Status:
WITHDRAWN
Botulinum-A Toxin Injection for Detrusor Hyperreflexia in Spinal Cord Injury: A Non-Surgical Approach.
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Overactive Bladder
Urinary Incontinence
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to determine whether Botulinum-A toxin injected in the bladder muscle will help prevent the frequency and degree of urinary incontinence in Spinal Cord Injured and Multiple...
Detailed Description
OBJECTIVE OF THE PROJECT The major aim of the present study is to use a double blind randomized clinical trial design to evaluate the long-term efficacy and safety of two different doses, 300 and 400 ...
Eligibility Criteria
Inclusion
- Patients must be 18-80 years old with suprasacral spinal cord injury (SCI) or multiple sclerosis (MS) refractory Neurogenic bladder overactivity and/or detrusor compliance associated with small bladder capacity.· Impaired bladder compliance less than 50 ml/cm, H2O and bladder (cystometric) capacity less than 300ml.-
Exclusion
- Allergy to Botulinum Toxin Type-A· Pregnancy· Breast-feeding women· Active medical or psychiatric disorders· Upper urinary tract changes unrelated to lower tract dysfunction· Aminoglycoside use during the last 3 months-
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00262496
Last Update
June 26 2015
Active Locations (1)
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1
Miami VA Medical Center
Miami, Florida, United States, 33125