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A tiny bladder sensor could one day replace catheters for people with spinal cord injury

NCT ID NCT04800523

Knowledge-focused Sponsor: University of British Columbia Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 23, 2026 · Last updated Sep 24, 2026 · Updated 1 time

Summary

Researchers at the University of British Columbia are studying whether a non-functioning version of the UroMonitor device can be safely inserted into the bladder, monitored for a few hours, and removed in people with spinal cord injury and neurogenic bladder. Participants are adults who are at least one year past a cervical or thoracolumbar injury and who use catheters or other bladder management. The team records discomfort during insertion, monitoring, and removal, and checks for irritation in the bladder or urethra afterward. The device does not measure bladder activity in this trial; the goal is to learn whether the procedure itself is tolerable and safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
UroMonitor System, an implantable bladder-monitoring device
What this could lead to
If the device proves safe to place and remove, it could point toward a future version that monitors bladder pressure wirelessly, without catheters.
What could go wrong
This is an early safety and feasibility study with a non-functioning device, so it cannot show whether monitoring actually helps. Insertion and removal involve cystoscopy, which carries risks of irritation, infection, or discomfort.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Expected to start

Oct 2021

An estimate. Start dates often move.

Expected to finish

Mar 2023

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

17 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

spinal cord injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Spinal cord injuries

Contacts and locations

Locations

  • Vancouver General Hospital

    Vancouver, British Columbia, Canada

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