About this trial
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
Eligibility criteria
Qualifiers
Age > 18
Able/willing to sit (or stand) in place for the time it takes for bladder to fill once.
No implanted devices
Able to toilet/void independently
Disqualifiers
Age < 18
Implanted devices (e.g., pacemakers)
Unable to toilet without assistance
Unable to stay relatively still for the time it takes bladder to fill once
Trial design
Treatments tested in this trial
- Wearable microwave Bladder Monitoring System
Treatment groups
Sponsors and collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator