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NCT Number: NCT04800523

"UroMonitor Trial" 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.

Why the study stopped: Similar study already completed
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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

17 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vancouver General Hospital

Vancouver, British Columbia, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

UroMonitor System

Device

Implantable device to wirelessly and without catheters monitor the neurogenic bladder on an ambulatory basis

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Congressionally Directed Medical Research Programs
  • United States Department of Defense

Registry information

Official study title

The "UroMonitor Trial": Safety, Feasibility, and Tolerability of UroMonitor Insertion in Spinal Cord Injury.

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 16, 2021
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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