Internal (formerly female) condoms

INTRODUCTION — The internal (formerly female) condom provides a physical barrier between genitalia and secretions during intercourse. It is designed to protect against both pregnancy and sexually transmitted infections. The internal condom consists of an outer ring attached to a sheath that lines the vagina, and an inner ring or sponge that covers the cervix. The internal condom provides coital-dependent reversible contraception that does not interfere with fertility and is available without prescription.

This topic will review the structure, patient counseling, and use of internal condoms, specifically the FC2. Similar information on external (formerly male) condoms and general information on contraceptive counseling and selection are presented separately.

●(See "External (formerly male) condoms".)

●(See "Contraception: Counseling and selection".)

In this topic, when discussing study results, we will use the terms "woman/en" or "patient(s)" as they are used in the studies presented. However, we encourage the reader to consider the specific counseling and treatment needs of transmasculine and gender-expansive individuals.

TYPES OF INTERNAL CONDOMS

Common structure — Internal condoms have an anchor (eg, ring, frame) outside of the vagina to prevent the condom from being pushed inside the vagina during use; the anchor is also used for removing the condom. The inner portion consists of a sheath that lines the vagina. Some internal condoms also have an inner ring (picture 1) or sponge that lies against the cervix. Internal condoms have been made out of natural rubber latex, nitrile (a synthetic latex), and polyurethane [1]. They prevent pre-ejaculatory fluid and semen from entering the user's vagina and thus theoretically should prevent both pregnancy and the spread of sexually transmitted infections (STIs). No spermicide is required, but a lubricant is often needed. An illustration can be seen at the US National Library of Medicine. Internal condoms account for less than 1 percent of condoms produced globally [2].

FC2 and FC1 devices — The most widely available internal condom is FC2 [3]. It is a soft, loose-fitting nitrile sheath or pouch with two flexible rings. One ring is contained within the closed end of the sheath and serves as an insertion mechanism and internal anchor that lies against the cervix. The other ring forms the external, open edge of the device; it remains outside of the vagina after insertion. Silicone-based lubricant lines the inside of the condom, but additional lubrication for the inside and/or outside could be used. The condom is approximately 17 cm (6.5 inches) in length (similar to an external condom).

In contrast to the FC2, the previously marketed FC1 was made of polyurethane and had a seam. In comparative trials, the FC2 performed as well as the FC1 in terms of patient satisfaction, breakage, slippage, and invagination (ie, when the outer ring of the condom pushes into the vagina during intercourse) [4,5]. No data on pregnancy prevention or STI prevention are available for FC2 specifically, but effectiveness is assumed to be similar to the FC1 given the similar design, specifications, and functionality. (See 'Efficacy' below.)

The FC2 is indicated for preventing pregnancy and transmission of HIV and other STIs [6]. It may make less noise during intercourse than the FC1 and is available in approximately 100 countries. It has been approved by the US Food and Drug Administration (FDA); has CE Marking, which certifies that the device meets consumer safety standards and can be marketed in countries in the European Union; and has been cleared by the World Health Organization (WHO) for purchase by United Nations agencies.

Other devices — Variations to the FC1/FC2 have been developed. One randomized crossover trial examining condom failure events (eg, breakage, slippage, and invagination) reported similar outcomes for the following three devices versus the FC2 [7]:

●Natural Latex Female Condom (commercial name: Cupid Angel) – The Natural Latex Female Condom has received WHO approval and is distributed in India, Brazil, Indonesia, Netherlands, South Africa, and Mozambique [8,9]. In a noninferiority crossover trial including 300 female participants, the clinical failure rate (clinical breakage and slippage, invagination, misdirection [the penis slipping between the vagina and the outer surface of the condom]) was similar for the Cupid2 and FC2 [10].

●Program for Appropriate Technology in Health Woman's Condom (PATH WC) – The PATH WC is made of polyurethane and placed using an insertion capsule, which dissolves after insertion and releases the condom [11]. Hydrophilic areas on the condom allow it to cling lightly to the vaginal wall and keep it in place. It is not prelubricated but is sold with a water-based lubricant [12]. The WC was granted CE Marking in 2010 and the South African Bureau of Standards certification mark in 2013. To support market registration in China, a single-arm use study was conducted to assess WC performance and safety. The study reported levels of functionality consistent with condom performance data from other internal condoms [13]. In 2016, the product was cleared by WHO for purchase by United Nations agencies [14]. Following that approval, the WC had been made available through donor-supported programs to expand contraceptive options in some sub-Saharan African countries.

