Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
Information source: Allergan
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Overactive Bladder
Intervention: botulinum toxin Type A (Biological); botulinum toxin Type A (Biological); Placebo/Botulinum toxin Type A (Other); Placebo/botulinum toxin Type A (Other)
Phase: Phase 3
Status: Recruiting
Sponsored by: Allergan Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan
Overall contact:
Allergan, Inc., Email: clinicaltrials@allergan.com
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.
Clinical Details
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Number of Episodes of Urinary Incontinence
Secondary outcome: Maximum cystometric capacity (urodynamics)Peak (amplitude) detrusor pressure (urodynamics) Incontinence Quality of Life Instrument
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
- Urinary tract infection at time of enrollment
Locations and Contacts
Allergan, Inc., Email: clinicaltrials@allergan.com
Royal Oak, Michigan, United States; Recruiting
Additional Information
Starting date: August 2006
Ending date: September 2010
Last updated: September 19, 2008
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