# Clinical Feasibility of Wireless Catheter-Free Urodynamics for Extended, Comprehensive Urological Evaluation in the Home Setting

> **NIH NIH R44** · BRIGHT URO, INC. · 2021 · $999,992

## Abstract

PROJECT SUMMARY/ABSTRACT
The primary objectives of this Phase II SBIR Proposal are to develop the UroMonitor (UM) with an ISO-13485
certified manufacturer and evaluate the safety and feasibility of the UM in a Clinical Feasibility Study.
Urodynamics evaluations are conducted to aid in diagnosis and treatment of patients with Lower Urinary Tract
Symptoms (LUTS). This evaluation measures the pressure and volume in the bladder to characterize bladder
performance and inform decisions regarding the appropriate course of treatment. In many cases, Urodynamics
evaluations fail to reproduce patient symptoms, which limit effectiveness. One major reason this occurs is
because the test requires patients to remain static and artificially fill their bladders using catheters. Bright Uro
has developed a method to conduct Ambulatory Urodynamic Monitoring that is wireless and catheter-free. We
are confident this will result in more accurate, more comprehensive evaluations that improve outcomes for
patients, clinicians and payers.
Bright Uro has developed the UM as a wireless sensing platform for extended urological monitoring in the home
environment. The UM can remain in the bladder for up to 7 days and record pressure and volume. When
synthesized with a Voiding Diary, Uroflowmetry, and other physiological data, the UM will provide the most
comprehensive Urodynamic report available to clinicians. The UM system leverages promising clinical results
from a First in Woman clinical study recently completed at the Cleveland Clinic. This lays the foundation for our
proposed Clinical Feasibility Study where we will evaluate the safety and feasibility of the UM for an extended
period in the home setting.
Data collected from this study will provide valuable insight and inform future clinical studies. If successful, the
UM will be postured for follow-on studies including a potential Phase IIB application and a larger pivotal study
with greater statistical power. Our goal is to bring the UM to market where it could revolutionize the way
Urodynamics evaluations are conducted and significantly improve outcomes for patients, clinicians, and payers.

## Key facts

- **NIH application ID:** 10384381
- **Project number:** 1R44DK131700-01
- **Recipient organization:** BRIGHT URO, INC.
- **Principal Investigator:** Derek Herrera
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $999,992
- **Award type:** 1
- **Project period:** 2021-09-23 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10384381

## Citation

> US National Institutes of Health, RePORTER application 10384381, Clinical Feasibility of Wireless Catheter-Free Urodynamics for Extended, Comprehensive Urological Evaluation in the Home Setting (1R44DK131700-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10384381. Licensed CC0.

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