Non-Hormonal Contraceptions Methods

#### **Chapter 5**

## Advances in Hormone-Free Contraceptive Devices

*Alfred A. Shihata, Steven A. Brody and Birgit Linderoth*

#### **Abstract**

Up to (99%) of women worldwide may use birth control for at least 30 years. However, most modern female contraceptives containing hormones can have undesirable side effects. Among the limited hormone-free options, the fertility awareness method is the safest and most effective when used correctly. This study explores a time-tested, safe, and effective barrier contraceptive called FemCap. FemCap not only aids in pinpointing the day of ovulation but also integrates electronic periodtracking technology to enhance the efficacy of the fertility awareness method. Stress Urinary Incontinence is a prevalent issue affecting women of all ages, often suffering in silence. Our research aims to address the unmet needs in women's reproductive health. We have discovered that FemCap can function as a pessary to manage Stress Urinary Incontinence by providing support to the bladder neck and straightening the urethra, thereby restoring the competence of the urethral sphincters. FemCap has emerged as a powerhouse for fertility awareness and stress urinary incontinence. However, due to the limitations of this study, the authors welcome any investigators who can validate our findings as well as provide suggestions to enhance the overall value of this research for the benefit of all women.

**Keywords:** hormone-free barrier contraception, fertility awareness methods, FemCap, stress urinary incontinence, vaginal drug delivery, pairing FemCap with electronic period tracking application

#### **1. Introduction**

The authors organized a series of small focus groups to discover what women consider the ideal birth control (**Figure 1**). Over the past decade, a noteworthy breakthrough has been the creation of a hormone-free contraceptive device known as Caya diaphragm, which is designed to fit most women due to its unique one-size feature (**Figure 2**). Microbicides are experimental products that could prevent Human Immune Virus (HIV) transmission from male to female and vice versa (**Figure 3**).

Male and Female condoms are the only devices approved for preventing Sexually transmitted diseases (STDs). Though FemCap is not approved for the prevention of STIs, it has all the biological and plausible potential for the prevention of STIs, see the comparative (**Table 1**).

**Figure 1.** *A women's ideal birth control.*

**Figure 2.** *Caya Diaphragm vs. Wide Seal Diaphragm.*

### **2. FemCap design and its evolution**

The cervix was determined to be the main portal of entry for HIV and Sexual Transmitted Infections (STI) organisms for transmission from men to women. This is due to the Os opening of the cervix as well as the presence of chemokine co-receptors for HIV on the cervix, called Chemo Chine Receptor 5 (CCR5) and Chemo X Receptor 4 (CXR4). HIV first fuses with these co-receptors and then invades the immune cell CD4 (**Figure 4**) [1].

In response to the HIV/Acquired Immune Deficiency Syndrome (AIDS) pandemic and according to the scientific recommendation for the prevention of transmission of HIV from male to female [2], the first author developed the *Advances in Hormone-Free Contraceptive Devices DOI: http://dx.doi.org/10.5772/intechopen.112255*

**Figure 3.** *FemCap Used to Deliver Microbicide.*

FemCap, specifically designed to mechanically covers and seal the cervix and store and deliver the microbicide. He also developed a microbicide/spermicide to kill the sperm and invading HIV and STIs organisms upon deposition into the vagina. Both were patented [3, 4]. However, the microbicide was abandoned due to the presence of Nonoxyle-9.



#### **Comparison of the Male and Female Condoms with the FemCap**

#### **Table 1.**

*Comparison of the Male and Female Condom with the FemCap.*

**Figure 4.** *HIV + CCR5+ CXR4 + CD4 cell = AIDS infection.*

*Advances in Hormone-Free Contraceptive Devices DOI: http://dx.doi.org/10.5772/intechopen.112255*

The first-generation FemCap (**Figure 5**) was not approved by the Federal Food and Drug Administration (FDA) due to the difficulty of removal and poor efficacy in multiparous women (**Figures 5**–**10**).

*The second generation FemCap that is FDA APPROVED* has a removal strap that improved its safety by eliminating the fingernail abrasion to the cervix. The increased dimensions of the brim increased the surface contact between the vagina and the FemCap, improving its stability. This is due to the fact that FemCap is held by the vaginal contraction preventing dislodgment and thus increasing its effectiveness and acceptability.

**Figure 5.** *First generation FemCap and the improved second generation.*

**Figure 6.** *FemCap three sizes.*

**Figure 7.** *Second generation showing improvements.*

**Figure 8.** *FemCap diagram all views.*

Unfortunately, some institutions still cite the obsolete effective rate of the first generation that was not used or approved by the FDA.

The following Video 1 (https://www.youtube.com/watch?v=4FgvJbl\_X\_M) will visually demonstrate the difference between the obsolete first-generation and the FDA-APPROVED second-generation. The references [5–8] will cite the difference in the effective rate of the first versus the second-generation FemCap.

Careful consideration was taken when designing FemCap's second-generation model. Its DOME provided full coverage for protecting the cervix and preventing it from prolapsing, while its RIM fits snugly into the vaginal Fornices and encompassed its entrance (**Figures 7**–**10**). A LIP was implemented to grasp onto her cervix to secure its hold (**Figure 10**). Regarding its BRIM formation, it had an outward flare to press against the inward vaginal contraction (**Figures 7**, **10** and **11**), thus creating a tight seal, preventing sperm from penetrating along the vaginal walls. Anatomically wise as well, it possessed a more extended posterior section than other parts. Together these features bring about a comfortable and secure fitting of the FemCap.

