Elsevier

Contraception

Volume 68, Issue 1, July 2003, Pages 39-45
Contraception

Original research article
Clinical breakage, slippage and acceptability of a new commercial polyurethane condom: a randomized, controlled study

https://doi.org/10.1016/S0010-7824(03)00075-1Get rights and content

Abstract

Although latex remains the primary material for male condoms, a number of condoms made from synthetic materials have appeared in commercial markets in recent years. Published data on the safety and efficacy of these condoms is still limited, but nevertheless synthetic condoms do offer the user a wider choice and may encourage greater use of condoms for contraception and sexual transmitted infection prophylaxis. This paper reports on a study carried out in the Paris region of France on a new, commercial polyurethane condom marketed in Japan as Sagami Original and in Europe as Protex Original. A standard latex condom complying with the European standard for condoms (EN 600:1996) from the same manufacturer was used as the control in the study. The clinical breakage rate for the polyurethane condom was 0.6% (95% confidence interval 0.2–1.4%) compared to 1.3% (95% confidence interval 0.6–2.2%) for the latex condom. The difference was not statistically significant (χ2 = 1.9, p = 0.168). Clinically significant slippage (complete slippage of the condom off the penis) was 1.1% (95% confidence interval 0.5–1.9%) for the polyurethane condom, compared to 0.5% (95% confidence interval 0.2–1.2%) for the latex; a difference that again was not statistically significant (χ2 = 1.783, p = 0.182). The polyurethane condom was therefore equivalent to the latex condom in terms of clinical failure rate.

Introduction

Given the relatively recent introduction of synthetic condoms into the market, the scientific literature on these products is still limited. Details of clinical trials (slippage and breakage studies) on the Tactylon condom, which is made from a thermoplastic elastomer, have been published [1], [2] along with several studies on the Avanti polyurethane condom [3], [4], [5]. A three-way comparison between Avanti, Tactylon and Trojan-Enz (latex) has also been reported [6]. Other published studies on synthetic condoms include one on a prototype polyurethane condom [7] and a study on Ezon, a condom made from polyurethane film [8].

Summaries of the clinical breakage and slippage results obtained for these condoms are given in Table 1, Table 2. There is considerable variability between the results of the individual studies but, in general, the clinical breakage rates (breaks that occurred during intercourse) for synthetic condoms have tended to be higher than for the latex control condoms used in the studies. Typically, the breakage rates for the latex condoms fall in the range 0.4–2% compared to 3–6% for the synthetic products. Slippage rates (complete slippage of the condom off the penis) have also tended to be higher for the polyurethane condoms when compared to the latex controls. Slippage rates for latex condoms in these studies have tended to be in the range 0.6–1.3% compared to 0.7–4.5% for the synthetics.

Section snippets

Materials and methods

The polyurethane condom used in this study was supplied by Sagami Rubber Industries Co., Ltd., Japan. It is marketed as Sagami Original in Japan and Protex Original in Europe. The control latex condom was also supplied by Sagami Rubber Industries Co., Ltd. Both products were commercially available within France and were approved to carry the CE mark, demonstrating compliance with the harmonized European condom standard EN 600:1996 and/or the Medical Device Directive 93/42/EEC of 14 June 1993.

Recruitment and selection

In total, 2800 individuals were contacted for possible inclusion in the trial. Of these, 950 expressed interest, 299 were interviewed and 250 met the acceptance criteria and were recruited. Of those recruited, 36 did not return any questionnaires, 6 returned only some of the questionnaires and 208 returned all the questionnaires. Two couples were excluded from the analysis because there were errors in the questionnaires that resulted in ambiguous results, leaving 206 couples included in the

Discussion

The study population was typical of regular condom users, although for ethical reasons it was necessary to exclude certain categories, such as individuals at risk from STIs. All participants relied on the condom for contraception. Similar study populations were used in studies conducted by Frezieres et al. [5], Frezieres and Walsh [6] and Callahan et al. [2] whereas other studies, particularly those on prototype products, have used couples who were using concurrent alternative methods of

Conclusions

This study has demonstrated that the polyurethane condom, Sagami Original/Protex Original, is equivalent in terms of clinical failure rate to a high-quality latex condom in a typical condom using population. The results for the latex control condom, which were at the low end of the normally expected range, confirm the validity of the study design and participating population.

Acknowledgements

Dominique Infurchia at Stephenson Etudes, 15, rue Chaudron 75010 Paris, for recruiting the couples, collecting and collating all the trial data. Mr. G.W. Hough, CChem FRSC of G.W. Hough Consultancy for independently auditing the breakage and slippage data.

References (9)

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