Efficacy and tolerability of fesoterodine in women with overactive bladder

Sand PK, Morrow JD, Bavendam T, Creanga DL, Nitti VW

International urogynecology journal and pelvic floor dysfunction, 2009

1,548 participants

Abstract

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.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 1,548 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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