"UroMonitor Trial" in Spinal Cord Injury.

Not Applicable

Withdrawn

• Conditions: Spinal Cord Injuries
• Interventions: Device: UroMonitor System

• Registration Number: NCT04800523
• Lead Sponsor: University of British Columbia

Brief Summary

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 Timeline

• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-03-12
• Study First Posted: 2021-03-16
• Status Verified: 2021-10
• Study Start: 2021-10
• Last Update Submitted: 2021-10-20
• Last Update Posted: 2021-10-28
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1 - Non-functional Device	UroMonitor System	a non-functional UroMonitor will be inserted by urologist.

Primary Outcome Measures

Name	Time	Method
Device Insertion Form for Urology Specialist	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 Implantation	Day 1 Timepoint: post insertion	11-point numerical visual analogue scale for the participant to document discomfort during the implantation of the UroMonitor.
Device Removal Form for Urology Specialist	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 3-Hour Monitoring	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
Participant Symptoms during Device Removal Form	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	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

Trial Locations

Locations (1)

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada