Study design of a phase 4, real-world study (COMPOSUR) to evaluate vibegron in patients with overactive bladder.

ABSTRACT:

Background

Overactive bladder (OAB) is defined as urinary urgency accompanied by frequency and nocturia, with or without urge urinary incontinence (UUI). Vibegron, a selective β₃-adrenergic receptor agonist approved in the US in December 2020, demonstrated efficacy in reducing symptoms of OAB and was safe and well tolerated in the 12-week EMPOWUR trial and its 40-week, double-blind extension trial. The goal of the COMPOSUR study is to evaluate vibegron in a real-world setting to assess patient treatment satisfaction, tolerability, safety, duration of treatment, and persistence.

Methods

This is a 12-month, prospective, observational, real-world study, with an optional 12-month extension to 24 months, in the US assessing adults ≥ 18 years old starting a new course o

SUBMITTER: Dmochowski RR 

PROVIDER: S-EPMC10124676 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature