Clinical trial NCT05463081: Clinical Trial of "Magic Gyno" Laser Device
Official title: Clinical Trial of the Safety and Efficacy of Medical Device "Laser Medical Device "Magic Gyno""
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Urogenital Diseases
Urinary Incontinence
Prolapse Genital
Menopausal Syndrome
Postmenopausal Period
Vaginal Atrophy
Vaginal Prolapse
Postpartum Period
Sexual Dysfunction
Preoperative Care
Postoperative Care
Keywords: Laser
Vaginal
Neodymium Laser
Laser Treatment
Nanosecond
Female Urogenital Diseases
Pelvic Organ Prolapse
Lead sponsor: MeLSyTech, Ltd
Sponsor class: INDUSTRY
First posted: 2022-07-18
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: The principle of participant distribution into groups is the character of vaginal walls and vulva pathology. Total up to 70 participants 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 types of examination of each group are the same and include:

General methods: demographic data determination, vital signs determination, gynecological examination, physical examination, clinical blood analysis with glucose determination, clinical urine test, vaginal smear for flora and oncocytology, pelvic ultrasound.

Special methods: vaginal smear for flora, vaginal pH determination, filling out the questionnaire (Female Sexual Function Index, International Consultation on Incontinence Questionnaire - Short Form, The Short Form Health Survey), Vaginal Health Index determination.

The treatment procedure of this study is the laser treatment of the vagina and vulva with a "Magic Gyno" laser with subsequent monitoring.

Treatment Technique:

Laser treatment procedure will be carried out in three stages. In total, three procedures will be performed with an interval of 4-6 weeks. One follow-up visit will follow: 90 days after the last procedure.

During the procedure, the following sequence of actions will be performed:

1. st Stage - vaginal processing with a conical mirror handpiece,
2. nd Stage - vaginal processing with a corner mirror handpiece,
3. rd Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.

Laser radiation is emitted by a series of pulses following each other through a pause. The duration of one pulse is 20-200 nanoseconds (ns), the pause between pulses is 30 microseconds (us). The energy of one pulse is about 1 millijoule (mJ). The procedure is performed without anesthesia. The doctor always focuses on the participant's feeling of warmth.

Participants of all groups will be tested with the general methods necessary to include the participant in the study at the first visit.

For both group: Studies will be carried out using special methods and then laser treatment of the vagina and vulva and paraurethral region will be performed during the 2nd, 3d, and 4th visits. Studies with all special methods will be performed during the 1st (to include participant in the study), 2nd (before the first treatment), 4th (before the last treatment) and 5th (90 days after the last treatment) visits.

Thus, direct comparison between participants condition before and 90 days after treatment within each group will be carried out.

The study will be carried out with the participation of Tver State Medical Academy.

All data obtained during the study will be transferred to the manufacturer of "MeLSyTech" Ltd.

The study will be monitored by "MeLSyTech" Ltd as follows:

In the start of study to ensure awareness of researchers about the plan, the rules for filling in case research forms, work with the device.

Once a 3 month, monitoring of provided documents (copies of individual registration records of participants (case research forms), informed consent, test results) for the complete filling of the forms; the clarity of filling out forms, the possibility of systematizing information from the forms of their assessment. Monitoring will be conducted with a coordinator visit of the research center and analysis activities, such as participants recruitment, data collection, data management, data analysis, reporting for adverse events, and change management.

In the end of study monitoring will be conducted with a coordinator visit of the research center and analysis activities, such as participants recruitment, data collection, data management, data analysis, reporting for adverse events, and change management. The investigator submits a clinical evaluation report to the sponsor.

Statistics The analysis will be carried out within groups at different time intervals (analysis of matched groups).

Before performing statistical analysis of the data, the distribution type of the variables will be assessed. To assess the normality of distribution for each variable, histograms of frequency distributions will be visually evaluated, indicators of skewness, kurtosis, and the D'Agostino-Pearson normality test will be used.

In addition to checking the type of distribution of variables, the equality of variances of the studied groups will be assessed using the methods of analysis of variance, in particular the Brown-Forsythe test.

Methods of descriptive analysis will be used depending on the type of distribution of the variable. With a normal distribution, the mean (M) and standard deviation (SD) will be calculated. In case of an nongaussian distribution, the median (Me) and interquartile range will be calculated. Different algorithms of statistical analysis will be applied depending on the type of distribution of variables.

Comparison of the paired groups with a normal distribution, in case of the equality of the variances, will be carried out by the methods of analysis of variance ANOVA. Comparison of groups in pairs will be performed using the post-hoc method of posterior multiple comparisons (Tukey test).

Comparison of groups in which variables do not follow the normal distribution will be carried out using the methods of nonparametric analysis of variations: the Friedman test for matched groups.

Differences will be considered statistically significant if the significance P values are \<0.05.

Eligibility criteria: 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 administration;
* Decompensated somatic diseases;
* Decompensated cardiovascular disease, and other decompensated common diseases;
* Severe somatic diseases (heart failure, chronic renal failure, hepatitis, liver cirrhosis);
* Severe autoimmune diseases (including hemorrhagic vasculitis);
* Immunodeficiency (including HIV infection and AIDS);
* Severe mental and neurological disorders;
* Bedridden and immobile patients;
* COVID 19;
* Acute inflammatory diseases of the urogenital area;
* Acute purulent processes of the urogenital region;
* Bleeding of a natural nature (menstruation) and any other types of bleeding in the urogenital area;
* Postoperative scars up to 6 months;
* Lateral cysts of the vagina;
* Growing uterine fibroid;
* Fillers / suture in the area of laser exposure;
* The presence of varicose veins of the urogenital region and dilated capillary plexuses of the mucosa.

Primary outcomes:
measure: 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)
Secondary outcomes:
measure: Mean Change from Baseline of "Desire" Score on the Female Sexual Function Index Questionnaire
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)
measure: Mean Change from Baseline of "Arousal" Score on the Female Sexual Function Index Questionnaire
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)
measure: Mean Change from Baseline of "Lubrication" Score on the Female Sexual Function Index Questionnaire
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)
measure: Mean Change from Baseline of "Orgasm" Score on the Female Sexual Function Index Questionnaire
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)
measure: Mean Change from Baseline of "Satisfaction" Score on the Female Sexual Function Index Questionnaire
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)
measure: Mean Change from Baseline of "Pain" Score on the Female Sexual Function Index Questionnaire
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)
measure: Mean Change from Baseline of Total Score on International Consultation on Incontinence Questionnaire - Short Form
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)
measure: Mean Change from Baseline of "Physical Health Component Score" on The Short Form Health Survey
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)
measure: Mean Change from Baseline of "Mental Health Component Score" on The Short Form Health Survey
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)
measure: Mean Change from Baseline of pH of vagina
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)
measure: Mean Change from Baseline of Lactobacilli quantity
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)
Other outcomes:
Locations:
city: Tver
country: Russian Federation
facility: Tver State Medical Academy
state: Tver Oblast
Study officials:
affiliation: Tver State Medical Academy
name: Vladislav V Dubenskij, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: