In recent years, an increasing number of laser and radiofrequency device outpatient treatments have been heralded as safe and effective interventions for various gynecologic conditions. Laser devices and radiofrequency technology rapidly have been incorporated into certain clinical settings, including medical practices specializing in dermatology, plastic surgery, and gynecology. While this developing technology has excellent promise, many clinical and research questions remain unanswered.
Concerns about energy-based vaginal treatments
Although marketing material often suggests otherwise, most laser and radiofrequency devices are cleared by the US Food and Drug Administration (FDA) only for nonspecific gynecologic and hematologic interventions. However, both laser and radiofrequency device treatments, performed as outpatient procedures, have been touted as appropriate interventions for many conditions, including female sexual dysfunction, arousal and orgasmic concerns, vaginal laxity, vaginismus, lichen sclerosus, urinary incontinence, and vulvar vestibulitis.
Well-designed studies are needed. Prospective, randomized sham-controlled trials of energy-based devices are rare, and most data in the public domain are derived from case series. Many studies are of short duration with limited follow-up. Randomized controlled trials therefore are warranted and should have stringent inclusion and exclusion criteria. Body dysmorphic syndrome, for example, should be a trial exclusion. Study design for research should include the use of standardized, validated scales and long-term follow-up of participants.
Which specialists have the expertise to offer treatment? Important ethical and medical concerns regarding the technology need to be addressed. A prime concern is determining which health care professional specialist is best qualified to assess and treat underlying gynecologic conditions. It is not uncommon to see internists, emergency medicine providers, family physicians, plastic surgeons, psychiatrists, and dermatologists self-proclaiming their gynecologic “vaginal rejuvenation” expertise.
In my experience, some ObGyns have voiced concern about the diverse medical specialties involved in performing these procedures. Currently, no standard level of training is required to perform them. In addition, those providers lack the training needed to adequately and accurately assess the potential for confounding, underlying gynecologic pathology, and they are inadequately trained to offer patients the full gamut of therapeutic interventions. Many may be unfamiliar with female pelvic anatomy and sexual function and a multidisciplinary treatment paradigm.
We need established standards. A common vernacular, nosology, classification, and decision-tree assessment paradigm for genitopelvic laxity (related to the condition of the pelvic floor and not simply a loose feeling in the vagina) is lacking, which may make research and peer-to-peer discussions difficult.
Which patients are appropriate candidates? Proper patient selection criteria for energy-based vaginal treatment have not been standardized, yet this remains a paramount need. A comprehensive patient evaluation should be performed and include a discussion on the difference between an aesthetic complaint and a functional medical problem. Assessment should include the patient’s level of concern or distress and the impact of her symptoms on her overall quality of life. Patients should be evaluated for body dysmorphic syndrome and relationship discord. A complete physical examination, including a detailed pelvic assessment, often is indicated. A treatment algorithm that incorporates conservative therapies coupled with medical, technologic, and psychologic interventions also should be developed.
Various energy-based devices are available for outpatient procedures
Although the number of procedures performed (such as vaginal rejuvenation, labiaplasty, vulvar liposculpturing, hymenoplasty, G-spot amplification, and O-Shot treatment) for both cosmetic and functional problems has increased, the published scientific data on the procedures’ short- and long-term efficacy and safety are limited. The American College of Obstetricians and Gynecologists (ACOG) published a committee opinion stating that many of these procedures, including “vaginal rejuvenation,” may not be considered medically indicated and may lack scientific merit or ample supportive data to confirm their efficacy and safety.1 ObGyns should proceed with caution before incorporating these technologic treatments into their medical practice.
Much diversity exists within the device-technology space. The underpinnings of each device vary regarding their proposed mechanism of action and theoretical therapeutic and tissue effect. In device marketing materials, many devices have been claimed to have effects on multiple tissue types (for example, both vaginal mucosa and vulvar tissue), whereas others are said to have more focal and localized effects (that is, targeted behind the hymenal ring). Some are marketed as a one-time treatment, while others require multiple repeated treatments over an extended period. When it comes to published data, adverse effect reporting remains limited and follow-up data often are short term.
Radiofrequency and laser devices are separate and very distinct technologies with similar and differing proposed utilizations. Combining radiofrequency and laser treatments in tandem or sequentially may have clinical utility, but long-term safety may be a concern for lasers.