●VA w.o.w (worn of women; sample brand names: Condom Feminine, L'amour female condom, Reddy FC) – The VA w.o.w is made of natural rubber latex and is available in some parts of Europe, Asia, and Latin America. It has been granted CE Marking and India Drug Control Authority approval. The condom has a medical-grade sponge at one end that is used for insertion; the other end has a triangular frame to anchor it outside of the vagina. It is prelubricated [12].

●Phoenurse – The polyurethane Phoenurse is distributed in China [15]. A randomized crossover trial conducted in China showed that breakage, slippage, and misdirection of the penis were significantly more common with the Phoenurse than with the FC2 [16].

●Natural Sensation Panty Condom – The Natural Sensation Panty Condom, consisting of a woman's panty with a replaceable condom made of polyethylene resin, is available in parts of Europe and South America [12].

COUNSELING POINTS

Mechanism — All internal condoms provide a physical barrier that prevents pre-ejaculatory fluid and semen from entering the female reproductive tract. Internal condoms must be used correctly with every act of vaginal intercourse to be effective at preventing pregnancy and sexually transmitted infection (STI) transmission.

Efficacy

Pregnancy prevention — The most rigorous data regarding contraceptive effectiveness of internal condoms were derived from a cohort study of 221 couples using the FC1 (Reality) internal condom [17]. The estimated rates of pregnancy during the first 12 months of perfect use and typical use were 5 and 21 percent, respectively; these pregnancy rates are higher than those associated with use of external condoms (perfect and typical use pregnancy rates of 2 and 13 percent, respectively (table 1) [1,18]). While other less rigorous studies conducted with FC1 [19-21] suggested lower pregnancy rates with use of internal condoms, we use the rates presented above when counseling patients [21]. The effectiveness of the FC2 is assumed to be similar to that of the FC1, given its similar design, specifications, and functionality [4,5].

Sexually transmitted infections — A small number of laboratory and clinical studies suggest that internal condoms help to protect against transmission of STIs, but data are much more limited than for external condoms [22-30]. (See "External (formerly male) condoms".)

In vitro data suggest the internal condom may provide an impermeable barrier to HIV and cytomegalovirus, as well as other STIs [23,24], but no clinical studies have specifically evaluated the internal condom's ability to prevent HIV transmission. Two of three randomized trials of behavioral interventions to promote use of the internal condom observed that groups assigned to use FC1 had lower STI rates than groups assigned to use external condoms, but the differences were not statistically significant [26,27]. In the third trial, the STI rate in the group who only had access to external condoms was the same as that for the group with access to both external and internal condoms [29]. (See "Prevention of sexually transmitted infections".)

By contrast, an observational study provided evidence that adding internal condoms (FC1) to an external condom distribution program targeting sex workers significantly increased the proportion of protected sex acts and significantly reduced STI prevalence [28].

Why choose internal condoms?

General advantages — The internal condom offers several contraceptive and noncontraceptive benefits to users:

●Safe, effective, reversible method of contraception with no delay in return of fertility following discontinuation of the method.

●Can be obtained without a medical examination, prescription, or special fitting.

●Minimal side effects since it is relatively inert and the body is exposed to it only in anticipation of coitus and not at other times.

●Provides protection against STIs and offers an option to users whose sexual partners cannot or will not use an external condom. It offers broader coverage of external genitalia than the external condom and thus may give better coverage against STIs transmitted via skin lesions or shedding. (See 'Sexually transmitted infections' above.)

●May stimulate the clitoris with the external ring, thus enhancing sexual arousal [31].

General disadvantages — The only contraindication to internal condom use is allergy to nitrile. Fortunately, most people with latex allergies can still use nitrile products. (See "Common allergens in allergic contact dermatitis", section on 'Rubber accelerators' and "Latex allergy: Epidemiology, clinical manifestations, and diagnosis".)

However, internal condoms do have some disadvantages that may lead to inconsistent, incorrect, or nonuse, including:

●Some users find it difficult to insert and remove.

●The outer ring is visible outside of the vagina, which can be unacceptable to users or their sexual partners.

●It has a higher failure rate in preventing pregnancy compared with most other female contraceptive methods and the external condom (figure 1).

●It can make noise during intercourse.

●Some patients feel embarrassed or uncomfortable when obtaining condoms or suggesting use of condoms.

●Internal condoms are not as widely available as external condoms.

Comparison of coital-dependent methods — Patients who desire contraception that is used only at the time of intercourse can choose among external condoms, internal condoms, diaphragms, cervical caps, contraceptive sponges, and spermicide. The typical-use pregnancy rates range from 12 percent (diaphragm) to over 20 percent (internal condom, contraceptive sponge, spermicide) for the group (figure 1).

