A Phase III, Multicentre, Randomised, Double Blind, Parallel Group, Placebo Controlled Study To Assess The Efficacy And Safety Of One Or More Intradetrusor Treatments Of 600 Or 800 Units of Dysport® For The Treatment Of Urinary Incontinence In Subjects With Neurogenic Detrusor Overactivity Due To Spinal Cord Injury Or Multiple Sclerosis
Inclusion and Exclusion Criteria
- Urinary Incontinence for at least 3 months prior to Screening as a result of Neurogenic Detrusor Overactivity due to Spinal Cord Injury or Multiple Sclerosis.
- Subjects with Spinal Cord Injury must have a stable neurological injury at T1 level or below which occurred at least 6 months prior to Screening.
- Subjects with Multiple Sclerosis must be clinically stable in the investigator's opinion, with no exacerbation (relapse) of MS for at least 3 months prior to Screening.
- Subjects must have had an inadequate response after at least 4 weeks of oral medications used in the treatment of NDO (e.g. anticholinergics, beta-3 agonists) and/or have intolerable side-effects.
- Routinely performing Clean Intermittent Catheterization (CIC) to ensure adequate bladder emptying.
- An average of at least two episodes per day of Urinary Incontinence recorded on the screening bladder diary. Key
- Any current condition (other than NDO) that may impact on bladder function.
- Previous or current, tumour or malignancy affecting the spinal column or spinal cord, or any other unstable cause of SCI.
- Any condition that will prevent cystoscopic treatment administration or CIC usage, e.g. urethral strictures.
- Current indwelling bladder catheter, or removal of indwelling bladder catheter less than 4 weeks prior to Screening.
- BTX-A treatment within 9 months prior to Screening for any urological condition (e.g. detrusor or urethral sphincter treatments).
- Any neuromodulation/electrostimulation usage for urinary symptoms/incontinence within 4 weeks prior to Screening. Any implanted neuromodulation device must be switched off at least 4 weeks prior to Screening.
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.