title: Treatment satisfaction and improvement in health-related quality of life with onabotulinumtoxinA in patients with urinary incontinence due to neurogenic detrusor overactivity.
abstract: OBJECTIVE
  OnabotulinumtoxinA significantly reduces urinary incontinence (UI) and improves bladder management in patients with neurogenic detrusor overactivity (NDO). We evaluated the impact of onabotulinumtoxinA on patient-reported outcomes (PROs) in patients with UI due to NDO in a double-blind, placebo-controlled study.
  
  
  METHODS
  Patients with UI due to NDO (from multiple sclerosis or spinal cord injury) were randomized to intradetrusor placebo (n = 92) or onabotulinumtoxinA 200 U (n = 92) or 300 U (n = 91). PROs included Incontinence Quality of Life (I-QOL) Questionnaire to assess health-related quality of life (HRQoL), the 16-item modified Overactive Bladder-Patient Satisfaction with Treatment Questionnaire (OAB-PSTQ) to assess treatment satisfaction, and Patient Global Assessment to assess treatment goal achievement.
  
  
  RESULTS
  Mean improvement in I-QOL total score at weeks 6 and 12 was significantly greater with both onabotulinumtoxinA 200 U and 300 U versus placebo (Δ12.3 for 200 U and Δ14.9 for 300 U vs. placebo; P < 0.001), and was clinically meaningful. For those patients who completed the OAB-PSTQ, improvement in satisfaction at weeks 6 and 12 was significantly greater for onabotulinumtoxinA versus placebo (P < 0.001, all comparisons). At 6 weeks, greater proportions of onabotulinumtoxinA-treated patients than placebo reported being somewhat or very satisfied (200 U, 77.5% and 300 U, 67.8% vs. placebo, 39.5%), and significant progress toward or complete achievement of primary treatment goal (200 U, 62.9% and 300 U, 61.6% vs. placebo, 16.5%).
  
  
  CONCLUSIONS
  NDO patients treated with onabotulinumtoxinA 200 or 300 U had significantly greater improvement in HRQoL and greater treatment satisfaction compared with placebo-treated patients, with no clinically relevant differences between onabotulinumtoxinA doses.
authors.affiliation: University of Medicine and Dentistry of New Jersey-School of Osteopathic Medicine, Division of Urology, Stratford, New Jersey 08084, USA. dosuss@comcast.net
authors.forename: David
authors.initials: D
authors.lastname: Sussman
authors.forename: Vaishali
authors.initials: V
authors.lastname: Patel
authors.forename: Giulio
authors.initials: G
authors.lastname: Del Popolo
authors.forename: Wayne
authors.initials: W
authors.lastname: Lam
authors.forename: Denise
authors.initials: D
authors.lastname: Globe
authors.forename: Peter
authors.initials: P
authors.lastname: Pommerville
mesh_terms: D000328:Adult; D000704:Analysis of Variance; D019274:Botulinum Toxins, Type A / Q000009:adverse effects / Q000627:therapeutic use*; D001938:Brazil; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D009656:North America; D017060:Patient Satisfaction; D011788:Quality of Life; D013019:South Africa; D011795:Surveys and Questionnaires; D013624:Taiwan; D013997:Time Factors; D016896:Treatment Outcome; D001743:Urinary Bladder / Q000187:drug effects* / Q000503:physiopathology; D001750:Urinary Bladder, Neurogenic / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D053201:Urinary Bladder, Overactive / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A