title: Efficacy of fesoterodine on nocturia and quality of sleep in Asian patients with overactive bladder.
abstract: OBJECTIVE
  To investigate the efficacy of fesoterodine vs placebo on nocturia, sleep disturbance, and sleep-related quality of life (QoL) in patients with overactive bladder and nocturia.
  
  
  METHODS
  This posthoc analysis used data from a 12-week, randomized, placebo-controlled trial of fesoterodine 4 and 8 mg per day in Asian adults reporting ≥8 micturitions and ≥1 urgency urinary incontinence episodes per 24 hours at baseline. Patients who reported ≥1 nocturnal micturition/24 h were included in this analysis. Efficacy variables included change from baseline to week 12/end of treatment in nocturnal micturitions/24 h, nocturnal voided volume/micturition, and hours of undisturbed sleep. Sleep-related QoL was assessed using King's Health Questionnaire Sleep/Energy domain. Treatment comparisons were made using analysis of covariance.
  
  
  RESULTS
  Among 555 patients, reductions in nocturnal micturitions with fesoterodine 4 mg (-0.63) and 8 mg (-0.77) were numerically greater vs placebo (-0.56), but differences were not significant (P >.05). When patients with a nocturnal polyuria index >33% were excluded, the decrease in nocturnal micturitions was significantly greater with fesoterodine 8 mg vs placebo (-0.24; P = .031). Increases in nocturnal voided volume/micturition were significantly greater with fesoterodine 4 (38.07 mL; P = .013) and 8 mg (42.05 mL; P <.001) vs placebo (14.89 mL). Hours of undisturbed sleep was significantly longer with fesoterodine 4 mg vs placebo (80 vs 54 minutes; P = .032); improvement in King's Health Questionnaire Sleep/Energy scores was significantly greater with fesoterodine 4 (P = .034) and 8 mg (P = .019) vs placebo.
  
  
  CONCLUSIONS
  These results suggest that fesoterodine may reduce nocturnal micturitions and improve sleep quality and QoL in overactive bladder patients with nocturia.
authors: Department of Urology, Faculty of Medical Science, University of Fukui, Fukui, Japan. Electronic address: oyoko@u-fukui.ac.jp.
authors: Osamu
authors: O
authors: Yokoyama
authors: Pfizer Japan Inc, Tokyo, Japan.
authors: Shintaro
authors: S
authors: Hiro
authors: Pfizer Japan Inc, Tokyo, Japan.
authors: Shinichi
authors: S
authors: Hotta
authors: Pfizer Japan Inc, Tokyo, Japan.
authors: Satoru
authors: S
authors: Mogami
authors: Pfizer Japan Inc, Tokyo, Japan.
authors: Hidetomi
authors: H
authors: Yamagami
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D044466:Asian People; D001559:Benzhydryl Compounds / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D053158:Nocturia / Q000188:drug therapy* / Q000208:ethnology; D011788:Quality of Life; D012890:Sleep; D012893:Sleep Wake Disorders / Q000188:drug therapy* / Q000208:ethnology; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy* / Q000208:ethnology; D014549:Urinary Incontinence / Q000188:drug therapy / Q000208:ethnology; D014554:Urination / Q000187:drug effects; D064804:Urological Agents / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D001559:Benzhydryl Compounds; D064804:Urological Agents; C526675:fesoterodine