Status:
COMPLETED
High Frequency SARS for Neurogenic Bladder and Bowel Emptying
Lead Sponsor:
VA Office of Research and Development
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to determine if bladder emptying can be achieved using stimulation of the sacral roots at certain frequencies. Neurogenic bladder dysfunction occurs after spinal cord inju...
Detailed Description
Background: Spinal cord injury (SCI) leads to neurogenic bladder dysfunctions, and often includes difficulty with emptying the bladder due to detrusor-sphincter dyssynergia (DSD). Current bladder mana...
Eligibility Criteria
Inclusion
- Uses a SARS System for bladder management
- Suprasacral SCI
- Neurologically stable
- Skeletally mature
Exclusion
- Active sepsis
- Open pressure sores on or around pelvis
- Bleeding diathesis
- Significant urethral trauma, erosion, or stricture
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT05214378
Start Date
July 1 2022
End Date
July 31 2024
Last Update
August 22 2025
Active Locations (2)
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1
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, United States, 13210-2716
2
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106-1702