivariable logistic regression was used to refine risk estimates while adjusting for randomization group, macrosomia, and maternal age.Among the 941 women participating in the pelvic floor follow-up, 793 women had Pelvic Organ Prolapse Quantification assessments at 6 weeks with 91 of 793 women (11.5%) demonstrating stage 2 or greater prolapse. Of the 728 women followed up at 6 months, stage 2 or greater prolapse was identified in 58 of 728 women (8.0%). Prostaglandin use for induction of labor was associated with an increased risk at 6 months (adjusted odds ratio, 2.15; 95% confidence interval, 1.18-3.91; P.01). The length and type (spontaneous vs induced) of the first stage of labor were not significantly associated with stage 2 or greater prolapse. Moreover, increased length of the second stage of labor and duration of pushing were not associated with stage 2 or greater prolapse. After adjusting for confounding factors, cesarean delivery was protective of pelvic organ prolapse at 6 months (adjusted odds ratio, 0.12; 95% confidence interval, 0.02-0.90).The management of the first and second stages of labor, including time length, was not associated with stage 2 or greater prolapse at 6 months. The findings that prostaglandin exposure was associated with increased risk likely were not directly affecting the risk of prolapse but may be surrogates for other labor features that deserve exploration. Cesarean delivery was associated with protection from stage 2 or greater pelvic organ prolapse at 6 months, consistent with previous literature.

Fecal incontinence is a highly prevalent and debilitating condition that negatively impacts quality of life. The etiology is often multifactorial and treatment can be hindered by lack of understanding of its mechanisms and available treatment options. This article reviews the evidence-based update for the management of fecal incontinence.

The urogenital microbiome is associated with urgency and mixed urinary incontinence symptoms and differential treatment responses to pharmacotherapy for urgency urinary incontinence.This study aimed to describe whether the preoperative urinary and vaginal microbiomes were associated with surgical treatment responses at 12 months after a midurethral sling operation in women with mixed urinary incontinence.This cohort study compared the preoperative microbiome compositions of urine and vaginal samples from a subset of women undergoing a midurethral sling operation in the Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence trial (NCT01959347) and compared the microbiota in women who were surgical responders vs surgical nonresponders. Twelve-month objective response was defined as a ≥70% reduction from baseline urinary incontinence episodes on a 3-day diary. Subjective response was defined as a change from baseline in the Urogenital Distress Inventory scores. Bacterial abundance and beta diversity were assessed using 16S ribosomal RNA sequencing. The primary differential abundance analysis described predominant bacterial operational taxonomic units associated with responders vs nonresponders using unadjusted and age-adjusted linear models.Objective nonresponders (n=28) compared with responders (n=72) were older (58.5±10.7 vs 51.6±10.2 years) and more likely postmenopausal without hormone use (odds ratio, 6.4; 95% confidence interval, 1.8-22.6). Vaginal and urinary microbiota beta diversities were associated with age (P.05) for both responders and nonresponders. Overall, predominant operational taxonomic units (genera) were Lactobacillus, Gardnerella, Tepidimonas, Escherichia, Streptococcus, and Prevotella. Operational taxonomic units from baseline urine samples were not significantly associated (P threshold=.05) with surgical treatment responses. A greater abundance of baseline vaginal Lactobacillus was associated with an objective response (P=.04) and Prevotella with an objective nonresponse (P=.01). Adjusting for age, only a greater abundance of baseline vaginal Prevotella was associated with an objective nonresponse (P=.01). Moreover, less abundant vaginal operational taxonomic units were associated with objective and subjective responses and persistent urinary incontinence symptoms (P.05).Women meeting a 70% reduction of urinary incontinence treatment episodes (objective responders) had greater vaginal Lactobacillus at the time of the surgical procedure; however, controlling for age diminished this association. Women not meeting a 70% reduction of urinary incontinence episodes 1 year after a midurethral sling operation had greater vaginal Prevotella at the time of the midurethral sling operation. Further research is needed to determine whether therapy altering the vaginal microbiome may impact surgical treatment responses in women with mixed urinary incontinence.

