Energy-Based Devices for Functional Vaginal Problems: Issues and Answers

The term “vaginal rejuvenation” also encompasses genital procedures aimed to reduce vaginal laxity and enhance sexual function. Genital procedures include, but are not limited to, labiaplasty, perineoplasty, and vaginoplasty [29]. Additional surgical therapies include g-spot amplification (via injections of hyaluronic acid or autologous fat transfer) and vaginal rugation restoration. Newer procedure such as platelet-rich plasma (PRP) and lipofilling can also be considered in this category. Current research on these techniques is mostly expert opinion, case series, and case reports as they are newer techniques; thus, safety and efficacy profiles are very limited [16, 29]. Surgical interventions may alter the cosmesis of the genital tissue and/or act to eliminate some functional complaints. For example, women with elongated and asymmetrical labia may complain of poor cosmetic appearance (esthetic complaint); additionally, they may have functional complaints such as chaffing and or the labia dragged into the vagina during intercourse resulting in painful intercourse.

Other nonhormonal treatment options include PRP and lipofilling or fillers.

The use of lipofilling and PRP for functional vaginal problems has been described in case reports, but has not been widely studied. Lipofilling involves depositing autologous fat in the vulvovaginal tissues to restore the soft tissues; there is the potential for the fatty tissue to contain stem cells which may aid in tissue regeneration at the implantation sites. The process of PRP involves the injection of autologous plasma with high platelet fraction into the vulvovaginal tissues. The PRP which is rich in growth factors may promote tissue repair, angiogenesis, and inflammation [30].

Noninvasive strategies for functional vaginal problems have the benefit of avoiding the potential morbidity of surgery. Current noninvasive standard of care treatment for GSM includes vaginal topical estrogen, moisturizers, and lubricants. Vaginal moisturizers are typically water-based products that are applied to the vaginal tissues regularly to treat vaginal dryness symptoms. Lubricants are applied to the genital tissue as needed to reduce symptoms of dyspareunia and decrease coital pain. Both moisturizers and lubricants are aimed at alleviation of symptoms of GSM as compared to vaginal estrogen which has the ability to revitalize the underlying vaginal tissues [6]. While topical estrogens are effective in some patients, there are groups of patients with contraindications to hormonal therapy and patients in which self-application of topical therapies is not feasible. Specifically, the use of topical estrogen is controversial in women with a history of breast cancer, estrogen sensitive tumors, including some gynecologic cancers, and thromboembolism due to the fact that these conditions are potentially responsive to serum estrogen levels [14•]. At this point, studies cannot conclude with certainty that topical estrogen does not increase serum estrogen level to a clinically significant degree of provocation in these diseases [31]. Most studies suggest that topical estrogen can be considered for patients with a history of breast cancer and some gynecologic cancers with shared decision-making when GMS is refractory to other treatment lines and without certain high risk features; however, it is stressed that there is insufficient high-quality evidence regarding the risks [31, 32]. Patients with breast cancer often have severe GSM as a result of hypoestrogenism following treatment with chemotherapy, GnRH agonists, or anti-estrogen therapy [33]. Alternative noninvasive methods that are nonhormonal may be the only option for some of the aforementioned patients with significant GSM and inability or reluctance to use topical estrogen.

Energy-based devices apply the energy of radiofrequency (RF) or a laser to the vulvovaginal tissue to induce remodeling and revitalization of tissues [19•]. There are two types of lasers commonly used to treat vulvovaginal tissue, carbon dioxide (CO₂) and erbium:yttrium-aluminum-garnet (Er:YAG). All of the aforementioned devices have been used in dermatologic practice in rejuvenation of the face and neck with evidence for efficacy and safety [2]. Numerous studies have shown that the energy-based devices show promising efficacy in the treatment of GSM, vaginal laxity, sexual dysfunction, potentially SUI, and improvements in QOL; however, previously, very few of these studies reduced bias in the form of randomization, control groups, blinding, and sham treatments.

