Acceptability evaluation of a natural rubber latex, a polyurethane, and a new non-latex condom.

After more than a century of reliance on latex condoms, male condoms fabricated from new materials are finally becoming commercially available to consumers. This study was an open label acceptability study that compared three lubricated condom products during vaginal intercourse: a natural rubber latex condom, a polyurethane condom, and a new non-latex (styrene ethylene butylene styrene, SEBS) condom. Fifty-four couples who were using condoms for birth control were enrolled in this three-way crossover study. Each couple tested three condoms of each type in a randomized sequence. Couples reported condom performance after each use and rated condom acceptability after use of three condoms of each type. At the completion of the study, participants selected their preferred condom type for overall acceptability, sensitivity, ease of use, appearance, and comfort. All three condom types had low clinical breakage and slippage rates (

Evaluation of the efficacy of a polyurethane condom: results from a randomized, controlled clinical trial.

CONTEXT: Condoms made of latex are not comfortable or appropriate for all consumers. Polyurethane condoms may provide a needed alternative. METHODS: In a double-masked study, 805 monogamous couples were randomized to use either the polyurethane condom or the latex condom for six months. Couples recorded the frequency of intercourse, of condom use and of breakage and slippage throughout the trial in coital diaries and in detailed reports on the first five uses. Breakage and slippage rates were determined, and typical-use and consistent-use pregnancy rates were calculated using life-table analysis, adjusted for use of emergency contraception. RESULTS: The six-month pregnancy rate during typical use (adjusted for use of emergency contraception) was 4.8% for the polyurethane condom and 6.3% for the latex condom. Similarly adjusted pregnancy rates during consistent use over six completed menstrual cycles--2.4% for the polyurethane condom and 1.1% for the latex condom--did not differ significantly. Clinical failure rates (including breakage and slippage occurring during either intercourse or withdrawal) were 8.5% for the polyurethane condom and 1.6% for the latex condom. In general, male participants were more satisfied with the latex condom, and users of latex were significantly less likely to drop out of the study for condom-related reasons than were users of polyurethane. CONCLUSIONS: Although polyurethane and latex condoms provide equivalent levels of contraceptive protection, the polyurethane condom's higher frequency of breakage and slippage suggests that this condom may confer less protection from sexually transmitted infections than does the latex condom.

PIP: Latex condoms are neither comfortable nor appropriate for all condom users. In a double-blinded study, 805 monogamous heterosexual couples aged 18-45 years were randomized to use either a polyurethane condom or the Ramses Sensitol latex condom for 6 months. The polyurethane condom had specifications similar to those of the commercially available Avanti condom. While both condoms are 180 mm long, with an open end diameter of 33 mm, when laid flat, the polyurethane and latex condoms are 64 and 52 mm wide, respectively. Recruited from Los Angeles, California, study participants were of mean age 27 years; 66% non-Hispanic Whites, 16% Hispanic, 6% Black, and 6% Asian; and with an average of 15 years education. Approximately 75% of the men were circumcised, and according to participants' measurements, the erect penis averaged 131 mm in midshaft circumference and 159 mm in length. 89% were using condoms as their contraceptive method at the start of the study. The 6-month pregnancy rate during typical use, adjusted for the use of emergency contraception, was 4.8% for the polyurethane condom and 6.3% for the latex condom. Similarly adjusted pregnancy rates during consistent use over 6 completed menstrual cycles were 2.4% for the polyurethane condom and 1.1% for the latex condom. Clinical failure rates, including breakage and slippage occurring during either intercourse or withdrawal were 8.5% for the polyurethane condom and 1.6% for the latex condom. Male participants were generally more satisfied with the latex condom, and users of latex were significantly less likely to drop out of the study for condom-related reasons than were polyurethane condom users.

Evaluation of prostate-specific antigen as a quantifiable indicator of condom failure in clinical trials.

The ability of condoms to retain all elements of semen during intercourse has been assessed by postcoital visual inspection and in vitro permeability studies. Yet, these observations may not be sufficiently precise or realistic. This pilot study evaluated prostate-specific antigen (PSA) as a semen marker of inapparent failure of the condom barrier under conditions of actual use. Twelve couples collected samples from the vagina and surfaces of the condom using sterile cotton swabs. We obtained precoital and postcoital samples for 24 acts of unprotected intercourse, 54 acts of intercourse using intact condoms, and 40 acts of intercourse using condoms that had been deliberately punctured. We used electrophoresis to determine the amount of PSA present in the samples. PSA was detected in 100% (24/24) of vaginal samples collected immediately after unprotected intercourse and in none of the vaginal samples collected more than 24 h after intercourse (0/90). PSA was also present in 98% (83/85) of the samples collected from the inside of the condom that had failed during intercourse. Excluding uses where the condom failed during intercourse, PSA was detected in 2% (1/47) of the postcoital vaginal samples collected after use of intact condoms and in 41% (14/34) of the samples collected after use of condoms with known 1-mm punctures. We conclude that PSA shows great promise as a semen biomarker in clinical trials of barrier methods. We recommend that future studies further investigate the ability of this biomarker to identify condom failures and quantify the extent of semen exposure associated with various types of condom failures.

PIP: The ability of condoms to retain all elements of semen during intercourse has been assessed by postcoital visual inspection and in vitro permeability studies. Yet, these observations may not be sufficiently precise or realistic. This pilot study evaluated prostate-specific antigen (PSA) as a semen marker of inapparent failure of the condom barrier under conditions of actual use. 12 couples collected samples from the vagina and surfaces of the condom using sterile cotton swabs. The authors obtained precoital and postcoital samples for 24 acts of unprotected intercourse, 54 acts of intercourse using intact condoms, and 40 acts of intercourse using condoms that had been deliberately punctured. They used electrophoresis to determine the amount of PSA present in the samples. PSA was detected in 100% (24/24) of vaginal samples collected immediately after unprotected intercourse and in none of the vaginal samples collected more than 24 hours after intercourse (0/90). PSA was also present in 98% (83/85) of the samples collected from the inside of the condom that had failed during intercourse. Excluding uses where the condom failed during intercourse, PSA was detected in 2% (1/47) of the postcoital vaginal samples collected after use of intact condoms and in 41% (14/34) of the samples collected after use of condoms with known 1-mm punctures. The authors conclude that PSA shows great promise as a semen biomarker in clinical trials of barrier methods. They recommend that future studies further investigate the ability of this biomarker to identify condom failures and quantify the extent of semen exposure associated with various types of condom failures.

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

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.

Response of individuals with reactive airway disease to sulfates and other atmospheric pollutants.

Severity of daytime and nighttime symptoms and medication requirements of 34 asthmatic volunteers were correlated to pollutant-pollen levels and to meteorologic characteristics continuously recorded over an eight-month period. Results of this longitudinal study suggest that as many as 9% of asthmatics may be sensitive to levels of sulfate in the ambient air and that reduction of sulfate levels to below 10 microgram/ml3 would significantly reduce tha frequency and severity of symptoms and needs for medication in these individuals.