Vaginal wellness: whose turf is it?

Vaginal wellness: whose turf is it?

Min-Wei Christine Lee, MD, MPH1,2

Abstract

Dermatologists were the pioneers in the development of laser technology and have the most experience using these lasers to treat the external genitalia for many cutaneous disorders. Dermatologists who have experience and expertise using lasers and devices, are already using them to treat the external genitalia, and are comfortable performing female gynecologic exams may want to explore the wide range of options that are available to treat the functional and aesthetic needs of the female population. Dermatologists should work with obstetricians and gynecologists to ensure that patients are proper candidates for the procedures.

Semin Cutan Med Surg 37:238-241 ? 2018 Frontline Medical Communications

Female rejuvenation includes a range of functional and aesthetic procedures in the female genital region. Therapies are aimed at correcting and restoring the vagina's structural form and surrounding tissues and improving the vaginal mucosa's hydration and elasticity. More than half of the female population over age 50 suffers from stress urinary incontinence (SUI) or some degree of uterine or pelvic organ prolapse.1 Almost all postmenopausal women have vaginal atrophy, dryness, dyspareunia, and other symptoms associated with menopause.2 Almost all women have some degree of vaginal laxity after bearing children. Female SUI most commonly affects middle-aged and elderly women.3 Its prevalence has been estimated to be as high as 40% in European countries4-6 and 50% in the United States.7

Many of the symptoms associated with these common gynecologic disorders can be effectively and safely treated with lasers and other noninvasive devices. In terms of evaluating effectiveness of laser procedures, the areas of genital rejuvenation can be broken down into 3 distinct areas: (1) vaginal atrophy and laxity, (2) SUI, and (3) uterine/pelvic organ prolapse. The laser procedures can further be categorized as follows: noninvasive and invasive. The only noninvasive laser procedure on the market is a nonablative fractional Erbium:YAG (Er:YAG) laser (Intimalase and Incontilase, Fotona, Dallas, Texas). All the other laser wavelengths are invasive and include fractional carbon dioxide (CO2), fractional ablative Er:YAG, and fractional ablative Er:YAG combined with

1The Skin and Laser Treatment Institute, Walnut Creek, California. 2Department of Dermatologic Surgery, University of California, San Francisco, California. Disclosures: The work reported took place at The East Bay Laser and Skin Care Center now known as the The Skin and Laser Treatment Institute. Dr Lee has nothing to disclose. Correspondence: Min-Wei Christine Lee, MD, MPH; eastbaylaser@

the nonablative 1470 diode laser. Devices using radiofrequency are also noninvasive.

One of the first reports on the use of Er:YAG laser technology for gynecological treatments dates back to 2000 when Dr Claudia Pidal and colleagues reported on the use of a Fotona Fidelis Er:YAG laser (now known as the Intimalase and Incontilase, Fotona, Dallas, Texas) for treating vaginal tissue.8,9 The treatment was effective and painless and led to the rapid development of various Er:YAG ablative procedures, including the treatment of human papilloma virus infections, cervical ectropion, vulvar intraepithelial neoplasia, dystrophic lesions, melanosis, and many other conditions. These treatments have also obtained US Food and Drug Administration (FDA) clearance, and since then thousands of such procedures have been performed in many countries. A high rate of success, with only minor complications, was reported when performing ablation of the lower genital tract, treatment of multifocal and multicentric lesions, and excisions and tissue coagulation.9

As an interesting and unexpected side effect, many patients reported that they felt a vaginal tightening effect following these Er:YAG treatments, which resulted also in their enhanced sexual experience. This discovery initiated further research in the direction of developing a minimally invasive, nonsurgical, and nonablative Er:YAG treatment for vaginal relaxation syndrome (VRS).9

With so many women in the population who could potentially benefit from noninvasive vaginal rejuvenation procedures, the number of technological advances that are readily available, and the ability to perform these procedures safely, the question becomes which physicians are qualified to perform these procedures?

As a physician who had training and education in Obstetrics and Gynecology (Ob/Gyn) prior to switching to Dermatology, I believed I was in an ideal position to perform female rejuvenation procedures. In addition to being a board-certified dermatologist with fellowship training in Mohs surgery, skin cancer surgery, reconstructive surgery, dermatologic surgery, and laser and cosmetic surgery, I have been in private practice as a laser expert for 20 years and own a large laser center equipped with more than 40 lasers. I became aware of the research in the area of vaginal laser rejuvenation in the early 2000s and have been following this area with interest. The first device for tightening of the vaginal canal was the nonablative fractional Er:YAG laser with 2 handpieces: Intimalase (for VRS) and Incontilase (for SUI) by Fotona (which was based in Slovenia at the time but now has headquarters in the United States), both of which became available internationally several years ago. Fotona had the first and only vaginal rejuvenation device available in the United States, and I became the first US doctor to my knowledge to perform procedures with it in 2014. Since then, many other competitors have entered the US market. I currently have several other vaginal rejuvenation devices in my practice. Since introducing the procedure in my practice in 2014, I

238 Seminars in Cutaneous Medicine and Surgery, Vol 37 December 2018

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have treated many patients and have had zero complications. There is high patient satisfaction with these procedures.

