Elsevier

Contraception

Volume 62, Issue 2, August 2000, Pages 63-72
Contraception

Original research article
Structural integrity of the female condom after a single use, washing, and disinfection

https://doi.org/10.1016/S0010-7824(00)00142-6Get rights and content

Abstract

The Reality® female condom is approved for use during a single act of intercourse, but is expensive relative to other barrier methods. Re-use is a potential strategy to reduce its per-use cost. We tested the structural integrity of female condoms (n = 318) after a single act of vaginal intercourse. We also measured the impact of laboratory washing (1, 5, or 10 times) with and without disinfection on the structural integrity of unused condoms. Structural integrity was measured via 5 tests: seam tensile strength, water leakage, air-burst, tear propagation, and device dimensions. No degradation in device structural integrity occurred after a single use when compared to control for seam tensile (16.0 vs.15.7 mPa; p = 0.558); water leakage (1.9% vs. 0.9%; p = 0.618); air burst (3.9 vs. 3.6 kPa; p <0.001); or tear propagation (344.6 vs. 336.8 psi; p = 0.313). Mean length was slightly increased [single use vs. control (177.9 vs. 172.5 mm; p <0.001)]. No consistent pattern of structural degradation emerged across all wash/disinfection groups. Our data suggest the structural integrity of the female condom remains intact after a single use and cleaning.

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.

Section snippets

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.

References (11)

There are more references available in the full text version of this article.

Cited by (15)

  • Acceptance and use of the female condom among women with incomplete abortion in rural Tanzania

    2007, Contraception
    Citation Excerpt :

    An alternative and more cost-effective solution could be to reuse the female condom. Several studies testing the structural integrity of the female condom after reuse and cleaning have been performed with promising results [18–21]. However, evidence of a small increase in the number of condoms with holes following repeated disinfection and washing cycles has been found, suggesting that excessive or rough handling can damage the condom [18,20,21].

View all citing articles on Scopus
View full text