Bladder Function and Safety of Vibegron in Men With Overactive Bladder Receiving Treatment for Benign Prostatic Hyperplasia: Outcomes From the Phase 3 Randomized Controlled COURAGE Trial.
Document Type
Article
Publication Date
12-9-2025
Publication Title
Neurourology and urodynamics
Abstract
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-Q
RESULTS: In the SAF, differences between vibegron (n = 553) and placebo (n = 551) in PVR and Uroflow-Q
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.
Recommended Citation
Rovner ES, Owens-Grillo J, Thomas E, Herschorn S, Peters KM, Staskin D et al Bladder function and safety of vibegron in men with overactive bladder receiving treatment for benign prostatic hyperplasia: Outcomes from the phase 3 randomized controlled courage trial. Neurourol Urodyn. 2025 Dec 9. doi: 10.1002/nau.70199. Epub ahead of print. PMID: 41363221.
DOI
10.1002/nau.70199
ISSN
1520-6777
PubMed ID
41363221