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

摘要 进行尿动力学（UDS）评估以帮助诊断和治疗下尿路疾病患者 消化道功能障碍（LUTD）。虽然传统的UDS（cUDS）是目前的客观标准，但高达46%的 UDS评估无法复制患者的症状。这种失败主要是由于缺乏生理 研究本身的重要性。导尿管直肠导管膀胱逆行充盈 在压力-流量研究期间，研究中涉及的患者不适和焦虑都已确定 作为错误的来源，并混淆了cUDS的诊断准确性。因此，这项研究从根本上 由于技术的局限性而存在缺陷，并且仅在人工测量中提供膀胱性能的快照 控制设置。因此，临床上需要一种诊断研究，可以准确地再现患者的 症状，以识别逼尿肌活动不足的患者，并使泌尿科医生能够计划他们的治疗路径 相应地虽然门诊UDS（aUDS）已显示出希望，但泌尿和直肠的存在， 导管继续混淆系统的诊断能力。此外，允许自然填充 消除了临床医生精确监测膀胱中液体量的能力，这可能影响 这种方法的特殊性。虽然aUDS是对cUDS的改进，但由于 研究的复杂性、所需时间以及这些系统的技术故障率。因此 是一个明确的临床需要的无线，无导管的UDS，提供更生理相关和自然的 膀胱功能的评估。为了满足这一需求，Bright Uro开发了UroMonitor， 在更生理相关的条件下关于膀胱功能的分辨率信息，以更好地复制 患者症状，提高诊断准确性。UroMonitor已在两种临床前模型中进行了测试 和人类受试者，并在同时评估期间显示与cUDS的一致性为0.874， 准确度和精密度高。母公司第二阶段奖励的总体目标是证明安全性， 在一项严格的关键性研究中评估UroMonitor的临床可行性。在家长奖中，我们正在优化 UroMonitor包括压力传感，并改善器械性能以供临床使用（具体目标1）。 随后，我们将评估UroMonitor用于扩展泌尿外科监测的安全性和可行性， 家庭环境（具体目标2）。在本增刊中，我们指派了布列塔尼·卡特博士， 临床事务总监，该项目的临床研究管理角色，并将支持她 创业技能，最终使她能够在医疗行业的临床领导中发展自己的职业生涯。 设备启动空间。她将管理由PD/PI领导的临床研究，并指导Derek Herrera先生， 并执行临床策略和健康与经济学成果研究，以支持未来的商业化 泌尿监视器为布列塔尼拟定的工作将在母合同的总体范围内进行。

ABSTRACT Urodynamics (UDS) evaluations are conducted to aid in diagnosis and treatment of patients with Lower Urinary Tract Dysfunction (LUTD). Although conventional UDS (cUDS) is the current objective standard, up to 46% of UDS evaluations fail to replicate the patient’s symptoms. This failure is primarily due to the lack of physiological relevance of the study itself. The placement of a urinary catheter, a rectal catheter, retrograde filling of the bladder during pressure-flow studies, and the patient discomfort and anxiety involved in the study have all been identified as sources of error and have confounded the diagnostic accuracy of cUDS. Thus, the study is fundamentally flawed due to limitations of technology, and only provides a snapshot of bladder performance in an artificially controlled setting. Therefore, there is a clinical need for a diagnostic study that can accurately reproduce patient symptoms to identify patients with detrusor underactivity and enable Urologists to plan their treatment path accordingly. While ambulatory UDS (aUDS) has shown promise, the presence of both a urinary and rectal catheter continue to confound the diagnostic capabilities of the system. In addition, allowing for natural filling removes the clinician’s ability to precisely monitor the amount of fluid in the bladder, which can impact the specificity of this approach. While aUDS is an improvement over cUDS, it has not been widely adopted due to the complexity of the study, the time demand, and the technical failure rate of these systems. Therefore, there is a clear clinical need for a wireless, catheter-free UDS that provides a more physiologically relevant and natural assessment of bladder function. To address this need, Bright Uro has developed the UroMonitor to provide high- resolution information about bladder function under more physiologically relevant conditions to better replicate patient symptoms and improve diagnostic accuracy. The UroMonitor has been tested in both preclinical models and human subjects and has shown a concordance with cUDS during simultaneous assessment of 0.874, with high accuracy and precision. The overall goal of the parent Phase II award is to demonstrate the safety and clinical feasibility of the UroMonitor in a rigorous, pivotal study. In the parent award, we are optimizing the UroMonitor to include pressure sensing and improve device performance for clinical use (Specific Aim 1). Subsequently, we will evaluate the safety and feasibility of the UroMonitor for extended urological monitoring in the home environment (Specific Aim 2). In the present supplement, we have assigned Dr. Brittany Carter, Director of Clinical Affairs, a clinical research management role in the project and will support her entrepreneurship skills to ultimately allow her to advance her career in clinical leadership within the Medical Device startup space. She will manage the clinical study led by PD/PI and mentor Mr. Derek Herrera and develop and execute clinical strategies and health and economics outcomes research to support future commercialization of the UroMonitor. The proposed work for Brittany will be performed within the overall scope of the parent award.