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The role of moisturizers and lubricants in genitourinary syndrome of menopause and beyond.

What role do moisturizers and lubricants play for women across patient populations? By openly talking to patients, we can individualize treatment choices and pave the way to sexual health.

Vaginal/vulvar dryness and atrophy, along with painful sexual intercourse, are frequent problem reports among postmenopausal women. So frequent, in fact, that the term "genitourinary syndrome of menopause," or GSM, recently was adopted, largely in an effort to develop an accurate and more inclusive term that would improve and ease conversations about the subject between postmenopausal women and their health care professionals. (1,2) But postmenopausal women are not the only ones affected: vaginal dryness and sexual discomfort can affect women of any age. (3) The American College of Obstetricians and Gynecologists reports that nearly 3 of every 4 women experience painful intercourse at some point during their lifetime, stemming from a variety of causes. (4)

Although reduced levels of estrogen, such as those that occur with menopause, childbirth, and breastfeeding, are the chief culprits, a host of other factors can lead to vaginal dryness and dyspareunia. These factors include cancer treatments; certain medications, such as antihistamines and aromatase inhibitors; and medical conditions including diabetes and immune dysfunction. Left untreated, vaginal dryness and atrophy and painful sexual intercourse are chronic and progressive medical conditions that can last a lifetime, profoundly affecting a woman's quality of life and sexual health. (3,5)

In recent years, there has been a veritable explosion of safe and effective treatments that have come to market, both prescription and over the counter (OTC), for vaginal/vulvar dryness and painful intercourse. Yet study data suggest the issues remain underreported and undertreated, (5) and this highlights the importance of having open discussions with patients and, if feasible, their partners to normalize the need for moisturizers and lubricants across a variety of diverse patient populations. With this backdrop, OBG MANAGEMENT assembled a panel of experts in gynecology and sexual health to discuss available agents, treatment choices, and strategies for effectively opening a dialogue with patients.

Meet the panel

Michael L. Krychman, MD, Moderator: I am from the Southern California Center for Sexual Health and Survivorship Medicine in Newport Beach. With the recent explosion of OTC moisturizers and lubricants, the consumer is left with much confusion regarding product selection and utilization. Misinformation exists concerning ingredients and additives as well as efficacy of use and the US Food and Drug Administration is now looking toward research to ensure that no false claims are misleading the consumer. Some products have obtained 510K clearance as a medical device. See the TABLE of select products. (6,7)

Here to help me set the record straight is my esteemed panel of sexual health and gynecologic experts: Dr. Alyssa Dweck from CareMount Medical in Mt. Kisco, New York, Dr. Sheryl Kingsberg from Case Western Reserve in Cleveland, Ohio, and Dr. Lisa Larkin from Cincinnati, Ohio.

Patient selection: Postmenopausal women and beyond

Dr. Krychman: When we think of moisturizers for adequate tissue hydration and lubricants for lovemaking, we often think of the older woman reporting symptoms of GSM. Who is the patient that can benefit from moisturizers or lubricants for overall sexual health? Let's define her.

Sheryl Kingsberg, PhD: First, this discussion should not be limited to older women and post-menopausal women. We know that in women of all ages, lubricants are particularly helpful during sexual activity regardless of gender or partner. It is important that we normalize for women that lubricant use is common and does not necessarily reflect any inadequacy or dysfunction on their part. Although effective lubrication and pain-free sexual activity is an important issue for women of any age, we must certainly educate our patients to the fact that, as they age, they may want to use lubricants and moisturizers.

Further, we need help to differentiate between lubricants and moisturizers. That is, that lubricants should be used during sexual activity and are short acting, whereas moisturizers are used daily (similar to facial and body moisturizers). With postmenopausal women, we want to be very clear about the limitations of lubricants and moisturizers with regard to GSM. Lubricants and moisturizers will be not be effective in treating the underlying cause of GSM, which is best addressed with prescription therapies including estrogens and such topical preparations as creams, rings, and tablets, and the newly approved prasterone (topical dehydroepiandrosterone [DHEA]).

Dr. Krychman: I agree. In my clinical practice, I sometimes treat women who are taking a variety of medications, like antihistamines, or even young women taking oral contraceptives, who report vaginal dryness or painful intercourse and who may benefit from using moisturizers and lubricants. Some patients are not well versed with arousal, or they may have partners who have delayed ejaculation, so they may have longer duration of intercourse that may impact comfort.

