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Digital Uroflowmetry for Office and Home

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44DK127835-03
Agency Tracking Number: R44DK127835
Amount: $889,432.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 400
Solicitation Number: PA22-176
Solicitation Year: 2022
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-09-18
Award End Date (Contract End Date): 2026-08-31
Small Business Information
Richboro, PA 18954-1246
United States
DUNS: 117427675
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (267) 679-4077
Business Contact
Phone: (267) 679-4077
Research Institution

Uroflowmetry is the most common urodynamic test performed by urologists to assess the function of the lower
urinary tract. This simple non-invasive study measures urinary flow rates and when summarized graphically
offers insights into various types of lower urinary tract symptoms. Current systems call upon a patient to void
into a commode with a funnel to direct the flow of urine into a vessel placed on a digital scale which in turn
drives its output into a processor. The processor is connected to a printer which produces summary data
such as voided volume, peak flow, average flow, total void time, as well as a graphical representation of the
flow curve anywhere from 20-30 seconds after the void is initiated or completed. The physician or their
assistant will then empty the vessel, and the system can be used again. Traditionally the paper containing the
printed collected data was filed into a paper chart. Today this tracing is taped to a 2nd paper containing the
patient’s name and medical record number, and this is scanned into the electronic record as an image and the
data become non-searchable. Given this labor intensive process which is restricted to the office, conventional
uroflowmetry is ripe for disruptive innovations that will allow for testing in the patient’s home or office with the
data being driven into the electronic medical record (EMR).
We seek to offer a service to address to these logistical problems based on a detector that is paired with
customized software. Our detector fits in any regular toilet (it can be used in an office setting or at home by
males and females). Uroflow data are acquired in real time by a blue tooth or tablet, which sends the data to
the UroGenie cloud based server, and the summary data is delivered into the EMR. This will allow for a
physician to review multiple flows over time to monitor a patient’s progress without having to open up each
individual image. In this proposal we seek to refine our detector, and modify the software to work in the
home market, and test the service in both office and home locations. Once this system is fully operational we
envision this system being used in office and home settings, and playing a role in drug trials for lower urinary
tract symptoms. The instantaneous detection of flow rate also means it has the potential for future
applications in biofeedback training for selected patients with specific lower urinary tract symptoms.

* Information listed above is at the time of submission. *

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