*Advances in Hormone-Free Contraceptive Devices DOI: http://dx.doi.org/10.5772/intechopen.112255*

**Figure 9.** *FemCap covering cervix.*

**Figure 10.** *FemCap views.*

**Figure 11.** *The FemCap covering the cervix.*

#### **3. Size selection**

Vaginal anatomy varies in different women and even in the same woman in response to pregnancy and delivery., so a one-size-fits all approach simply will not work. To solve this issue the FemCap comes with three sizes to choose from, the 22 mm for those who have never been pregnant, 26 mm for those who have experienced pregnancy without vaginal delivery (e.g. C-section or miscarriage) and 30 mm for women who have delivered vaginally (**Figure 6**).

Utilizing the 3 sizes eliminated the need for time-consuming and inaccurate measurement and custom fitting. The woman's obstetrical history determines the FemCap size selection.

This study yielded an interesting outcome; the height and weight of women have no or very little relation to cervical diameter or vaginal elasticity. It was found out that pregnancy and delivery are the only factors that influence these two characteristics.

The FemCap is designed with a unique deep groove facing the vaginal opening. (**Figures 6**, **7**, and **9**) This groove was intended to trap and expose the sperm and bacteria or viruses to the spermicide upon deposition into the vagina for a prolonged period to ensure the complete killing of sperm and microorganisms (**Figure 7**).

The following Video 2 (https://www.youtube.com/IZkxCbZ0WtU) will visually explain the features of the second Generation FemCap versus the obsolete cervical cap.

FemCap provided a much-needed alternative to traditional hormone-based birth control and was quickly approved for contraception in both United States and Europe. Unfortunately, approval of FemCap for HIV/AIDS prevention was denied due to ethical and logistical considerations (**Figure 12**).

The FemCap is a well-established, time-tested, safe, and effective non-hormonal contraceptive device [5–12]. The FemCap have been used by women world-wide for two decades with good success and without any reported side effects. It has never been withdrawn from any country for any reason. The FemCap's unique storage groove for spermicide/microbicides can potentially be utilized to treat sexually transmitted infections topically (**Figures 8**–**11**).

#### **Figure 12.** *FemCap viewed by speculum.*

#### **4. The fertility awareness method**

The Fertility Awareness Method (FWM) is the safest and most cost-effective contraceptive method, yet it is the least prescribed by clinicians and used by women. This method does not need equipment, drugs, or professional supervision after the initial training. There is also a common misconception that this method is difficult to learn and has a high failure rate. The subjective observation of collecting the fertile cervical mucous from the underwear or inserting a finger in the vagina may yield a very small amount of cervical secretions mixed with vaginal fluid. All the above factors might lead to missing the fertile window [13, 14].

We spared no effort in enhancing the effectiveness and simplifying the learning of this wonderful method [13–24]. We attributed the high failure rate to the fact that women miss the most vital sign of ovulation and thus miss their fertile window.

We used a two-prong approach to enhance this method's effectiveness and simplify its learning [13–24]. We utilized FemCap to collect the fertile cervical mucous directly from the cervix. Starting 2 days after the end of menstruation until the clear translucent stretchy preovulatory mucous (Spinnbarkeit) (**Figure 13**) appears just before ovulation. The FemCap allowed women to collect a large quantity and excellent quality of their fertile cervical mucous directly from the cervix. The FemCap also prevents the fertile cervical mucous from mixing with other vaginal secretions.

The following Video 3 (https://www.youtube.com/watch?v=oYoYb0gM-w4) will visually teach and simplify the learning of this method.

The second prong was using the Smart Telephone technology (**Figure 14**) to monitor the menstrual cycle and inform women of the fertile and infertile days. This innovative technology allowed women to pinpoint the precise day of ovulation, and thus they can decide whether to become pregnant or prevent it.

We recruited 40 healthy women with regular periods to participate in this pilot research. We randomized twenty women to use the traditional Fertility Awareness Method (FAM) with basal body temperature and the usual subjective

**Figure 14.** *FemCap paired with period tracking technology.*

collection of fertile cervical mucus. The other 20 women used the FemCap to collect their fertile cervical mucus (Spinnbarkeit) directly from the cervix from day nine until they detected fertile mucus [22]. We also instructed women to record their findings and any side effects on the basal temperature chart (**Figure 15**) [14, 23].

*Advances in Hormone-Free Contraceptive Devices DOI: http://dx.doi.org/10.5772/intechopen.112255*

**Figure 15.** *Basal body temperature chart.*

#### **5. Result**

The results of this study utilizing the FemCap to collect the cervical mucous showed that 95% of the participants could accurately identify preovulatory fertile cervical mucus. These same users also verified ovulation with a positive urinary L.H. (Luteinizing Hormone) surge, accompanied by biphasic Basal Body Temperature charts (**Figure 15**) that supported the L.H. surge results.

However, the control group that used subjective detection of their fertile cervical mucous were successful in only 55%. Collecting cervical mucus directly from the cervix without mixing with any vaginal fluid content yielded higher quantities and better-quality samples (Spinnbarkeit). This enabled women to shorten fertile window to three days for conception, and eight days for contraception (**Figure 15**).

#### **6. Conclusion**

Collecting mucus directly from the cervix yielded a large quantity and excellent quality of fertile mucus. This allowed women to pinpoint the day of ovulation with astonishing precision.

The Smartphone Technology teamed up with FemCap, ultimately providing women with an unprecedentedly accurate prediction of their ovulation day. This new method established a three-day window for conception and eight days for contraception (**Figure 15**).

