Long-term safety, tolerability and efficacy of flexible-dose fesoterodine in elderly patients with overactive bladder: Open-label extension of the SOFIA trial


  • Karl-Erik Andersson led the peer-review process as the Associate Editor responsible for the paper
  • Conflict of interest: A.W. is a consultant for Pfizer, Astellas, Watson, and SCA. V.K. is a consultant for Pfizer, Astellas, and Allergan. M.M. has been a consultant for Allergan, AltheRx, Astellas, Bayer, and Pfizer and is currently an employee of Boehringer Ingelheim. M.O. is a consultant for Apogepha, Astellas, GSK, Lilly, Pfizer, Teva, Recordati, and Ferring. A.D. is an employee of Pfizer. C.E.B. is an employee of Pfizer.
  • Clinical Trial Registration: ClinicalTrials.Gov ID NCT00798434.



To assess the long-term safety, tolerability, and efficacy of flexible-dose fesoterodine in elderly patients with OAB.


Patients aged ≥65 years who completed a 12-week, randomized, double-blind, placebo-controlled trial were eligible for the 12-week, open-label (OL) extension phase. Patients who received double-blind placebo started on fesoterodine 4 mg and could increase to 8 mg after 4 or 8 weeks of OL treatment, while fesoterodine-treated patients continued on their double-blind dose; only one dose escalation or de-escalation was permitted. Discontinuations and adverse events (AEs) were monitored, and patients completed 3-day bladder diaries and patient-reported outcomes at the beginning and end of the 12-week OL phase.


Six hundred fifty-four patients entered the 12-week OL extension (mean age 72 years; 52% women). AEs were reported by 30.7% and 48.1% of patients who had received double-blind fesoterodine and placebo, respectively; 1.9% and 9.4%, discontinued due to AEs, respectively. Patients who received double-blind fesoterodine maintained their efficacy response. After 12 weeks of OL treatment, efficacy outcomes in patients who received double-blind placebo were similar to those who had received double-blind fesoterodine. On average, the efficacy response was maintained for the duration of the study.


Fesoterodine was well tolerated and improvements in OAB symptoms and quality of life measures were not diminished with longer-term treatment of patients aged ≥65 years. Neurourol. Urodynam. 33:106–114, 2014. © 2013 Wiley Periodicals, Inc.