In addition to their promising efficacy, the energy-based devices have been shown to be cost-effective, and do not require sedation or downtime for patients. Wallace et al. [34] conducted a retrospective review study in 2020 comparing the cost-effectiveness of vaginal estrogen, ospemifene, and vaginal CO₂ laser therapy. All treatments were found to be cost-effective; however, they found vaginal CO₂ laser therapy to be the most cost-effective when assuming the following based on published data in their review of the research: typical adherence rates of the three treatment options, efficacy of the treatments, and patient costs for each treatment. While the findings are promising for the energy-based devices, it must be mentioned that the typical adherence rate for vaginal CO₂ laser therapy was assumed based on adherence rates to other in-office procedures such as percutaneous tibial nerve stimulation and on data from RCTs which is significant given the fact that the researchers found that the variable that most influenced the cost-effectiveness results was adherence to the treatment regimen. Additionally, the cost of each treatment was estimated based only on patient cost and did not evaluate physician office and hospital costs [34].

Another attraction to these devices is safety. Current data reports the energy-based devices to be well tolerated and result in limited and infrequent complications [35]. There remains limited data on long-term safety and currently there is unawareness of the optimal treatment duration and when to offer patients a repeat procedure. With the above benefits considered, the use of energy-based devices for the treatment of GSM, VL, sexual dysfunction, and urinary incontinence has become widespread. In a recent global survey conducted by Gambacciani et al. [36] among practitioners using the vaginal erbium laser, it was reported that among only 535 responding practitioners, a total of 113,174 patients spanning six continents were treated from 2012 to 2019.

In treatments of the vulvogaginal tissue with radiofrequency (RF) therapy, a device emits focused electromagnetic waves to generate heat that is applied to tissue. Heating of the tissue’s collagen fibers leads to folding of its triple helix structure which causes the fibers to become thicker and shorter. Furthermore, this process causes a mild inflammatory response which activates fibroblasts for collagen and elastin synthesis [2, 50, 51]. The efficacy of this process has been shown histologically. Kent et al. conducted a study to evaluate histologic evidence of the efficacy of RF treatment on vulvovaginal tissue using an animal model of multiparous swine. The swine were administered RF treatment once per week for 3 weeks; biopsies were collected at baseline and at week four. The histology showed an increased density of elastin and collagen fibers after treatment with RF. A histologic study on post-menopausal women (N=20) by Leibaschoff et al. [52•] found that following three treatments with RF in the study group versus a sham treatment in the control group, biopsies of the study group showed increased concentration of collagen.

Regarding clinical studies, numerous prospective cohort studies have shown that RF is potentially effective as therapy for vaginal laxity, GSM, sexual dysfunction, improvement in QOL, and, notably, SUI [27, 28, 45, 51, 53‐56]. In the past few years, there have been reports of efficacy for RF in treatment of functional vaginal problems as well as improvements in QOL in randomized control trials as well [52, 57, 58] (Table 3). Leibaschoff et al. [52•] performed a double-blinded randomized control trial in 2016 in which (N=20) post-menopausal women with SUI and vaginal laxity were randomized into either the study group which was administered 3 treatments with RF therapy, or randomized into the control group which was given 3 treatments with a sham device; a double-blinded method was used. Results showed improvement in SUI including 70% with negative post-treatment cough stress test, and improvement in VHI and VAS [52•]. In 2017, Krychman et al. [57•] performed a randomized placebo sham-controlled and blinded study in which pre-menopausal women (N=174) with VL were randomized to a study group which received 1 treatment with RF, and a control group which received 1 treatment with a sham device. At a 6-month evaluation, there was significant improvement in vaginal laxity and sexual function in the group treated with RF [57•]. Most recently, in 2020, Allan et al. [58•] completed a randomized control study in which (N=35) women with SUI were randomized to receive either one or two treatments with RF. When evaluated at 12 months post-treatment, both groups had improvements in SUI and QOL [58•].

Another interesting study regarding RF conducted by Sarmento et al. [59] in 2020 is a prospective cohort study in which post-menopausal women with GSM underwent 3 treatments with RF. At timepoints throughout the treatment course, vaginal smears were obtained and assessed. Compared to baseline, there was a significant increase in the concentration of lactobacillus species, a decrease in the vaginal pH, increased amount of parabasal cells and superficial epithelial cells, and improvement in VHI score and GSM [59].

