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Energy-Based Devices for Female Rejuvenation: RF-Based Vs Laser-Based devices

The laxity of the vaginal canal, harm to the pelvic floor, and deterioration of the mucosal tone of the vaginal wall can all be caused by physiological changes in a woman's life, such as childbearing, weight changes, and hormonal changes brought on by aging and menopause. These occurrences frequently result in the genitourinary disorders stress urinary incontinence, vaginal atrophy, dryness, and physiologic distress, which have an impact on a woman's sexuality, self-esteem, and quality of life.


The management of these indications is presently supported by a variety of therapeutic approaches, ranging from invasive vaginal surgery to less harmful procedures like topical vaginal hormonal gels or hormone replacement therapy. The development of energy-based vaginal rejuvenation devices is a new trend that is picking up steam. These devices use thermal or nonthermal energy to stimulate collagen regeneration, contracture of elastin fibers, neovascularization, and improved vaginal lubrication in the different layers of the vaginal tissue. This review seeks to outline the vaginal rejuvenation technologies currently on the market as well as the research supporting their efficacy and safety in this application.


The Rise of Energy-Based Devices for Vaginal Rejuvenation

Recently, surgical procedures and systemic and topical treatments have been supplemented with new, noninvasive, energy-based systems, which is a welcome development for the many women wary of surgery due to the risk, expense, and downtime involved. These devices have opened up a new market for nonsurgical vulvovaginal correction procedures that can be performed by a wider range of practitioners including dermatologists. Among the new modalities being applied to feminine rejuvenation include CO2-based or erbium:yttrium-aluminum-garnet (Er:YAG) lasers and radiofrequency (RF)-based energy devices. By harnessing laser or RF waves to heat the connective tissue of the vaginal wall to 40 °C to 42 °C, these energy-based devices aim to induce collagen contraction, neocollagenesis, vascularization, and growth factor infiltration that ultimately revitalize and restore the elasticity and moisture of the vaginal mucosa.


Although numerous studies have demonstrated the therapeutic efficacy of energy-based devices in rejuvenation of the face, neck, and decollete, their application in the vaginal canal is a fairly new concept with a paucity of clinical studies currently available to validate their efficacy. Nevertheless, a plethora of devices are currently available, marketed, and developed with specific hand-pieces for this indication. The array of these devices, their underlying mechanism of action, and any available studies pertinent to their safety and efficacy will be described in this review.


See table below about laser and radiofrequency-based devices for vaginal rejuvenation:


When to use RF-based and Laser-Based Devices


Radiofrequency (RF) device treatments are used for outpatient procedures, do not require topical anesthesia, are constructed to emit focused electromagnetic waves, are applied to vaginal, vulvar, or vaginal introital or vestibular tissue, and deliver energy to the deeper connective tissue of the vaginal wall architecture.


New emerging data support the efficacy and safety of this specific radiofrequency treatment in patients with mild to moderate urinary stress incontinence; further studies confirming these outcomes are anticipated. Specifc RF treatments are approved in many countries for various conditions, including urinary incontinence (1 country), sexual function (17 countries), vaginal laxity (41 countries), and electrocoagulation and hemostasis (4 countries, including the United States).


Laser (Light Amplification by Stimulated Emission of Radiation) therapy on the other hand, uses a carbon dioxide (CO2), argon, YAG, or erbium energy source and is currently marketed as a method to improve various gynecologic conditions, including genital pelvic relaxation syndrome, vaginal laxity, GSM, lichen sclerosus, and sexual problems such as dyspareunia and arousal or orgasmic disorders.


Although trials have included small numbers of patients, early evidence suggests some lasers with reportedly deeper penetration may be useful for treatment of vaginal laxity, but further studies are needed. In smaller studies, the Er:YAG laser has shown efficacy and safety in the treatment of stress urinary incontinence and improved lower urinary tract symptoms, quality of life, and sexual function.


RF-based Studies and Approaches


RF devices that emit focused electromagnetic waves generating heat upon meeting tissue impedance have been widely applied for an array of aesthetic indications in facial and off-face sites, targeting cellulite, laxity, and noninvasive fat removal. Since RF energy is unabsorbed by melanin, the technology is safe for all skin types and has a proven clinical history in terms of safety, efficacy, and patient satisfaction. Although transurethral monopolar RF has been used to treat stress urinary incontinence with minimal risk of adverse events, nonablative RF has only recently been explored as a noninvasive strategy to achieve tightening of the vaginal canal.


Several devices in the market currently offer RF-based vaginal rejuvenation. None of these technologies require anesthesia, and on average, the treatment duration spans 15 to 30 min. Patients report feeling a sensation of warmth, which is very tolerable, and due to the lack of downtime, they can resume their normal activities the same day.


