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

项目摘要/摘要流DX 下尿路症状(LUTS)是老年男性最常见的医疗问题之一-影响 到50岁时有33%的男性，到80岁时有75%。LUTS是一种 一种进行性疾病，已被证明会显著增加患抑郁症的风险并降低生活质量。 早期发现、早期干预和积极治疗是治疗成功的关键。尿流率测定是 在男性LUTS的诊断、监测和治疗后评估中，这是一项重要而普遍的测试。 尿流量计是一种设备，它可以收集完整的尿液，然后生成图形来表征尿液的 空隙的体积和流速模式。从这些曲线图中，医生应该能够识别出峰值 尿流率(Qmax)是预测患者尿流是否受阻的最佳单项指标。 然而，临床上进行的尿流率检测有严重的局限性和固有的缺陷。第一，拥有 患者在人工和不熟悉的临床环境中无效，导致与 让他们在家里作废。其次，临床测试导致大量无法解释的空洞 病人在陌生的环境中无法排出足够的尿液。无法解释的空洞不能由护理提供者计费，并且 在诊所尝试收集这些数据所花费的时间被浪费了，这给患者和 临床医生。第三，残疾、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.开发了一种低成本、临床准确的电子产品 家用流量计，SDX01。该设备获得了专利，在FDA注册，并已被引入 到市场上。它是一种早期的尿流量计，可以准确地产生相同的体积和流量数据 这是由临床尿流量计收集的，但可以在内存中存储数天的患者无效数据。 SDX01收集每个空洞的数据，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。临床医生可以立即解决他们直接关心的问题 有耐心的。在此阶段IIb计划中，Stream Dx将显著改进产品并降低成本，同时 保持临床准确性。我们希望通过增加流体消耗以及 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。用于实时访问患者数据。这些是不会刺激的 改进是确保患者可用性和结果、最大化临床医生时间和患者的关键 相互作用，最终产生黄金标准的产品。今天，这款产品中的现有设备或应用程序 重点监测液体摄入和尿液流出的关系，向患者提供通知 提高患者的依从性，提供医生警报，或在未来收集尿液分析或其他生理数据 申请。当此阶段IIb完成后，Stream Dx的SDX01将成为监控的黄金标准 和治疗LUT，并将整合到美国各地的市场。

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.