Urethral Catheter to Measure Distributed Occlusive Pressures and Sphincter EMG

DESCRIPTION (provided by applicant): Urinary incontinence is defined as the complaint of involuntary leakage of urine. It affects at least 13 million people in the United States and this number is expected to increase sharply with the aging of the baby boomers. Urodynamic studies are often used to diagnose the cause of urinary incontinence and consist of measurements of the storage and voiding functions of the urinary bladder and outlet. This project proposes the development of a novel instrumented urethral catheter that will enable significant enhancements to current urodynamic diagnosis. The instrumented catheter will enable measurement of urethral occlusion profiles during provocative maneuvers in both clinical as well as ambulatory environments. This will help determine structural and neurological causes of urinary incontinence, provide instantaneous and continuous measurements of functional urethral length, and help in determining appropriate rational procedures for surgical intervention. The proposed urethral catheter will contain sensors to allow simultaneous measurement of a) Urinary bladder pressure b) Sphincter EMG c) Distributed urethral closure pressures during filling cystometry The catheter will utilize novel device design and micro-fabrication technologies to create the distributed micro- sensors that enable measurement of EMG signals and closure pressure at multiple urethral locations. Embedded signal lines will transfer signals to a single interface at the distal end of the catheter, eliminating the need for wires to individual sensors. The developed catheter will first be tested in a hydraulic pressure chamber in which the fluid pressure can be controlled to different static values and also changed to track dynamic pressure profiles. The linearity of the sensor measurements, repeatability from sensor to sensor, sensor range, sensor resolution and dynamic sensor bandwidth will be evaluated. Finally the sensors will be evaluated in an IACUC approved canine study and an IRB approved clinical study. In the clinical study, we expect to find that the artifactual pressure and EMG signals observed during provocative maneuvers with single site catheters are greatly reduced with the new distributed sensing catheter. The research team for the project includes engineering experts in sensor design and fabrication, surgeons in urology and a professor in urology who has co-founded leading urologic device companies.