CO<sub>2</sub> laser and the genitourinary syndrome of menopause: a randomized sham-controlled trial
Stefano Salvatore, Eleni Pitsouni, Themos Grigoriadis, D. Zacharakis, Giuseppe Pantaleo, Massimo Candiani, Stavros Athanasiou
Abstract
Purpose This study aimed to clarify the efficacy of intravaginal CO2-laser treatment in postmenopausal women with genitourinary syndrome of menopause (GSM).Materials and methods This double-blind, randomized, sham-controlled trial included postmenopausal women diagnosed with GSM and bothersome dryness and dyspareunia. Treatment consisted of three sessions. Active CO2-laser treatments (active group) were compared to sham treatments (sham group) with the primary endpoints being changes in dryness and dyspareunia intensity, as assessed by the 10-cm visual analog scale. Secondary endpoints were as follows: changes in Female Sexual Function Index (FSFI; total score and all domains), itching, burning, dysuria, and Urogenital Distress Inventory (UDI-6); incidence of symptoms; and presence of adverse events. All outcomes were evaluated at baseline and 4 months post baseline.Results Fifty-eight women (28 in the active group and 30 in the sham group) were eligible for inclusion. In the active group, dryness, dyspareunia, FSFI (total score), itching, burning, dysuria, and UDI-6 were significantly improved (mean [standard deviation] –5.6 [2.8], −6 [2.6], 12.3 [8.9], −2.9 [2.8], −2.3 [2.8], −0.9 [2.1], and −8.0 [15.3], respectively). In the sham group, dryness, itching, and burning were significantly improved (–1.9 [2], −1.4 [1.9], and −1 [1.9], respectively). All changes were in favor of the active group. After completion of the protocol, the proportion of participants with dryness, dyspareunia, and sexual dysfunction was significantly lower in the active group compared to those in the sham group (all p < 0.005).Conclusions CO2 laser could be proposed as an effective alternative treatment for the management of GSM as it is superior to sham treatments.