title: Efficacy and safety of flexible dose fesoterodine in men and women with overactive bladder symptoms including nocturnal urinary urgency.
abstract: OBJECTIVE
  Awakening from sleep to urinate is the hallmark of nocturia, a condition that impacts several facets of health related quality of life and for which current therapy is suboptimal. Given the paucity of prospective data on antimuscarinics for the management of nocturia, we investigated the efficacy and safety of flexible dose fesoterodine for the treatment of nocturnal urgency in subjects with nocturia and overactive bladder.
  
  
  METHODS
  Subjects with 2 to 8 nocturnal urgency episodes per 24 hours began a 2-week, single-blind, placebo run-in followed by 1:1 randomization to 12 weeks of double-blind treatment with fesoterodine (4 mg daily for 4 weeks with an optional increase to 8 mg) or placebo using predefined criteria for nocturnal urgency episodes, nocturnal urine volume voided and total 24-hour urine volume voided. The primary end point was change from baseline to week 12 in the mean number of micturition related nocturnal urgency episodes per 24 hours.
  
  
  RESULTS
  Overall 963 subjects were randomized from 2,990 screened, and 82% of subjects treated with fesoterodine and 84% of those treated with placebo completed the study. Significant improvements in the primary end point (-1.28 vs -1.07), in nocturnal micturitions per 24 hours (-1.02 vs -0.85) and in nocturnal frequency urgency sum (-4.01 vs -3.42) were observed with fesoterodine vs placebo (all p ≤0.01). Health related quality of life measures (overactive bladder questionnaire Symptom Bother -20.1 vs -16.5, sleep 22.3 vs 19.9 and other domains; all p <0.05) were improved with fesoterodine.
  
  
  CONCLUSIONS
  To our knowledge this is the first prospective study to assess antimuscarinic efficacy for reducing nocturnal urgency. Flexible dose fesoterodine significantly reduced nocturnal urgency episodes vs placebo in subjects with overactive bladder.
authors.affiliation: SUNY Downstate College of Medicine, Brooklyn, New York 11203, USA. urojock@aol.com
authors.forename: Jeffrey P
authors.initials: JP
authors.lastname: Weiss
authors.forename: Zhanna
authors.initials: Z
authors.lastname: Jumadilova
authors.forename: Theodore M
authors.initials: TM
authors.lastname: Johnson
authors.forename: Mary P
authors.initials: MP
authors.lastname: Fitzgerald
authors.forename: Martin
authors.initials: M
authors.lastname: Carlsson
authors.forename: Diane L
authors.initials: DL
authors.lastname: Martire
authors.forename: Atul
authors.initials: A
authors.lastname: Malhotra
mesh_terms: D000328:Adult; D001559:Benzhydryl Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D053158:Nocturia / Q000188:drug therapy*; D011446:Prospective Studies; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*
chemical_list: D001559:Benzhydryl Compounds; C526675:fesoterodine