Vulvovaginal Atrophy Correction Using Neodymium Laser
Status:
Recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
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.