Spinal Cord Injuries
Conditions
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 UDS, a non-functioning UroMonitor device will be inserted and removed after 3 hours. Participants' symptoms will be monitored after the UroMonitor is inserted, following the 3 hour monitoring period, and again after UroMonitor removal. A second cystoscopy will be conducted for research purposes after removal to examine the urethra and bladder for any irritation or trauma. During insertion and removal, the urologist will document the time required for insertion and any difficulties encountered
Interventions
DEVICEUroMonitor System
Implantable device to wirelessly and without catheters monitor the neurogenic bladder on an ambulatory basis
Sponsors
United States Department of Defense
University of British Columbia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Cervical or Thoracolumbar (T2-L1 spinal level) spinal cord injury with AIS A, B, C, or D severities of injury. 2. Age 17-75. 3. At least 1 year post-injury. 4. 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. 5. History of neurogenic bladder symptoms requiring some form of intervention (e.g. clean intermittent catheterization, condom catheter)
Exclusion criteria
1. Lumbar injuries (L2-S1 spinal level) where the injury is primarily to the cauda equina and not to spinal cord. 2. History of autonomic dysreflexia (such individuals are excluded to minimize the chance of inducing autonomic dysreflexia with device insertion). 3. Active urinary tract infection. 4. Past urethral or bladder reconstruction surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Symptoms During Implantation | Day 1 Timepoint: post insertion | 11-point numerical visual analogue scale for the participant to document discomfort during the implantation of the UroMonitor. |
| Device Insertion Form for Urology Specialist | Day 1 Timepoint: post insertion | Study form registers the data on application of the device, such as the time and ease of insertion. |
| Participant Symptoms During 3-Hour Monitoring | Day 1 Timepoint: 1 hr post insertion | Study form used for the purpose of registering data on details of participant symptoms during the 3-hour monitoring period |
| Device Removal Form for Urology Specialist | Day 1 Timepoint: post device remove | Study form used for the purpose of recording the condition of the device and patient's experience at the time of sensor removal |
| Participant Symptoms during Device Removal Form | Day 1 Timepoint: post device remove | Data on details of patient symptoms during device removal is recorded with this form |
| Second Cystoscopy Form for Urology Specialist | Day 1 Timepoint: post secondary cyctoscopy | This form is used for the purpose of recording the existence of irritation in bladder or urethra after the removal of the device |
Countries
Canada
Outcome results
None listed