Special populations

Alyssa Dweck, MD: Another group of women who are hit with a double whammy are the lactating and postpartum women. First of all, they may not have returned to ovulation and menstruation; therefore, their estrogen levels remain low and their vaginas are drier and more delicate. In addition, many of these women have taken a break from sexual relations, so less lubrication and lack of use creates this double whammy. I recommend lubricants as a quintessential element in their return to sexual intercourse, and I reassure them that the vagina will return to a natural lubricating state once ovulation and menstrual cycles resume.

Lisa Larkin, MD: Also overlooked are cancer survivors--specifically, survivors of breast and other gynecologic cancers--women who have undergone chemotherapy and have chemotherapy-induced menopause and are taking medications that result in significant vaginal atrophy and dryness and often pain with intercourse. This is a patient population that often needs very aggressive treatment with moisturizers and lubricants and a lot of education about how these can be helpful to manage their symptoms.

Dr. Krychman: Education is especially important for patients during active treatment, such as during chemotherapy or radiation. Regardless of whether patients are undergoing intravaginal radiation or systemic chemotherapy, they often have been advised not to use local hormones or other medications that may interfere with treatment, but they still have problematic symptoms--not only intra-vaginally but also externally.

Counseling approaches

Dr. Krychman: What are your recommendations for talking with patients about lubricants and moisturizers, and how do you broach the topic?

Dr. Larkin: I think the most important thing to do is open the dialogue with patients, who often are very reluctant to bring up their symptomatology. I start with the basics--the difference between moisturizers and lubricants--and then expand into water-based versus silicone-based lubricants. I have a handout that I provide with a few products in each category.

I also discuss "kitchen pantry" solutions. Today's patients are often very interested in natural and holistic approaches to managing their symptoms, so some women will use olive or peanut oil or other things that they find in their bathroom, such as mineral oil, baby oil, and petroleum jelly. I talk about why those products are probably not the best options and that there are others that would be more beneficial. There are some concerns about those agents promoting bacterial infection, such as bacterial vaginosis and yeast infection, (8,9) and many of them stain when they are being used.

Ingredients matter

Dr. Krychman: How do you differentiate between agents, and under what circumstances would you recommend one used over another?

Dr. Dweck: The amount of choices can be overwhelming for women. I typically make very specific recommendations, usually beginning with an over-the-counter water-based lubricant, such as K-Y Jelly or Astroglide. I explain to my patients that they are easy to find, cost-effective, compatible with condoms, and do not stain bedding. Some women report that water-based lubricants are sticky and require frequent reapplication, particularly with long sexual sessions. In that case, I recommend a silicone lubricant. Silicone lubricants are very slick, last longer, and are compatible with condoms. They are so slick, in fact, that just a little bit needs to be used with each sexual act. I advise exercising extreme caution when using silicone lubricants during water play, such as in the shower or bath, because they are so slick that they can cause slipping.

Dr. Kingsberg: We always think about lubricants and moisturizers with regard to vaginal penetration, but we should think about anal sex as well. There are gels specifically designed to be used as anal lubrication that are thicker and last longer, although they tend to be stickier. Some contain a bit of antiseptic to reduce sensitivity, and that can be a good thing. It also can be a bad thing, because it is important for there to be sensation to warn if the sex is causing problems or injury.

Counsel to empower

Dr. Krychman: I think counseling is very important, especially regarding which products patients are using and what sexual activity they are engaging in. It is very important to empower women to start reading labels, not only to see what is included but also to see what is excluded from the product. Osmolality, pH, and additives remain important. We are so focused on reading food labels, we often do not think about reading the labels on over-the-counter products.

Individualize choices for different patient populations

Dr. Kingsberg: I agree. Couples trying to conceive should read the labels. There is a lot of controversy over whether there is a difference between lubricants and what is going to help or interfere with couples conceiving. (10)

Dr. Krychman: Infertile couples or those trying to conceive are often under pressure to perform and the time scheduling may impact natural lubrications, so we often recommend they use adjunctive products. One of my favorites is Pre-Seed. It is marketed specifically for the couple trying to conceive and does not harm sperm or the vagina.

Dr. Kingsberg: You are absolutely right. Couples who are trying hardest to conceive often have difficulty getting aroused under pressure and are likely to benefit from lubricants. However, lubricants do tend to affect sperm motility. It is really about the vaginal pH levels--some lubricants change the level in a way that is negative toward sperm motility. Fertility-friendly lubricants are designed to minimize this. In addition to Pre-Seed, there is Conceive Plus, Yes Baby, and Astroglide TTC. We do not have clear evidence about which lubricants are better than others, but couples often have so much anxiety about trying to conceive that if you can promote the so-called fertility-friendly products to them, I think it will reduce some anxiety.

