This chapter should be cited as follows: This chapter was last updated:
Kiley, J, Sobrero, A, Glob. libr. women's med.,
(ISSN: 1756-2228) 2008; DOI 10.3843/GLOWM.10385
June 2008

Contraception

Use and Effectiveness of Barrier and Spermicidal Contraceptive Methods

Jessica Kiley, MD
Assistant Professor, Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
Aquiles J. Sobrero, MD (Deceased)
formerly Professor Emeritus of Obstetrics and Gynecology, Northwestern University Medical School, Chicago, Illinois, USA

INTRODUCTION

The prevention of pregnancy is an integral part of modern medical practice and is of major public health interest. Each year, 80 million women worldwide experience unintended pregnancies.1 Methods for controlling fertility are necessary and desired. Traditionally, the practice of family planning centered almost exclusively on the prevention of unwanted conception. In recent years, shifts in sexual behavior, infection risks, and disease burden have turned the focus of family planning towards more complete women's reproductive health.2 In particular, family planning addresses the dual threats of unintended pregnancy and prevention of sexually transmitted disease (STD) infection, especially human immunodeficiency virus (HIV) infection and subsequent development of acquired immunodeficiency syndrome (AIDS).3 The widespread dissemination of HIV/AIDS has reached crisis levels and requires intervention by policymakers, health care providers, and patients alike. Disparities exist in the acquisition of HIV; women—especially young women—are more susceptible than men. Several factors contribute to this inequality; biological factors include differences in reproductive anatomy predisposing women to higher rates of infection, and social factors include problems in controlling the timing of intercourse, issues with partner infidelity, and gender inequality. Combining STD acquisition risks with the risk of pregnancy conferred by unprotected intercourse, women need methods of contraception which serve a dual role—simultaneous protection from STDs and unintended pregnancy.

The growing epidemic of STDs, in particular HIV/AIDS, has stimulated interest in mechanical and chemical contraceptives and has provoked a reevaluation of the social and public health impact they have in preventing both unintended conception and STDs. There are more than 20 diseases that may be acquired during sexual relations.4 Theoretically, during unprotected coitus, a woman could become pregnant and be infected with all STDs. From an infectious epidemiology perspective, at the time of coitus, a person is potentially exposed to the STD status of all previous mates of his or her current consort. Barrier contraceptives are the only contraceptive methods offering protection against STDs; however, this protection is not absolute. Prevention of HIV infection and other STDs is a global public health emergency. The AIDS pandemic and the recognition that coinfection with other STDs greatly facilitate HIV transmission have generated a new interest in barrier contraception because of the role they may play in controlling the spread of those diseases.5, 6, 7, 8, 9, 10 Because of the difficulty of carrying field studies in the United States (e.g. cost, reluctant very movable population, liability concerns related to side effects and contraceptive failures, not always related to the use of the product being tested), domestic data on new contraceptives are scarce. Development of new contraceptives and products that are safe, effective, and acceptable to consumers is a long, tedious, and arduous process, usually taking decades. In the meantime, imperfect as they are, it is important for health care providers to encourage use of available therapies. Barrier methods are the only devices currently available that help mitigate the impact of the expanding health crisis caused by HIV and other STDs. Anxiety about the magnitude of the progression of HIV infection has motivated even some Catholic authorities, always in opposition to contraception, to consent to their use to some extent.11, 12

CHARACTERISTICS OF BARRIER METHODS AND DETERMINANTS OF CONTRACEPTIVE EFFECTIVENESS

Barrier contraceptives are devices that physically prevent dissemination of sperm in the vagina, blocking the access of spermatozoa to the upper genital tract. Spermicides are pharmaceutical agents containing chemicals that kill or incapacitate sperm administered vaginally in a vehicle (gel, foam, cream, tablet, suppository, or film).13 Table 1 lists the common physical and chemical barrier methods of contraception. Barrier and spermicidal methods of contraception are coitus-dependent; all are temporally associated with sexual intercourse. All are female-dependent methods, except for the male condom. Barrier methods and spermicides may used alone or in combination with one another. Spermicides are often used in conjunction with barrier methods.

 

Table 1. Barrier contraceptives and spermicides

 
Physical barrier methods
Male condom
Female condom
Diaphragm
Cervical cap
Contraceptive vaginal sponge
 
Chemical methods
Spermicidal gels, jellies, creams
Vaginal foams, films, suppositories, tablets
 

Although there are marked differences among various barrier methods of contraception, there are also some similarities. They are intimately associated with the users' sexuality and sexual behavior. Each sexual encounter provides a unique situation in which the partners must decide whether to use the method. One or both partners must make a decision and take action before every episode of sexual intercourse. Therefore, barrier contraceptives demand substantial motivation and necessitate cooperation from the partner.

The decision to comply with a contraceptive method depends on the perceived risk of becoming pregnant, the desire to avoid pregnancy, and numerous other factors, such as the need for confidentiality, side effects, cost, self-efficacy, knowledge of how a contraceptive works, and noncontraceptive benefits. For many people, the successful and consistent use of barrier methods necessitates a change in sexual behavior.14, 15

Safety and Effectiveness of Barrier Methods

Barrier contraceptives are very safe. They are used inconsistently more often than noncoitus-dependent methods. Barrier contraceptive methods are the only ones currently recommended for the prevention of STDs and HIV, making them important for ensuring reproductive health. Finally, barrier contraceptives make an important contribution to family planning and public health because they are safe, have no systemic side effects or risks, are effective when used properly, and play a prominent role in the prevention of STDs.16, 17

Barrier methods are reputed to be less effective than other methods. This applies only to spermicides used alone; however, they have a significant historical role in the process of making contraception universally available.18 Most of them can be distributed easily through community-based organizations and women's health maintenance groups, and in developing countries by social marketing programs through existing commercial outlets. They extend the accessibility of reliable contraceptives to a greater number of people than ordinarily would be reached by the formal healthcare system. In particular, the male condom has been shown to reduce the spread of HIV infections in large populations, translating into significant public health benefits.19, 20

There are two measures of how a contraceptive works: efficacy (how it performs under ideal conditions, perfect use) and effectiveness (how well it works under typical use).16 Contraceptive effectiveness depends on many factors: frequency of intercourse, fecundity of the users, how the method is used, and the quality of the product. But more than for other birth-control methods, the effectiveness of barrier methods depends on how well couples use them.21 A method that is rated as less effective could actually be more effective for a particular couple if they use it correctly and regularly. Most contraceptive failures can be ascribed to inadequate compliance or misuse of the prescribed regimen. Barrier contraceptives and condoms used correctly at every episode of sexual intercourse are very effective in preventing pregnancy.15

The reported range of failure or pregnancy rates is vast, from fewer than one to more than 30 per 100 woman-years, depending on the study, the method, and the population.15 The best results are shown in clinical studies using exacting patient selection with considerable input of resources to diminish follow-up losses, reinforce instructions, counter weak motivation, and increase compliance by encouraging correct and consistent use, thus increasing the reliability of the data. Couples available for the follow-up required for clinical studies are often not representative of patients most likely to benefit from them. Thus, the results of most clinical studies tend to be better than the actual performance of any given method during general population use, when a method is more subject to human error and inconsistent behavior. Clinical studies of contraceptives are subject to investigator and participant biases, and study endpoint of use effectiveness should be viewed with caution. Measured thus imperfectly, the generally credited failure rates of various contraceptive methods are shown in Table 2. The physician prescribing a contraceptive should take into consideration the patient's lifestyle and preferences and must be nonjudgmental and unbiased in discussing the benefits and disadvantages of the methods available. Occasionally, physicians are criticized for their involvement in providing contraceptive advice, education, and prescription; however, more criticism is deserved for physicians who ignore an opportunity when contraceptive advice was pertinent, needed, and even requested.

 

 

Table 2. Percentage of women experiencing an unintended pregnancy in the first year of use, United States.

Method

Typical use (%)

Perfect use (%)

No method

85

85

Spermicides

29

18

Withdrawal

27

4

Periodic abstinence

25

 

Calendar method

 

9

Ovulation method

 

3

Cervical cap with spermicide  

Nulliparous women

16

9

Parous women

32

26

Sponge  

Nulliparous women

16

9

Parous women

32

20

Condom  

Female

21

5

Male

15

2

Combined pill and minipill

8

0.3

Ortho-Evra patch

8

0.3

NuvaRing

8

0.3

Depo-Provera

3

0.3

Intrauterine contraception  

ParaGard (copper T)

0.8

0.6

Mirena (levonorgestrel)

0.1

0.1

Female sterilization

0.5

0.5

Male sterilization

0.15

0.1

Source: Trussell J. The essentials of contraception: Efficacy, safety, and personal considerations. In: Hatcher R, ed. Contraceptive Technology. 18th ed. New York: Ardent Media; 2004:221-252.
 

