IMPORTANCE:Older women have a high prevalence of and bother from overactive bladder (OAB) and urgency urinary incontinence (UUI), with unique treatment challenges. It is important to improve care for this long-overlooked and understudied group. OBJECTIVE:The objective was to describe the design and rationale for a randomized controlled noninferiority trial of low-dose (50 unit) versus standard-dose (100 unit) onabotulinumtoxinA (OnabotA) for OAB symptoms in women 70 years or older with UUI. STUDY DESIGN:Study population, injection procedure, and conduct are described. The primary outcome is change in quality of life (QOL) between groups as measured by the OAB Questionnaire (OABq-SF) 3 months posttreatment, including confirmatory heterogeneity of treatment effect analysis by frailty status. Secondary outcomes include patient-reported symptom bother and distress, satisfaction, goal attainment, depression scores, adverse events (AEs), cost analysis, and qualitative interviews. Patients will be assessed monthly for safety and efficacy through 12 months and can receive up to 2 additional treatments. RESULTS:A sample size of 278 is needed to achieve 90% power to detect noninferiority. Assuming a withdrawal of 26%, the target randomization is 376 participants. Adult females aged 70 years and older are recruited if they have urgency or urgency-predominant mixed urinary incontinence. Exclusion criteria include postvoid residual volume >150 mL, need for treatment under sedation, current other treatment for OAB, and conditions that affect bladder emptying. CONCLUSIONS:This trial will contribute important data on symptom-specific and health-related QOL, patient-reported and clinical outcomes, and AEs among older women with UUI being treated with the standard dose versus reduced dose of OnabotA.

IMPORTANCE:Transurethral bulking agent (TBA) injections and single incision slings (SIS) are low risk, minimally invasive options increasingly being used in the treatment of primary stress urinary incontinence (SUI); however, comparative trials are lacking. OBJECTIVES:We describe the study design and rationale for the Transurethral Bulking Agent Injection versus Single-Incision Sling for Stress Urinary Incontinence (BASIS) trial. STUDY DESIGN:The study methods, inclusion criteria, assessments, safety and efficacy outcomes, and follow-up are reported. We also present methods for selection of surgical devices and public private partnerships for product donation. The engagement of anesthesia co-investigators to develop an office-based protocol is also described. RESULTS:The BASIS trial is a multicentered, double-blind, randomized controlled, superiority study of up to 2 injections of TBA (Bulkamid) versus SIS (Solyx) at 12 months, with follow-up through 36 months. Women with primary, stress-predominant urinary incontinence without indication for general or regional anesthesia are eligible. A patient-centered primary outcome of Patient Global Impression of Improvement was used to calculate the sample size of 358. Secondary efficacy and safety outcomes of objective and subjective success, retreatment, and adverse events (including de novo pelvic floor muscle tenderness and dyspareunia), and cost-effectiveness analyses are planned. The feasibility of an office-based anesthesia protocol with sedation and local anesthesia will also be evaluated. CONCLUSIONS:Results from the BASIS study will provide level 1 evidence on the comparative-effectiveness of 2 minimally invasive office-based treatments. Important safety data and 3-year outcomes will help clinicians and patients make informed decisions about primary SUI procedure options.

(Abstracted from Obstet Gynecol 2025;145(1):17–20) Urinary tract infection (UTI) is a significant health care burden in the United States, with 50% of women experiencing at least 1 in their lifetime and a quarter of those experiencing recurrent infections. During the COVID-19 pandemic, telehealth visits for UTI care became common, which raised concerns among clinicians about overprescription of antibiotics due to the lack of urine testing during telemedicine.

