GSM encompasses a constellation of symptoms involving the vulva, vagina, urethra, and bladder, and it can affect quality of life in more than half of women by 3 years past menopause.1,2 Local estrogen creams, tablets, and rings are considered the gold standard treatment for GSM.3 The rising cost of many of these pharmacologic treatments has created headlines and concerns over price gouging for drugs used to treat female sexual dysfunction.4 Recent alternatives to local estrogens include vaginal moisturizers and lubricants, vaginal dehydroepiandrosterone (DHEA) suppositories, oral ospemifene, and vaginal laser therapy.
Laser treatment (with fractionated CO2, erbium, and hybrid lasers) activates heat shock proteins and tissue growth factors to stimulateneocollagenesis and neovascularization within the vaginal epithelium,but it is expensive and not covered by insurance because it is considered a cosmetic procedure.5Most evidence on laser therapy for GSM comes from prospective case series with small numbers and short-term follow-up with no comparison arms.6,7 A recent trial by Cruz and colleagues, however, is notable because it is one of the first published studies that compared vaginal laser with vaginal estrogen alone and with a combination laser plus estrogen arm. We need level 1 comparative data from studies such as this to help us counsel the millions of US women with GSM.
Details of the study
In this single-site randomized, double-blind, placebo-controlled trial conducted in Brazil, postmenopausal women were assigned to 1 of 3 treatment groups (15 per group):
- CO2 laser (MonaLisa Touch, SmartXide 2 system; DEKA Laser; Florence, Italy): 2 treatments total, 1 month apart, plus placebo cream (laser arm)
- estriol cream (1 mg estriol 3 times per week for 20 weeks) plus sham laser (estriol arm)
- CO2 laser plus estriol cream 3 times per week (laser plus estriol combination arm).
The primary outcome included a change in visual analog scale (VAS) score for symptoms related to vulvovaginal atrophy (VVA), including dyspareunia, dryness, and burning (0–10 scale with 0 = no symptoms and 10 = most severe symptoms), and change in the objective Vaginal Health Index (VHI). Assessments were made at baseline and at 8 and 20 weeks. Participants were included if they were menopausal for at least 2 years and had at least 1 moderately bothersome VVA symptom (based on a VAS score of 4 or greater).
Secondary outcomes included the objective FSFI questionnaire evaluating desire, arousal, lubrication, orgasm, satisfaction, and pain. FSFI scores can range from 2 (severe dysfunction) to 36 (no dysfunction). A total FSFI score less than 26 was deemed equivalent to dysfunction. Cytologic smear evaluation using a vaginal maturation index was included in all 3 treatment arms. Sample size calculation of 45 patients (15 per arm) for this trial was based on a 3-point difference in the VHI.
The baseline characteristics for participants in each treatment arm were similar, except that participants in the vaginal estriol group were less symptomatic at baseline. This group had less burning at baseline based on the FSFI and less dyspareunia based on the VAS.
On July 30, 2018, the US Food and Drug Administration (FDA) issued a safety warning against the use of energy-based devices for vaginal "rejuvenation"1 and sent warning letters to 7 companies--Alma Lasers; BTL Aesthetics; BTL Industries, Inc; Cynosure, Inc; InMode MD; Sciton, Inc; and Thermigen, Inc.2 The concern relates to marketing claims made on many of these companies' websites on the use of radiofrequency and laser technology for such specific conditions as vaginal laxity, vaginal dryness, urinary incontinence, and sexual function and response. These devices are neither cleared nor approved by the FDA for these specific indications; they are rather approved for general gynecologic conditions, such as the treatment of genital warts and precancerous conditions.
The FDA sent the safety warning related to energy-based vaginal therapies to patients and providers and have encouraged them to submit any adverse events to MedWatch, the FDA Safety Information and Adverse Event Reporting system.1 The "It has come to our attention letters" issued by the FDA to the above manufacturers request additional information and FDA clearance or approval numbers for claims made on their websites--specifically, referenced benefits of energy-based devices for vaginal, vulvar, and sexual health.2 This information is requested from manufacturers in writing by August 30, 2018 (30 days).
- FDA warns against use of energy-based devices to perform vaginal 'rejuvenation' or vaginal cosmetic procedures: FDA safety communication. US Food and Drug Administration website. https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm615013.htm. Updated July 30, 2018. Accessed July 30, 2018.
- Letters to industry. US Food and Drug Administration website. https://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm111104.htm. Updated July 30, 2018. Accessed July 30, 2018.