| Condom was one of the most important choices of contraception crowd, because it could not only be used to contraception but also could effectively reduce sexually transmitted infections. Compared to male condom (MC), female condom (FC) had better contraception and disease prevention effects and was promoted by the World Health Organization (WHO). Condom researches were mainly related to functional performance and contraceptive efficacy. The contraceptive efficacy of FC and MC were similar during correct and consistent use of condom (both below5%). In addition, condom was class Ⅱ medical device in China, which was required to get registration approval before be on sale. The condoms also need to be done a series of rigorous tests, often including electronic detection, leak detection and air blast testing. Each production batch should be detected all of the above tests, or by random sampling, then the products could be packaged and sold if all test results were in line with national standards. These provisions assured the quality of condoms, thereby ensuring its contraceptive efficacy. However numerous studies found that incorrect and inconsistent use was the key cause of contraceptive failure, so this research focused on fanctional performance which caused the presence of semen in the vagina. The U.S. Food and Drug Administration (USFDA) managed FC in accordance with class III medical device standard, meaning that clinical trials must be submitted before be approved to marketing. WHO developed a series of recommendations on functionality study, including study design, subjects selection and implementation processes, etc. The requirements contained FC failure model (clinical breakage, misdirection, invagination, slippage), safety (itching, pain, rash, burning or other discomfort) and acceptability (ease of use, feel, noise). The test FC in this study was Phoenurse FC (Chinese FC), which was produced by Tianjin Condom Bao Medical Polyurethane Tech.Co.,Ltd. and was approved by the Tianjin Food and Drug Administration. FC2was the standard control FC which made by the Female Health Company and was approved by US Food and Drug Administration. FC2was similar in appearance to polyurethane FC1and Chinese FC but was made of synthetic nitrile rubber latex and did not have a seams.In addition, FC2had completed the technical review process by the WHO,which found it acceptable for bulk procurement by all UN agencies in2007. What’s more, our hypothesis was Chinese FC could achieve non-inferiority on functional performance compared with FC2.[Objectives]Primary objectives: To study the functional performance comparison of Chinese FC and FC2to provide policy recommendations for the promotion of Chinese FC. Performance was include four failure modes: clinical breakage, misdirection, slippage, invagination. Non-inferiority trial compare the total female condom failure rate and total clinical failure rate.Secondary objectives:To assess the acceptability and safety of Chinese FC and FC2, and provide policy recommendations for Chinese FC promoting.Concrete objectives:1.To compare the total female condom failure rate and total clinical failure rate to test our non-inferiority hypothesis.2.To describe the frequency distributions and compare the failure rates of the two FC.3.To describe the frequency distributions and compare the acceptability of the two FC.4.To describe the frequency distributions and compare the safety of the two FC.5.To investigate the influence factors of FC promotion in the general population.[Subjects and Methods]This study was carried out from April to October in2013, in Maternal and child health care in Qingdao Economic and Technological Development Zone.300couples were surveyed. Potential participants had to be in good general health with no known allergies to the study products, at least18years of age, using a reliable, non-barrier method of contraception and free of sexually transmitted infections (STIs), as determined by pelvic examination and use of a syndromic diagnostic tool. Pregnant (according to urine pregnancy test) or breastfeeding women were excluded. Participants were required to be sexually active, monogamous and could not be practicing sex workers. Since take-home coital logs were used to gather data, participants were also required to be literate.The study adopted the mix method of integrating qualitative study and quantitative study. The quantitative study was a two-period, cross-over randomized controlled trial to determine the functional performance, safety and acceptability of four FC models (Chinese FC and FC2). Statistical analysis methods in the quantitative study included: descriptive analysis, single factor analysis (t test,chi-square test), multivariate analysis (Logistic regression).20key information individuals were interviewed for in-depth interview in the qualitative study according to the principle of information saturation; the process of interview was taped with a record pen. We transcribed and coded the data, listed the sorting form, and wrote the report.[Results]During the study, we planned to investigate300couples, mainly were married women who were with IUD and in high level of education. Actually we enrolled300participants,299completed our study, and290were eligible. The eligible questionnaire rate was96.7%.1.Demographic characteristics and the comparison between the two groups of subjuestsThe female mean age of two groups were both about33years old. and the male was about34years old in two group. On the level of education of two groups, both female and male subjects’education level in the high school and above were accounted for nearly90%. On the local household registration, nearly90%subjects were local. On subjects whether had a kid, more than95%subjects had one kid. In the occupation, the top four profession of female subjects were social services or civil servants, unemployed, medical personnel, manufacturing and for male subjects were social services or civil servants, transportation, manufacturing, medical personnel. On average household monthly income, the group A was9668.53yuan, group B was9330.82yuan. The differences of these demographic characteristics in two groups were not statistically significant. The results showed that the two groups in terms of demographic characteristics were balanced comparable.2Functional performance