A 12 Week Study to Confirm the Effectiveness of 8mg of Fesoterodine Compared to 4mg of Fesoterodine

Summary

This study is designed to confirm if 8mg of fesoterodine is more effective in reducing overactive bladder symptoms than 4mg of fesoterodine. In addition the study is designed to assess if the higher dose reduces the overall effect of overactive bladder on the subject's daily life more than the lower dose. The study also assesses the side effects and safety of the two doses.

Timeline

Start

2011-05

Primary completion

2012-11

Completion

2012-11

Outcome

Met primary endpoint

registry Fesoterodine 4 Milligram (mg) vs Fesoterodine 8 mg; p = 0.0109; Least squares mean difference -0.27 (95% CI -0.48 to -0.06) NCT01302067 ↗

paper patients receiving fesoterodine 8 mg (779 patients) had significantly greater reductions from baseline in UUI episodes PMID 24552358 ↗

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.
• Wagg AS, Herschorn S, Carlsson M, Fernet M, Oelke M. A plain language summary of the likelihood of symptom relief for patients taking fesoterodine for overactive bladder. J Comp Eff Res. 2022 Sep;11(13):919-925. doi: 10.2217/cer-2022-0041. Epub 2022 Jul 26.
• Chapple C, Schneider T, Haab F, Sun F, Whelan L, Scholfield D, Dragon E, Mangan E. Superiority of fesoterodine 8 mg vs 4 mg in reducing urgency urinary incontinence episodes in patients with overactive bladder: results of the randomised, double-blind, placebo-controlled EIGHT trial. BJU Int. 2014 Sep;114(3):418-26. doi: 10.1111/bju.12678. Epub 2014 Jul 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fesoterodine	Other / unclassified	4 mg	Oral
Subject	Fesoterodine	Other / unclassified	8 mg	Oral

Indications