Preliminary evaluation of REALITY, a condom for women to wear.

Abstract

Drawbacks of the male latex condom include the need for women to depend upon men to wear them during intercourse reduced sexual spontaneity reduced sensitivity and the fear of condom slippage or breakage. The female condom is an alternative method of contraception which women may use to protect themselves against pregnancy and sexually transmitted diseases. Effectively covering the vaginal entrance urethra and penis base women insert it of their own volition before commencing intercourse. Resistant to oils the polyurethane condom is also stronger than latex yet nonetheless soft and thin. Preclinical studies have shown the female condom to be impermeable to human HIV and cytomegalovirus. Clinical comparisons of barrier integrity in female and male condoms are summarized in this paper. 4 studies were conducted and together employed the post-coital standard ASTM water leak test spillage risk assessment questionnaires and direct post-coital exams for sperm presence in the vagina as well as performance evaluation questionnaires regarding lubricant choice in the female condom. REALITY the female condom under consideration produced a leakage rate of 0.6% versus the male latex condom rate of 3.5%. Vaginal exposure to seminal fluid was 2.7% for REALITY compared to 8.1% while overall combined risk of barrier failure for REALITY was 3% compared to condoms at 11.6%. No statistical difference was observed for performance between the 2 lubricants under study. Finally post-coital vaginal exam found no sperm present in 74 episodes of intercourse with REALITY. The studies find REALITY to be less prone to leakage and risking of female exposure to seminal fluid than the male latex condom.