One unique handpiece emits monopolar RF and is widely used for facial skin rejuvenation, has been used off-label for nonsurgical reduction of the labia majora. The device’s thermal energy denatures the dermal collagen, inducing remodeling and tissue tightening and subsequent reduction of redundant skin in the area. Treatments at monthly intervals for three or four sessions have been recommended to achieve optimal clinical results. Another device employs bipolar RF energy that utilizes three distinct RF frequency channels (0.8 MHz, 1.7 MHz,and 2.45 MHz) and an additional fourth multichannel mode, combining all three RF frequencies to improve labial skin laxity and texture using the unit’s V-ST handpiece. This proprietary technology is designed to ensure accurate energy delivery for safe and painless treatments, broader dermal effect, and higher energy absorption for optimal clinical results. The V-ST handpiece emits RF energy fluency

of up to 130 J/cm^3 with pulse duration of up to 200 ms and includes an integral cooling mechanism that cools the electrodes to 6 °C.


A single-center blinded study with 14 healthy female patients, mean age of 50 years, investigating the safety and efficacy of V-ST handpiece for labial skin laxity and texture demonstrated moderate improvement score according to the investigator ratings with 67% of the patients reporting great satisfaction with the treatmentresults. Patients underwent an average of 5.6 treatments with no anesthesia, which lasted 30 min, and sessions were at 2- to 3-week intervals. Treatments were well tolerated by all patients with no adverse events or side effects recorded.


Another pilot study was conducted in 24 women (aged 25–44 years) using reverse gradient RF energy (75–90 J/cm2), delivered through the vaginal mucosa. Post-treatment assessments were at 10 days and 1, 3, and 6 months. Results from the study showed that after 1 month, post-treatment self-reported vaginal tightness significantly improved in 67% of subjects and in 87% at 6 months. Mean sexual function scores also improved, and no adverse events were reported. In another prospective study, 30 premenopausal women (aged 21–52 years) were treated with a single 30-min office treatment. Results included significant improvement in sexual function at 6 months in all subjects and decreased in distress related to sexual activity. Subjects also reported decreased vaginal laxity within the first month after the procedure, and effectiveness was sustained through 12 months. Another RF-based device uses an S-shaped handpiece that tightens external and internal vulvovaginal tissue via a thermistor tip, which also controls heat delivered to the skin. Monitoring of tissue temperature is done via a minimally invasive treatment probe.


In a prospective study, 23 subjects (age range 26–58 years, mean 43.6 years; median vaginal births = 2, mean parity 1.7; 5 menopausal, 6 perimenopausal) with mild to moderate vulvovaginal laxity, sexual dysfunction, and mild to moderate stress urinary incontinence were treated using the ThermiVa device for approximately 5 min per zone. The clinical endpoint was achievement of the target temperature range of 40 °C to 45 °C for approximately 3 to 5 min per zone (or longer, depending on heat tolerance). This was followed by treatment of the mucosal surface of the vaginal introitus starting at the hymenal ring and advancing to approximately 4 to 9 cm into the cavity for each zone of the vaginal wall. Total treatment time was less than 30 min. A complete course of therapy consisted of three treatments with the device, at an interval of approximately 4–6 weeks. Assessment occurred at baseline, 10 days after first treatment, before second treatment, before third treatment, and 30 days after the third treatment session. Patients were able to resume all activity as normal, including sexual intercourse, immediately after each treatment. All patie nts experienced a ti ghtening resu lt immediately after the first treatment with a significant change in the vaginal laxity score by 3 points on a 7-point scale at the second treatment visit. Significant improvement in sexual satisfaction and decrease in urinary incontinence was also noted. Treatments were well tolerated, and no adverse effects were reported.


Laser-based Studies and Approaches


Minimally ablative fractional laser therapy has gained acceptance as a safe, precise, and efficient method for skin resurfacing and restoration, especially in the field of plastic surgery and dermatology. The basis of fractional photothermolysis lies in using an array of small laser beams to create many microscopic areas of thermal necrosis within the skin, known as microscopic treatment zones. Epidermis and dermis within the microscopic treatment zones are destroyed inducing a wound-healing cascade with subsequent new collagen and elastin fiber formation that translates into healthier, firmer, and tighter skin. The CO2 (10,600 nm) and the Er:YAG laser, with its 2,940-nm wavelength that emits laser energy in the mid-infrared invisible light spectrum are the most widely used lasers in the skin rejuvenation field and have recently been applied to the vaginal tissues a for the treatment of symptomatic vulvar and vaginal atrophy.


Several fractional ablative lasers have been utilized for noninvasive rejuvenation of the vaginal canal and their safety profile, and efficacy has been underscored by peer-reviewed clinical studies. Typically, treatment sessions last 10 to 20 min, and no anesthetic is required. Most patients report almost no discomfort other than a warming sensation, but if a patient prefers, a topical anesthetic cream can be applied prior to treatment. No downtime is required, and regular activities can be resumed the same day.


