title: OnabotulinumtoxinA improves quality of life in patients with neurogenic detrusor overactivity.
abstract: OBJECTIVE
  To evaluate the effects of onabotulinumtoxinA on patient-reported outcomes including health-related quality of life (HRQOL), treatment satisfaction, and treatment goal attainment in patients with urinary incontinence (UI) due to neurogenic detrusor overactivity (NDO).
  
  
  METHODS
  In this multicenter, double-blind, randomized, placebo-controlled, phase III, 52-week study (ClinicalTrials.gov NCT00311376), patients with UI due to NDO who were not adequately managed with anticholinergic therapy were treated with intradetrusor injections of onabotulinumtoxinA (200 or 300 U) or placebo (0.9% saline). HRQOL measures included the Incontinence Quality of Life (I-QOL) Questionnaire total score, and the 3 domain scores (avoidance and limiting behavior, psychosocial, and social embarrassment), the modified Overactive Bladder Patient Satisfaction with Treatment Questionnaire (OAB-PSTQ), and Patient Global Assessment. Assessments were made at baseline, posttreatment week 6 (primary time point), week 12, and at 12-week intervals.
  
  
  RESULTS
  Patients (mean age of 46 years with 30.5 weekly UI episodes at baseline) were randomized to receive placebo (n = 149) or onabotulinumtoxinA (200 U [n = 135] or 300 U [n = 132]). At week 6, improvements from baseline in I-QOL Questionnaire total score were greater (p < 0.001) in both onabotulinumtoxinA-treated groups vs placebo. Responses to the OAB-PSTQ also demonstrated greater mean improvements from baseline (p < 0.001) in both onabotulinumtoxinA-treated groups vs placebo at week 6. Patients who received onabotulinumtoxinA also reported greater improvement in the Patient Global Assessment than those in the placebo group (p ≤ 0.001 vs placebo).
  
  
  CONCLUSIONS
  Patients with UI due to NDO reported greater improvement in HRQOL and treatment satisfaction with onabotulinumtoxinA than with placebo consistently across several patient-reported outcome instruments.
  
  
  METHODS
  This study provides Class I evidence that onabotulinumtoxinA intradetrusor injections (200 or 300 U) can improve quality of life measures in patients with NDO not adequately managed with anticholinergic therapy.
authors.affiliation: Oakland University, William Beaumont School of Medicine, Royal Oak, MI, USA. chancellormb@gmail.com
authors.forename: Michael B
authors.initials: MB
authors.lastname: Chancellor
authors.forename: Vaishali
authors.initials: V
authors.lastname: Patel
authors.forename: Wendy W
authors.initials: WW
authors.lastname: Leng
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Shenot
authors.forename: Wayne
authors.initials: W
authors.lastname: Lam
authors.forename: Denise R
authors.initials: DR
authors.lastname: Globe
authors.forename: Alex L
authors.initials: AL
authors.lastname: Loeb
authors.forename: Christopher R
authors.initials: CR
authors.lastname: Chapple
mesh_terms: D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D001750:Urinary Bladder, Neurogenic / Q000188:drug therapy; D053201:Urinary Bladder, Overactive / Q000175:diagnosis / Q000188:drug therapy*; D014549:Urinary Incontinence / Q000188:drug therapy
chemical_list: D019274:Botulinum Toxins, Type A
references.citation: Neurourol Urodyn. 2013 Mar;32(3):242-9
references.pmid: 22965657
references.citation: Value Health. 2008 Jul-Aug;11(4):726-32
references.pmid: 18179666
references.citation: JAMA. 2011 Jan 5;305(1):89-90
references.pmid: 21205970
references.citation: Arch Phys Med Rehabil. 2007 May;88(5):646-52
references.pmid: 17466735
references.citation: Am J Phys Med Rehabil. 2006 Jun;85(6):536-45
references.pmid: 16715024
references.citation: Qual Life Res. 2010 Apr;19(3):323-31
references.pmid: 20094804
references.citation: BJU Int. 2007 Nov;100(5):987-1006
references.pmid: 17922784
references.citation: Control Clin Trials. 1989 Dec;10(4):407-15
references.pmid: 2691207
references.citation: J Urol. 2012 Jun;187(6):2131-9
references.pmid: 22503020
references.citation: J Urol. 2005 Jul;174(1):196-200
references.pmid: 15947626
references.citation: Eur Urol. 2009 Jul;56(1):81-8
references.pmid: 19403235
references.citation: Int Urogynecol J. 2012 Aug;23(8):1017-25
references.pmid: 22273813
references.citation: Eur Urol. 2007 Sep;52(3):850-8
references.pmid: 17467889
references.citation: J Clin Epidemiol. 1994 Jan;47(1):81-7
references.pmid: 8283197
references.citation: Eur Urol. 2011 Oct;60(4):742-50
references.pmid: 21798658