Contoured Diaphragm Offers Nonhormonal Contraception

A single-size, reusable diaphragm offers an improved barrier method for birth control, expanding options for women who do not want hormonal treatments.

The Caya contoured diaphragm is made of silicone—which is more durable than diaphragms made from latex—providing a shelf life of five years and a use life of up to two years. User-centered design features include a rim that contains a proprietary nylon spring that compresses during insertion and removal; grip dimples on the rim of the device offer a cue where to squeeze it for insertion, and a removal dome. As one size fits most women, there is no need for a fitting exam to determine correct diaphragm size.

The Caya diaphragm is inserted into the vagina like a tampon just before sexual intercourse. It fully covers the cervical os and is placed between the posterior vaginal vault and the space behind the pubic bone. During and after intercourse, the Caya prevents sperms from entering the uterus, but it must remain in the vagina for at least six hours. The Caya diaphragm is a product of Kessel MEDintim (Mörfelden-Walldorf, Germany), and has been approved by the US Food and Drug Administration (FDA).

“In talking with family planning providers about this single-size diaphragm over the past few months, their eyes 'light up' when they hear that a new diaphragm is coming to market and no fitting exam is required,” said Bob Patane, founder of HPSRx (Salem, VA, USA), designated marketer of the Caya in the USA. “Reducing barriers at the provider level could help bring this new method to a whole new generation of women who have not known that diaphragms are even an option.”

The Caya diaphragm was designed through a collaboration between PATH (Seattle, WA, USA), a global health nonprofit organization; CONRAD (Norfolk, VA, USA), a reproductive health product development organization operated through the Eastern Virginia Medical School (Norfolk, VA, USA); and the United States Agency for International Development (USAID, Washington DC, USA). During product development and clinical studies, it was called the SILCS diaphragm.

“Clinical studies confirm the single-size design fits most women who could wear a traditional diaphragm. In the recently published contraceptive effectiveness study, 76% of women were able to insert and correctly position the diaphragm simply using instructions,” said Gustavo Doncel, MD, PhD, scientific and executive director of CONRAD. “With coaching, 94% of women were able to insert, correctly position, and remove the diaphragm. This should make it easier to provide and use consistently.”

“This woman-initiated, nonhormonal contraceptive barrier method has great potential to improve women’s reproductive health options by addressing several of the reasons for unmet contraceptive need,” said Judy Manning, team lead for contraceptive research and development at USAID. “The device may fill another needed role by serving as a delivery method for gels that help protect against HIV and other sexually transmitted infections. It could be our first true multipurpose prevention product.”

Related Links:
Kessel MEDintim
HPSRx 
PATH