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

Abstract

Study Objective: To evaluate the clinical and morphological efficacy and safety of laser remodeling therapy in patients with genitourinary syndrome of menopause.Study Design: An open, multicentre, comparative, independent, prospective clinical and morphological study.Materials and Methods: This study included 114 patients aged 52.04 ± 1.48 years with a verified diagnosis of postmenopausal atrophic vaginitis 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. The total course of topical hormone therapy was 3 months. In group II (n = 55) all patients underwent laser remodeling of the vulvovaginal region 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. The control group (n = 30) included women of similar age who did not have a verified diagnosis of postmenopausal atrophic vaginitis, N95.2.In all patients, tissue specimens (up to 3 mm in diameter) were obtained by punch biopsy at baseline and 3 months after the treatment. Morphological examination was carried out using the light microscopy, which was preceded by standard preparation of biopsy specimens (fixation in neutral formalin, histological processing, staining with hematoxylin and eosin, embedding). Two tissue samples, namely from the anterior and posterior vaginal walls, were obtained in each patient at two time points, i.e., prior to and 3 months after the treatment for GSM. A total of 516 vaginal wall histopathological examinations (114 patients * 2 biopsy specimens * 2 time points + 30 * 2 biopsy specimens in the morphological control group) were performed using light microscopy (hematoxylin and eosin staining) and immunohistochemistry. The results of the IHC with anti-type IV collagen, anti-VEGF-A, and anti-CD-31 antibodies were scored based on the percentage of stained cells and the staining intensity. For objectification, the clinical manifestations of GSM in study patients were rated 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, respectively. The mean postmenopausal period was 2.44 ± 0.86 years and 2.26 ± 0.84 years in group I and group II, respectively. 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.This study demonstrated similar clinical and morphological efficacy of the two treatments: 3 months after the therapy the expression of this marker significantly increased by 1.19 (2.19 ± 0.57 versus 2.61 ± 0.5; p<0.001) and 1.14 times (2.29 ± 0.63 versus 2.6 ± 0.49; p<0.001) in groups I and II, respectively; as well there were 1.17-fold (13.6 ± 3.8 versus 15.97 ± 4, p<0.001) and 1.3-fold (12.75 ± 4.26 versus 16.69 ± 4.3, p<0.001) increases in the expression of the above marker of angiogenesis and 1.25-fold (14.63 ± 9.01 versus 18.33 ± 10.83, p<0.001) and 1.22-fold (16.78 ± 10, 13 versus 20.51 ± 11.50, p<0.001 respectively) increases in the expression of type IV collagen. In groups I and II the vaginal health scores using the G. Bachmann scale significantly increased 1.27-fold (2.98 ± 0.75 vs. 3.78 ± 1.15; p = 0.006) and 1.17-fold (3.14 ± 0.65 vs. 3.66 ± 1.58; p=0.006), respectively, 3 months after the treatment for GSM.CONCLUSIONS: In summary, in this study the laser remodeling treatment for symptoms of vulvovaginal atrophy using the SmartXide2 V2LR Monalisa Touch fractional CO2 laser (DEKA, Florence, Italy) was shown to have similar clinical and morphological efficacy to topical hormone therapy in improving the parameters of angio- and collagenogenesis in postmenopausal patients: following the treatment the expression of the VEGF-A marker significantly increased 1.19- and 1.14-fold along with increases in the expression level of CD-31 of 1.17- and 1.3-fold, in the expression of type IV collagen of 1.25- and 1.22-fold and in the vaginal health scores using the G. Bachmann scale of 1.27- and 1.17-fold (p<0.05).

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Keywords

vulvovaginal atrophy, genitourinary syndrome of menopause, laser treatment, pathogenesis, clinical and morphological efficacy

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