Women reported that FemCap allowed them to collect large amounts of topnotch cervical secretions that resembled clean egg whites; moreover, these could be stretched up to 2 inches before breaking. This simple, affordable strategy can

maximize success rates when trying to conceive or avoid pregnancy among healthy women with regular menstrual cycles.

Synergy created between the FemCap and a Smartphone application (**Figure 14**) provides the safest and most cost-effective birth control without side effects. Investigators and nurses should be encouraged to validate this pilot study.

#### **7. Stress urinary incontinence**

Stress Urinary Incontinence (SUI) is prevalent among women of all ages, particularly menopausal women. Women are embarrassed to complain about stress incontinence and silently endure the inconvenience and shame. The (SUI) is underreported by women, which leads to under-diagnosis and under-treatment [24].

A woman using the FemCap for contraception reported to the first author that she noticed that on the days she wore the FemCap, for contraception, she did *not* suffer from incontinence. Consequently, she decided to wear the FemCap even when she did not need it for contraception [25–27].

This woman's observation led us to investigate a new usage for the FemCap as an SUI pessary (**Figures 16**–**18**). The current state of the treatment for SUI is pelvic floor muscle (Kegel) exercises and vaginal pessaries. The most popular is the ring pessary; however, various shapes and sizes (**Figures 19**–**21**) are now available to hopefully achieve better results before recommending surgery. The most recent are Uresta (**Figure 20**) and Introl, and Revive (**Figure 21**).

We began our analysis by comparing the FemCap with the vaginal ring pessary with support (**Figure 16**). The bowl of the FemCap (**Figures 16** and **17**) is designed to secure itself entirely around and below the cervix thereby preventing it prolapse. Additionally, its rim fits closely into the fornices, providing support to the bladder neck (**Figure 21**). The out flaring of the brim distributes pressure evenly against the vaginal wall, the cystocele and over the mid- urethra to restore the anatomy of the cystocele and to straighten the urethra. The FemCap offers a unique advantage when treating or preventing Stress Urinary Incontinence.

**Figure 16.** *Ring pessary with support.*

*Advances in Hormone-Free Contraceptive Devices DOI: http://dx.doi.org/10.5772/intechopen.112255*

**Figure 17.** *FemContinence pessary.*

**Figure 18.** *Vaginal pessaries.*

Unlike the ring pessary with support, that usually have a metal knob (**Figure 16**) The FemCap is composed entirely of soft, pliable material. The knob and the rim of the ring pessary with support has an internal metal to exert pressure against the Cystocele and the urethra (**Figures 16** and **20**).

The investigators, Alfred Shihata and Birgit Linderoth, Midwife of Falun of Sweden, did investigate the feasibility of using the FemCap to manage SUI (**Figure 21**) [28].

**Figure 19.** *Courtesy of Uresta.*

**Figure 20.** *Ring pessary with support & knob, introl, revive.*

#### *Advances in Hormone-Free Contraceptive Devices DOI: http://dx.doi.org/10.5772/intechopen.112255*

The Current management of mild to moderate SUI is Kegel exercise and ring pessary. We conducted a limited pilot study for 2 weeks to validate the experience of the woman who used the FemCap to control her Stress incontinence. We were pleasantly surprised to validate her experience [29]. We were encouraged and decided to expand the study into Sweden and increase the number of participants [28]. It is worth mentioning that we enrolled 118 women in a very short time.

This study protocol included women with mild to moderate SUI, but those with severe incontinence or 3rd-degree prolapse were excluded.

We asked women to record each episode of incontinence and what precipitated it for one week before using the FemCap, (**Table 2**), as the women's her own control.

We instructed women to follow the same protocol above while using the FemCap (**Table 3**). That Shows the same woman's experience while using FemContinence (FemCap).

#### **7.1 Results**

99 women completed the study; 85 were completely dry while using the FemCap. Nine (9) women were partially dry, and 5 women were not satisfied with the results. Ninety-four women, including the partially dry said, they would like to use the FemContinence if available. No side effects were reported by the participants, and pelvic examinations did not show any erosion or ulceration of the vagina. (**Tables 2** and **3**) are an example of a woman who became completely dry [28].


**You should insert the FemCap first thing in the morning\* . Do not remove it until bedtime and then wash and store it in container until you use it the next morning.**

\* *If you are using FemCap for birth control use spermicide* \* *If you are using FemCap for incontinence only use with a water soluble lubricant*.

#### **Table 2.**

*Incontinence tracker the week before trying FemContinence.*


3. Comments I did not have leakage when jumping on the trampoline while using the FemCap, Coughing and sneezing no longer was an issue when I had a cold while using FemCap

#### **Table 3.**

*Vaginal drug delivery.*

#### **7.2 Conclusion**

The innovative *FemContinence* (FemCap) device provides a safe, reusable, and self-administered treatment to help manage stress urinary incontinence. The FemCap was able to restore the anatomical structure of the bladder, the bladder neck, and the urethra. Research has revealed that in 85% of cases, this device reduced or eliminated symptoms that negatively impact the overall quality of life. This presents an ideal, low-cost, non-invasive solution for clinicians treating a condition often unspoken about. Further clinical trials should be conducted to verify these results.

*Due to the small number of the participants and limitation of this study we welcome any investigator who would like to validate this study. As a token of our appreciation, we will provide all the FemCap (FemContince) free of charge for treating or preventing mild to moderate Stress Urinary Incontinence (SUI)*. We would not have achieved this result unless the FemCap did restore and maintain the anatomy and by supporting the bladder neck and straighten the urethra and thereby made the urethral sphincters competent.

