Wearable Bladder Monitor for Neurogenic Bladder
What You Need to Know Before You Apply
What is the purpose of 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
Who Is on the Research Team?
Emily Porter, Ph.D.
Principal Investigator
McGill University
Lysanne Campeau, Ph.D.
Principal Investigator
McGill University
Are You a Good Fit for This Trial?
This trial is for adults, including those with spinal cord injury who manage their bladder using self-catheterization. Participants should be able to complete study procedures and questionnaires. People with conditions that prevent safe participation may not be eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Study Visit
Participants undergo two bladder filling and voiding cycles with MW measurements
Data Analysis
Collected MW measurement data will be analyzed to investigate signal trends and feasibility
Follow-up
Participants are monitored for safety and effectiveness after the study visit
What Are the Treatments Tested in This Trial?
Interventions
- Wearable microwave Bladder Monitoring System
Trial Overview
The study is testing a wearable device that uses microwave sensors placed on the lower abdomen to monitor how full the bladder is. The device's accuracy and comfort are compared to standard ultrasound scans during two cycles of filling and emptying the bladder.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Healthy participants and participants with spinal cord injury (SCI) who use self-catheterization for bladder management will undergo non-invasive microwave (MW)-based bladder monitoring during two bladder filling and voiding cycles. Up to six externally applied MW sensors will be positioned over the lower pelvic region to collect measurements associated with bladder filling. Measurements will be acquired approximately every five minutes while the bladder fills naturally. Ultrasound bladder scans and voided urine volumes will be used as reference measurements for bladder volume estimation and bladder fullness assessment. The study will evaluate the feasibility, usability, comfort, and preliminary performance of the wearable MW bladder monitoring system in both healthy participants and individuals with SCI.
Find a Clinic Near You
Who Is Running the Clinical Trial?
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead Sponsor
Congressionally Directed Medical Research Programs
Collaborator
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