Radio-frequency (RF) Bladder Monitor
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
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:
- Can the MW-based monitoring system distinguish between non-full and full bladder states?
- How accurately do MW-based bladder volume estimates agree with ultrasound bladder scans and voided urine volumes?
- Is the wearable monitoring system feasible, comfortable, and usable for individuals with SCI?
Participants will:
- Complete questionnaires about bladder symptoms and quality of life
- Wear up to six non-invasive MW sensors on the lower pelvic region
- Undergo two bladder filling and voiding cycles during the study visit
- Have MW measurements collected approximately every five minutes during bladder filling
- Undergo ultrasound bladder scans and bladder volume measurements for comparison
- Complete a post-study usability and comfort survey
详细描述
Spinal cord injury (SCI) presents significant long-term challenges for affected individuals, among which bladder dysfunction is a leading concern. Neurogenic lower urinary tract dysfunction (NLUTD), commonly referred to as neurogenic bladder dysfunction, may result in urinary retention, incomplete bladder emptying, urinary incontinence, urinary tract infections (UTIs), bladder distension, urinary reflux, renal complications, and reduced quality of life. Current bladder management approaches, including clean intermittent catheterization (CIC), indwelling catheterization, and external collection methods, may be associated with substantial time burden, complications, excessive bladder filling or incomplete emptying, and poor adherence. Studies have also shown that improving bladder function remains one of the highest rehabilitation priorities among individuals with SCI.
This study investigates the feasibility of a wearable radio-frequency (RF)-based bladder monitor operating in the microwave (MW) frequency range for non-invasive bladder monitoring and bladder volume estimation. The proposed system is intended to measure and track bladder volume and may ultimately support future development of discreet alerts indicating when the bladder is appropriately full and it is time to void. RF/MW sensing approaches provide several potential advantages for bladder monitoring applications because they are non-invasive, low-cost, safe for repeated use within established exposure limits, and compatible with wearable device designs.
Previous computational and experimental studies investigating RF/MW approaches for bladder-state detection have demonstrated proof-of-concept feasibility; however, many earlier studies relied on simplified anatomical models and limited experimental conditions. More recent work by the investigators demonstrated bladder-state discrimination using realistic anatomical pelvic models and preliminary measurements in healthy volunteers. This study includes measurements in both healthy volunteers and individuals with SCI who self-catheterize.
The objectives of the study are:
i) to provide a clinical proof-of-concept demonstration of MW bladder monitoring and bladder volume quantification; and ii) to provide data regarding the short-term functionality, utility, and comfort of the wearable MW bladder monitoring prototype.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究者
Emily Porter
Scientist
McGill University Health Centre/Research Institute of the McGill University Health Centre
