title: Clinical efficacy, safety, and tolerability of once-daily fesoterodine in subjects with overactive bladder.
abstract: OBJECTIVE
  To determine the efficacy, tolerability, and safety of fesoterodine in subjects with overactive bladder (OAB).
  
  
  METHODS
  This was a multicentre, randomised, double-blind, placebo- and active-controlled trial with tolterodine extended release (ER) to assess the efficacy and safety of fesoterodine. Eligible subjects (> or =18 yr) with increased micturition frequency and urgency and/or urgency urinary incontinence (UUI) were randomised to placebo, fesoterodine 4 mg, fesoterodine 8 mg, or tolterodine ER 4 mg for 12 wk. The primary efficacy variable was a change from baseline to week 12 in micturitions per 24 h. Co-primary end points included change from baseline to week 12 in UUI episodes per 24 h and Treatment Response ("yes" or "no," based on four-point treatment benefit scale). Secondary efficacy variables included mean volume voided per micturition, continent days per week, and number of urgency episodes.
  
  
  RESULTS
  At the end of treatment, subjects taking fesoterodine 4 and 8 mg had significant (p<0.05) and clinically relevant improvements versus placebo in the primary, co-primary, and most secondary efficacy variables. Tolterodine ER (active control) also provided significantly greater improvement than placebo for most efficacy variables, confirming the sensitivity of the study design. A more pronounced effect was observed with fesoterodine 8 mg at most end points.
  
  
  CONCLUSIONS
  Both doses of fesoterodine were significantly better than placebo in improving the symptoms of OAB and produced a significantly greater Treatment Response versus placebo. Efficacy was more pronounced with fesoterodine 8 mg compared with the other treatments. Active treatments were well tolerated.
authors.affiliation: The Royal Hallamshire Hospital, Sheffield, UK. c.r.chapple@shef.ac.uk
authors.forename: Christopher
authors.initials: C
authors.lastname: Chapple
authors.forename: Philip
authors.initials: P
authors.lastname: Van Kerrebroeck
authors.forename: Andrea
authors.initials: A
authors.lastname: Tubaro
authors.forename: Cornelia
authors.initials: C
authors.lastname: Haag-Molkenteller
authors.forename: Hans-Theo
authors.initials: HT
authors.lastname: Forst
authors.forename: Ute
authors.initials: U
authors.lastname: Massow
authors.forename: Joseph
authors.initials: J
authors.lastname: Wang
authors.forename: Marina
authors.initials: M
authors.lastname: Brodsky
mesh_terms: D000328:Adult; D000368:Aged; D001559:Benzhydryl Compounds / Q000627:therapeutic use*; D003408:Cresols / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000627:therapeutic use; D018579:Patient Selection; D010665:Phenylpropanolamine / Q000627:therapeutic use; D012449:Safety; D000068737:Tolterodine Tartrate; D053201:Urinary Bladder, Overactive / Q000145:classification / Q000188:drug therapy* / Q000503:physiopathology; D014549:Urinary Incontinence / Q000453:epidemiology; D014554:Urination / Q000187:drug effects / Q000502:physiology
chemical_list: D001559:Benzhydryl Compounds; D003408:Cresols; D018727:Muscarinic Antagonists; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate; C526675:fesoterodine