Efficacy and tolerability of fesoterodine versus tolterodine in older and younger subjects with overactive bladder: a post hoc, pooled analysis from two placebo-controlled trials

Neurourol Urodyn. 2012 Nov;31(8):1258-65. doi: 10.1002/nau.22252. Epub 2012 Aug 20.


Aims: To assess the efficacy and tolerability of fesoterodine 8 mg versus tolterodine extended release (ER) 4 mg in subjects with overactive bladder (OAB) stratified by age (<65, 65-74, and ≥75 years).

Methods: This was a post hoc analysis of data from two double-blind trials. Subjects reporting ≥1 urgency urinary incontinence (UUI) episode and ≥8 micturitions/24 hr at baseline were randomized to fesoterodine (4 mg for 1 week, 8 mg for 11 weeks), tolterodine ER 4 mg, or placebo. Subjects completed 3-day bladder diaries, Urgency Perception Scale (UPS), Patient Perception of Bladder Condition (PPBC), and OAB questionnaire (OAB-q) at baseline and week 12. The primary endpoint in both studies was change from baseline to week 12 in UUI episodes.

Results: Among subjects <65 years (n = 2,670), improvements in UUI episodes, micturitions, urgency episodes, severe urgency episodes, frequency-urgency sum, UPS, PPBC, and all OAB-q scales and domains were significantly greater with fesoterodine versus tolterodine ER, and diary-dry rates were significantly higher. Among subjects 65-74 years (n = 990), improvements in mean voided volume per void, PPBC, and OAB-q Symptom Bother and Coping were significantly greater with fesoterodine versus tolterodine ER. Among subjects aged ≥75 years (n = 448), improvements in urgency episodes, severe urgency episodes, frequency-urgency sum, UPS, and OAB-q Symptom Bother were significantly greater with fesoterodine versus tolterodine ER. Both active treatments produced significant improvements in most outcomes versus placebo across age groups. Adverse event rates were similar among age groups.

Conclusions: Fesoterodine 8 mg consistently improved several OAB-related variables versus tolterodine ER 4 mg in subjects aged <65, 65-74, and ≥75 years, with some differences reaching statistical significance, and was generally well tolerated.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Age Factors
  • Aged
  • Aged, 80 and over
  • Benzhydryl Compounds / adverse effects
  • Benzhydryl Compounds / therapeutic use*
  • Cresols / adverse effects
  • Cresols / therapeutic use*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Muscarinic Antagonists / adverse effects
  • Muscarinic Antagonists / therapeutic use*
  • Phenylpropanolamine / adverse effects
  • Phenylpropanolamine / therapeutic use*
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Surveys and Questionnaires
  • Time Factors
  • Tolterodine Tartrate
  • Treatment Outcome
  • Urinary Bladder / drug effects*
  • Urinary Bladder / physiopathology
  • Urinary Bladder, Overactive / diagnosis
  • Urinary Bladder, Overactive / drug therapy*
  • Urinary Bladder, Overactive / physiopathology
  • Urinary Bladder, Overactive / psychology
  • Urinary Incontinence, Urge / diagnosis
  • Urinary Incontinence, Urge / drug therapy*
  • Urinary Incontinence, Urge / physiopathology
  • Urinary Incontinence, Urge / psychology
  • Urination / drug effects
  • Young Adult


  • Benzhydryl Compounds
  • Cresols
  • Muscarinic Antagonists
  • Phenylpropanolamine
  • Tolterodine Tartrate
  • fesoterodine