●Comparison with external condoms

•Internal condoms can be placed before intercourse, do not require an erect penis, and can be removed any time after ejaculation, so they are potentially less disruptive of intimacy. (See 'Patient instructions' below.)

•External condoms are usually made of latex while internal condoms are usually made of synthetic materials (nitrile, polyurethane), which do not have special storage requirements, can be used with both oil- and water-based lubricants, are unlikely to cause allergic reaction, and are stronger than latex. (See "External (formerly male) condoms".)

•Internal condoms are more expensive than external condoms (approximately USD $6 to $7 versus less than USD $1) but may be available for free or at a reduced cost through family planning programs [32-35].

•The internal condom is a vaginal device. Unlike the external condom, it is not recommended for anal sex due to reported problems with use and sparse evidence about clinical effectiveness [36].

•In contrast with external condoms, internal condoms are not tight.

•No published randomized trials have compared the clinical effectiveness of external and internal condoms for prevention of either pregnancy or STIs (including HIV). However, two randomized crossover trials of internal and external condoms in the United States and Brazil used proxy measures of breakage, slippage, and prostate-specific antigen (PSA) as indicators of semen exposure [37,38]. Participants used both condom types, completed condom-specific questionnaires to report problems, and collected precoital and postcoital samples of vaginal fluid for PSA. Although PSA detection rates were similar for both internal and external condoms, users in both trials reported internal condoms were associated with significantly more mechanical problems (eg, slippage, breakage, misdirection of the penis) than external condoms [39]. Regardless of the type of internal condom, difficulties with use, such as slippage and invagination, decrease with experience: markedly so after as few as five uses [40].

●Comparison with diaphragms and cervical caps

•Unlike the internal condom, diaphragms and cervical caps are contained completely within the vagina and are therefore not visible to users or their sexual partners. All three devices need to be inserted prior to any vaginal sexual activity. Internal condoms can be removed immediately after intercourse, while diaphragms and caps should remain in place for at least six hours after the last act of intercourse. (See "Pericoital (on demand) contraception: Diaphragm, cervical cap, spermicides, and sponge".)

•Similar to the internal condom, the single-size silicone diaphragm does not require a medical examination, fits most female patients, does not interfere with fertility, and is used on-demand. The diaphragm requires use of a separate spermicide, which also makes it more effective at preventing pregnancy than the internal condom (typical use pregnancy rate of 12 versus 21 percent). However, only the internal condom can provide protection against STIs. (See "Pericoital (on demand) contraception: Diaphragm, cervical cap, spermicides, and sponge", section on 'Single size'.)

•In contrast to the internal condom, the cervical cap requires a medical examination for proper fitting, needs to be resized after pregnancy, and requires separate spermicide application with every use. The risk of unintended pregnancy is similar for the two methods, but only the internal condom protects against STIs. (See "Pericoital (on demand) contraception: Diaphragm, cervical cap, spermicides, and sponge", section on 'Cervical cap'.)

•Unlike the single-size diaphragm and cervical cap, the internal condom is not intended to be reused. (See 'Reuse' below.)

●Comparison with spermicides and contraceptive sponge

•The internal condom, spermicide, and contraceptive sponge all provide over-the-counter, on-demand protection against pregnancy and do not require a medical examination. First-year typical-use failure rates exceed 20 percent for all three methods (figure 1). Only the internal condom definitively provide protection against STIs. (See "Pericoital (on demand) contraception: Diaphragm, cervical cap, spermicides, and sponge", section on 'Vaginal spermicide and pH regulator gel' and "Pericoital (on demand) contraception: Diaphragm, cervical cap, spermicides, and sponge", section on 'Spermicidal contraceptive sponge'.)

Strategies for promoting effective internal condom use — The optimal methods of counseling to ensure correct and consistent internal condom use are not known. The World Health Organization (WHO) advises the following steps to support patients who wishes to use internal condoms [1]:

●Ensure correct understanding of use – Once the instructions for internal condom use have been explained, ask the patient to repeat back the five basic steps (see 'Patient instructions' below). Ideally, a plastic model of the female pelvis can be used to practice insertion and removal.

●Explain the importance of properly using a condom with every sex act – As with all contraceptives, internal condoms are most effective when used correctly and consistently with every episode of vaginal intercourse. Educate patients that one sex act can lead to unintended pregnancy and/or an STI, including HIV infection.

