Long-Term Objective: Determine effectiveness and site utilization of innovative air infusible condom (""""""""SUPERCONDOM(TM)"""""""") expected to increase usage by l) Facilitating and sustaining erection/rigidity (functionality) on older/mature adults including those with non- physiological erectile dysfunction) 2) Teenage/young adults (novelty appeal). Effectiveness deriving from strategically directed (controlled) air-flow through channels creating specific pressure areas: a) Base of penis (erection enhancement); b) Sides of penis (support/stimulation). Benefits: Offset universal reluctance toward condom use and mitigate associated health risks (minimizing disease transmission and unwanted pregnancies). SUPERCONDOM(TM) is expected to prevent(reduce slippage and breakage; extend erection time; increase stimulation to male/female. Specific Objectives Phase I: (Based on successful pilot tests conducted) 1) Test optimized condom prototypes at independent lab following F.D.A.'s requirements. 2) Refine instruments. 3) Conduct clinical trials using 36 heterosexual non-physiological erectile dysfunctional couples (ages 21-34, 35-49, 50-65). 4) Evaluate experimental design feasibility. Subjects demographically representing U.S. population (minorities oversampled) will be used in clinical trials testing the eventual Phase II feasibility of a factorial proportional repeated measures with alternating treatments design during Phase I research. Condom type (SUPERCONDOM(TM) vs. conventional condom) as primary independent variable will be tested using series of dependent variables including condom slippage/breakage. Other independent variables will be age/race.
Benefits of the patented SUPERCONDOM(TM) are expected to significantly increase condom use at minimal cost (15 cents over existing condoms). With 27-30 million users (14% of the over-21 market), 1 billion condoms ($650 million market) are sold annually in the U.S. If only a small % of existing condom users were to use SUPERCONDOM(TM) more often and some non-condom users begin to use it, the commercial viability and contribution to the U.S. healthcare system would be immense.
