title: Efficacy, Safety and Tolerability of Fesoterodine in Asian Patients with Overactive Bladder.
abstract: OBJECTIVE
  To assess the efficacy, safety, and tolerability of fesoterodine 4 and 8 mg once daily (QD) compared with placebo in Asian subjects with overactive bladder (OAB) after 12 weeks of treatment.
  
  
  METHODS
  This phase II, dose-finding study consisted of a 2-week placebo run-in period followed by a 12-week, randomized, double-blind, placebo-controlled, treatment period. Eligible subjects were aged ≥20 years with ≥8 micturitions per 24 h and ≥1 urgency urinary incontinence (UUI) episodes per 24 h reported in a 3-day diary. The subjects were randomized to receive placebo, fesoterodine 4 mg, or fesoterodine 8 mg QD for 12 weeks.
  
  
  RESULTS
  Of 1232 subjects who entered the placebo run-in period, 951 received double-blind treatment. The mean number of UUI episodes per 24 h at baseline was 2.2 among the three treatment groups. The two fesoterodine groups showed statistically significant decreases from baseline in the mean number of UUI episodes per 24 h at week 12 (primary endpoint) compared with placebo. Most all-causality adverse events (e.g. dry mouth and constipation) were mild or moderate. The percentage of subjects with severe adverse events was low and similar among the treatment groups (placebo, 1.3%; fesoterodine 4 mg, 1.9%; fesoterodine 8 mg, 1.0%).
  
  
  CONCLUSIONS
  Fesoterodine 4 and 8 mg QD were significantly better than placebo in improving OAB symptoms. Overall, the two fesoterodine dosing regimens were well tolerated. These results suggest that fesoterodine 4 and 8 mg QD are effective and well-tolerated treatments for OAB in Asian subjects.
authors.affiliation: Department of Urology, Fukushima Medical University School of Medicine, Fukushima, JapanDepartment of Urology, Shinshu University School of Medicine, Nagano, JapanDepartment of Urology, Yamanashi University, Yamanashi, JapanDepartment of Medical Informatics, Japan Labor Health and Welfare Organization, Kumamoto Rosai Hospital, Kumamoto, JapanDepartment of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, KoreaDepartment of Urology, College of Medicine, Korea University, Seoul, KoreaDepartment of Surgery, Taipei Veterans General Hospital and National Yang Ming University, Taipei, TaiwanDepartment of Obstetrics and Gynecology, National Taiwan University Hospital, Taipei, TaiwanDepartment of Surgery, Kwong Wah Hospital, Hong Kong, ChinaPfizer Japan Inc, Tokyo, Japan.
authors.forename: Osamu
authors.initials: O
authors.lastname: Yamaguchi
authors.affiliation: Department of Urology, Fukushima Medical University School of Medicine, Fukushima, JapanDepartment of Urology, Shinshu University School of Medicine, Nagano, JapanDepartment of Urology, Yamanashi University, Yamanashi, JapanDepartment of Medical Informatics, Japan Labor Health and Welfare Organization, Kumamoto Rosai Hospital, Kumamoto, JapanDepartment of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, KoreaDepartment of Urology, College of Medicine, Korea University, Seoul, KoreaDepartment of Surgery, Taipei Veterans General Hospital and National Yang Ming University, Taipei, TaiwanDepartment of Obstetrics and Gynecology, National Taiwan University Hospital, Taipei, TaiwanDepartment of Surgery, Kwong Wah Hospital, Hong Kong, ChinaPfizer Japan Inc, Tokyo, Japan.