Multiple prospective studies that were reviewed in which the energy-based devices were used for vulvovaginal treatments reported minimal or no adverse events, and none of the studies reported severe adverse events. The mild adverse events in the studies reviewed were dysuria, discomfort during treatment, urinary tract infection, vaginal discharge, edema, vaginal bleeding, vaginitis, and mild vaginal burn. Other sources report side effects may include itching, burning, or swelling that occurs immediately after the procedure and acutely resolves, bacterial vaginosis, UTI, and rarely the development of scarring [60, 61]. In a recent editorial, Delancey [62] voiced concern that while the tissue initially appears re-vascularized following laser or RF treatments over time the tissue would become avascular and form scar tissue similar to other wound healing processes.

The study by Wallace et al. [34] previously discussed found that there was less probability of side effects or complications when using CO₂ vaginal laser therapy compared to vaginal estrogen. Additionally, in a prospective cohort study conducted by Donato et al. [35] (N=53) to evaluate satisfaction and safety of treatment of GSM with CO₂ vaginal laser therapy, only acute and minor complications were reported including minor bleeding with insertion of the treatment probe and dysuria. After 30 days of treatment, no complications were reported, and no severe complications were reported during any time period. In Gaspar’s [47•] study in 2017, the study group receiving Er:YAG laser therapy had less side effects (4%) than the control group that was treated with topical estrogen (12%).

While these results have shown promising safety profiles for the devices, a case series published by Gordon et al. [63] in 2019 reported four cases of adverse outcomes in patients following treatment with the CO₂ laser which included vaginal agglutination with resultant stenosis, and three cases of continued or worsening dyspareunia.

Ahluwali et al. [3•] published an analysis of the Manufacturer and User Facility Device Experience (MAUDE) database for events related to laser and energy-based devices for vulvovaginal problems. In review of the database, 45 adverse events had been reported, including (N=19) reporting vulvar, bladder, or urethral pain. Thirty-three of the patients reported that these adverse events involved chronicity including numbness, discomfort, bladder disturbance, scarring, dyspareunia, disfigurement, or worsening of previous gynecologic symptoms.

In summation, most of the information regarding the safety of the energy-based devices in their use for vulvovaginal problems supports that the energy-based devices are safe; however, there have been very few randomized control trials assessing their safety, and most studies to present day have not followed patient adverse events for a greater time period than 12 months.

The positions of esteemed governing bodies including the US Food and Drug Administration (FDA), American College of Obstetricians and Gynecologists (ACOG), International Urogynecological Association (IUGA), the American Urogynecolgic Society (AUGS), and European Society for Sexual Medicine (ESSM) are essentially in agreement regarding the use of energy-based devices for vulvovaginal problems vaginal rejuvenation [64]. In July of 2018, the FDA issued a warning against the use of energy-based devices including laser and RF to perform vaginal rejuvenation procedures due to the fact that the safety and efficacy of the devices had not been established. The FDA stated that the devices had not been cleared for the treatment of GSM, SUI, and sexual dysfunction or for cosmetic purposes. This statement was invoked for concern that the energy-based devices could cause serious adverse events including burns, scarring, dyspareunia, and chronic pain [65•]. ACOG published a position stating that though the energy-based devices show potential utility they believed there was insufficient evidence for the efficacy and long-term safety of these treatments [66]. ACOG also published the opinion that women should be counseled about the lack of high-quality data supporting the effectiveness of vaginal rejuvenation or other female genital cosmetic surgery procedures and the potential complications including pain, bleeding, infection, scarring, adhesions, altered sensation, and dyspareunia [4]. IUGA further agreed with the previous opinions in their statement in September 2018. IUGA stated that there is necessity for randomized case control trials with long-term follow-up to further investigate efficacy and safety profile of the energy-based devices in the treatment of GSM, VL, sexual dysfunction, and SUI symptoms [60]. Most recently, AUGS stated that the energy-based devices have a favorable safety profile based on short-term data, while the long-term effects of the therapies are undetermined. AUGS also commented that the patient criteria for utilizing or having contraindications to the energy-based devices as well as the appropriate treatment regimen have not been established [61].