Clinically Meaningful Improvements With Vibegron in Men With Overactive Bladder and Benign Prostatic Hyperplasia: A Responder Analysis of the Phase 3 COURAGE Trial.
Document Type
Article
Publication Date
9-1-2025
Publication Title
Urology
Abstract
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.
Volume
S0090-4295
Issue
25
First Page
00829-5
Recommended Citation
Peters KM, Owens-Grillo J, Thomas E, Staskin D, Rovner ES, Mujais S. clinically meaningful improvements with vibegron in men with overactive bladder and benign prostatic hyperplasia: A responder analysis of the phase 3 courage trial. Urology. 2025 Sep 1:S0090-4295(25)00829-5. doi: 10.1016/j.urology.2025.08.051. Epub ahead of print. PMID: 40902908.
DOI
10.1016/j.urology.2025.08.051
ISSN
1527-9995
PubMed ID
40902908