Overview

Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder

Status:
Terminated
Trial end date:
2012-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Allergan
Treatments:
abobotulinumtoxinA
Botulinum Toxins
Botulinum Toxins, Type A
incobotulinumtoxinA
onabotulinumtoxinA
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.

- 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