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Similar study already completed
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Non-functional Device | Experimental | a non-functional UroMonitor will be inserted by urologist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UroMonitor System | Device | Implantable device to wirelessly and without catheters monitor the neurogenic bladder on an ambulatory basis |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Kwon, MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver General Hospital | Vancouver | British Columbia | Canada |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| D014947 | Wounds and Injuries |