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. Due to this, early detection and active management of LUTS is critical. Uroflowmetry is an important test in the diagnosis, monitoring, and post-treatment evaluation of men with LUTS. Uroflowmeters are devices that generate graphs that characterize the volume and flow rate pattern of the void. From these graphs, physicians can identify the peak urinary flow (Qmax) which is the best single measure to predict whether or not a patient?s urine stream is obstructed. However, all uroflowmetry testing is currently being done in-clinic, which has limitations. First, having patients void in an artificial and unfamiliar clinic setting results 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 isn?t able to void enough in the clinic. Uninterpretable voids are not billable by the care provider and the time spent attempting to collect this data in the clinic is wasted. In order to provide an alternative to in-clinic testing, Stream Dx, Inc. has developed and patented a low-cost, clinically accurate electronic flowmeter for at-home use. This uroflowmeter can generate the same volume and flow data that is collected by in-clinic uroflowmeters and can store multiple days? worth of patient void data in memory. Data collected on the device can then either be uploaded by the patient to our web-based portal for clinician viewing or, be uploaded by Stream Dx, Inc. after mailing the device back to the Company. In this Phase II Proposal, Stream Dx, Inc. plans to increase the usability of the Stream Dx uroflowmeter for patients and physicians. First, the Company will modify the existing device for handheld use to increase usability and compliance by patients. Second, the Company will develop mobile apps to capture intake and outflow data for patients and physicians to use in an at-home and in-clinic setting, respectfully. Third, data analytical tools will be developed on the Stream Dx website to provide physicians with additional methods of analyzing patient void data. Finally, the patient data will be integrated with the local hospital?s Electronic Health Record (EHR) for improved accessibility of the data by physicians.
/ 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 probably 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 and proposes to improve the usability of this device by making the device handheld, developing patient and physician mobile apps, developing analytical tools, and integrating Stream Dx data into patient Electronic Health Records.