Mixed urinary incontinence, which includes both stress and urgency urinary incontinence, adversely affects quality of life and can be difficult to manage. Studies comparing procedural-based treatments for mixed urinary incontinence are lacking. To determine whether intradetrusor onabotulinumtoxinA is more effective than midurethral sling for the treatment of mixed urinary incontinence in females. Randomized, superiority trial involving females (aged ≥21 years) with moderate to severe bother from both stress and urgency urinary incontinence who had unsuccessful conservative treatments and oral medications. The study was conducted at 7 US sites with enrollment between July 2020 and September 2022; the last date of follow-up was December 29, 2023. Intradetrusor injection of onabotulinumtoxinA, 100 U (treatment focused on the urgency component), vs surgical synthetic mesh midurethral sling (treatment focused on the stress component). Recipients of onabotulinumtoxinA could receive an additional injection between 3 and 6 months. All participants could receive additional treatment (including crossover to the alternative treatment) between 6 and 12 months. The primary outcome was change at 6 months in mixed incontinence symptoms as measured by the Urogenital Distress Inventory (UDI) total score (0-300 points; higher scores indicate worse symptoms; minimal clinically important difference, 26.1). Secondary outcomes included stress and irritative UDI subscores. Among 150 females randomized, 137 were treated, had postbaseline outcome data, and were included in the primary analysis (mean [SD] age, 59.0 [11.5] years). Both groups demonstrated mean improvement in UDI total score at 6 months with no significant difference between groups (onabotulinumtoxinA: −66.8 points [95% CI, −84.9 to −48.8]; sling: −84.9 [95% CI, −100.5 to −69.3]; mean difference, 18.1 points [95% CI, −4.6 to 40.7]; P = .12). For secondary outcomes, greater UDI stress score improvement was seen with the sling (−45.2 [95% CI, −53.7 to −36.8]) compared with onabotulinumtoxinA (−25.1 [95% CI, −34.1 to −16.1]) (P < .001); however, no significant difference was seen between groups in UDI irritative score (onabotulinumtoxinA: −32.9 [95% CI, −40.3 to −25.6] vs sling: –27.4 [95% CI, −34.6 to −20.3]; P = .27). In the onabotulinumtoxinA group, 12.7% and 28.2% received a second injection by 6 and 12 months, respectively. By 12 months, 30.3% in the sling group received onabotulinumtoxinA, and 15.5% in the onabotulinumtoxinA group received a sling. Overall, adverse events were not different between groups. There was no observed difference in UDI total score improvement at 6 months between the onabotulinumtoxinA and midurethral sling groups in females with moderate to severe mixed urinary incontinence who previously did not respond to conservative treatments. These findings may help inform treatment decisions based on patient preference in partnership with clinician recommendations. ClinicalTrials.gov Identifier: NCT04171531

ImportanceOveractive bladder is a distressing syndrome that significantly affects quality of life. Transcutaneous tibial nerve stimulation (TTNS) has been proposed as a home-based, patient-centered therapy that could improve access to treatment for this condition.ObjectiveWe aimed to determine the efficacy of 12 weeks of TTNS versus sham therapy in reducing symptomatic bother in ambulatory women with urgency urinary incontinence.Study DesignThis was a double-masked, sham-controlled randomized trial. The primary outcome was the change in Overactive Bladder Questionnaire scores. Secondary outcomes included those with 50% or greater reduction in urgency incontinence episodes on 3-day voiding diaries and Patient Global Impression of Improvement.ResultsOne hundred women were randomized (65 intervention, 35 sham) and included in analysis. Both groups experienced clinically meaningful improvement in Overactive Bladder Questionnaire scores postintervention from baseline, which was not significant between groups (symptom severity: intervention -19.5 +/- 20.2 vs sham -19.4 +/- 20.4, P = 1.0; health-related quality of life -16.6 +/- 18.5 vs -13.8 +/- 16.8, P = 0.5). In the TTNS group, 58.8% of women achieved 50% or greater reduction in urgency incontinence episodes versus 41.7% of women in the sham group (P = 0.2), and 25% versus 18% were "much" or "very much improved" (P = 0.2). A sensitivity analysis confirmed these findings.ConclusionsClinically meaningful reductions in overactive bladder symptoms were observed in both TTNS and sham therapy without significant differences between groups; however, a trend toward greater reduction in incontinence episodes and overall impression of improvement was noted in the active treatment. The therapeutic benefit from regularly connecting with a clinician should be considered when developing new therapies.

