In women with genitourinary syndrome of menopause (GSM), both fractionated CO2 laser therapy and estrogen treatment resulted in similar improvements in vaginal symptoms at 6 months, according to study results published in Menopause.
Researchers conducted a randomized clinical trial of menopausal women (no menstruation for at least 12 months) who were enrolled at institutions related to the Foundation for Female Health Awareness. The women had reported bothersome symptoms of GSM (vaginal dryness, vaginal burning, vaginal itching, dysuria). Patients were randomly assigned to either 3 intravaginal CO2 laser treatments at least 6 weeks apart or conjugated estrogen cream applied intravaginally daily for 14 days followed by twice weekly for 24 weeks.
Follow-up questionnaires and assessment included an examination of vaginal caliber using a dilator, completion of a GSM symptom scale, with subjective improvement of vaginal dryness being the primary study outcome. Secondary outcomes included comparisons between groups of the vaginal health index and vaginal maturation index scores, the effect of treatment on sexual function, the effect of treatment on urinary symptoms, and comparison of patient satisfaction.
From June 2016 to September 2017, 69 women from 6 medical centers met inclusion criteria; 62 completed the 6-month protocol (30 laser, 32 estrogen). Scores for vaginal dryness, burning, itching, and dysuria did not differ between groups. At follow-up, changes in vaginal maturation index scores were higher in the estrogen group compared with the laser group (25 vs 3.9, respectively),
A total of 71.9% of patients who received laser treatment rated their improvement as “better or much better” and 75.8% reported being either “satisfied or very satisfied” compared with 82.8% and 75.9% in the estrogen group. Of the patients, 9 (30%) in the laser group and 4 (13.8%) in the estrogen group reported no change in symptoms.
Adverse events were reported in 10 patients and did not differ between the study groups. These included vaginal bleeding (2 laser, 2 estrogen), pain and/or discharge (2 laser), breast tenderness (1 estrogen), urinary tract infection (1 laser), migraine (1 estrogen), and abdominal cramping (1 estrogen).
The investigators acknowledged that a study limitation was their inability to enroll enough patients to reach their original goal. In this investigation, “the CO2 laser was shown to be safe and effective in treating GSM symptoms, and, preliminarily, CO2 laser and vaginal estrogen resulted in patient satisfaction and improved clinical outcomes,” the investigators concluded.
Paraiso MFR, Ferrando CA, Sokol ER, et al. A randomized clinical trial comparing vaginal laser therapy to vaginal estrogen therapy in women with genitourinary syndrome of menopause: The VeLVET Trial. Menopause. 2020;27(1):50-56.