Clinical Trial of "Magic Gyno" Laser Device

Summary

The aim of this prospective study is investigation of efficiency and safety of medical device "Magic Gyno" in accordance with the stated purpose. To assess the condition of the vaginal walls and vulva before and after laser treatment, the following methods will be used: gynecology examination, vaginal health index, clinical blood test, vaginal flora examination, vaginal pH. International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), Female Sexual Function Index (FSFI) and The Short Form Health Survey (SF-36) will be used to collect feedback on changes in the participants life quality. Total up to 70 participants with pathology of pelvic organs will be involved in the study. Participants will be divided into two groups: group with genitourinary symptoms and group with vaginal relaxation symptoms, by 35 participants in each. The time intervals between tests will be the same for both groups. The main hypothesis of the study is improvement in condition of the vaginal walls after laser treatment compared with the condition before treatment.

Conditions

• Female Urogenital Diseases
• Urinary Incontinence
• Prolapse Genital
• Menopausal Syndrome
• Postmenopausal Period
• Vaginal Atrophy
• Vaginal Prolapse
• Postpartum Period
• Sexual Dysfunction
• Preoperative Care
• Postoperative Care

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.

DIAGNOSTIC_TEST

Blood test

Taking blood from a vein for 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) and clinical blood analysis (to include the participant in the study and evaluate procedure efficiency)

DIAGNOSTIC_TEST

Clinical 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 and 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

International Consultation on Incontinence Questionnaire - Short Form

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

OTHER

The Short Form Health Survey

The Short Form Health Survey 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

Vital signs determination

Vital signs determination (respiration rate, blood pressure, pulse rate, body temperature).

DIAGNOSTIC_TEST

pH of vagina determination

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

DIAGNOSTIC_TEST

Physical parameters determination

Physical parameters determination (body weight, age, height, body mass index).

Sponsors & Collaborators

• MeLSyTech, Ltd

  lead INDUSTRY

Principal Investigators

• Vladislav V Dubenskij, Ph.D. · Tver State Medical Academy

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-08-05

Primary Completion

2024-01-22

Completion

2024-01-22

Countries

• Russia

Study Locations