Back to results"UroMonitor Trial" in Spinal Cord Injury.
Primary Purpose
Spinal Cord Injuries
Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
UroMonitor System
Sponsored by
About this trial
This is an interventional device feasibility trial for Spinal Cord Injuries
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Vancouver General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1 - Non-functional Device
Arm Description
a non-functional UroMonitor will be inserted by urologist.
Outcomes
Primary Outcome Measures
Participant Symptoms During Implantation
11-point numerical visual analogue scale for the participant to document discomfort during the implantation of the UroMonitor.
Device Insertion Form for Urology Specialist
Study form registers the data on application of the device, such as the time and ease of 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
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
Participant Symptoms during Device Removal Form
Data on details of patient symptoms during device removal is recorded with this form
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04800523
First Posted
March 11, 2021
Last Updated
October 20, 2021
Sponsor
University of British Columbia
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT04800523
Brief Title
"UroMonitor Trial" in Spinal Cord Injury.
Official Title
The "UroMonitor Trial": Safety, Feasibility, and Tolerability of UroMonitor Insertion in Spinal Cord Injury.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Similar study already completed
Study Start Date
October 2021 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
March 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
United States Department of Defense
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1 - Non-functional Device
Arm Type
Experimental
Arm Description
a non-functional UroMonitor will be inserted by urologist.
Intervention Type
Device
Intervention Name(s)
UroMonitor System
Intervention Description
Implantable device to wirelessly and without catheters monitor the neurogenic bladder on an ambulatory basis
Primary Outcome Measure Information:
Title
Participant Symptoms During Implantation
Description
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
Title
Device Insertion Form for Urology Specialist
Description
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
Title
Participant Symptoms During 3-Hour Monitoring
Description
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
Title
Device Removal Form for Urology Specialist
Description
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
Title
Participant Symptoms during Device Removal Form
Description
Data on details of patient symptoms during device removal is recorded with this form
Time Frame
Day 1 Timepoint: post device remove
Title
Second Cystoscopy Form for Urology Specialist
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Kwon, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
"UroMonitor Trial" in Spinal Cord Injury.
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