Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis

Summary

The purpose of this study is to determine the efficacy and safety of a single dose of 750 U of Dysport compared to placebo for the improvement in the daily incontinence episode frequency for each administration mode in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis.

Timeline

Start

2011-05

Primary completion

2013-03

Completion

2013-03

Outcome

Missed primary endpoint

registry analysis (unspecified test); Dysport 750 U (15 Injection Sites) vs Placebo (15 Injection Sites); p = 0.11; Mean Treatment Difference -1.54 (95% CI -3.47 to 0.39); ANCOVA NCT01357980 ↗

registry analysis (unspecified test); Dysport 750 U (30 Injection Sites) vs Placebo (30 Injection Sites); p = 0.07; Mean Treatment Difference -0.61 (95% CI -1.27 to 0.05); ANCOVA NCT01357980 ↗

Publications

• Background Denys P, Del Popolo G, Amarenco G, Karsenty G, Le Berre P, Padrazzi B, Picaut P; Dysport Study Group. Efficacy and safety of two administration modes of an intra-detrusor injection of 750 units dysport(R) (abobotulinumtoxinA) in patients suffering from refractory neurogenic detrusor overactivity (NDO): A randomised placebo-controlled phase IIa study. Neurourol Urodyn. 2017 Feb;36(2):457-462. doi: 10.1002/nau.22954. Epub 2016 Jan 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Botulinum toxin type A	Protein / enzyme biologic	750 iu	Other

Indications