"UroMonitor Trial" in Spinal Cord Injury.

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04800523
• Other study ID #: H20-01267
• Status: Withdrawn
• Phase: N/A
• Start date: October 2021
• Est. completion date: March 15, 2023

Study information

• Verified date: October 2021
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to determine if a non-functioning UroMonitor device can be safely inserted, monitored, and removed in patients with SCI.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 15, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Device:
• UroMonitor System
Implantable device to wirelessly and without catheters monitor the neurogenic bladder on an ambulatory basis

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	United States Department of Defense

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Symptoms During Implantation	11-point numerical visual analogue scale for the participant to document discomfort during the implantation of the UroMonitor.	Day 1 Timepoint: post insertion
Primary	Device Insertion Form for Urology Specialist	Study form registers the data on application of the device, such as the time and ease of insertion.	Day 1 Timepoint: post insertion
Primary	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	Day 1 Timepoint: 1 hr post insertion
Primary	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	Day 1 Timepoint: post device remove
Primary	Participant Symptoms during Device Removal Form	Data on details of patient symptoms during device removal is recorded with this form	Day 1 Timepoint: post device remove
Primary	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	Day 1 Timepoint: post secondary cyctoscopy