Treatment of Vaginal Atrophy With Low Intensity Nanosecond Neodymium Laser

Launched by MELSYTECH, LTD · Apr 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a special type of laser treatment on women experiencing vaginal atrophy, a condition that can occur after menopause, leading to dryness and discomfort. The goal is to see how effective this laser treatment is compared to hormone therapy and no treatment at all. The study will involve up to 100 women aged 40 to 75 who have vaginal atrophy or a mild form of vaginal prolapse. Participants will be divided into three groups: one group will receive the laser treatment, another will receive hormone therapy, and the last group will not receive any treatment. Throughout the study, various tests will be conducted to evaluate changes in the vaginal walls and how participants feel about their quality of life.

Eligible participants must provide consent and meet specific criteria, such as being within the age range and having vaginal atrophy or mild prolapse. Women with certain health conditions or recent childbirth are not eligible. If you decide to participate, you can expect to undergo several tests before and after the treatment to help researchers understand the benefits of the laser therapy. This study aims to improve the quality of life for women experiencing these issues, and your participation could contribute to valuable findings in this area.

Gender

FEMALE

Eligibility 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.