Vaginal CO2 laser therapy versus sham for genitourinary syndrome of menopause management: a systematic review and meta-analysis of randomized controlled trials

Abstract

Importance:The research of new therapeutic modalities, especially with energy-based devices, has been increasing nowadays for genitourinary syndrome of menopause (GSM) management. Microablative fractional CO2 laser has been used for pelvic floor dysfunction management.Objective:To conduct a systematic review and meta-analysis of randomized controlled trials to compare fractional CO2 laser therapy versus sham therapy for GSM management.Evidence Review:We searched for the available randomized clinical trials in Cochrane Library, PubMed, ISI web of science, and Scopus during March 2021. We included randomized clinical trials that compared CO2 laser to sham among postmenopausal women with GSM diagnosis. We extracted the available data from included studies and pooled them in a meta-analysis model using RevMan software. Our main outcomes were total vaginal score assessment using the Vaginal Assessment Scale, sexual function using the Female Sexual Function Index, urinary symptoms using the Urogenital Distress Inventory-6, and satisfaction.Findings:Three studies met our inclusion criteria with a total number of 164 women. The CO2 laser was linked to a significant reduction in Vaginal Assessment Scale score when compared with the sham group (mean difference [MD] = −0.49, 95% CI [−0.75 to −0.22], P = 0.004). The CO2 laser was associated with a significant improvement in Female Sexual Function Index score in comparison with sham group (MD = 9.37, 95% CI [6.59-12.14], P < 0.001). In addition, a significant reduction in Urogenital Distress Inventory-6 score was reported among the CO2 laser group (MD = −6.95, 95% CI [−13.24 to −0.67], P = 0.03). More women were significantly satisfied among the CO2 laser group (risk ratio = 1.98, 95% CI [1.36-2.89], P = 0.004).Conclusions and Relevance:CO2 laser therapy is a promising alternative for GSM management. Further randomized trials with larger sample sizes are required to confirm our findings.

The effect of CO2 laser therapy on vaginal microcirculatory parameters in an animal model for genitourinary syndrome of menopause

“…Together, these results imply that vaginal CO 2 laser therapy does not induce thickening of the vaginal epithelium and thereby is ineffective in the treatment of GSM. Contrarily, multiple clinical trials have demonstrated significant improvement in experienced symptoms (dryness, burning, itching, dysuria, and dyspareunia) and sexual satisfaction 20 . Hence, there seems to be a discrepancy between these clinical trials and our findings.…”

Clinical Consensus Statement: Vaginal Energy-Based Devices

“…A systematic review of three sham-controlled trials [13][14][15] for 82 women undergoing 3 monthly CO 2 laser treatments demonstrated improvement in the Vaginal Assessment Score of −0.49 and the FSFI of 9.37 4 weeks after treatment. 16 A sham-controlled trial with a 6-mo follow-up studied 30 women, and there were no differences in the proportion improved (64% vs 67%) and no differences in scores in the Vaginal Health Index, the VAS, the modified global assessment (PGI-I), the FSFI, the Day-to-Day Impact of Vaginal Aging, or the Urinary Distress Inventory short-form. 17 However, a longer-term sham-controlled trial with 1 y of follow-up in which 85 women received 3 monthly CO 2 laser treatments showed no improvement in vaginal symptoms by VAS or the Vulvovaginal Symptom Questionnaire score.…”

Menopause, wellbeing and health: A care pathway from the European Menopause and Andropause Society

“…Energy-based therapies include fractional CO 2 laser or erbium YAG laser and radiofrequency devices; however, none of these approaches has received FDA approval due to safety concerns [18]. Although clinical studies have shown benefit and safety [148][149][150], recent experimental data and data from randomized controls trials question the efficacy of laser treatment [151,152].…”