Prior to these laser procedures, the surgical solutions for many gynecologic conditions were extremely painful, had long recovery times, and had a high risk of complications. There was a great need for noninvasive and safer options for women. Even if they only had modest improvement, women suffering from these gynecologic conditions are very grateful for any improvement. I have treated hundreds of women who all experienced improvement in their gynecologic conditions with no side effects or complications. There are still patients who opt for surgical procedures after attempting noninvasive vaginal rejuvenation laser procedures for SUI and uterine and pelvic organ prolapse, but they did experience improvement, which greatly helped until they were able to undergo surgery.

The areas that dermatologists should feel comfortable treating are postmenopausal symptoms and vaginal atrophy and laxity. The areas of SUI and uterine and pelvic organ prolapse would probably be better treated by Ob/Gyn or urogynecologists. A dermatologist could work with an Ob/Gyn or urogynecologist to perform the initial evaluation and provide clearance for the dermatologist to perform the procedure. I felt comfortable treating SUI and uterine and pelvic organ prolapse because of my background in obstetrics and gynecology, but I would limit these procedures to patients with mild to moderate SUI and mild to moderate uterine prolapse (stage I and II). Most dermatologists would probably not want to treat these conditions and may prefer to refer to an Ob/Gyn or urogynecologist.

The concern at present is that most Ob/Gyns are not familiar

with lasers or even convinced that these procedures have any utility. Most of the physicians performing laser vaginal rejuvenation procedures are not trained in Ob/Gyn and are in many different specialties that do not have training in gynecology or in lasers. Dermatologists were the pioneers in development of lasers, including CO2, Er:YAG, hair removal, ablative and nonablative, and fractionated and photorejuvenation devices. Dermatologists have the most experience using these lasers to treat the external genitalia for genital warts, precancerous lesions, skin cancers, other gynecologic conditions, laser hair removal, tattoo removal, and rejuvenation procedures of the external genitalia for cosmetic appearance.10

Dermatologists treat all parts of the skin. Traditionally, they have been the pioneers and experts in all laser procedures applied to the skin. The vaginal mucosa is a continuation of the skin. Dermatologists are very experienced and adept at treating the mucocutaneous juncture (which includes oral mucosa, vaginal mucosa, and rectal mucosa). Because dermatologist thought leaders are also the leading experts at dealing with lasers and complications from lasers, it was natural for laser companies to seek their advice in terms of how to assess and evaluate tissue interaction and clinical application of laser wavelengths as it applies to any skin surface, including vaginal mucosa.

The primary concern about any physician entering this field is that most doctors do not understand the vast differences between the different lasers. Most physicians who have purchased the vaginal rejuvenation devices do not even know the wavelengths of the lasers. Or at best, if they could cite the wavelength, they have no understanding about its mechanism of action. There is a vast differ-

TABLE. Summary of competitors in the market grouped by mechanism of action

Laser/Mechanism of Action

Nonablative fractional Erbium:YAG (250 msec long pulse duration) Ablative fractional Erbium:YAG CO2

Radiofrequency

Abbreviations: CO2, carbon dioxide; Er:YAG, Erbium:YAG.

Competitors

Intimalase and Incontilase (Fotona, Dallas, Texas) (the only laser with this unique wavelength)

Petit Lady (Lutronic, Korea) Juliet (Asclepion, Germany; distributed by Cutera) DiVa (Sciton, Palo Alto, California; fractional ablative Er:YAG + fractional nonablative 1470 diode) MonaLisa Touch (Deka, Italy; distributed by Cynosure) FemiLift (Alma, Israel) CO2RE Intima (Syneron, Israel-USA) FemTouch (Lumenis, Israel) EdgeOne (Jeisys, Korea) Beladona (Won Tech, Korea) ThermiVa (ThermiAesthetics, Irving, Texas) Ultra Femme (BTL, Boston, Massachusetts) Geneveve (Viveve, Sunnyvale, California) Revive (Viora, Manhattan, New York) Pelleve (Ellman, Phoenix, Arizona) Votiva Forma V (Inmode, Lake Forest, California)

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 Vaginal wellness: whose turf is it?

ence between the energy sources used for the wide range of available lasers and their efficacy and resulting outcomes (Table).