Barrier methods' effectiveness as contraceptives and in STD and HIV prevention is enhanced by their consistent and correct use. Frequently, these methods are overlooked and not prescribed; more often, people may fail to use them, change to other methods, or abandon their use and switch to no contraception, resulting in more user failures.22 Conversely, a desire for the privacy offered by some barrier methods made them more acceptable, especially to women who are not willing to admit their sexual activity or will not consult a physician and be examined without having a health problem. For many potential users, the imminence of coitus and the fear of pregnancy are the only stimuli sufficiently powerful to arouse interest in contraception. Most barrier contraceptives are available over-the-counter without a prescription, do not necessitate a physical examination, and, for some people, in certain particular circumstances, may be the best or only effective method available. The correct and consistent use of barrier and spermicidal methods of contraception is determined by the complex interaction of the inherent attributes of the method, user characteristics, and situation. Method attributes include the extent of interference with sexual spontaneity and enjoyment, the amount of partner's cooperation required, and the ability of the method to protect against unwanted pregnancy, STDs, and HIV. User characteristics include motivation to avoid unintended pregnancy, fear of contracting an STD, ability to plan, cultural and religious attitudes regarding sexuality and contraception to which she is subjected, comfort with sexuality, and previous contraceptive experience. Characteristics of the relationship, stage of reproductive career, and previous sexual experiences are important situational influences. User preferences are critical considerations for practitioners recommending a contraceptive method, especially one that requires motivation for proper use.23

Obtaining valid estimates of the reduction in STD transmission conferred by barrier contraceptive use is challenging,24, 25 but it is clear that condoms provide significant protection from STDs, even with imperfect use.26, 27 It is reported that barrier and spermicide methods provide approximately 50% protection against STDs and pelvic inflammatory disease.28, 29, 30 Their use has been associated with lower rates of cervical cancer than other methods of contraception.31, 32, 33, 34, 35 Women who never use barrier methods have twice the chance of having cancer of the cervix develop.36 Barrier methods also contribute to the prevention of infertility.29, 30, 37, 38, 39, 40, 41 A rare problem associated with the use of certain barrier contraceptives is toxic shock syndrome (TSS), an uncommon but potentially fatal systemic infection with Staphylococcus aureus. Occurrences of TSS associated with the diaphragm and contraceptive sponge have been reported.42 However, the actual risk is exceedingly rare; the Centers for Disease Control and Prevention (CDC) estimates the annual incidence of TSS as 1–2 per 100,000 women.43, 44

Choice of Contraceptive Methods

Although their characteristics vary widely, each contraceptive method in use today has limitations. As such, there are currently gaps in women's ability to control fertility safely, effectively, and in culturally acceptable ways throughout their reproductive lives. The consistent use of barrier contraception depends on a woman's perception of her risks of pregnancy and sexually transmitted infection with each act of intercourse, and these risks may not be equally important to every woman.45, 46 Although a woman's fertile period is limited, no woman knows when ovulation occurs, so women should be advised to use contraception at all times. A woman is fertile only a few days every menstrual cycle. The chance of pregnancy of any one act of sexual intercourse has been estimated to be approximately 2–4%.47

The main considerations against the acceptability of barrier contraceptives are the necessity for touching the genitalia, messiness, storage, resupply, disposal, and direct relation to coitus. Some methods are bulky and difficult to store, carry, and use discreetly. In addition, planning and motivation are required to ensure consistent use. All these challenges occur to some extent with most users in most cultures.48

Contraceptive methods are complementary, not competitive. Each method offers a different balance of advantages and disadvantages, and the physician should be ready to advise or prescribe another method when the patient is not satisfied with the current one. The prescription or fitting of a contraceptive device should always be accompanied by thorough instructions for its proper use. Never assume the patient understands the correct use of the method chosen, and consider that the printed material for most contraceptives is usually above the level of literacy of the intended audience.49, 50, 51 Functional health literacy influences contraceptive understanding, attitudes, and behavior, and low literacy levels are a problem in family planning clinics.52 Women with more education are better able to control their own sexuality. More education is associated with better health outcomes, a lower number of pregnancies, and lower infant and maternal morbidity and mortality, as well as higher life expectancy.

Reproductive health involves not only the prevention of unintended pregnancy but also of STDs, especially HIV. To increase the degree of prevention, it is appropriate under many circumstances to recommend simultaneous use of two contraceptive methods (e.g. systemic hormonal contraceptives or IUDs and condoms, or sterilization and condoms). In fact, dual method use is widely advocated and has been the subject of intensive research in recent years.53, 54, 55, 56, 57 It has been speculated that emphasizing the important advantage of disease prevention increases the acceptability of condoms and their consistency of use. Patients usually attach different priorities to preventing pregnancy or STDs, and these priorities may change over time and among relationships.3, 58, 59, 60, 61

GENERAL INDICATIONS FOR BARRIER METHODS

Barrier contraceptives are indicated for: (1) women in whom other forms of contraception are contraindicated; (2) women who prefer a reversible contraceptive method without hormonal effects or requiring implantation of a specialized device; (3) women seeking an interim method until hormonal or intrauterine contraception is initiated or sterilization is performed; (4) women during lactation and the puerperium, often as an adjunct to lactational methods; (5) women who elect to use barrier methods for infrequent episodes of intercourse, (6) women who plan to conceive in the near future, and (7) women at risk for sexually transmitted infection, who may elect to use barrier methods alone or in conjunction with another contraceptive method (dual method use).

MALE CONDOMS

The condom (also known as a prophylactic, rubber, sheath, or French letter) is the only male method of contraception available besides coitus interruptus (withdrawal) and male sterilization. Its invention is attributed to Gabriel Fallopio (1564).62 It is one of the oldest and most extensively used contraceptives. The worldwide upsurge of STDs as well as the unstoppable pandemic of HIV/AIDS contributed to dilute most of the reservations about condoms and its use held by society at large. Because of its excellent record of infection prevention and contraceptive protection, its availability, and its simplicity of use, the condom has become a cornerstone of family planning care. It offers protection against unintended pregnancy and serves as the greatest defense against STD transmission; its historical role in the prevention of STDs is unmatched by any other method of contraception.

Benefits and Limitations

There is consistent clinical evidence from prospective studies of discordant couples, in which one partner is infected with HIV and the other not, that latex condoms used correctly during every act of sexual intercourse are very effective, not only in preventing unintended pregnancy, but also in HIV transmission.27, 63, 64 When used correctly during each sexual act, condoms are very effective in preventing unintended pregnancies and STDs. In this dual capacity, condoms may be regarded as the contraceptive gold standard against which all other contraceptive methods might be compared. In strict comparison, most other contraceptive methods fall short, because of their lack of ability to prevent sexually transmitted infection. Consider the specifications for an ideal contraceptive: high effectiveness, safe, reversible, inexpensive, free from side effects, small and inconspicuous, aesthetically acceptable, self-administered, simple to use, requiring no special skills or professional intervention, easy to store and distribute, offers STD prevention, long shelf life, and use independent of sex. Male condoms answer with ease all those requirements except the last, although the last criterion presents a major hurdle in effectiveness.65 Additionally, condoms play an important role in rare cases in which women are hypersensitive (atopic allergy) to contact with semen.

Male condoms confer several benefits. They are widely available, easily obtainable, and reasonably inexpensive (even provided without charge by many family planning and STD clinics and some student health services). Condoms are frequently distributed through public health campaigns and programs, increasing their availability.66, 67 They do not require prescription or fitting. Condoms have virtually no contraindications or side effects, except in persons with preexisting allergies to latex rubber or lubricant.68, 69 Problems possibly related to being powdered with talc have been reported.70, 71 Condoms are inconspicuous. They are simple to use, and their use is easy to teach and understand, even by people with limited education. Condoms can be used for sporadic or unanticipated coitus, or by those who have infrequent intercourse. Condoms are a viable method for couples who wish to share the responsibility for contraception, as well as when immediate assurance of successful protection against conception is psychologically important to either partner. They are valuable as an interim method before hormonal contraception is initiated or intrauterine contraception is inserted or sterilization is performed. Table 3 lists the indications and contraindications for male condom use.

 

Table 3. Indications and contraindications for male condom use

 
INDICATIONS
MaleFemaleBoth
Genital or penile disease, including active sexually transmitted infectionContraindications to hormonal or intrauterine contraceptionUncertain partner fidelity
Sensitivity or allergy to vaginal secretionsAs 'backup' method when use of other contraceptive methods (e.g. oral contraceptive or injectable) is suboptimalMale contraceptive control preferred
Temporary use while awaiting vasectomyTemporary use when initiating hormonal contraception, or awaiting intrauterine contraception or sterilizationRisk of sexually transmitted infection
Premature ejaculationGenital tract infection, including active sexually transmitted infectionSpontaneous sexual encounter or infrequent intercourse
 Vaginitis, including vaginitis under treatmentActive or suspected sexually transmitted infection
 Desires assurance that semen was no released into vaginaHistory of inactive viral sexually transmitted infection
 Aversion or allergy to contact with semen 
 Psychological, cultural, or religious conflict with personal use of contraception 
 Postpartum 
 
CONTRAINDICATIONS
Allergy to latex in either partner
Either partner unable or unwilling to use condom consistently
 
Modified from: Sobrero AJ Sciarra JJ: Contraception, In Cohn HP (ed): Current Therapy 1978, Baltimore, WB Saunders Company, 1978
 

Drawbacks or perceived negative attributes of the condom are its historic connection with illicit sex, promiscuity, and distrust of the partner's health. Like all barrier contraceptives, condoms necessitate persistent, recurrent motivation to achieve dependable protection against pregnancy and sexually transmitted infection. They must be used correctly at each sexual engagement. A commonly mentioned drawback is the need to interrupt intercourse for placement; however, couples may surmount this by making the placement of the condom part of the sexual experience.

