Novel Artificial Urinary Sphincter for Stress Urinary Incontinence Treatment

Abstract

The American Medical System’s AMS 800TM has been the gold standard for over 40 years with over 150,000 patients treated for Urinary Incontinence and is the leading treatment for male stress urinary incontinence (SUI) following prostate surgery. Type III SUI, or intrinsic sphincter deficiency, is the inability of the urethra to maintain closure pressure sufficient to keep the patient clinically dry at rest and during periods of heightened activity (~120 cmH2O; coughs, sneezes, posture changes, and exercises). The current AMS 800TM is not personalized to a patient’s needs and compromises with an in between pressure- as high (61-70 cmH2O) as it can be without exceeding safety threshold levels. As such many men still leak when they are active. The market is hungry for a device that can adapt to the patient’s level of activity, reducing pressure most of the day to protect the urethra and then briefly increasing the pressure when he is more active. We are developing a novel implantable pump (henceforth called “add-on device”) which will be an add-on to the AMS 800TM and it includes a solenoid coil-cum-plunger and a fluid reservoir within the pump body. The add-on device will be small, light-weight and battery powered, and maintain compatibility with the AMS 800TM device. The device idea is in its proof-of-concept stage. This add-on device can be a possible solution to reducing the risks including urethral atrophy (leading to return of incontinence) and erosion (leading to infection of the implant) resulting from the constant pressure.