Importance:Mixed urinary incontinence, which includes both stress and urgency urinary incontinence, adversely affects quality of life and can be difficult to manage. Studies comparing procedural-based treatments for mixed urinary incontinence are lacking. Objective:To determine whether intradetrusor onabotulinumtoxinA is more effective than midurethral sling for the treatment of mixed urinary incontinence in females. Design, Setting, and Participants:Randomized, superiority trial involving females (aged ≥21 years) with moderate to severe bother from both stress and urgency urinary incontinence who had unsuccessful conservative treatments and oral medications. The study was conducted at 7 US sites with enrollment between July 2020 and September 2022; the last date of follow-up was December 29, 2023. Interventions:Intradetrusor injection of onabotulinumtoxinA, 100 U (treatment focused on the urgency component), vs surgical synthetic mesh midurethral sling (treatment focused on the stress component). Recipients of onabotulinumtoxinA could receive an additional injection between 3 and 6 months. All participants could receive additional treatment (including crossover to the alternative treatment) between 6 and 12 months. Main Outcomes and Measures:The primary outcome was change at 6 months in mixed incontinence symptoms as measured by the Urogenital Distress Inventory (UDI) total score (0-300 points; higher scores indicate worse symptoms; minimal clinically important difference, 26.1). Secondary outcomes included stress and irritative UDI subscores. Results:Among 150 females randomized, 137 were treated, had postbaseline outcome data, and were included in the primary analysis (mean [SD] age, 59.0 [11.5] years). Both groups demonstrated mean improvement in UDI total score at 6 months with no significant difference between groups (onabotulinumtoxinA: -66.8 points [95% CI, -84.9 to -48.8]; sling: -84.9 [95% CI, -100.5 to -69.3]; mean difference, 18.1 points [95% CI, -4.6 to 40.7]; P = .12). For secondary outcomes, greater UDI stress score improvement was seen with the sling (-45.2 [95% CI, -53.7 to -36.8]) compared with onabotulinumtoxinA (-25.1 [95% CI, -34.1 to -16.1]) (P < .001); however, no significant difference was seen between groups in UDI irritative score (onabotulinumtoxinA: -32.9 [95% CI, -40.3 to -25.6] vs sling: -27.4 [95% CI, -34.6 to -20.3]; P = .27). In the onabotulinumtoxinA group, 12.7% and 28.2% received a second injection by 6 and 12 months, respectively. By 12 months, 30.3% in the sling group received onabotulinumtoxinA, and 15.5% in the onabotulinumtoxinA group received a sling. Overall, adverse events were not different between groups. Conclusions and Relevance:There was no observed difference in UDI total score improvement at 6 months between the onabotulinumtoxinA and midurethral sling groups in females with moderate to severe mixed urinary incontinence who previously did not respond to conservative treatments. These findings may help inform treatment decisions based on patient preference in partnership with clinician recommendations. Trial Registration:ClinicalTrials.gov Identifier: NCT04171531.

OBJECTIVE:The impact of frailty and compromised mobility on immediate postoperative complications, geriatric outcomes, and treatment failure after prolapse surgery remains uncertain. The objective of this study was to prospectively characterize frailty and mobility and their impact on immediate postoperative complications, geriatric outcomes, and treatment success in older patients undergoing major urogynecologic surgery for pelvic organ prolapse. STUDY DESIGN:A nested prospective cohort study within a 3-arm randomized clinical trial was conducted at 9 clinical sites in 146 participants. Participants aged ≥65 years with symptomatic vaginal vault prolapse underwent baseline assessments of frailty and compromised mobility. Frailty was measured using the Robinson Frailty Index. The Robinson Frailty Index score ranges from 0 to 7 and scores ≥2 were considered prefrail/frail. Compromised mobility was defined as Timed Up and Go ≥15 seconds, use of an assistive device, or observed gait difficulties. The primary outcome was immediate postoperative moderate to severe adverse events assessed according to the Clavien-Dindo Severity Classification (grade≥II). Geriatric-specific outcomes included 30-day postoperative complications, need for increased social support assessed 6 weeks postoperatively, falls, new admission to skilled nursing facilities, all-cause hospital admissions, and mortality. Treatment outcome was time to composite treatment failure. Geriatric and treatment outcomes were assessed biannually for 36 up to 60 months. RESULTS:146 supplemental study participants underwent randomized prolapse surgery in the main trial: 50 in the transvaginal native tissue repair, 47 in the abdominal sacral colpopexy, and 48 in the transvaginal mesh repair arms. Compared with nonfrail subjects, prefrail/frail participants experienced no difference in geriatric-specific outcomes. Prefrail/frail participants living alone before surgery were more likely to require support (family/friends or assistance) in the first 6 weeks after surgery (19% vs 6%, P=.04). Prefrail/frail and compromised mobility participants had a shorter time to surgical treatment failure than did nonfrail or noncompromised patients (frail vs nonfrail adjusted hazard ratio, 2.1; 95% confidence interval, 1.2, 3.6). CONCLUSION:Despite measurable frailty or compromised mobility, many older patients underwent prolapse surgery with few complications; however, enhanced social support was needed in the first 6 weeks after surgery. Treatment failure was higher in patients with preoperative frailty, suggesting that frailty is important to incorporate in surgical treatment planning for the correction of pelvic organ prolapse in older patients.

