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"UroMonitor Trial" in Spinal Cord Injury.

NCT ID: NCT04800523

Last Updated: 2021-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-31

Study Completion Date

2023-03-15

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

Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Arm 1 - Non-functional Device

a non-functional UroMonitor will be inserted by urologist.

Group Type EXPERIMENTAL

UroMonitor System

Intervention Type DEVICE

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

Interventions

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UroMonitor System

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Brian Kwon

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brian Kwon, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H20-01267

Identifier Type: -

Identifier Source: org_study_id