Background: The SILCS diaphragm is a new, single-size contraceptive diaphragm. The objective of this crossover pilot study was to assess the fit and acceptability of the SILCS diaphragm compared to the Ortho ALL-FLEX diaphragm to validate the product design among parous women in a low-resource setting.
Study design: Sexually active couples not at risk of pregnancy and at low risk of sexually transmitted infection were recruited and randomly assigned to one of two groups to determine order of device use. Couples used each device four times and provided feedback on key performance indicators via product-use questionnaires, a simple coital log and a gender-specific debriefing interview.
Results: Twenty couples provided data on a total of 160 product uses (80 for each device). Couples indicated that both diaphragms were acceptable with respect to ease of use, comfort and satisfaction with sex. At the end of the study, 19 of 20 women and 15 of 20 men reported preferring the SILCS diaphragm over the Ortho diaphragm (p<or=.01 for both).
Conclusion: Short-term acceptability of the SILCS and Ortho diaphragms during use was comparable, although overall both women and men preferred the SILCS diaphragm over the Ortho diaphragm. Acceptance of diaphragms in general, and the SILCS diaphragm in particular, is likely among couples willing to use a barrier method.