Original research articleStructural integrity of the female condom after a single use, washing, and disinfection
Introduction
The Reality® female condom was approved by the United States Food and Drug Administration (USFDA) in May of 1993, and has been marketed to US consumers since 1994. The device is a polyurethane sheath measuring 7.8 cm wide and 17 cm long. The sheath lines the vagina, extends outside the vagina once inserted, and is pre-lubricated with a medical grade, silicone lubricant known as dimethicone. Approved for contraception and for prevention of sexually transmitted diseases (STD), the device has been hailed as an important new protective method for women, as it is the first dual-protection barrier method that is used at the initiative of women [1]. However, the current high cost of the device (∼$3.50 each if purchased over-the-counter and $1.25 in the domestic public sector) makes it expensive relative to other barrier methods such as the male condom ($0.33–$1.00 each, depending on point of purchase) [2]. The device is currently approved for use during a single act of intercourse; re-use of the condom might reduce its per-use cost. Before undertaking a clinical trial involving multiple uses of a single device, we conducted this study to evaluate the structural integrity of the device after a single use. If the female condom remains above manufacturing specifications after a single use, further investigation into the safety, function, and structural integrity of the device after multiple use is justified.
The primary purpose of this study was to measure the structural integrity of the Reality female condom after a single act of vaginal intercourse. Secondary objectives were to measure the independent and combined impact of washing and disinfection on the structural integrity of the device. In both cases, we measured structural integrity using 5 laboratory tests: seam tensile strength, water leakage, air-burst, tear propagation, and device dimensions. The manufacturer does not use tear propagation as a measure of quality assurance; we included this test at the suggestion of USFDA staff.
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Study participants
After obtaining local institutional approvals, we recruited participants for the single use (intercourse) component from two sites to ensure demographic diversity in the sample. Persons residing in Wake, Durham, or Orange counties in North Carolina who were registered in an existing database maintained by Family Health International (FHI) constituted one source population. Participants attending two primary care health facilities located in Manhattan and in the Bronx, both in New York City,
Results
A total of 111 couples contributed 318 used condoms (159 per site). Participants from North Carolina tended to be in their mid-30s, mainly white, college educated, married, and most had been with their current sexual partner for over 10 years (Table 2). Participants from New York were generally in their lower 30s, virtually all either African American or Hispanic, educated to the high school level, not married, and most had been with their current sexual partner for 3 years or less. Previous
Discussion
We observed no overall degradation of the female condom after a single act of intercourse in any of the five tests of structural integrity. The device remained well above the manufacturing specification for seam tensile strength, one of the pivotal tests of device strength and integrity. These findings are encouraging since our “single use” group included an act of intercourse, a hand washing, and disinfection—a sequence of events that would likely mimic real-life practice. In addition, condoms
Acknowledgements
This study was conducted by Family Health International with funds provided by the US Agency for International Development; and at the New York Academy of Medicine with funds provided by the Female Health Foundation, of the Female Health Company. The authors would like to express thanks to Dr. Zena Stein for her scientific input and Daisy Rosario, Patricia Stewart and Leda Hardesty for their assistance with project recruiting and monitoring.
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