BACKGROUND:Body image (a woman's perceptions and attitudes about her body) likely plays a role in pelvic organ prolapse treatment satisfaction and postoperative sexual function. OBJECTIVE:The primary aim of this study was to describe changes in body image after surgical repair of vaginal vault prolapse. The secondary aim was to evaluate whether changes in sexual function are correlated with changes in body image. STUDY DESIGN:This was a planned secondary analysis of a randomized three-arm trial comparing surgical approaches for vaginal vault prolapse. Women with symptomatic posthysterectomy vault prolapse were randomized to: transvaginal native tissue repair, mesh placed abdominally (sacrocolpopexy), or mesh placed transvaginally (TVM). Body image was measured using the validated Body Image in Pelvic Organ Prolapse questionnaire at baseline, 6, 12, 24, and 36 months. Sexual activity and function were measured using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA revised at similar time points. Longitudinal analysis for changes from baseline in mean Body Image in Pelvic Organ Prolapse score and the proportion of women who met a distribution-based estimate of the minimally important difference was performed using general mixed models for repeated measures. The same method was used as a model to predict change in sexual function based on body image. RESULTS:A total of 335 women were included in the analysis: native tissue repair=123, sacrocolpopexy=107, TVM=105. Mean age was 66.1±8.5 years and a majority (242, 72%) had stage 3 prolapse. Baseline total and subscale Body Image in Pelvic Organ Prolapse scores were not significantly different by treatment arm. All arms improved by 6 months, and this improvement was sustained to 36 months with no significant differences between the groups for change in Body Image in Pelvic Organ Prolapse score nor minimally important difference-equivalent improvement. Ninety-nine (30%) women reported being sexually active at all visits, 131 (39%) reported they were not sexually active at all visits, and the remainder changed sexual activity status throughout the study. Amongst sexually active participants, there were no baseline differences in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA revised scores between groups (native tissue repair, 54 women, 3.2±0.7; sacrocolpopexy, 43 women, 3.3±0.7; TVM, 46 women, 3.1±0.6). In sexually active women, change in Body Image in Pelvic Organ Prolapse and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA revised scores were correlated at each visit and a significant association between these measures (P<.001) remained after adjustment for baseline sexual function, site, age, surgical treatment arm, and baseline dyspareunia. CONCLUSION:Body image improves following repair of vaginal vault prolapse, regardless of the surgical approach. Improvements in body image and sexual function are positively correlated among sexually active women.

