URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence

Summary

This study will evaluate the efficacy, safety, and tolerability of a single dose of URO-902 24 milligrams (mg) and 48 mg (administered via intradetrusor injection), compared with placebo, in participants with overactive bladder (OAB) and urge urinary incontinence (UUI) up to 48 weeks post-dose.

Timeline

Start

2019-12-16

Primary completion

2021-11-18

Completion

2022-07-20

Outcome

Met primary endpoint

registry analysis (other test); Placebo vs URO-902 48 mg; p =0.0159; Least Square Mean Difference -2.24 (95% CI -4.04 to -0.43); Mixed model for repeated measures NCT04211831 ↗

Drugs

Indications