Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence
Overview
- Phase
- Phase 3
- Intervention
- onabotulinumtoxinA
- Conditions
- Overactive Bladder
- Sponsor
- Allergan
- Enrollment
- 557
- Primary Endpoint
- Change From Baseline in Number of Daily Episodes of Urinary Incontinence
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
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
Arms & Interventions
onabotulinumtoxinA
OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
Intervention: onabotulinumtoxinA
placebo/onabotulinumtoxinA
Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
Intervention: onabotulinumtoxinA
placebo/onabotulinumtoxinA
Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
Intervention: normal saline
Outcomes
Primary Outcomes
Change From Baseline in Number of Daily Episodes of Urinary Incontinence
Time Frame: Baseline, Week 12
A urinary incontinence episode is defined as an incident of involuntary loss of urine as recorded in a patient bladder diary during the 3 days before the Baseline and Week 12 study visits. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
Secondary Outcomes
- Change From Baseline in Number of Daily Micturition Episodes(Baseline, Week 12)
- Change From Baseline in Volume Voided Per Micturition(Baseline, Week 12)