Demand for male contraception.

The biological basis for male contraception was established decades ago, but despite promising breakthroughs and the financial burden men increasingly bear due to better enforcement of child support policies, no viable alternative to the condom has been brought to market. Men who wish to control their fertility must rely on female compliance with contraceptives, barrier methods, vasectomy or abstinence. Over the last 10 years, the pharmaceutical industry has abandoned most of its investment in the field, leaving only nonprofit organisations and public entities pursuing male contraception. Leading explanations are uncertain forecasts of market demand pitted against the need for critical investments to demonstrate the safety of existing candidate products. This paper explores the developments and challenges in male contraception research. We produce preliminary estimates of potential market size for a safe and effective male contraceptive based on available data to estimate the potential market for a novel male method.

Identification of allergenic proteins in condoms by immunoenzymatic methods.

BACKGROUND: A large increase of allergy to latex proteins has been observed lately probably as a result of a great use of latex-containing goods. At present these untoward reactions have led to consideration of this problem as a health and occupational hazard. It is therefore, necessary to identify the allergens contained in latex-manufactured products and to develop effective diagnostic tools to detect sensitized individuals. OBJECTIVE: The objective of this study is to identify antigenic and allergenic components in latex condoms by using chemical, immunochemical, and immunoenzymatic methods. METHODS: The protein content of extracts obtained from several brands of condoms was determined and characterized by using a modified Lowry method, a quantitative ELISA assay and SDS-PAGE. The allergenic behavior of these proteins was studied by IgE immunoblotting, EAST and ELISA techniques, using sera from subjects allergic to latex products, particularly to latex condoms. RESULTS: Wide variations in the protein content (38 to 740 microg/g product) and composition were observed. The SDS-PAGE protein profiles showed components ranging from 7 to 94 kD of relative molecular weights; most of them were also detected in natural rubber latex. The most prominent bands were revealed in the 14 and 30 kD zones. A strong band of 69 kD in the SDS-PAGE profiles would correspond to a neoantigen, since it was not observed in natural latex. The immunoblotting analysis employing sera from 5 patients allergic to latex condoms showed the presence of 4 components with IgE binding capacity (14, 30, 69, and 94 kD). The EAST and ELISA methods showed the presence of allergens in all the condom brands studied. CONCLUSIONS: The presence of allergenic proteins in several condom brands was demonstrated by different immunoenzymatic methods.

Effect of external urinary collection system on colonization and urinary tract infections with Pseudomonas and Klebsiella in men with spinal cord injury.

Urinary tract infection of men with spinal cord injuries has been associated with a high incidence of colonization of the patients with gram-negative bacilli. We have examined the factors influencing colonization of 119 patients with Pseudomonas and Klebsiella and studied methods of reducing this colonization. The urethra, perineum, rectum, and drainage bag of all patients were cultured on selective media at two week intervals until discharge. The use of the external urinary collection system (EUCS) was discontinued in a group of patients at night, in an attempt to reduce colonization. Pseudomonas and Klebsiella were isolated from one or more body sites in 65 percent and 69 percent of total culture days. The urethra, perineum, rectum, and drainage bags were reservoirs of Pseudomonas and Klebsiella in men with spinal cord injuries, even in the absence of urinary tract infections. The EUCS proved to be an important factor influencing colonization. Pseudomonas and Klebsiella colonization was higher in patients using the EUCS. Removal of the EUCS at night reduced urethral colonization with Pseudomonas, but did not significantly reduce urethral colonization with Klebsiella. The prevalence of bacteriuria with Pseudomonas and Klebsiella was not significantly influenced by the use of the EUCS.

[Urethral lesion caused by a condom: description of a case]. / Lesione uretrale da "condom": descrizione di un caso.

We report a case of severe urethral lesion in a male patient with a vascular cerebral stroke. The wrong application of condom catheter without pain or other symptoms developed the urethral lesion.

Contact urticaria caused by rubber. Analysis of seven cases.

