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.

概括 尿失禁和排尿功能障碍在世界范围内非常普遍，并导致耻辱和排尿障碍。 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 对于所有个人和患者来说，他们之间循环。因此，鉴别诊断对于高效、准确地诊断至关重要。 对这些常见病症进行适当的治疗。客观评价膀胱的金标准方法 下尿路功能是尿动力学，这是一项基于临床的测试，其中将导管插入膀胱 通过尿道。将液体泵入膀胱，同时测量膀胱压力并由患者报告 感觉。在多达一半的患者中，尿动力学无法重现患者的抱怨。因此，新 需要能够提供客观、描述性测量泌尿功能障碍的设备来提供改进的 诊断和帮助个体化治疗。由于失禁是因患者而异且部分是行为原因， 需要对患者家庭环境进行定量客观监测。我们正在开发 UroMonitor， 一种无线、无导管的方法，用于在家监测膀胱功能，就像动态心电图监测仪一样 心。这项研究的目标是证明无线、无导管 UroMonitor 可以安全、可靠地 自然充盈周期期间膀胱功能的有效表征。目前 UroMonitor 可以传输 女性膀胱压力，但不能测量膀胱容量。它不能用于男性，因为目前 插入工具没有 Coude 尖端。因此，本项目提出的研究分为以下几个部分 5 个里程碑。里程碑 1. 为 UroMonitor 开发精确的体积和浓度传感并实现 通过满足设计规范来完成设计；里程碑 2. 开发可靠的蓝牙中继原型 加速度测量数据可纠正由于位置变化而引起的压力和体积测量变化 用于临床医生界面的运动和手机应用程序；里程碑 3. 设计和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 具有足够的耐用性和性能 雄性和雌性猪以及单通道逼尿肌压力估计；里程碑 5. 验证插入、拔出、 UroMonitor 作为一种非显着风险设备在针对男性和女性的急性临床研究中的表现； 里程碑 6. 准备与 FDA 举行的 Pre-IDE 会议。项目完成后，我们将为最终的临床做好准备 在家测试 UroMonitor 的试验。这种范式转换系统将能够改善较低水平的诊断 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，实现基于门诊的“临床医生循环”治疗模式和临床指南 家庭环境中的数据。