BACKGROUND: Many clinical trials use systematic methodology to monitor adverse events and determine grade (severity), expectedness, and relatedness to treatments as determined by clinicians. However, patient perspectives are often not included in this process. OBJECTIVE: This study aimed to compare clinician vs patient grading of adverse event severity in a urogynecologic surgical trial. Secondary objectives were to estimate the association of patient grading of adverse events with decision-making and quality of life outcomes and to determine if patient perspective changes over time. STUDY DESIGN: This was a planned supplementary study (Patient Perspectives in Adverse Event Reporting [PPAR]) to a randomized trial comparing 3 surgical approaches to vaginal apical prolapse. In the parent trial, adverse events experienced by patients were collected per a standardized protocol every 6 months during which clinicians graded adverse event severity (mild, moderate, severe/life-threatening). In this substudy, we obtained additional longitudinal patient perspectives for 19 predetermined "PPAR adverse events." Patients provided their own severity grading (mild, moderate, severe/very severe/life-threatening) at initial assessment and at 12 and 36 months postoperatively. Clinicians and patients were masked to each other's reporting. The primary outcome was the interrater agreement (kappa statistic) for adverse event severity between the initial clinician and patient assessment, combining patient grades of mild and moderate. The association between adverse event severity and the Decision Regret Scale, Satisfaction with Decision Scale, the 12-Item Short-Form Health Survey, and Patient Global Impression of Improvement scores was assessed using the Spearman correlation coefficient (rho) for continuous scales, the Mantel-Haenszel chi-square test for Patient Global Impression of Improvement, and t tests or chi-square tests comparing the assessments of patients who rated their adverse events or symptoms as severe with those who gave other ratings. To describe patient perspective changes over time, the intraobserver agreement was estimated for adverse event severity grade over time using weighted kappa coefficients. RESULTS: Of the 360 randomly assigned patients, 219 (61%) experienced a total of 527 PPAR adverse events (91% moderate and 9% severe/life-threatening by clinician grading). Mean patient age was 67 years; 87% were White and 12% Hispanic. Among the patients reporting any PPAR event, the most common were urinary tract infection (61%), de novo urgency urinary incontinence (35%), stress urinary incontinence (22%), and fecal incontinence (13%). Overall agreement between clinician and participant grading of severity was poor (kappa=0.24 [95% confidence interval, 0.14-0.34]). Of the 414 adverse events that clinicians graded as moderate, patients graded 120 (29%) as mild and 80 (19%) as severe. Of the 39 adverse events graded as severe by clinicians, patients graded 15 (38%) as mild or moderate. Initial patient grading of the most severe reported adverse event was mildly correlated with worse Decision Regret Scale (rho=0.2; P=.01), 12-Item Short-Form Health Survey (rho=-0.24; P<.01), and Patient Global Impression of Improvement (P<.01) scores. There was no association between adverse event severity and Satisfaction with Decision Scale score. Patients with an initial grading of "severe" had more regret, lower quality of life, and poorer global impressions of health than those whose worst severity grade was mild (P<.05). Agreement between the patients' initial severity ratings and their ratings at 12 months (kappa=0.48 [95% confidence interval, 0.39-0.58]) and 36 months (kappa=0.45 [95% confidence interval, 0.37-0.53]) was fair. CONCLUSION: Clinician and patient perceptions of adverse event severity are discordant. Worse severity from the patient perspective was associated with patient-centered outcomes. Including the patient perspective provides additional information for evaluating surgical procedures.

ImportanceThis review aimed to describe research initiatives, evolution, and processes of the Eunice Kennedy Shriver National Institute of Child Health and Human Development-supported Pelvic Floor Disorders Network (PFDN). This may be of interest and inform researchers wishing to conduct multisite coordinated research initiatives as well as to provide perspective to all urogynecologists regarding how the PFDN has evolved and functions.Study DesignPrincipal investigators of several PFDN clinical sites and Data Coordinating Center describe more than 20 years of development and maturation of the PFDN.ResultsOver two decades, the PFDN used an intentionally driven approach to answering clinically important questions to inform the surgical and nonsurgical care of women with pelvic floor disorders (PFDs) including pelvic organ prolapse, urinary incontinence, and fecal incontinence. From its inception, the PFDN refined network procedures and processes affecting trial design, protocol development, and standardization of outcomes and publications. This strategy resulted in a credible, robust, and productive portfolio of randomized clinical trials, secondary analyses, prospective cohort, and supplementary studies emphasizing the use of validated patient-reported outcomes, longer-term outcomes, an increase in translational science aims, and standardized long-term collection of adverse events.ConclusionsThe processes the PFDN has developed and implemented have led to impactful research initiatives in women's PFDs. Patient participants and research coordinators have been an integral part of this contribution. Through consistent funding and committed investigators, the state of science in the surgical and nonsurgical care and understanding of PFD pathophysiology has been advanced.

Urinary tract infections (UTIs) are a common cause of health care utilization in the United States. The coronavirus disease 2019 (COVID-19) pandemic accelerated virtual care for UTIs. This retrospective cohort study analyzes more than 1.2 million encounters for UTI based on diagnosis codes, examining temporal trends focusing on virtual compared with in-person encounters, antibiotic dispensation rates, and culture-confirmed UTIs. From 2015 to 2022, UTI encounters increased by 325.9%, with a majority occurring at virtual visits. The rate of UTI encounters per 1,000 adult female patients increased by 241.6%. Antibiotic dispensation rates increased, surpassing the rise in rate of positive urine cultures, suggesting increasing use of empiric antibiotics. Our findings underscore the importance of balancing telemedicine's accessibility with maintaining antibiotic stewardship and highlight the need for updated guidelines.

