Most women and men do not understand how the vagina, vulva and clitoris work. Even scientists have devoted far less research to analyzing what happens to women’s bodies during sexual excitement than in learning about the penis and men’s erections.
Up to 80% of women who are menopausal after cancer treatment have vaginal dryness and pain with sex, so vaginal “rejuvenation” treatments using special lasers or low-intensity radiofrequency waves have generated tremendous excitement in online communities or survivorship conferences. Our limited knowledge makes it challenging to evaluate these new treatments. Certainly many women past menopause would love to go back to the days when sex was not dry, tight, and painful.
The Problem
After menopause, the process of sexual arousal changes. Normally, when a woman gets sexually excited, extra blood rushes into the genital area. The vaginal lining and vulva turn a deeper color and the cells that line the vagina produce clear droplets of slippery fluid. The vagina also lengthens, becoming a third deeper than in the unexcited state. The clitoris and vulva also swell and fill with blood. These changes prepare the vagina for sexual caressing and penetration, making sex comfortable and pleasurable for the woman. Collagen plays a role in sexual arousal, since it helps the vaginal walls to stretch easily. Collagen is the most common protein in our bodies. It helps to create and strengthen hair, skin, nails, bones, ligaments and tendons. In the vagina, collagen is found in the spongy tissue of the vaginal walls. However, the amount of collagen depends on the hormone estrogen, which is mostly made in a woman’s ovaries. After menopause, estrogen becomes scarce. Genes in the vaginal tissue actually change, making less collagen. The collagen that does get produced is also less stretchy and elastic. Loss of estrogen also reduces the number of small blood vessels in the vaginal and vulvar tissue. All of these changes are noticed by a woman and her sexual partner as a loss of vaginal size, with burning and pain if the friction of sexual stimulation irritates or tears the newly fragile, vaginal lining. Pain contributes to losing desire for sex too. It is hard to get in the mood knowing that sex will hurt. Menopausal pain and dryness is even more common in women treated for cancer than in other menopausal women.
Current Treatments
Many women do not realize that a combination of using a gel-type moisturizer in the vagina at bedtime plus lots of water-based or silicone-based sexual lubricant during love-making may be enough to prevent dryness and pain. For women who try this option, but still have problems, using a low dose of estrogen in the vagina after menopause can ease more severe vaginal dryness and pain. Vaginal estrogen can be supplied in a suppository, cream, or time-releasing vaginal ring. However, women who have had breast cancer (and also some types of uterine or ovarian cancer) are usually told by their oncologists to avoid any kind of estrogen, out of concern that some will get into the bloodstream and nourish any remaining cancer cells in the body. A very low dose of vaginal estrogen usually does not raise the level of hormones in the bloodstream very much, but also may have limited ability to help with vaginal dryness and pain. A somewhat higher dose in the vagina usually works better for sexual problems but also leads to a greater amount escaping into the bloodstream. Many gynecologists believe that oncologists worry overly much about cancer risk from using vaginal estrogen. A recent large, long-term study on the cancer and heart disease risks of using vaginal estrogen was reassuring, but researchers still need to follow larger numbers of women with breast cancer.
Other options that help many women, but still do not have enough safety research in breast cancer survivors to prevent a warning from the Food and Drug Administration include ospemiphene (Osphena®), a daily synthetic hormone pill that is a selective estrogen receptor modifier (SERM) in the same class of drugs as tamoxifen; or prasterone (Intrarosa®), a vaginal suppository containing the hormone, dehydroepiandrosterone (DHEA). Women may also be able to reduce pain during sex by using vaginal dilators to stretch the vagina and provide muscle feedback, or by applying lidocaine (a local anesthetic gel) before sex.
The New Options
Women who do not want to risk using vaginal estrogen are often very excited to hear about the new laser or radiofrequency treatments. As a psychologist who specializes in helping cancer patients with sexual problems, I would also love to have more treatment options for pain and dryness. Can these new treatments truly restore the vagina to its former youth and glory? If treatments do help some women, who are the best candidates, and how long does the improvement last--especially if a woman does not use any form of postmenopausal estrogen treatment? Without any estrogen, will the new collagen and blood vessels disappear over time?
