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

Overactive Bladder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00910845
• Other study ID #: 191622-095
• Status: Completed
• Phase: Phase 3
• First received: May 28, 2009
• Last updated: January 29, 2013
• Start date: September 2009
• Est. completion date: July 2011

Study information

• Verified date: January 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 557
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Number of Daily Episodes of Urinary Incontinence	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).	Baseline, Week 12	No
Secondary	Change From Baseline in Number of Daily Micturition Episodes	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).	Baseline, Week 12	No
Secondary	Change From Baseline in Volume Voided Per Micturition	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).	Baseline, Week 12	No