"UroMonitor Trial" in Spinal Cord Injury.

NCT04800523 | Withdrawn

• 1 other identifier: H20-01267
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Arm 1 - Non-functional Device

EXPERIMENTAL

a non-functional UroMonitor will be inserted by urologist.

Device: UroMonitor System

Interventions

UroMonitor System DEVICE

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

Arm 1 - Non-functional Device

Eligibility Criteria

• Age: 17 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• United States Department of Defense: collaborator

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Brian Kwon, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 16, 2021
• Study Start: October 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 15, 2023
• Last Updated: October 28, 2021

Record last verified: 2021-10

Locations

CA (1)