●Review ways to discuss condom use and troubleshoot anticipated problems – Internal condom use requires partner cooperation, but not all people are comfortable discussing condom use. Encourage patients to bring up their plan for internal condom use before intercourse to improve the odds that a condom is used and that it is used correctly. The patient and their sexual partner(s) may benefit from counseling. This conversation allows the clinician, patient, and partner to address any questions or concerns.

●Supply internal condoms or provide access information – Ideally, patients are sent home with a supply of internal condoms for both practice and use. New users may benefit from trial insertion (ie, insertion before intercourse is anticipated) and removal. If they are unavailable, discuss where internal condoms can be purchased (eg, local retail pharmacies and online sites). Encourage the patient to keep a supply of internal condoms in case one breaks or becomes damaged.

●Encourage the patient and/or sexual partner(s) to come back anytime – Advise patients that they, along with their sexual partner, are welcome to return anytime to discuss problems, questions, or concerns with this method.

●Inform patients about limitations – Advise them that, compared with external condoms and intrauterine and hormonal methods, information on efficacy is limited and that internal condoms may be difficult to buy.

INFORMATION FOR INTERNAL CONDOM USE

Patient instructions — The basic steps of internal condom use below are reviewed with the patient and partner, if present (figure 2). A free interactive FC2 training program is available for health care providers online. FC2 can be purchased online or from retail pharmacies. It is also available from some state and municipal health agencies and nonprofit organizations.

●A new internal condom should be used with every act of vaginal intercourse. The internal condom should not be used concurrently with an external condom since friction between the two condoms may cause breakage.

●The user can assume any position that is comfortable for inserting the internal condom. It can be inserted up to eight hours before intercourse. Before insertion, the user should make sure the condom is adequately lubricated for passage through the vagina, which will also minimize noise during sex. Either water-based or oil-based lubricants can be used.

●The inner ring at the closed end of the FC2 is squeezed with the thumb and middle finger, as with a diaphragm, and then inserted into the vaginal opening. The index finger is then placed inside the condom and used to push the inner ring as far into the vagina as it will go, without allowing the condom to twist. The outer ring remains outside the vagina and extends approximately 1 inch beyond the labia.

●At intromission, it is important to ensure that the penis does not slip between the vagina and the outer surface of the condom. It may be helpful for the partner to guide penis insertion into the ring. During intercourse, it is important to ensure that the outer ring does not get pushed into the vagina. The internal condom can be used during menses and for any position of vaginal intercourse. (See 'Use with lubricants and/or medications' below.)

●The internal condom can be removed any time after intercourse. It should be taken out before the user stands up to avoid having the semen spill out. The outer ring of the condom is twisted (clockwise or counterclockwise) to seal the condom, and then pulled out and wrapped in the package it came in and/or in a tissue. It should be disposed of in waste containers, not in the toilet. The internal condom cannot migrate into a patient's uterus or body.

Reuse — Internal condoms, including the FC2, are not recommended for reuse since this approach has not been studied [1]. However, use of a new device with every act of intercourse may be difficult because of problems with cost or access. Limited data support disinfecting protocols for reuse of the FC1 condom [41-43]. Thus, for users with limited access to condoms and contraceptive methods, a program of washing, disinfecting, and reusing internal condoms may be preferable to having unprotected intercourse, although the efficacy of reused internal condoms is unknown.

Complications or failure — The main complications are penis insertion to the side of the condom, invagination (ie, when the outer frame of the condom pushes into the vagina during intercourse), and condom breakage. To help avoid misdirection of the penis, it may be helpful for the partner to guide the tip of the penis into the center of the external condom ring. Invagination can be minimized by using one hand on the outer ring to hold it in place. Should invagination occur, the outer ring is pulled out of the vagina and seated back into proper location. Breakage can be minimized by using a new condom with every act of vaginal intercourse and using adequate lubrication. (See 'Use with lubricants and/or medications' below.)

Use with lubricants and/or medications — In contrast with latex external condoms, the FC2 can be used with both water- or oil-based lubricants because it is made of nitrile, a synthetic latex (rubber). Commonly available products that can be used as lubricants for non-latex internal condoms include saliva, clean water, butter, and cooking oils.

Storage and expiration — Most available internal condoms are made of synthetic materials (nitrile, polyurethane) and do not have special storage requirements. The product should be used before the manufacturer's expiration date.

RESOURCES FOR PATIENTS AND CLINICIANS — Additional information about internal condoms and other contraceptive options can be found at the following sites:

●World Health Organization Family Planning Global Handbook for Providers (2018)

●Planned Parenthood – A nonprofit organization dedicated to reproductive health with resources for patients and clinicians.