Author(s): Nager, Charles W; Visco, Anthony G; Richter, Holly E; Rardin, Charles R; Rogers, Rebecca G; Harvie, Heidi S; Zyczynski, Halina M; Paraiso, Marie Fidela R; Mazloomdoost, Donna; Grey, Scott; Sridhar, Amaanti; Wallace, Dennis

OBJECTIVE: To present the design of the Apical Suspension Repair for Vault Prolapse in a Three-Arm Randomized Trial (ASPIRe) which compares the efficacy and safety of three apical repairs: native tissue transvaginal repair, transvaginal mesh, and sacral colpopexy. METHODS: Patient selection criteria, primary and secondary outcome measures including patient-reported outcome questionnaires, masking, surgeon certification, procedure standardization, adverse events collection and adjudication, and cost analysis will be described for this multi-centered randomized trial. Given the unique risks/ benefits of each technique, a non-inferiority design will be used to compare apical transvaginal mesh to mesh sacral colpopexy. A superiority design will be used to compare the two mesh repairs to native tissue transvaginal apical repair. Survival analysis will be used to assess a composite primary outcome for success composed of a subjective measure (no prolapse symptoms), objective measure (no prolapse beyond the hymen) and no prolapse retreatment, with a minimum follow up of 36 months. Secondary outcome measures collected every 6 months include assessment of validated general and condition-specific quality of life measures, global impression of improvement, satisfaction and regret, body image, and sexual function. RESULTS: Randomization and surgical treatment of 360 participants is complete and the study is in the follow-up phase. CONCLUSIONS: This report will provide valuable insight on the design of a novel 3-arm surgical trial utilizing mesh versus native tissue to repair vaginal vault prolapse. This trial will provide level 1 evidence on the risks and benefits of mesh augmented versus native tissue apical repairs.

Summary Background Well designed, large comparative effectiveness trials assessing the efficacy of primary interventions for faecal incontinence are few in number. The objectives of this study were to compare different combinations of anorectal manometry-assisted biofeedback, loperamide, education, and oral placebo. Methods In this randomised factorial trial, participants were recruited from eight clinical sites in the USA. Women with at least one episode of faecal incontinence per month in the past 3 months were randomly assigned 0·5:1:1:1 to one of four groups: oral placebo plus education only, placebo plus anorectal manometry-assisted biofeedback, loperamide plus education only, and loperamide plus anorectal manometry-assisted biofeedback. Participants received 2 mg per day of loperamide or oral placebo with the option of dose escalation or reduction. Women assigned to biofeedback received six visits, including strength and sensory biofeedback training. All participants received a standardised faecal incontinence patient education pamphlet and were followed for 24 weeks after starting treatment. The primary endpoint was change in St Mark's (Vaizey) faecal incontinence severity score between baseline and 24 weeks, analysed by intention-to-treat using general linear mixed modelling. Investigators, interviewers, and outcome evaluators were masked to biofeedback assignment. Participants and all study staff other than the research pharmacist were masked to medication assignment. Randomisation took place within the electronic data capture system, was stratified by site using randomly permuted blocks (block size 7), and the sizes of the blocks and the allocation sequence were known only to the data coordinating centre. This trial is registered with ClinicalTrials.gov, number NCT02008565. Findings Between April 1, 2014, and Sept 30, 2015, 377 women were enrolled, of whom 300 were randomly assigned to placebo plus education (n=42), placebo plus biofeedback (n=84), loperamide plus education (n=88), and the combined intervention of loperamide plus biofeedback (n=86). At 24 weeks, there were no differences between loperamide versus placebo (model estimated score change −1·5 points, 95% CI −3·4 to 0·4, p=0·12), biofeedback versus education (−0·7 points, −2·6 to 1·2, p=0·47), and loperamide and biofeedback versus placebo and biofeedback (−1·9 points, −4·1 to 0·3, p=0·092) or versus loperamide plus education (−1·1 points, −3·4 to 1·1, p=0·33). Constipation was the most common grade 3 or higher adverse event and was reported by two (2%) of 86 participants in the loperamide and biofeedback group and two (2%) of 88 in the loperamide plus education group. The percentage of participants with any serious adverse events did not differ between the treatment groups. Only one serious adverse event was considered related to treatment (small bowel obstruction in the placebo and biofeedback group). Interpretation In women with normal stool consistency and faecal incontinence bothersome enough to seek treatment, we were unable to find evidence against the null hypotheses that loperamide is equivalent to placebo, that anal exercises with biofeedback is equivalent to an educational pamphlet, and that loperamide and biofeedback are equivalent to oral placebo and biofeedback or loperamide plus an educational pamphlet. Because these are common first-line treatments for faecal incontinence, clinicians could consider combining loperamide, anal manometry-assisted biofeedback, and a standard educational pamphlet, but this is likely to result in only negligible improvement over individual therapies and patients should be counselled regarding possible constipation. Funding Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women's Health

