Study: NCT04735549

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Laser Treatment
Description: 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.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Laser Treatment
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Topical hormone estriol
Description: 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.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Topical hormone estriol
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Сlinical blood analysis
Description: 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).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Сlinical blood analysis
Description: 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).

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Сlinical blood analysis
Description: 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).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Сlinical urine test
Description: Urine sampling for Clinical urine test (to include the participant in the study).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Сlinical urine test
Description: Urine sampling for Clinical urine test (to include the participant in the study).

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Сlinical urine test
Description: Urine sampling for Clinical urine test (to include the participant in the study).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Vaginal smear
Description: Vaginal smear for flora investigation (to include the participant in the study), cytology, microbiological analysis with Gram staining (to evaluate procedure efficiency).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Vaginal smear
Description: Vaginal smear for flora investigation (to include the participant in the study), cytology, microbiological analysis with Gram staining (to evaluate procedure efficiency).

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Vaginal smear
Description: Vaginal smear for flora investigation (to include the participant in the study), cytology, microbiological analysis with Gram staining (to evaluate procedure efficiency).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Pelvic ultrasound
Description: Pelvic ultrasound investigation to determine pathologies of the pelvic through a gynecological probe (to include the participant in the study).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Pelvic ultrasound
Description: Pelvic ultrasound investigation to determine pathologies of the pelvic through a gynecological probe (to include the participant in the study).

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Pelvic ultrasound
Description: Pelvic ultrasound investigation to determine pathologies of the pelvic through a gynecological probe (to include the participant in the study).

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Female Sexual Function Index
Description: Female Sexual Function Index will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency).

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Female Sexual Function Index
Description: Female Sexual Function Index will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency).

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Female Sexual Function Index
Description: Female Sexual Function Index will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency).

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire
Description: 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).

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire
Description: 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).

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire
Description: 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).

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Vulvovaginal Symptoms Questionnaire
Description: Vulvovaginal Symptoms Questionnaire will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency).

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Vulvovaginal Symptoms Questionnaire
Description: Vulvovaginal Symptoms Questionnaire will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency).

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Vulvovaginal Symptoms Questionnaire
Description: Vulvovaginal Symptoms Questionnaire will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Vaginal Health Index
Description: 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).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Vaginal Health Index
Description: 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).

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Vaginal Health Index
Description: 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).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Elastography (ultrasound investigation)
Description: Ultrasound investigation for assessing elasticity / stiffness of tissues of vulva region with Mindray device (head L14-6WU) (to evaluate procedure efficiency).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Elastography (ultrasound investigation)
Description: Ultrasound investigation for assessing elasticity / stiffness of tissues of vulva region with Mindray device (head L14-6WU) (to evaluate procedure efficiency).

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Elastography (ultrasound investigation)
Description: Ultrasound investigation for assessing elasticity / stiffness of tissues of vulva region with Mindray device (head L14-6WU) (to evaluate procedure efficiency).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Perineometry
Description: Pressure force of vaginal walls measurement with EmbaGYN device (to evaluate procedure efficiency).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Perineometry
Description: Pressure force of vaginal walls measurement with EmbaGYN device (to evaluate procedure efficiency).

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Perineometry
Description: Pressure force of vaginal walls measurement with EmbaGYN device (to evaluate procedure efficiency).

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Visual Analogue Scale (VAS)
Description: Visual Analogue Scale will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency).

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Visual Analogue Scale (VAS)
Description: Visual Analogue Scale will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency).

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Visual Analogue Scale (VAS)
Description: Visual Analogue Scale will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency).