Effectivenss of a New Non-Invasive Erectile Support System in Aging Populations

DESCRIPTION (provided by applicant): As a normal consequence of aging, most men experience some form of erectile dysfunction (ED), which, in severe cases, causes impotence (the inability to sustain an erection sufficient to engage and complete vaginal intercourse). Conservative estimates place the incidence of all forms of ED in the general population at 30 million cases; the percentage in the aging population, specifically in men over 50, is as high as 50%. This unfortunate but totally natural condition contributes to feelings of insecurity, depression, abandoning relationships, social isolation, and the diminishment of the quality-of-life for both men and their partners. The ancillary negative psychological effects on earning potential and job stability are unknown but suspected to be significant. Solutions include: Over-the-counter chemical remedies, mechanical vacuum devices, still controversial prescribed pills, and more invasive treatments including, transurethral inserts, penile injections, and penileimplants. Although these have varying inter/intra-use success, none are universally acceptable, none include protection against sexually transmitted infections, none offer nearly spontaneous use. These circumstances and a maturing populace signal the needfor new technology. METHODS: Fifty, mature, heterosexual couples (ages 50-75), demographically selected from diagnosed populations of moderate and severe erectile dysfunction, will participate in 250 at-home clinical trials using a new, non-invasive', air-infused', erectile support system, able to be used throughout intercourse and designed, using scaled-down elements of the sphygmomanometer, to gently and non-ischemically compress ambient fluids permitting the then flaccid or semi-flaccid penis to hardensufficiently for intercourse. Comparisons will be made to a small group reporting no erectile dysfunction. Highly experienced investigators, including Urologists and Obstetrics specialists, will conduct the research protocol using physical examinations, previously validated questionnaires, and participant interview techniques. Prior to the clinical trials, focus groups will be used to modify the questionnaires and research design to fit the specific concerns voiced by the target age group. The questionnaires will measure, comfort, ease of use, and satisfaction. AIMS: The objective of this research proposal is a feasibility test of the effectiveness and safe- functioning of the new technology and to determine the ability of the new device-system to assist and permit men suffering from the effects of ED or impotence and their partners to participate in satisfactory sexual relations. The low projected cost ( 5.00) and 'instant use when needed', non- invasive, nature of the new 'I-Rect ' device-system should help make it a commercial success. PUBLIC HEALTH RELEVANCE: The fact that so much National attention is being placed on the solvency of the Social Security Administration reflects the fact that during the next thirty years the number of retired, hence over 62 year old individuals will triple from the current roles and underscores the consequential effects that aging will have in all areas of American life and, of course, on sexual functioning. This research investigates a Patented means of allowing men and their partners to continue to enjoy near- normal sexual relationships despite the natural diminishment of erectile functioning that ordinarily is a component of aging without resorting to chemical prescriptions that can alter blood pressure or otherinvasive techniques and devices that erode and interrupt natural love-making activities as practices by harmonious couples. The research also compares and contrasts this New I-RECT System to conventionally packaged condoms alone to establish the feasibility in function and the measure the satisfaction achieved as reported by both partners after private at-home use.