Effects of voluntary dose escalation in a placebo‐controlled, flexible‐dose trial of fesoterodine in subjects with overactive bladder

Aims To characterize the response to fesoterodine treatment for overactive bladder (OAB) in subjects who did or did not choose to dose escalate in a flexible‐dose study. Methods Subjects were randomized to fesoterodine 4 mg or placebo. At week 2, subjects could remain on 4 mg (non‐escalators) or choose to increase to 8 mg (escalators) for the remaining 10 weeks (sham escalation for placebo). Subjects completed 3‐day bladder diaries at baseline, week 2 and week 12 noting micturitions, urgency episodes, and urgency urinary incontinence (UUI) episodes. Results Sixty‐three per cent of 438 subjects randomized to fesoterodine and 73% of 445 randomized to placebo dose escalated. At baseline, fesoterodine escalators had significantly more micturitions and urgency episodes than fesoterodine non‐escalators ( P  < 0.001); at week 2, before dose escalation, diary‐dry rate and improvement in micturitions and urgency episodes were significantly greater among fesoterodine non‐escalators versus escalators ( P  < 0.001); and by week 12, after dose escalation, diary‐dry rate and improvements in micturitions and UUI episodes were similar between fesoterodine non‐escalators and escalators ( P  > 0.05). The placebo escalator group did not demonstrate a similar response over placebo non‐escalators following the dose escalation decision point. Conclusion A rapid and robust response to fesoterodine 4 mg was demonstrated in non‐escalators. Subjects who chose to dose escalate to fesoterodine 8 mg at week 2 showed significant improvement by week 12 versus baseline and week 2 (prior to escalation), as well as versus placebo. Dose escalation to 8 mg fesoterodine provided subjects with efficacy and tolerability similar to those who were satisfied with the 4‐mg dose. Neurourol. Urodynam. Neurourol. Urodynam. 30: 1480–1485, 2011. © 2011 Wiley Periodicals, Inc.