UroMonitor Trial in Spinal Cord Injury.

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

Detailed Description
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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

Official Title
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The UroMonitor Trial: Safety, Feasibility, and Tolerability of UroMonitor Insertion in Spinal Cord Injury.

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Device: UroMonitor System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |