Fesoterodine Flexible Dose Study

Summary

This Phase 3B study is designed to test if a fesoterodine flexible dose regimen is more effective than placebo in reducing micturition frequency and other overactive bladder (OAB) symptoms, e.g., urgency, urgency incontinence episodes in patients with overactive bladder and if the fesoterodine regimen is safe and well tolerated.

Timeline

Start

2007-08

Primary completion

2008-03

Completion

2008-03

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Fesoterodine; p = 0.0002; Mean Difference (Final Values) -0.7 (95% CI -1.1 to -0.4) NCT00536484 ↗

Publications

• Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.

Drugs

Indications