Dr. Dweck: The 2 ingredients that are talked about most in my patient population are glycerin and parabens. Glycerin is the main ingredient in many water-based lubricants. Some studies suggest that glycerin might increase the risk of yeast infections, especially in those who are particularly prone to yeast. (7) For those patients, I recommend a lubricant that does not contain glycerin. Parabens are used as preservatives to increase shelf-life and are often ingredients in various lubricants; they also have been considered possible hormone disruptors, with estrogen-like qualities. (7) Although the jury is still out on them, I think it is best to avoid products with parabens if a patient is particularly sensitive or has a history of a hormone-sensitive cancer.

Dr. Krychman: The American Cancer Society and other organizations have stated that, in such low quantities, these chemicals are not causative agents of cancer. (7) However, if you have an option to avoid them, it might be prudent to read the labels and avoid them.

There are emerging data indicating that some of these products cause microabrasions, not only in the vaginal mucosa but also in the anal mucosa, (7) and that they may actually increase the risk of sexually transmitted infections or HIV. We have to be very cautious about some additives.

Consider plasma osmolality and hyaluronic acid

Dr. Larkin: Another important topic is plasma osmolality. We have known for a long time that when cells are exposed to hypertonic fluid, it causes fluid shifts and this can cause cellular disruption and cellular compromise. The same is true in the vagina. Normal plasma osmolality is somewhere between 285 and 295 mOsm/kg; human semen is a litiie bit higher, 250 to 380 mOsm/kg. We have learned that most water-based lubricants on the market have a very high osmolality, somewhere in the range of 2,000 to 6,000 mOsm/kg, so they are very hypertonic. This can cause fluid shifts in the vaginal cells, and cellular compromise can be one of the factors that contributes to vaginal irritation and worsening symptoms. According to the World Health Organization, an ideal water-based lubricant or moisturizer should have an osmolality of not greater than 1,200 mOsm/kg, and this is an important feature to consider when choosing a product to recommend. (11)

Dr. Dweck: Hyaluronic acid is naturally found in the body and is "all the rage" right now as an anti-aging and smoothing ingredient. The dermatologic and ophthalmologic communities have been using it for a while in their products. As a vaginal gel, hyaluronic acid has been shovm to improve vaginal itching, painful intercourse, and vaginal burning related to aging, (7) so we are seeing this ingredient in more and more products, including vulvar and vaginal washes. Lubrigyn cream and lotion come to mind, which are from Italy. In addition, many of the compounding pharmacies are making compounded moisturizers for vaginal use that contain hyaluronic acid with good result.

Let's discuss recommendations

Dr. Krychman: I recommend Lubrigyn Cream, with hyaluronic acid (a littie goes a long way). It is a high-quality product and is not very expensive. Cost is always an issue; it is not necessarily the more you pay, the better the product.

I also have recommended Lubrigyn as a vulvar wash. Many women use a douche, which may contain caustic ingredients like sodium lauryl sulfate that may actually strip away the natural protective barrier of the vulvar skin. The vagina, the vulva, the clitoris, and the whole genital pelvic area can be sensitive with estrogen decline, so vulvar washes are becoming more common.

I like several water-based lubricants, like Good Clean Love, which also has very good osmolality; the K-Y products, which are tried, tested, and true; and Sylk, which is all natural, too. I also recommend Uberlube, which is silicone and a little vitamin E, as well as the Wet products, which seem to be very well tolerated and affordable.

Dr. Kingsberg: I like products that offer a variety of choices, such as a sensitive skin gel, a thicker formula gel, a silicone option, a water-based liquid, and paraben-free. It is about patient preference, and the good clinician is going to have several samples in his or her office. I suggest having a water-based and a silicone-based option so that patients can see the difference for themselves. I think letting patients sample products is very helpful because some of preference is related to sensation--the tackiness, the slipperiness, perhaps the scent. Women who are prone to irritation, particularly postmenopausal women with thinning tissue, might find warming lubricants more problematic than beneficial. Patients appreciate having all the options listed in a handout, and having lots of samples.

