Outlook for energy-based therapies: Cautiously optimistic
Preliminary outcome data on the use of energy-based therapies for female genital cosmetic surgery is largely positive for the treatment of vulvovaginal atrophy, but some case series suggest the potential for scarring, burning, and inefficacy. This prompted the FDA to send “It has come to our attention” letters to a number of device manufacturers in 2018.6
Supportive evidence is weak. Early data are encouraging regarding fractionated laser therapy for the treatment of vulvovaginal atrophy and stress UI and radiofrequency wand therapy for vaginal laxity and stress UI. Unfortunately, the level of evidence to support wide use of these technologies for all pelvic floor disorders is weak. A recent committee opinion from the International Urogynecology Association noted that only 8 studies (1 randomized trial and 7 observational studies) on these conditions fulfilled the criteria of good quality.19 The International Continence Society and the International Society for the Study of Vulvovaginal Disorders recently published a best practice consensus document declaring laser and energy-based treatments in gynecology and urology to be largely experimental.20
Questions persist. Knowledge gaps exist, and recommendations related to subspecialty training—who should perform these procedures (gynecologists, plastic surgeons, urologists, dermatologists, family practitioners) and the level of training needed to safely perform them—are lacking. Patient selection and physician knowledge and experience related to female genital anatomy, female sexual function and dysfunction, multidisciplinary treatment options for various pelvic support problems and UI, as well as psychologic screening for body dysmorphic disorders, need to be considered in terms of treating both the functional and aesthetic aspects related to cosmetic and reconstructive gynecologic surgery.
Special considerations. The use of energy-based therapies in special populations, such as survivors of breast cancer or other gynecologic cancers, as well as women undergoing chemotherapy, radiation therapy, and hormonal manipulation (particularly with antiestrogenic SERMs and aromatase inhibitors) has not been adequately evaluated. A discussion of the risks, benefits, alternatives, and limited long-term outcome data for energy-based therapies in cancer survivors, as for all patients, must be included for adequate informed consent prior to undertaking these treatments.
Guidelines for appropriate tissue priming, laser settings, and concomitant energy-based technology with local hormone treatment (also known as laser-augmented drug delivery) need to be developed. Comparative long-term studies are needed to determine the safety and effectiveness of these technologies.
Caution advised. Given the lack of long-term safety and effectiveness data on energy-based therapies for the vague indications of vaginal laxity, and even for the well-defined conditions of stress UI and vulvovaginal atrophy, clinicians should exercise caution before promoting treatment, which can be expensive and is not without potential complications, such as vaginal pain, adhesive agglutination, and persistent dryness and dyspareunia.21
Fortunately, many randomized trials on various energy-based devices for gynecologic indications (GSM, stress UI, vaginal laxity, lichen sclerosus) are underway, and results from these studies will help inform future clinical practice and guideline development.