Contraceptive Effectiveness and Protection against Infection

Condoms are made of latex rubber, polyurethane, and natural membranes (Lamb's cecal pouch). Most commercially available condoms are made of latex rubber. They come in an astounding variety of shapes (e.g. blunt or with a reservoir tip, ribbed, speckled, peppered with dots, contoured, with a helix or spiral rib, with a loose pouch over the glans or the penile shaft). Condoms come in an assortment of colors, combinations of colors, even fluorescent, and they may be flavored. They come in different sizes: standard (170 mm long and 50 mm wide), long (30% longer), extra-large (45% larger); narrower (6%); and shorter (15%). They come as extra-strength and extra-thin. They may be lightly powdered or lubricated with silicone or a water-soluble spermicide or without spermicide, or a desensitizing product. Their variety seems to be limited only by the imagination of the manufacturers. Indications are that there is a market for such diversity and attesting to the contemporary losing of old social restraints about sexual intimacy. Usually, condoms are neatly rolled and packaged flat in paper, plastic, or aluminum foil. They have a long shelf-life, especially if they are protected from direct sunlight, heat, oily substances, and ozone, all of which contribute to rapid latex deterioration.72, 73

Effectiveness of the male condom is associated with user ability, sexual practices, propensity for breakage, and issues related to manufacturing. Latex condoms lubricated with a spermicide are common and often favored. However, no studies demonstrate that condoms lubricated with a spermicide are more effective than unlubricated condoms in preventing pregnancy. Condoms with spermicide decrease the risk of pelvic inflammatory disease (PID), infertility, and ectopic pregnancy.74 Problems of slippage occur more often with lubricated than non-lubricated condoms. Regarding sexual practices, vigorous coitus appears to increase ruptures. Reported figures on the incidence of condom breakage suggest a range between 0–12%, with most publications giving figures of 2–5%.75, 76, 77, 78 In a US survey with a breakage rate of one to 12 per 100 episodes of vaginal intercourse, one pregnancy resulted from every three condom breakages.79

During manufacture, condoms are individually tested electronically for holes and imperfections, and must meet the stringent standards set by the American Society for Testing Materials and the US Food and Drug Administration (FDA).80 In the United States, condoms are imprinted with the date of manufacture or an expiration date. Aging is a major predictor for condom breakage, so patients must be advised to discard condoms when past their expiration date.81 However, equally important are the manufacturer's packaging and storage procedures and the user's appropriate handling at the time of intercourse. Latex condoms form a continuous, impervious barrier to bacteria and viruses. In vitro laboratory tests have shown that latex condoms provide effective protection against gonorrhea, nongonococcal urethritis, Chlamydia trachomatis, cytomegalovirus, human papillomavirus (HPV), herpes simplex virus, HIV, and hepatitis B virus.82, 83, 84, 80 One FDA study found that fluorescent polystyrene microspheres similar in diameter (110 nm) to the HIV virus (90–130 nm) could pass through 29 of 89 unlubricated latex condoms. The harsh physical conditions of the in vitro test under which the study was performed included 30 mL of a watery suspension of particles at a concentration 100 times that reported for the average normal human ejaculate (3 mL) under high pressure over 30 minutes. Based on the rigorous nature of study conditions, the authors acknowledge the superior capacity of the latex condoms in containing HIV virus. They emphasize that even in their worst-case scenario analysis (prevention of fluid transfer), condom use was 10,000 times better than not using a condom.78 In another, unique study, seamen on leave in a port with a high prevalence of infected commercial sex workers produced striking evidence of the effectiveness of the male condom in STD prevention. None of 29 sailors who reported using condoms became infected, but 71 (14%) of 499 sailors who did not use condoms contracted gonorrhea or nongonococcal urethritis.3 Women who are partners of HIV-positive condom users are less likely to seroconvert than those whose partners did not use condoms.85, 86, 87 One study followed 245 HIV-discordant couples for an average of 20 months. Among 124 who used condoms at every coitus, no new cases of HIV were detected among approximately 15,000 coital acts. Among the 121 couples who used condoms irregularly, 12 new cases of HIV resulted, an incidence rate of 4.8 per 100 person-years.27

Most users of condoms are more worried about avoiding unwanted conception than preventing an STD; however, this important personal and public health aspect of barrier contraception should not be relegated to a secondary role. It is worthwhile to emphasize that the prevention of STDs may prevent future infertility29, 39, 40, 74, 88 and cancer of the cervix.31, 32, 33, 34, 35 Barriers to condom use among women ages 15–30 years attending four Planned Parenthood clinics were related to two restricting factors: pleasure and intimacy, and low perceived need.89 Much contemporary research focuses on access to condoms and reasons for use and non-use in various domestic and foreign populations.90, 91, 92, 93

Nonoxynol-9 (N-9), the spermicide used in many lubricated condoms, causes release of a natural rubber latex protein that may increase the risk of allergic reaction in individuals with latex hypersensitivity.69, 94 Although theories suggest that latex condoms increase the risk of developing latex allergy, studies show that exposure to condoms does not increase the risk of subsequent latex allergy.95 For latex-sensitive persons, condoms with or without N-9 may cause an allergic reaction.68, 96 However, overall latex allergy associated with barrier contraceptive use is rare.

Latex-free and deproteinised latex condoms are good alternatives for latex-allergic patients.97, 98 Male synthetic condoms are manufactured using a dipped process similar to latex condoms or a cut-and-seal process using a synthetic elastomeric film. They are less elastic and wider than latex condoms, making them less constrictive. Avanti (London International Group, London, U.K.) is a popular, commercially-available synthetic male condom, FDA-approved in 1991. It is made from Duron, a thermoplastic polyester polyurethane, and it is straight-sided and reservoir-tipped. It is wider, approximately 64 mm when lying flat versus 52 mm for the standard latex condoms. Tactylon (Sensicon Corp., Vista, CA), another plastic condom produced by the dipping process from another synthetic elastomer, has been cleared by the FDA, but it is not found commercially. Three Tactylon models were manufactured (standard, baggy, and with a wider closed end of 80 mm) to allow greater comfort by diminishing glans constriction and to provide a more elastic, standard shape condom. Ezon (Mayer Laboratories, Oakland, CA) is another synthetic elastomeric condom, but it is not cleared by the FDA. It bears a unique design. Rather than being rolled on like latex condoms, Ezon is slipped onto the penis. Trojan Supra (Carter-Wallace Inc., New York, NY) is polyurethane male condom, FDA-approved and commercially available in the United States. It is somewhat larger than most condoms, measuring 189 mm long and 59 mm wide.99 According most reports, synthetic condoms break and slide more often than latex condoms.100, 101, 102, 103, 104, 105, 106, 107 A recent Cochrane review comparing latex-free and latex condoms reported that non-latex condoms are an acceptable alternative to latex condom use when indicated, despite higher rates of clinical breakage. The authors noted that the contraceptive efficacy of non-latex products needs further investigation.98

Natural membrane condoms made of lamb cecum are also available. They fit loosely on the penis and conduct more heat than latex condoms, supposedly providing more sensitivity during intercourse. Their thicknesses are variable but similar to that of rubber latex condoms (approximately 0.07–0.08 mm). They are considerably more expensive than their latex counterparts. These condoms must be kept moist to prevent cracking of the animal membrane, so they are packaged with water-based lubricant. Laboratory tests show that natural membrane condoms contain micropores that allow passage of HIV, hepatitis B virus, and herpes simplex virus, and thus they are not indicated for STD prevention. No use-effectiveness data are available on natural membrane condoms, but they have been shown to prevent the passage of sperm and are permitted by the FDA to be labelled for pregnancy prevention.108, 99

In recent years, much deserved attention has centered on the ability of N-9 to prevent HIV transmission. Disruption of the vaginal and upper reproductive tract epithelium by N-9 was demonstrated in animal and human studies.109, 110, 111 Concern developed that N-9 actually increased HIV transmission, due to viral entry through microscopic lesions in the vaginal mucosa caused by the spermicidal agent. A 2003 World Health Organization report summarized the research findings on use of condoms with N-9 lubricant. The committee concluded that condoms with N-9 were not more effective than condoms alone in pregnancy prevention, and that such condoms should not be encouraged for use. Use of condoms with N-9, however, was better than using no condom at all. N-9 was found to increase the risk of HIV transmission in high-risk women, but it remains a contraceptive option for women at low risk of HIV infection.112 

Some research suggests an association between male condom use and urinary tract infection (UTI) in females. Condoms lubricated with N-9 have been associated with an increased frequency of UTIs with Escherichia coli and Staphylococcus saprophyticus versus condoms without the spermicide,113, 114, 115, 116 and others conclude that non-lubricated condoms are also associated with UTI.117

The first-year failure rates for male condoms with typical use is usually quoted as 15% in the United States.16 Data from the 2002 National Survey of Family Growth document a 17.4% pregnancy rate in the first year of condom use. Risk factors for condom failure included younger age, multiparity, non-Hispanic black race, and poverty.118 The contraceptive effectiveness of the condom is acknowledged to be less than that of oral contraceptives, hormonal injections, implantable contraceptives, and intrauterine contraception. However, condoms used consistently and correctly are highly effective at preventing pregnancy, with perfect-use failure rates of only 2%.16

Clinicians, counselors, educators, and public health advocates all serve as sources for encouraging proper condom use. All must be familiar with the instructions for condom use and be able to direct patients appropriately (Table 4).

