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Radio-frequency (RF) Bladder Monitor

NCT07639541 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-06-10

No results posted yet for this study

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

Conditions

  • Spinal Cord Injuries (SCI)
  • Neurogenic Lower Urinary Tract Dysfunction
  • Neurogenic Bladder (NB)

Interventions

DEVICE

Wearable microwave Bladder Monitoring System

The investigational device is a non-invasive wearable microwave (MW) bladder monitoring system designed to monitor bladder filling and estimate bladder volume. The system uses low-power radio-frequency (RF) signals and externally applied sensors positioned over the lower pelvic region to collect electromagnetic measurements associated with bladder filling. Measurements will be collected approximately every five minutes during natural bladder filling cycles. The device is intended for investigational use only and does not provide therapeutic intervention or automated clinical decision-making.

Sponsors & Collaborators

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    lead OTHER

Principal Investigators

  • Emily Porter, Ph.D. · McGill University

  • Lysanne Campeau, Ph.D. · McGill University

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2026-12-31
Completion
2027-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07639541 on ClinicalTrials.gov