Importance As surgical techniques evolve in the treatment of pelvic organ prolapse and patient preferences are better understood, more studies are investigating uterine-sparing procedures for efficacy, safety, and potentially improved quality of life. Much of the literature reflects the use of mesh material in uterine-sparing procedures, and there is a paucity of data regarding the safety and efficacy of native tissue uterine-sparing procedures for the treatment of pelvic organ prolapse. Objective To summarize existing evidence regarding objective and subjective outcomes of uterine-preserving procedures including the Manchester procedure (MP) as well as native tissue uterovaginal hysteropexy with repairs, namely, uterosacral hysteropexy (USH) and sacrospinous hysteropexy (SSH), compared with outcomes of total vaginal hysterectomy (TVH) with repairs for the management of uterovaginal prolapse. Evidence Acquisition A review of the literature included MEDLINE, Cochrane, and clinicaltrials.gov databases. Results Few level 1 data exist comparing outcomes of native tissue hysteropexy to vaginal hysterectomy for management of uterovaginal prolapse. In general, outcomes of the MP for the management of uterovaginal prolapse revealed that compared with TVH it is associated with shorter operative times, lower estimated blood loss and risk of blood transfusion with no difference in hospital stay, and similar quality of life and sexual function outcomes. Retrospective data suggest no difference with respect to recurrent prolapse of any compartment between USH and TVH with repairs. Level 1 data reveal that SSH has been shown to have similar 1-year outcomes and safety compared with TVH with native tissue suspension. Women with stage 4 prolapse who undergo an SSH may be at higher risk of recurrence and may benefit from an alternative method of apical prolapse repair. Conclusions and Relevance More level 1 data are needed in order to robustly understand long-term differences in outcomes between native tissue uterine-conserving versus vaginal hysterectomy surgical approaches in women with uterovaginal prolapse.

Study Objective To determine the prevalence and awareness of pelvic floor disorder symptoms among female adolescents. Design Cross-sectional study via a written, anonymous survey of adolescents. The survey was composed of validated measures for determination of symptom prevalence. Setting Pediatric and adolescent gynecology clinic in the southeast United States. Participants Female adolescents ages 14-21 years. Interventions None. Main Outcome Measures We used χ2 analyses for categorical variables and t test for continuous variables. Results Two hundred sixteen questionnaires were completed. The mean age of respondents was 17.1 (±2.1) years and most respondents had at least heard about urinary (UI) and fecal incontinence (FI; 62.9%). The prevalence of any UI was 31.5%. Urgency UI (UUI) was reported by 15.7% and stress UI was reported by 6.9% of adolescents; 8.8% of participants experienced UUI and stress UI symptoms. FI and pelvic organ prolapse symptoms were reported by 0.9%. There were no differences in reported prevalence rates of UI (31.7% vs 27.9%), FI (1.4% vs 0%), or pelvic organ prolapse (1.4% vs 0%) between younger (14-17 years) and older (18-21 years) adolescent participants, respectively (all P > .05). Although UI was fairly prevalent among respondents, most stated that it had a minimal effect on daily living. Conclusion UI symptoms were common among female adolescents, with UUI being the most reported. Early education regarding pelvic floor disorder symptoms might lead to prevention or empowerment to seek treatment as adolescents age.

OBJECTIVES The authors used 2-dimensional images from pelvic 3 T magnetic resonance imaging (MRI) to characterize changes in the internal anal sphincter (IAS) and external anal sphincter (EAS) from prepregnancy to postdelivery in the same cohort. METHODS This secondary analysis studied a prospective cohort of women undergoing 3 T MRI before their first pregnancy and 6 or more months after delivery. Radial thickness was measured at 12, 3, 9, and 6 o'clock from axial proximal and mid views and oblique distal views of the IAS, and at 3 and 9 o'clock from oblique views of the EAS. Measurements were compared prepregnancy to postdelivery; 10 women had 80% power (α = 0.05) to detect a 0.85-mm change. RESULTS Nineteen women completed initial 3 T MRI, 15 achieved pregnancy and birth, and 10 completed postdelivery MRI (4 vaginal birth and 6 Cesarean delivery). Mean change in measurement from prepregnancy to postdelivery was -0.01 mm ± 1.03 mm for the distal 12 o'clock IAS (P = 0.98) and +0.19 ± 0.64 mm for the lateral EAS (P = 0.32). All prepregnancy and postdelivery women had discontinuous EA sphincters at 6 and 12 o'clock. There were no statistically significant changes from prepregnancy to postdelivery in any IAS or EAS location (all >0.05) for the entire cohort, those with vaginal birth, or after Cesarean. CONCLUSIONS Anal sphincter measurements on MRI did not change significantly in nulliparous women prepregnancy to postdelivery at any location, and the EAS was not measurable at 12 o'clock in any women at either time point, challenging classic concepts of EAS anatomy.

