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).

Studies found plastic condom unsafe, yet FDA cleared it for market. Food and Drug Administration.

AIDS: Five unpublished studies, primarily funded by the National Institute of Child Health and Human Development (NICHD), found that Avanti condoms broke at an overall rate more than four times greater than latex condoms. Avanti, the first male polyurethane condom, was approved by the Food and Drug Administration (FDA) in 1991, before the agency began requiring manufacturers of medical devices to perform extensive clinical testing prior to marketing. FDA officials now acknowledge that allowing the innovative condom on the market without clinical efficacy data was a mistake. However, rather than recalling the condom, the FDA is requesting that both the NICHD and the company that manufactured Avanti retest the condom. Avanti is the first latex-free, HIV-impermeable condom available to the estimated five percent of the population that is allergic to latex. According to the FDA, denying those users the condom until efficacy studies are completed is not an option with the AIDS epidemic. However, the FDA does not encourage it for the general public. Avanti's manufacturer, London International U.S. Holding Inc., is conducting an efficacy trial that will provide the first data on protection against pregnancy and sexually transmitted diseases.^ieng

Enfoque actual de la adolescente por el ginecólogo

Excelentemente ilustrado y escrito, a partir de la experiencia y casuística del Programa de Adolescencia del Hospital de Clinicas de Bs. As., y de la primer cátedra de ginecología de la UBA. Enfoque integral médico de la adolescente, sus problemas, sus enfermedades, su psicología. De gran utilidad para ginecólogos y profesionales interesados en el tema

Enfoque actual de la adolescente por el ginecólogo

Excelentemente ilustrado y escrito, a partir de la experiencia y casuística del Programa de Adolescencia del Hospital de Clinicas de Bs. As., y de la primer cátedra de ginecología de la UBA. Enfoque integral médico de la adolescente, sus problemas, sus enfermedades, su psicología. De gran utilidad para ginecólogos y profesionales interesados en el tema

Comparison of condom breakage during human use with performance in laboratory testing.

This paper combines results from a study of the determinants of condom quality and use conducted by The Population Council in two countries in the Caribbean with results from a condom breakage study conducted by Family Health International (FHI) in the United States. The studies, conducted two years apart, compared the breakage rates of condoms from the same lot during human use to their performance in laboratory test results. Breakage rates of 12.9% for Barbados, 10.1% for St. Lucia and 6.7% for the United States compared to passing ASTM laboratory tests suggest that existing laboratory tests as used with the current pass/fail standards are either not sufficiently sensitive or not well-defined to reliably predict condom performance during human use. The study also suggests that user behaviors and practices may be a factor in condom breakage. If the condom is to be an effective method against unplanned pregnancy and STD/HIV infection, and if consumer confidence is to be retained, condom breakage during sexual intercourse must be reduced.

PIP: Family Health International (FHI) in North Carolina sampled and tested 52mm contour condoms with a reservoir tip and silicone lubrication in November 1988 and March 1990. Condoms from this same lot were used in 2 human use studies conducted in 2 Caribbean countries and in the US. The Population Council conducted 1 human use study in Barbados and St. Lucia among 50 heterosexual male condom users from each country. FHI conducted the other study in the Research Triangle area of North Carolina among 50 heterosexual male condoms users. Condom breakage rates of the human studies were high (12.9% in Barbados, 10.1% for St. Lucia, and 6.7% for North Carolina) in comparison with other studies (1-7%). Breakage did not occur due to poor storage conditions or oil based lubricant use. The researchers thought that it occurred due to men misusing the condoms or other user behaviors and practices. This belief was supported by the differences in breakage between the Caribbean men and the US men. More men experienced multiple condom breakages than those who experienced only 1 breakage. Condoms used in the study were from the same lot which passed elongation and tensile strength standards of the American Society for Testing and Materials (ASTM) in both 1988 and 1990, but failed the International Organization of Standardization (ISO) airburst tests in 1988 and just barely passed in 1990. Apparently the standards are not sensitive enough to predict increases in condom breakage. These findings suggest that the ISO standard for airburst testing is a more accurate predictor of condom quality than the ASTM standards for tensile strength and elongation. Further the breakage rates are too high given the AIDS epidemic. Moreover high breakage reduces customer confidence. In conclusion, researchers need to conduct studies on sexual behavior and practices to determine their effect on condom breakage rates.