The first new option is the fractionated CO2 laser. Several different companies manufacture them, but the most frequently used type has the brand name MonaLisa Touch™. This special laser is used inside the vagina and on the vulva to create tiny holes in the mucous membranes. The goal is to trigger a healing process that will produce new collagen and blood vessels, eliminating problems with vaginal dryness and pain. Usually 3 to 4 treatment sessions take place in a doctor's office, spaced 4 to 6 weeks apart. Most women apparently just notice minor vaginal irritation for several days after each treatment, but if you look in online reviews, some complain of major pain reactions. Studies published in journals do not report "adverse events" like long-term tissue damage or scarring.
The second option is a low-energy radiofrequency device (ThermiVa®) using radio waves to heat up the tissue beneath the vaginal lining. ThermiVa®, like the laser treatments, has the goal of creating new collagen and blood vessels in the vaginal walls through a series of 3 treatments in the doctor's office.
A third treatment is Viveve®, a different kind of radiofrequency device. It uses cryogenic cooling of the surface while pulses of radiofrequency waves heat up the underlying tissue. Only one, 30-minute treatment is given. Viveve® does not have the goal of treating vaginal dryness. It has been shown to have positive effects on sexual function in women who complain that the vaginal entrance has become overly loose since childbirth. It also is being used to treat some postmenopausal women who have pain during sex.
Some Concerns
One thing that worries me is that some clinics offering laser or radiofrequency treatments also advertise a variety of questionable remedies that have been condemned by researchers and professional societies, including “orgasm o-shots,” prescribing compounded bioidentical hormones, and cosmetic surgery to enlarge or trim women’s labia.
Vaginal rejuvenation treatments are also quite expensive. Currently, insurance will not cover them. Each of the 3 or 4 initial treatments using laser or ThermiVa® usually costs $1,000 to $2,000, totally paid out of a woman’s pocket. Even clinics that claim high rates of satisfaction recommend that a woman get at least one “touch-up” treatment every 6 to 12 months. Safety and effectiveness needs more testing for women who get multiple “touch-ups.”
Insurers do not want to cover these treatments in part because of the lack of scientific evidence that they are effective. Studies from scientific journals report that the treatments do not cause major injuries to women. In the short-term, most women report satisfaction and relief of pain with sex. Unfortunately, these “studies” are often of limited quality and based on small numbers of women.
Emerging Evidence
What kind of study would convince insurers to cover these treatments? The gold standard is to compare a new treatment with a fake treatment that is equally convincing, not informing a woman of which treatment she will get. The researcher should also not know which women get the real treatment or the placebo. (This is called a double-blind study.) For example, women would agree to be in a study in which half would get the real laser or heat treatment and the other half would be “treated” with a machine that looked the same and made noises or heated up so that the women would not be able to guess if they were getting the real or the placebo treatment. Ideally even the doctor doing the treatment should not know if it is the real thing. Women would complete well-validated questionnaires at the start of the study, after the treatments were completed, and at least 6 and 12 months later. Such questionnaires are designed to measure women’s sexual pain symptoms and also other aspects of their sex lives (desire, pleasure, lubrication, satisfaction, orgasms). The goal is to show that women who get the real treatment report large and sustained improvements in sexual pain and sexual satisfaction that are not found in women given the fake treatment. We know from many years of research on women’s sexual function that placebos (i.e. sugar pills or fake treatments) can be very effective as long as women believe they may be getting the real thing. Women often report that placebos improve their sexual desire or function, making it difficult to prove that new treatments are truly effective.
An excellent example of a well-designed randomized trial was done with Viveve®. Women either received the actual treatment or a sham version in which the instrument delivered a very weak frequency, so both treatments were believable. The study was done at 9 centers in 4 countries and 164 out of the original 174 completed their 6-month follow-up questionnaires (which were well-validated measures). The women were all premenopausal and felt that the entrance to the vagina had become loose since childbirth, reducing their sexual pleasure and satisfaction. The actual treatment was more successful than the sham treatment in improving ratings of this problem as well as overall sexual function. Trials like this one are now needed with treatments designed to improve vaginal dryness and pain.
