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Mekan R. Orazov Viktor E. Radzinskiy Elena S. Silantyeva Liudmila M. Mikhaleva Elizaveta A. Khripach Evgeniy D. Dolgov

Abstract

Study Objective: To evaluate the comparative efficacy of the treatments for genitourinary syndrome of menopause.Study Design: An open-label, multicentre, prospective, comparative studyMaterials and Methods: This study included 114 patients aged 52.04 ± 1.48 years with a verified diagnosis of postmenopausal atrophic vaginitis (ICD N.95.2) who provided voluntary informed consent to participate in this study. Patients were divided into two study groups. To treat vulvovaginal atrophy, patients in group I (n = 59) administered intravaginal suppositories containing 0.5 mg of estriol, 1 suppository per day for the first 4 weeks and then 1 suppository 2 times a week for 8 weeks. Thus, the total course of topical hormone therapy was 3 months. In group II (n = 55) all patients underwent laser remodeling of the vulvovaginal area using the SmartXide2 V2LR Monalisa Touch laser system (DEKA, Florence, Italy) in the mode of 40/1400/1000/1 ST/DP for 3 sessions in total with a 1-month interval. Thus, the total laser remodeling treatment course was 3 months. The control group (n = 30) included women of similar age who did not have a verified diagnosis of postmenopausal atrophic vaginitis, N95.2.For objectification, the clinical manifestations of GSM in study patients were scored using a 5-point D. Barlow scale and the vaginal health index was calculated (G. Bachmann, 1995).results: The mean age of patients in groups I and II was 51.85 ± 1.37 and 52.1 ± 1.26 years with the mean postmenopausal period of 2.44 ± 0.86 years and 2.26 ± 0.84 years, respectively. Thus, the mean time from the onset of clinical manifestations of vulvovaginal atrophy was 2.32 ± 0.84 years in group I and 2.26 ± 0.84 years in group II.In this study, two treatment options, i.e., the topical hormone therapy and the microablative laser remodeling treatment using the SmartXide2 V2LR Monalisa Touch fractional CO2 laser (DEKA, Florence, Italy) in the mode of 40/1400/1000/1 ST/DP, demonstrated similar clinical efficacy in management of GSM symptoms and restoration of vaginal health in studied patients and had no adverse effects associated with burns and/or adhesions to the vaginal mucosa.conclusions: The use of the SmartXide2 V2LR Monalisa Touch fractional CO2 laser (DEKA, Florence, Italy) in treatment of GSM is pathogenetically justified and is an effective treatment option in postmenopausal patients with contraindications to topical hormone therapy.

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Keywords

vulvovaginal atrophy, genitourinary syndrome of menopause, vaginal dryness, laser treatment, estrogen therapy, topical hormone therapy.

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