Prior to 1979, there had been no reports of contact urticaria to rubber products. Since that time, many cases have been reported. At New York University, the first case, secondary to cornstarch allergy, was seen in 1985. Since that time, we have seen an additional six cases, five of them in the last year. Of these six cases, three were attributable to H. brasiliensis and three to the accelerators. Although the use of latex products has increased dramatically within the past 9 years in response to the epidemic of human immunodeficiency virus infections, it is not clear whether increased exposure alone accounts for the sudden increase in the number of patients with contact urticaria. Four of the patients presented here are hospital personnel involved in surgical procedures, in which, for decades, latex gloves have been used. Furthermore, two of our seven patients are paraplegics, who, as a group, have long had frequent exposure to rubber products. Two possibilities seem most likely: either the diagnosis has been missed by physicians for decades, or in response to the worldwide demand for latex products, the manufacture of latex has become altered in such a fashion that more products from which the allergens (accelerators and H. brasiliensis) are easily leached are now reaching the marketplace.

The vaginal contraceptive diaphragm and the condom--a reevaluation and comparison of two barrier methods with the rhythm method.

The use-effectiveness and continuation rates of two barrier methods of contraception, the diaphragm and condom, were studied during a two-year follow-up in a group of 85 and 98 women, respectively. All were highly motivated. Results were compared to a group of 64 women using the periodic abstinence or rhythm method, i.e. not using any contraceptive. The patients selected the method of contraception they preferred and were instructed in their proper use. Results showed good continuation rates in the groups using a diaphragm and the condom for 2 years, for a total follow-up of 5570 cycles. Pregnancy rate after 24 months of use, as calculated by Pearl's formula, was 2.48 for the diaphragm, 3.21 for the condom, and 5.19 in the rhythm group. No serious side effects or complications occurred in either group. The study demonstrated a fair acceptability and use-effectiveness for barrier contraceptive. We suggest that these harmless and complication-free methods may still be reasonable alternatives for the "modern" methods, the pill and the IUD.

Allergic reactions to rubber condoms.

With the increased use of condoms, contact dermatitis to rubber is being seen more often. To develop a rubber condom suitable for use by rubber sensitive people, a "hypoallergenic" condom, which is washed in ammonia to reduce the residues of rubber accelerators, has been manufactured. Fifty patients allergic to various rubber accelerators were patch tested with an ordinary condom and the new washed condom. Fifty patients undergoing routine patch test investigation who were not allergic to rubber were also tested as controls. Twenty two of the rubber sensitive patients had a positive reaction to the new rubber condom compared with four of the control patients. Washing rubber condoms in ammonia does not appear to reduce the residues of rubber accelerators sufficiently for their use by rubber sensitive people. A non-allergenic condom is required.

PIP: Contact dermatitis to rubber is more common with increased use of condoms, due to the acquired immunodeficiency syndrome (AIDS). A condom has been produced which is washed in ammonia to reduce the residues of rubber accelerators for use by people sensitive to rubber. Testing done on rubber sensitive people indicate that 44% of them reacted to the washed condom and therefore would be unable to use them as well. Contact dermatitis to rubber is a well established clinical problem; 5- 10% of all patients are allergic to rubber compounds including gloves and footwear. There may be many unreported cases because the doctor has not considered this, or the patient was too embarrassed to inform the doctor. Washing the condom in these solutions reduces the shelf life of the product from 5 years to 18 months. Condoms made of sheep gut made in the US can be used by rubber sensitive patients, and also polyurethane condoms made in Denmark are available. There is a need for more development of non-rubber or non-allergenic condoms.

Condoms as a source of latex allergen and cause of contact urticaria.

To examine the occurrence of latex allergen in condoms and to study the symptoms caused by contact with condoms, 46 patients with latex-glove contact urticaria (LGCU) were investigated. 7 (24%) of the 29 patients with a history of condom use had experienced local swelling and/or pruritus during intercourse, confirming that condoms can cause local symptoms in latex allergic subjects. Prick tests performed on 16 different condom brands showed that 4 brands caused positive reactions in 52-67% of patients. The remaining 12 brands were not as allergenic and 1 brand was totally negative on prick testing. 1 highly allergenic condom brand was examined by high-pressure liquid chromatography (HPLC), which showed similar protein profiles to those detectable in latex gloves and natural rubber. These results show that, in addition to rubber gloves and balloons, condoms should also be considered as possible sources of latex, and that patients with LGCU should be advised to avoid condoms.

