Treatment of Vaginal Atrophy With Low Intensity Nanosecond Neodymium Laser

• Status: Not yet recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: Female

Summary

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 50, 50 and 20 participants in each group respectively. The time intervals between special tests and the tests themselves will be the same for all groups. Thus, a direct comparison between conventional treatment (topical hormones), laser treatment of the vaginal atrophy and normal condition without treatment will be made. The main hypothesis of the study is improvement in condition of the vaginal walls after laser treatment compared with the initial state of not less than thirty percent of participants, and improvement in condition on average compared with the control group.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: MeLSyTech, LLC
• Treatments: Hormones

Criteria

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.