authors.forename: Osamu
authors.initials: O
authors.lastname: Nishizawa
authors.affiliation: Department of Urology, Fukushima Medical University School of Medicine, Fukushima, JapanDepartment of Urology, Shinshu University School of Medicine, Nagano, JapanDepartment of Urology, Yamanashi University, Yamanashi, JapanDepartment of Medical Informatics, Japan Labor Health and Welfare Organization, Kumamoto Rosai Hospital, Kumamoto, JapanDepartment of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, KoreaDepartment of Urology, College of Medicine, Korea University, Seoul, KoreaDepartment of Surgery, Taipei Veterans General Hospital and National Yang Ming University, Taipei, TaiwanDepartment of Obstetrics and Gynecology, National Taiwan University Hospital, Taipei, TaiwanDepartment of Surgery, Kwong Wah Hospital, Hong Kong, ChinaPfizer Japan Inc, Tokyo, Japan.
authors.forename: Masayuki
authors.initials: M
authors.lastname: Takeda
authors.affiliation: Department of Urology, Fukushima Medical University School of Medicine, Fukushima, JapanDepartment of Urology, Shinshu University School of Medicine, Nagano, JapanDepartment of Urology, Yamanashi University, Yamanashi, JapanDepartment of Medical Informatics, Japan Labor Health and Welfare Organization, Kumamoto Rosai Hospital, Kumamoto, JapanDepartment of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, KoreaDepartment of Urology, College of Medicine, Korea University, Seoul, KoreaDepartment of Surgery, Taipei Veterans General Hospital and National Yang Ming University, Taipei, TaiwanDepartment of Obstetrics and Gynecology, National Taiwan University Hospital, Taipei, TaiwanDepartment of Surgery, Kwong Wah Hospital, Hong Kong, ChinaPfizer Japan Inc, Tokyo, Japan.
authors.forename: Masaki
authors.initials: M
authors.lastname: Yoshida
authors.affiliation: Department of Urology, Fukushima Medical University School of Medicine, Fukushima, JapanDepartment of Urology, Shinshu University School of Medicine, Nagano, JapanDepartment of Urology, Yamanashi University, Yamanashi, JapanDepartment of Medical Informatics, Japan Labor Health and Welfare Organization, Kumamoto Rosai Hospital, Kumamoto, JapanDepartment of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, KoreaDepartment of Urology, College of Medicine, Korea University, Seoul, KoreaDepartment of Surgery, Taipei Veterans General Hospital and National Yang Ming University, Taipei, TaiwanDepartment of Obstetrics and Gynecology, National Taiwan University Hospital, Taipei, TaiwanDepartment of Surgery, Kwong Wah Hospital, Hong Kong, ChinaPfizer Japan Inc, Tokyo, Japan.
authors.forename: Myung-Soo
authors.initials: MS
authors.lastname: Choo
authors.affiliation: Department of Urology, Fukushima Medical University School of Medicine, Fukushima, JapanDepartment of Urology, Shinshu University School of Medicine, Nagano, JapanDepartment of Urology, Yamanashi University, Yamanashi, JapanDepartment of Medical Informatics, Japan Labor Health and Welfare Organization, Kumamoto Rosai Hospital, Kumamoto, JapanDepartment of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, KoreaDepartment of Urology, College of Medicine, Korea University, Seoul, KoreaDepartment of Surgery, Taipei Veterans General Hospital and National Yang Ming University, Taipei, TaiwanDepartment of Obstetrics and Gynecology, National Taiwan University Hospital, Taipei, TaiwanDepartment of Surgery, Kwong Wah Hospital, Hong Kong, ChinaPfizer Japan Inc, Tokyo, Japan.
authors.forename: Jeong
authors.initials: J
authors.lastname: Gu Lee
authors.affiliation: Department of Urology, Fukushima Medical University School of Medicine, Fukushima, JapanDepartment of Urology, Shinshu University School of Medicine, Nagano, JapanDepartment of Urology, Yamanashi University, Yamanashi, JapanDepartment of Medical Informatics, Japan Labor Health and Welfare Organization, Kumamoto Rosai Hospital, Kumamoto, JapanDepartment of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, KoreaDepartment of Urology, College of Medicine, Korea University, Seoul, KoreaDepartment of Surgery, Taipei Veterans General Hospital and National Yang Ming University, Taipei, TaiwanDepartment of Obstetrics and Gynecology, National Taiwan University Hospital, Taipei, TaiwanDepartment of Surgery, Kwong Wah Hospital, Hong Kong, ChinaPfizer Japan Inc, Tokyo, Japan.
