Prosthesis to Mitigate Erectile Dysfunction

Indiana Labs, Llc, Bloomington IN

Investigators

Abstract

DESCRIPTION (provided by applicant): Phase I studies will investigate the safety and effectiveness of a novel, easy to use, non-invasive device, which mitigates erectile dysfunction (ED). This device, the Erectile Prosthetic Support (EPS) (U.S. Patent 6251067), utilizes a specially engineered elastic band, and a back supporting plate. The elastic band, which when wrapped around the penis, provides uniform light compression and support, to hold a flaccid penis, and creates a comfortable elastic cylindrical tube of sufficient rigidity to permit intromission. Pilot and engineering studies indicate potential effectiveness of the EPS device for the general ED population, which presents an intimate, psychologically debilitating, and lasting challenge to male sufferers and their partners. Estimates of ED in the U.S., indicate 600,000 new male cases appear every year, and the total ED population approaches 30 million men with 20 million affected female partners (1,2). Existing approaches to mitigate ED include but are not limited to penile implants, pharmacological injections or inserts, and prescriptive medicines. These have had limited success, are invasive, expensive, and/or cumbersome to use. Phase I will utilize a series of in-clinical and laboratory studies to determine the safety and effectiveness of the EPS to provide penile support to permit natural intromission for a range of ED sufferers including men no longer able to produce or maintain an erection. Studies will be on a demographically representative sample of men with varied degrees of ED, from mild to severe. Similarly, clinical trials (in-home), with monogamous, married, living together, demographically representative couples, proportionately involving men with varied ED, will be performed to determine the EPS device effectiveness and safety. The studies will provide design information for the manufacture of an optimized EPS device and for Phase II studies suitable on wider population groups. The device's benefits, and a low projected cost, will provide an effective alternative solution for those who suffer from this dysfunction, and improve the quality of life and relations, for a growing group of aging men and their partners.