Safety and Efficacy Study of OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity (NDO) in... | NCT01600716 | Trialant
Safety and Efficacy Study of OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity (NDO) in Non-Catheterizing Patients With Multiple Sclerosis (MS)
ClinicalTrials.gov ID
NCT01600716
Lead Sponsor
AllerganINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Enrollment
144Actual
Last Update Posted
Apr 30, 2019Actual
Start Date
Jun 13, 2012Actual
Primary Completion Date
Apr 4, 2014Actual
Completion Date
Mar 27, 2015Actual
Brief Summary
This study will evaluate the safety and efficacy of OnabotulinumtoxinA (BOTOX®) for the treatment of urinary incontinence due to NDO in non-catheterizing patients with MS.
Urinary Incontinence
Multiple Sclerosis
Neurogenic Bladder
OnabotulinumtoxinA
Placebo (Normal Saline)
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 3 episodes of urinary incontinence over a 3-day period
History of Multiple Sclerosis (MS)
Urinary incontinence not adequately controlled by anticholinergic medication
Exclusion Criteria:
Current use of intermittent catheter or indwelling catheter to manage urinary incontinence
Previous or current botulinum toxin therapy of any serotype for any urological condition
Previous or current botulinum toxin therapy of any serotype for any non-urological condition within the last 12 weeks
Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, or Amyotrophic Lateral Sclerosis