 

Table 4. Instructions for proper male condom use

For prevention of STD transmission, use condoms made of latex rather than natural membrane, except in cases of latex allergy.
Do not use torn condoms, those in damaged packages, or those with signs of age (brittle, sticky, discolored, past expiration date).
Place the condom on the penis before it touches a partner's mouth, vagina, or anus.
Place the condom on the penis when it is erect. Make sure you have the rim side up so you can unroll it all the way down to the base of the penis, before the penis comes in contact with a body opening.
Leave a space at the tip of the condom to collect semen; remove air pockets in the space by pressing the air out towards the base.
Use only water-based lubricants. Lubricants such as petroleum jelly, mineral oil, cold cream, vegetable oil, or other oils may damage the condom.
Replace a broken condom immediately.
After ejaculation and while the penis is still erect, withdraw the penis while holding the condom carefully against the base of the penis so that the condom remains in place.
Do not reuse condoms.
Modified from: Fox CE. Clinician's Handbook of Preventive Services, 2nd edition. U.S. Department of Health and Human Services, U.S. Government Printing Office, 1998.
 

Although issues exist with consistent method use, the dual function role of male condoms in preventing pregnancy and sexually transmitted infection must be emphasized. Currently, the condom is the only available method providing dual protection, and this importance must be conveyed to users for promotion of individual and public health.

FEMALE CONDOM

The female condom offers female-controlled dual protection against STDs and pregnancy, and thus is an important recent development in barrier contraceptives. First introduced in Europe in 1992, they were first approved for use in the United States in 1993. They are produced under a variety of brand names—FC, FC2, Reality, Care, Protectiv', Femy, Dominique (Female Health Company, Chicago, IL); V'Amour, Reddy, VA-Feminine (Medtech Health Products, Chennai, India). Others are in various stages of development.119 In addition to the benefits of female control, it carries the advantage that it can be inserted well in advance of coitus.120, 121, 122 Most female condoms are made of polyurethane, which is hypoallergenic, stronger, and more resistant to heat than latex condoms, and it is not sensitive to oily lubricants or storage under conditions that would damage rubber latex condoms.120 The FC2 condom, introduced in 2005, is composed of nitrile and has similar properties.123

A soft polyurethane pouch to be used by women prevents contact with the penis and the ejaculate. The female condom (Fig. 1) consists of a soft, medical-grade polyurethane sheath open at one end and closed at the other. It has two flexible rings of the same material, one at each end. The external open ring is designed to stay outside the vagina, resting against the vulva. The inner ring, at the closed end of the sheath, is firmer and must be inserted into the vagina. The device is lubricated with a silicone-based lubricant without spermicide and an additional supply of lubricant. Insertion is facilitated by squeezing the inner ring with one hand while separating the vulvar labia with the other as when inserting a tampon or a diaphragm. Care should be taken not to twist the sheath; otherwise, insertion of the penis will be impossible. The internal ring should be pushed beyond the pubic bone and as close as possible to the cervix. The internal ring, which is not incorporated into the wall of the condom, should not be removed. After intercourse, the open ring should be squeezed and twisted to keep the semen inside without spilling. The device is intended for single use.

 

Fig. 1. Clockwise from top left. ( A) Reality female condom. ( B) Holding it for insertion. ( C) Insertion. ( D) Pushing the internal ring beyond the pubic bone, close to the uterine cervix, and ( E) the device in place.

 

The female condom is somewhat more expensive than its male counterpart. However, given the potential impact in reducing HIV infection afforded by a female-controlled method, some donor organizations have contracted with producers to provide the devices at low cost. These social campaigns have negotiated costs of less than one US dollar per device, and some studies indicate that such campaigns are cost-effective.119, 123 The ability of the female condom in preventing HIV is believed to rival that of the male condom.124 One study estimated that perfect use of the female condom would decrease the risk of HIV transmission by 90% annually in women having intercourse twice weekly with an infected male partner.125 Also, like male condoms, female condoms protect against other STDsChlamydia, gonorrhea, herpes simplex virus, human papillomavirus, and syphilis. They may be more effective than the male condom at preventing transmission of genital ulcer diseases, since they cover more of the vulva and perineum.8 A systematic review found that female and male condoms were equally effective at preventing STD transmission.124

Reuse of the female condom has been reported in many countries, especially those with limited resources. The general recommendation is to use a new condom for each act of intercourse, due to concerns for compromised structural integrity of the condom with handling and washing. Some studies examine the possibility of reuse of female condoms; most found that repeated cleansing of the condoms was associated with structural defects, but usually only after multiple washes.126, 127, 128, 129 In one study, devices were still within FDA standards for structural integrity after repeated washings.130 The World Health Organization (WHO) does not recommend or promote reuse of the device, but acknowledging that access to new condoms may be limited in developing areas, has issued a protocol for the safe cleaning and handling of female condoms for reuse.131, 132

The contraceptive effectiveness of female condoms is similar to that of male condoms. Studies from various countries reported unintended pregnancy rates of 1–9% for perfect use and 3–22% for typical use.133, 134, 135 First-year failure rates in the United States are estimated at 5 and 21%, respectively, for perfect and typical use.16 Most users consider the device acceptable, and widespread uptake of female condom use should prove possible with social marketing and directed counseling in at-risk populations.136, 137, 138, 139

The female condom offers major potential as a dual-function method, as its effectiveness at preventing pregnancy and sexually transmitted infection is similar to that of the widely-accepted male condom. The female condom is a welcome addition to the contraceptive armamentarium. It is acceptable to women of many different cultures and provides its users with credible dual protection under female control.

CONTRACEPTIVE DIAPHRAGM

Invention of the contraceptive diaphragm is credited to the German gynecologist Wilhelm Mensinga, who described it in 1881.18 It was introduced in America in the early part of this century by the illustrious feminist Margaret Sanger, who brought the diaphragm from Holland upon return from her self-imposed exile. It was popularized by her followers and the family planning movement she initiated as part of her efforts to liberate women from the burdens of undesired pregnancy. The vaginal diaphragm was the first highly effective method of contraception available to women. As such, and for more than 40 years until the advent of oral contraceptives and the intrauterine device, it was the backbone of the family planning movement in the United States. The diaphragm was originally used by upper- and middle-class women who had not only the sophistication to recognize their sexual rights but also the means and privacy to take advantage of them. It placed the contraceptive initiative and responsibility under the control of women. Important advantages of the diaphragm include moderate protection against sexually transmitted infections, lack of systemic side effects, cost-effectiveness, reversibility, and low maintenance, with requirement for only a single physician visit in most cases.140 

The original Mensinga vaginal diaphragm consisted of a narrow, flat steel band, forming a ring. Vulcanized rubber completely covered the ring and closed the space, shaping a dome. This domed rubber cup, with no modifications except for improvements in the quality of the rubber and the ring, has remained virtually unchanged as an excellent female-controlled barrier contraceptive. Those constructed with rubber or latex rubber are sensitive to oily substances and lubricants. When properly fitted and placed, diaphragms ride diagonally in the vagina between its posterior fornix and the tissues on the back of the pubic arch.

Types of Diaphragms

Diaphragms are available in three general types: coil spring, flat spring, and arcing spring (Fig. 2 and Table 5).140 Most are made of latex or rubber. The flat spring or Mensinga diaphragm allows lateral compression but has no frontal elasticity. The coil spring type has a ring made of coiled steel that permits good lateral as well as limited frontal elasticity. Flat and coil spring diaphragms form a straight line when compressed to insert them. Because of their construction, they offer only lateral elasticity. They are suitable for most women, and they fit well, even when there is moderate vaginal relaxation without cystocele. Arcing spring diaphragms come in two types. The hinged or 'bow-bend' diaphragm has in the core of its steel coil two semicircles of rigid steel that permit it to bending only in one position, forming a pointed arc. It is rigid in the anteroposterior axis and exerts strong lateral pressure. It cannot be fitted in most women with a retroverted uterus. The other arcing diaphragm is the All-Flex. The rim of this diaphragm forms an arch regardless of where it is compressed. It also offers some frontal elasticity. Most women find arcing diaphragms easier to insert because their curving assists in guiding it. They fit well, even in those vaginas with some relaxation or in the presence of a long cervix. The differences among them are only the type of ring and the degree of vaginal support they may offer and the ease of fitting and of insertion and removal by the user. For women with latex sensitivity, the arcing spring and coil spring types include a silicone-derived alternative. These silicone diaphragms are not available from pharmacies and must be ordered from the manufacturers.140

Fig. 2. Contraceptive diaphragms. A. Flat spring. B. Arcing spring. C. Hinged spring (arrows indicate hinges ). (From Speroff L, Darney P: A Clinical Guide for Contraception. Baltimore, Williams & Wilkins, 1992.)

