Vaginal Barriers
Supplement to Population Reports, New Contraceptive Choices, Series M, Number 19, April 2005

The new barrier methods are designed for ease of use and also dual protection against both pregnancy and sexually transmitted infections (STIs), including HIV/AIDS. While no studies have yet demonstrated the protective effect against HIV of physically covering the cervix during sex, it is plausible that a method that protects the cervix would protect against infections by limiting access to cells in the cervix (18). Cervical barriers also could reduce the amount of viral shedding into vaginal secretions, thereby protecting partners of infected women (1).

Substantial epidemiologic and biological evidence suggests that the cells of the cervix are particularly susceptible to infection by HIV and other STI-causing organisms, in part due to a higher concentration of receptors in the cells lining the cervix (3, 18, 29). A clinical trial among 4,500 women in South Africa and Zimbabwe is assessing the impact of diaphragm use on women’s acquisition of HIV. Results are expected by 2006 (28).

While cervical barrier methods used alone may provide some protection from HIV infection, they may be more effective when used with a microbicide. Microbicides are gels, creams, or other substances that are designed, when applied vaginally, to reduce transmission of HIV or other STIs. Several are in development, but none has yet proved effective. (See INFO Reports, “Microbicides: New Potential for Protection,” January 2005). A diaphragm-like device or a sponge may help hold the microbicide near the cervix, which should enhance its ability to protect the cervix (17).

Diaphragm-Like Devices

Researchers are designing new diaphragm-like cervical barriers to be more effective, more comfortable, easier to insert and remove, and appropriate for use along with a microbicide. More rigorous studies are needed, however, to evaluate whether the devices alone would reduce STI risk (18). One device, Lea’s Shield^®, is already marketed in several countries. Another device, the SILCS contraceptive, is under development. Clinical trials are conducted largely by CONRAD and Family Health International, funded by USAID.

Lea’s Shield. Lea’s Shield is a cup-shaped device made of soft silicone rubber. It comes in one size designed to fit most women. The shield is placed over the cervix and features a one-way valve designed to allow air and cervical secretions to pass out, while maintaining a tight fit. It also contains a loop at the front end to facilitate removal. It covers the cervix, blocking sperm from reaching the cervical canal, and has been designed to hold a spermicide or microbicide (13, 14).

The US FDA approved Lea’s Shield for use with a spermicide in 2002. It has been approved in several other countries, including Austria, Canada, Germany, and Switzerland (4). In the US, Lea’s Shield is available by prescription only and costs US$65. The device does not require fitting by a doctor and therefore, in principle, could be made available over the counter instead of by prescription (5, 26).

Data on effectiveness are limited. In a clinical trial among 146 women studied for six months, about 9 women per 100 who used Lea's Shield with spermicide, and 13 women per 100 who used it without spermicide, became pregnant (16).

SILCS intravaginal contraceptive device. SILCS is a silicone device placed in the vagina to cover the cervix. It has “grip dimples” on the sides of the rim, and its shape makes insertion and removal easy (2). The device was developed by PATH and SILCS, Inc., and CONRAD supported product development and clinical trials.

The designers of the device relied heavily on results from studies of current and former diaphragm users and clinicians to improve acceptability and satisfaction. Women are evaluating the new device for comfort and ease of use in studies underway in the Dominican Republic, South Africa, Thailand, and the US (2, 21). A phase II trial is expected to begin in the US in 2005 (2).

Cervical Caps

Two new contraceptive cervical caps, FemCap™ and Ovès™, are on the market in several countries. Worldwide, few women use cervical caps, in part because they usually require fitting by a provider, and few providers are trained in fitting (24). New cervical caps are designed to reduce fitting time.

FemCap. FemCap, manufactured by FemCap, Inc., is a silicone rubber device with a dome that fits snugly over the cervix and blocks the passage of sperm (15). It has been available for several years in Austria, Finland, Germany, Italy, and Switzerland. In 2003 the US FDA approved it for use with spermicide (6).

