Study of VESIcare® In Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of Life

Summary

Evaluate the effect of VESIcare® on symptom bother for subjects with OAB

Timeline

Start

2007-08

Primary completion

2008-07

Completion

2008-07

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Solifenacin Succinate; p <0.0001; Least Square Mean Difference 9.4 (95% CI 6.6 to 12.2); ANCOVA NCT00573508 ↗

Publications

• Results Vardy MD, Mitcheson HD, Samuels TA, Wegenke JD, Forero-Schwanhaeuser S, Marshall TS, He W. Effects of solifenacin on overactive bladder symptoms, symptom bother and other patient-reported outcomes: results from VIBRANT - a double-blind, placebo-controlled trial. Int J Clin Pract. 2009 Dec;63(12):1702-14. doi: 10.1111/j.1742-1241.2009.02209.x.
• 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.
• Crosby RD, Mathias SD, Marshall TS. Relationships between symptoms, symptom bother, and health-related quality of life in patients with overactive bladder taking solifenacin or placebo in the VIBRANT study. Int J Clin Pract. 2011 Feb;65(2):211-8. doi: 10.1111/j.1742-1241.2010.02532.x.

Drugs

Indications