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RHO archives : Topics : Contraceptive Methods

Female Barrier Methods

Overview

Female barrier methods are contraceptives that a woman places in her vagina before sex to prevent pregnancy. Mechanical barrier methods include devices such as the diaphragm, the cervical cap, and the female condom. (For a discussion of chemical barrier methods, please see the Spermicides page.) The contraceptive sponge is both a mechanical and chemical barrier. In the past decade, this method has been updated and reintroduced in some countries. See the contraceptive sponge discussion below for a description of the three sponges that are becoming available.

  • The diaphragm is a latex device that covers the cervix and part of the vaginal wall, and is held in place by a flexible rim.
  • The cervical cap is a smaller rubber device that fits snugly around the cervix. (Since the cap is not widely available, information presented below is focused primarily on the diaphragm, unless otherwise noted.)
  • The female condom is a sheath made of thin, transparent, soft plastic that a woman inserts in her vagina before sex. It has two rings: a flexible removable ring at the closed end to aid with insertion, and a larger flexible ring that stays outside the vagina at the open end to help protect the external genitalia.

Barrier methods are best suited for a woman who finds using a method near or at the time of intercourse acceptable, can learn the insertion technique, and has sufficient privacy for insertion and removal. In addition, women who use the diaphragm and cap must be able to care for and store the device. The methods can be very effective when used correctly and consistently with each intercourse. Typically, however, accidental pregnancy rates are high compared to many other methods; women for whom an accidental pregnancy would present a serious health concern should use a more effective method. Barriers can provide important protection from sexually transmitted infections (STIs) and can be used even if a partner refuses to use condoms. Clients at risk for STIs could be counseled to use dual methods: a barrier method for STI protection and a second, more effective method for pregnancy prevention (IPPF 2000). Although significant challenges still remain before safe and reliable microbiocidal products will become readily available, some researchers have begun to reevaluate the protective nature of cervical barrier devices in protecting against bacterial and viral STIs (Moench 2001). Key characteristics of mechanical barrier methods are highlighted below.

For information about new female barrier methods, please see the Contraceptive Research and Development page.

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Characteristics of mechanical female barrier methods

Effectiveness

First year failure rates for typical use: diaphragm, 20%; cervical cap, 20% for women who have not had children and 26% for women who have had children; female condom, 21%. Effectiveness depends on whether a woman uses a vaginal method correctly every time she has sex and on which method she uses.

Age limitations

No restrictions on age.

Parity limitations

No restrictions on use for nulliparous or parous women although parous women may experience higher rates of pregnancy with the diaphragm and cap.

Mode of action

Creates a physical barrier to block passage of sperm into the uterus and fallopian tubes; diaphragm and cervical cap effectiveness is increased by use of spermicide.

Effect on STI risk

Diaphragm and cervical cap are somewhat protective against agents that attack the cervix; the female condom offers significant protection for all STIs.

Drug interaction

None.

Duration of use

Used near or at the time of intercourse. The diaphragm and cap must be left in place for at least six hours after intercourse. Appropriate for both short-term and long-term use. Women can use barrier contraceptives throughout their reproductive years.

Return to fertility

Immediately upon discontinuation.

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Key issues

Protection Against STIs

With the widespread epidemic of sexually transmitted disease and HIV infection, barrier contraceptives have taken on renewed importance in reproductive health programs for infection prevention (FHI 2000). A review of several female barrier methods estimated that they reduce transmission of STIs by 50 to 75 percent (Elias 1996; Feldblum 1994).

Recently researchers have advocated that covering the cervix with mechanical barriers such as diaphragms and cervical caps may reduce the risk of HIV infection because cervical tissue is particularly susceptible to infection (Moench et al. 2001). Several ongoing studies are evaluating the effectiveness of cervical barriers, particularly diaphragms, in protecting women from sexually transmitted infections (PATH 2003). One drawback to provision of diaphragms and cervical barriers has been the provider fitting required to determine the appropriate size device. A recent article that draws on re-analysis of fitting data from previous barrier method clinical trials suggests that many women could be correctly fit with a one-size diaphragm (Mauck et al. 2004). See materials from the Diaphragm Renaissance meeting for more information on cervical barriers and HIV.

While few data are available on the degree of STI protection conferred by female condom use, use-effectiveness results from U.S. and Thai studies are promising (PATH/Outlook 1997; IPPF 1998). In a summary review of the safety, effectiveness, and acceptability of the female condom, WHO estimated that perfect use could possibly reduce HIV transmission by 93 percent (WHO 1997). Results of a recent study looking at the use-effectiveness of the female versus the male condom in preventing sexually transmitted infection in women found that women who are educated and supplied with female condoms are protected at least as much—if not more so—than women who are educated and supplied with male condoms alone (French 2003). A synthesis of evidence available about the effectiveness, acceptability, and use of female condoms can be found at www.fhi.org/en/RH/Pubs/Briefs/fcbriefs/index.htm.

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Reuse of the Female Condom

Since its introduction in the early 1990s, the female condom has become an important option to assist some women in protecting themselves and their partners from unwanted pregnancies and STIs. The only currently available female condom is the soft, transparent, polyurethane sheath inserted in the vagina before sex. Although the device is marketed and approved as a single-use-only device, reuse by women who are not able to access a new female condom has been reported in a number of countries.

