Urology
Volume 75, Issue 5 , Pages 1149-1155, May 2010

Efficacy and Tolerability of Fesoterodine in Men With Overactive Bladder: A Pooled Analysis of 2 Phase III Studies

  • Sender Herschorn

      Affiliations

    • Sunnybrook Health Sciences Centre, Division of Urology, Toronto, Ontario, Canada
    • Corresponding Author InformationReprint requests: Sender Herschorn, M.D., Sunnybrook Health Sciences Centre, 2075 Bayview Ave, Toronto, ON M4N3M5, Canada
  • ,
  • J. Stephen Jones

      Affiliations

    • Glickman Urological & Kidney Institute, Cleveland Clinic, Beachwood, Ohio
  • ,
  • Matthias Oelke

      Affiliations

    • Hannover Medical School, Department of Urology, Hannover, Germany
  • ,
  • Scott MacDiarmid

      Affiliations

    • Alliance Urology Specialists, Greensboro, North Carolina
  • ,
  • Joseph T. Wang

      Affiliations

    • Pfizer Inc, New York, New York
  • ,
  • Zhonghong Guan

      Affiliations

    • Pfizer Inc, New York, New York

Received 10 June 2009; accepted 1 September 2009. published online 16 November 2009.

Objectives

To assess the efficacy, safety, and tolerability of fesoterodine 4 and 8 mg in men with overactive bladder.

Methods

This was a subanalysis of pooled data from 358 men enrolled in 2 double-blind, placebo-controlled phase III trials. Subjects with frequency and urgency or urgency urinary incontinence (UUI) were randomized to fesoterodine 4 mg, fesoterodine 8 mg, or placebo for 12 weeks. Efficacy endpoints included bladder diary variables and subject-reported treatment response.

Results

By week 12, men treated with fesoterodine 4 or 8 mg had significantly greater median percentage improvements in micturition frequency, urgency episodes, and UUI episodes versus placebo and significantly greater percentages reported a treatment response versus placebo. Significant increases in mean voided volume (MVV) per micturition versus placebo occurred with fesoterodine 8 mg only. At week 12, fesoterodine 8 mg was significantly more efficacious than fesoterodine 4 mg in improving UUI episodes and MVV per micturition. The most commonly reported adverse events with fesoterodine 4 and 8 mg were dry mouth (12.5% and 37.7% vs 5.6% with placebo) and constipation (2.5% and 8.8% vs 0.8% with placebo). Symptoms suggestive of urinary retention were reported in 0.8%, 0.8%, and 5.3% of men in the placebo, fesoterodine 4 mg, and fesoterodine 8 mg groups, respectively; only 1 subject, in the fesoterodine 8 mg group, was catheterized.

Conclusions

Fesoterodine 4 and 8 mg are generally safe, efficacious, and well tolerated for the treatment of overactive bladder symptoms in men. The 8 mg dose provides additional benefit and allows for treatment individualization.

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 This study was funded by Schwarz BioSciences GmbH and Pfizer Inc.

PII: S0090-4295(09)02529-1

doi:10.1016/j.urology.2009.09.007

Urology
Volume 75, Issue 5 , Pages 1149-1155, May 2010