Novel, Wirelessly Controlled, and Adaptive Artificial Urinary Sphincter

Severe stress urinary incontinence is a nonnegligible complication that affects men as well as women. When initial therapies are not sufficient, implantation of artificial urinary sphincters (AUS) is considered the gold standard treatment. This hydromechanical device applies constant pressure on the urethra to keep urine inside the bladder. Although recovery from incontinence is full or partial, this approach has certain disadvantages. In addition to the difficulties and discomfort encountered when operating the device, insufficient pressure, urethral atrophy, and erosion from constant pressure on the urethra may necessitate revision surgery. In this study, we present a novel, remote-controlled AUS with variable urethral pressure that improves continence and avoids revision surgery. The proposed design eliminates the manual pump, facilitating implantation in men and women. It is compatible with current AUS. The device requires very little power and its parameters can be monitored and updated post-operatively. It has been tested on pig bladders ex vivo. Different pressure control algorithms have been developed, and expected performances have been achieved. Design challenges and experimentation results are reported.