Status:

COMPLETED

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

Lead Sponsor:

Allergan

Conditions:

Overactive Bladder

Eligibility:

All Genders

18-80 years

Phase:

PHASE3

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.

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

August 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2010

Estimated Enrollment :

416 Patients enrolled

Trial Details

Trial ID

NCT00311376

Start Date

August 1 2006

End Date

May 1 2010

Last Update

December 4 2015

Active Locations (14)

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Page 1 of 4 (14 locations)

1

Royal Oak, Michigan, United States

2

Randwick, New South Wales, Australia

3

Innsbruck, Austria

4

Ghent, Belgium