The Female Condom: Where Method and User Effectiveness Meet
By JoDean Nicolette, B.A.
Medical Student, Stanford University School of Medicine
Controlling the spread of sexually transmitted diseases (STDs) is a major public health challenge for the 1990s. The only methods for slowing the transmission of STDs are behavioral change and barrier contraception. Barrier contraception methods include condoms, diaphragms, spermicides, and contraceptive sponges. Although spermicides alone or in conjunction with diaphragms or sponges reduce the transmission of STDs, they are not optimal because they leave the penis and vaginal wall exposed. Condoms provide a more complete barrier to STD pathogens, but many studies suggest that condom use is inconsistent. Women may use protection more consistently because they face more serious consequences from unprotected intercourse in the form of pregnancy, and disease such as pelvic inflammatory disease, ectopic pregnancy and sterility. Female controlled methods, although less method effective, may be more use effective due to more consistent and correct utilization. This article suggests that the female condom may be a complete form of protection that is used consistently because it is controlled by women. Acceptability studies have yielded encouraging results. Given the disease risks that women face today, health care providers must provide complete information about all STD prevention options, including the female condom, in STD prevention counseling.
Controlling the rapid spread of sexually transmitted diseases (STDs) is a major public health challenge for the 1990s. According to the Centers for Disease Control (CDC), 12 million Americans each year will acquire STDs, including 1.5 million cases of gonorrhea, and 3 million cases of trichomoniasis, and 4 million cases of chlamydia (1). These STDs mostly affect women, with the rate of chlamydia, for example, being 6 times higher in women than in men.2 Between 1984 and 1990, the incidence of syphilis among women almost tripled (3). In 1991, heterosexual sex surpassed intravenous drug use among women as the leading source of infection with HIV, the virus that causes acquired immunodeficiency syndrome (AIDS) (4). AIDS is now the leading cause of death in women ages 25-44 in urban areas of North America, and the leading cause of death in this age-group overall for African-American women (5, 6). In addition, it has been shown that both ulcerative and non-ulcerative STDs increase the risk for acquiring HIV from sexual encounters (7, 8). To date, two methods that have been shown to slow transmission of STDs: behavioral change and barrier contraception.
Barrier contraception methods include condoms, diaphragms, spermicides, and the contraceptive sponge. Spermicides may be used alone or in conjunction with one of the other methods. Condoms have been shown in vitro to be impermeable to virtually all sexually transmitted organisms studied (9,10). Because they prevent fluid exchange and provide a complete barrier between the penis and the vaginal wall and cervix, male condoms have been promoted by the health care community as the most effective method of barrier protection in the prevention of STD transmission (11,12). In fact, though efficacious at providing a barrier to STD pathogens in the laboratory, condoms may not be effective at preventing STDs in practice.
Although at least four prospective studies with discordant couples have shown that consistent male condom use can be effective for the prevention of HIV transmission (13,14,15,16), a startling number of studies suggest that male condom use is not generally consistent. In one survey at Planned Parenthood clinics, only 10% of women reported using condoms consistently with regular partners, and 14% with casual partners (17). In a 1991 study at a Baltimore STD clinic, 9 out of 10 sexually active men and women reported condom use, but less than one third reported using a condom in the last 30 days. Only 17% reported using a condom at last intercourse (18). Some recent studies suggest an improvement in the frequency of condom use, including a report finding that condom use among college women to has increased from 12% in 1975 to 41% in 1989 (19). Most recently, the CDC╣s Youth Risk Behavior Study demonstrated an increase in condom use at last sexual intercourse among high school students from 46% in 1991 to 53% in 1993 (20). While the improvement seems heartening, the increase in condom use in the latter study was reported only among women and African Americans, and both reports still suggest that 50% of youth are still not using condoms. Also important to point out is that the parameters measured in many studies, "condom use at last intercourse," or "use of condom in last 30 days," imply single uses and do not necessarily provide any information about consistency. These suboptimal use rates, and the fact that breakage rates of up to 5% and higher have been reported, create the large discrepancy between the method effectiveness and the use effectiveness of the male condom (21,22,23).
