Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 1

Summary

The purpose of this study is to provide confirmatory evidence of the safety and efficacy of two Dysport® (AbobotulinumtoxinA) doses (600 units \[U\] and 800 U), compared to placebo in reducing urinary incontinence (UI) in adult subjects treated for neurogenic detrusor overactivity (NDO) due to spinal cord injury (SCI) or multiple sclerosis (MS).

Timeline

Start

2016-03

Primary completion

2018-11-09

Completion

2019-02-14

Outcome

Met primary endpoint

Stopped (Enrollment): “Low recruitment of patients”

registry analysis (superiority test); Placebo vs Dysport® 600 U; p = 0.0001; LS Mean Difference -10.83 (95% CI -16.36 to -5.31); MMRM NCT02660138 ↗

registry analysis (superiority test); Placebo vs Dysport® 800 U; p <0.0001; LS Mean Difference -12.19 (95% CI -17.65 to -6.73); MMRM NCT02660138 ↗

Publications

• Kennelly M, Cruz F, Herschorn S, Abrams P, Onem K, Solomonov VK, Del Rosario Figueroa Coz E, Manu-Marin A, Giannantoni A, Thompson C, Vilain C, Volteau M, Denys P; Dysport CONTENT Program Group. 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 (CONTENT1 and CONTENT2). Eur Urol. 2022 Aug;82(2):223-232. doi: 10.1016/j.eururo.2022.03.010. Epub 2022 Apr 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Botulinum toxin type A	Protein / enzyme biologic	600 iu	Other
Subject	Botulinum toxin type A	Protein / enzyme biologic	800 iu	Other

Indications