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: placebo/botulinum toxin Type A (Biological); botulinum toxin Type A (Biological); botulinum toxin Type A (Biological); Botulinum toxin Type A (Biological)
Phase: Phase 2
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 explore the effectiveness and safety of several doses of
botulinum toxin type A in treating overactive bladder in patients with spinal cord injury.
Clinical Details
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Number of episodes of urinary incontinence
Secondary outcome: Maximum cystometric capacity (urodynamics)Peak detrusor pressure (urodynamics)
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
- Inadequate response to anticholinergic medication used to treat overactive bladder
Exclusion Criteria:
- History or 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
Belgrade, Serbia; Recruiting
Additional Information
Starting date: December 2007
Ending date: June 2010
Last updated: November 14, 2008
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