Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
70 participants
INTERVENTIONAL
2022-08-05
2024-01-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Genitourinary disorder
Participants with:
* 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.
Laser treatment of the vagina, vulva, and paraurethral region with "Magic Gyno" laser. In total, three procedures will be performed with an interval of 4 weeks.
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. d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
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.
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)
Clinical urine test
Urine sampling for Clinical urine test (to include the participant in the study).
Vaginal smear
Vaginal smear for flora investigation (to include the participant in the study and evaluate procedure efficiency)
Pelvic ultrasound
Pelvic ultrasound investigation to determine pathologies of the pelvic through a gynecological probe (to include the participant in the study).
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).
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).
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).
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).
Vital signs determination
Vital signs determination (respiration rate, blood pressure, pulse rate, body temperature).
pH of vagina determination
Potential of hydrogen (pH) of vagina will be investigated by test-lines paper (to evaluate procedure efficiency).
Physical parameters determination
Physical parameters determination (body weight, age, height, body mass index).
Relaxation of vagina
Participants with:
* 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.
Laser treatment of the vagina, vulva, and paraurethral region with "Magic Gyno" laser. In total, three procedures will be performed with an interval of 4 weeks.
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. d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
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.
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)
Clinical urine test
Urine sampling for Clinical urine test (to include the participant in the study).
Vaginal smear
Vaginal smear for flora investigation (to include the participant in the study and evaluate procedure efficiency)
Pelvic ultrasound
Pelvic ultrasound investigation to determine pathologies of the pelvic through a gynecological probe (to include the participant in the study).
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).
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).
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).
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).
Vital signs determination
Vital signs determination (respiration rate, blood pressure, pulse rate, body temperature).
pH of vagina determination
Potential of hydrogen (pH) of vagina will be investigated by test-lines paper (to evaluate procedure efficiency).
Physical parameters determination
Physical parameters determination (body weight, age, height, body mass index).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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)
Clinical urine test
Urine sampling for Clinical urine test (to include the participant in the study).
Vaginal smear
Vaginal smear for flora investigation (to include the participant in the study and evaluate procedure efficiency)
Pelvic ultrasound
Pelvic ultrasound investigation to determine pathologies of the pelvic through a gynecological probe (to include the participant in the study).
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).
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).
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).
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).
Vital signs determination
Vital signs determination (respiration rate, blood pressure, pulse rate, body temperature).
pH of vagina determination
Potential of hydrogen (pH) of vagina will be investigated by test-lines paper (to evaluate procedure efficiency).
Physical parameters determination
Physical parameters determination (body weight, age, height, body mass index).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
80 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
MeLSyTech, Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vladislav V Dubenskij, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Tver State Medical Academy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tver State Medical Academy
Tver', Tver Oblast, Russia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CTMGLD-2022
Identifier Type: -
Identifier Source: org_study_id