After Fotona developed the first vaginal rejuvenation device, other laser companies have tried to copy the concept, but they have used more invasive modalities such as fractional CO2 or ablative fractional Er:YAG. Besides the Intimalase and Incontilase lasers developed by Fotona, the only noninvasive options on the market are the radiofrequency devices. These include the Ultra Femme 360 (BTL, Boston, Massachusetts), Geneveve (Viveve, Sunnyvale, California), and ThermiVa (ThermiAesthetics, Irving, Texas; Table).

The vast majority of articles published on vaginal laser treatment has been for the Fotona nonablative Er:YAG laser. It is the only laser on the market that utilizes a nonablative laser which causes no injury to the vaginal mucosa. All other laser devices utilize either fractional CO2 or ablative Er:YAG laser, which cause ablation and injury to the vaginal mucosa. Radiofrequency devices are also noninvasive, but the published studies are few compared to the large number of articles published on the nonablative Er:YAG laser and have been for genitourinary syndrome of menopause and VRS and not for SUI and pelvic organ prolapse. There is rightful concern in the medical communities that so many laser companies are trying to claim efficacy and safety using the fractional CO2 or ablative Er:YAG. These lasers have a higher risk of adverse effects, without providing long-term studies. The convincing evidence to treat these conditions has been done with the nonablative Er:YAG laser, which is a better and safer option, both from the standpoint that it has the scientific studies to back it up and that there is minimal risk with the procedure. When faced with a more invasive option with higher adverse effects and less scientific data compared to a safer noninvasive option with no adverse effects and a high volume of scientific data, it would appear prudent for a physician considering performing procedures in this area to consider the noninvasive option, especially if they were already skeptical about whether these procedures have any effect.

Lasers also have important applications in treatment of conditions involving the external genitalia. Ablative Er:YAG laser has many useful applications for treatment of gynecologic disorders, such as ablating various lesions on the cervix and vaginal wall, removing genital warts, resurfacing, whitening, and tightening of the vulvar region, as well as labioplasty, lichen sclerosus et atrophicus, and many other procedures.9

Although multiple radiofrequency devices are being used for vaginal rejuvenation, few studies have been published showing efficacy and safety for this application. The radiofrequency devices are not FDA approved for use in the vaginal or genital region; all the use in these areas has been off-label.

BTL (Boston, Massachusetts) developed an intravaginal radiofrequency device called the Ultra Femme 360, which is the first of its kind on the market. They incorporate a "ring solution," which is a circumferential 360? band of radiofrequency delivery at the end of a phallus-shaped intravaginal probe that is inserted into the vaginal canal. This ring solution provides homogeneous heating throughout the entire vaginal canal and introitus. There is also a separate external tip that is used to treat the external genitalia. The intravaginal procedure takes 10 minutes, and the external genitalia requires 20 minutes.

Another radiofrequency-based device, ThermiVa from ThermiAesthetics (Irving, Texas), uses an S-shaped, long, thin treatment probe with a thermistor tip that can treat the internal and external vaginal tissue by direct contact, requiring the operator to use a rubbing back and forth or thrusting motion. Compared to the BTL Ultra Femme, the ThermiVa has complicated movements, does not heat homogeneously (there are cold spots), and is reliant on the operator's manual thrusting motions which deliver heat in an inconsistent manner, requiring a longer treatment time (30 minutes to treat only the intravaginal canal) without the assurance that the tissue is heated uniformly. The BTL Ultra Femme 360 is heating homogeneously in all directions, eliminates operator error, and tissue is heated to the target temperature in a shorter time.

Despite promising research in this area, the skepticism and caution expressed by the medical establishment is warranted because of confusion and lack of understanding of the many different lasers being marketed for vaginal rejuvenation without adequate studies being performed by the vast majority of the companies. Most of the companies are copying the design of the nonablative Erbium laser but using a different ablative laser wavelength and then marketing the device to physicians saying the laser can be used for the same applications and indications, but without any studies to prove that the ablative laser would have the same efficacy and safety profile.

If a dermatologist or Ob/Gyn wants to introduce vaginal rejuvenation to their practice, they should only consider a noninvasive option in order to minimize side effects and complications. They should also proceed cautiously in terms of establishing realistic expectations and avoid overselling or overhyping these procedures to their patients. They should also warn the patients that the results may be temporary and that there are not sufficient studies showing the longterm effects of these procedures.

