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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04800523
Other study ID # H20-01267
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 2021
Est. completion date March 15, 2023

Study information

Verified date October 2021
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 15, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 17 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
UroMonitor System
Implantable device to wirelessly and without catheters monitor the neurogenic bladder on an ambulatory basis

Locations

Country Name City State
Canada Vancouver General Hospital Vancouver British Columbia

Sponsors (2)

Lead Sponsor Collaborator
University of British Columbia United States Department of Defense

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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