Introduction and Hypothesis Standardized digital rectal examination (DRE) correlates with anorectal manometry (ARM) measures. However, less is known about the relationship between DRE/ARM measures and patient-reported outcomes (PROs), especially among women with fecal incontinence (FI). Our aims were to evaluate associations between DRE and ARM measures and compare PROs with diagnostic evaluation measures for women with FI. Methods We analyzed data from the parent clinical trial, Controlling Anal incontinence by Performing Anal exercises with Biofeedback or Loperamide (CAPABLe). We pooled data from randomized women who completed standardized ARM, DRE, and validated PROs at baseline and 12 and 24 weeks post-treatment initiation. PROs included FI severity, impact on quality of life, and bowel diary data. We analyzed ARM pressure and volume data and DRE using the Digital Rectal Examination Scoring System (DRESS) resting and squeeze mean scores. We used Spearman Rank Correlation to measure associations between the ARM measures and mean DRESS scores, and between PROs and ARM/DRESS scores. Results Among 291 randomized women with ARM and DRE data, the correlation between DRESS and ARM resting measures was 0.196 (p<0.001) and between squeeze measures was 0.247 (p<0.001). At most timepoints, PROs more consistently correlated with squeeze ARM pressures and squeeze DRESS scores than resting measures. Conclusions We found weak correlations between ARM and DRE measures and between those measures and PROs. Although DRE and ARM are commonly used diagnostic measures among women with FI, the weak correlations with patient-reported symptoms raises questions about their utility in clinical care.

Importance:The optimal surgical repair of vaginal vault prolapse after hysterectomy remains undetermined. Objective:To compare the efficacy and safety of 3 surgical approaches for vaginal vault prolapse after hysterectomy. Design, Setting, and Participants:This was a multisite, 3-arm, superiority and noninferiority randomized clinical trial. Outcomes were assessed biannually up to 60 months, until the last participant reached 36 months of follow-up. Settings included 9 clinical sites in the US National Institute of Child Health and Human Development (NICHD) Pelvic Floor Disorders Network. Between February 2016 and April 2019, women with symptomatic vaginal vault prolapse after hysterectomy who desired surgical correction were randomized. Data were analyzed from November 2022 to January 2023. Interventions:Mesh-augmented (either abdominally [sacrocolpopexy] or through a vaginal incision [transvaginal mesh]) vs transvaginal native tissue repair. Main Outcomes and Measures:The primary outcome was time until composite treatment failure (including retreatment for prolapse, prolapse beyond the hymen, or prolapse symptoms) evaluated with survival models. Secondary outcomes included patient-reported symptom-specific results, objective measures, and adverse events. Results:Of 376 randomized participants (mean [SD] age, 66.1 [8.7] years), 360 (96%) had surgery, and 296 (82%) completed follow-up. Adjusted 36-month failure incidence was 28% (95% CI, 20%-37%) for sacrocolpopexy, 29% (95% CI, 21%-38%) for transvaginal mesh, and 43% (95% CI, 35%-53%) for native tissue repair. Sacrocolpopexy was found to be superior to native tissue repair (adjusted hazard ratio [aHR], 0.57; 99% CI, 0.33-0.98; P = .01). Transvaginal mesh was not statistically superior to native tissue after adjustment for multiple comparisons (aHR, 0.60; 99% CI, 0.34-1.03; P = .02) but was noninferior to sacrocolpopexy (aHR, 1.05; 97% CI, 0-1.65; P = .01). All 3 surgeries resulted in sustained benefits in subjective outcomes. Mesh exposure rates were low (4 of 120 [3%] for sacrocolpopexy and 6 of 115 [5%] for transvaginal mesh) as were the rates of dyspareunia. Conclusions and Relevance:Among participants undergoing apical repair for vaginal vault prolapse, sacrocolpopexy and transvaginal mesh resulted in similar composite failure rates at study completion; both had lower failure rates than native tissue repair, although only sacrocolpopexy met a statistically significant difference. Low rates of mesh complications and adverse events corroborated the overall safety of each approach. Trial Registration:ClinicalTrials.gov Identifier: NCT02676973.

