An open-label, randomized, post-authorization study of mirabegron in Chinese participants with overactive bladder.

ABSTRACT:

Objective

To assess efficacy and safety of mirabegron 25 mg/day and 50 mg/day for overactive bladder in Chinese participants.

Methods

Participants of ≥18 years with overactive bladder symptoms lasting for ≥12 weeks, a mean of ≥8 micturitions per 24 h, and a mean of at least one episode of Grade 3 or 4 urgency or urge incontinence per 24 h based on the Patient Perception of Intensity of Urgency Scale over a 3-day micturition diary period were randomized 2:1 to open-label treatment with oral mirabegron 50 mg or 25 mg once daily for 12 weeks (15 sites in China, January 2021-March 2022). A dose escalation from 25 mg/day to 50 mg/day was permitted at weeks 4 and 8 according to the investigators' discretion. The primary efficacy endpoint was the change from baseline to Week 12 in

SUBMITTER: Zhang Z 

PROVIDER: S-EPMC11840303 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature