"UroMonitor Trial" in Spinal Cord Injury.

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.

Study Overview

• Status: Withdrawn
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Device: UroMonitor System

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Vancouver General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 71 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 - Non-functional Device; a non-functional UroMonitor will be inserted by urologist.	Device: UroMonitor System; Implantable device to wirelessly and without catheters monitor the neurogenic bladder on an ambulatory basis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: United States Department of Defense

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): March 15, 2023

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 12, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: H20-01267

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No