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Abstract: Purpose: The objective of this study is to evaluate acceptability of the PATH Woman''s Condom among user populations in Mexico, South Africa and Thailand. Methods: A nonrandomized, nonblinded, nonsignificant risk study was conducted among 20 couples per site. Data were collected via structured questionnaires after the first, second and third condom uses and through in-depth interviews after all condoms were used. Results: Women from all sites reported that the PATH Woman''s Condom was easy and comfortable to insert, and the pouch and ring were very stable during use. Both women and men reported that the comfort and sensation of sex while using the condom was acceptable. Conclusions: The PATH Woman''s Condom is easy to use, stable during use, comfortable and satisfactory during sex among users from diverse populations and cultures. The iterative user-driven product development process helped ensure that this new product addresses a wide range of user preferences. [Copyright &y& Elsevier]

Abstract: Background: We performed a pilot study to evaluate in vivo the fit of the new SILCS diaphragm, a single-size cervical barrier, using magnetic resonance imaging (MRI) in a group of women varying in body mass and parity. Study Design: Two healthy premenopausal women were recruited for each of the following groups: body mass index (BMI)<25, BMI=25–30 and BMI>30. One woman in each group was nulliparous and one was multiparous. Subjects were instructed on the placement of the SILCS diaphragm. Each subject underwent three MRI scans: baseline, with the SILCS diaphragm in place and after placement of intravaginal contrast and simulated intercourse. Results: The SILCS diaphragm was easily identified on MRI. In all subjects, the diaphragm covered the cervix. The position of the diaphragm did not change after simulated intercourse. The appropriate position of the diaphragm, as assessed by the subjects and the practitioner, was corroborated by the MR images. The intravaginal contrast was not readily visible on the images, precluding assessment of the diaphragm''s barrier properties. Conclusion: MRI confirms the anatomic position of the SILCS diaphragm in vivo, among a sample of women varying in body mass and parity. [Copyright &y& Elsevier]