Radio-frequency (RF) Bladder Monitor

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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

Eligibility

Primary outcome measure(s)

• Mean difference in microwave S-parameter magnitude between full and empty bladder states (dB) — Through study completion, an average of 4-8 hours
  Microwave S-parameter measurements collected during bladder filling and voiding cycles will be compared between empty and full bladder states. The outcome will be reported as the mean difference and standard deviation in S-parameter magnitude between full and empty bladder states across the measured frequency range, expressed in decibels (dB).
• Mean error of microwave-based bladder volume estimation (mL) relative to ultrasound bladder volume estimates and voided urine volume — Through study completion, an average of 4-8 hours
  Bladder volume estimates derived from microwave S-parameter measurements will be compared with ultrasound bladder volume estimates and voided urine volumes obtained during bladder filling and voiding cycles. The outcome will be reported as the mean difference and standard deviation between microwave-based bladder volume estimates and the corresponding reference measurements (mL).

Trial sites (1)

More McGill University Health Centre/Research Institute of the McGill University Health Centre trials in Canada

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