Efficacy and Safety of Abobotulinumtoxina in Patients with Neurogenic Detrusor Overactivity Incontinence Performing Regular Clean Intermittent Catheterization: Pooled Results from Two Phase 3 Randomized Studies

Abstract

Background: For patients with neurogenic detrusor overactivity incontinence (NDOI), treatment with oral medications is often unsatisfactory. Objective: To assess the efficacy and safety of abobotulinumtoxinA (aboBoNT-A) for NDOI.Design, setting, and participants: Two randomized, double-blind phase 3 studies (CONTENT1, NCT02660138; CONTENT2, NCT02660359) enrolled patients with NDOI who were regularly performing clean intermittent catheterization (CIC) and were inad-equately managed with oral therapy. Pooled results from the first placebo-controlled treatment cycle are reported.Intervention: Patients received injections of aboBoNT-A 600 U (n = 162) or 800 U (n = 161) or placebo (n = 162) into the detrusor muscle. Outcome measurements and statistical analysis: The primary endpoint was the mean change from baseline in NDOI episodes per week at week 6. Secondary endpoints reported are the proportion of patients with no NDOI episodes, the volume per void, uro-dynamic parameters, and quality of life (QoL). Safety was also assessed. Statistical anal-yses were conducted for the pooled study populations (each aboBoNT-A dose vs placebo).