Vulvovaginal Atrophy Correction Using Neodymium Laser

NACompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

September 1, 2021

Primary Completion Date

October 20, 2023

Study Completion Date

October 20, 2023

Conditions
Postmenopausal PeriodVaginal AtrophyFemale Urogenital Diseases
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 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."

DRUG

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.

DIAGNOSTIC_TEST

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).

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), cytology, microbiological analysis with Gram staining (to evaluate procedure efficiency).

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

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).

OTHER

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).

OTHER

Vulvovaginal Symptoms Questionnaire

Vulvovaginal Symptoms 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. Potential of hydrogen (pH) will be investigated by test-lines paper (to evaluate procedure efficiency).

DIAGNOSTIC_TEST

Elastography (ultrasound investigation)

Ultrasound investigation for assessing elasticity / stiffness of tissues of vulva region with Mindray device (head L14-6WU) (to evaluate procedure efficiency).

DIAGNOSTIC_TEST

Perineometry

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

OTHER

Visual Analogue Scale (VAS)

Visual Analogue Scale will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency).

Trial Locations (1)

117997

"Federal State Budget Institution National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov", Moscow

All Listed Sponsors
lead

MeLSyTech, Ltd

INDUSTRY

NCT04735549 - Vulvovaginal Atrophy Correction Using Neodymium Laser | Biotech Hunter | Biotech Hunter