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Clinical Trials/NCT00461292
NCT00461292CompletedPhase 3

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

Allergan12 sites in 12 countries275 target enrollmentStarted: May 1, 2007Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Allergan
Enrollment
275
Locations
12
Primary Endpoint
Change From Baseline in Number of Weekly Episodes of Urinary Incontinence
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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 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).

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)

Investigators

Sponsor
Allergan
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (12)

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