Pilot study on functional performance and acceptability of two new synthetic adhesive male condoms (Wondaleaf): a randomized cross-over trial.

OBJECTIVES: This study compared the condom failure rate, safety and acceptability of two new synthetic adhesive male condoms, Wondaleaf-Cap® (WLC) and Wondaleaf-On-Man® (WLM), with a marketed latex external condom Durex®-Together (DT). STUDY DESIGN: We enrolled healthy married, monogamous, heterosexual condom users in a randomized controlled, cross-over, pilot trial in Malaysia. We randomized participants to six groups with different condom use-orders of the experimental WLC and WLM and control latex condom for four episodes for vaginal sex over 1 month for each condom type. We summarized the clinical and non-clinical failure rate, safety and acceptability of each condom type using descriptive statistics. We tested differences in condom failure and acceptability using generalized estimating equations and repeated measure ANOVA respectively. RESULTS: We screened 75 couples and randomized 50 eligible couples. Two couples withdrew before receiving any condom. The remaining used 576 condoms with 192 uses for each condom variant. Clinical failure rates of WLC, WLM and DT were 1.04%, 0% and 0.52%, respectively. Non-clinical failure rates of WLC, WLM and DT were 2.08%, 3.12% and 1.04%, respectively. Removal was found more painful with Wondaleaf products than the DT. Preferences of participants for WLC, WLM and DT were 33.3%, 29.2% and 25%, respectively. Overall, WLC and DT had greater acceptances among male participants than WLM. CONCLUSION: Results of this pilot study support that use of synthetic adhesive male condoms is associated with failure rates similar to those seen with existing latex, and with greater acceptability. A larger study to ascertain non-inferiority is underway. IMPLICATIONS: The availability of synthetic adhesive male condoms may increase the acceptability of condom use. However, removal pain and clinical performance requires further study.

Structural integrity of the polyurethane female condom after multiple cycles of disinfection, washing, drying and relubrication.

The female condom provides an important alternative means of protection against HIV and other sexually transmitted infections for women, particularly in situations where partners are reluctant or refuse to use male condoms. The relatively high cost of the device, however, is a barrier to its use in resource-poor environments. This has led to some reuse of the product and two studies have demonstrated that female condoms can withstand a limited level of reuse without an excessive loss of structural integrity when washed with soap and water. A consultation on female condom reuse convened by the World Health Organization and the Joint United Nations Programme on AIDS in June 2000 recommended that all used female condoms should be disinfected immediately after use, before washing. The effect of such treatments on the female condom was not known. This study was undertaken to assess the effect of the disinfection, washing, drying and relubrication on the properties of the condom. Samples from three batches of female condoms were subjected to seven treatment cycles before being tested for structural integrity. In all cases the batches of condoms complied with the manufacturer's release specification for the product after treatment. Some minor changes in properties were seen but these were not considered important. There was evidence of a small increase in the number of condoms with holes following repeated disinfection and washing cycles, suggesting that excessive or rough handling can damage the condom. Condoms should therefore be handled carefully and inspected thoroughly for signs of damage after washing and drying before being stored with the intention of subsequently reusing the device.