Clinical Trial

Radio-frequency (RF) Bladder Monitor

Not Yet Recruiting
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Summary
The goal of this pilot feasibility study is to evaluate a wearable microwave (MW)-based bladder monitoring system in adult volunteers and those with spinal cord injury (SCI) who use self-catheterization for bladder management. The study aims to learn whether the device can monitor bladder filling and estimate bladder volume non-invasively. The main questions the study aims to answer are: 1. Can the MW-based monitoring system distinguish between non-full and full bladder states? 2. How accurately do MW-based bladder volume estimates agree with ultrasound bladder scans and voided urine volumes? 3. Is the wearable monitoring system feasible, comfortable, and usable for individuals with SCI? Participants will: 1. Complete questionnaires about bladder symptoms and quality of life 2. Wear up to six non-invasive MW sensors on the lower pelvic region 3. Undergo two bladder filling and voiding cycles during the study visit 4. Have MW measurements collected approximately every five minutes during bladder filling 5. Undergo ultrasound bladder scans and bladder volume measurements for comparison 6. Complete a post-study usability and comfort survey
Trial Details
NCT Number NCT07639541
Lead Sponsor McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators: Congressionally Directed Medical Research Programs
Conditions Spinal Cord Injuries (SCI), Neurogenic Lower Urinary Tract Dysfunction, Neurogenic Bladder (NB)
Enrollment 40 participants
Start Date 2026-07-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-10