Urinary incontinence is a largely spread disfunction that affects more than 300 million people worldwide. At present, no technological solutions are able to restore continence in a minimally invasive and effective way. In this article the authors report the design, fabrication, and testing of a novel artificial endourethral urinary sphincter able to fully restore continence. The device can be inserted/retracted in a minimally invasive fashion without hospital admission, does not alter the body scheme and can be applied to both women and men. The device core is a unidirectional polymeric valve and a magnetically activated system able to modulate its opening pressure. Bench tests and ex vivo tests on a human cadaver demonstrated that the device is able to fully restore continence and to allow urination when desired. Overall, the proposed system shows a high potential as a technological solution able to restore a normal daily life in patients affected by urinary incontinence.
Keywords: Artificial sphincter; Magnetic device; Minimally invasive therapy; Unidirectional valve; Urinary incontinence.