authors.forename: Alex
authors.initials: A
authors.lastname: Tong-Long Lin
authors.affiliation: Department of Urology, Fukushima Medical University School of Medicine, Fukushima, JapanDepartment of Urology, Shinshu University School of Medicine, Nagano, JapanDepartment of Urology, Yamanashi University, Yamanashi, JapanDepartment of Medical Informatics, Japan Labor Health and Welfare Organization, Kumamoto Rosai Hospital, Kumamoto, JapanDepartment of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, KoreaDepartment of Urology, College of Medicine, Korea University, Seoul, KoreaDepartment of Surgery, Taipei Veterans General Hospital and National Yang Ming University, Taipei, TaiwanDepartment of Obstetrics and Gynecology, National Taiwan University Hospital, Taipei, TaiwanDepartment of Surgery, Kwong Wah Hospital, Hong Kong, ChinaPfizer Japan Inc, Tokyo, Japan.
authors.forename: Ho-Hsiung
authors.initials: HH
authors.lastname: Lin
authors.affiliation: Department of Urology, Fukushima Medical University School of Medicine, Fukushima, JapanDepartment of Urology, Shinshu University School of Medicine, Nagano, JapanDepartment of Urology, Yamanashi University, Yamanashi, JapanDepartment of Medical Informatics, Japan Labor Health and Welfare Organization, Kumamoto Rosai Hospital, Kumamoto, JapanDepartment of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, KoreaDepartment of Urology, College of Medicine, Korea University, Seoul, KoreaDepartment of Surgery, Taipei Veterans General Hospital and National Yang Ming University, Taipei, TaiwanDepartment of Obstetrics and Gynecology, National Taiwan University Hospital, Taipei, TaiwanDepartment of Surgery, Kwong Wah Hospital, Hong Kong, ChinaPfizer Japan Inc, Tokyo, Japan.
authors.forename: Wai-Chun
authors.initials: WC
authors.lastname: Andrew Yip
authors.affiliation: Department of Urology, Fukushima Medical University School of Medicine, Fukushima, JapanDepartment of Urology, Shinshu University School of Medicine, Nagano, JapanDepartment of Urology, Yamanashi University, Yamanashi, JapanDepartment of Medical Informatics, Japan Labor Health and Welfare Organization, Kumamoto Rosai Hospital, Kumamoto, JapanDepartment of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, KoreaDepartment of Urology, College of Medicine, Korea University, Seoul, KoreaDepartment of Surgery, Taipei Veterans General Hospital and National Yang Ming University, Taipei, TaiwanDepartment of Obstetrics and Gynecology, National Taiwan University Hospital, Taipei, TaiwanDepartment of Surgery, Kwong Wah Hospital, Hong Kong, ChinaPfizer Japan Inc, Tokyo, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Isowa
authors.affiliation: Department of Urology, Fukushima Medical University School of Medicine, Fukushima, JapanDepartment of Urology, Shinshu University School of Medicine, Nagano, JapanDepartment of Urology, Yamanashi University, Yamanashi, JapanDepartment of Medical Informatics, Japan Labor Health and Welfare Organization, Kumamoto Rosai Hospital, Kumamoto, JapanDepartment of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, KoreaDepartment of Urology, College of Medicine, Korea University, Seoul, KoreaDepartment of Surgery, Taipei Veterans General Hospital and National Yang Ming University, Taipei, TaiwanDepartment of Obstetrics and Gynecology, National Taiwan University Hospital, Taipei, TaiwanDepartment of Surgery, Kwong Wah Hospital, Hong Kong, ChinaPfizer Japan Inc, Tokyo, Japan.
authors.forename: Shintaro
authors.initials: S
authors.lastname: Hiro
keywords: fesoterodine; overactive bladder; randomized controlled trial