120
Participants
Start Date
September 1, 2021
Primary Completion Date
October 20, 2023
Study Completion Date
October 20, 2023
Laser Treatment
"Laser radiation is emitted by a series of pulses following each other through a pause. The duration of one pulse is 20-200 ns, the pause between pulses is 30 us. The energy of one pulse is about 1 mJ.~General laser radiation parameters for 1st and 2nd stages are: beam with diameter of 4 millimeters (mm) scans treatment area by 4 circles with step of 2 mm (50 percentage (%) overlap), average power of 10-25 Watt (W), treatment time in one point of 1-10 seconds (s), treatment step of 5 mm, from 1 to 5 repetitions of total vagina treatment. General laser radiation parameters for 3d stage are: beam diameter of 6 mm, average power of 15-30 W, duration of ns-pulses packet of 50-100 milliseconds (ms), pause between packets of 50-100 ms, treatment duration up to 65 s, treatment in permanent motion with speed of 10-50 mm/s.~The procedure is performed without anesthesia. The doctor always focuses on the participant's feeling of warmth."
Topical hormone estriol
Estriol ((17 beta)-estra-1,3,5 (10)-trien-3,17-diol). Daily dose will be 0.5 gram daily for 2 weeks, later 0.5 gram twice a week for 12 months.
Сlinical blood analysis
Taking blood from a vein for Clinical blood analysis, Wassermann reaction (WR), human immunodeficiency viruses (HIV), hepatitis B infection (HBsAg), hepatitis C infection (HCVAg) determination, glucose test (to include the participant in the study).
Сlinical urine test
Urine sampling for Clinical urine test (to include the participant in the study).
Vaginal smear
Vaginal smear for flora investigation (to include the participant in the study), cytology, microbiological analysis with Gram staining (to evaluate procedure efficiency).
Pelvic ultrasound
Pelvic ultrasound investigation to determine pathologies of the pelvic through a gynecological probe (to include the participant in the study).
Female Sexual Function Index
Female Sexual Function Index will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency).
The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire
The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency).
Vulvovaginal Symptoms Questionnaire
Vulvovaginal Symptoms Questionnaire will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency).
Vaginal Health Index
Vaginal Health Index will be investigated by clinical examination for vaginal elasticity, vaginal secretions, epithelial mucous membrane, vaginal hydration. Potential of hydrogen (pH) will be investigated by test-lines paper (to evaluate procedure efficiency).
Elastography (ultrasound investigation)
Ultrasound investigation for assessing elasticity / stiffness of tissues of vulva region with Mindray device (head L14-6WU) (to evaluate procedure efficiency).
Perineometry
Pressure force of vaginal walls measurement with EmbaGYN device (to evaluate procedure efficiency).
Visual Analogue Scale (VAS)
Visual Analogue Scale will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency).
"Federal State Budget Institution National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov", Moscow
MeLSyTech, Ltd
INDUSTRY