Clinical trial NCT04800523: "UroMonitor Trial" in Spinal Cord Injury.
Official title: The "UroMonitor Trial": Safety, Feasibility, and Tolerability of UroMonitor Insertion in Spinal Cord Injury.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2021-03-16
Enrollment: 0
Sex: ALL
Minimum age (years): 17
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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

Eligibility criteria: 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

Primary outcomes:
measure: Participant Symptoms During Implantation
timeFrame: Day 1 Timepoint: post insertion
measure: Device Insertion Form for Urology Specialist
timeFrame: Day 1 Timepoint: post insertion
measure: Participant Symptoms During 3-Hour Monitoring
timeFrame: Day 1 Timepoint: 1 hr post insertion
measure: Device Removal Form for Urology Specialist
timeFrame: Day 1 Timepoint: post device remove
measure: Participant Symptoms during Device Removal Form
timeFrame: Day 1 Timepoint: post device remove
measure: Second Cystoscopy Form for Urology Specialist
timeFrame: Day 1 Timepoint: post secondary cyctoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Brian Kwon, MD
role: PRINCIPAL_INVESTIGATOR
References: