International Urogynecology Journal

, Volume 30, Issue 2, pp 239–244 | Cite as

Do patient characteristics predict which patients with overactive bladder benefit from a higher fesoterodine dose?

  • Howard B. GoldmanEmail author
  • Matthias Oelke
  • Steven A. Kaplan
  • Tekeya Kitta
  • David Russell
  • Martin Carlsson
  • Daniel Arumi
  • Erin Mangan
  • Fady Ntanios
Original Article


Introduction and hypothesis

We sought to determine whether baseline characteristics predict which overactive bladder (OAB) patients benefit from fesoterodine 8 mg versus 4 mg.


In double-blind, placebo-controlled, flexible-dose trials, baseline characteristics of OAB patients with ≥ 1 urgency urinary incontinence (UUI) episodes/24 h who escalated from fesoterodine 4 mg to 8 mg were evaluated. Possible dose-escalation predictors (age; sex; previous antimuscarinic use; UUI, micturitions, and urgency episodes/24 h; race; body mass index; time to dose escalation; OAB duration) were compared in escalators versus non-escalators. Patients from fixed-dose trials with dose-escalator characteristics were identified (matched dose-escalator sample) to assess changes from baseline with fesoterodine 4 mg, 8 mg, and placebo.


In flexible-dose trials, significant predictors of fesoterodine dose escalation were younger age (≤ 65.8 years), greater number of baseline micturitions (≥ 13.1) and urgency episodes/24 h (≥ 10.9), greater OAB duration (≥ 9.1 years), and more frequent previous antimuscarinic use (58.3%), but not baseline UUI episodes/24 h. In the matched dose-escalator sample (fesoterodine 4 mg: n = 215; 8 mg: n = 198; placebo: n = 217), change from baseline in UUI episodes significantly improved with fesoterodine 8 mg versus 4 mg (P = 0.043) and with both doses versus placebo (P < 0.001). Dry mouth and constipation rates were higher with fesoterodine 8 mg.


Dose-escalator patients had a significantly greater UUI response with fesoterodine 8 mg versus 4 mg. Given the potential for adverse events, fesoterodine 4 mg is recommended to start; however, patients with UUI and identified predictors may benefit from initial treatment with fesoterodine 8 mg or rapid dose escalation.


Urinary bladder, overactive Urinary incontinence, urge Fesoterodine Dose-response relationship, drug Randomized-controlled trials 



This study was sponsored by Pfizer Inc., and Pfizer employees participated in the analysis plan, data analysis, and manuscript preparation. Medical writing assistance was provided by Patricia B. Leinen, PhD, of Complete Healthcare Communications, LLC, a CHC Group company, and was funded by Pfizer Inc.

Compliance with ethical standards

Conflicts of interest

H. Goldman is a consultant for Pfizer, Allergan, Medtronic, and Axonics and was previously a consultant for Astellas. M. Oelke is a consultant for and/or has received honoraria or travel expenses from Apogepha, Astellas, Duchesnay, and Pfizer. S. Kaplan is a consultant for Pfizer. T. Kitta has no disclosures. E. Mangan is a former employee of Pfizer Inc. D. Russell, D. Arumi, M. Carlsson, and F. Ntanios are employees of Pfizer Inc.

Summary statement

This study was sponsored by Pfizer Inc., and Pfizer employees participated in the analysis plan, data analysis, and manuscript preparation.


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Copyright information

© The International Urogynecological Association 2018

Authors and Affiliations

  • Howard B. Goldman
    • 1
    Email author
  • Matthias Oelke
    • 2
  • Steven A. Kaplan
    • 3
  • Tekeya Kitta
    • 4
  • David Russell
    • 5
  • Martin Carlsson
    • 5
  • Daniel Arumi
    • 6
  • Erin Mangan
    • 5
  • Fady Ntanios
    • 5
  1. 1.Cleveland Clinic Main CampusClevelandUSA
  2. 2.St. Antonius HospitalGronauGermany
  3. 3.Weill Cornell Medical CollegeNew YorkUSA
  4. 4.Hokkaido UniversitySapporoJapan
  5. 5.Pfizer IncNew YorkUSA
  6. 6.Pfizer EuropeMadridSpain

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