Vulvovaginal Atrophy Correction Using Neodymium Laser

Summary

The aim of this prospective study is characteristic of changes in the vaginal wall and vulva after treatment of neodymium laser radiation with a wavelength of 1064 nm. To assess the condition of the vaginal walls and vulva before and after laser treatment, the following methods will be used: vaginal health index, perineometry, elastography of vulva, cytological methods. Female Sexual Function Index (FSFI), The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), Vulvovaginal Symptoms Questionnaire (VSQ), Visual Analogue Scale (VAS) will be used to collect feedback on changes in the participants life quality. Total up to 120 participants with postmenopausal atrophy will be involved in the study. Participants will be divided into three groups: laser treatment group, topical hormones treatment group, and both laser treatment with topical hormones application group, by 40 participants in each. The time intervals between tests will be the same for all groups. Thus, a direct comparison between conventional treatment (topical hormones), laser treatment and combine laser and topical hormones therapy of the vaginal atrophy will be made. The main hypothesis of the study is improvement in condition of the vaginal walls after laser treatment and laser treatment with hormones application compared with the initial state of not less than thirty percent of participants, and improvement in condition on average compared with the hormones only therapy group.

Conditions

• Postmenopausal Period
• Vaginal Atrophy
• Female 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).

Sponsors & Collaborators

• MeLSyTech, Ltd

  lead INDUSTRY

Principal Investigators

• Inna A Apolikhina, Ph.D. · Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-01

Primary Completion

2023-10-20

Completion

2023-10-20

Countries

• Russia

Study Locations