INTRODUCTION:For more than four decades, the AMS-800 has remained the clinical benchmark device for the treatment of male stress urinary incontinence (SUI). Although it remains the gold standard for male SUI, the AMS-800 has continued to have limitations such as suboptimal post-operative continence rates, fixed hydraulic pressure, need for manual pump use, revision burden, and risk of urethral atrophy and erosion. These limitations have influenced a new generation of AUS devices. This review summarizes commercially available, early-development, discontinued, and emerging AUS devices, with a focus on how new designs address limitations of prior devices. METHODS:We searched PubMed, Embase, clinical trial registries, regulatory and device materials, abstracts, and manufacturer information when available. DISCUSSION:The current device innovations include postoperative pressure adjustability, stress-responsive hydraulic systems, simplified pre-filled or pre-connected designs, electronic remote control, and nonhydraulic electromechanical compression. Several of the new and emerging devices have shown promising early data; however, most are limited to cohort data, early safety studies, or preclinical studies involving animal, cadaver, and ex vivo implementation. Importantly, direct comparisons with the AMS-800 are limited. CONCLUSION:As these new devices continue to be created and introduced into clinical use, long-term data will be needed to determine if these design advantages actually result in consistent improvements in continence outcomes, safety, durability, usability, and revision burden.

The mainstay of surgical management of urethral diverticula is transvaginal urethral diverticulectomy. Intraoperative complications of bleeding and injury to the urinary tract are typically managed surgically at the time of diverticulectomy. Postoperative complications include both stress and urgency incontinence, dyspareunia, and more rarely, urethrovaginal fistula, urethral stricture, and diverticulum recurrence. Malignant neoplasm of a urethral diverticulum is rare, with the most common histopathology being adenocarcinoma.

INTRODUCTION:The management and interpretation of big data appears to be an increasingly attractive but challenging issue in functional urology. The International Continence Society (ICS) Global Urodynamics (UDS) Data Repository (GUDRep) project aims to record and analyse UDS data to share research and clinical information about UDS. OBJECTIVES:The aim of this Think Tank was to identify the main research questions and critical issues related to the GUDRep project. METHODS:This article reports and summarises the discussions on the GUDRep from the 2025 meeting of the International Consultation on Incontinence-Research Society (ICI-RS). RESULTS AND CONCLUSIONS:Several research questions on the GUDRep project need to be considered, including both issues/barriers in building the Repository and economic, clinical and research advantages which could potentially be obtained by the GUDRep itself.

PURPOSE:Vibegron was associated with improvements in efficacy versus placebo and was well tolerated in men with overactive bladder (OAB) on pharmacotherapy for benign prostatic hyperplasia (BPH) in the COURAGE trial (NCT03902080). Additional safety, bladder function, and urodynamics data are provided. METHODS:This 24-week, phase 3, double-blind, placebo-controlled trial randomized men ≥ 45 years with OAB and BPH receiving α-blocker ± 5α-reductase inhibitors to once-daily vibegron or placebo (1:1). From the safety analysis set (SAF), postvoid residual urine volume (PVR), maximum urinary flow rate (Uroflow-Qmax), International Prostate Symptom Score (IPSS) total score, and urologic-related adverse events (AEs) were collected throughout the trial. Qmax and detrusor pressure at Qmax (PdetQmax) were collected at baseline and week 12 in a urodynamics substudy (urodynamics evaluable set [UES]). RESULTS:In the SAF, differences between vibegron (n = 553) and placebo (n = 551) in PVR and Uroflow-Qmax were minimal at baseline, week 12, and week 24. Mean (SD) change from baseline (CFB) at week 24 in IPSS total score was -7.3 (6.96) with vibegron and -5.7 (7.14) with placebo. Urinary retention was reported as an AE for 5 (0.9%) and 4 (0.7%) participants receiving vibegron and placebo, respectively. In the UES (vibegron, n = 21; placebo, n = 22), least squares mean difference (95% CI) between vibegron and placebo in CFB at week 12 was 2.75 (0.16, 5.34) mL/s in Qmax and 2.86 (-13.52, 19.25) cmH2O in PdetQmax. CONCLUSIONS:There were no safety signals related to bladder function identified by urodynamics; risk of protocol-defined AEs of urinary retention or residual urine volume increase was not increased with vibegron compared with placebo in this population. CLINICAL TRIAL REGISTRATION:This study is registered at www. CLINICALTRIALS:gov. The registration identification number is NCT03902080.

