Status:
TERMINATED
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
Lead Sponsor:
Allergan
Conditions:
Overactive Bladder
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This study will assess the safety and efficacy of botulinum toxin Type A for the treatment of urinary incontinence overactive bladder in patients with a spinal cord injury or multiple sclerosis.
Detailed Description
Botulinum toxin Type A 300U has been discontinued from the study after regulatory approval of botulinum toxin Type A 200U. Patients remaining in the study who were allocated to receive botulinum toxin...
Eligibility Criteria
Inclusion
- 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.
- Neurological respiratory impairment and abnormal pulmonary function test results
Exclusion
- History or evidence of pelvic or urologic abnormality
- Previous or current diagnosis of bladder or prostate cancer
- Symptomatic or untreated urinary tract infection at time of enrollment
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00439140
Start Date
June 1 2007
End Date
December 1 2012
Last Update
January 24 2014
Active Locations (4)
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1
Philadelphia, Pennsylvania, United States
2
Herston, Queensland, Australia
3
Victoria, British Columbia, Canada
4
Chennai, India