Stream Dx: Point of Care Cellular Enabled IoT Communication Hub for Improved Diagnosis, Monitoring, and Post-Treatment Evaluation of LUTS

项目概要/摘要- STREAM DX 下尿路症状（LUTS）是老年男性中最常见的医学问题之一， 33%的男性到50岁时，75%的男性到80岁时。LUTS是一个 进行性疾病，已被证明会显着增加抑郁症的风险，降低生活质量。 早期发现，干预和积极管理是成功治疗LUTS的关键。尿流率是 在诊断、监测和治疗后评估男性下尿路症状中的一种重要且普遍存在的检测。 尿流量计是收集完整的尿液，然后生成表征尿流率的图表的设备。 空隙的体积和流速模式。从这些图中，医生应该能够识别峰值 尿流（Qmax），其是预测患者的尿流是否被阻塞的最佳单一量度。 然而，有严重的局限性和固有的缺陷，在临床上进行尿流率测试。第一，拥有 患者在人工和不熟悉的诊所环境中排尿，导致与 让他们在家里作废第二，临床试验导致大量无法解释的空隙， 病人在不熟悉的环境下无法充分排尿无法解释的空隙不能由护理提供者计费， 在诊所中试图收集这些数据所花费的时间被浪费了，这给患者和医生带来了挫折感。 临床医生第三，残疾人、农村和老年患者往往难以到达医生办公室 进一步加剧了测试过程。Stream Dx，Inc.已经开发出一种低成本，临床上精确的电子 家用流量计，SDX 01。该设备已获得专利，在FDA注册，并已推出 到市场。这是一个早期阶段的尿流计，准确地产生相同的体积和流量数据 其由诊所内尿流计收集，但可以在存储器中存储多天的患者排泄数据。 SDX 01收集每个空隙的数据，然后由患者或Stream Dx上传到公司的 基于Web的门户网站，供临床医生查看。临床医生可以立即直接与 病人在此IIb期提案中，Stream Dx将显著改进产品并降低成本， 保持临床准确性。我们希望通过增加液体消耗以及 收集额外的尿流数据。我们将把数据传输迁移到支持无线蜂窝的物联网 通过蓝牙5.0的通信集线器。用于对患者数据的真实的实时访问。这些是无刺激性的 改进和关键，以确保患者可用性和结果，最大限度地提高临床医生的时间和患者 相互作用，最终产生黄金标准产品。今天，没有一个现有的设备或应用程序在这方面， 区域重点监测液体摄入与尿液流出的关系，向患者提供通知， 提高患者依从性，提供医生警报或可以在将来收集尿液分析或其他生理数据 应用.当第IIb阶段完成后，Stream Dx的SDX 01将成为监测的黄金标准 和LUTS的治疗，并整合到整个美国的市场。

PROJECT SUMMARY / ABSTRACT - STREAM DX Lower urinary tract symptoms (LUTS) is one of the most common medical problems among older men – affecting 33% of men by the time they reach 50 years of age and 75% by the time they reach the age of 80. LUTS is a progressive disease that has been shown to significantly increase the risk of depression and reduce quality of life. Early detection, intervention and active management is critical to successful treatment of LUTS. Uroflowmetry is an important and ubiquitous test in the diagnosis, monitoring, and post-treatment evaluation of men with LUTS. Uroflowmeters are devices that collect a complete urine void and then generate graphs that characterize the volume and flow rate pattern of the void. From these graphs, physicians should be able to identify the peak urinary flow (Qmax) which is the best single measure to predict whether a patient’s urine stream is obstructed. However, there are serious limitations and inherent pitfalls to uroflowmetry testing done in-clinic. First, having patients void in an artificial and unfamiliar clinic setting resulting in a different flow characteristic compared to having them void at home. Second, in-clinic testing results in a high number of uninterpretable voids when the patient can’t void enough in the unfamiliar setting. Uninterpretable voids are not billable by the care provider and the time spent attempting to collect this data in the clinic is wasted, creating frustration for the patient and the clinicians. Third, disabled, rural and elderly patients often have difficulty in getting to the doctor’s office exacerbating the testing process further. Stream Dx, Inc. has developed a low-cost, clinically accurate electronic flowmeter for at-home use, SDX01. The device is patented, registered with the FDA and has been introduced to the marketplace. It is an early stage uroflowmeter which accurately generates the same volume and flow data that is collected by in-clinic uroflowmeters but can store multiple days’ worth of patient void data in memory. SDX01 collects the data for each void, which is then either uploaded by the patient or Stream Dx to the company’s web-based portal for clinician viewing. The clinician can them immediately address concerns directly with the patient. In this Phase IIb proposal, Stream Dx will significantly improve the product and reduce costs while maintaining clinical accuracy. We expect to improve the device and data by adding fluid consumption as well as collecting additional urine flow data. We will migrate data transfer to a wireless cellular enabled IoT communications hub via Bluetooth 5.0. for real time access to patient data. These are non-irritative improvements and key to assuring patient usability and outcomes, maximize clinician time and patient interactions, ultimately producing the gold standard product. Today, none of the existing devices or apps in this area have a focus on monitoring the relationship of fluid intake to urine outflow, provide patient notifications to improve patient compliance, provide physician alerts or can collect urinalysis or other physiological data in future applications. When this Phase IIb is complete, Stream Dx’s SDX01 will be the gold standard in the monitoring and treatments of LUTS and be integrated into the marketplace across the U.S.