Περίληψη:
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. © 2020 International Menopause Society.
Συγγραφείς:
Salvatore, S.
Pitsouni, E.
Grigoriadis, T.
Zacharakis, D.
Pantaleo, G.
Candiani, M.
Athanasiou, S.
Λέξεις-κλειδιά:
adult; adverse event; Article; clinical article; clinical effectiveness; clinical outcome; controlled study; disease severity; double blind procedure; dyspareunia; dysuria; female; female sexual dysfunction; Female Sexual Function Index; human; incidence; laser therapy; lower urinary tract symptom; menopausal syndrome; middle aged; multicenter study; orgasm; patient-reported outcome; postmenopause; priority journal; randomized controlled trial; scoring system; sexual arousal; sexual function; sexual satisfaction; sham procedure; skin irritation; stress incontinence; symptomatology; urge incontinence; urinary frequency; Urogenital Distress Inventory; urogenital tract disease; vagina atrophy; vaginal burning sensation; vaginal dryness; vaginal lubrication; vaginal pruritus; visual analog scale; vulva disease; clinical trial; complication; drug therapy; dyspareunia; gas laser; pain measurement; postmenopause; sexual dysfunction; syndrome; treatment outcome; urogenital tract disease; vagina; vagina disease, carbon dioxide, Carbon Dioxide; Double-Blind Method; Dyspareunia; Female; Female Urogenital Diseases; Humans; Lasers, Gas; Middle Aged; Pain Measurement; Postmenopause; Sexual Dysfunction, Physiological; Syndrome; Treatment Outcome; Vagina; Vaginal Diseases
