title: Long-Term Efficacy and Safety of OnabotulinumtoxinA in Patients with Neurogenic Detrusor Overactivity Who Completed 4 Years of Treatment.
abstract: OBJECTIVE
  We assessed the year-to-year consistency of outcomes in patients with urinary incontinence due to neurogenic detrusor overactivity who completed 4 years of onabotulinumtoxinA treatment.
  
  
  METHODS
  Eligible patients who completed a 52-week phase 3 trial of onabotulinumtoxinA for urinary incontinence could enter a 3-year open label extension study of onabotulinumtoxinA 200 or 300 U administered as needed for symptom control. This analysis focused on 227 patients who completed the 4-year study. Outcomes assessed by year of treatment included mean treatments per year, mean change from baseline at week 6 in urinary incontinence episodes per day and the I-QOL (Incontinence Quality of Life) total summary score, the proportion of patients with 50% or greater and 100% reductions in urinary incontinence episodes per day, duration of effect and adverse events.
  
  
  RESULTS
  Patients reported 4.3 urinary incontinence episodes per day at baseline and received 1.4 to 1.5 onabotulinumtoxinA treatments per year. The decrease in urinary incontinence following onabotulinumtoxinA consistently ranged from -3.4 to -3.9 episodes per day across 4 years. A high proportion of patients achieved 50% or greater and 100% urinary incontinence reductions in each year (range 86.6% to 94.1% and 43.6% to 57.4%, respectively). Consistent and clinically relevant improvements in I-QOL scores were observed in each treatment year. The overall median duration of effect of onabotulinumtoxinA was 9.0 months or greater (range 3.0 to 49.2) and 26.0% or more of patients experienced a duration of effect of 12 months or greater. The most common adverse event was urinary tract infection with no increased incidence with time.
  
  
  CONCLUSIONS
  Patients with neurogenic detrusor overactivity who completed 4 years of onabotulinumtoxinA treatment experienced a consistent duration of treatment effect and year-to-year improvements in urinary incontinence and quality of life with no new safety signals.
authors.affiliation: Department of Urology, Medical University of South Carolina, Charleston, South Carolina. Electronic address: rovnere@musc.edu.
authors.forename: Eric
authors.initials: E
authors.lastname: Rovner
authors.affiliation: Advanced Urology Centers of New York, Bethpage, New York.
authors.forename: Alfred
authors.initials: A
authors.lastname: Kohan
authors.affiliation: Department of Urology, Pitié-Salpétrière Academic Hospital, University Paris 6, Paris, France.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Chartier-Kastler
authors.affiliation: Department of Urology and Pediatric Urology, Klinik für Urologie und Kinderurologie, Universitätsklinikum Schleswig-Holstein, Kiel, Germany.
authors.forename: Klaus-Peter
authors.initials: KP
authors.lastname: Jünemann
authors.affiliation: Department of Neurourology, Careggi University Hospital, Florence, Italy.
authors.forename: Giulio
authors.initials: G
authors.lastname: Del Popolo
authors.affiliation: Division of Urology, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Sender
authors.initials: S
authors.lastname: Herschorn
authors.affiliation: Allergan plc, Irvine, California.
authors.forename: Manher
authors.initials: M
authors.lastname: Joshi
authors.affiliation: Allergan plc, Bridgewater, New Jersey.
authors.forename: Andrew
authors.initials: A
authors.lastname: Magyar
authors.affiliation: Department of Urology, New York University School of Medicine, New York, New York.
authors.forename: Victor
authors.initials: V
authors.lastname: Nitti
mesh_terms: D065087:Acetylcholine Release Inhibitors / Q000008:administration & dosage; D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage*; D003558:Cystoscopy; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular / Q000379:methods; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D016896:Treatment Outcome; D001750:Urinary Bladder, Neurogenic / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D014563:Urodynamics / Q000187:drug effects*
chemical_list: D065087:Acetylcholine Release Inhibitors; D019274:Botulinum Toxins, Type A
keywords: onabotulinumtoxinA; quality of life; urinary bladder, neurogenic; urinary incontinence; urinary tract infections