[Rubber gloves and condoms cause immediate hypersensitivity]. / Kumikäsineiden ja kondomin aiheuttama välitön yliherkkyys.

PIP: Surgical gloves, condoms, and air balloons made of natural rubber or latex contain approximately 2% protein. With the use of instruments made of rubber, reddening, urticaria, itching, and, in extreme cases, anaphylactic reaction can occur. Milder symptoms disappear within 1/2-2 hours without intervention. In the past 5 years, 100 such cases have been reports, 50% from Finland and Sweden. During testing of hospital personnel, 15 out of 512 people developed urticaria caused by the latex content of surgical gloves. According to Finnish data, another 24% of those allergic to gloves got similar urticaria or itching from using condoms. There was a US report of a case of anaphylactic reaction caused by the condom. The sensitivity test can be based on the determination of immunoglobulin E (IgE) antibody or on the determination of histamine release. The reliability of the former is 60% and that of the latter 94%. The symptoms are treatable, but it is best to avoid contact with materials containing latex; in surgical practice it is advisable to use gloves made of artificial rubber, such as Elastyren or Dermaprene.^ieng

Condom dermatitis in either partner.

PIP: Condom sales rose in the 1980s because condoms protect against the spread of sexually transmitted diseases and AIDS. In anticipation of corresponding increase in the incidence of condom dermatitis, a dermatologist prepared a brief overview of the condition and ways to treat it to prepare health professional for the anticipated increase. In men, allergic reactions may consist of edema of the penis, especially the prepuce; penile itching; and eczematous dermatitis which extends to the scrotum, inguinal areas, and the inner thighs. Symptoms in women vary and may include pubic and groin dermatitis, vulvitis, pruritus vulvae, a burning vaginal sensation, vulval redness and edema, and eczema on nearby skin. Antioxidants or accelerators in the rubber are generally responsible for condom dermatitis. When a health professional believes the dermatitis to be allergic rubber condom dermatitis, he/she should request patch tests for the same make of condom that came in contact with the patient and for rubber chemicals known to induce an allergic reaction, e.g., mercaptobenzothiazole (MBT). To assist, the dermatologist includes a patch test series for such allergens. Natural latex condoms and condoms made of processed sheep intestine cecum may prevent most allergic reactions. Sometimes patients are allergic to condom lubricants, and not the rubber itself. Health professionals must be sure to inform dermatitis patients allergic to the lubricant to not switch to oils or petroleum jelly because they destroy the rubber. Spermicidal contraceptive agents also can cause contact dermatitis, particularly nonoxynol 9. A condom with corn starch can produce urticaria. Further, paralyzed male patients are especially prone to allergic dermatitis from either the rubber in the condom urinals and/or the medical adhesive.^ieng

[Contraceptive methods]. / Estemenetelmät.

PIP: Interest in contraceptive devices has increased in recent years due to their safety and protection offered against venereal disease. Use of the devices prevents sperm from entering the uterine canal. Failure of a device is usually caused either because the contraceptive outside the uterus is wrongly positioned or because not enough active spermicidal ingredients were released before ejaculation. Mass production of condoms was made possible through utilization of latex rubber. Different color and shape alternatives have made condom usage more popular in developing countries. The diaphragm and its variation, the cervical cap, are treated with spermicide and then placed inside the vagina. Correct size of the contraceptive is an important consideration. Spermicides consist of active substances that kill sperm, as well as a carrier substance such as foam, ointment and jelly. The newest preventive device is the contraceptive sponge, which can stay in place for up to 36 hours. IN vitro studies show that effectiveness of condoms is 0.5-2.0 (Pearl's index). Combination use of diaphragm and spermicide yields a protection rate of 2-20 (life-table index), and spermicides 0.3-30.0. Risks associated with these methods include local irritation. It was believed that some spermicides increased rats of miscarriage, Down's Syndrome and other chromosomal abnormalities, as well as limb anomalies. Diaphragm use increases potential for urinary tract infections. Toxic shock may occur with some users of sponge and diaphragm. All the mentioned contraceptives protect from infection, and are most suitable for people who cannot tolerate hormonal preparations or IUD's, who are in a casual sexual relationship or nursing mothers or youth.^ieng

Bacterial flora of the cervix in women using different methods of contraception.

