Efficacy and tolerability of fesoterodine in men with overactive bladder: a pooled analysis of 2 phase III studies.
OBJECTIVE
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.
Herschorn
Sender
S
Sunnybrook Health Sciences Centre, Division of Urology, Toronto, Ontario, Canada. s.herschorn@utoronto.ca
Jones
J Stephen
JS
Oelke
Matthias
M
MacDiarmid
Scott
S
Wang
Joseph T
JT
Guan
Zhonghong
Z
D001559:Benzhydryl Compounds / Q000627:therapeutic use*; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*
D001559:Benzhydryl Compounds; C526675:fesoterodine