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 尿失禁和空隙功能障碍在世界范围内高度普遍，并引起污名和 有害的心理和身体影响。几种治疗是可能的，但它们有副作用，不起作用 对于所有个人，患者之间的循环。因此，鉴别诊断对高效和 适当治疗这些常见条件。弹性评估膀胱的黄金标准方法 较低的尿路功能是尿动力学，这是一种基于诊所的测试，其中导管插入膀胱 通过尿道。测量膀胱压力并报告患者报告时，将液体泵入膀胱中 感觉。在多达一半的患者中，尿动力学无法再现患者的投诉。因此，新的 需要提供客观，描述性测量的尿功能障碍的设备以提供改进的设备 诊断和帮助个性化治疗。由于尿失禁是特定于患者的，部分行为，因此 需要在患者家庭环境中进行定量客观监测。我们正在开发uromonitor， 一种无线，无导管的方法，用于监测家里的膀胱功能，就像一台Holter Monitor 心。这项研究的目的是证明无线无导管的尿液剂可以安全和 自然填充周期中膀胱功能的有效表征。目前，泌尿诺诺机可以传输 女性膀胱压力，但不能测量膀胱体积。它不能用作当前的人 插入工具没有Coude提示。这是该项目中提出的研究分为以下 5个里程碑。里程碑1。为uromonitor发展准确的体积和浓度感测和成就 通过满足设计规范来设计最终确定；里程碑2。开发可靠的蓝牙继电器原型 加速度计数据以纠正由于位置变化而导致的压力和音量测量的变化，并且 移动和电话应用程序用于临床接口；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。确认足够的耐用性和在 雄性和雌性猪和单通道截然压力估计；里程碑5。验证插入，提取， 在男性和女性的急性临床研究中，尿液核的表现是一种无关紧要的风险装置； 里程碑6。准备与FDA的易ID前会议。在项目完成时，我们将为确定的临床准备 试验在家中测试乌马诺菌。这种范式移动系统将使较低的诊断能够改进 尿路功能障碍和尿失禁以及个性化治疗和治疗的客观验证 有效性，实现基于非卧床的治疗和临床指南的“临床医生” 在家庭环境中的数据。