The UroMonitor: Innovative Technology to Improve Management of Bladder Dysfunction

UroMonitor：改善膀胱功能障碍管理的创新技术

• 批准号: 10426506
• 负责人: MARGOT S. DAMASER
• 金额: $ 94.88万
• 依托单位: CLEVELAND CLINIC LERNER COM-CWRU
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10426506
• 关键词: Accelerometer; Acute; Agreement; Algorithms; Animal Experimentation; Awareness; Behavioral; Bladder; Bladder Dysfunction; Bluetooth; Cadaver; Catheters; Clinic; Clinical; Clinical Research; Clinical Trials; Computer software; Data; Databases; Development; Devices; Diagnosis; Differential Diagnosis; Electrodes; Electronics; Engineering; Environment; Esthesia; Event; Excision; Exercise; Family suidae; Female; Fortune; Freezing; Functional disorder; Future; Goals; Gold; Guidelines; Heart; Holter Electrocardiography; Home; Home environment; Hour; Human; Incontinence; Joints; Laboratories; Legal patent; Liquid substance; Longevity; Lower urinary tract; Measurement; Measures; Methods; Modeling; Molds; Monitor; Morbidity - disease rate; Motion; Movement; Nursing Homes; Operative Surgical Procedures; Overactive Bladder; Patient Outcomes Assessments; Patients; Pelvic floor structure; Performance; Pharmaceutical Preparations; Physicians; Physiology; Population; Positioning Attribute; Pre-Clinical Model; Prevalence; Privacy; Psyche structure; Pump; Records; Recurrence; Research; Risk; Sampling; Stigmatization; Study Subject; Symptoms; System; Telephone; Testing; Translating; Treatment Effectiveness; Urethra; Urinary Incontinence; Urodynamics; Urology; Validation; Wireless Technology; Woman; Work; Writing; base; biomaterial compatibility; common treatment; data exchange; design; digital; experience; heart function; human female; human subject; improved; individual patient; individualized medicine; innovative technologies; male; meetings; men; mortality; neuroregulation; pressure; prevent; prototype; sex; side effect; social stigma; tool; treatment planning; urinary; urologic; user-friendly

SUMMARY Urinary incontinence and voiding dysfunction are highly prevalent worldwide and result in stigma and detrimental mental and physical effects. Several treatments are possible but they have side effects, don't work for all individuals, and patients cycle between them. Therefore differential diagnosis is critical to efficient and appropriate treatment of these common conditions. The gold standard method of objectively evaluating bladder and lower urinary tract function is Urodynamics, a clinic-based test in which a catheter is inserted into the bladder via the urethra. Fluid is pumped into the bladder while bladder pressure is measured & the patient reports sensations. In up to half of patients, Urodynamics is not able to reproduce patients complaints. Therefore, new devices to provide objective, descriptive measurements of urinary dysfunction are needed to provide improved diagnosis & aid in individualizing therapy. Since incontinence is patient-specific and in part behavioral, quantitative objective monitoring in a patient's home environment is needed. We are developing the UroMonitor, a wireless, catheter-free approach for monitoring bladder function at home, much like a Holter monitor for the heart. The Goal of this study is to demonstrate that the wireless, catheter-free UroMonitor allows safe and effective characterization of bladder function during natural filling cycles. Currently the UroMonitor can transmit bladder pressure in women but it does not measure bladder volume. It cannot be used in men as the current insertion tool does not have a Coude tip. Thus, the research proposed in this project is divided into the following 5 Milestones. Milestone 1. Develop accurate volume & concentration sensing for the UroMonitor and achieve design finalization by meeting design specifications; Milestone 2. Develop reliable Bluetooth relay prototype with accelerometry data to correct pressure and volume measurement changes due to position changes and movement and phone app for clinician interface; Milestone 3. Design and validate an easy-to-use insertion tool suitable for males and females; Milestone 4. Confirm sufficient durability and performance of the UroMonitor in male and female swine & single channel detrusor pressure estimation; Milestone 5. Verify insertion, extraction, and performance of UroMonitor in an acute clinical study of men and women as a nonsignificant risk device; Milestone 6. Prepare for Pre-IDE meeting with FDA. At project completion we will be ready for definitive clinical trials testing the UroMonitor at home. This paradigm-shifting system will enable improved diagnoses of lower urinary tract dysfunction and incontinence as well as individualized therapy and objective validation of treatment effectiveness, enabling a “clinician in the loop” model of therapy and clinical guidelines based on ambulatory data in the home environment.

总结 尿失禁和排尿功能障碍在世界范围内非常普遍，并导致耻辱感， 有害的精神和身体影响。有几种治疗方法是可行的，但它们有副作用，不起作用 所有的个体，病人在他们之间循环。因此，鉴别诊断是至关重要的， 对这些常见病的正确治疗。客观评价膀胱功能的金标准法 下尿路功能是尿动力学，一种基于临床的测试，其中将导管插入膀胱 通过尿道液体被泵入膀胱，同时测量膀胱压力&病人报告 感觉在多达一半的患者中，尿动力学无法重现患者的投诉。因此，新 需要提供泌尿功能障碍的客观、描述性测量的装置 诊断和帮助个性化治疗。由于尿失禁是患者特异性的，部分是行为性的， 需要在患者的家庭环境中进行定量客观监测。我们正在开发尿监测器， 一种在家中监测膀胱功能的无线无导管方法，就像霍尔特监测仪一样， 心本研究的目的是证明无线无导管UroMonitor可以安全且 在自然充盈周期期间有效表征膀胱功能。目前UroMonitor可以传输 女性的膀胱压力，但它不能测量膀胱容量。它不能像电流一样用于男性 插入工具没有Coude头端。因此，本项目提出的研究分为以下几个方面 五百万。里程碑1.为UroMonitor开发精确的体积和浓度传感，并实现 通过满足设计规范完成设计;里程碑2。开发可靠的蓝牙中继原型， 加速度测量数据，以校正由于位置变化引起的压力和体积测量变化， 用于临床医生界面的移动和电话应用程序;里程碑3。设计并验证易于使用的插入工具 适合男性和女性;里程碑4。确认UroMonitor的足够耐用性和性能， 雄性和雌性猪&单通道逼尿肌压力估计;里程碑5。验证插入、拔出， UroMonitor作为非重大风险器械在男性和女性急性临床研究中的性能; 里程碑6.准备与FDA的IDE前会议。在项目完成后，我们将准备进行最终的临床试验。 在家中测试UroMonitor。这种范式转换系统将能够改善对低血糖的诊断。 尿路功能障碍和尿失禁以及个体化治疗和治疗的客观验证 有效性，实现“临床医生在环”的治疗模式和基于门诊的临床指南 家庭环境中的数据。