Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder

Allergan0 sites74 target enrollmentDecember 2007

ConditionsOveractive Bladder

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Overactive Bladder
Sponsor: Allergan
Enrollment: 74
Primary Endpoint: Change From Baseline in Number of Weekly Episodes of Urinary Incontinence
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to explore the effectiveness and safety of several doses of botulinum toxin type A in treating overactive bladder in patients with spinal cord injury.

Registry

clinicaltrials.gov

Start Date

December 2007

End Date

July 2010

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Allergan

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury
•Inadequate response to anticholinergic medication used to treat overactive bladder

Exclusion Criteria

•History or evidence of pelvic or urologic abnormality
•Previous or current diagnosis of bladder or prostate cancer
•Urinary tract infection at time of enrollment

Outcomes

Primary Outcomes

Change From Baseline in Number of Weekly Episodes of Urinary Incontinence

Time Frame: Baseline, Week 6

Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).