●bedsider.org – A free website developed by the National Campaign to Prevent Teen and Unplanned Pregnancy, a private nonprofit group.

●CHOICE Project – A free website sponsored by the Washington University School of Medicine in St. Louis that provides resources on contraceptive options and training resources for clinicians.

●Center for Young Women's Health – A free website run by Boston Children's Hospital that addresses the reproductive health needs of teens and young adults.

●Beyond the Pill – A free website run by the University of California San Francisco.

●Sex & U – An educational site run by the Society of Obstetricians and Gynaecologists of Canada that includes descriptions of various methods and a tool to help with selection of birth control.

●American College of Obstetricians and Gynecologists (ACOG) Contraceptive FAQs – ACOG addresses frequently asked questions (FAQs) about contraception.

SOCIETY GUIDELINE LINKS — Links to society and government-sponsored guidelines from selected countries and regions around the world are provided separately. (See "Society guideline links: Contraception".)

INFORMATION FOR PATIENTS — UpToDate offers two types of patient education materials, "The Basics" and "Beyond the Basics." The Basics patient education pieces are written in plain language, at the 5^th to 6^th grade reading level, and they answer the four or five key questions a patient might have about a given condition. These articles are best for patients who want a general overview and who prefer short, easy-to-read materials. Beyond the Basics patient education pieces are longer, more sophisticated, and more detailed. These articles are written at the 10^th to 12^th grade reading level and are best for patients who want in-depth information and are comfortable with some medical jargon.

Here are the patient education articles that are relevant to this topic. We encourage you to print or e-mail these topics to your patients. (You can also locate patient education articles on a variety of subjects by searching on "patient info" and the keyword(s) of interest.)

●Basics topics (see "Patient education: Barrier methods of birth control (The Basics)")

●Beyond the Basics topics (see "Patient education: Barrier and pericoital methods of birth control (Beyond the Basics)")

SUMMARY AND RECOMMENDATIONS

●Internal (formerly female) condoms consist of an anchor (eg, ring, frame) that sits outside of the vagina, a sleeve that lines the vagina, and often an inner ring or sponge that holds the device in place. Internal condoms are commonly made out of nitrile (a synthetic latex) but have also been made out of natural rubber latex and polyurethane. The FC2 condom is the most commonly available internal condom globally. (See 'Types of internal condoms' above.)

●The internal condom provides a physical barrier that prevents pre-ejaculatory fluid and semen from entering the female reproductive tract. Internal condoms must be used correctly with every act of vaginal intercourse to be effective at preventing pregnancy and sexually transmitted infection (STI) transmission. (See 'Mechanism' above.)

●The best estimates for the rates of unintended pregnancy during the first 12 months of perfect use and typical use of the FC2 internal condom are 5 and 21 percent, respectively; these rates are higher than those associated with use of the external (formerly male) condom (perfect- and typical-use pregnancy rates of 2 and 13 percent, respectively). Use of internal condoms can also provide protection from acquisition and transmission of STIs, although data are very limited. (See 'Efficacy' above.)

●Internal condoms are a safe, effective, reversible method of contraception that does not delay return of fertility. They can be obtained without a medical examination, prescription, or special fitting. Internal condoms are an option for patients who could be exposed to STIs when the sexual partner cannot or will not use an external condom. (See 'General advantages' above.)

●The only contraindication to internal condom use is allergy to nitrile. Most people with latex allergies can still use nitrile products. Other disadvantages can include problems with insertion or removal. (See 'General disadvantages' above.)

●The internal condom offers several advantages over the external condom (eg, it can be placed before intercourse, does not need to be removed immediately after ejaculation), as well as some disadvantages (eg, it is more expensive and should not be used for anal intercourse). Compared with the diaphragm and cervical cap, the internal condom should provide better protection against acquisition and transmission of STIs. (See 'Comparison of coital-dependent methods' above.)

●A new internal condom should be used with every act of vaginal intercourse but not concurrently with an external condom. It can be inserted into the vagina up to eight hours before intercourse. Unlike external condoms, either water-based or oil-based lubricants can be used with internal condoms. (See 'Patient instructions' above.)

●Internal condoms, including the FC2, are not recommended for reuse since this approach has not been studied. (See 'Reuse' above.)

ACKNOWLEDGMENT — The UpToDate editorial staff acknowledges Willard Cates, Jr, MD, MPH, who contributed to an earlier version of this topic review.

The findings and conclusions in this topic review are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention (CDC).