TerminatedInterventionalPhase 2Updated Oct 2, 2015
Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence | NCT00910520 | Trialant
CompletedInterventionalPhase 3Updated Mar 5, 2013
Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence
ClinicalTrials.gov ID
NCT00910520
Lead Sponsor
AllerganINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Enrollment
548Actual
Last Update Posted
Mar 5, 2013Estimated
Start Date
Sep 2009
Primary Completion Date
Aug 2011Actual
Completion Date
Aug 2011Actual
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.
Overactive Bladder
onabotulinumtoxinA
normal saline
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
Overactive Bladder caused by neurological condition
Patient has predominance of stress incontinence
History or evidence of pelvic or urological abnormality