A prospective randomized controlled study on the effectiveness of neodymium (Nd:YAG) laser therapy for vulvovaginal atrophy in postmenopausal women
Ramazanova M.O., Apolikhina I.A., Shatilova K.V., Khlopkov A.D., Sencha L.M.
Objective: To evaluate the effectiveness and safety of non-ablative neodymium laser for the treatment of vulvovaginal atrophy (VVA) symptoms in postmenopausal women.
Materials and methods: The study included 120 patients aged 50 to 85 years with symptoms of postmenopausal VVA. According to the standard regimen, all patients underwent treatment with topical estriol (n=40), or three sessions of non-ablative neodymium laser therapy with an interval of 4–6 weeks between sessions (n=40), or a combination of laser treatment and topical estriol (n=40) between 2021 and 2023. The effectiveness of the therapy was assessed using the vaginal health index (VHI) and validated questionnaires: the Female Sexual Function Index (FSFI), the Vulvovaginal Symptom Questionnaire (VSQ), the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), and the visual analogue scale (VAS). The observation period accounted for 9 months from the onset of treatment.
Results: Statistically significant differences were observed between pre-treatment and follow-up visits, and between groups at follow-up visits. It was shown that in the laser and combination therapy groups, compared with the hormonal treatment group, after 3 and 9 months from the start of therapy, the average score on the PISQ-12 questionnaire significantly increased, and the severity of VVA symptoms on the VAS scale decreased (up to complete elimination). According to the VHI data, a statistically significant difference was noted after 3 and 9 months from the start of therapy in the laser and combination treatment groups compared to the hormonal treatment group. Analysis of the changes in the VSQ questionnaire scores revealed a significantly more pronounced symptoms reduction in the laser and combination therapy groups in comparison with the hormonal treatment. However, no statistically significant differences were found in the effectiveness of laser monotherapy and combination therapy. When assessing the FSFI questionnaire scores 3 and 9 months after the start of therapy, a statistically significant increase in scores was observed in all groups. A statistically significant difference was noted after 3 and 9 months from the start of therapy in the laser and combination treatment groups compared to the hormonal treatment group, while the highest changes in subjectively assessed indicators of the quality of sexual life were detected in the laser treatment group without the use of hormonal therapy.
Conclusion: Localized neodymium laser therapy is an effective treatment for VVA symptoms and has a positive effect on the quality of women's sexual life.
Authors’ contributions: Ramazanova M.O. – study design, collection of clinical material, text writing and editing;
Apolikhina I.A. – study design, collection of clinical material, text editing; Shatilova K.V. – participation in the study planning, data analysis, and text editing; Khlopkov A.D. — data collection and analysis; Sencha L.M. — statistical analysis and text editing.
Conflicts of interests: Melsytech LLC was the sponsor of this study. Shatilova K.V., Khlopkov A.D., and Sencha L.M. are employees of Melsytech LLC.
Funding: Melsytech LLC was the sponsor of this study.
Ethical Approval: The study protocol was approved by the Ethics Committee for Biomedical Research at the Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia.
Patient Consent for Publication: All patients provided informed consent for the publication of their data.
Authors' Data Sharing Statement: The data supporting the findings of this study are available on request after approval from the principal investigator.
For citation: Ramazanova M.O., Apolikhina I.A., Shatilova K.V., Khlopkov A.D., Sencha L.M. A prospective randomized controlled study on the effectiveness of neodymium laser therapy for vulvovaginal atrophy in postmenopausal women.
Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2025; (11): 102-118 (in Russian)
https://dx.doi.org/10.18565/aig.2025.149
Keywords
References
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Received 10.06.2025
Accepted 25.11.2025
About the Authors
Marina O. Ramazanova, obstetrician-gynecologist, PhD student, V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology,Ministry of Health of Russia, 117997, Russia, Moscow, Ac. Oparina str., 4, mar1naramazanova@yandex.ru, https://orcid.org/0000-0003-2508-7109
Inna A. Apolikhina, Dr. Med. Sci., Professor, Head of the Department of Aesthetic Gynecology and Rehabilitation, V.I. Kulakov National Medical Research Center
for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia, 117997, Russia, Moscow, Ac. Oparina str., 4; Professor at the Department of Obstetrics, Gynecology, Perinatology, and Reproductology, Institute of Professional Education, I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia,
119991, Russia, Moscow, Trubetskaya str., 8-2, i_apolikhina@oparina4.ru, https://orcid.org/0000-0002-4581-6295
Ksenia V. Shatilova, PhD, Head of the Department of Medical Laser Technologies, Melsytech LLC, 606000, Russia, Nizhny Novgorod Region, Dzerzhinsk,
Igumnovskoye Highway, 11D, kshatilova@mail.ru, https://orcid.org/0000-0002-7056-9871
Andrey D. Khlopkov, Senior Researcher at the Department of Medical Laser Technologies, Melsytech LLC, 606000, Russia, Nizhny Novgorod Region, Dzerzhinsk, Igumnovskoye highway, 11D, anbion@yandex.ru, https://orcid.org/0000-0003-0786-9975
Ludmila M. Sencha, Senior Researcher at the Department of Medical Laser Technologies, Melsytech LLC, 606000, Russia, Nizhny Novgorod Region, Dzerzhinsk, Igumnovskoye highway, 11D, luda-sencha@mail.ru, https://orcid.org/0000-0001-7800-5475