  

Table 5. Types of contraceptive diaphragms

Diaphragm TypeBrand NameManufacturerMaterialSizes (mm)
Flat springOrtho WhiteOrthoRubber55–105
Coil springKoromexLondon InternationalLatex rubber50–95
 Ortho Coil SpringOrthoRubber50–105
 Omniflex CoilMilexSilicone60–95
Arcing springAll-flexOrthoRubber55–95
 Koro-flexLondon InternationalLatex rubber50–95
 Wide-sealMilexSilicone60–95
Modified from: Allen RE. Diaphragm fitting. Am Fam Physician 2004;69:97-100.

 

 

Each type of diaphragm offers its own advantages; however, not all women can be appropriately fitted (Table 6). Satisfactory results are obtainable with any of the varieties, provided a good fit is achieved and the woman uses it consistently. A major benefit of the diaphragm is that it is free of systemic side effects.

 

Table 6. Indications and contraindications for the contraceptive vaginal diaphragm

Indications

Female control desired

Systemic hormonal contraceptives and IUD contraindicated or unacceptable

Contraindications

AbsoluteRelativeTemporary

Psychological/mental inability to learn correct use

Aversion to touch own genitals

Physical inability to master correct use (e.g. marked obesity, fingers too short)

Poor pelvic support, with severe cystocele, urethrocele, uterine prolapse

History of vaginoplasty, rigid vaginal walls, vaginal malformations, strictures

History of recurrent cystitis

History of toxic shock syndrome

Vaginismus

Need for contraceptive method of greater effectiveness

Lack of privacy

Moderate cystocele or rectocele or both

Dyspareunia

Fixed uterine retroflexion

Chronic vulvar dermatosis, eczema genitalis, genital psoriasis, contact dermatitis

History of cervical dysplasia

History of herpes simplex virus infection

Recent delivery (<12 weeks postpartum)

Recent episiotomy

Acute or subacute vulvovaginitis or cervicitis of any etiology until treated

Cystitis, urethritis, or other genital infection until diagnosed and treated

Modified from: Sobrero AJ, Sciarra JJ. Contraception. In Cohn HF (ed): Current Therapy. Baltimore, WB Saunders Company, 1978.



Diaphragm Fitting

Diaphragms are measured by their diameter in steps of 5 mm. They come in sizes from 50–105 mm (Table 5). Extreme sizes are difficult to find; most common are 70–80 mm. Fitting sets generally come with fitting rings, or actual diaphragms, with diameters of 65–85 mm. Using actual diaphragms for fitting instead of fitting rings facilitates the patient's understanding of how the diaphragm works and how it feels when placed in the vagina.

The diaphragm should be selected only after a gynecologic examination and careful assessment of the condition of the pelvic organs. Note the depth and elasticity of the vagina and the tone of vaginal walls and the perineum, as well as the presence or absence of cystocele, rectocele, or urethrocele, and of a recess behind the symphysis pubis. Not infrequently, two women with the same vaginal depth require a different size or type of diaphragm because of marked differences in vaginal wall tone and elasticity. Individual anatomy determines the choice.

One anatomic point of much value in determining the type of diaphragm that can be properly fitted is the condition of the retropubic space. In most women, a well-defined recess is located behind the pubic arch; the anterior part of the diaphragm rim should fit in this space, resting in front against the symphysis. When the anterior vaginal wall is relaxed due to poor vaginal tone or a cystourethrocele, this space is obliterated. In these cases the diaphragm will not fit well and tends to sag. In such cases, the diaphragm cannot be prescribed and another method should be advised.

The proper diaphragm size is the largest one that fits snugly between the posterior vaginal fornix and the retropubic recess without being felt by the patient. If the diaphragm is too small when placed in the posterior fornix, it will not reach the retropubic groove, and if it fits in the retropubic space, it may have been placed onto the cervix without covering it. In both instances, the diaphragm will not form an adequate barrier. When it is too large, it falls anteriorly and causes discomfort, or it may project from the vagina and drop posteriorly, allowing the penis to pass over it during intercourse. In either case, the diaphragm does not provide a barrier, negating its contraceptive value. With correct sizing, only the tip of the index finger tightly fits between the anterior part of the diaphragm rim and the retropubic vaginal mucosa.

Once the appropriate size is found, the patient should be asked to cough or Valsalva to test whether the diaphragm remains in place. The diaphragm forms a partition that divides the genital tract in two sections: the upper including the cervix and the lower serving as the channel for the penis. Inserting the diaphragm with the dome up or down makes no difference as long as it is well fitted. The rubber of the dome wrinkles under the lateral vaginal compression against the ring; this action provides adequate space and elasticity for unimpeded normal coital activity without either partner feeling the device.

Women requesting the diaphragm should be taught to palpate the cervix and probe the retropubic space where the anterior portion of the diaphragm rim is positioned. Digital palpation of the cervix, how it feels when covered by the rubber, and touching the rim behind the pubic bone are critical steps for her to master. She should be instructed on the important anatomic landmarks and how the diaphragm works. A pelvic model and a diaphragm may be useful for this purpose. Using actual diaphragms for fitting facilitates understanding. The patient learns that the vagina is internally closed and that there is no danger that the device will enter the uterus and be lost in her body, impossible to retrieve. Many women need assurance that the size of the diaphragm has little relation to the amplitude of the vagina.

The patient should be encouraged to practice inserting and removing the diaphragm several times to familiarize herself with the technique. This practice provides confidence about her handling of the device, as well as reassuring the physician about the patient's mastery of the technique. The need for thorough washing of the hands before insertion and removal should be stressed. Consider a follow-up appointment in one week, during which the woman should practice insertion and removal at home, leaving it in the vagina overnight or even a full day. Caution should be taken in recommending it for contraception until after proper use is confirmed. Inserting the diaphragm at home might be facilitated by squatting or sitting on a toilet or standing with one foot on a stool or the toilet seat while bending forward. If the diaphragm causes discomfort, it is too large, wrongly inserted, or contraindicated. The success of the method often depends on the care taken to instruct the woman on the proper technique.

Diaphragm Use and Care

Gels or creams provide lubrication to facilitate insertion of the diaphragm. A lubricant must not contain products damaging to the rubber or irritating to the woman or her partner. Approximately two inches or a spoonful of the spermicidal jelly or cream is placed in the cup of the diaphragm, and some of it is smeared on the rim and the other face of the device. Jellies provide more lubrication. A cream or foam is indicated when less lubrication is desired; foams are less favorable for this purpose. The adjuvant spermicidal jellies and creams may carry bactericidal properties and may diminish the risk of acquiring some STDs.13 

Traditional teaching advocates that the diaphragm and spermicidal agent may be inserted hours before intercourse, but if more than two hours elapse, additional spermicide should be placed in the upper vagina for maximal protection from pregnancy. Without any scientific data to support it, removal of the diaphragm is advised after 6–8 hours from ejaculation. The diaphragm may remain in the vagina overnight but not for more than 24 hours. When repeated coitus occurs, a fresh application of the spermicide may be inserted with an applicator or with a finger without removing the diaphragm. A Brazilian study comparing subjects who used a diaphragm without spermicide continuously, with subjects using a diaphragm plus spermicide only at the time of intercourse, demonstrated that the continuous users experienced lower failure rates and were more likely to continue the method.141 For the sexually active woman, insertion of the diaphragm may become part of her daily routine before retiring, because many users prefer to have it in place well in advance of any possible coitus to avoid the need for extemporaneous preparation. To remove the diaphragm, the patient inserts her index finger under the anterior portion of the rim and pulls the device downward and outward.

Diaphragm use during menstruation is typically not recommended, but if it is desired, the diaphragm should not be placed too long before intercourse, and it should be removed shortly afterward. The danger of toxic shock syndrome (TSS) with prolonged retention of the device should be emphasized, because TSS has been described after diaphragm use.142, 143 Although TSS is rare, approximately 95% of cases reported have been temporally related to menstruation.42, 144, 142, 143 Patients should be counseled that prolonged retention and improper fitting can cause vaginal irritation, even mucosal damage.

A major problem in prescribing a diaphragm is the absence of well-trained personnel. Fitting demands skill, patience for teaching, and time (usually 15–20 minutes). Because diaphragms are less popular now than they were historically, adequate supplies (all models and sizes) often are not available in clinics. Another issue is societal in nature; many women are conditioned not to touch or explore their genitals. In some instances, a woman's attitude toward the insertion of tampons may provide insight to her feelings about placing the device in the vagina and ensuring its proper position. Obese women, women with short fingers, and those with manual limitations may not be able to use this method.

