MatCH [Maternal, Adolescent and Child Health], Department of Obstetrics and Gynaecology, University of the Witwatersrand, Overport 4091, South Africa.
Contraception. 2012 Aug;86(2):127-31. doi: 10.1016/j.contraception.2011.11.071. Epub 2012 Jan 20.
Female condom (FC) failure (breakage, slippage, invagination and misdirection) declines with user experience. Participants in FC performance trials are commonly novice users, and failure rates may be inflated related to inexperience.
This was a randomized, crossover study assessing preference, safety, acceptability and function of three new FCs (WC, FC2 and V-Amour) among 170 women in Durban, South Africa. FC failure by condom type use period was investigated in women using five FCs of each type.
Of the 2411 condoms used during intercourse, 96 failures (breakage, slippage, invagination and misdirection) occurred in 86 condoms (77 condoms had one failure, 8 condoms had two failures, and 1 condom had three failures). Total clinical failure was comparable across FC types. The number of failures in the first condom use period was 58 (7.0%), and this decreased to 21 events (2.6%) in the second and, finally, 17 (2.1%) in the last condom use period. No failures were reported in the last use of the FC in the final condom use period.
FC failure rates decreased markedly after use of the first five condoms, regardless of FC type, and stabilized in the second and third use periods. Consideration should be given to the number of condoms used in trials to ensure that failure rates are not inflated by limiting the numbers of condoms used by novice users.
随着使用者经验的增加，女用避孕套（FC）的失败率（破裂、滑脱、套体卷入和错位）会降低。FC 性能试验的参与者通常是新手使用者，由于缺乏经验，失败率可能会偏高。
这是一项在南非德班的 170 名女性中进行的随机、交叉研究，评估了三种新型 FC（WC、FC2 和 V-Amour）的偏好、安全性、可接受性和功能。通过对每位女性使用五种不同类型的 FC 进行研究，调查了 FC 失败类型与使用期之间的关系。
在 2411 次性交中使用的 2411 个避孕套中，96 个避孕套发生了故障（破裂、滑脱、套体卷入和错位），涉及 86 个避孕套（77 个避孕套出现一个故障，8 个避孕套出现两个故障，1 个避孕套出现三个故障）。不同类型的 FC 之间总临床失败率相当。在第一个避孕套使用期间发生了 58 次失败（7.0%），在第二个避孕套使用期间减少到 21 次事件（2.6%），最后在最后一个避孕套使用期间减少到 17 次（2.1%）。在最后一次使用 FC 时，没有报告失败。
无论 FC 类型如何，在使用前五个避孕套后，FC 的失败率显著下降，并且在第二和第三个使用期趋于稳定。在试验中应考虑使用的避孕套数量，以确保通过限制新手使用者使用的避孕套数量来避免失败率过高。