A CO2 laser developed in Europe, is designed to stimulate and promote the regeneration of collagen fibers and to restore hydration and elasticity within the vaginal mucosa. The device is targeted for the treatment of atrophic vaginitis, vaginal laxity, mild urinary incontinence, or other sexual problems related to postpartum. It has also been utilized as an ancillary instrument in female genital surgery (labioplasty, vaginal reshaping, and clitoral unhooding), ensuring that surgery is effective and safe while also reducing postoperative discomfort. The MonaLisa fractional CO2 laser uses patented DOT Therapy to apply laser energy to the vaginal walls in a noncontinuous mode in small 200-micron dots, thus directly affecting only a small percentage of vaginal tissue. Different types of probes (360°, single-mirror, disposable, and vulvar applicator) accompany the device to adapt to the specific clinical and/or anatomic needs of individual patients.


In an independent study on biopsies from vaginal mucosa samples extracted from 50 postmenopausal nonestrogenized women treated with the MonaLisa, restoration of the vaginal thick squamous stratified epithelium with a significant storage of glycogen in the epithelial cells was observed together with fibroblast activation and neosynthesis of extracellular matrix. The laser settings used in this study were energy fluence above 100 mJ per pulse, with a pulse duration of 1,000 μs, and a single spot size of 200 μm.


A prospective study in 77 postmenopausal women (mean age 60 years) treated for vulvovaginal atrophy to investigate the effect of treatment on sexual satisfaction. Sexual function and quality of life were evaluated with the Female Sexual Function Index and the Short Form 12, respectively, both at baseline and at 12-week follow-up. A 10-mm visual analog scale was used to measure the overall satisfaction with sexual life and the intensity of vulvovaginal symptoms (vaginal burning, vaginal itching, vaginal dryness, dyspareunia, and dysuria) before and after the study period. Results demonstrated a significant improvement in the total score and the scores in each specific domain of the Female Sexual Function Index at 12-week follow-up compared to baseline as well as significant overall satisfaction with sexual life. Seventeen out of 20 women, sexually inactive because of the severity of their condition, regained a normal sexual life at the 12-week follow-up.


Several clinical studies have utilized the Er:YAG for both improvement of vulvovaginal atrophy and stress urinary incontinence. In a pilot prospective study, 45 postmenopausal women with genitourinary syndrome of menopause received three treatments at 30-day intervals with Er:YAG laser (spot size 7 mm, 1.6 Hz, 6.0 J/cm2), and the results were compared with the effects of a standard treatment of hormonal vaginal gel therapy in a group of 25 postmenopausal women. Results demonstrated that compared to the vaginal gel, the Er:YAG treatment led to significant decrease in both vaginal dryness and dyspareunia as well as significant improvement of urinary incontinence. The effects were rapid and long lasting, up to the 24th week of the observation period, and treatments were well tolerated with less than 3% of patients discontinuing treatment due to adverse events.


Lastly, an international multicenter observational study is currently underway to evaluate the efficacy and safety of Er:YAG laser for the treatment of genitourinary syndrome and stress urinary incontinence called the Vaginal Erbium Laser Academy Study (VELAS). This study will evaluate the effects of three laser applications in mid-infrared 1,500 postmenopausal women. Subjective and objective symptoms will be evaluated at baseline with follow-up visits after 4 weeks from the last laser application, and subsequently every 3 months for 1 year. Findings from the VELAS have the potential to affect clinical care practice and health decisions for millions of women worldwide and substantiate the use of laser-based devices for the amelioration of genitourinary conditions.


The Fututre of Energy-Based Devices for Female Rejuvenation


New prevention, treatment, and management strategies are continuously explored to alleviate medical and aesthetic concerns in women regarding their genital area. The emergence of energy-based devices enables women and their physicians to have another treatment option in their armamentarium to consider, while weighing the associated risks and benefits. Although there is a lack of a robust, qualitative body of data on the therapeutic advantages of these technologies for vaginal rejuvenation, the research field is very active with large multicenter studies currently being conducted to facilitate the acquisition of knowledge and best practices. Laser and RF technologies are widely and successfully used for treatments in dermatology and aesthetic medicine, stimulating the remodeling tissue properties and inducing the production of new collagen and elastic fibers. Thus, their application in the vaginal canal for feminine rejuvenation simply represents an expansion of therapeutic indications and hallmarks their versatility and the reactivity of biologic tissues to the beneficial effects of their mechanism of action. In the hands of well-trained physicians, energy-based devices are likely to benefit millions of women by aiding them in reclaiming, relishing, and reveling in their femininity at full capacity.




Reference

Vaginal rejuvenation using energy-based devices (2016)

Comparison of two novel laser treatments in aesthetic gynecology (2012)

Temperature controlled radiofrequency for vulvovaginal laxity (2015)

Labiaplasty: plastic or cosmetic surgery? (2010)

The techno vagina: The laser and radiofrequency device boom in gynecology (2018)

 

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