Original research articleComparative crossover study of the PATH Woman's Condom and the FC Female Condom®
Introduction
The Reality® Female Condom (currently called FC Female Condom®) (FC1; Female Health Company, Chicago, IL, USA) was approved by the US Food and Drug Administration (FDA) in 1993 as the first barrier contraceptive for women that offered limited protection against sexually transmitted infections (STIs). This female condom has a 6-month typical use pregnancy rate of 12.4 per 100 woman-years in a US population [1], has not been associated with trauma to the genital tract [2], prevents trichomoniasis recurrence [3], and may offer as much protection from STIs as male condoms [4]. The FC2 has been introduced as an updated version of this condom using synthetic latex for greater affordability [5].
Despite global need for a female controlled barrier device, there has been poor sustained utilization of this method and the potential impact of the device, as an HIV prevention strategy has not been fully evaluated. In female condom studies conducted over the past decade, varying proportions of users have liked the device and succeeded in using it, resulting in differing acceptability ratings in short-term acceptability studies, depending on the study population and the type of intervention [6], [7], [8], [9], [10]. These studies have identified a constellation of problems with female condom use including difficulty with insertion, discomfort and suboptimal functional performance during intercourse that may contribute to poor utilization.
The Program for Appropriate Technology in Health (PATH), a nonprofit, international health organization, has used an iterative user-driven development process to produce a novel female condom product in an attempt to overcome these obstacles. The PATH Woman's Condom (WC) has a thin, pliable plastic pouch that conforms to the shape of the vagina, is 9 in. long and has a flexible soft outer ring that is intended to protect the external genitalia (Fig. 1). The four oblong foam pieces on the outside of the pouch are intended to cling lightly to vaginal walls, ensuring stability of the device. The distal end of the pouch and foam pieces are packaged into a capsule which serves as an insertion aid and dissolves quickly when inserted into the vagina. The PATH Woman's Condom was easy to use and comfortable in a short-term acceptability study [11].
This study was designed to further test the functional performance, safety and acceptability of this novel female condom and to gain additional information for further development. This crossover study compared the PATH Woman's Condom (WC) to the FC1 after four uses of each condom type by 75 couples.
Section snippets
Materials and methods
Seventy-five couples were enrolled between December 2004 and August 2005 in this Phase I, comparative, open-label, two-period crossover study comparing the WC to the FC1 at three clinical centers: University of Pennsylvania Medical Center; University of Pittsburgh/Magee Womens Research Institute; and Advances in Health, Houston, TX, USA. The sample size was not selected on the basis of hypothesis testing. The crossover design was chosen because between-patient variation can be eliminated, and
Results
Of the 82 couples screened for eligibility, 75 were enrolled and 73 completed the study (Fig. 2). The functional performance definitions are detailed in Appendix A. Participant characteristics are described in Table 1. Participants at the Houston site differed from those at the other two sites in that they were likely to be older (female mean=34.3, male mean=35.5), identified themselves as Hispanic or black more frequently, and were less educated (female mean=13.2 years, male mean=12.6). They
Discussion
This was the first breakage and slippage study of the PATH Woman's Condom. The WC performed better than the FC1 with lower total clinical failure and total failure using female condom performance definitions adapted from male condom definitions of slippage and breakage [13]. There was significantly less failure with WC than with FC1 in regard to partially turning inside out and partial slippage and a trend toward significance with complete slippage. The statistical significance of these results
Acknowledgments
The authors thank Sarah Maitz for preparing the manuscript. Support for this study was provided by CONRAD through USAID. The opinions expressed herein do not necessarily reflect the opinions of USAID.
References (16)
- et al.
Evaluation of the effects of a female condom on the female lower genital tract
Contraception
(1991) - et al.
Short-term acceptability of the Reality® polyurethane female condom and a synthetic latex prototype: a randomized crossover trial among South African women
Contraception
(2006) - et al.
Short-term acceptability of the PATH Woman's Condom among couples at three sites
Contraception
(2006) - et al.
Performance of the Reality polyurethane female condom and a synthetic latex prototype: a randomized crossover trial among South African women
Contraception
(2006) - et al.
Contraceptive efficacy and acceptability of the female condom
Am J Public Health
(1994) - et al.
Prevention of vaginal trichomoniasis by compliant use of the female condom
Sex Transm Dis
(1993) - et al.
Effectiveness of female controlled barrier methods in preventing sexually transmitted infections and HIV: current evidence and future research directions
Sex Transm Inf
(2005) - et al.
Acceptability of the female condom among sex workers in Thailand: results from a prospective study
Sex Transm Dis
(2001)
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