Status:
COMPLETED
Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence
Lead Sponsor:
Allergan
Conditions:
Overactive Bladder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary incontinence.
Eligibility Criteria
Inclusion
- Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months
- Inadequate response or limiting side effects with anticholinergics for the treatment of OAB
Exclusion
- Overactive Bladder caused by neurological condition
- Patient has predominance of stress incontinence
- History or evidence of pelvic or urological abnormality
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
548 Patients enrolled
Trial Details
Trial ID
NCT00910520
Start Date
September 1 2009
End Date
August 1 2011
Last Update
March 5 2013
Active Locations (7)
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1
Laguna Hills, California, United States
2
Ghent, Belgium
3
Prague, Czechia
4
Tübingen, Germany