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

This study is currently recruiting participants.
Study NCT00575016.   Last updated on November 14, 2008.   Information provided by Allergan

This Tabular View shows the required WHO registration data elements as marked by †

Descriptive Information Fields
Brief Title † Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
Official Title †
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.
Detailed Description
Study Phase Phase II
Study Type † Interventional
Study Design † Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure † Number of episodes of urinary incontinence [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Secondary Outcome Measure † Maximum cystometric capacity (urodynamics) [ Time Frame: Weeks 6 - 24 ] [ Designated as safety issue: No ]
Peak detrusor pressure (urodynamics) [ Time Frame: Weeks 6 - 24 ] [ Designated as safety issue: No ]
Condition † Overactive Bladder
Intervention † Biological: placebo/botulinum toxin Type A
Biological: botulinum toxin Type A
Biological: Botulinum toxin Type A
MEDLINE PMIDs
Links Related Info This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status † Recruiting
Enrollment † 160
Start Date † December 2007
Completion Date June 2010
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
Gender Both
Ages 18 Years to 80 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Allergan Inc         clinicaltrials@allergan.com    
Location Countries † Serbia
Administrative Information Fields
NCT ID † NCT00575016
Organization ID 191622-518
Secondary IDs ††
Study Sponsor † Allergan
Collaborators ††
Investigators †
Study Director:     Medical Director     Allergan    
Information Provided By Allergan
Verification Date November 2008
First Received Date † December 13, 2007
Last Updated Date November 14, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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