of Chinese FC and FC22.1The overall situation and non-inferiority resultsSubjects received2900Chinese FC, and opened2898packages of this FC. One reported that it had already broken, before opened the package. Actually,2897Chinese FC could use. For the failure rates, the highest was slippage rate (6.01%), the second was invagination rate (3.00%), the third was misdirection rate (2.97%) and the least was clinical breakage rate (0.03%). Subjects opened2900FC2, and one report FC2was break after opened the package. And,2899FC2could actually use. For the failure rates, the highest was slippage rate (4.97%), the second was invagination rate (2.21%), the third was misdirection rate (1.93%) and the least was clinical breakage rate (0.03%).The total female condom failure rates of Chinese FC and FC2were respectively12.04%and9.17%. The total clinical failure rates of Chinese FC and FC2were respectively12.01%and9.14%. The two-sided90%CI and one-sided95%upper limit of this two rates differences in two groups were [1.55%,4.19%] and4.45%.4.19%and4.45%were both less than Δ=5%in this study, so the total female condom failure rate and total clinical failure rate of Chinese FC were non-inferiority compared to FC2.2.210times use comparison of two groupsFor A group, the ten times comparison showed that except for clinical breakage rate, the differences in the other three rates were statistically significant and the rates of Chinese FC were higher than FC2.For B group, the ten times comparison showed that except for the differenceof slippage rate was statistically significant, the other three rates of two groups were not statistically significant. That means in group B, the functional performance of Chinese FC and FC2was similar.2.310times comparison of two FCsFor Chinese FC, the ten times comparison showed that except for slippage rates were different, the differences of two FCs in the other three rates were not statistically significant. For Chinese FC, the rates of misdirection, clinical breakage and invagination in first10times use were basically the same with the after10times use.For FC2, the ten times comparison showed that except for the difference of clinical breakage rate was not statistically significant, the differences of the other three rates were statistically significant. For FC2, misdirection, slippage and invagination of the first10times use were higher than after10times use.3Acceptability issues between the two groupsThis survey used2897Chinese FC and2899FC2. On the enhanced acceptability than usual,Chinese FC were less than FC2; on the lower acceptability than usual,Chinese FC were higher than FC2. In addition, the chi-square test results show that in sexual pleasure, orgasm, vaginal lubrication, the difference between the two FC were statistically significant, i.e. there are differences between the two FCs in sexual pleasure, orgasm and vaginal lubrication. Enhanced rate ofChinese FC is less than FC2, reduced rate ofChinese FC is higher than FC2.4Safety issues between the two groupsSubjects used2897Chinese FC and2899FC2. The safety issues of Chinese FC were higher than FC2, whether female or male. For men, it’s about7%higher and for women, it’s about3%.In addition, the chi-square test showed that both men and women in safety issues of two kinds of FC, the differences were statistically significant (P values were less than0.001).And,the safety issues in male and female were higher in Chinese FC than FC2.5. Influential factors analysis of total clinical faluire and sexual pleasureThe fewer times use, sexual intercourse pain, lack of sexual pleasure, had no orgasm, not enough vaginal lubrication were more likely to get higher total clinical failure.Chinese FC, frequency of use more forward, FC slippage, safety issues in female, feelling anxious when intercourse, not interested in sex, not enough vaginal lubrication were more likely to get the lower sexual pleasure.[Conclusions]On the functional performance,Chinese FC is slightly lower than FC2, but in line with the non-inferiority hypothesis. Except for the difference of misdirection rate was statistically significant of two FC, the other rates were basically the same. In terms of acceptability, FC2was better than Chinese FC. For the safety issues,Chinese FC was worse than FC2. More use frequency, acceptability and the female safety issues were important factors for FC promotion. Therefore, Chinese FC should be concerned about acceptability and safety issues while maintaining good functional performance in order to have a better market.1. The basic demographic characteristics of the two groups were equilibrium comparable.2. Compared Chinese FC with FC2, its functional performance could meet the non-inferiority test requirements.3.The10times use comparison of group A showed that the functional performance of Chinese FC was lower than FC2. The10times use comparison of group B showed that the functional performance of Chinese FC was basically the same with FC2.4.Chinese FC’s functional performance was similar between the previous and later10times. The later10time functional performance of FC2was higher than the previous10times.5. The acceptability difference of Chinese FC and FC2was statistically significant, and FC2had the better acceptability.6. The difference of safety, was statistically significant, and FC2had the better safety.7. For the promotion suggestion, the major impact factors on acceptability and safety were as follows: intercourse pain, lack of sexual pleasure, had no orgasm, not enough vaginal lubrication, and slippage, female safety problems, anxiety during intercourse and not interested in sex.[Policy Recommendations]1.The functional performance differences of Chinese FC and FC2were not statistically significant, so Chinese FC could promoted both at home and abroad.2. Chinese FC still need to improve the acceptability, especially in feeling of sexual pleasure, orgasm and vaginal lubrication.3. Chinese FC still need to improve the safety, and the main problem was the pain of female which could be reduce by improving the craft.4. To promote Chinese FC, we should encourage lubricant use, and ensure use correctly. Also, sexual health education (excluding anxiety, enhance interest in sex) and sufficient introduction to make women wanting to use FC were needed. |
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