Vulvovaginal Atrophy Correction Using Neodymium Laser

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

The aim of this prospective study is characteristic of changes in the vaginal wall and vulva after treatment of neodymium laser radiation with a wavelength of 1064 nm. To assess the condition of the vaginal walls and vulva before and after laser treatment, the following methods will be used: vaginal health index, perineometry, elastography of vulva, cytological methods. Female Sexual Function Index (FSFI), The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), Vulvovaginal Symptoms Questionnaire (VSQ), Visual Analogue Scale (VAS) will be used to collect feedback on changes in the participants life quality. Total up to 120 participants with postmenopausal atrophy will be involved in the study. Participants will be divided into three groups: laser treatment group, topical hormones treatment group, and both laser treatment with topical hormones application group, by 40 participants in each. The time intervals between tests will be the same for all groups. Thus, a direct comparison between conventional treatment (topical hormones), laser treatment and combine laser and topical hormones therapy of the vaginal atrophy will be made. The main hypothesis of the study is improvement in condition of the vaginal walls after laser treatment and laser treatment with hormones application compared with the initial state of not less than thirty percent of participants, and improvement in condition on average compared with the hormones only therapy group.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MeLSyTech, LLC
• Treatments: Hormones

Criteria

Inclusion Criteria:

• Age of over 50 years old, inclusive;

• Participants diagnosed with genitourinary menopausal syndrome with severe signs of vulvovaginal atrophy;

• Participants were examined according to the proposed protocol;

• Participants who signed informed consent and fully informed about the purpose of the study.

Exclusion Criteria:

• Tendency to photoallergy including taking photosensitizing drugs (diuretics, antihistamines, antipsychotics);

• Porphyria;

• Active tuberculosis;

• Damage to the vaginal mucosa;

• Urinary tract infections in the acute stage;

• Genital herpes in the acute stage;

• Inflammatory diseases of the vulva and vagina in the acute stage;

• Oncological diseases of the female reproductive system, including history of oncological diseases;

• Precancerous diseases of the cervix, vagina and vulva;

• The use of drugs and other methods of treatment (including laser) that can affect the result, less than 1 month before the start of the study and during the study (Menopausal hormone therapy, the use of topical estriol; Kegel exercises, physiotherapy, the use of pelvic floor muscle trainers).

• 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 occurrence of adverse events or other symptoms that are contraindications to laser procedures, as well as the occurrence of cases described in the exclusion criteria.