Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)

Summary

This study will assess the efficacy of vibegron compared with placebo in men with overactive bladder (OAB) symptoms on pharmacological therapy for benign prostatic hyperplasia (BPH) as defined by micturition and urgency episodes.

Timeline

Start

2019-03-26

Primary completion

2023-06-15

Completion

2023-06-15

Outcome

Met primary endpoint

registry analysis (superiority test); Vibegron 75 Milligrams (mg) Once Daily (QD) vs Placebo; p <0.0001; Least square mean difference -0.74 (95% CI -1.02 to -0.46); NCT03902080 ↗

registry analysis (superiority test); Vibegron 75 Milligrams (mg) Once Daily (QD) vs Placebo; p <0.0001; Least Squares Means Difference -0.95 (95% CI -1.37 to -0.54); NCT03902080 ↗

Publications

• Rovner ES, Owens-Grillo J, Thomas E, Herschorn S, Peters KM, Staskin D, Mujais S. 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. 2026 Feb;45(2):299-304. doi: 10.1002/nau.70199. Epub 2025 Dec 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vibegron	Unknown	75 mg	Oral

Indications