Consequently, WHO and UNAIDS convened a meeting in June 2000 on the safety and feasibility of reuse of the female condom. Experts in microbiology, sexually transmitted infections, condom production and quality assurance testing, and programmatic issues evaluated relevant safety data and the feasibility of reuse. After reviewing relevant data, the group concluded that insufficient evidence is available to determine whether washing with soap and water will remove a broad range of sexually transmitted pathogens (WHO 2000). They also were concerned about the potential risk to women during washing, and to partners during subsequent re-use.

Recognizing the need for risk reduction strategies for women who cannot or do not access new condoms, the consultation developed a draft protocol for safe handling and preparation of female condoms intended for re-use. This protocol has not yet been extensively studied for safety or evaluated for efficacy in humans. In response to requests for advice on the safety of re-use of the FC female condom, WHO convened two consultations to examine this issue. At the first (held in June 2000), a draft protocol for re-use was outlined and additional research to test the safety and efficacy of this protocol was identified. The second (held in January 2002) allowed review of the results of the new research and of programmatic issues related to re-use of the female condom. A summary of the WHO re-use protocol can be found at www.reusefemalecondom.org/resources/docs/20who_femdom.pdf (WHO 2002). Additional resources concerning re-use of the female condom also can be found at www.reusefemalecondom.org/guidelines.asp.

Results from a recent South African reuse study showed that the structural integrity of the device was affected by washing, drying, and relubricating devices up to 10 times. The researchers presumed that the holes detected in the devices were most likely caused by the testing itself or the researchers washing the devices, but this could not be determined conclusively (Pettifor et al. 2000). Furthermore, although it is unlikely  that STI pathogens would survive a bleach soak followed by a soap and water wash, there is concern that this process might cause more damage to the condom. Questions also were raised about the effect on the vaginal flora of using a washed or bleach-soaked condom. Vaginal flora are not harmed by use of a new female condom, but no data exist on the effect of reprocessed condoms that may carry residual chemicals (IPPF 2000). Given the available data and gaps in knowledge, the group recommends use of a new male or female condom for every act of intercourse; reuse of the female condom is not recommended at this time.

A recently published study also from South Africa evaluated the structural integrity of the female condom after multiple uses, with washing, drying, and relubrication. In the study, sex workers were allowed to use the device up to eight times. Between uses, the condoms were washed, dried, and relubricated with vegetable oil. Results revealed no deterioration in the strength of the condom when evaluated by FDA-approved seam strength and burst tests. The breakage rate was not significantly different from that found in a single-use study from the United States. These researchers conclude that, while it is preferable to use a new female or male condom, reuse of a female condom may be an acceptable alternative if a new, unused device is not available (Beksinska et al. 2001).

Recent research has led to greater understanding around issues pertaining to the introduction and use of female condoms (FHI website, WHO/UNAIDS).

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Contraceptive Sponge: New Choices Becoming Available

Natural sea sponges soaked in spermicide and inserted in the vagina before intercourse have been used throughout history for contraception. In the past decade, several companies have worked to update and reintrouce this method. The sponge creates a physical barrier between the semen and the cervix and traps the sperm in the sponge. It also acts as a chemical barrier by releasing spermicide. Three contraceptive sponges currently are available in some counties for contraception. The sponge provides between 12 and 24 hours of protection, depending on which brand is used. First-year failure rates (for perfect to typical use) range from 9 to 20 percent for nulliparous women and from 20 to 40 percent for parous women. (For more information on spermicides, see the Spermicides page.)

The Today Sponge is a small polyurethane foam sponge containing 1 gram of nonoxynol-9 (N-9). It is a one-size, over-the-counter product. It was approved by the USFDA in 1983 for sale in the United States. In 1994, the manufacturer halted production of the device because of production problems. The product line was bought by Allendale Pharmaceuticals in 1995, who has been trying to reintroduce production for the U.S. market. Recent estimates are that it might be available in the United States by the end of 2003. The Today Sponge is available in Canada. It can be worn for 24 hours.

The Protectaid Contraceptive Sponge was introduced in Canada in 1996, and in Europe in 2000. It is not approved by the U.S. FDA for sale in the United States It contains a combination of low-doses of three spermicides: N-9 (6.25 mg), benzalkonium chloride (6.25 mg), and sodium cholate (25 mg). It can be worn for 12 hours.

The Pharmatex Sponge contains 60 mg of the spermicide benzalkonium chloride. It was introduced in Europe in 1984, and has not been approved by the U.S. FDA. The sponge can be worn for up to 24 hours.

A recent Cochrane Review of randomized, controlled trials comparing the Today vaginal contraceptive sponge with any diaphragm used with nonoxynol-9 to prevent pregnancy found the sponge was less effective than the diaphragm in preventing pregnancy (Kuyoh et al. 2003). Two studies were included in the review. The 12-month, cumulative life table termination rates per 100 women for overall pregnancy were 17.4 for the sponge versus 12.8 for the diaphragm in the larger U.S. trial, and 24.5 for the sponge and 10.9 for the diaphragm in a trial in the United Kingdom. The 12-month discontinuation rate also was higher for the sponge than the diaphragm.

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