Treatment of Vaginal Atrophy With Low Intensity Nanosecond Neodymium Laser

NARecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

April 18, 2022

Primary Completion Date

September 1, 2025

Study Completion Date

December 1, 2025

Conditions
Postmenopausal PeriodVaginal AtrophyVaginal Prolapse
Interventions
DEVICE

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% overlap), average power of 10-25 Watt (W), treatment time in one point of 1-10 seconds (s), treatment step of 5 mm (total handpiece length of 10 centimeter (cm), 20 treatment points along vagina), 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 100 milliseconds (ms), pause between packets of 50 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."

DRUG

Topical hormone estriol

Estriol suppository ((17 beta)-estra-1,3,5 (10)-trien-3,17-diol). Active ingredient of 0.5 milligram in 1 suppository. Daily dose will be 1 suppository.

DIAGNOSTIC_TEST

Сlinical blood analysis

Taking blood from a vein for Clinical blood analysis (to include the participant in the study).

DIAGNOSTIC_TEST

Сlinical urine test

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

DIAGNOSTIC_TEST

Vaginal smear

Vaginal smear for flora investigation (to include the participant in the study), immunocytochemical examination and cytology (to evaluate procedure efficiency).

DIAGNOSTIC_TEST

Cervical oncocytology test.

Cervical smear for oncocytology test (to include the participant in the study).

DIAGNOSTIC_TEST

Extended colposcopy

Extended colposcopy is performed under a microscope using a Lugol to determine external changes in the epithelium in order to determine atrophy and pathologies of the cervix and vaginal vault (dysplasia, erosion, cancer, etc.) (to include the participant in the study).

DIAGNOSTIC_TEST

Pelvic ultrasound

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

OTHER

King's Health Questionnaire

The King's Health Questionnaire will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency).

DIAGNOSTIC_TEST

Vaginal Health Index

Vaginal Health Index will be investigated by clinical examination for vaginal elasticity, vaginal secretions, epithelial mucous membrane, vaginal hydration. pH (potential of hydrogen) will be investigated by test-lines paper (to evaluate procedure efficiency).

DIAGNOSTIC_TEST

Ultrasound investigation

Ultrasound investigation with General Electric Voluson E8 Expert for assessing blood vessels (Doppler sonography) and vaginal wall thickness measurement (to evaluate procedure efficiency).

DIAGNOSTIC_TEST

Perineometry

Pressure force of vaginal walls measurement with IEASE device (to evaluate procedure efficiency).

DIAGNOSTIC_TEST

Optical coherence tomography

Optical non-invasive method of investigation vaginal mucus morphological and functional condition.

DIAGNOSTIC_TEST

Biopsy

Biopsy of the vaginal wall to assess the condition of the vaginal wall and compare the obtained data with the data of optical coherence tomography.

DIAGNOSTIC_TEST

Femoflor screen

Femoflor screen for the study of vaginal microbiocenosis, specifically for the detection of the pathogens, opportunistic flora and normal flora and their qualitative and quantitative evaluation (to include the participant in the study).

Trial Locations (1)

603126

RECRUITING

"State-Funded Healthcare Institution of the Nizhny Novgorod region Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko", Nizhny Novgorod

All Listed Sponsors
lead

MeLSyTech, Ltd

INDUSTRY