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

项目摘要/摘要 该第二阶段SBIR提案的主要目标是开发符合ISO-13485标准的尿液监测仪(UM 并在临床可行性研究中评估UM的安全性和可行性。 尿流动力学评估有助于下尿路疾病的诊断和治疗 症状(LUT)。这项评估通过测量膀胱内的压力和容量来确定膀胱的特征 表现，并告知关于适当疗程的决定。在许多情况下，尿动力学 评估未能再现患者的症状，这限制了有效性。发生这种情况的一个主要原因是 因为这项测试要求患者保持静止，并使用导尿管人工填充膀胱。明亮的尿路 已经开发出一种无线和无导管的动态尿流监测方法。我们 相信这将导致更准确、更全面的评估，从而改善 患者、临床医生和付款人。 Bright Uro将UM开发为一个无线传感平台，用于家庭中扩展的泌尿系统监测 环境。UM可以在膀胱中保留长达7天，并记录压力和容量。什么时候 综合排尿日记、尿流率和其他生理数据，UM将提供最多 临床医生可获得全面的尿流动力学报告。UM系统利用前景看好的临床结果 从最近在克利夫兰诊所完成的第一项女性临床研究开始。这为我们的 建议的临床可行性研究，我们将评估UM的安全性和可行性 在家庭环境中的句号。 这项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将为后续研究做好准备，包括潜在的IIB阶段应用和更大的关键研究 具有更大的统计能力。我们的目标是将UM推向市场，在那里它可以彻底改变 进行尿动力学评估，显著改善患者、临床医生和支付者的预后。

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.