Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
Phase 3
- Registration Number
- CTRI/2009/091/000360
- Lead Sponsor
- Allergan, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 135
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.
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Forced Expiratory VolumeTimepoint: Week 2;Forced Vital CapacityTimepoint: Week 2
- Secondary Outcome Measures
Name Time Method Maximum cystometric capacity (urodynamics)Timepoint: Weeks 2 - 52;Number of episodes of urinary incontinence (urodynamics)Timepoint: Weeks 2 - 52;Peak (amplitude) detrusor pressure (urodynamics)Timepoint: Weeks 2-52;Pulmonary functionTimepoint: Weeks 2 - 52