A Clinical Study in Patients With Overactive Bladder With Leakage of Urine, to Find Out if the Medicine, Fesoterodine, Works in Those Patients Who Did Not Have Enough Response to the Medicine, Tolterodine.
Summary
Patients with overactive bladder are often treated with tolterodine, a medication that helps relax the bladder, helping symptoms of urinary incontinence and urinary frequency. Sometimes patients do not have a satisfactory response, and may benefit from trying an alternative oral medicine. Fesoterodine is related to tolterodine by producing the same active substance that acts on the bladder, but potentially at higher and more effective levels. So, a patient who has a poor response to tolterodine may still obtain a good response to fesoterodine. This study will help find out if this is what happens.
Timeline
- Start
- 2011-05
- Primary completion
- 2012-05
- Completion
- 2012-05
Outcome
Met primary endpoint
registry analysis (superiority or other test); Fesoterodine: Double-Blind Baseline vs Fesoterodine: Double-Blind Week 12; p <0.0001; Least Squares Mean Difference -2.37 (95% CI -2.63 to -2.02) NCT01302054 ↗
registry analysis (superiority or other test); Fesoterodine vs Placebo; p = 0.0079; Least Squares Mean Difference -0.50 (95% CI -0.87 to -0.13); ANCOVA; NCT01302054 ↗
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.
- Kaplan SA, Cardozo L, Herschorn S, Grenabo L, Carlsson M, Arumi D, Crook TJ, Whelan L, Scholfield D, Ntanios F; Assessment of Fesoterodine after Tolterodine ER (AFTER) Study Group. Efficacy and safety of fesoterodine 8 mg in subjects with overactive bladder after a suboptimal response to tolterodine ER. Int J Clin Pract. 2014 Sep;68(9):1065-73. doi: 10.1111/ijcp.12464. Epub 2014 Jun 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fesoterodine | Other / unclassified | 8 mg | Oral |