Performance of the Woman's Condom among couples in Shanghai, China

ABSTRACT

Background The Woman's Condom, a second-generation female condom, is poised for introduction in China.

Study design This single-arm couples’ use study was conducted in China in 2010 to assess performance and safety of the Woman's Condom and feasibility of mobile phone technology to record adherence data.

Results Sixty couples were enrolled in this study, and 59 couples completed all four of the condom uses, resulting in 234 condom uses. Two condoms were opened but not used. Total breakage was 0.85% (two non-clinical breakages). Misdirection (2%), invagination (0.85%) and slippage (1%) were consistent with data on condom failure from other studies. Total clinical failure was 4%. Fifteen mild and no serious adverse events were reported during the study.

Conclusions This study has shown that in China, the Woman's Condom performs well. Mobile phones cannot yet replace the use of a coital log and questionnaire. Further work on effectiveness is required.

KEYWORDS:

• Female condoms
• China
• Performance
• Safety

ACKNOWLEDGEMENTS

We would like to thank the field investigators and coordinators in the four sites for their hard work and commitment. We are indebted to the study participants without whom this study could not have been completed. We appreciate the thoughtful review of the manuscript by Mags Beksinska and preparation of the manuscript by Clarissa Lord Brundage. Support for this study was made possible by the generous support of the American people through the United States Agency for International Development (USAID) under the terms of the HealthTech IV Cooperative Agreement #GPH-A-00-01–00005-00 and other donors. The contents are the responsibility of PATH and do not necessarily reflect the views of USAID or the US Government or other donors.

Declaration of interest: P.S. Coffey and M. Kilbourne-Brook work for Program for Appropriate Technology in Health (PATH), an international, non-profit, non-governmental organisation whose mission is to improve the health of people around the world by advancing technologies, strengthening systems, and encouraging healthy behaviours (www.path.org). PATH designed and developed the Woman's Condom with support from USAID and other donors. In 2008, PATH licensed the Woman's Condom technology for commercialisation to Shanghai Dahua Medical Apparatus Corporation, though PATH has no financial or royalty interest in the arrangement. Shanghai Dahua Medical Apparatus Cooperation provided financial assistance to the Shanghai Institute of Planned Parenthood Research and the Obstetrics and Gynaecology Hospital of the Fudan University Medical Centre in support of the study referenced in this article.

APPENDIX

Functional performance definitions

Non-clinical breakage is defined as breakage which is noticed before intercourse or which occurs after removal of the condom from the vagina.

Clinical breakage is defined as a female condom that breaks during intercourse or removal of the condom from the vagina. Clinical breakage includes events where the outer frame breaks or the pouch becomes detached from the outer rim.

Total breakage is defined as female condom breakage at any time before, during, or after intercourse. It includes both clinical and non-clinical breakages. The total breakage rate and the non-clinical breakage rate are calculated by dividing the number of condoms that broke by the number of condom packages opened.

Slippage is defined as a female condom that slips completely out of the vagina during intercourse.

Misdirection is defined as vaginal penetration whereby the penis is inserted between the female condom and the vaginal wall.

Invagination is defined as part or all of the external components of the female condom being pushed into the vagina during intercourse.

Total clinical failure is defined as the number of female condoms that clinically break, or slip, or are associated with misdirection or invagination during intercourse.

The clinical breakage rate, slippage rate, misdirection rate, invagination rate and total clinical failure rate are calculated by dividing the number of female condoms affected by one of the aforementioned clinical failures by the number of female condoms used during intercourse.