Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis

A Phase IIa, Multicentre, Double Blind, Single Dose, Parallel Group, Placebo Controlled, Clinical Pilot Study to Assess the Efficacy and Safety of a Single Dose, Intra-Detrusor Injections of 750 Units of Dysport® in Subjects Suffering From Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis.

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.

Inclusion Criteria:

• Subject, family member or care giver was willing and able to perform clean intermittent catheterisation (CIC) for the duration of the study
• Inadequate response or refractory to anticholinergic medication
• Botulinum Toxin naive for intradetrusor injections and with no previous treatment with Botulinum Toxin of any type, within 3 months prior to study entry for any other condition
• Have a minimum of 2 incontinences per day calculated as the average daily incontinence episode frequency (IEF) over the 3 days preceding the baseline visit

Exclusion Criteria:

• Significant Baseline renal and/or urinary tract pathology
• Previous treatment with any endovesical pharmacology agent including detrusor Botulinum Toxin injection