70
Participants
Start Date
August 5, 2022
Primary Completion Date
January 22, 2024
Study Completion Date
January 22, 2024
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."
Blood test
Taking blood from a vein for 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) and clinical blood analysis (to include the participant in the study and evaluate procedure efficiency)
Clinical 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 and 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).
International Consultation on Incontinence Questionnaire - Short Form
International Consultation on Incontinence Questionnaire will be used to collect feedback on changes in the participants' life quality (to evaluate procedure efficiency).
The Short Form Health Survey
The Short Form Health Survey 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).
Vital signs determination
Vital signs determination (respiration rate, blood pressure, pulse rate, body temperature).
pH of vagina determination
Potential of hydrogen (pH) of vagina will be investigated by test-lines paper (to evaluate procedure efficiency).
Physical parameters determination
Physical parameters determination (body weight, age, height, body mass index).
Tver State Medical Academy, Tver'
MeLSyTech, Ltd
INDUSTRY