#### **8. Vaginal drug delivery by the FemCap**

Millions of women have used and still using vaginal applicators to introduce creams and gels into the vagina. The regular rhythmic contraction of the vagina is designed to rid itself of menstrual blood and cervical discharges, as well as any treatment-oriented vaginal creams that could be rendered them less effective through these natural forces (**Figures 22** and **23**).

Video 4 (https://www.youtube.com/watch?v=6JNFIOoXeLI) describe the alternative to the currently available vaginal Applicator.

*Advances in Hormone-Free Contraceptive Devices DOI: http://dx.doi.org/10.5772/intechopen.112255*

**Figure 22.** *Vaginal expulsion of cream.*

**Figure 23.** *Shower-head applicator.*

The first author developed a showerhead applicator for better distribution and retention of therapeutic vaginal medications. Unfortunately, the vagina did expel the cream rendering them less effective.

The primary focus of this study was to analyze the possibility of offering women an alternative to traditional vaginal applicators and investigate how long FemCap, a new cervical barrier, could keep therapeutic preparations in contact with the cervix and vagina. We wanted to see whether FemCap could effectively treat Bacterial Vaginosis, Candida infections, and some sexually transmitted diseases topically. To prove this concept, we recruited 40 women to insert a stained gel with Gentian violet into the vaginas.

To assess the efficacy of the FemCap device, we randomized women into two groups. Group A of 20 women used a vaginal applicator as the control, and group B employed the FemCap to insert the identical gel into their vaginas. Pads were provided for monitoring any expulsion of the gel while using the traditional applicators and the FemCap. We photographed the cervix and the vagina at 12 and 24 hours.

(See **Figure 24**).

**Figure 24.** *The FemCap retained stain over 24 hours vs. The applicator.*

#### **8.1 Results**

During the study, no adverse effects were noted among participants in either group that used the stained gel. Interestingly, several women reported leakage while using a vaginal applicator. While none of the women who used the FemCap had any leakage. Upon examination of cervical photographs taken 12 hours and 24 hours after insertion. Women who used the vaginal applicators had no visible stain after 12 hours. The Stain was visible over the cervix, 24 hours after insertion, with the FemCap.

#### **8.2 Conclusion**

This pilot study results showed that, applications of vaginal preparations by the FemCap into the vagina will have better retention and distribution than if it were applied with vaginal applicator.

Further research should investigate whether FemCap can effectively treat ailments such as bacterial vaginosis, candida, and some STIs like gonorrhea and chlamydia topically.

#### **Acknowledgements**

This research chapter is written at the request of MS. Tea Jurcic, Author Service Manager of IntechOpen of London. We are indebted to the women who participated in the research study, we thank Dr. Steven Brody, who co-authored and edited this manuscript, and Ms. Birgit Linderoth, a Midwife from Falun, Sweden, who volunteered to enroll her patients in the trials. No funding was requested or received from any institution. We wish to Thank Mr. Sam Awada for donating the FemCap devices. The authors are responsible for the contents of this chapter.

*Advances in Hormone-Free Contraceptive Devices DOI: http://dx.doi.org/10.5772/intechopen.112255*

#### **Author details**

Alfred A. Shihata1 \*, Steven A. Brody2 and Birgit Linderoth3

1 Scripps Institution of Medicine and Science San Diego, Del Mar, CA, USA

2 LifeSpan Medical Institute San Diego, CA, USA

3 Midwife, Falun, Sweden

\*Address all correspondence to: alfred@femcap.com

© 2023 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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[2] Alfred Shihata, Steven Brody. HIV/ STIs and pregnancy prevention, using a cervical barrier and Microbicide.

[3] US patent NO:5,207232 New barrier Contraceptive device FemCap

[4] US patent No 5,778,886 Vaginal compositions combining a spermicidal agent and a peroxygen compound.

[5] https://femcap.com/resources\_assets/ news-articles/medical\_news.htm#WHCJ

[6] Shoupe D, Kjos S. The Handbook of Contraception, Barrier Contraceptives Chapter 10. Humana Press; 2006. pp. 147-177

[7] Carcio H, Clarke SM, Koeniger-Donohue R. Advanced Health Assessment of Women: Clinical Skills and Procedures Chapter 15 the FemCap. Springer. Publishing Company; 2010. pp. 271-278

[8] Scan-Jan-1244-2022.pdf (femcap. com) Advanced Health Assessment of Women.

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[12] Shihata A. The FemCap™, a new contraceptive choice. The European Journal of Contraception and Reproductive Health Care. 1998;**3**:160-166

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[14] Wolcox A, Weinberg M, Baird D. Timing of sexual intercourse in relation to ovulation. Effects on the Probability of Conception, Survival of the Pregnancy, and Sex of the Baby The New England Journal of Medicine. 1995;**333**:1517-1521

[15] Shihata A, Brody S. Novel approach for women to identify the precise day of ovulation to conceive or contracept. International Journal of Medical Science and Health Research. 2020;**4**(3)

[16] Pyper CMM. Fertility Awareness & Natural Family Planning. The European Journal of Contraception & Reproductive Health Care. 1997;**2**:131-146

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[18] Marshall. The Infertile Period– Principles and Practice. London: Darton, Longman and Todd; 1963

[19] Clubb E, Knight J. Fertility–Fertility Awareness and Natural Family Planning. 3rd ed. David & Charles; 1996

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[20] Arevalo M, Sinai I, Jennings V. A fixed formula to define the fertile window of the menstrual cycle as the basis of a simple method of NFP. Contraception. 1999;**60**:357-360

