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Clinical efficacy, safety, and tolerability of once-daily fesoterodine in subjects with overactive bladder.

Author(s): Chapple C(1), Van Kerrebroeck P, Tubaro A, Haag-Molkenteller C, Forst HT, Massow U, Wang J, Brodsky M.

Affiliation(s): Author information: (1)The Royal Hallamshire Hospital, Sheffield, UK. c.r.chapple@shef.ac.uk

Publication date & source: 2007, Eur Urol. , 52(4):1204-12

OBJECTIVE: To determine the efficacy, tolerability, and safety of fesoterodine in subjects with overactive bladder (OAB). METHODS: This was a multicentre, randomised, double-blind, placebo- and active-controlled trial with tolterodine extended release (ER) to assess the efficacy and safety of fesoterodine. Eligible subjects (> or =18 yr) with increased micturition frequency and urgency and/or urgency urinary incontinence (UUI) were randomised to placebo, fesoterodine 4 mg, fesoterodine 8 mg, or tolterodine ER 4 mg for 12 wk. The primary efficacy variable was a change from baseline to week 12 in micturitions per 24 h. Co-primary end points included change from baseline to week 12 in UUI episodes per 24 h and Treatment Response ("yes" or "no," based on four-point treatment benefit scale). Secondary efficacy variables included mean volume voided per micturition, continent days per week, and number of urgency episodes. RESULTS: At the end of treatment, subjects taking fesoterodine 4 and 8 mg had significant (p<0.05) and clinically relevant improvements versus placebo in the primary, co-primary, and most secondary efficacy variables. Tolterodine ER (active control) also provided significantly greater improvement than placebo for most efficacy variables, confirming the sensitivity of the study design. A more pronounced effect was observed with fesoterodine 8 mg at most end points. CONCLUSIONS: Both doses of fesoterodine were significantly better than placebo in improving the symptoms of OAB and produced a significantly greater Treatment Response versus placebo. Efficacy was more pronounced with fesoterodine 8 mg compared with the other treatments. Active treatments were well tolerated.

Erratum in Eur Urol. 2008 Jun;53(6):1319.

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