To evaluate the efficacy and tolerability of flexible-dose fesoterodine vs placebo
in subjects with overactive bladder (OAB).
In a 12-week double-blind trial, subjects were randomized to fesoterodine 4 mg or
placebo once daily, taken within 4 hours of bedtime. At week 2, subjects could increase
the fesoterodine dose to 8 mg (sham escalation for placebo). Subjects completed 3-day
bladder diaries, Patient Perception of Bladder Condition, and Urgency Perception Scale
at baseline and weeks 2, 6, and 12 as well as OAB Questionnaire at baseline and week
12.
Of 883 subjects, 63% and 73% of the fesoterodine (n = 438) and placebo (n = 445) groups,
respectively, opted for dose escalation. Week 12 improvements from baseline in total
micturitions, urgency episodes, urgency urinary incontinence episodes, frequency-urgency
sum, and all OAB Questionnaire scales and domains, but not nocturnal micturitions
or nocturnal urgency episodes, were significantly greater with fesoterodine than placebo
(all P <.05). Treatment differences in micturitions and frequency-urgency sum were
significant by week 2 and in urgency urinary incontinence and urgency episodes by
week 6. Significantly greater percentages of subjects taking fesoterodine had improved
Patient Perception of Bladder Condition and Urgency Perception Scale scores at weeks
2, 6, and 12 (P <.05). Dry mouth (fesoterodine, 26%; placebo, 8%) and constipation
(fesoterodine, 11%; placebo, 6%) were the most common adverse events. In both groups,
87% of the subjects completed the trial; 8% and 5% of the fesoterodine and placebo
groups, respectively, discontinued because of an adverse event.
Flexible-dose fesoterodine was efficacious and generally well tolerated for treatment
of OAB symptoms.
2010 Elsevier Inc. All rights reserved.