[21] Odeblad E. Cervical mucus and their functions. Journal of the Irish Colleges of Physicians and Surgeons. 1997;**26**(1)

[22] Fordney-Settlage D. A review of cervical mucus and sperm interactions in humans. International Journal of Fertility. 1981;**26**:161-169

[23] Shihata A. New FDA approved woman-controlled, latex-free barrier contraceptive device "FemCap™". Fertil Steril. International Congress Series 1271. 2004;**05**(103):303-330

[24] Viera AJ, Larkins-Pettigrew M. Practical use of the pessary [published correction appears in Am fam physician 2002 Jul 1;66(1):30]. American Family Physician. 2000;**61**(9):2719-2729

[25] Al-Shaikh G, Syed S, Osman S, Bogis A, Al-Badr A. Pessary use in stress urinary incontinence: A review of advantages, complications, patient satisfaction, and quality of life. International Journal of Womens Health. 2018;**10**:195-201. Published 2018 Apr 17. DOI: 10.2147/IJWH.S152616

[26] Jones K, Harmanli O. Pessary use in pelvic organ prolapse and urinary incontinence. Reviews in Obstetrics & Gynecology. 2010. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/ articles/PMC2876320/

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## Barrier Methods of Contraception

*Naana Boadiwaa Asante, Jude Anim and Raida Koray*

#### **Abstract**

Barrier methods of contraception prevent the exchange of bodily fluids such as semen, vaginal and anal secretions, and blood between partners during intercourse. Thus, the primary function of these methods of contraception is pregnancy prevention. Some, such as internal and external condoms, provide protection against sexually transmitted infections (STIs) as well. Barrier methods of contraception include condoms (external and internal), diaphragm, cervical cap, contraceptive gel, spermicide, and contraceptive sponge. Since they are non-hormonal and have no systemic effects, these are alternatives for women who cannot use hormonal contraceptives due to certain medical conditions or medications prescribed. The efficacy of these methods of contraception is contingent on their correct and consistent use. This chapter aims to discuss the various barrier methods, their usage, mechanisms of action, advantages, and disadvantages as well as the comparison of some of these methods to one another.

**Keywords:** barrier methods, contraception, non-hormonal, sexually transmitted infection, efficacy

#### **1. Introduction**

Contraception has been around for some centuries now. Using various techniques to prevent pregnancy, ancient writings dating back to 1850 BC recorded the insertion of various substances into the vagina. Substances such as crocodile dung, gum, honey, and acacia were used. At that time, it was believed that these substances created a hostile environment for sperm to survive [1]. Another well-known method dating back to centuries which is still being used is coitus interruptus (withdrawal method). The effectiveness of withdrawal is dependent on timing, self-control, and apt removal of the penis before ejaculating. Due to the high failure rates of this method, other methods had to be devised to address contraception [2]. As medicine extended its tentacles to address contraception, the main points of focus were efficiency, efficacy, mechanism of action, and the failure rates of each device and pill created.

Contraception can be classified into barrier and non-barrier methods. Barrier methods act as blockages that prevent sperms from reaching the egg [1]. Barrier methods of contraception which are the focus of this chapter have been recognized many centuries ago. As early as the 18th and 19th centuries, items such as leaves, sponges, and lemons were used to block sperm from entering the uterus [3]. For instance, some ancient Egyptian arts display men with decorative coverings of their penises [3]. Just like the withdrawal method which has a high failure rate, these barrier methods were to some extent unreliable because of their fragility, nature, and low to no proficiency rate. Over time, barrier methods including spermicides, condoms, diaphragms, cervical caps, and contraceptive gels and sponges were discovered. The game changer for barrier methods to be unleashed was when rubber was discovered in 1839 by Hancock and Goodyear [3]. With this discovery, many of the barrier methods from the 19th century up until now were made of rubber which made them inexpensive and easily accessible to many. On a wide scale, even though barrier methods can interrupt pregnancy, most are not effective in protecting against sexually transmitted diseases.

The vast types of barrier methods give an individual many options to birth control depending on the conduciveness of lifestyle, accessibility, risk, consistency, and usage. Other factors to consider in selecting a barrier method include allergies, bouts of sexual encounters, duration, and frequency of the device's usage. Some barrier methods require a physician's discretion while others can be purchased over the counter. Even in some cases, the efficiency of contraception can be achieved by the combination of various barrier methods. Advantageously over non-barrier methods, barrier methods can be used intermittently and possibly overcome systemic side effects [1]. In this book chapter, we will discuss the various barrier methods, their mechanism of action, efficacy, advantages, and disadvantages.

#### **2. External (male) condoms**

#### **2.1 Introduction**

It is a thin protective sheath worn over an erect penis during intercourse [4]. External condoms reduce the likelihood of unintended pregnancy and transmission of sexually transmitted infections (STIs) when used correctly and during every sexual activity [4].

#### **2.2 Types of external condoms**

External condoms are made from various materials and come in different shapes, sizes, thicknesses, colors, flavors, and with or without reservoir tips that collect semen. They may or may not contain lubricants or spermicides [5, 6].

#### *2.2.1 Latex condoms*

Most condoms manufactured commercially are made of latex. They are less expensive and have higher tensile strength than non-latex condoms. Latex condoms are more effective than non-latex condoms at protecting against all common types of STIs with correct and consistent use [7]. Although the advantages of latex have made it the most preferred material for condoms, it has a few drawbacks. Latex condoms can trigger an allergic reaction in people who are allergic to latex [1, 4, 8] and are degraded by oil-based lubricants; therefore, they should not be used in conjunction with oil-based lubricants [1, 4, 9].

