10 years out: Cervical cap overcoming barriers

Are your patients interested in using female-controlled barrier contraceptives but uncomfortable with diaphragms or female condoms? The cervical cap may be a perfect fit for them.

The Prentif Cavity-Rim Cervical Cap is the sole product in this category approved by the federal Food and Drug Administration (FDA). Since its 1988 U.S. introduction, the Prentif has enjoyed slowly increasing sales each year, with much of its growth attributed to college health services and midwifery practices, says Liz Summerhayes, owner of Cervical Cap Ltd. of Los Gatos, CA. The company is the U.S. distributor for the Prentif, manufactured by Lamberts (Dalston) Ltd. in Luton, England.

The Prentif is a thimble-shaped device made of latex rubber, with a firm yet pliant rim. It fits snugly over the cervix and is held in place by suction and support of the vaginal wall. When used with spermicide, it acts as a physical and chemical barrier to sperm. It is available in four sizes: 22 mm, 25 mm, 28 mm, and 31 mm (internal rim diameter). The cap does not require additional spermicide before each instance of intercourse, and it may be left in place for 48 hours.

While the Prentif cap gained FDA approval in 1988, the method has been used as birth control for centuries. Lamberts (Dalston) has manufactured caps for over 70 years and sells two other caps, the Dumas and the Vimule, outside the United States, says Summerhayes.

Among typical couples who use a cervical cap before having a child, about 20% will exper ience an accidental pregnancy, according to Con traceptive Technology (CT).1 If the cap is used consistently and correctly, about 9% will become preg nant. More pregnancies happen if the cervical cap is used after a woman has had a child.

The trend toward use of birth control methods with higher levels of efficacy has impacted the use of all barrier contraceptives, observes Felicia Stewart, MD, director of reproductive health programs for the Kaiser Family Foundation in Menlo Park, CA, and one of authors of CT.

"There has been a general decline over time in popularity of all the barrier methods, including the diaphragm and the cap," she says. "I think, generally speaking, couples are seeking methods that provide a higher level of efficacy."

For those seeking nonhormonal methods, though, the ability to choose among barrier contraceptives is an important option. Many women who have experienced urinary tract infections while using the diaphragm have been pleased with the Prentif cap, reports Elizabeth Davis, CPM, of Woman to Woman, a San Francisco, CA-based private practice. Davis participated in the original clinical trials leading to the Prentif’s approval and now serves as a provider trainer.

For women who have never seen or felt their cervices, the learning process in becoming comfortable with cap gives them new insight in how their bodies work, Davis notes.

While some women may not be able to use a Prentif cap due to their individual vaginal anat omy, there are virtually no contraindications for cap users, says Stewart.

"I have fit women who are virgins, women who were discouraged about having to give up more convenient chemical methods, and women with a history of sexual abuse," says Davis. "I wouldn’t want to limit it [to any particular set of women.]"

Cost, training addressed

The patient’s cost for obtaining a cap ranges from $50 to $150, depending on the fee for the medical examination and device fitting. Cost of the cap alone ranges from $30 to $40, and the cap is available by prescription only. The company recommends the Prentif be replaced on an annual basis for optimum performance.

Providers who are interested in offering the cap can get hands-on training through a national network of trainers or through an educational video, says Summerhayes. (For contact information, see resources, below.) An average training session usually lasts four to six hours, depending on the group’s size, Davis says. A typical class covers the history of the cap, results of clinical trials, details about fitting and use, and ideas on how to market the service.

New options on horizon

There is discussion on production of a non-latex Prentif, Summerhayes reports. With planning now in the early stages, she is hesitant to predict a timetable for such a release. Femcap, a silicone cervical cap developed by Alfred Shihata, MD, a Del Mar, CA, researcher, is now going through the FDA approval process. (For more information on the Femcap, see CTU, March 1998, p. 40.)

A polyurethane cervical cap is now in the development stage, reports Michael Rosenberg, MD, MPH, clinical professor of OB/GYN and epidemiology at the University of North Carolina and president of Health Decisions, a private research firm, both in Chapel Hill. Researchers are looking at using this particular cap for both contraception and conception, he notes.

Reference

1. Hatcher RA, Trussell J, Stewart F, et al. Contraceptive Technology. 17th ed. New York City: Ardent Media; 1998.

Resource

For more on the Prentif cervical cap, contact:

Liz Summerhayes, Cervical Cap Ltd., 430 Montgomery Ave., Suite 18, Los Gatos, CA 95030. Telephone: (408) 395-2100. Fax: (408) 395-2103. E-mail: info@cervcap.com. Web: http://www.cervcap.com. Cost of a provider training video is $50; a patient information video is $30. Check the Web site for a list of independent trainers. Since many wholesale drug supply companies do not routinely stock the Prentif cap, providers may order them directly from Cervical Cap Ltd.

More on the cervical cap is available in Women, Sex and Desire — Exploring Your Sexuality at Every Stage of Life, a book by Elizabeth Davis. For more information, contact:

Hunter House Publishers Inc., 15151/2 Park St., Alameda, CA 94501. Telephone: (800) 266-5592 or (510) 865-5282. Web: http://www.hunterhouse.com. Cost is $12.95.