title: Efficacy and safety of once-daily oxybutynin patch versus placebo and propiverine in Japanese patients with overactive bladder: A randomized double-blind trial.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of once-daily oxybutynin patch therapy for overactive bladder.
  
  
  METHODS
  A randomized double-blind trial was carried out in patients with overactive bladder syndrome, who received an oxybutynin patch, propiverine (20 mg) or placebo once daily for 12 weeks. The primary efficacy end-point was the change of the mean daily number of micturitions in week 12.
  
  
  RESULTS
  A total of 1530 patients were randomized to receive the oxybutynin patch (573), propiverine (576) or placebo (381). The change of the mean daily frequency of micturition from baseline in the full analysis set was -1.89 ± 2.04 with the oxybutynin patch, which was significantly higher than with placebo (-1.44 ± 2.23) (P = 0.0015). The difference of the mean change in the mean daily number of micturitions between the oxybutynin patch and propiverine groups showed a 95% confidence interval of -0.28 to 0.21, and the upper limit of this interval was below the predefined non-inferiority margin of 0.37, showing non-inferiority of the oxybutynin patch to propiverine. The incidence of dry mouth and constipation was higher with propiverine than with the oxybutynin patch or placebo. Application site dermatitis was more frequent with the oxybutynin patch (31.8%) than with propiverine (5.9%) or placebo (5.2%), but the dermatitis was generally mild.
  
  
  CONCLUSIONS
  This trial shows the efficacy of the new once-daily oxybutynin patch for overactive bladder. Despite a higher rate of dermatitis with the oxybutynin patch, dry mouth and constipation occurs less often than during treatment with propiverine.
authors.affiliation: Division of Lower Urinary Tract Dysfunction Research and Bioengineering, Nihon University School of Engineering, Koriyama, Japan.
authors.forename: Osamu
authors.initials: O
authors.lastname: Yamaguchi
authors.forename: Eiji
authors.initials: E
authors.lastname: Uchida
authors.forename: Naruhito
authors.initials: N
authors.lastname: Higo
authors.forename: Hidenao
authors.initials: H
authors.lastname: Minami
authors.forename: Shigeo
authors.initials: S
authors.lastname: Kobayashi
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Sato
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001561:Benzilates / Q000008:administration & dosage; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008333:Mandelic Acids / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D057968:Transdermal Patch; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy; D014554:Urination; D055815:Young Adult
chemical_list: D001561:Benzilates; D008333:Mandelic Acids; D018727:Muscarinic Antagonists; C015586:propiverine; C005419:oxybutynin
keywords: antimuscarinic; overactive bladder; oxybutynin patch; propiverine; randomized controlled trial