#### *2.2.2 Non-latex condoms*

Non-latex condoms can be made from lambskin and synthetic materials such as polyurethane, silicone, or polyisoprene [1, 4]. Non-latex condoms are an alternative *Barrier Methods of Contraception DOI: http://dx.doi.org/10.5772/intechopen.111767*

for individuals who are allergic to latex [1, 4, 8]. Polyurethane condoms do not stretch like latex or polyisoprene, making them more susceptible to slippage and breakage. Polyurethane condoms are thinner and conduct heat better than latex and polyisoprene which may enhance sensitivity. Polyurethane condoms can be used with both water-based and oil-based lubricants. In contrast to polyurethane condoms, polyisoprene condoms are cheaper, stretchier, thicker, conduct heat poorly, and are incompatible with oil-based lubricants [1]. Lambskin condoms are manufactured from the intestine of a lamb and are not as common as the other external condoms [1, 4, 8], and can be used with any type of lubricant [6]. Because of their porous nature, viruses such as HIV, hepatitis, and herpes simplex as well as bacteria such as gonorrhea can easily pass through; thus, they do not offer protection against STIs. They are only effective for preventing pregnancy [1, 4, 8].

#### **2.3 Mechanism of action**

It functions by creating a physical barrier that prevents the entry of semen into the vagina. Also, it prevents direct contact with genital lesions, secretions from the penis, vagina, anus, and subclinical viral shedding on the genitals. Thus, pregnancy as well as STIs like HIV can be prevented [4, 5].

#### **2.4 How to put on and remove an external condom**


#### **2.5 Efficacy**

The most important factor in determining the efficacy of condom use is correct and consistent use [4, 8]. External condoms are highly efficacious in pregnancy

prevention, with just about 2% of women becoming pregnant within the first year of perfect use of condoms and approximately 13% being pregnant within the first year of typical use [4, 10]. Perfect use of condoms refers to correct and consistent usage while typical use refers to the way most people use them [11]. With correct and consistent usage, external condoms are estimated to be 80–95% effective in preventing the spread of HIV and other STIs [4].

### **2.6 Advantages**


#### **2.7 Disadvantages**


#### **3. Internal (female) condoms**

#### **3.1 Introduction**

Internal condoms are the only female-controlled contraceptive method that has been proven to reduce the likelihood of both unintended pregnancy as well as transmission of sexually transmitted infections (STIs). It is a tool for empowering women as it bolsters their sexual confidence and offers them more control over their reproductive health.

Typically, an internal condom consists of a soft sheath and two flexible rings. The closed end of the sheath has an inner ring which is inserted vaginally. An outer ring at the open end lies outside the vagina after insertion [15]. It is intended for only one-time use. In contrast to external condoms, internal condoms can be inserted at any time up to 8 hours prior to intercourse [4]. Note: Internal and external condoms should not be used concurrently, as friction between the two can result in slippage or tearing [4].

#### **3.2 Types of internal condoms**

#### *3.2.1 Polyurethane condoms (FC1)*

FC1, which is no longer commercially available, was made of Polyurethane. They were the first generation of internal condoms that was approved by the United States Food and Drug Administration (USFDA) in 1993 [15]. However, polyurethane condoms have been replaced by newer versions of female condoms that are less expensive and have high acceptance rates. Although internal condoms available on the market today differ in designs and materials, they have many functional and structural similarities [15]. It was approximately 17 cm long and pre-lubricated with dimethicone, a silicone-based lubricant [15].

#### *3.2.2 FC2*

The Femidom female condom (FC2), which replaced the FC1, is just as efficacious as its predecessor but is made of nitrile and does not have a seam. It makes less noise than FC1 during intercourse [15]. It is pre-lubricated with a silicone-based lubricant on both the interior and exterior. It is the only commercially available internal condom approved by the FDA. It has received CE marking and approval by the WHO [16]. Studies comparing FC2 and FC1 found that the FC2 was on par with the FC1 in terms of patient's acceptability, breakage, slippage, and invagination but sold at a lower price [15, 17].

#### *3.2.3 VA w.o.w (worn of women)*

L'amour, Condom Feminine, and Reddy FC are some of the brand names under which it is sold. It is made of latex, just like external condoms. Its unique design features a medical-grade sponge anchored to its closed end for insertion and a triangular frame at the open end which lies outside the vagina. It has received CE Marking and is currently being evaluated by the WHO [ 16, 17].

#### *3.2.4 The Woman's condom*

The PATH (Program for Appropriate Technology in Health) Women's condom is manufactured with polyurethane and has an insertion capsule that dissolves inside

the vagina. It is not pre-lubricated; rather, a water-based lubricant is included in the package that the user must apply. The presence of hydrophilic areas on the condom allows it to adhere lightly to the walls of the vagina, which keeps the condom in place [16, 17]. Data from a single-arm study carried out in China to evaluate the performance of WC in terms of function and safety, were consistent with data already available on the effectiveness of the other internal condoms, indicating that the WC performs as well as the other internal condoms [18]. It has CE marking and is currently under review by the WHO [16].

#### *3.2.5 Phoenurse (PFC)*

It is a polyurethane condom that comes pre-lubricated with a water or siliconebased lubricant and has an insertion tool attached to the inner ring [15, 19]. It is only distributed in China, [15, 19, 20] and received approval from the China State Food and Drug Administration (CFDA) only [15, 19]. In a randomized control trial conducted in China, FC2 was preferred over PFC in terms of lubrication, color, and overall fit [21]. Another study conducted in China revealed that breakage, misdirection of the penis, and slippage were significantly more common with the PFC than with the FC2 [22]. It has received only CE marking [16].

