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Clinical Trials/NCT00311376
NCT00311376
Completed
Phase 3

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

Allergan0 sites416 target enrollmentAugust 2006
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ConditionsOveractive Bladder

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Overactive Bladder
Sponsor
Allergan
Enrollment
416
Primary Endpoint
Change From Baseline in Number of Weekly Episodes of Urinary Incontinence
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients.

Registry
clinicaltrials.gov
Start Date
August 2006
End Date
May 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 or multiple sclerosis
  • •Inadequate response to anticholinergic medication used to treat overactive bladder

Exclusion Criteria

  • •History of 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).

Secondary Outcomes

  • Change From Baseline in Maximum Cystometric Capacity (MCC)(Baseline, Week 6)
  • Change From Baseline in Maximum Detrusor Pressure (MDP)(Baseline, Week 6)
  • Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire(Baseline, Week 6)

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