title: OnabotulinumtoxinA improves health-related quality of life in patients with urinary incontinence due to idiopathic overactive bladder: a 36-week, double-blind, placebo-controlled, randomized, dose-ranging trial.
abstract: BACKGROUND
  Patients with urgency urinary incontinence (UUI) due to overactive bladder (OAB) refractory to oral antimuscarinics have limited therapeutic options. OnabotulinumtoxinA appears to be an effective new treatment.
  
  
  OBJECTIVE
  Assess disease-specific quality-of-life outcomes and general health-related quality-of-life (HRQOL) outcomes following treatment with onabotulinumtoxinA in patients with idiopathic OAB and UUI inadequately managed with antimuscarinics.
  
  
  METHODS
  A phase 2, randomized, double-blind, placebo-controlled, dose-ranging study conducted at 40 sites from July 2005 to June 2008 with 313 patients (288 females) with idiopathic OAB experiencing eight or more UUI episodes per week and eight or more micturitions per day at baseline, with follow-up of 36 wk.
  
  
  METHODS
  Intradetrusor onabotulinumtoxinA (50 U, 100 U, 150 U, 200 U, or 300 U) or placebo.
  
  
  METHODS
  HRQOL was assessed using the urinary Incontinence-Specific Quality-of-Life Instrument (I-QOL), the King's Health Questionnaire (KHQ) symptom component, and the Medical Outcomes Study 36-Item Short-Form Health Survey. Descriptive statistics were used for absolute scores/changes from baseline. Within-group changes from baseline were assessed using paired t tests. Change from baseline for each onabotulinumtoxinA group compared with placebo was analyzed using an analysis of covariance model.
  
  
  CONCLUSIONS
  OnabotulinumtoxinA treatment at doses≥100 U produced significantly greater improvements than placebo in the I-QOL total and subscale scores at all follow-up visits from week 2 through week 24 (p<0.05). OnabotulinumtoxinA doses≥100 U produced significantly greater improvements than placebo in the KHQ symptom score at a majority of follow-up visits. HRQOL instruments demonstrated low to moderate correlations (Spearman correlation range: 0.01-0.51) with the symptoms of UUI recorded using daily diary data, with I-QOL demonstrating the highest correlations. A study limitation was that certain quality-of-life measures were exploratory and not validated.
  
  
  CONCLUSIONS
  A single onabotulinumtoxinA treatment with doses≥100 U resulted in statistically significant and clinically meaningful improvement in HRQOL by week 2 compared with placebo, and this improvement was sustained for ≤36 wk in patients with idiopathic OAB and UUI who were inadequately managed by oral antimuscarinics.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT00168454.
authors.affiliation: The National Hospital for Neurology and Neurosurgery, London, UK. C.Fowler@ion.ucl.ac.uk
authors.forename: Clare J
authors.initials: CJ
authors.lastname: Fowler
authors.forename: Stephen
authors.initials: S
authors.lastname: Auerbach
authors.forename: David
authors.initials: D
authors.lastname: Ginsberg
authors.forename: Douglass
authors.initials: D
authors.lastname: Hale
authors.forename: Piotr
authors.initials: P
authors.lastname: Radziszewski
authors.forename: Tomasz
authors.initials: T
authors.lastname: Rechberger
authors.forename: Vaishali D
authors.initials: VD
authors.lastname: Patel
authors.forename: Jihao
authors.initials: J
authors.lastname: Zhou
authors.forename: Catherine
authors.initials: C
authors.lastname: Thompson
authors.forename: Jonathan W
authors.initials: JW
authors.lastname: Kowalski
mesh_terms: D000368:Aged; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009498:Neurotoxins / Q000627:therapeutic use*; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000150:complications / Q000188:drug therapy* / Q000523:psychology; D014549:Urinary Incontinence / Q000188:drug therapy* / Q000209:etiology / Q000523:psychology
chemical_list: D009498:Neurotoxins; D019274:Botulinum Toxins, Type A