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Effects of voluntary dose escalation in a placebo‐controlled, flexible‐dose trial of fesoterodine in subjects with overactive bladder
Author(s) -
Staskin David,
Khullar Vik,
Michel Martin C.,
Morrow Jon D.,
Sun Franklin,
Guan Zhonghong,
Dmochowski Roger
Publication year - 2011
Publication title -
neurourology and urodynamics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 90
eISSN - 1520-6777
pISSN - 0733-2467
DOI - 10.1002/nau.21099
Subject(s) - overactive bladder , medicine , placebo , randomized controlled trial , urology , pathology , alternative medicine
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.