CompletedNot Applicable

Clinical Trial of "Magic Gyno" Laser Device

Russia70 participantsStarted 2022-08-05

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women from 18 years old in conditions caused by collagen deficiency in the treated area, women in premenopause and menopause; * Participants who signed informed consent and fully informed about the purpose of the study; Following disorders: * Stress urinary incontinence, * Mixed urinary incontinence with a predominance of the stress component, * Genitourinary menopausal syndrome, * Dystrophic and atrophic processes in the genital area, * Scleroatrophic changes in the urogenital region, * Prolapse of the genitals I-II degree, * Vaginal relaxation syndrome, * Postpartum recovery, * Sexual dysfunctions, * Restoration of tone, turgor and tissue density of the urogenital area (Intimate rejuvenation, correction of age-related changes), * Preoperative preparation for genital prolapse surgery and postoperative rehabilitation. Exclusion Criteria: * Age up to 18 years; * Inability or unwillingness to give informed consent to participate in a trial or to fulfill the requirements of a clinical trial; * The presence of contraindications to the use of a medical device; * Pregnancy; * Bleeding disorders accompanied by a violation of blood clotting; * Use of anticoagulant medicines (post-infarction and post-stroke conditions); * Autoimmune diseases; * Emerging infection diseases of any etiology; * Damage to the skin (mucous membranes) in the area of laser treatment; * Oncological diseases, cancer alertness; * Decompensated diabetes; * Photosensitizing drug administ…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Change from Baseline of Vaginal Health Index Score

Timeframe: 1st visit (initial screening); 2nd visit (before the first treatment, no latter 2 months after 1st visit), 4th visit (before the last treatment, 8-12 weeks after 2nd visit); 5th visit (90 days after the last treatment - 4th visit)

Trial details

NCT IDNCT05463081

SponsorMeLSyTech, Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-22

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