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.

Online purchases of an expanded range of condom sizes in comparison to current dimensional requirements allowable by US national standards.

BACKGROUND: Across studies, 35-50% of men describe condoms as fitting poorly. Rates of condom use may be inhibited in part due to the inaccessibility of appropriately sized condoms. As regulated medical devices, condom sizes conform to national standards such as those developed by the American Society for Testing and Materials (ASTM) or international standards such as those developed by the International Organisation for Standardisation (ISO). We describe the initial online sales experience of an expanded range of condom sizes and assess uptake in relation to the current required standard dimensions of condoms. METHODS: Data regarding the initial 1000 sales of an expanded range of condom sizes in the United Kingdom were collected from late 2011 through to early 2012. Ninety-five condom sizes, comprising 14 lengths (83-238mm) and 12 widths (41-69mm), were available. RESULTS: For the first 1000 condom six-pack units that were sold, a total of 83 of the 95 unique sizes were purchased, including all 14 lengths and 12 widths, and both the smallest and largest condoms. Initial condom purchases were made by 572 individuals from 26 countries. Only 13.4% of consumer sales were in the ASTM's allowable range of sizes. CONCLUSIONS: These initial sales data suggest consumer interest in an expanded choice of condom sizes that fall outside the range currently allowable by national and international standards organisations.

Obstetrical and gynecological devices; designation of special controls for male condoms made of natural rubber latex.

The Food and Drug Administration (FDA) is amending the classification regulation for condoms to designate a special control for male condoms made of natural rubber latex (latex). The special control for the device is the guidance document entitled "Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300." The FDA will publish a notice in the Federal Register announcing the availability of the special control guidance document no later than the effective date of this final rule.

Does a choice of condoms impact sexually transmitted infection incidence? A randomized, controlled trial.

OBJECTIVE: The objective of this study was to assess whether providing a choice of condoms would increase condom acceptability, increase self-reported use, and decrease incident sexually transmitted infection. STUDY: We randomized 414 men presenting with urethral discharge in Jamaica to receive either the "standard" clinic condom or a choice of 4 different types of condoms. Men were treated presumptively at enrollment and followed up at 1, 2, 4, and 6 months. RESULTS: Participants in the choice group had a strong preference (P <0.01) for the most popular condom available in Jamaica. This preference did not translate into higher condom use (P = 0.16). The 6-month cumulative probability of first incidence of gonorrhea, chlamydia, or trichomoniasis was slightly higher in the choice group (21%; 95% confidence interval [CI], 15-28%) versus the control group (17%; 95% CI, 11-23%); the difference in the survival curves was not significant (P = 0.35). CONCLUSION: A choice of condoms may increase perceived acceptability but not lead to increased condom use and subsequently lower sexually transmitted infection rates.

A methodology based on NMR spectroscopy for the forensic analysis of condoms.

Both solution and solid state Nuclear Magnetic Resonance (NMR) spectroscopic techniques have been used to determine differences in commercially available condoms. Whilst solid state NMR is useful for determining the polymer backbone, it is not useful for forensic analysis due to the commonality of the latex condom. However solution NMR spectra obtained following a simple extraction procedure using hexane, provides a fingerprint of the additives in the lubricants. Following the development of a flow chart, basing decisions on the presence of particular peaks present in the solution spectra, 33 of 38 condoms could be individualized. Samples were also analyzed after having the lubricant manually removed and soaking the condom in water for 3 to 24 h. These experiments were performed to simulate a case of the sample having been used and disposed of by flushing down the toilet, as may be experienced in a case of a sexual assault. The results indicated that the only significant water soluble component was polyethylene glycol. The overall results suggest that the method developed may be a quick and useful technique in characterizing condoms. The information obtained can be used to provide associative evidence between suspect and crime, and so be useful in sexual assault cases.

Brief report on the effect of providing single versus assorted brand name condoms to hospital patients: a descriptive study.

OBJECTIVES: This study examined condom acquisition by persons in a hospital setting when single versus assorted brand name condoms were provided. METHODS: Condom receptacles were placed in exam rooms of two clinics. During Phase 1, a single brand name was provided; for Phase 2, assorted brand names were added. Number of condoms taken was recorded for each phase. RESULTS: For one clinic there was nearly a two-fold increase in number of condoms taken (Phase 1 to Phase 2); for the second clinic there was negligible difference in number of condoms taken. CONCLUSIONS: The provision of assorted brand name condoms, over a single brand name, can serve to increase condom acquisition. Locations of condoms and target population characteristics are related factors.

A protocol for the forensic analysis of condom and personal lubricants found in sexual assault cases.

In sexual assault cases, lubricant trace evidence may supplement biological evidence, or may be the primary physical evidence where biological evidence is unavailable. This study considered a total of 50 lubricants from condoms and personal lubricant products available in Australia. Differentiation of the samples was attempted using fluorescence examination, Fourier transform infrared spectroscopy (DRIFTS), gas chromatography-mass spectrometry, liquid chromatography-tandem mass spectrometry, and pyrolysis gas chromatography-mass spectrometry. Eleven of the samples were uniquely identified by the analysis scheme, while the remainder of the samples were separated into nine groups. As a result of this study, a recommended protocol for the detection and analysis of an "unknown" biological swab was produced.

Interaction of condom design and user techniques and condom acceptability.

In 1991, the source of public sector condom supplies in an African country changed from USAID to WHO. Following a complaint, the two types of condoms were sampled and compared. Laboratory tests indicated that the new-style condoms were of adequate quality, but a number of differences were noted between the two types. Complaints that the condoms were short and broke frequently could not be reconciled with measurements. Lubricant quantities on the WHO-supplied condoms were found to be lower than on the USAID condoms, but still within the range found on the commercial market. Also, the WHO condoms were marginally narrower and thicker. WHO asked the authors to conduct field interviews to seek reasons for the reported problems. These revealed that the relative dissatisfaction with the WHO condoms was largely confined to a group of sex workers in a follow-up programme conducted by two educators funded by a European agency. The instructions for use being given by the educators magnified the risk of incorrect application of the condom. Design changes to the WHO condoms (regarding lubricant, size and thickness) were subsequently made to minimise the chance of wrong use.

PIP: In November 1991 in Cotonou, Benin, 30 sex workers complained that the World Health Organization (WHO) blue condoms were not as good as the USAID condoms. The National AIDS Programme had replaced the USAID condoms with WHO condoms. Leading complaints about WHO condoms were in order of importance: causes pain in vagina, too short, too small, insufficient lubrication, breaks easily, and several condoms needed per client due to breakage. Samples of both condoms underwent laboratory tests to learn more about the complaints. Informal interviews were conducted with professionals in contact with users (e.g., family planning workers and condom vendors) and condom users (prostitutes, bar girls, and men). There were some differences between the two condom types. For example, the USAID condom exerted 20-30% less pressure on the penis than the WHO condom. However, researchers considered the differences to be too small to completely explain the complaints. Two social workers had done a suboptimal job of explaining to sex workers how to unroll condoms. Other than these sex workers, others accepted the WHO condom well. Both condoms had at least the same strength, suggesting that other factors likely explain the complaints (e.g., breakage). The WHO condom had less lubricant than the USAID condom (223 vs. 451 mg), yet the amount was within the range of that on the commercial market. One batch of WHO condoms had much less lubricant than other WHO batches. Even though the sex workers complained that the WHO condom was too short, it was actually longer than the USAID condom, suggesting that the WHO condoms were not unrolled completely. These findings indicate the need to teach correct application procedures to condom users and to make condoms as immune as possible to incorrect or suboptimal techniques (e.g., changes in lubricant).