R44DK113878

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.PROJECT NARRATIVE / PUBLIC HEALTH RELEVANCE 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. Uroflowmetry plays an important role in the diagnosis, monitoring, and post-treatment evaluation of men with LUTS as peak urinary flow rate is the single best measure to evaluate the probability of a patient being urodynamically obstructed. In order to bridge the gap between inexpensive devices that obtain limited flow data and expensive devices with the capabilities of clinic uroflowmeters, Stream Dx Inc. has developed a low-cost, clinically accurate electronic flowmeter for at-home use. Voiding diaries, which include frequency, volume voided, and fluid consumption during several 24-hour periods, are necessary in identifying and treating LUTS.