Radio-frequency (RF) Bladder Monitor

NCT07639541 | Not Yet Recruiting

• 2 other identifiers: 2025-10205CDMRP-SC240005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 1.Can the MW-based monitoring system distinguish between non-full and full bladder states?
2. 2.How accurately do MW-based bladder volume estimates agree with ultrasound bladder scans and voided urine volumes?
3. 3.Is the wearable monitoring system feasible, comfortable, and usable for individuals with SCI?
4. 4.Complete questionnaires about bladder symptoms and quality of life
5. 5.Wear up to six non-invasive MW sensors on the lower pelvic region
6. 6.Undergo two bladder filling and voiding cycles during the study visit
7. 7.Have MW measurements collected approximately every five minutes during bladder filling
8. 8.Undergo ultrasound bladder scans and bladder volume measurements for comparison
9. 9.Complete a post-study usability and comfort survey

Conditions

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

Keywords

Spinal Cord Injury; Neurogenic Bladder; Neurogenic Lower Urinary Tract Dysfunction; Bladder Monitoring; Bladder Management; Microwave Sensing; Radio-Frequency Sensing; Wearable Medical Device; Bladder Fullness Detection; Bladder Volume Estimation; Non-Invasive Monitoring; Assistive Technology; Pilot Feasibility Study; Urology

Outcome Measures

Primary Outcomes (2)

• Mean difference in microwave S-parameter magnitude between full and empty bladder states (dB)

  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).

  Through study completion, an average of 4-8 hours

• Mean error of microwave-based bladder volume estimation (mL) relative to ultrasound bladder volume estimates and voided urine volume

  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).

  Through study completion, an average of 4-8 hours

Secondary Outcomes (2)

• Total score on the investigator-developed post-participation bladder monitor questionnaire

  Day 1

• Frequency points exhibiting the greatest difference in microwave S-parameter magnitude between full and empty bladder states (MHz)

  Through study completion, an average of 4-8 hours

Study Arms (1)

Microwave Bladder Monitoring in Individuals with Spinal Cord Injury

EXPERIMENTAL

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.

Device: Wearable microwave Bladder Monitoring System

Interventions

Wearable microwave Bladder Monitoring System DEVICE

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.

Microwave Bladder Monitoring in Individuals with Spinal Cord Injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• No pregnancy

You may not qualify if:

• 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
• Pregnancy

Sponsors & Collaborators

• Congressionally Directed Medical Research Programs: collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Centre for Innovative Medicine (CIM) - McGill University Health Centre (MUHC)

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (4)

• A. Farshkaran and E. Porter, "Importance of Sex-Based Modelling of the Pelvic Region for Microwave Medical Applications," 2022 IEEE MTT-S International Microwave Biomedical Conference (IMBioC), Suzhou, China, 2022, pp. 1-3, doi: 10.1109/IMBioC52515.2022.9790287. keywords: {Microwave technology;Biomedical equipment;Biological system modeling;Conferences;Scattering;Medical services;Physiology;bladder;microwave medical applications;pelvic region}

  BACKGROUND

• A. Raterink, A. Farshkaran and E. Porter, "Microwave Reflection-based Bladder State Discrimination with Realistic Pelvic Models: Impact of Urine Conductivity and Volume," 2021 IEEE MTT-S International Microwave and RF Conference (IMARC), KANPUR, India, 2021, pp. 1-4, doi: 10.1109/IMaRC49196.2021.9714587. keywords: {Microwave antennas;Solid modeling;Shape;Bladder;Conductivity;Microwave theory and techniques;Dielectrics;bladder;microwave imaging;pelvic region model.}

  BACKGROUND

• E. Porter, A. Raterink and A. Farshkaran, "Microwave-Based Detection of the Bladder State as a Support Tool for Urinary Incontinence [Bioelectromagnetics]," in IEEE Antennas and Propagation Magazine, vol. 64, no. 1, pp. 112-122, Feb. 2022, doi: 10.1109/MAP.2021.3129687. keywords: {Wireless communication;Ultrasonic imaging;Magnetic resonance imaging;Computed tomography;Wearable computers;Microwave devices;Monitoring}

  BACKGROUND

• Farshkaran A, Fry A, Raterink A, Santorelli A, Porter E. Proof-of-Concept of Microwave-Based Bladder State Detection Using Realistic Pelvic Models. IEEE Open J Eng Med Biol. 2023 Aug 16;5:140-147. doi: 10.1109/OJEMB.2023.3305838. eCollection 2024.

  PMID: 38445237 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emily Porter, Ph.D.

  McGill University

  PRINCIPAL INVESTIGATOR

• Lysanne Campeau, Ph.D.

  McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Porter, Ph.D.

CONTACT

514-934-1934; emily.porter@mcgill.ca

Lysanne Campeau, Ph.D.

CONTACT

514-340-8222; lysanne.campeau@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Model Details: The study will include 40 participants: 20 healthy volunteers and 20 patients. All participants will undergo the same protocol.

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)