Dr. Krychman: For academic centers or other institutions that are not allowed to have samples, a good referral is the MiddlesexMD website, which has a lubricant sampler for a small cost. Patients can then fill out a card after and send it back to receive a full bottie of their favorite lubricant. The site also has dovraloadable patient education materials about moisturizers and lubricants.

Dr. Larkin: MiddlesexMD.com is a terrific website. Their sampler package is a great way for patients to try different products. Breast cancer patients and survivors taking aromatase inhibitors often have vaginal concerns and report painful intercourse--the tissue is very fragile in that population. I have seen that vulvar washes can be very helpful in this setting; I like Lubrigyn. As for the water-based lubricants. Good Clean Love is certainly popular in my practice. For a silicone-based product, I frequently recommend Pjur. In terms of vaginal moisturizers, I like Yes VM--it has an appropriate pH and low osmolality. Among the hybrid products, I do like Lubrigyn and Luvena very much, and patient feedback has been positive for both.

Dr. Dweck: The products mentioned are favorites of mine as well. I also give patients a handout that differentiates moisturizers from lubricants because I find that is a very confusing issue for people and that patients get overwhelmed by the amount and number of products available over the counter. I try to give them one example each of a water-based and silicone-based. For my more naturally inclined patient I recommend coconut oil--the best oil for moisturizing and lubricating the area. I also like to mention that silicone lubricants and silicone toys are often not compatible, so it is important to exercise caution.

Lubrigyn is definitely my "go to" for my menopausal population. I often rely on the compounded hyaluronic acid formulas for my breast cancer survivor population. I find they are very hesitant to use anything over the counter that might contain a concerning ingredient, so the one that I use contains hyaluronic acid, vitamin E, and aloe. It can be compounded at any compounding pharmacy, and I get a very good result from it. Dr. Krychman: I will add that Luvena is a hybrid; it acts as a moisturizer and lubricant. Replens and RepHresh also can be helpful for many patients.

As you can see, there are several products. Just in our small group, we have a variety of recommendations and suggestions for selection. As clinicians, we need to individualize product choices. I believe many of the companies that produce the products mentioned would be happy to send the readership samples and information, so clinicians can begin gathering samples to share with their patients.

Dr. Kingsberg: I would urge readers to take into account how important it is to have this conversation with patients--to let them know that there are products available OTC that can be very safe and have a huge impact on quality of life. If you do not want to spend a lot of time talking about it, be sure to have a handout that differentiates lubricants from moisturizers and from treating the GSM with local estrogen, an oral tablet, or DHEA. Normalize the use of lubricants and moisturizers for women of all ages and populations. Simply talking about these issues validates patients' sexuality, and I think that increases patient satisfaction with you and their overall life.

Dr. Krychman: Thank you, panel members, for joining me for this OBG Management program. Moisturizers and lubricants are not just for postmenopausal women with GSM. Thank you for your insights.

References

(1.) Portman D J, Bachmann GA, Simon JA; Ospemifene Study Group. Ospemifene, a novel selective estrogen receptor modulator for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy. Menopause. 2013; 20(6):623-630.

(2.) Lewis R. Introducing 'genitourinary syndrome of menopause.' http:// www.medscape.com/viewarucle/830398. Published August 25, 2014. Accessed March 15, 2017.

(3.) Mayo Clinic. Vaginal dryness, http://www.mayoclinic.org/symptoms /vaginal-dryness/basics/causes/sym-20151520. Updated December 1, 2015. Accessed March 15, 2017.

(4.) American College of Obstetricians and Gynecologists. When sex is painful. http://www.acog.org/Patients/FAQs/When-Sex-Is-Painful. Published May 2011. Accessed March 15, 2017.

(5.) Edwards D, Panay N. Treating vulvovaginal atrophy/genitourinary syndrome of menopause: how important is vaginal lubricant and moisturizer composition? Climacteric. 2016; 19(2): 151-161.

(6.) Kaunitz AM, Kingsberg S, Krychman M, et al. Advances in menopause transition management. DBG Manag. 2016; 28 (suppl 5):S1-S33.

(7.) Patterson f, Millheiser L, Krychman ML. Moisturizers, lubricants, and vtilvar hygiene products: issues, answers, and clinical implications. Curr Sex Healdi Rep. 2016; 8(4):213-221.

(8.) Fashemi B, Delaney ML, Onderdonk AB, Fichorova RN. Effects of feminine hygiene products on the vaginal mucosal biome. Microb Ecol Health Dis.2013; 24.