Several recent studies have indicated that barrier methods that women control may be more use effective than the male condom at preventing STD transmission. Austin, et. al. (1984), conducting a study at an Alabama STD clinic, reported the relative risk for acquiring gonorrhea infection among women using a diaphragm with spermicide to be half the risk of women whose male partners used condoms (24). Rosenberg, et. al. (1992), reported that women who used the sponge or diaphragm had a lower incidence of trichomoniasis and gonorrhea than those using condoms (25). Another study showed that the risk for being hospitalized for pelvic inflammatory disease was less for diaphragm users than for condom users (26). A 1986 study reported that the risk for invasive cervical cancer in spermicide users is half that of condom users (27). Finally, in a survey of 10 studies, Rosenberg et. al. (1992) observes that several other studies have been conducted comparing the effects of various barrier methods, most of which report that the relative risk for acquiring STDs is lower for female-controlled barrier methods than for the male-controlled condom. Although many of the differences do not fall under what has been arbitrarily defined as "significant," Rosenberg observes that the consistency is remarkable (21).
One reason for this use effectiveness may be that women have more to protect. Women are at much greater risk as a consequence of unprotected intercourse in the form of pregnancy and disease such as pelvic inflammatory disease, ectopic pregnancy, and sterility (28). Unfortunately, many of the barrier methods that women control are not optimal. Spermicides such as nonoxynol-9, and sponges provide a less substantial barrier than latex, as well as incomplete coverage of the exposed vaginal wall or vulva. In addition, although nonoxynol-9 has been shown in vitro and in vivo to kill a variety of STD pathogens, its effects on the transmission of HIV are unclear (29-35). Desperately needed is an efficient method of barrier protection that women control (28). The female condom may fill such a need.
The female condom is a loose-fitting polyurethane sheath with two flexible polyurethane rings at either end. One ring lies at the closed end of the sheath and serves as an insertion mechanism and an anchor against the cervix. The other ring remains outside the vagina. The female condom protects the vulva and the base of the penis, in addition to the areas of contact covered by the male condom. Polyurethane is a softer and stronger material than latex, with breakage rates reported at less than 1% (36). In addition, unlike latex, oil based lubricants can be used with polyurethane without compromising its integrity. The female condom also has the advantage of being more convenient than the male condom as it can be positioned earlier during sexual contact.
The female condom has been shown in vitro to be impermeable to HIV, and cytomegalovirus (CMV), and in one clinical trial to prevent trichomoniasis reinfection (37,38). Data from prospective clinical studies demonstrating the efficacy of STD prevention with consistent use are lacking and warranted, but prospective studies designed to measure contraceptive efficacy have yielded a "failure rate" among US participants to be similar to that of the diaphragm, sponge, and cervical cap (39,40). The in vitro impermeability to STD pathogens, and the contraceptive efficacy suggest that the female condom may provide at least the same method effectiveness for STD prevention as the male condom, perhaps more, given that it covers the vulva and the base of the penis.
Worldwide acceptability trials have been encouraging in both high risk and low risk populations of women. One hundred percent of Danish couples surveyed found the female condom good or acceptable (41). Seventy nine percent of British women reported their sexual pleasure to be the same or better than with the male condom (42). Fifty six percent of American women surveyed found the female condom acceptable or very acceptable, and 82% said they would recommend its use against STDs (36). Seventy five percent of women at a methadone clinic gave the female condom a strongly or somewhat favorable rating (43). A study of commercial sex workers (prostitutes) in Thailand reported that 2/3 of the women liked the female condom, but most discontinued its use at the insistence of clients (44). A recent study of commercial sex workers in Zimbabwe showed that 100% of women liked the female condom very much or fairly well, and that greater than 95% of clients responded favorably (author, unpublished data). Frequently mentioned problems with the female condom include that it is visible, too big, and significantly, that it is too expensive.
The most striking feature of the female condom is that it gives women the means to protect themselves from STDs, without relying on partner cooperation. Many women do not have the leverage in sexual encounters to negotiate the use of a male condom due to culturally sanctioned male dominance in relationships. The female condom has been approved by the FDA and is currently available in the United States under the trade name Reality. The cost is about $2.00 per condom, and is usually not covered by insurance plans, however 27 states have approved the female condom for medicaid reimbursement and other state funded programs (45). Health care professionals can write to Wisconsin Pharmacal (Jackson, Wisconsin) makers of Reality, for information about the female condom for themselves and their patients.
Given the disease risks women face from intercourse, including the risk of contracting HIV, health care providers must include informed discussion of the female condom in prevention counseling. Unfortunately, the protective virtues of female controlled barrier methods are not realized by many health care professionals. Providing information to the community about all preventive options including the method and use effective female condom, allows for individual choice based on lifestyle, tastes, and financial resources.
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