Schwartz Jill L, Barnhart Kurt, Creinin Mitch D, Poindexter Alfred, Wheeless Angie, Kilbourne-Brook Maggie, Mauck Christine K, Weiner Debra H, Callahan Marianne M
Department of Obstetrics and Gynecology, CONRAD, Eastern Virginia Medical School, Arlington, VA 22209, USA.
Contraception. 2008 Dec;78(6):465-73. doi: 10.1016/j.contraception.2008.07.020. Epub 2008 Sep 18.
Only one female condom [FC1 Female Condom (FC1)] is currently marketed, but it is poorly utilized, perhaps due to difficulty with insertion, discomfort and suboptimal functional performance during intercourse. The Program for Appropriate Technology in Health (PATH) Woman's Condom (WC) was developed in an effort to overcome these obstacles.
This was a randomized crossover study to evaluate the functional performance, safety and acceptability of the FC1 and WC. Seventy-five couples were assigned to one of two condom use sequences (WC/FC1 or FC1/WC) at three centers. Four condoms of the first type were used by couples in four acts of intercourse at home over a 2-4-week period. After a follow-up visit, these procedures were repeated with the second assigned condom type. In a substudy of participants (n=25), a colposcopy was performed prior and subsequent to the first condom use of each of the two condom types. Condom performance was evaluated by calculating measures of function from questionnaires completed by the couple after each condom use. Safety was evaluated by reported urogenital symptoms with a given condom during or immediately following condom use and colposcopic signs of genital irritation in the substudy. Acceptability of each given condom type was measured by questionnaire.
Total condom failure (slippage, breakage, etc., divided by the number of female condoms opened) was 31% for the WC and 42% for the FC1. Total clinical failure (slippage, breakage, etc., divided by the number of female condoms used) was 17% for the WC and 24% for the FC1. The proportion of condom failures was 10.9 percentage points less, and the proportion of clinical failure 6.7 percentage points less, when couples used the WC compared to the FC1 [90% CI: -18.5 to -3.3 and -12.6 to -0.8, respectively). Fewer women reported symptoms of urogenital irritation when using the WC vs. the FC1 either overall or when analyzing each use of the condom [woman as unit: -20 percentage points (90% CI: -30.5 to -9.3); condom use as unit: -12.3 percentage points (90% CI: -18.0 to -6.7)]. A similar result was seen for signs of urogenital irritation [woman as unit: -20 percentage points (90% CI: -42.7 to 4.8)]. Among participants with a preference, WC was preferred over the FC1 by twice as many males and by 2.6 times as many females.
While both female condoms were safe and acceptable in short-term use, the PATH Woman's Condom leads to less failure, was associated with fewer adverse events, and was more acceptable than the FC1 Female Condom.
目前市面上仅有一款女用避孕套[FC1女用避孕套（FC1）]，但其使用率较低，这可能是由于插入困难、不适以及性交过程中功能表现欠佳所致。健康适宜技术规划组织（PATH）研发了女用避孕套（WC），旨在克服这些障碍。
这是一项随机交叉研究，旨在评估FC1和WC的功能表现、安全性及可接受性。75对夫妇被分配至三个中心的两种避孕套使用顺序（WC/FC1或FC1/WC）之一。每种第一种类型的四个避孕套由夫妇在家中在2至4周的时间内用于四次性交行为。在一次随访后，对第二种分配的避孕套类型重复这些步骤。在一项针对参与者（n = 25）的子研究中，在使用两种避孕套类型中的每一种的第一个避孕套之前和之后进行了阴道镜检查。通过计算夫妇在每次使用避孕套后填写的问卷中的功能指标来评估避孕套性能。通过报告使用避孕套期间或之后立即出现的泌尿生殖系统症状以及子研究中生殖器刺激的阴道镜检查迹象来评估安全性。通过问卷测量每种给定避孕套类型的可接受性。
WC的总避孕套失败率（滑脱、破裂等，除以打开的女用避孕套数量）为31%，FC1为42%。总临床失败率（滑脱、破裂等，除以使用的女用避孕套数量）WC为17%，FC1为24%。与使用FC1相比，夫妇使用WC时避孕套失败的比例低10.9个百分点，临床失败的比例低6.7个百分点[90%CI：分别为-18.5至-3.3和-12.6至-0.8]。总体而言或在分析每次使用避孕套时，使用WC的女性报告泌尿生殖系统刺激症状的较少[以女性为单位：-20个百分点（90%CI：-30.5至-9.3）；以避孕套使用为单位：-12.3个百分点（90%CI：-18.0至-6.7）]。在泌尿生殖系统刺激迹象方面也观察到类似结果[以女性为单位：-20个百分点（90%CI：-42.7至4.8）]。在有偏好的参与者中，男性选择WC的人数是选择FC1的两倍，女性是2.6倍。
虽然两种女用避孕套在短期使用中都是安全且可接受的，但PATH女用避孕套导致的失败更少，不良事件更少，并且比FC1女用避孕套更可接受。