This is also an area in which the specialties could work well together. Dermatologists can partner with Ob/Gyns who may not feel comfortable learning and investing in expensive laser equipment nor want to invest time and effort to offer these procedures in their practices. They may prefer to work with or refer patients to dermatologists to treat these patients after they have performed an initial examination.

Dermatologists should be cautioned against treating uterine prolapse because they could encounter problems, including risk of causing uterine perforation with certain lasers. Uterine perforation is not known to happen with Fotona's Intimalase/Incontilase therapies, nor is it ever likely to be a risk because it utilizes a protective disposable speculum that confines the laser to the vaginal canal and prevents contact with the uterus. The protective disposable speculum is sanitary, creates a sterile field around the treatment area, prevents direct contact with the laser handpiece, provides support to the surrounding soft tissue, and makes the procedure almost failproof. But uterine, cystocele, or rectocele perforation, or injury to the surrounding soft tissue, could potentially happen with a device such as ThermiVa that relies on using a long thin probe requiring continual manual back and forth thrusts without visualization or protection of the uterus or cervical canal or other protruding pelvic organs. Also, dermatologists may not adequately be able to assess if a patient has uterine or pelvic prolapse, cystocele, or rectocele.

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Patients should have a complete examination and clearance by an Ob/Gyn before performing a laser vaginal rejuvenation procedure. They should also be required to provide documentation of a normal PAP smear within the last 6-12 months and a negative pregnancy test before performing any vaginal rejuvenation procedure. Pertinent medical and social history and review of systems especially pertaining to gynecologic status need to be reviewed for any potential contraindications. An external and internal gynecologic exam should also be performed by the treating physician immediately before performing the vaginal rejuvenation procedure. My office has also developed a questionnaire designed to assess the patient's and their partner's overall satisfaction with sexual intercourse before and after the procedure. I have patients follow up after one month to evaluate their results and determine if they would benefit from additional treatments.

Female rejuvenation is a very new area and quite controversial, so it is difficult for many physicians in dermatology and Ob/Gyn specialties to know how to deal with the various questions and issues concerning this area. There is also great variability in laser devices, and most practitioners are unable to discern the difference among the various offerings. The ability of a practitioner to perform these procedures needs to be looked at on an individual basis. Generalizations cannot be made at this point as to who should perform these procedures. Certainly physicians who are already using lasers to treat the external genitalia and have experience and expertise using lasers and are comfortable performing female gy-

necologic exams should explore the wide range of options that are available to treat the functional and aesthetic needs of the female population.

References

1. Barber MD, Maher C. Epidemiology and outcome assessment of pelvic organ prolapse. Int Urogynecol J. 2013;24(11):1783-1790. doi: 10.1007/s00192-013-2169-9.

2. Nappi RE, Lachowsky M. Menopause and sexuality prevalence of symptoms and impact on quality of life. Maturitas. 2009;63(2):138-141. doi: 10.1016/j.maturitas.2009.03.021.

3. Luber KM. The definition, prevalence, and risk factors for stress urinary incontinence. Rev Urol. 2004;6(Suppl 3):S3-S9.

4. MacLenna AH, Taylor AW, Wilson DH, Wilson D. The prevalence of pelvic floor disorders and their relationship to gender, age, parity and mode of delivery. BJOG. 2000;107(12):1460-1470.

5. Castro RA, Arruda RM, Bortolini MA. Female urinary incontinence: Effective treatment strategies. Climacteric. 2015;18(2):135-141. doi: 10.3109/13697137.2014. 947257.

6. Hunskaar S, Lose G, Sykes D, Voss S. The prevalence of urinary incontinence in women in four European countries. BJU Int. 2004;93(3):324-330.

7. National Women's Health Resource Center. Prevalence and Treatment Patterns of Pelvic Health Disorders Among U.S. Women. Washington, DC: Tech Rep National Women's Health Resource Center 2007.

8. Mansilla EC, Pidal CM, Rios VE, San Martino JA. Erbium YAG Laser. Nuevo Aporte Terapeutico en Tracto Genital Inferior. Presented at: 11th International Congress of Cervical Pathology and Colposcopy; June 9-13, 2002; Barcelona, Spain.

9. Vizintin Z, Lukac M, Kazic M, Tettamanti M. Erbium laser in gynecology. Climacteric. 2015;18(Suppl 1):4-8. doi: 10.3109/13697137.2015.1078668.

10. Bangash HK, Eisen DB, Armstrong AW, et al. Who are the Pioneers? A Critical Analysis of Innovation and Expertise in Cutaneous Noninvasive and Minimally Invasive Cosmetic and Surgical Procedures. Dermatol Surg. 2016;42(3):335-351. doi: 10.1097/DSS.0000000000000661.

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