#### *3.2.6 Natural latex female condom (cupid FC and cupid FC2)*

It is made of natural latex and pre-lubricated with a silicone-based lubricant. It also has a medical-grade polyurethane sponge attached to the inner ring for insertion and stability and has an octagonal outer ring. The only differences between Cupid2 and Cupid® are that Cupid2 is a bit shorter and has a smaller sponge [19]. In a randomized noninferiority clinical trial, Cupid2 and FC2 had similar clinical failure rates in terms of invagination, clinical breakage, penile misdirection, and slippage [23]. It has received CE marking and approval by the WHO [16].

#### *3.2.7 Panty female condoms*

It is composed of a reusable nylon woman's panty and a condom sheath. The panty serves as the outer ring and secures the condom sheath during intercourse. The condom sheath must be replaced following each use. A pilot study conducted in South Africa revealed that, the clinical failure rate of the Panty Condom in terms of clinical breakage, misdirection, slippage, and invagination was about twice that seen in functionality studies of the other internal condoms [24].

#### **3.3 Mechanism of action**

Internal condoms are sheaths that line the vagina acting as physical barriers that prevent the introduction of sperms directly into the female reproductive tract, thereby preventing pregnancy. Also, they prevent the transmission of sexually transmitted infections by preventing the exchange of genital secretions [4].

#### **3.4 How to put on an internal condom**

1. For every sexual intercourse, a new condom should be used.


#### **3.5 Efficacy**

During the first year of using internal condoms, approximately 5% of women will get pregnant with perfect use and about 21% of women will get pregnant with typical use [4]. These estimated failure rates are from studies conducted on the efficacy of FC1. Currently, there is no specific data on FC2 condoms' ability to prevent pregnancy and STIs. Since the FC2 condom shares many characteristics with the FC1 condom, including its functionality and design, its effectiveness in preventing pregnancy and STIs is assumed to be comparable to that of the FC1 [15, 19]. Although in vitro studies have suggested that internal condoms are impermeable to HIV and other STIs, there are limited clinical studies that have evaluated the internal condom's ability to prevent HIV transmission.

#### **3.6 Advantages**


#### **3.7 Disadvantages**


#### **3.8 Internal condoms vs. external condoms**


#### **4. Diaphragms**

#### **4.1 Introduction**

Diaphragms are shallow silicone dome-shaped cups with a flexible rim that are inserted into the vagina to cover the cervix. Diaphragms are reusable for up to two years and are available in various sizes– single-size and multisize. The single-size

*Barrier Methods of Contraception DOI: http://dx.doi.org/10.5772/intechopen.111767*

diaphragm, also known as the Caya diaphragm, is the standard and measures about 75 mm long by 67 mm wide. It does not require traditional fitting by a healthcare provider [4, 25]. Instructions are easily applicable by the user. Multisided diaphragms are diaphragm-fitting kit that is used by the clinician to figure out which best fits the woman's anatomy and to educate patients on how to insert and remove the device without complications [4, 25]. Notably, diaphragms are often used with contraceptive gels to increase its efficacy. Usually used with a spermicide, it provides both a chemical and physical barrier to the sperm. Males condoms can be used at the same time a woman uses a diaphragm to increase contraceptive effectiveness and accuracy.

#### **4.2 Mechanism of action**

The diaphragm works by covering the cervix, therefore, preventing sperms from getting through the cervix to the uterus. With the combination of the contraceptive gel or spermicide, the sperms are held back by the shallow silicone-shaped dome in the cervix, and the sperms are killed by the spermicide. The diaphragm consists of little bumps on the outer layer which help grip the device around the cervix and for easier insertion into the vagina with a grip or a squeeze [4, 25].

#### **4.3 How it is used**

A woman can learn to use a diaphragm herself. It is simple to insert without any complications.


#### *4.3.1 To remove the diaphragm*


#### **4.4 Efficacy**

With consistent and correct use together with spermicide, the failure rate for typical use is 12% and that for perfect use is 6%. In comparison to other contraceptive methods such as cervical cap and contraceptive sponge, the diaphragm is more effective and can be used for a longer time (up to 2 years) [25, 27].

#### **4.5 Advantages**


• Diaphragms do not cause systemic adverse effects. Unlike other contraceptives such as oral contraceptives and implants, diaphragms do not affect the hormonal balance of the user [4, 25, 28].

#### **4.6 Disadvantages**


syndrome (TSS).

### **5. Cervical cap**

#### **5.1 Introduction**

The cervical cap is a reusable silicone cup shaped like a sailor's hat. It is inserted into the vagina before coitus with the dome-shaped area of the cap covering the cervix. Usually, a cervical cap is used with a spermicide to boost its efficacy [4, 28]. The spermicide increases contraception by killing the sperms that come into contact with the cervical cap and reduces the fetid discharge brought on by the continuous use of the cervical cap [4].

#### **5.2 Mechanism of action**

The cervical cap fits snugly over the cervix, preventing sperm from entering the uterus. Similar to the mechanism of the diaphragm, the cervical cap blocks the sperm from entering the cervix and the spermicide in the dome kills the sperms. It provides both physical and chemical barriers at the entrance of the cervix.

