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

Abstract

Vaginal rejuvenation is a marketing term that encompasses surgical and medical treatments for functional vaginal/vulvar problems including but not limited to genitourinary syndrome of menopause (GSM), sexual dysfunction, vaginal laxity, and stress urinary incontinence (SUI) and for esthetic concerns including dissatisfaction with vulvovaginal appearance. Multiple treatment options have become available for indications of functional vaginal problems. Noninvasive management options including the use of more novel treatments such as energy-based devices have gained interest. Previously, studies regarding the efficacy and safety of the energy-based devices for functional vaginal problems were mostly limited to cohort studies without sham treatment, control groups, randomization, or double blinding. As a result of this insufficient data in 2018, the FDA released a statement of warning against the use of energy-based devices in the treatment of functional vaginal problems or vaginal cosmetic procedures (Https://Www.Fda.Gov/Medical-Devices/Safety-Communications/Fda-Warns-Against-Use-Energy-Based-Devices-Perform-Vaginal-Rejuvenation-or-Vaginal-Cosmetic. 1–4, 2018). Purpose of Review This article reviews the most current treatment modalities in the realm of vaginal rejuvenation therapy with an emphasis on the efficacy and safety of the energy-based devices. Recent Findings In the most recent literature, there have been studies with improvements in study design that support the efficacy and the short-term safety of the energy-based devices. Summary More recent studies with improved study design evidence that the use of energy-based devices results in improvements in functional vaginal problems and that serious adverse events appear to be rare. The availability of these devices as treatment options for functional vaginal problems has the potential to impact patient by improving their symptoms and quality of life. Caution still remains however regarding their safety following a longer period of time after their use.

Radiofrequency in Cosmetic Gynecology, Literature Review 2018-2023

“…The RF modality in treating GUS of menopause addresses multiple indications, including genital, sexual, and urinary tract symptoms. Based on numerous prospective cohort studies, RF, precisely the bipolar type, has demonstrated effectiveness in treating GUS of menopause [4,7,8]. This assertion delineates the extent of RF technology developments within the nonsurgical cosmetic gynecology subspecialty as stakeholders strive to counter underlying physiological changes associated with GUS of menopause.…”

“…As established in a study, RF, just like laser technology, is one of the most commonly utilized energybased devices, authorized by the Food and Drug Administration (FDA) agency for various gynecological applications, including the treatment of abnormal cervical muscles, vaginal tissues, and genital warts [5,10]. The efficacy of this technology underlies multiple prospective cohort studies which have demonstrated that RF therapy is a promising and effective treatment for vaginal laxity [4]. In another study on an animal model of multiparous swine, administering RF treatment once per week for three weeks showed an increased density of elastin and collagen fibers in vulvovaginal tissue [4].…”

“…The efficacy of this technology underlies multiple prospective cohort studies which have demonstrated that RF therapy is a promising and effective treatment for vaginal laxity [4]. In another study on an animal model of multiparous swine, administering RF treatment once per week for three weeks showed an increased density of elastin and collagen fibers in vulvovaginal tissue [4]. This suggestion indicates that RF treatment may positively affect the structural integrity and elasticity of the vulvovaginal tissue, which is beneficial for tissue laxity or damage-related conditions.…”

“…Irritation, burning, dysuria, impaired sexual function, stress incontinence, and pain, among other indications, exemplify the complexity associated with the GUS of menopause and broader medical problems facing women. Although the elective surgery subspecialty comprises insufficient medical professionals available to address these problems [3][4][5], its growth rate is considerably high as more gynecology specialists advance their qualifications to offset the patient demand. Despite being a relatively new field with fewer fellowship programs, the availability of reputable preceptorship programs for surgeons willing to start this career inspires growing interest [2].…”

Cosmetic Gynecology: Present and Future Perspectives

“…Energy-based devices are the latest development in this sector which has brought with it a promising approach to help alleviate vaginal concerns [68,69] . The EBDs apply thermal or nonthermal energy to the skin tissue which stimulates collagen formation, contraction of elastin fibres, neovascularization, induce tissue remodeling, and improve lubrication.…”