Contraceptive efficacy of polyester-induced azoospermia in normal men.

The contraceptive effect of a polyester sling applied to the scrotum was studied in 14 men. The suspensor was worn for 12 months. Follow-up investigations comprised periodic check of semen character, testicular size, rectal-testicular temperature difference, serum reproductive hormones and testicular biopsy. The electrostatic potentials generated by friction between the polyester suspensor and the scrotal skin were determined. Female partners used contraceptives until the men became azoospermic. After 12 months, the suspensor was abandoned and the aforementioned investigations were performed again. In the suspensor-wearing period, all men became azoospermic after a mean of 139.6 +/- 20.8 sd days, with decrease in both testicular volume (P less than 0.05) and rectal-testicular temperature difference (P less than 0.001). Serum reproductive hormones showed no significant change (P greater than 0.05). Seminiferous tubules revealed degenerative changes. No pregnancy occurred during this period. The polyester suspensor generated electrostatic potentials (mean 366.4 +/- 30.5 sd volt/cm2 by day and 158.3 +/- 13.6 sd volt/cm2 by night). In the suspensor-release period, the sperm concentration returned to the pre-test level in a mean period of 156.6 +/- 14.8 sd days. Likewise, the testicular volume and rectal-testicular temperature difference were normalized. The 5 couples, who had planned to become pregnant, conceived. The azoospermic effect of the polyester sling seems to be due to two mechanisms: 1) the creation of an electrostatic field across the intrascrotal structures, and 2) disordered thermoregulation. To conclude, fertile men can be rendered azoospermic by wearing the polyester sling. It is a safe, reversible, acceptable and inexpensive method of contraception in men.

PIP: Every 2 weeks, a physician at the Faculty of Medicine at Cairo University in Egypt examined 14 32-47 year old male volunteers wearing a polyester scrotal sling day and night for 12 months to determine if polyester fabrics can act as a contraceptive in men. They changed the sling only when it became dirty. None of the men dropped out of the study. The sling did not cause any complications or reactions. Their partners took an oral contraceptive until 3 sperm samples proved the men to be azoospermic. The men became azoospermic from 120-160 days (mean 139.6 days) after 1st putting on the sling. They remained azoospermic throughout the study. None of the partners became pregnant during the study. All 5 couples who wanted a pregnancy after the study period did indeed conceive. 4 had normal live births and 1 a miscarriage. The volume of their testicles fell greatly from 22.2-18.6 sd ml during the 12 months (p.05), but returned to pretest levels 75-135 days after removal. Further the mean rectal-testicular temperature difference was lower 3 months after wearing the sling than it was before they wore it (1.3-3 degrees Celsius; p.001). 3 months after they stopped wearing the sling, the mean rectal-testicular temperature difference reverted to normal. The polyester in the sling generated greater electrostatic potentials during the day than at night (326-395 volt/sq. cm. vs. 142-188 volt/sq. cm.; p.01). This was a result of the friction between the scrotum and the polyester sling. Germ cells of the seminiferous tubules still exhibited degenerative changes 6 months after removal of the sling. Within 140-170 days after removal, sperm concentration levels returned to pretest levels (40 million/ml). Apparently the electrostatic field effect and the disordered thermoregulatory effect of the polyester sling produced azoospermia. In conclusion, the sling is a safe, acceptable, inexpensive, and reversible method of contraception in men.

Helping patients to reduce their risk of acquiring sexually transmitted disease.

This monthly series was developed from the AOA Task Force on AIDS Writers' Workshop, held August 16 to 18, 1991, in New York. The workshop was sponsored by an education grant from Burroughs Wellcome. It will provide brief clinical updates and perspectives on the human immunodeficiency virus (HIV). Readers may request tear sheets from the AOA editorial offices.