#### **5.3 To insert a cervical cap**


#### *5.3.1 Remove cervical cap*


#### **5.4 Efficacy**

Women who are nulliparous or who have never given birth vaginally respond best to the cervical cap as a method of contraception. Out of 100 women who will become pregnant with typical use of the cervical cap, only about 13% are nulliparous and about 32% are multiparous. Since the sizes of the cervix alter because of pregnancy and abortion, the small size (22 mm) is usually for patients who have not been pregnant before, while the medium size (26 mm) is for patients who have had an abortion or cesarean delivery and large size (30 mm) for users who have had full term delivery vaginally [25].

#### **5.5 Advantages**


#### **5.6 Disadvantages**


#### **5.7 Differences associated with diaphragm and cervix**

Cervical caps are smaller than diaphragms, so therefore they fit snugly on the cervix. Cervical caps can be used for up to 48 hours while diaphragms can be used for 24 hours.

Cervical caps are more expensive than diaphragms.

#### **6. pH regulator contraceptive gel**

#### **6.1 Introduction**

The contraceptive gel is a formulation that contains lactic acid (18 mg/g), citric acid (10 mg/g), and potassium bitartrate (4 mg/g) as active ingredients. It is marketed under the brand name Phexxi (previously on the market as Amphora and ACIDFORM). It comes in 12 pre-filled applicators, each containing 5 grams of gel, and is available by prescription only. It provides on-demand contraception when used prior to intercourse. It was approved for contraceptive use in 2020. It works better when used in conjunction with other barrier methods like condoms, diaphragms, and cervical caps [29–34].

#### **6.2 Mechanism of action**

It works by lowering the pH of the vagina to between 3.5 and 4.5 even in the presence of alkaline semen, creating a more acidic environment that affects the viability and motility of sperms thus preventing fertilization [35].

#### **6.3 How it is used**


#### **6.4 Efficacy**

The estimated failure rates are 7% within the first year of perfect use and 14% within the first year of typical use. It does not provide users with protection against sexually transmitted infections [7, 35, 37].

#### **6.5 Advantages**


#### **6.6 Disadvantages and side effects**


#### **6.7 Contraindications**


### **7. Spermicides**

#### **7.1 Introduction**

Spermicidal contraceptives contain a spermicidal agent and a carrier. The active ingredient commonly used is nonoxynol-9 which is a surfactant. Currently, nonoxynol-9 and octoxynol-9 are the only FDA-approved spermicidal agents. Spermicidal contraceptives come in a variety of formulations such as gels, creams, jellies, foaming

*Barrier Methods of Contraception DOI: http://dx.doi.org/10.5772/intechopen.111767*

tablets, suppositories, films, and sponges. They can be used alone or combined with condoms, diaphragms, and cervical caps for increased efficacy. They are only effective when utilized prior to intercourse, and are available over the counter [4, 25].

#### **7.2 Mechanism of action**

Nonoxynol-9 in spermicidal products damages the cell wall of sperms, impeding their transit from the vagina to the uterus [25].

#### **7.3 How they are used**


#### **7.4 Efficacy**

Spermicide is one of the least effective means of contraception. For spermicides such as foam, gel, cream, film, suppository, tablets, and jelly, the estimated failure rates with typical use and perfect use are 21% and 16% respectively. Spermicides are ineffective in preventing the transmission of sexually transmitted infections [4].

#### **7.5 Advantages**


#### **7.6 Disadvantages**


#### **7.7 Contraindications**


How does pH contraceptive gel differ from spermicide?

pH contraceptive gel does not contain nonoxynol-9 (N-9) which is the active ingredient in spermicide. N-9 can cause disruption of the epithelial cells of the vagina when used repeatedly which may enhance HIV transmission in high-risk individuals [33, 34].

#### **8. Contraceptive sponge**

#### **8.1 Introduction**

It is a polyurethane sponge that contains a nonoxynol-9 spermicidal agent and is marketed under the brand name Today sponge. It is available over the counter and does not require to be fitted by a health professional [38].

#### **8.2 Mechanism of action**

In addition to the effect nonoxynol-9 has on sperms, the sponge blocks the opening of the cervix and absorbs semen thus preventing the entry of sperms into the uterus [38].

#### **8.3 How it is used**

• Inspect the package and check the expiration date. Do not use it if the package is broken or expired.


#### **8.4 Efficacy**

For nulliparous women and multiparous women, the typical use failure rates are 12% and 24%, respectively. It does not offer the user protection against sexually transmitted infections [25, 27].

#### **8.5 Advantages**


#### **8.6 Disadvantages**


#### **8.7 Contraindications**


### **9. Conclusion**

Barrier methods of contraception are the most effective coitus-dependent contraceptive method for preventing unintended pregnancies and STIs. There are a variety of options with varying levels of efficacy from which one can choose from based on one's preferences and lifestyle. Consistent and correct use are crucial to maximizing their effectiveness irrespective of the method chosen. In contrast to hormonal contraceptives, barrier methods do not cause systemic side effects, therefore they are especially suitable for women with medical conditions that preclude the use of hormonal contraception.

### **Conflict of interest**

None.

*Barrier Methods of Contraception DOI: http://dx.doi.org/10.5772/intechopen.111767*

#### **Author details**

Naana Boadiwaa Asante1 \*, Jude Anim2 and Raida Koray3

1 37 Military Hospital, Accra, Ghana

2 Georgia Gwinnett College, Georgia, United States

3 Eastern Regional Hospital, Accra, Ghana

\*Address all correspondence to: naanababywaa@hotmail.com; naanababywaa@gmail.com

© 2024 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Section 4
