Breakage and acceptability of a polyurethane condom: a randomized, controlled study

Abstract

Context: Although the first commercial polyurethane condom was approved for use several years ago, no U.S. clinical trial has compared its performance to that of the latex condom.

Methods: In a masked crossover study, 360 couples were randomized to use three polyurethane condoms and three latex condoms. After each use, couples recorded condom breaks, condom slips and other aspects of performance. At completion of the study, couples compared the sensitivity, ease of use, fit and lubrication of the two types of condoms.

Results: The clinical breakage rate of the polyurethane condom was 7.2%, compared with 1.1% for the latex condom (relative risk of 6.6, 95% confidence interval of 3.5-12.3). The complete slippage rate (combining incidents during intercourse and withdrawal) of the polyurethane condom was 3.6%, compared with 0.6% for the latex condom (relative risk of 6.0, 95% confidence interval of 2.6-14.2). Most male users preferred the sensitivity provided by the polyurethane condom to that of the latex condom.

Conclusions: The clinical breakage rate of the polyurethane condom is significantly higher than that of the latex condom. However, nearly half of the users preferred the polyurethane condom, which provides an option for couples who have rejected conventional condoms or who cannot use latex products.

PIP: The only nonsurgical method of male contraception marketed worldwide, the condom is also known to be highly effective against the sexual transmission of HIV and other diseases. Condoms, however, are underutilized compared to other methods. In 1994, the London International Group introduced the first male polyurethane condom in the US. This paper reports findings from a study comparing users' experience with polyurethane and latex condoms. The 360 couples who participated in the masked crossover study were randomized to use 3 polyurethane condoms and 3 latex condoms. After each use, couples recorded condom breaks, condom slips, and other aspects of performance. At the completion of the study, couples compared the sensitivity, ease of use, fit, and lubrication of the 2 types of condoms. The clinical breakage rates of the polyurethane and latex condoms were 7.2% and 1.1%, respectively. The complete slippage rates of the polyurethane and latex condoms were 3.6% and 0.6%, respectively. Most male users found the polyurethane condom to be more sensitive than the latex condom.