Clinical Feasibility of Wireless Catheter-Free Urodynamics for Extended, Comprehensive Urological Evaluation in the Home Setting

无线无导管尿动力学在家庭环境中进行扩展、综合泌尿外科评估的临床可行性

• 批准号: 10384381
• 负责人: Derek Herrera
• 金额: $ 100万
• 依托单位: BRIGHT URO, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-23 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10384381
• 关键词: Address; Anesthesia procedures; Bladder; Calibration; Catheters; Clinic; Clinical; Clinical Research; Data; Data Analyses; Data Collection; Data Set; Development; Device Safety; Devices; Diagnosis; Effectiveness; Ensure; Equipment; Equipment and supply inventories; Evaluation; Excision; Feasibility Studies; Foundations; Functional disorder; Future; Generations; Goals; Health system; Home; Home environment; Human; Human Resources; Incontinence; Institutional Review Boards; Knowledge; Lidocaine; Life Style; Lower urinary tract; Maintenance; Manufacturer Name; Manuscripts; Measures; Methods; Monitor; Nocturia; Pain; Patient-Focused Outcomes; Patients; Performance; Phase; Physiological; Posture; Preparation; Publications; Rectum; Rehabilitation Centers; Reporting; Research; Risk; Safety; Site; Small Business Innovation Research Grant; Sterilization; Symptoms; System; Testing; Time; Update; Urethra; Urodynamics; Urologist; Urology; Vagina; Wireless Technology; Woman; algorithm development; arm; biomaterial compatibility; clinical decision-making; clinical research site; data streams; design; diagnosis standard; diaries; fitbit; improved; improved outcome; innovation; insight; invention; lower urinary tract symptoms; novel; patient population; patient tolerability; pressure; product development; prospective; safety and feasibility; smart watch; treatment optimization; urologic

PROJECT SUMMARY/ABSTRACT The primary objectives of this Phase II SBIR Proposal are to develop the UroMonitor (UM) with an ISO-13485 certified manufacturer and evaluate the safety and feasibility of the UM in a Clinical Feasibility Study. Urodynamics evaluations are conducted to aid in diagnosis and treatment of patients with Lower Urinary Tract Symptoms (LUTS). This evaluation measures the pressure and volume in the bladder to characterize bladder performance and inform decisions regarding the appropriate course of treatment. In many cases, Urodynamics evaluations fail to reproduce patient symptoms, which limit effectiveness. One major reason this occurs is because the test requires patients to remain static and artificially fill their bladders using catheters. Bright Uro has developed a method to conduct Ambulatory Urodynamic Monitoring that is wireless and catheter-free. We are confident this will result in more accurate, more comprehensive evaluations that improve outcomes for patients, clinicians and payers. Bright Uro has developed the UM as a wireless sensing platform for extended urological monitoring in the home environment. The UM can remain in the bladder for up to 7 days and record pressure and volume. When synthesized with a Voiding Diary, Uroflowmetry, and other physiological data, the UM will provide the most comprehensive Urodynamic report available to clinicians. The UM system leverages promising clinical results from a First in Woman clinical study recently completed at the Cleveland Clinic. This lays the foundation for our proposed Clinical Feasibility Study where we will evaluate the safety and feasibility of the UM for an extended period in the home setting. Data collected from this study will provide valuable insight and inform future clinical studies. If successful, the UM will be postured for follow-on studies including a potential Phase IIB application and a larger pivotal study with greater statistical power. Our goal is to bring the UM to market where it could revolutionize the way Urodynamics evaluations are conducted and significantly improve outcomes for patients, clinicians, and payers.

项目总结/摘要 本阶段II SBIR提案的主要目标是开发符合ISO-13485标准的UroMonitor（UM） 在临床可行性研究中评估UM的安全性和可行性。 进行尿动力学评价以帮助下尿路患者的诊断和治疗 症状（LUTS）。该评估测量膀胱中的压力和体积以表征膀胱 性能和通知有关适当的治疗过程的决定。在许多情况下，尿动力学 评估不能再现患者症状，这限制了有效性。发生这种情况的一个主要原因是 因为这项测试需要病人保持静止，并用导管人工填充膀胱。明亮的乌罗 已经开发出一种方法来进行无线和无导管的动态尿动力学监测。我们 我们相信，这将导致更准确，更全面的评价，改善成果， 患者、临床医生和付款人。 Bright Uro开发了UM作为家庭扩展泌尿监测的无线传感平台 环境UM可以在膀胱中保留长达7天，并记录压力和容量。当 结合排尿日记、尿流率和其他生理数据，UM将提供最多的 为临床医生提供全面的尿动力学报告。UM系统利用有前景的临床结果 来自克利夫兰诊所最近完成的一项首次女性临床研究。这为我们的 拟议的临床可行性研究，我们将在其中评估UM用于扩展的安全性和可行性 在家庭环境中。 本研究收集的数据将提供有价值的见解，并为未来的临床研究提供信息。如果成功，则 UM将用于后续研究，包括潜在的IIB期申请和更大的关键性研究 更大的统计力量。我们的目标是将UM推向市场， 进行尿动力学评价，并显著改善患者、临床医生和付款人的结局。