PIP: Counseling patients about sexually transmitted disease (STD) prevention is imperative to primary care. Physicians have a tendency not to discuss STDs, however. The AIDS epidemic makes STD counseling very essential. In the US, heterosexual adolescents and heterosexual women suffer from the highest increase in HIV infections rates. AIDS 1st struck the homosexual community which has reduced the incidence of all STDs including HIV infection by counseling and condom use. Thus physicians should speak to their patients frankly about STD prevention including the details of how to use a condom properly regardless of their STD and HIV status. They should also promote sex education of younger people before they become sexually active. The only way to not acquire STDs is to practice sexual abstinence. Another safe way to prevent STDs is a monogamous relationship between uninfected partners. If a partner was sexually active in the past, he/she should undergo serologic testing to determine STD and HIV status. Each sexually active individual not in a monogamous relationship must practice risk reduction behavior to prevent transmission of STDs and HIV. The best condom to use is a latex condom with a tip and lubricated with the spermicide nonoxynol-9. Users must put on the condom on an erect penis before it comes in contact with any mucus regardless of the mucous origin. The man should withdraw the condom protected penis while still erect. Physicians should stress to younger or sexually less experienced people the difference between contraception and prophylaxis. They should also inform all patients that anal intercourse is the riskiest sexual activity. Vaginal intercourse, fellatio, and cunnilingus also pose sizable risk of STD and HIV transmission. Physicians must remind patients to be extra careful during oral or anal intercourse and that condoms can leak. They must remember that low risk groups do not exist, but low risk behaviors do.

Altered surface character of stretched condom latex.

A new type of imperfection in condom latex, present during moderate stretching, was observed by low magnification scanning electron microscopy. The normally smooth surface of relaxed natural latex was transformed into an accordion-like arrangement of ripples in addition to tears. A corollary experiment with Alcian blue dye placed into both stretched and unstretched condoms leaked no dye. These surface features are consistent with latex acting as a molecular barrier. The tears may represent areas of lowered mechanical resistance and raise questions concerning quality control.

PIP: The dependability of latex condoms was investigated using the electron microscope (SEM) to examine the stretched and unstretched state and the boundary lubricating ability of biological fluids. Ramses 19 nonlubricated latex condoms and one other available by retail purchase within 6 months of manufacture were uses. Stretching was accomplished over a circular graphite electron microscope holder and fixed in place with adhesive. Surfaces were washed with running distilled deionized water for 5 minutes in order to remove dusting powder, and air dried. Then condoms were sputter coated with a 20 nm thick layer of gold palladium to increase conductivity. An Amray 1400 SEM operating at 10 keV was used to examine the condoms and images were recorded on Polaroid 52 black and while film. Condoms from the same lots were filled with 1% (w/v) toluidine blue and inserted in a container of 230 ml distilled deionized water for an hour. Then the condom was assayed spectrophotometrically at 640 nm for the presence of the blue. The results indicated rippling and tears following colinearly the direction of the stretch, and did not appear to be related to age of the condom. Unstretched latex appeared under low magnification different from stretched in that there were puckers and dimples but no holes. Stretched latex showed acordianlike ripples in the direction of the stretch and characterized the entire stretched surface. Tears were formed perpendicular to ripples to a length of 48 +or- 12 um se (n=10) in a straight line. It could not be determined whether the tear extended through the full thickness. The dye experiment was used to assess the tears. It was found that a small molecule like tuluidine blue with a molecular weight of 306 daltons was contained. Important considerations of these results were twofold. 1) A rippled latex surface may provide greater depth penetration of ozone, which increases the rate of deterioration during extended condom use. 2) Since the thickness of condoms tested was .065 mm out of the possibilities o .04, .065, and .1 mm thickness, condoms may be strengthened by increasing the thickness. Lower rates of condoms breakage are reported with thicker condoms. Questions are also raised about whether quality control measurements should be performed; i.e., air burst, tensile strength testing.

Condom performance during vaginal intercourse: comparison of Trojan-Enz and Tactylon condoms.

Forty-nine mutually monogamous couples used a total of 478 condoms during vaginal intercourse in a prospective trial whose purpose was to discover whether the performance of a new non-latex hypoallergenic condom was substantially equivalent to that of a leading condom brand already being marketed. Of these 478 condoms, seven (1.46%) either broke or fell off the penis during intercourse. Two (0.42%) of the 471 condoms that did not break or fall off during intercourse fell off the penis when it was being withdrawn from the vagina. Altogether, 469 (98.1%) of the 478 condoms used for intercourse survived intact throughout intercourse and withdrawal. Differences in breakage and slippage rates for the two condom brands were statistically insignificant. The overall 98.1% success rate is much higher than the rate of success found in a previous condom trial with nearly identical research protocol. The reason for the difference is attributed to much more precise questioning of subjects in the current trial.

