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

> **NIH NIH R44** · STREAM DX, INC. · 2021 · $983,074

## Abstract

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...

## Key facts

- **NIH application ID:** 10224688
- **Project number:** 5R44DK113878-05
- **Recipient organization:** STREAM DX, INC.
- **Principal Investigator:** James Hotaling
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $983,074
- **Award type:** 5
- **Project period:** 2017-04-03 → 2023-02-15

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10224688

## Citation

> US National Institutes of Health, RePORTER application 10224688, Stream Dx: Point of Care Cellular Enabled IoT Communication Hub for Improved Diagnosis, Monitoring, and Post-Treatment Evaluation of LUTS (5R44DK113878-05). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10224688. Licensed CC0.

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