If properly maintained, a diaphragm can last several years, making it a cost-effective contraceptive method. After use, the diaphragm should be washed, dried thoroughly, and placed in its container. If desired, it can be powdered with corn starch. However, talcum powder contributes to the rapid deterioration of the rubber. Periodically, the diaphragm should be inspected against a strong light for weak spots or perforations. After childbirth or a change in weight (10 lb or more), a recheck of the fitting is advised, but routine adherence to this policy has been questioned.145

Effectiveness

The diaphragm is an effective method of birth control when fitted properly and used consistently. The degree of effectiveness depends to a large extent on the adequacy of the fitting and the motivation of the user. Estimates of first-year pregnancy rates in the US with perfect and typical use are 6 and 16%, respectively.16 Failure rates do not differ by parity, compared with the contraceptive sponge or cervical cap.21 One study reported a lower failure rate in women older than 35 years than in younger women. In this study, successful diaphragm users are older and married, have completed their families, are experienced with the diaphragm or other barrier methods, are better educated, and have higher socioeconomic status.146 However, successful use by very young females showed that the method is suitable for all age groups, provided adequate fitting, training, and support are available.21

Insufficient evidence exists to support use of adjuvant spermicidal products to increase the effectiveness of the diaphragm, although the practice is common. The spermicide theoretically offers two added contraceptive advantages: spermicidal activity and an additional mechanical obstacle to sperm migration. A superior pregnancy rate of one per 100 woman-years with the continuous use of a 60-mm fit-free arcing diaphragm without spermicide, removing it briefly every day for washing only, was reported.147 A retrospective analysis in Brazil of the same practice found that continuous use carried a lower failure rate than the one found in a group of women using the diaphragm with a spermicide before each act of intercourse.141 It was speculated that the difference was due to the failure of noncontinuous diaphragm users to use the device on every sexual occasion because of the inconvenience of inserting it on demand. In contrast, a prospective British study projected to study 200 volunteers using a fit-free 60 mm diaphragm for one year was halted after enrolling 110 women because of a high failure rate—24.1 per 100 woman-years (29.5 for the women without diaphragm experience and 17.9 for women with barrier contraceptive experience). Major reasons for discontinuation, apart from contraceptive failure, were malodor and problems with removal and insertion.148

Diaphragm use offers protection against sexually transmitted infections.149 The utility of diaphragms with or without spermicides and lubricants in preventing HIV transmission has been a recent focus of family planning research. Many studies and programs are evaluating the role of vaginal microbicides in conjunction with diaphragm use.150, 151, 152, 153, 154 More research is needed to explore this potentially significant HIV-reduction strategy.155 

The diaphragm offers protection from human papilloma virus, as diaphragm users experience fewer changes in cervical cytology and fewer cases of cervical dysplasia, carcinoma in situ, and cervical cancer.156, 32, 33, 34, 35, 157

An increased incidence of urinary tract infection (UTI) occurs in diaphragm users, compared with users of hormonal methods of contraception.158, 159, 160 It is usually associated with vaginal colonization with E. coli.82, 83, 161, 162 It was long believed that the pathogenesis was compression of the distal urethra by the rim of the diaphragm, causing stasis, urinary retention, and ultimately infection. Subsequent studies have shown that a change in the vaginal flora occurs during barrier contraceptive use. The normal vaginal environment, rich in Lactobacillus acidophilus, possesses an acidic pH around 4, except during menstruation, infection, and after semen deposition. Spermicides used with the diaphragm, as with other barrier methods, change the natural vaginal microenvironment, replacing it with a flora rich in anaerobes and E. coli. Studies also indicate that spermicide use can increase the risk of bacteriuria with E. coli because of an alteration of the vaginal flora.163, 164, 165 A comparison of sexual intercourse alone with sexual intercourse with a diaphragm and spermicide used in the preceding three days was strongly associated with increased rates of vaginal colonization with uropathogenic flora, including E. coli, other gram-negative uropathogens, group D streptococci, and Candida. It was concluded that bacterial and fungal vaginal microflora are strongly influenced by the recent use of a diaphragm and spermicide, and minimally affected by sexual intercourse alone.166

CERVICAL CAP

First described by a German gynecologist in the 1830s, the cervical cap was once a commonly used method of barrier contraception in western Europe. It was similarly popular in the United States in the 1930s until the diaphragm replaced it in popularity. Cervical cap use further decreased with the invention of oral contraceptives in the 1960s.167

Despite its relative lack of popularity in the U.S., the cervical cap offers effective reversible contraception free of systemic side effects. It likely also offers protection against sexually transmitted infection. Traditional cervical caps, as well as some new variations, are available in Europe and the U.S. today.

Types of Cervical Caps

Cervical caps commercially available in the United States are manufactured in England (Lamberts Ltd., UK). They are composed of latex or silicone. In the 1900s, three different types were available: the Prentif or cavity-rim cap, a rubber device with a thick rim; the Dumas or vault cap, a shallow dome-like latex cap; and the Vimule cap, also a dome-like latex cap, thin at the center and thick at the periphery with a slanted rim. All are intended to fit snugly over the cervix; the Vimule and Dumas extend to the vaginal fornices (Fig. 3). After 2000, two additional products were introduced: the FemCap (FemCap, Inc., Del Mar, CA), a silicone cap with an indented bowl for covering the cervix and a strap intended to ease removal; and Oves (Veos Ltd., UK), a disposable silastic device with a thin membrane designed to fit over the cervix. Lea's Shield (YAMA, Union, NJ) is a silicone bowl-shaped barrier contraceptive device somewhat different in design from the diaphragm and cervical cap.

Fig. 3. Mechanical contraceptive devices. A. Vaginal coil spring diaphragm. B. Dumas cervical cap. C. Prentif cervical cap. D. Vimule cervical cap.

 

Since patient anatomy and factors such as parity will affect the size of cervical cap required, each type of cervical cap is available in a range of sizes. The Prentif cap is available with internal rim diameter of 22, 25, 28, and 31 mm.168, 169 These caps require individual fitting. Because they are made of rubber, all are sensitive to oily and greasy substances. The Prentif cap should be filled approximately one-third full with a spermicidal cream before insertion.

The FemCap is a unique barrier device composed of highly elastic silicone rubber (Fig. 4), with a shape aptly described as a sailor hat. It consists of a thin dome to fit and cover the cervix completely, a rim extending into the vaginal fornices, and a brim that conforms to the vaginal walls around the cervix.170, 171 The border of the dome at its junction with the brim forms a slightly narrower and thicker soft, rounded ring to seal the device to the cervix. The one-piece device is provided with a strap of the same material, located over the dome, to facilitate removal. The FemCap comes in three sizes: small (22 mm), for women who have never been pregnant; medium (26 mm), for women who have been pregnant but have not had a vaginal delivery; and large (30 mm), for women who have had a vaginal delivery.172

 

Fig. 4. FemCap is a new cervical cap made of silicone rubber. A. The FemCap in place. B. Diagram of FemCap components.

 

 

 

       A                   B

 

A newly introduced barrier contraceptive is Lea's shield (Fig. 5). This intriguing silicone device is unique because a single size may be used by all women. It consists of a thick bowl-shaped dome with an internal diameter of 30 mm to fit and cover the cervix. The rim of the dome is thickest posteriorly, and the opposite side contains a strong, thick loop to facilitate removal. The loop, placed against the anterior vaginal wall, contributes to its fixation and is accessible to the fitting and removal finger. The dome contains a hole at its apex connecting with a tubular valve running parallel to the dome and the loop. This valve permits the escape of air trapped at insertion and the passage of cervical secretions, thus creating better fit over the cervix. The device, designed to fit all women, is intended to be sold over-the-counter, but currently it requires a prescription in the United States. It is currently available through the Planned Parenthood Federation of America.

 

Fig. 5. Lea's shield. A. Cervical view. B. Lea's shield in position as far as it can comfortably go. It will settle in place, covering the cervix automatically. The loop is kept frontally and pressed behind the pubis bone. C. For removal, the loop is held with the index finger and it is then twisted and pulled out. (From: Hunt WL, Gabbay L, Potts M: Lea's shield, a new barrier contraceptive preliminary clinical evaluations, three days' tolerance study. Contraception 50:551, 1994.)

According to manufacturer instructions, Lea's shield should be used with a spermicidal gel. Approximately one third of the dome should be covered with the gel, which should also be applied to the thick edge of the dome to facilitate insertion.173, 174, 175

Use of the Cervical Cap

Conventional cervical caps differ from diaphragms because they are not placed to fit in the vagina but only to shield the cervix. Less elastic than the diaphragm, the Prentif cervical cap is held in place by both suction on the cervix and by the positive abdominal pressure and weight of the abdominal viscera on the vagina. When fitted and placed properly, the cervical cap is somewhat more difficult to place properly and remove than a diaphragm, even when the cap is provided with a removal string. Typical cervical caps are inserted before intercourse and can be worn for up to 48 hours. 

Proper use of the cervical cap requires extensive handling of the genitalia, ability to locate the cervix, and manipulation of the device into proper position. In general, cervical caps should not be worn longer than two days and not during menstruation. Based on WHO Medical Eligibility Criteria, women who are being treated or initiating treatment for cervical dysplasia or cancer should not use the cervical cap.176 In addition, caution should be exercised in recommending the cap to women with a very short cervix, poor vaginal support, a severely lacerated, inflamed, infected cervix. It is also contraindicated in women with short fingers, a lack of mechanical dexterity, or an aversion to touching their own genitals. Women in the postpartum period or recent second-trimester spontaneous or induced abortion should defer cervical cap use for six weeks. Table 7 lists guidelines for the use of cervical caps.

 

Table 7. Use of the Cervical Cap

Insertion
 

Fill one-third of the cap with spermicidal gel, cream, or foam.

Place the rim of the cap around the cervix until the cervix is completely covered.

Press gently on the dome of the cap to apply suction and seal the cap.

Insert the cap any time up to 42 hours prior to intercourse.

Removal

Leave the cervical cap in place for at least six hours after the last intercourse, but not for more than 48 hours from the time it was placed.

Tip the cap rim sideways to break the seal against the cervix, then gently pull the cap downwards and out of the vagina.

