Clinical Research Directory

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 1.5 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.

Taking blood from a vein for clinical blood analysis, glucose test, hepatitis B, C viruses, human immunodeficiency viruses and syphilis test, blood clotting tests, blood type and rhesus factor determination (to include the participant in the study).

Urine sampling for Clinical urine test (to include the participant in the study).

Electrocardiography investigation to determine cardiac abnormalities (to include the participant in the study).

Vaginal smear for flora investigation, oncocytology (to include the participant in the study).

Colposcopy investigation to determine pre-malignant and malignant lesions of cervix, vagina or vulva (to include the participant in the study).

Pelvic ultrasound investigation to determine pathologies of the pelvic through a gynecological probe (to include the participant in the study).

Ultrasound investigation for assessing blood flow in the tissues of vulva region (to evaluate procedure efficiency).

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).

Sampling of the vaginal wall material in the posterior fornix area including the mucous membrane and muscle layer will be performed during colporrhaphy or any pelvic surgical procedure for histological, immunohistochemical studies, and optical coherence tomography (elastography) (to evaluate procedure efficiency)

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).

Pelvic Floor Distress Inventory Questionnaire will be used to collect feedback on changes in the participants' life quality (to evaluate procedure efficiency).

International Consultation on Incontinence Questionnaire will be used to collect feedback on changes in the participants' life quality (to evaluate procedure efficiency).

Pelvic Floor Impact Questionnaire will be used to collect feedback on changes in the participants' life quality (to evaluate procedure efficiency).

Surgical procedure to repair pelvic organ prolapse followed by biopsy for histological, immunohistochemical studies, and optical coherence tomography (elastography).

Any pelvic surgical procedure which do not affect condition of vagina, vulva and paraurethral region followed by biopsy for histological, immunohistochemical studies, and optical coherence tomography (elastography).

Pelvic examination (to include the participant in the study and observe throughout the study)

Сonsultation of a therapist about the absence of contraindications for surgical treatment (to include the participant in the study)

Buccal smear to performing genetic testing. The following markers will be analyzed: ESR1 rs2234693, ESR1 rs2228480, COL3A1 rs1800255, COL14A1 rs4870723, MMP9 rs3918253, MMP10 rs17435959, LOXL1 rs2304719, WNT4 rs3820282, MMP2 rs243865, TIMP2 rs2277698, CD31 / PECAM1 rs1131012, Ki67 rs11016076.