OBJECTIVE:To demonstrate the impact of vibegron treatment in the phase 3 COURAGE trial (NCT03902080) on clinically meaningful response parameters in men with overactive bladder (OAB) receiving pharmacological therapy for benign prostatic hyperplasia (BPH) as measured by standard, validated patient-reported outcomes. METHODS:Men age ≥45 years with OAB receiving pharmacotherapy for BPH were randomly assigned 1:1 to vibegron 75 mg or placebo for 24 weeks. Participants completed bladder diaries assessing changes in micturition frequency, nocturia, and urge urinary incontinence (UUI); International Prostate Symptom Score (IPSS); and OAB questionnaire (OAB-q). Post hoc analyses assessed the percentage of responders (ie, ≤8 daily micturitions, ≤1 nightly nocturia episodes, ≤1 daily UUI episodes, ≥3-point decrease in IPSS scores, ≥10-point improvement in OAB-q subscale scores). Responder endpoints were analyzed using a Cochran-Mantel-Haenszel common risk difference estimation. RESULTS:Of 1105 participants, 1080 were included in the analysis (vibegron, n=538; placebo, n=542). At week 12, greater percentages of participants receiving vibegron vs placebo achieved responder endpoints for micturitions (33.3% vs 20.5%, respectively; P<.0001), nocturia episodes (34.6% vs 26.8%; P=.0036), and UUI episodes (65.8% vs 53.0%; P=.0267). At week 12, greater percentages of participants receiving vibegron versus placebo achieved a ≥3-point decrease in IPSS storage, voiding, and total scores and 10-point increase in OAB-q subscale scores. Results were generally sustained through week 24. CONCLUSION:In this post hoc responder analysis from the phase 3 COURAGE trial, participants receiving vibegron vs placebo achieved clinically relevant reductions in bothersome OAB symptoms, as well as improvements in IPSS and OAB-q scores.

The COMPOSUR study is evaluating vibegron for the treatment of overactive bladder (OAB) in a real-world setting. We report results of a prespecified 6-month interim analysis, assessing patient-reported treatment satisfaction, persistence, safety, and tolerability over the first 6 months after receiving a new prescription for vibegron. COMPOSUR (NCT05067478) is a 12-month, phase 4 study of vibegron. Patients were enrolled if they were ≥ 18 years of age with OAB, initiating vibegron after previously receiving anticholinergics (Cohort A) or mirabegron with/without anticholinergics (Cohort B). Satisfaction was assessed via the OAB Satisfaction With Treatment Questionnaire (OAB-SAT-q; domain scores on 0−100 scale, higher scores denoting greater satisfaction). The primary endpoint is the OAB-SAT-q satisfaction domain score. The key secondary endpoints are the percentage of positive responses to OAB-SAT-q questions 1–3 and 11. Additional secondary endpoints include OAB-SAT-q scores for side effects, endorsement, preference, and convenience. Persistence was assessed as an exploratory endpoint. Safety was assessed via adverse events (AEs). A total of 403 patients were enrolled and initiated treatment with vibegron; 104 patients discontinued the study before month 6, most commonly owing to withdrawal of consent (n = 32) and AEs (n = 8). Mean (SD) patient age was 56.1 (12.5) years, and 29

Dimethyl Sulfoxide (DMSO) remains an option for the treatment of bladder pain syndrome/interstitial cystitis (BPS/IC) in select patients. This review will discuss the mechanism of action and the role of intravesical DMSO cocktail therapy, as well as outcomes and adverse events for this therapy. Several, but not all historical studies have demonstrated some efficacy for DMSO in the treatment of BPS/IC symptoms including pain and lower urinary tract symptoms such as urgency and frequency. Although DMSO appears superior to placebo, there remain few well-done studies demonstrating support for DMSO use versus other intravesical or alternative BPS/IC treatments. AUA guidelines regarding the role of DMSO have been recently updated. Despite a long history of utilization in the treatment of BPS/IC, the literature supporting its use is not particularly robust. Current AUA guidelines support DMSO as an option in selected patients with a modest level of evidence.