Importance The optimal surgical repair of vaginal vault prolapse after hysterectomy remains undetermined. Objective To compare the efficacy and safety of 3 surgical approaches for vaginal vault prolapse after hysterectomy. Design, Setting, and Participants This was a multisite, 3-arm, superiority and noninferiority randomized clinical trial. Outcomes were assessed biannually up to 60 months, until the last participant reached 36 months of follow-up. Settings included 9 clinical sites in the US National Institute of Child Health and Human Development (NICHD) Pelvic Floor Disorders Network. Between February 2016 and April 2019, women with symptomatic vaginal vault prolapse after hysterectomy who desired surgical correction were randomized. Data were analyzed from November 2022 to January 2023. Interventions Mesh-augmented (either abdominally [sacrocolpopexy] or through a vaginal incision [transvaginal mesh]) vs transvaginal native tissue repair. Main Outcomes and Measures The primary outcome was time until composite treatment failure (including retreatment for prolapse, prolapse beyond the hymen, or prolapse symptoms) evaluated with survival models. Secondary outcomes included patient-reported symptom-specific results, objective measures, and adverse events. Results Of 376 randomized participants (mean [SD] age, 66.1 [8.7] years), 360 (96%) had surgery, and 296 (82%) completed follow-up. Adjusted 36-month failure incidence was 28% (95% CI, 20%-37%) for sacrocolpopexy, 29% (95% CI, 21%-38%) for transvaginal mesh, and 43% (95% CI, 35%-53%) for native tissue repair. Sacrocolpopexy was found to be superior to native tissue repair (adjusted hazard ratio [aHR], 0.57; 99% CI, 0.33-0.98; P = .01). Transvaginal mesh was not statistically superior to native tissue after adjustment for multiple comparisons (aHR, 0.60; 99% CI, 0.34-1.03; P = .02) but was noninferior to sacrocolpopexy (aHR, 1.05; 97% CI, 0-1.65; P = .01). All 3 surgeries resulted in sustained benefits in subjective outcomes. Mesh exposure rates were low (4 of 120 [3%] for sacrocolpopexy and 6 of 115 [5%] for transvaginal mesh) as were the rates of dyspareunia. Conclusions and Relevance Among participants undergoing apical repair for vaginal vault prolapse, sacrocolpopexy and transvaginal mesh resulted in similar composite failure rates at study completion; both had lower failure rates than native tissue repair, although only sacrocolpopexy met a statistically significant difference. Low rates of mesh complications and adverse events corroborated the overall safety of each approach. Trial Registration ClinicalTrials.gov Identifier: NCT02676973

Urinary tract infections (UTIs) are the most common bacterial infections in the United States. The rise of virtual visits for UTIs, particularly post the COVID-19 pandemic, marks a significant shift in healthcare delivery. However, despite the surge in patients opting for virtual care for UTIs, there's a noticeable lack of data on outcomes and safety compared to traditional in-person consultations.

Importance Mixed urinary incontinence (MUI) is common and can be challenging to manage. Objectives We present the protocol design and rationale of a trial comparing the efficacy of 2 procedures for the treatment of women with MUI refractory to oral treatment. The Midurethral sling versus Botulinum toxin A (MUSA) trial compares the efficacy of intradetrusor injection of 100 U of onabotulinimtoxinA (an office-based procedure directed at the urgency component) versus midurethral sling (MUS) placement (a surgical procedure directed at the stress component). Study Design The MUSA is a multicenter, randomized trial of women with MUI electing to undergo procedural treatment for MUI at 7 clinical centers in the NICHD Pelvic Floor Disorders Network. Participants are randomized to either onabotulinumtoxinA 100 U or MUS. OnabotulinimtoxinA recipients may receive an additional injection between 3 and 6 months. Participants may receive additional treatment (including crossover to the alternative study intervention) between 6 and 12 months. The primary outcome is change from baseline in Urogenital Distress Inventory (UDI) at 6 months. Secondary outcomes include change in UDI at 3 and 12 months, irritative and stress subscores of the UDI, urinary incontinence episodes, predictors of poor treatment response, quality of life and global impression outcomes, adverse events, use of additional treatments, and cost effectiveness. Results Recruitment and randomization of 150 participants is complete and participants are currently in the follow-up phase. Conclusions This trial will provide information to guide care for women with MUI refractory to oral treatment who seek surgical treatment with either onabotulinumtoxinA or MUS.