Objectives The aim of this study was to investigate the association between urinary phytoestrogen levels with symptoms of pelvic organ prolapse (POP) and fecal incontinence (FI) in postmenopausal women. Methods This is a cross-sectional study using the National Health and Nutrition Examination Survey database from 2005 to 2010 including postmenopausal women 40 years or older who either had both ovaries removed and/or had no period in the past year due to hysterectomy and/or menopause. Urinary concentrations of 6 phytoestrogens were measured. Pelvic organ prolapse symptoms were defined as a positive response to the question, "Do you see or feel a bulge in the vaginal area?" Fecal incontinence was defined as leakage of mucus, liquid, or solid stool occurring at least monthly. Using appropriate sample weights, prevalence estimates and 95% confidence intervals were calculated. Logistic regression was performed assessing associations between pelvic floor symptoms and log-transformed phytoestrogen levels adjusting for appropriate covariates. Results Participants included 1341 postmenopausal women with phytoestrogen data; 1213 with or without POP symptoms and 1221 with or without FI symptoms. Multivariable analysis revealed no association of urinary phytoestrogen levels with POP symptoms. Higher urinary O-desmethylangolensin level was associated with decreased odds of FI symptoms in postmenopausal women (adjusted odds ratio, 0.92; 95% confidence interval, 0.86-0.99). Conclusions Increased urinary O-desmethylangolensin level was associated with lower odds of FI. Future research may be warranted to further investigate the potential of specific phytoestrogens as mediators of FI, as well as the role of phytoestrogens on POP symptoms.

To determine whether use of an intravaginal motion-based digital therapeutic device for pelvic floor muscle training (PFMT) was superior to PFMT alone in women with stress-predominant urinary incontinence (SUI).A multicenter, randomized-controlled trial was conducted where women with SUI or SUI-predominant mixed urinary incontinence were treated with either PFMT using the device (intervention group) or PFMT alone (control group). Primary outcomes, measured at 8 weeks, included change in Urinary Distress Inventory, short-version and improvement in the Patient Global Impression of Improvement, defined as "much better" or "very much better." Participants also completed Pelvic Organ Prolapse and Colorectal-anal Distress Inventories, Pelvic-Floor-Impact Questionnaire and a 3-day bladder diary. Primary analysis used a modified intention-to-treat approach. Statistical analysis used Student t test and χ2 test. The trial was prematurely halted due to device technical considerations.Seventy-seven women were randomized, and final analysis included 61 participants: 29 in intervention and 32 in control group. There was no statistical difference in Urinary Distress Inventory, short-version scores between the intervention (-13.7 ± 18.7) and the control group (-8.7 ± 21.8; P = 0.85), or in Patient Global Impression of Improvement (intervention 51.7% and control group 40.6%; P = 0.47). Pelvic Organ Prolapse and Colorectal-anal Distress Inventories and Pelvic-Floor-Impact Questionnaire scores improved significantly more in the intervention group than the control group (all P0.05). Median number of SUI episodes decreased from baseline to 8 weeks by -1.7 per-day [(-3)-0] in the intervention group and -0.7[(-1)-0] in the control group, (P = 0.047).In this prematurely terminated trial, there were no statistically significant differences in primary outcomes; however, PFMT with this digital therapeutic device resulted in significantly fewer SUI episodes and greater improvement in symptom-specific quality of life outcomes. A larger powered trial is underway.

OBJECTIVE: To identify baseline clinical and demographic characteristics associated with clinically important treatment responses in a randomized trial of non-surgical therapies for fecal incontinence (FI). METHODS: Women (N=296) with FI were randomized to loperamide or placebo and manometry-assisted biofeedback exercises or educational pamphlet in a 2×2 factorial design. Treatment response was defined in 3 ways: minimally clinically important difference (MID) of −5 points in St. Mark’s score, ≥50% reduction in FI episodes and combined St. Mark’s MID and ≥50% reduction FI episodes, from baseline to 24 weeks. Multivariable logistic regression models included baseline characteristics and treatment group with and without controlling for drug and exercise adherence. RESULTS: Treatment response defined by St. Mark’s MID was associated with higher symptom severity (adjusted Odds Ratio [aOR] 1.20, 95%CI 1.11 – 1.28) and being overweight vs normal/underweight (aOR 2.15, 95%CI 1.07 – 4.34); these predictors remained controlling for adherence. 50% reduction in FI episodes was associated with combined loperamide/biofeedback group compared to placebo/pamphlet (aOR 4.04, 95%CI 1.36 – 11.98), St. Mark’s score in the placebo/pamphlet group (aOR 1.29, 95%CI 1.01–1.65), FI subtype of urge vs urge plus passive FI (aOR 2.39, 95%CI 1.09–5.25) and passive vs urge plus passive FI, (aOR 3.26, 95% CI 1.48–7.17). Controlling for adherence, associations remained, except St. Mark’s score. CONCLUSION: Higher severity of FI symptoms, being overweight, drug adherence, FI subtype, and combined biofeedback and medication treatment were associated with clinically important treatment responses. This information may assist in counseling patients regarding efficacy and expectations of non-surgical treatments of FI.

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.