NCT04800523

"UroMonitor Trial" in Spinal Cord Injury.

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 17 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
DEVICE	UroMonitor System	Implantable device to wirelessly and without catheters monitor the neurogenic bladder on an ambulatory basis

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-12-31
• Completion: 2023-03-15
• First posted: 2021-03-16
• Last updated: 2021-10-28

Locations

1 site across 1 country: Canada