1. Long-Term Efficacy and Safety of OnabotulinumtoxinA in Patients with Neurogenic Detrusor Overactivity Who Completed 4 Years of Treatment.
- Author
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Rovner E, Kohan A, Chartier-Kastler E, Jünemann KP, Del Popolo G, Herschorn S, Joshi M, Magyar A, and Nitti V
- Subjects
- Acetylcholine Release Inhibitors administration & dosage, Adult, Aged, Cystoscopy, Dose-Response Relationship, Drug, Female, Humans, Injections, Intramuscular methods, Male, Middle Aged, Treatment Outcome, Urinary Bladder, Neurogenic physiopathology, Urinary Bladder, Neurogenic psychology, Botulinum Toxins, Type A administration & dosage, Quality of Life, Urinary Bladder, Neurogenic drug therapy, Urodynamics drug effects
- Abstract
Purpose: 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., Materials and 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., (Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)
- Published
- 2016
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