(9.) Edwards D, Panay N. Treating vulvovaginal atrophy/genitourinary syndrome of menopause: how important is vaginal lubricant and moisrnrizer composition? Climacteric. 2016; 19(2):151-161.

(10.) Mesen TB, Steiner AZ. Effect of vaginal lubricants on natural fertility. Curr Opin Obstet Gyn. 2014; 26(3):186-192.

(11.) World Health Organization. Use and procurement of additional lubricants for male and female condoms: WHO/UNFPA/FHI360 Advisory note, http://apps.who.int/iris/bitstream/10665/76580/1 /WHO_RHR_12.33_eng.pdf. Accessed March 15, 2017.

Dr. Krychman reports receiving research support from New England Research institutes (NERI) and being a consuitant for Paiatin, Shionogi, inc, Sylik USA, TherapeuticsMD, and Valeant Pharmaceuticals; a speaifer for Shionogi and Valeant; and an advisor for Uniderm.

Dr. Dweck reports being a consultant to Uniderm and a speaker for Bayer Pharmaceuticals.

Dr. Kingsberg reports receiving grant or research support from Paiatin; being a consultant to Acerus, AMAG, Emotional Brain, EndoCeutics, Materna, NovoNordisk, Nuelle, Paiatin, Pfizer, Scientific Strategic Solutions, Shionogi, TherapeticsMD, and Valeant Pharmaceuticals; and being a speaker for Valeant

Dr. Larkin reports being a consultant and speaker for Valeant Pharmaceuticals.

OBG MANAGEMENT and the roundtable faculty do not endorse any specific product mentioned over another in this roundtable discussion.
TABLE: Lubricants and moisturizers for treating GSM and VVA * (6,7)

Treatment                              Comments

Lubricants

Water-based            Ingredients: deionized water, glycerin,
                       propylene glycol; latex safe; rare
                       irritation; dry out with extended sexual
                       activity

Oil-based              Ingredients: avocado, olive, peanut,
                       corn; latex safe; can be used with
                       silicone products; staining; safe
                       (unless peanut allergy); nonirritating

Silicone-based         Ingredients: silicone polymers;
                       staining; typically nonirritating; long
                       lasting; waterproof; should not be used
                       with silicone dilators, sexual toys, or
                       gynecologic products

Petroleum-based        Staining; ingredients: mineral oil,
                       petroleum jelly, baby oil; irritating;
                       not latex safe and not for use with
                       cervical caps or intravaginal diaphragms

Fertility friendly     Minimize harm to sperm motility;
                       designed for couples trying to conceive

Moisturizers

Vaginal moisturizers   For maintenance use 1 to 3 times weekly;
                       can benefit women with dryness, chafing
                       with ADL, and recurrent vaginal
                       infections irrespective of sexual
                       activity timing

Hybrids                Properties of both water- and
                       silicone-based products (combination of
                       a vaginal lubricant and moisturizer);
                       nonirritating; good option for women
                       with allergies and sensitivities

Treatment                         Available products

Lubricants

Water-based            Astroglide, Good Clean Love, K-Y Jelly,
                       Natural, Organic, Pink, Sliquid, Sylk,
                       Yes

Oil-based              Coconut oil, vegetable oil, vitamin E
                       oil

Silicone-based         Astroglide X, Oceanus Ultra Pure, Pink
                       Silicone, Pjur Eros, Replens Silky
                       Smooth, Silicone Premium JO, SKYN,
                       Uberlube, Wet Premium

Petroleum-based        Rarely recommended

Fertility friendly     Astroglide TIC, Conceive Plus, Pre-Seed,
                       Yes Baby

Moisturizers

Vaginal moisturizers   Balance Active Menopause Vaginal
                       Moisturizing Lubricant, Canesintima
                       Intimate Moisturizer, Replens, Rephresh,
                       Sylk Natural Intimate Moisturizer, Yes
                       Vaginal Moisturizer

Hybrids                Lubrigyn, Luvena

* Before using or recommending a product patients and their providers
should check a product's pH, ingredients, and additives, and ensure
the product is 51 OK FDA cleared.

Abbreviations: ADL, activities of daily living: FDA, US Food and Drug
Administration: GSM, genitourinary syndrome of menopause; VVA,
vulvovaginal atrophy.
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Title Annotation:ROUNDTABLE
Author:Krychman, Michael L.; Dweck, Alyssa; Kingsberg, Sheryl; Larkin, Lisa
Publication:OBG Management
Date:Apr 1, 2017
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