NCT00910845

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 557 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
BIOLOGICAL	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). Or, if placebo is administered at Day 1, onabotulinumtoxinA 100 U injected after a minimum of 12 weeks (if applicable).
DRUG	normal saline	Normal saline (placebo) injected into the detrusor at Day 1.

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2009-06-01
• Last updated: 2013-03-05
• Results posted: 2013-03-05

Locations

2 sites across 2 countries: United States, Canada