Introduction and Objectives Relevant, meaningful, and achievable data points are critical in objectively assessing quality, utility, and outcomes in female stress urinary incontinence (SUI) surgery. A minimum data set female SUI surgery studies was proposed by the first American Urological Association guidelines on the surgical management of female SUI in 1997, but recommendation adherence has been suboptimal. The Female Stress Urinary Incontinence Surgical Publication Working Group (WG) was created from members of several prominent organizations to formulate a recommended standard of study structure, description, and minimum outcome data set to be utilized in designing and publishing future SUI studies. The goal of this WG was to create a body of evidence better able to assess the outcomes of female SUI surgery. Methods The WG reviewed the minimum data set proposed in the 1997 AUA SUI Guideline document, and other relevant literature. The body of literature was examined in the context of the profound changes in the field over the past 25 years. Through a DELPHI process, a standard study structure and minimum data set were generated. Care was taken to balance the value of several meaningful and relevant data points against the burden of creating an excessively difficult or restrictive standard that would disincentivize widespread adoption and negatively impact manuscript production and acceptance. Results The WG outlined standardization in four major areas: 1) study design, 2) pretreatment demographics and characterization of the study population, 3) intraoperative events, and 4) post-treatment evaluation, and complications. Forty-two items were evaluated and graded as: STANDARD - must be included; ADDITIONAL - may be included for a specific study and is inclusive of the Standard items; OPTIMAL - may be included for a comprehensive study and is inclusive of the Standard and Additional items; UNNECESSARY/LEGACY - not relevant. Conclusions A reasonable, achievable, and clinically meaningful minimum data set has been constructed. A structured framework will allow future surgical interventions for female SUI to be objectively scrutinized and compared in a clinically significant manner. Ultimately, such a data set, if adopted by the academic community, will enhance the quality of the scientific literature, and ultimately improve short and long-term outcomes for female patients undergoing surgery to correct SUI.

Importance Urinary tract infection (UTI) is a common and potentially avoidable postoperative (PO) adverse event after urogynecologic surgery. Understanding pathophysiology will help prevent the associated morbidity of the disease and treatment of PO-UTI. Objective The objective of this study is to determine the following: (1) risk factors for both PO-UTI and PO recurrent UTI (RUTI) after urogynecologic surgery, (2) temporal distribution of UTI, and (3) uropathogen identification. Study Design Women undergoing urogynecologic surgery were retrospectively reviewed. Urinary tract infection was defined by culture or antibiotic prescription for symptoms. Recurrent UTI was defined as occurring outside a 6-week perioperative period. The χ2 test or Fischer exact and Student t tests or Mann-Whitney U test were used as appropriate. Individual odds ratio (OR), 95% confidence interval [CI], and sequential multivariable logistic regression were calculated. Statistical significance was set at P < 0.05. Results The 6-week PO-UTI rate after 33,626 procedures was 12.9%. Recurrent UTI increased from 3.7% preoperatively to 4.4% postoperatively (P < 0.001). A 6-week preoperative UTI and RUTI increased the risk of 6-week PO-UTI (OR, 1.65; 95% CI < 1.26–2.16; P = 0.001 and OR, 2.19; 95% CI, 1.84–2.62; P < 0.001, respectively) and PO-RUTI (OR, 2.95; 95% CI, 2.11–4.11; P < 0.001 and OR, 6.79; 95% CI, 5.61–8.23; P < 0.001, respectively). Compared with pelvic organ prolapse (POP) surgery only, stress urinary incontinence (SUI) surgery (OR 1.57[1.30–1.89]), and combined POP/SUI surgery (OR, 1.36; 95% CI, 1.13–1.63]) increased the risk of PO-RUTI (P < 0.001). Urinary tract infection within 1 week preoperatively was protective against 6-week PO-UTI (OR, 0.68; 95% CI, 0.48–0.97; P = 0.035). No perioperative factors were protective of PO-RUTI. Conclusions The PO-RUTI rate in the first year after urogynecologic surgery is low; however, SUI procedures may increase PO-RUTI risk. Potentially, modifiable risk factors for both PO-UTI and PO-RUTI include UTI diagnosis within 6 weeks preoperatively or preoperative RUTI diagnosis. Retesting women the week before surgery to ensure adequate treatment of preoperative UTI may reduce 6-week PO-UTI.