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Non-invasive urodynamics without catheter
- 1. Urodynamics Without a Catheter© Michael Mooreville, MD, Aaron Meller, BS, Eng., Charles Generotti, BS, Reuben Kron, MD Urology Care Center, Lansdowne, PA The Non-invasive Uroflow-CystometerTM “NUC”TM © 2018 BioFluid Technology, Inc.
- 2. Affiliations to disclose†: Funding for speaker to attend: Self-funded Institution (non-industry) funded Sponsored by: Michael Mooreville, MD Uramix, Inc., Co-founder, Medical Director BioFluid Technology, Medical Consultant BioFluid Technology † All financial ties (over the last year) that you may have with any business organisation with respect to the subjects mentioned during your presentation XX
- 3. The NUC was imagined as an urologist’s fundamental tool, essentially a urological “sphygmomanometer” for the early detection of bladder hypertension. The NUC strategy for managing bladder hypertension is based on the very successful diagnostic and therapeutic approach to vascular hypertension, prevention, which is the core of current Internal Medicine and Cardiology practice. INTRODUCTION
- 4. How It Works Patient Urinates Into Closed Air Space
- 5. Sample of Pressure v Flow Data from NUC Maximum Urine Flow at Zero Back-Pressure Isovolumetric Bladder Pressure at Zero Flow Flow(mL/s) Pressure (mm Hg) Maximum Flow occurs at zero back-pressure Isovolumetric pressure (back-pressure) occurs at zero flow
- 6. Comparison Between Normal and LUTS Data
- 7. Decompensated Obstruction Bladder Failure Bladder Failure Bladder Decompensation Compensated Obstruction Normal Bladder Bladder Compensation Patient data (avg age ~67 yrs, n=33) Normal controls (avg age ~25 yrs, n=2) Distribution of Flow-Pressure Data from a Community Outpatient Urology Practice
- 8. Bladder Failure normal flow, normal pressure Bladder Compensation Early detection of elevated pressure allows for earlier treatment to prevent further bladder dysfunction. Early Diagnosis of Obstruction From Flow-Pressure Data Bladder Decompensation normal flow, high pressure low flow, high pressure low flow, low pressure
- 9. Summary • The NUC is a new tool for: (1) the diagnosis of asymptomatic bladder hypertension - Bladder hypertension was associated with normal urine flow Rate in about 25% of BPH patients in a community urological practice (2) differential diagnosis and management of LUTS - (a) “obstruction vs hypotonic detrusor contraction” (b) objective evaluation of response to treatment • The NUC => early diagnosis of BOO before onset of LUTS and early intervention may prevent irreversible detrusor hypertrophy and diminished bladder capacity.
- 10. MORE INFORMATION AVAILABLE: www.biofluidtechnology.com Questions: Michael Mooreville, MD urocare@comcast.net
- 12. NUC Features • Bladder Pressure • Urine Flow Rate • Urine Volume • Urethral Resistance • Urethral Compliance MEASURES: BENEFITS: • Office procedure • Noninvasive • Painless • No special lab • No special personnel
- 13. Representative NUC Flow-Pressure Curves Natural History of Lower Urinary Tract Symptoms (LUTS) Normal (Normal F/Normal P) Compensated obstruction (Normal F/High P) Decompensated obstruction (Low F/High P) Bladder Failure (Low F/Low P) F = Maximum Bladder Flow P = Maximum Bladder Pressure LUTS (“weak stream”) No LUTS (“normal stream”)
Editor's Notes
- I would like to introduce a revolutionary non-invasive urological device which can measure bladder pressure without a catheter. The NUC was incubated in Philadelphia and is currently under development by SRS Medical. There are a number of applications, two of which are addressed in this presentation. First, preventing bladder damage due to Bladder Outlet Obstruction (BOO) prior to onset of lower urinary tract symptoms (LUTS). Second, determining whether LUTS is caused by BOO or by bladder dysfunction and then objectively measuring response to treatment.
- Diagram of the NUC hydraulic flow circuit: Bladder is the pump; urethra is the pipe; closed air space creates back-pressure as urine enters and compresses the air. Back pressure does not affect flow as the air is compressed and the device measures multiple pressure changes (a selenoid cuts off the pressure at 60 mm of Hg) between 0-60 mm to keep the data in a low-pressure segment of the linear curve created.
- A sample linear low-pressure segment of the Pressure-Flow curve from which the Maximum Flow can be extrapolated based on application of Poiseuille’s Law. The y-intercept gives the Qmax and the x-intercept gives the Pmax.
- These are actual subjects; the blue line is a normal subject. The red line is an obstructed patient with BPH. The green line is the same subject after alpha blockers. Easy to read output.
- The device was validated in a COUP (Community Outpatient Urology Practice). About 25% of the BPH patients had asymptomatic BOO. The compensated obstruction manifested normal flow associated with bladder hypertension.
- The patients with bladder compensation could not be identified by a pee-in-a-funnel uroflow device. Early diagnosis and treatment of BOO may prevent permanent damage to bladder anatomy and function.
- This is what the device looks like in an early embodiment, which was used in the study.
- This is the UED (urethral extender device) in which the patient will void. It is made up of 2 chambers: the top chamber, which creates the closed system (air-lock created with a mild vacuum) and the bottom part, which actually measures the back-pressure.
- These are some graphs, which indicate various states in the progression of bladder dysfunction with prolonged BOO. The black line indicated normal bladder pressure and flow. The green line is a progression towards compensated obstruction with increasing bladder pressures to maintain normal flow. The red line indicates progression of obstruction with failure to maintain normal flows at elevated bladder pressure. Finally the blue line indicates a loss of muscle tone as well as decreased flow.