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Overactive Bladder II (PD54)1 May 2024PD54-12 EFFECT OF VIBEGRON ON QUALITY OF LIFE IN MEN WITH BENIGN PROSTATIC HYPERPLASIA AND SYMPTOMS OF OVERACTIVE BLADDER: PATIENT-REPORTED OUTCOMES FROM THE PHASE 3 RANDOMIZED CONTROLLED COURAGE TRIAL David R. Staskin, Janet Owens-Grillo, Elizabeth Thomas, Eric S. Rovner, Kevin Cline, and Salim Mujais David R. StaskinDavid R. Staskin , Janet Owens-GrilloJanet Owens-Grillo , Elizabeth ThomasElizabeth Thomas , Eric S. RovnerEric S. Rovner , Kevin ClineKevin Cline , and Salim MujaisSalim Mujais View All Author Informationhttps://doi.org/10.1097/01.JU.0001008724.35538.9c.12AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Men being treated for benign prostatic hyperplasia (BPH) may have reduced quality of life (QoL) due to persistent overactive bladder (OAB) symptoms. We report health-related QoL (HRQL) outcomes from a phase 3 trial of vibegron, a selective β3 agonist under investigation for use in men with pharmacologically treated BPH and persistent OAB symptoms. METHODS: COURAGE (NCT03902080) was a 24-week, phase 3, multicenter, randomized, double-blind, placebo-controlled trial. Men ≥45 years with OAB and BPH receiving a stable dose of α-blocker ± 5α-reductase inhibitors were randomized 1:1 to once-daily vibegron 75 mg or placebo. QoL was assessed by the overactive bladder questionnaire (OAB-q) long form, comprising the symptom bother subscale score and the HRQL total score (including coping, concern, sleep, and social interaction subscores), with 1-week recall. Change from baseline (CFB) at Week 12 and 24 was analyzed using a mixed model for repeated measures. RESULTS: Overall, 969 patients (vibegron, n=487; placebo, n=482) and 923 patients (vibegron, n=464; placebo, n=459) had evaluable CFB in OAB-q scores at Weeks 12 and 24, respectively. Baseline OAB-q scores were similar between treatment groups. Vibegron was associated with significant improvements from baseline at Week 12 vs placebo in symptom bother score (LS mean [SE] CFB, −20.3 [0.87] vs−14.1 [0.87]; LS mean difference [LSMD], −6.2; p<0.0001) and total HRQL score (16.7 [0.83] vs 12.4 [0.83]; LSMD, 4.2; p<0.0001), as well as in the concern (16.8 [0.91] vs 12.4 [0.91]; LSMD, 4.4; p=0.0001), coping (18.1 [0.97] vs 13.4 [0.97]; LSMD, 4.7; p=0.0001), sleep (20.0 [1.06] vs 14.5 [1.07]; LSMD, 5.5; p<0.0001), and social interaction (10.9 [0.75] vs 8.6 [0.75]; LSMD, 2.2; p=0.0175) subscores (Figure 1). Improvements remained significant at Week 24 (p<0.0001) for all scores except social interaction. CONCLUSIONS: Vibegron was associated with improvements vs placebo in OAB-q scores at 12 and 24 weeks, indicating that vibegron treatment improved quality of life among men with pharmacologically treated BPH and residual OAB symptoms, consistent with the improvements in micturition frequency and urgency observed in this phase 3 trial. Download PPT Source of Funding: Sumitomo Pharma America © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e1148 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information David R. Staskin More articles by this author Janet Owens-Grillo More articles by this author Elizabeth Thomas More articles by this author Eric S. Rovner More articles by this author Kevin Cline More articles by this author Salim Mujais More articles by this author Expand All Advertisement PDF downloadLoading ...

Purpose of Review Within the last decade, a number of gene therapies have been developed as a treatment option for monogenic diseases. Overactive bladder is a multifactorial syndrome with likely many underlying causes and regulatory components. The goal of this paper is to review current gene therapy in and outside of the genitourinary system, review the pathophysiology and genetics of OAB, and discuss recent advances in application of this technology for OAB treatment. Recent Findings Various genes have been found to be upregulated in OAB patients including receptors involved in purinergic signaling, gap junctions between detrusor smooth muscle cells, proteins involved in detrusor myocyte cytoskeletal dynamics, cholinergic receptors, and some types of membrane channels. Fewer genes are downregulated but include receptors in purinergic signaling and a channel critical for detrusor smooth muscle cell relaxation. Results of a recent phase 2 trial exploiting a gene coding for a portion of a potassium channel suggest that gene therapy may have emerging relevance in OAB therapy. Summary OAB is a syndrome, and the pathophysiology is incompletely understood but likely is due to a combination of altered afferent signaling at the level of the bladder modified by a constant hyper- or hypo-excitability of the detrusor myocyte. Understanding the complex pathways underlying OAB as well as the related genetic components of the normal and abnormal bladder may provide novel therapeutic options for this widespread condition.

PURPOSE OF REVIEW:There has been a need for an acceptable common minimum data set in the scientific literature as regards the surgical treatment of female stress urinary incontinence (SUI). Such a data set, if widely adopted, would improve the quality of the literature and allow objective comparisons between and across interventions. RECENT FINDINGS:The surgical treatment of female stress urinary incontinence has evolved considerably over the past few decades. The corresponding body of literature has grown exponentially describing the outcomes of hundreds of studies of these novel interventions. However, historically, the literature in this space has been of uneven quality. In order to improve the reporting of clinical studies, and ultimately patient outcomes, a standard minimum data set for trial design and publications was created by a collaborative group formed from leading scientific societies. SUMMARY:The consensus document created from this novel collaboration between members of SUFU (Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction), AUGS (American Urogynecologic Society), and ICS (International Continence Society) provides clear guidance for the structure of clinical studies and reporting of results in the peer-reviewed literature. This has substantial potential ramifications for scientific journals, journal editors, peer reviewers, investigators, regulatory agencies, industry, clinicians, and patients.