PIP: This comparative study of the Tactylon condom and the Trojan-Enz condom was conducted in order to obtain FDA market approval. 50 female subjects were recruited through public notices for hospital and university personnel. The requirements were that female subjects must be between the ages of 18-55, fertile and not presently using another contraceptive, and not at risk for or have a significant medical history of sexually transmitted disease. Male partners were also to be in good health and currently not using another form of contraception. Couples were to use condoms in 10 acts of intercourse over a 5-week period without a lubricant. Each couple received 5 of each kind of condom and 10 questionnaires, each numbered sequentially from 1 to 10. Condoms and questionnaires were to be used in sequential order beginning with 1. Half the couples started with the Tactylon condom and the other half with Trojan-Enz. Demonstrations and instruction were given for use. Caution is advised in interpreting breakage rates due to the small sample sizes (250 for each brand). 49 of the subject completed the study. 82% were black and 18% were whites, non-Hispanic. 45% were married, 24% single, 27% were divorced, and 4% separated. 14% were nulliparous, 27% with 1 child, 37% with 2 children, and 22% with 3 children. 37% reported incomes of 20,000 or 35,000. The mean age was 34.4 for females and 37.2 for males. 84% of males were circumcised. The average monthly number of acts of intercourse was 14.5 and yearly 147.2. Condoms were used in this study similar to past behavior, with 10 condoms used in 21 days. 45% had not used condoms in the preceding month, and 16% in the preceding year. 10% had never used condoms in their relationship. The average use of condoms for those using in the past month was 7.8. The average breaking rate per condom for those who used condoms in the prior month was 6.2%, and in the prior year 5.0%. The breakage and slippage rates were high. Conditions for breakage and slippage were defined and clearly recorded. Evaluation for pleasure was requested of each party. The results were that breakage and slippage rates were similar for the 2 condoms, and lower than prior use and unrelated to use of a lubricant or prior use conditions. The frequency of slippage necessitates further research. The falling off rate of 3 in 472 condoms was not statistically different from retrospective rates of users. Prior trial rates were higher perhaps due to the condoms being lubricated, or the changed wording on the questionnaire to differentiate falling off. The subject's evaluations of condoms were also similar for both condoms.

Implicancias del control de calidad de preservativos en la prevención de las enfermedades de transmisión sexual / Legal impediment of quality control in the prevention of sexuals transmition diseases

Se realizó un estudio de control de calidad de los preservativos ofrecidos a la venta al público en Lima Cercado con la finalidad de determinar si cumple con los requisitos de control de calidad formulados por el ITINTEC y evaluar si son adecuados para la prevención de las ETS. Se utilizó un procedimiento de muestreo por conglomerados, utilizando como marco muestral el plano de Lima Cercado, los sectores fueron seleccionados utilizando una tabla de números aleatorios; se adquirieron 3 preservativos en cada sector obteniéndose una muestra de 96 unidades, las que fueron sometidas a los procedimientos de control de calidad formulados por el ITINTEC en las normas técnicas nacionales 399-146, 399-147. El 42.7 por ciento de las unidades fueron adquiridas en farmacias y 57.3 por ciento en puestos de venta ambulatoria; 86.5 por ciento corresponden a la marca Sultan producidos en Estados Unidos. Al ser sometidas a los procedimientos de control de calidad, 3 (3.13 por ciento) de las unidades fallaron en el ensayo de ausencia de perforaciones; 6 (6.25 por ciento) fallaron en el ensayo de resistencia de perforaciones; 6 (6.25 por ciento) no cumplían el espesor mínimo requerido, 6 (6.25 por ciento) fallaron en el ensayo de resistencia a la tensión y 1 (1.04) unidad tenía un tiempo de manufactura superior al de vencimiento. En total 15 unidades (15.63 por ciento intervalo de confianza del 95 por ciento con límites entre 9.02 por ciento y 24.46 por ciento) no cumplen los requisitos de control de calidad. No se encontraron diferencias estadísticamente significativas en cuanto a la calidad de los preservativos adquiridos en farmacias o en puestos de venta ambulatoria. Se revisó la literatura para discutir la eficacia preventiva del preservativo frente a las enfermedades de transmisión sexual ; existen evidencias que sustentan el efecto protector del preservativo, pero se necesitan estudios mejor diseñados para establecer de manera concluyente su efecto protector. Se concluye que los preservativos ofrecidos a la venta al público en Lima Cercado no cumplen los requisitos de control de calidad y por lo tanto no son adecuados para la prevención de las enfermedades de transmisión sexual

Test method for evaluating the permeability of intact prophylactics to viral-size microspheres under simulated physiologic conditions.

