Development and marketing of a prosthetic urinary control valve system

An implantable prosthetic for the control of urinary incontinence was developed and marketed. Three phases are presented: bench development studies, animal trials, and human clinical trials. This work was performed under the direction of a Research Team at Rochester General Hospital (RGH). Bench trials were completed on prototype hardware and provided early verification of the device's ability to withstand repeated cyclic testing. Configurational variants were evaluated and a preferred design concept was established. Silicone rubber (medical grade) was selected as the preferred material for the prosthesis.