Efficacy and safety of onabotulinumtoxin A 100U for treatment of urinary incontinence due to neurogenic detrusor overactivity in non-catheterising multiple sclerosis patients

Abstract

Objectifs We evaluated the efficacy/safety of onabotulinumtoxin A 100U versus placebo for treatment of urinary incontinence (UI) due to neurogenic detrusor overactivity (NDO) in non-catheterising multiple sclerosis (MS) patients inadequately managed by ≥ 1 anticholinergic. Methodes A multicentre, double-blind study randomised patients 1:1 to onabotulinumtoxin A 100U ( n = 66) or placebo ( n = 78). Assessments (week 6 primary endpoint) included change from baseline in UI episodes (UIE)/day (primary endpoint), maximum cystometric capacity (MCC), maximum detrusor pressure (MDP) during first involuntary detrusor contraction (IDC), incontinence-quality of life (I-QOL) total summary score, and proportions of patients achieving 100% UIE reduction. Median duration of effect (DOE), initiation of clean intermittent catheterisation (CIC), and adverse events (AEs) were also assessed. Resultats Baseline characteristics were similar between groups. The mean baseline EDSS score was 4.7. Onabotulinumtoxin A 100U significantly improved UIE (–3.3 vs–1.1; P P 2 O; P P P P Conclusion In non-catheterising MS patients with UI, onabotulinumtoxin A 100U resulted in significant and clinically-meaningful improvements in UI, MCC, MDP at first IDC, and QOL versus placebo and was well-tolerated.