Status:
WITHDRAWN
"UroMonitor Trial" in Spinal Cord Injury.
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
United States Department of Defense
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
17-75 years
Phase:
NA
Brief Summary
This study aims to determine if a non-functioning UroMonitor device can be safely inserted, monitored, and removed in patients with SCI.
Detailed Description
This prospective, observational study will be conducted with 10 patients with chronic thoracolumbar SCI who are already undergoing routine UDS studies as part of their care. Following their routine UD...
Eligibility Criteria
Inclusion
- Cervical or Thoracolumbar (T2-L1 spinal level) spinal cord injury with AIS A, B, C, or D severities of injury.
- Age 17-75.
- At least 1 year post-injury.
- At least one prior urodynamics study in the past 12 months that has objectively documented abnormalities on bladder function consistent with an upper motor neuro lesion.
- History of neurogenic bladder symptoms requiring some form of intervention (e.g. clean intermittent catheterization, condom catheter)
Exclusion
- Lumbar injuries (L2-S1 spinal level) where the injury is primarily to the cauda equina and not to spinal cord.
- History of autonomic dysreflexia (such individuals are excluded to minimize the chance of inducing autonomic dysreflexia with device insertion).
- Active urinary tract infection.
- Past urethral or bladder reconstruction surgery
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04800523
Start Date
October 1 2021
End Date
March 15 2023
Last Update
October 28 2021
Active Locations (1)
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1
Vancouver General Hospital
Vancouver, British Columbia, Canada