title: Once-daily oxybutynin patch improves nocturia and sleep quality in Japanese patients with overactive bladder: Post-hoc analysis of a phase III randomized clinical trial.
abstract: OBJECTIVE
  To investigate the efficacy of a once-daily oxybutynin patch for nocturia, and its influence on sleep quality in patients with overactive bladder.
  
  
  METHODS
  We carried out post-hoc analysis of a phase III, randomized, double-blind, comparative study in which an oxybutynin patch was administered once daily for 12 weeks to Japanese patients with overactive bladder. Patients with a baseline mean of one or more episodes of nocturia per night (data from voiding diaries) were analyzed. The mean number of micturitions, mean voided volume per micturition, mean first voided volume at night, mean sleep duration, and hours of undisturbed sleep were compared between the once-daily oxybutynin patch group and the placebo group. All parameters were expressed as the least squares mean values.
  
  
  RESULTS
  The analysis included 576 patients. The number of nocturia episodes decreased by 0.66 in the oxybutynin patch group versus 0.51 in the placebo group (P = 0.0249). Also, the voided volume per nocturnal micturition and the first voided volume at night showed a significant increase in the oxybutynin patch group compared with the placebo group (P = 0.0073 and P = 0.0005, respectively). The hours of undisturbed sleep showed significant prolongation by 76.14 min in the oxybutynin patch group versus 56.07 min in the placebo group (P = 0.0257).
  
  
  CONCLUSIONS
  Oxybutynin patch treatment reduces the number of nocturia episodes and prolongs the hours of undisturbed sleep, thus improving sleep quality and sleep-related quality of life in patients with overactive bladder.
authors.affiliation: Department of Urology, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.
authors.forename: Osamu
authors.initials: O
authors.lastname: Yokoyama
authors.affiliation: Division of Urology, Harasanshin Hospital, Fukuoka, Japan.
authors.forename: Akito
authors.initials: A
authors.lastname: Yamaguchi
authors.affiliation: Department of Urology, National Center for Geriatrics and Gerontology, Obu, Japan.
authors.forename: Masaki
authors.initials: M
authors.lastname: Yoshida
authors.affiliation: Department of Urology, Continence Center, Dokkyo Medical University, Tochigi, Japan.
authors.forename: Tomonori
authors.initials: T
authors.lastname: Yamanishi
authors.affiliation: Department of Urology, School of Medicine, Shinshu University, Matsumoto, Japan.
authors.forename: Osamu
authors.initials: O
authors.lastname: Ishizuka
authors.affiliation: Department of Urology, Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka, Japan.
authors.forename: Narihito
authors.initials: N
authors.lastname: Seki
authors.affiliation: Department of Urology, School of Medicine, Nihon University, Tokyo, Japan.
authors.forename: Satoru
authors.initials: S
authors.lastname: Takahashi
authors.affiliation: Division of Bioengineering, Lower Urinary Tract Dysfunction Research, School of Engineering, Nihon University, Koriyama, Japan.
authors.forename: Osamu
authors.initials: O
authors.lastname: Yamaguchi
authors.affiliation: Hisamitsu Pharmaceutical, Tokyo, Japan.
authors.forename: Naruhito
authors.initials: N
authors.lastname: Higo
authors.affiliation: Hisamitsu Pharmaceutical, Tokyo, Japan.
authors.forename: Hidenao
authors.initials: H
authors.lastname: Minami
authors.affiliation: Hisamitsu Pharmaceutical, Tokyo, Japan.
authors.forename: Yu
authors.initials: Y
authors.lastname: Masegi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D044466:Asian People; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008333:Mandelic Acids / Q000008:administration & dosage*; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage*; D053158:Nocturia / Q000188:drug therapy*; D011788:Quality of Life; D012890:Sleep; D057968:Transdermal Patch; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*; D014554:Urination / Q000187:drug effects*; D055815:Young Adult
chemical_list: D008333:Mandelic Acids; D018727:Muscarinic Antagonists; C005419:oxybutynin
keywords: antimuscarinic agent; nocturia; overactive bladder; oxybutynin patch; sleep quality