Spinal Cord InjuriesNCT04800523
"UroMonitor Trial" in Spinal Cord Injury.
A study testing UroMonitor System in people with Spinal Cord Injuries, run by University of British Columbia at 1 site in Canada.
Trial summary
This study aims to determine if a non-functioning UroMonitor device can be safely inserted, monitored, and removed in patients with SCI. Read more about this study
- Who is it for?
- Ages 17 to 75 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- UroMonitor System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2021to 15 Mar 2023
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The "UroMonitor Trial": Safety, Feasibility, and Tolerability of UroMonitor Insertion in Spinal Cord Injury.
This study aims to determine if a non-functioning UroMonitor device can be safely inserted, monitored, and removed in patients with SCI.
Read the 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
- Conditions
- Spinal Cord Injuries
- Being tested
- UroMonitor System
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UroMonitor SystemDevice
Implantable device to wirelessly and without catheters monitor the neurogenic bladder on an ambulatory basis
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Non-functional Device | Experimental | a non-functional UroMonitor will be inserted by urologist. Receives: Device: UroMonitor System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Symptoms During Implantation
11-point numerical visual analogue scale for the participant to document discomfort during the implantation of the UroMonitor.
Measured: Day 1 Timepoint: post insertion
Device Insertion Form for Urology Specialist
Study form registers the data on application of the device, such as the time and ease of insertion.
Measured: Day 1 Timepoint: post insertion
Participant Symptoms During 3-Hour Monitoring
Study form used for the purpose of registering data on details of participant symptoms during the 3-hour monitoring period
Measured: Day 1 Timepoint: 1 hr post insertion
Device Removal Form for Urology Specialist
Study form used for the purpose of recording the condition of the device and patient's experience at the time of sensor removal
Measured: Day 1 Timepoint: post device remove
Participant Symptoms during Device Removal Form
Data on details of patient symptoms during device removal is recorded with this form
Measured: Day 1 Timepoint: post device remove
Second Cystoscopy Form for Urology Specialist
This form is used for the purpose of recording the existence of irritation in bladder or urethra after the removal of the device
Measured: Day 1 Timepoint: post secondary cyctoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study startOct 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion15 Mar 2023 (estimated)
Why it stopped: Similar study already completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Brian Kwon, University of British Columbia
- Investigators
- Brian Kwon, MD, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800523
- Sponsor's protocol ID
- H20-01267
- Other IDs
- CDMRP-SC180061
- Status last verified
- Oct 2021
- First submitted
- 11 Mar 2021
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No