Modified from: World Health Organization Department of Reproductive Health and Research (WHO/RHR) and Johns Hopkins Bloomberg School of Public Health/Center for Communication Programs (CCP), INFO Project. Family Planning: A Global Handbook for Providers. Baltimore and Geneva: CCP and WHO, 2007.
 

In using the FemCap, the spermicide should be placed in the space between the outer aspect of the dome and the brim, and a smaller amount should be smeared on the edge and anterior of the dome. The FemCap requires a smaller amount of spermicide than the Prentif cervical cap. It is theorized that as ejaculation occurs, the brim, in close apposition to the vaginal wall, will direct the ejaculate and motile sperm toward the space surrounding the dome where most of the spermicide is located.177 Because the greater volume of spermicide is not in direct contact with the vaginal epithelium, it is assumed that there will be less local irritation. The device does not require additional doses of spermicide before repeated intercourse. Silicone rubber is nonallergenic, and the cap may be washed with any soap or detergent. It should be good for two years and should not change color, lose elasticity, or become malodorous. In the initial study, some women wore the device from 3–7 days without irritation or damage to the cervix or the vaginal vault; 5% reported vaginal odor, itching, and UTI.178 The study population was very satisfied with the device.179 The FemCap is available in three sizes (22, 26, and 30 mm) in the United States and Europe.

Some patients complain of recurrent dislodgment during coitus, malodor, and discoloration of the cap. More problems of malodor, vaginal or cervical irritation, and even damage to the vaginal mucosa are experienced when the cap is left in place for longer periods of time.107, 168 In addition, the risk of developing TSS increases with extended time intervals between insertion and removal.

The association between cervical cap use and cervical dysplasia has been evaluated. In one study, no changes in cervical cytology were detected after one year of Prentif cap use.180 In contrast, another study reported a 4% change from Pap class I to class II after 3 months of use of the Prentif cap versus 1.7% among diaphragm users.181 

A disposable silicone cervical cap, Oves Cap, is available in Europe. It is available in three sizes (26, 28, and 30 mm) and may worn for up to three days.

Lea's Shield remains in place by virtue of its volume, rather than its diameter. It does not require clinician fitting and can be left in the vagina for 48 hours.182

Effectiveness

The cervical cap is as effective as the diaphragm in nulliparous women, but less effective in parous women.16 Estimated failure rates among nulliparous women are 16% in the first year with typical use and 9% with perfect use. These rates in parous patients are 32% and 20, respectively.16, 176

On the basis of a six-month comparative study of the FemCap and a conventional diaphragm, one study calculated the annual probability of unintended pregnancy for the FemCap as 22.8%, versus 13.7% for the diaphragm. Based on the woman's pregnancy history, FemCap could be self-fitted on 84% of the women. There were more instances of difficult fitting as well as of insertion and removal of the device for the FemCap than for the diaphragm; however, it is reported that insertion of FemCap is easier than for the Prentif cap. Adverse experiences were similar with both devices, fewer than 6%. FemCap was considered safe and was associated with significantly fewer urinary tract infections. The estimated one-year pregnancy rate, based on the six-month pregnancy rate, was calculated of approximately 23%, ranging from 15% for nulliparous women and 30% for parous women.179, 173

Evaluation of Lea's Shield demonstrated acceptability, safety, and contraceptive efficacy. One study randomized women to Lea's Shield use with and without spermicide. Adjusted pregnancy rates were 5.6 per 100 women in spermicide users, compared with 9.3 per 100 in non-spermicide users, with a trend toward significance (p = 0.086). Unadjusted rates were similar between groups.182

The cervix is recognized as an important site of entry for HIV during intercourse,183 and cervical caps may provide protection against HIV and other STDs. In addition, the newer FemCap and Lea's Shield offer the potential for improved protection.124  

 

VAGINAL CONTRACEPTIVE INSERTS

Vaginal contraceptive inserts, most commonly in the form of films or suppositories, are intended for vaginal insertion minutes before sexual intercourse. Available contraceptive inserts in the United States contain N-9 as spermicide. The suppositories include: Encare, containing a 2.27% of N-9, Koromex Inserts with 125 mg of N-9, and Semicid with 100 mg of N-9. Also available is the vaginal contraceptive film (VCF) with 70 mg of N-9. Data on use effectiveness are scarce. A randomized trial of VCF versus placebo film concluded that VCF did not offer added protection against HIV, gonorrhea, and Chlamydia over condoms alone.184 Not available in the United States but widely available abroad is the Japanese vaginal foaming tablet NeoSampoon (Eisai Co., Tokyo, Japan). This tablet contains the spermicide menfegol.

CONTRACEPTIVE SPONGE

Perhaps the oldest mechanical intravaginal device used for contraception is the vaginal sponge and its variations. Wads of cloth, cotton tufts, sea sponges, powder puffs, and the like have been used throughout history and are still in use all over the world, either alone or in combination with different solutions, presumably spermicides. The sponge combines mechanical and chemical barriers to sperm. The vaginal sponge provides some advantages over the diaphragm and the cervical cap, although not as much contraceptive protection as the diaphragm. It is self-administered and does not require a pelvic examination or fitting; one size fits all. It has no contraindications, except for persons allergic to the sponge material or the spermicide or persons averse to touching their genitals. Available without prescription, the vaginal sponge can be personally procured, inserted, and removed. It can be used as a back-up method for the condom. There is no waiting period after insertion to be effective. It can be inserted hours before a sexual encounter, avoiding a potentially messy interruption of sexual activity, while upholding confidentiality. The user may engage in repeated coitus without the need for additional preparation.185 Sponges may offer protection against some STDs. Sponges are an appealing and effective option under a woman's control that do not require professional intervention.

The disposable Today sponge (Synova, Media, PA) was introduced to the US market in 1983. It was withdrawn from the market in 1995 due to FDA compliance issues, as the manufacturer chose to discontinue production rather than change design. In 2005, Today was reintroduced to the market after FDA clearance. The sponge consists of a molded hydrophilic polyurethane soft foam impregnated with 1 gram of N-9. An indentation on one side allows the sponge to fit against the cervix, and the other side contains a ribbon to facilitate removal. The sponge should be wet with tap water prior to insertion.

In Europe and Canada, there are two contraceptive sponges: Protectaid and Pharmatex. Protectaid is a polyurethane sponge containing low concentrations of three spermicides: benzalkonium chloride, sodium cholate, and N-9.186, 187 The Protectaid sponge is pre-moistened in the package; it is not necessary to apply water. The Pharmatex sponge contains 60 mg of benzalkonium chloride.173

A Cochrane review comparing the sponge with the diaphragm found the sponge significantly less effective at preventing pregnancy. In addition, discontinuation rates were higher with the sponge.188 As with the cervical cap, effectiveness varies between nulliparous and parous women. First-year unintended pregnancy rates for perfect and typical use are 9% and 16%, respectively, in nulliparous users, compared with 20% and 32% in their parous counterparts.16

Studies demonstrate protection from gonorrhea and Chlamydia acquisition in sponge users.189, 190 A study of commercial sex workers in Nairobi found that the sponge with N-9 did not offer protection against HIV infection.191 The sponge contributed to vaginal dryness, and the seroconversion was credited to an increase in vaginal sores that facilitated viral infection. Women in this study had multiple coital episodes with the sponge; the situation may be quite different in other clinical scenarios. Frequent use of N-9 has been linked to vaginal irritation and mucosal abrasions, which were dose-dependent.192 There have been cases of TSS temporally associated with use of the contraceptive sponge. The risk was mostly related to its use during menstruation and the puerperium and prolonged retention of the device.144, 193

SPERMICIDES

Substances for vaginal application formulated to prevent conception have been in use since pharaonic times and form part of the folklore of most cultures. From the time of their discovery, spermatozoa were found to be killed by many substances. Van Leeuwenhoek observed that rain water rendered dog spermatozoa motionless. Almost two centuries later, Kolliker did the first systematic study of compounds with antisperm activity and reported that organic and inorganic salts were toxic to spermatozoa. Until the late 1950s, different vaginal creams, pastes, suppositories, and other vaginal inserts were of uncertain quality, suspicious origin, and questionable effectiveness. Margaret Sanger and her followers took the lead until the FDA became involved and started to establish requirements for their safety and effectiveness.1

Globally, due the extent of the HIV epidemic, much research focuses on vaginally-administered agents protective against STD transmission. Increasing knowledge of the ecology of the human vagina provides basic knowledge related to the problems encountered in the general use of existing spermicides. Considerable research effort is being made by the private and public sector with the goal of finding products with strong bactericidal and viricidal activity, in addition to spermicidal activity, that will not affect the vaginal and cervical epithelia and will preserve vaginal mucosa integrity. Numerous products are at different stages of testing. The pharmaceutical industry seems to have remained uninterested in this quest since the market for preparations of this kind will be mostly for populations with meager acquisitive power.

Spermicides are agents that kill spermatozoa or render them incapable or normal function. Microbicides are self-administered prophylactic agents used to prevent transmission of sexually transmitted pathogens, with HIV being the most significant today. In the broadest terms, microbicides may be given through any route or mode of administration, but most current research centers on vaginally-administered, female-controlled products. Given these definitions, there is a basis for overlap between spermicidal and microbicidal agents. The most widely used spermicides—such as N-9, octoxynol-9, and menfegol—are surfactant agents, which disrupt cell membranes and kill bacteria, parasites, and most viruses in vitro.5 Other common compounds have shown spermicidal activity (e.g. benzalkonium chloride, chlorhexidine, gramicidin, cholate, and betadine).

