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Efficacy and tolerability of fesoterodine in women with overactive bladder.

Author(s): Sand PK(1), Morrow JD, Bavendam T, Creanga DL, Nitti VW.

Affiliation(s): Author information: (1)Evanston Continence Center, Department of Obstetrics and Gynecology, Northwestern University, Feinberg School of Medicine, 1000 Central Street, Suite 730, Evanston, IL 60201, USA. p-sand@northwestern.edu

Publication date & source: 2009, Int Urogynecol J Pelvic Floor Dysfunct. , 20(7):827-35

INTRODUCTION AND HYPOTHESIS: We assessed fesoterodine efficacy and tolerability in women with overactive bladder (OAB). METHODS: This post hoc analysis of pooled data from two clinical trials included 1,548 women with OAB randomized to placebo, fesoterodine 4 or 8 mg, or tolterodine extended release (ER) 4 mg (in 1 trial) for 12 weeks. Subjects completed 3-day bladder diaries at baseline and weeks 2 and 12 and rated Treatment Response at weeks 2 and 12. RESULTS: By weeks 2 and 12, all active-treatment groups showed significant improvements in all five bladder diary variables assessed and greater Treatment Response rates vs placebo. Fesoterodine 8 mg was significantly more efficacious than fesoterodine 4 mg and tolterodine ER in improving urgency urinary incontinence episodes and continent days per week. The most common adverse events were dry mouth and constipation, which were predominately mild or moderate. CONCLUSIONS: Fesoterodine is efficacious and well tolerated in women with OAB.

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