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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The "UroMonitor Trial": Safety, Feasibility, and Tolerability of UroMonitor Insertion in Spinal Cord Injury.
- ClinicalTrials.gov ID
- NCT04800523
- Acronym / sponsor ID
- H20-01267
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Similar study already completed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- United States Department of Defense, Congressionally Directed Medical Research Programs
- Study start
- Oct 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 15 Mar 2023 (estimated)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Non-functional Device | Experimental | Device: UroMonitor Systema non-functional UroMonitor will be inserted by urologist. |
Who may qualify
- Ages
- 17 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UroMonitor SystemImplantable device to wirelessly and without catheters monitor the neurogenic bladder on an ambulatory basis | Device | Arm 1 - Non-functional Device |
Primary outcome
Participant Symptoms During Implantation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
Related trials for Spinal Cord Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Kwon, MD, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UroMonitor System in people with Spinal Cord Injuries, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Symptoms During Implantation (time frame: Day 1 Timepoint: post insertion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.