Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence

Phase 3

Completed

• Conditions: Overactive Bladder
• Interventions: Biological: onabotulinumtoxinA; Drug: normal saline

• Registration Number: NCT00910520
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-28
• Study First Submitted QC: 2009-05-29
• Study First Posted: 2009-06-01
• Study Start: 2009-09
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Disposition First Submitted: 2012-08-24
• Disposition First Submitted QC: 2012-08-24
• Disposition First Posted: 2012-08-31
• Status Verified: 2013-01
• Results First Submitted: 2013-01-29
• Results First Submitted QC: 2013-01-29
• Last Update Submitted: 2013-01-29
• Results First Posted: 2013-03-05
• Last Update Posted: 2013-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 548

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo/onabotulinumtoxinA	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).
onabotulinumtoxinA	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).
placebo/onabotulinumtoxinA	normal saline	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).

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Number of Daily Episodes of Urinary Incontinence	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 Outcome Measures

Name	Time	Method
Change From Baseline in Volume Voided Per Micturition	Baseline, Week 12	The total volume voided was measured over one 24-hour period in the week prior to the Baseline and Week 12 study visit and recorded by the patient in the bladder diary. This was used to calculate volume voided per micturition. A positive number change from baseline indicates an increase in volume voided per micturition (improvement).
Change From Baseline in Number of Daily Micturition Episodes	Baseline, Week 12	The number of micturition episodes (the number of times a patient urinates into the toilet) was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the Baseline and prior to the Week 12 study visit. A negative number change from baseline indicates a reduction in micturition episodes (improvement).