Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder | NCT00311376 | Trialant
CompletedInterventionalPhase 3Updated Dec 4, 2015
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
ClinicalTrials.gov ID
NCT00311376
Lead Sponsor
AllerganINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Enrollment
416Actual
Last Update Posted
Dec 4, 2015Estimated
Start Date
Aug 2006
Primary Completion Date
May 2010Actual
Completion Date
May 2010Actual
Brief Summary
The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients.
Overactive Bladder
botulinum toxin Type A (200U)
botulinum toxin Type A (300U)
Normal Saline (Placebo); botulinum toxin Type A (200U)
Normal Saline (Placebo); botulinum toxin Type A (300U)
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis
Inadequate response to anticholinergic medication used to treat overactive bladder
Exclusion Criteria:
History of evidence of pelvic or urologic abnormality
Previous or current diagnosis of bladder or prostate cancer