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Treatment of Vaginal Atrophy With Low Intensity Nanosecond Neodymium Laser

RecruitingNAAges 40 Years - 75 YearsFemaleMeLSyTech, Ltd
NCT05335317 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The aim of study is characteristic of changes in the vaginal wall after treatment of neodymium laser radiation with a wavelength of 1064 nm. To assess the condition of the vaginal walls before and after laser treatment, the following methods will be used: vaginal health index, perineometry, measurement of the vaginal wall thickness by ultrasound, Doppler sonography of the vaginal walls vessels, optical coherence tomography, biopsy, cytological and immunocytochemical methods. The King's Health Questionnaire will be used to collect feedback on changes in the participants life quality. Total up to 100 participants with and 20 participants without postmenopausal atrophy will be involved in the study. Participants will be divided into three groups: laser treatment (study group), topical hormones treatment (control group 1) and no treatment (control group 2) by 70, 30 and 20 participants in ea

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age of 40-75 years, inclusive; * Vaginal atrophy or 1st grade vaginal prolapse with atrophy, or lack of vaginal atrophy in case of control group 2; * All participants have informed consent to conduct a course of procedures according to protocol, carry out follow-up visits, and conduct studies. Exclusion Criteria: * Age of under 40 and over 75 years old; * History of oncological diseases; * Active tuberculosis; * Inflammatory diseases of the vulva and vagina including genital herpes in the acute stage; * Urinary tract infections; * Damage to the vaginal mucosa; * Pregnancy; * Tendency to photoallergy including taking photosensitizing drugs (diuretics, antihistamines, antipsychotics); * Porphyria; * Cardiac deficiency of 2-3 degrees; * Chronic renal disease; * Participants with greater than 1st grade vaginal prolapse; * Women after childbirth up to 8 weeks; * Participants who, according to the doctor, are not able to complete the study; * Protocol non-compliance of laser exposure sessions; * Voluntary refusal to participate in the study; * Violation of recommendations for the management of the period after laser treatment; * Adverse events that occurred during laser processing and research, and associated with them. * The appearance of contraindications listed in the Exclusion criteria.
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What it tests

  • Laser Treatment
  • Topical hormone estriol
  • Сlinical blood analysis
  • Сlinical urine test
  • Vaginal smear
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Where

1 site
State-Funded Healthcare Institution of the Nizhny Novgorod region "Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko"
Nizhny Novgorod, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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