"UroMonitor Trial" in Spinal Cord Injury.

University of British Columbia

Overview

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

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

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Conditions

Spinal Cord Injuries

Interventions

UroMonitor SystemDEVICE

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

Eligibility

Sex: ALLMin age: 17 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Vancouver General Hospital

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

Participant Symptoms During Implantation

11-point numerical visual analogue scale for the participant to document discomfort during the implantation of the UroMonitor.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Day 1 Timepoint: post secondary cyctoscopy

Data from ClinicalTrials.gov

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