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.