The UroMonitor: Innovative Technology to Improve Management of Bladder Dysfunction

SUMMARY Urinary incontinence and voiding dysfunction are highly prevalent worldwide and result in stigma and detrimental mental and physical effects.

Several treatments are possible but they have side effects, don't work for all individuals, and patients cycle between them. Therefore differential diagnosis is critical to efficient and appropriate treatment of these common conditions.

The gold standard method of objectively evaluating bladder and lower urinary tract function is Urodynamics, a clinic-based test in which a catheter is inserted into the bladder via the urethra. Fluid is pumped into the bladder while bladder pressure is measured & the patient reports sensations. In up to half of patients, Urodynamics is not able to reproduce patients complaints.

Therefore, new devices to provide objective, descriptive measurements of urinary dysfunction are needed to provide improved diagnosis & aid in individualizing therapy.

Since incontinence is patient-specific and in part behavioral, quantitative objective monitoring in a patient's home environment is needed.

We are developing the UroMonitor, a wireless, catheter-free approach for monitoring bladder function at home, much like a Holter monitor for the heart.

The Goal of this study is to demonstrate that the wireless, catheter-free UroMonitor allows safe and effective characterization of bladder function during natural filling cycles. Currently the UroMonitor can transmit bladder pressure in women but it does not measure bladder volume. It cannot be used in men as the current insertion tool does not have a Coude tip.

Thus, the research proposed in this project is divided into the following 5 Milestones. Milestone 1.

Develop accurate volume & concentration sensing for the UroMonitor and achieve design finalization by meeting design specifications; Milestone 2.

Develop reliable Bluetooth relay prototype with accelerometry data to correct pressure and volume measurement changes due to position changes and movement and phone app for clinician interface; Milestone 3. Design and validate an easy-to-use insertion tool suitable for males and females; Milestone 4.

Confirm sufficient durability and performance of the UroMonitor in male and female swine & single channel detrusor pressure estimation; Milestone 5.

Verify insertion, extraction, and performance of UroMonitor in an acute clinical study of men and women as a nonsignificant risk device; Milestone 6. Prepare for Pre-IDE meeting with FDA. At project completion we will be ready for definitive clinical trials testing the UroMonitor at home.

This paradigm-shifting system will enable improved diagnoses of lower urinary tract dysfunction and incontinence as well as individualized therapy and objective validation of treatment effectiveness, enabling a ?clinician in the loop? model of therapy and clinical guidelines based on ambulatory data in the home environment.