Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
| Status: | Completed |
|---|---|
| Conditions: | Overactive Bladder |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 3/30/2013 |
| Start Date: | June 2007 |
| End Date: | December 2013 |
| Contact: | Allergan Inc. |
| Email: | clinicaltrials@allergan.com |
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.
Botulinum toxin Type A 300U has been discontinued from the study. Patients remaining in the
study who were allocated to receive botulinum toxin Type A 300U at treatment 2 (and had not
yet received it) will receive botulinum toxin Type A 200U instead.
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.
- Neurological respiratory impairment and abnormal pulmonary function test results
Exclusion Criteria:
- 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
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