The alarming number of AIDS cases has increased the attention given to barrier devices such as condoms. The authors describe a new test method that evaluates the permeability of the intact condom when subjected to simulated physiologic conditions. Fluorescent-labelled polystyrene microspheres (110 nm diameter) are used to model cell-free virus. Physical and chemical conditions that are present during coitus, such as pressure, pH, and temperature, are considered in the design of the method. The testing chamber is designed to be continuously monitored for changes in fluorescence due to leakage across the condom surface. The sensitivity of the system is 1 x 10(-5) of the original concentration of microsphere solution (3.4 x 10(11) particles/mL), which corresponds to leak rates as small as .001 microL/sec. The test provides an in vitro test of barrier material permeability relevant to actual use.

Condom use and breakage among women in a municipal hospital family planning clinic.

For those who choose to be sexually active, condoms are the best available means of protection against sexually transmitted diseases including the human immunodeficiency virus (HIV), which causes acquired immunodeficiency syndrome (AIDS). Condoms are also an effective method for preventing pregnancy. Unfortunately, condoms are not 100% effective at preventing pregnancy or the spread of infection, in part because condoms do break. In order to gain insight into condom breakage, a questionnaire was administered to women attending a municipal hospital family planning clinic. Thirty-six percent of the 106 subjects had experienced at least one condom breakage. Condom breakage occurred in approximately 1 out of 100 acts of intercourse using condoms, with a lifetime breakage rate of 10 per 1000 condom uses and a past year breakage rate of 8 per 1000 condom uses. Breakage rates did not differ substantially by age. Five percent of the women's unplanned pregnancies were attributed to broken condoms. The results of this study corroborate previously reported rates. Factors associated with these women's most recent breakage experiences included: vaginal intercourse, minimal foreplay, and breakage prior to ejaculation. Controlled studies will be needed to determine how the condom can be used to reduce the likelihood of breakage.

PIP: For those who choose to be sexually active, condoms are the best available means of protection against sexually transmitted diseases, including human immunodeficiency virus (HIV), which causes acquired immunodeficiency syndrome (AIDS). Condoms are also an effective method for preventing pregnancy. Unfortunately, they are not 100% reliable at preventing pregnancy or the spread of infection, in part because condoms break. In order to understand condom breakage, a questionnaire was administered to women attending a municipal hospital family planning clinic. 36% of the 106 subjects had experienced at least 1 condom breakage; condom breakage occurs in approximately 1 of 100 acts of intercourse where the condom is used, with a lifetime breakage rate of 10/1000 condom uses. The past year breakage rate was 8/1000 condom uses. The past year breakage rate was 8/1000 condom uses. Breakage rates did not differ substantially by age. 5% of the women's unplanned pregnancies were attributed to broken condoms. Results of this study corroborate previously reported rates. Factors associated with most recent breakage experiences included: vaginal intercourse, minimal foreplay, and breakage prior to ejaculation. Controlled studies will need to determine how the condom can be made to better withstand the likelihood of breakage.

A study of the relationship between tensile testing of condoms and breakage in use.

The ability of the condom wall to maintain its integrity throughout sexual intercourse is critical to its role in halting the spread of major sexually transmissible pathogens including the human immunodeficiency virus. There are three principal in vitro performance tests applied to condoms: a test for freedom from holes, an inflation test, and tensile testing. In this study we subjected condoms that had broken in use to tensile tests in order to determine any correlation between their in vivo and in vitro performance. Condoms which had broken in use showed similar tensile properties to those which had not. All passed all tensile test criteria. Thus, the inclusion of tensile testing in National Standards for condoms is not sufficient to insure strong products.

A common disinfectant used in condom processing inhibits endonuclease digestion of sperm DNA.

DNA recovered from a condom found at a crime scene appeared undigestible with restriction enzymes, preventing characterization by Southern blot and polymorphic probe hybridization. Several chemical substances used in the processing and treatment of condoms were tested for inhibitory action of restriction enzymes. In particular dibenzalkonium chloride appeared to promote enzyme inhibition at very low concentrations. The effectiveness of treatments to restore cleavage of sample DNA in the presence of such contaminants is discussed.