Treatment of Vaginal Atrophy With Low Intensity Nanosecond Neodymium Laser
Status:
Not yet recruiting
Trial end date:
2024-06-30
Target enrollment:
Participant gender:
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.