Cranberry Research Today is a free monthly online journal that collates and summarizes the latest research about Cranberry, including details on benefits, antioxidants, utis, cystitis.

Efficacy, safety and tolerability of fesoterodine for overactive bladder syndrome.

Nitti VW, Dmochowski R, Sand PK, Forst HT, Haag-Molkenteller C, Massow U, Wang J, Brodsky M, Bavendam T

Department of Urology, New York University School of Medicine, New York, New York 10016, USA. Victor.Nitti@nyumc.org

PURPOSE: We evaluated the efficacy, tolerability and safety of the new antimuscarinic agent fesoterodine relative to placebo for overactive bladder syndrome. MATERIALS AND METHODS: This was a randomized, double-blind, placebo controlled, multicenter trial performed in the United States. Overall 836 subjects with urinary frequency, urinary urgency or urgency urinary incontinence were randomized to placebo (274), 4 mg fesoterodine (283) or 8 mg fesoterodine (279) once daily for 12 weeks. The primary efficacy end point was the change in the number of micturitions per 24 hours. Co-primary end points were the change in the number of urgency urinary incontinence episodes per 24 hours and the treatment response. Secondary efficacy end points were other bladder diary variables, such as the change in mean voided volume per micturition, number of continent days and number of urgency episodes per 24 hours. Tolerability and safety were assessed by evaluating adverse events, electrocardiograms, post-void residual urine volume, laboratory parameters and treatment withdrawals. RESULTS: Treatment with 4 or 8 mg fesoterodine resulted in statistically significant and clinically relevant improvements from baseline to end of treatment for the primary and co-primary end points compared with placebo (p <0.05). Results for most secondary end points, including mean voided volume per micturition, number of continent days and number of urgency episodes per 24 hours, were also significantly improved vs placebo. The adverse events reported more frequently with fesoterodine than with placebo were dry mouth, constipation and urinary tract infection. CONCLUSIONS: The 2 doses of fesoterodine were well tolerated and they statistically significantly improved overactive bladder symptoms.

Published 12 November 2007 in J Urol, 178(6): 2488-94.
Full-text of this article is available online (may require subscription).

© 2004-2008 Cranberry Research Today. All Rights Reserved.