FemCap comes in three sizes. Women who have never been pregnant use the smallest size, women who have miscarried, had a termination of pregnancy, or delivered by Caesarian section use the medium size, and women who have delivered a full-term baby vaginally use the largest size. Obstetric history predicts the right size about 85% of the time. A provider must still check the fit of the device. In a comparative trial, pregnancy rates among users of the FemCap were significantly higher than those among diaphragm users, but within the range expected for cervical barriers. Pregnancy rates for the FemCap estimated based on this six-month study are 18 per 100 women per year of use (15).

FemCap contains a groove on the outside so that users can apply a spermicide, or microbicide once available, to the outside as well as the inside surface of the groove. It also features a brim that forms a seal against the vaginal walls for further protection. FemCap was designed to dislodge less often than other cervical caps and to put less pressure on the urethra than the diaphragm (27), although there is insufficient research to determine whether FemCap achieves these objectives.

Ovès. Ovès is a disposable cervical cap manufactured by Veos, Ltd., a French company, and first introduced in France in 1997. It is also available in several other European countries and Canada. Ovès is made of thin silicone instead of latex, as most diaphragms are. Like FemCap, it comes in three sizes and must be fitted by a provider. Its effectiveness has not yet been established (24).

Unlike other caps, Ovès does not rely on suction of the cap rim against the cervix. The thin dome of the cap resembles a membrane and adheres to the cervix like a film—a feature intended to make it comfortable and undetectable in use. In acceptability studies women report some difficulty in placing Ovès over the cervix and in removing it. Ease of insertion and removal increases with experience, but some women continue to have difficulty removing the cap (23, 24).

Contraceptive Sponges

Contraceptive sponges were first developed over three decades ago, but few are on the market today. Now, the previously available Today^® sponge has just arrived on the market and a new product, Protectaid^®, may soon be available to consumers.

Sponges may be more convenient than diaphragms or cervical caps for some users because they do not require fitting or a medical prescription. Sponges have been significantly less effective than the diaphragm in preventing pregnancy, however, and significantly more likely to cause allergic reactions (12).

The Today Sponge. The Today Sponge was discontinued in 1994, when the producer deemed new US FDA manufacturing standards too costly to meet. In 1999 the Allendale Pharmaceutical Company purchased the rights to manufacture the Today Sponge and in April 2005 received US FDA approval to market it in the US (11). The Today Sponge also has been rereleased in Canada and is expected to become available elsewhere within several years.

Until its discontinuation in 1994, the sponge was available in the US, Canada, and some European countries. In 1984 it was the method of choice for more than 1.2 million women in the US, about 4% of all US contraceptive users (19, 20).

The sponge is less effective than most other methods as commonly used. Among typical users 13 to 16 women per 100 become pregnant in the first year of use (19).

Protectaid. Distributed by Pirri Pharma, in Canada, Protectaid is a new polyurethane foam sponge that is premoistened and packed with a gel called F-5^®. The gel contains low concentrations of nonoxynol-9, sodium cholate, and benzalkonium chloride, along with a dispersal agent that encourages the diffusion of the gel to form a protective coating on the surface of the vagina. The F-5 gel has spermicidal and microbicidal properties. The manufacturer contends that the combination of three spermicides allows use of smaller amounts of each, and this minimizes the risk of irritation of vaginal and cervical tissue (8, 22).

The Protectaid sponge is available in Canada, China, Egypt, Hong Kong, Israel, Spain, the Ukraine, and the United Kingdom. The manufacturer is applying for regulatory approval in other countries and may also apply for US FDA approval (7, 25).

The Protectaid sponge should be inserted at least 15 minutes before sex and should be left in place at least 6 hours after the last act of intercourse but it should not be kept in the vagina for more than 12 hours at a time. In a clinical trial involving 129 women in four countries, the Protectaid sponge allowed 23 pregnancies per 100 users in one year as typically used (10).

In one clinical trial 85% of women reported no problems using the sponge (10). The most common problem was difficulty removing the device, which does not have a string for removal but instead has two finger slots. Users have reported no major side effects or health problems (9).

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