Bacteriologic culture samples were taken from the cervix in three groups of 10 healthy, sexually active women using barrier contraception, oral contraceptives, or a levonorgestrel-releasing intrauterine contraceptive device. Culture samples for Candida albicans and Trichomonas vaginalis were taken, a cytologic vaginal smear was obtained, and an amine sniff test was performed; these were in addition to a routine gynecologic examination. Multiple bacteria were isolated from the cervix in women using oral contraceptives or an intrauterine contraceptive device, whereas lactobacilli alone dominated the flora of women using barrier contraception. Significantly more anaerobic bacteria were isolated from the cervix in oral contraceptive and intrauterine contraceptive device users when compared with the barrier method users. Symptoms and findings evident of anaerobic vaginosis were associated with the occurrence of anaerobic bacteria in the cervix of three patients using the intrauterine contraceptive device. The results showed that the cervical bacterial flora in sexually active healthy women is rich in anaerobes that can be regarded as a normal finding in women using oral contraceptives or intrauterine contraceptive devices. Barrier contraception with a condom prevents this anaerobic shift and maintains a lactobacilli-dominated flora in the cervix.

Relationship between contraceptive method and vaginal flora.

This study was undertaken to assess whether the vaginal flora was affected by the method of contraception, and in particular as to whether the incidence of vaginal candidiasis increased when oral contraceptives were used. One thousand and two consecutive vaginal or cervical swabs from women attending a family planning centre were cultured. Candida albicans was isolated from 13% of women using no contraception, 16% using oral contraceptives, and from 9%, 19% and 18% of those using diaphragms, intrauterine contraceptive devices (IUCD) and condoms respectively. These differences were not statistically significant. Women using an IUCD had significantly more Gram-positive cocci cultured than women in any other group, while those using diaphragms had significantly more Gram-negative bacilli. Our clinical impression that the use of oral contraceptives led to an increase in vaginal candidiasis, was not confirmed by this study.

PIP: Increase in the number of positive cultures for fungi of bacteria taken from vaginal or cervical swabs, in oral contraceptive (OC) users was assessed. Women attending a family planning center in Christchurch, New Zealand, had a vaginal or cervical swab taken prior to a cervical smear. The swabs were placed in transport media and then cultured on brain-heart infusion agar with added chloramphenicol for Candida albicans isolation and modified Thayer-Martin agar and blood agar for Neisseria gonorrhoea. The presence of Trichomonas vaginalis was ascertained by examining a wet preparation and by culture onto Trichomonas medium. Other aerobic bacteria were isolated from the blood agar plates and identified using standard techniques. The culture results from 1002 consecutive swabs were assessed. There was no difference in the rates of infection with C. albicans between the different contraceptive groups. Similarly, there were no differences when the OC group was subdivided into those with either standard dose, low dose, or no estrogen content. When a similar analysis was carried out for the isolation of Gram positive cocci, the groups differed significantly due largely to the high rate of isolation of Gram positive cocci from women using IUDs. The patients also differed signifficantly in the rate of infection with Gram negative bacilli. To limit the number of multiple comparisons, the diaphragm and IUD groups were compared; the isolation rate of Gram negative bacilli was significantly higher in the diaphragm group. The isolation rate of Gram negative bacilli from women using IUDs or condoms was significantly higher than in those women using OCs. T. vaginalis was isolated from 1 woman who had never used contraceptives, 2 who were not using them at the time the swabs were taken, 7 taking OCs, and 1 using condoms. N. gonorrhoea was isolated from 3 women using 3Cs and 1 using an IUD. OC use was not associated with an increased incidence of cervical or vaginal infection by C. albicans, T. Vaginalis, N. gonorrhoea, or by any bacterial species. The highest rate of isolation of Gram-positive cocci was seen in women using IUDs.