Types of Spermicides

An ample array of pharmaceutical methods have been and are still used to deliver spermicides into the vagina. There are traditional forms, such as vaginal jellies and creams, suppositories, and effervescent tablets, with many improvements since their inception. There are newer forms, such as foams, and more recently, the vaginal contraceptive film (Table 8).

 

Table 8. Brand name spermicide products available in the United States

Gels, jellies, and creams

Advantage 24 Gel
Conceptrol Gel
Gynol II Original Formula Jelly
Gynol II Extra Strength Jelly
Koromex Cream*
Koromex Crystal Clear Gel
Koromex Jelly
KY Plus Jelly
Ortho Cream
Ortho-Gynol*
Ramses Crystal Clear Gel
Shur-Seal Gel

Film

Vaginal Contraceptive Film

Foams

Because
Delfen Foam
Emko
Emko Pre-fil
Koromex Foam

Suppositories/Inserts

Conceptrol Contraceptive Insert
Encare
Koromex Contraceptive Insert
Semicid
Sweet and Fresh

*Spermicidal agent, octoxynol 9. All others, nonoxynol 9.
Modified from: Spermicides, vaginal. Drugs.com. Available at: http://www.drugs.com/cons/advantage-24-vaginal.html. Accessed 13 May 2008.
 

Use of Spermicide Products

Vaginal spermicides are inserted before coitus. Jellies, creams, foams, and the film may be inserted immediately before sex; suppositories and effervescent tablets must be inserted a few minutes (up to 30 minutes) before intercourse to allow for melting, dissolving, and dispersion. A new dose should be inserted if coitus does not take place within one hour from the initial application. A new dose is required before each coital event. The time element, the need for repeated doses, and the handling of the genitals at each event may disrupt spontaneity and constitute an inhibiting nuisance for some potential users. As the vagina cleans itself by discharging its contents onto the perineum, the use of spermicides involves some messiness when part of the contraceptive and the ejaculate efflux from the vagina postcoitally. Douching is not recommended but if desired should not be performed until two hours after vaginal coitus.

Spermicides require a number of immediate precoital maneuvers and handling of the genital organs, which is not acceptable to some potential users. All conspire for misuse and frequent discontinuation. All have a number of disadvantages that limit their acceptability. When used alone, they offer limited contraceptive protection. The reported range of failure rates is vast, with estimates from 1–30% in the first year of use. Best estimates of typical use failure rates are near 20–25%.194 Table 9 lists the indications and contraindications for topical spermicides. In practice, vaginal spermicides are recommended as an occasional or provisional method prior to IUD insertion or initiation of hormonal contraception, or for the unexpected sexual encounter.

Spermicides are used mostly in combination with mechanical methods (e.g. condoms, diaphragms, and cervical caps), as lubricants, adjuvants in case of condom rupture, and secondary protection against STDs and HIV, although patients must be educated that commercially available spermicide products offer little, if any, protection against infection. Also, women desiring to use spermicides alone should be made aware that unintended conceptions are more the rule than the exception. Spermicides are not intended for postcoital use and are not substitutes for hormonal emergency contraception (oral levonorgestrel or combined levonorgestrel-ethinyl estradiol).

 

Table 9. Indications and contraindications for spermicide use

Indications

Adjuvant to mechanical contraceptives: diaphragm, cervical cap, condoms

Adjuvant to rhythm, calendar, or periodic abstinence contraceptive methods

Temporary use, at initiation of certain hormonal contraceptive methods

Increase in vaginal lubrication desired

Contraindications
AbsoluteRelativeTemporary

Need for contraceptive method of greater effectiveness

HIV infection

Allergy or sensitivity to ingredients in product by either partner

Chronic genital dermatitis, eczema genitalis, genital psoriasis, other chronic genital dermatosis

History of failed use of spermicides  

Dyspareunia

Vaginismus

Active or suspected STD until treated or condition clarified

Acute or subacute vaginitis

Urethritis

Cystitis

Modified from: Sobrero AJ, Sciarra JJ. Contraception. In Cohn HF (ed): Current Therapy. Baltimore, WB Saunders Company, 1978.

 

The practical value of vaginal spermicides is their wide availability. They are sold without prescription, which makes them accessible to a large population unwilling or unable to seek professional advice and examination. They are simple to use, relatively inexpensive, and are under a woman's control. Although their effectiveness against STDs and HIV is being questioned, vaginal spermicides may offer some protection against some STDs.195, 196

In general, spermicidal products are bulky and conspicuous. The recommended dose varies according to the physical characteristics of the product. Film, suppositories, and foaming tablets are dispensed in units for direct use. Foams, jellies, and creams are provided with a syringe inserter containing the recommended amount. Most users' complaints are of excessive lubrication, leakage and messiness after intercourse, local irritation and pruritus, and occasional allergy to the active ingredient or the vehicle. Jellies provide greater lubrication than creams but in general are aesthetically less acceptable because of excess leakage after coitus. Creams and foams are slightly 'drier' and perceived as less messy. The dosage of jellies and creams is approximately 5 mL, which is the capacity of the plastic applicator syringe with which these products are usually marketed. It is believed that the bulk of the vehicle in jellies and creams contributes as a partial mechanical barrier. Foams consist of a fluid base in which the spermicide is dissolved; they are packed in a pressurized container with a gas as propellant. The material is released as a foam in volumes of 7–10 mL. They adhere and distribute better in the vagina than do other products. Because the water in creams and jellies is substituted in foams by the propellant gas, foams tend to be less messy, leak less often, and aesthetically are more acceptable. Most spermicides have an excellent shelf-life when stored properly at room temperature. They should not be refrigerated and never frozen.

In the past, concern arose about pregnancy outcomes with spermicide exposure. Risks of miscarriage associated with spermicide use, whether before conception or at the time of conception, are inconsistent across studies.197, 198, 199, 200 Two prospective studies evaluated spermicide use both before and at the time of conception and found no association with spontaneous abortion.201, 198 A case-control study of spontaneous abortions of conceptions during spermicide use similarly showed no association.202 One study reported a loose association of spontaneous abortion with the use of spermicides,203 but after subsequent analysis, the association was considered spurious.204 Associations of tetrapod abortuses205 and Down's syndrome206, 207 with spermicides were reported, but such associations were denied by other studies.200, 207, 208 Two studies of births provide information on spermicide use previous to conception,207, 208, 209, 210 and neither detected a malformation. Considering the numerous analyses, a truly elevated risk for birth defects seems highly improbable.211, 212, 213 One study evaluated for associations between spermicides and trisomies, testing possible effects under various conditions.214 Data were collected on prenatal karyotypes at 17 medical centers in the United States and Canada. Spermicide use was compared among trisomies and among chromosomally normal karyotypes at the same time of gestation. Trisomy could not be linked to spermicide use in the cycle of conception.215

Nonoxynol-9

Formerly, studies of N-9 showed a potential reduction of sexually transmitted infections but were inconclusive in regard to its ability to prevent HIV infection. Laboratory studies indicate that in vitro N-9 inactivates many sexually transmitted pathogens, including Neisseria gonorrhoeae, C. trachomatis, herpes simplex viruses, Treponema pallidum, Candida albicans, Trichomonas vaginalis, and HIV, although clinical studies in humans do not demonstrate a benefit.5, 195, 216 N-9 lacks the ability to destroy human papillomavirus;217, 218 this is attributed to the fact that the virus is nonenveloped.217 In fact, recent research indicates that N-9 may actually potentiate HPV infection.219 N-9 also has a dose-dependent, deleterious effect on the integrity of the cells of the vaginal and cervical epithelium.192, 220 The resulting disruption of the normal epithelium makes it more susceptible to invasion by viruses.221, 222, 223, 224

Recently, much deserved attention has addressed the ability of N-9 to prevent HIV transmission. Damage to the vaginal and upper reproductive tract epithelium by N-9 was demonstrated in animal and human studies.109, 110, 111 Concern developed that N-9 actually increased HIV transmission, due to viral entry through microscopic lesions in the vaginal mucosa caused by the spermicidal agent, especially with repeated use. A recent FDA ruling establishes a new requirement that all over-the-counter vaginal contraceptive products containing N-9 must carry a warning statement that N-9 does not protect against HIV transmission.225

Hydrogen peroxide-producing strains of lactobacilli, responsible for the normal acidic vaginal pH, are susceptible to N-9. The antibacterial activity of N-9 against the normal vaginal flora reduces the peroxidase-producing L. acidophilus, and facilitates vaginal colonization by uropathogenic bacteria.114, 163, 164, 165, 166 Women who use spermicides regularly have increased colonization of the vagina with E. coli and may be predisposed to more frequent bacteriuria and recurrent cystitis.113, 114, 163, 164 Also, recent attention in microbicide research has focused on the antimicrobial properties of the normal, healthy vaginal mucosa. Scientists are evaluating, as potential microbicidal products, agents which restore the physiological environment of the vagina.226, 227, 228

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