Novel internal condom provides good sensation, secure fit vs other female products

A second-generation internal condom product, called the Woman’s Condom, is highly acceptable to users across the globe, a study has shown. Its special design features include easy insertion, secure fit during use, good sensation, and easy removal, as well as protection against pregnancy and sexually transmitted infections (STIs).

“Engaging users as codesigners through a human-centred design (HCD) approach resulted in a female condom that meets the needs of women and men from diverse regions,” the researchers said.

The novel reproductive health product was developed by a multidisciplinary team that pioneered the application of HCD principles. The design for the Woman’s Condom incorporated feedback from both female and male users from several sites in the US and Cuernavaca, Mexico; Durban, South Africa; and Khon Kaen, Thailand, to inform product development.

The researchers developed and tested more than 50 design iterations showing various solutions to user-related concerns. In the final locked design, the Woman’s Condom was shown to be easy to use, stable, comfortable, and provide satisfactory sensation during sex for both partners. [BMJ Innov 2021;doi:10.1136/bmjinnov-2020-000534]

“The ‘dissolving capsule’ to facilitate insertion and ‘soft cling’ design are key innovative features of the Woman’s Condom,” the researchers said.

Specific design features of the female condom were as follows: very thin film pouch (1.2 mil urethane film) to provide high level of sensation and comfort; low profile, soft urethane ring at the open end of the pouch gently hugging the body to provide flexible coverage; four foam shapes (small, thin sections of hydrophilic urethane foam) clinging lightly to vaginal walls to ensure stability during use; and a dissolving capsule insertion aid (made of polyvinyl alcohol used in contraceptive file) that contains condom pouch for easy handling during insertion and a rounded tip for comfort.

Of note, the Woman’s Condom is unlubricated and designed for single use. A water-based lubricant is provided in the package.

A validation study using the locked design among users in Mexico, South Africa, and Thailand confirmed the product’s ease of use, stability, comfort, and satisfactory sensation during sex for both partners. In addition, a phase I randomized cross-over clinical study at three sites in the US confirmed the performance, safety, and acceptability of the female condom compared with the currently available products among 75 couples. [Contraception 2006;73:588-93; Contraception 2008;78:465-473]

“In general, results from these studies showed that the Woman’s Condom performed well when compared with other female condom products,” the researchers said. “Women who reported preferring the Woman’s Condom cited ease of use, stability, and comfort as their main reasons.”

A multicentre open-label phase III trial also confirmed the overall acceptability of a new female-initiated barrier contraceptive option that can protect against pregnancy and STIs. [Contraception 2019;99:357-362; www.clinicaltrials.gov/ct2/show/NCT01223313]

“The female condom is a nonhormonal barrier method that can protect from unintended pregnancy and STIs such as HIV,” the researchers said. “Female condoms are an important contribution to women’s reproductive health globally as they are the only woman-initiated method currently available that can provide dual protection.”