Currently most studies on either laser or radiofrequency treatments are not randomized trials. Women are simply given the treatment and followed for some period of time. For example, Dr. Pieralli and colleagues in Florence, Italy, studied 184 women, including 56 cancer survivors, who had been menopausal for an average of 6.6 years. All received CO2 laser vaginal treatments. They were asked to rate their satisfaction with treatment on a 5-point scale at 1 month, 6, 12, 18 and 24 months, rather than completing a validated questionnaire. How many women were satisfied? Well, at 1 month it was 95%, at 6 months 92%, at 12 months 72%, and at 24 months 25%. We see that the positive effects of treatment appear to decrease over time. But there is yet another problem: at 1 month all 184 women were evaluated, but the group diminished to 170 at 6 months, 118 at a year, and only 16 at 2 years. What happened to all the other women? If they did not come back to the clinic, does that mean they were satisfied or dissatisfied?
Another study did randomize women—but not to real vs. fake laser treatments. Instead, 45 women were assigned randomly to get laser treatment, vaginal estrogen, or both. That means only 15 women were in each group, a rather small number. Women knew, obviously, whether or not they got the laser treatment. They were not told whether they got a real estrogen cream or a placebo, however. Women did complete a valid questionnaire on sexual function at the start of the study and at 8 and 20 weeks. Women in all 3 groups rated pain with sex as improved at 20 weeks and had similar scores on the sexual function questionnaire. The results are somewhat confusing and really do not point to one treatment being better than the others. Currently a larger trial is in progress, assigning women randomly either to have treatments with the MonaLisa Touch® or to get vaginal estrogen.
Companies that manufacture the equipment as well as government agencies should fund better studies of the outcomes of these new treatments. For now, my advice is to do your own research and make your personal decision on whether you think the cost will be worth the potential outcome. The most important thing is to find a gynecologist who is as expert as possible in treating menopause symptoms in cancer survivors, and who can offer you personalized treatment options.
References for the blog:
Shynlova O , Bortolini MA, Alarab M. Genes responsible for vaginal extracellular matrix metabolism are modulated by women's
reproductive cycle and menopause. International Brazilian Journal of Urology 2013;39:257-67.
Crandall C, et al. Breast cancer, endometrial cancer, and cardiovascular events in participants who used vaginal estrogen in the WHI observational study. North American Menopause Society 2017; Abstract S-1.
Sekiguchi Y, Utsugisawa Y, Azekosi Y, et al. Laxity of the vaginal introitus after childbirth: nonsurgical outpatient procedure for vaginal tissue restoration and improved sexual satisfaction using low-enery radiofrequency thermal therapy. Journal of Women's Health 2013;22:775-81.
Bradford A. Listening to placebo in clinical trials for female sexual dysfunction. Journal of Sexual Medicine 2013;10:451-9.
Krychman M, Rowan CG, Allan BB, et al. Effect of single-treatment, surface-cooled radiofrequency therapy on vaginal laxity and female sexual function: The VIVEVE I Randomized controlled trial. Journal of Sexual Medicine 2017;14:2015-25.
Pieralli A, Bianchi C , Longinotti M , et al. Long-term reliability of fractioned CO2 laser as a treatment for vulvovaginal atrophy (VVA) symptoms. Archives of Gynecology & Obstetrics September 2, 2017 [Epublication ahead of print].
Cruz VL, Steiner ML, Pompei LM, et al. Randomized, double-blind, placebo-controlled clinical trial for evaluating the efficacy of fractional CO2 laser compared with topical estriol in the treatment of vaginal atrophy in postmenopausal women. Menopause July 31, 2017 [Epublication ahead of print].
In our November 7 webinar, Michael Krychman, MD, Director of the Southern California Center for Sexual Health and Survivorship Medicine will be our guest speaker on the topic: 21st Century Innovations in Sexual Medicine for Women: Progress and Pitfalls. Register to learn about vaginal rejuvenation and more!
This educational material is intended for informational purposes only and is not intended to replace, or substitute for, professional advice, counseling, diagnosis, or treatment. Always seek the advice of a qualified health provider with any questions you may have regarding a condition. Never disregard professional advice or delay in seeking treatment because of something you have read in this educational material.
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