Female Urogenital DiseasesNCT05463081
Clinical Trial of "Magic Gyno" Laser Device
A study testing Laser treatment, Blood test and Clinical urine test in people with Female Urogenital Diseases and Urinary Incontinence, run by MeLSyTech, Ltd at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Female Urogenital Diseases, Urinary Incontinence, Prolapse Genital
- What is being tested?
- Laser treatment, Blood test and Clinical urine test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteRussia
- Study dates
- 5 Aug 2022to 22 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial of the Safety and Efficacy of Medical Device "Laser Medical Device "Magic Gyno""
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.
Read the 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:
- st Stage - vaginal processing with a conical mirror handpiece,
- nd Stage - vaginal processing with a corner mirror handpiece,
- 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
- Female Urogenital Diseases, Urinary Incontinence, Prolapse Genital, Menopausal Syndrome, Postmenopausal Period, Vaginal Atrophy
- Being tested
- Laser treatment, Blood test, Clinical urine test, Vaginal smear, Pelvic ultrasound
- Keywords
- Laser, Vaginal, Neodymium Laser, Laser Treatment, Nanosecond, Female Urogenital Diseases, Pelvic Organ Prolapse
- Medical subject headings
- Female Urogenital Diseases, Urinary Incontinence, Uterine Prolapse, Sexual Dysfunction, Physiological, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser treatmentDevice
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 testDiagnostic 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 testDiagnostic test
Urine sampling for Clinical urine test (to include the participant in the study).
Vaginal smearDiagnostic test
Vaginal smear for flora investigation (to include the participant in the study and evaluate procedure efficiency)
Pelvic ultrasoundDiagnostic test
Pelvic ultrasound investigation to determine pathologies of the pelvic through a gynecological probe (to include the participant in the study).
Female Sexual Function IndexOther
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 FormOther
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 SurveyOther
The Short Form Health Survey will be used to collect feedback on changes in the participants' life quality (to evaluate procedure efficiency).
Vaginal Health IndexDiagnostic test
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 determinationDiagnostic test
Vital signs determination (respiration rate, blood pressure, pulse rate, body temperature).
pH of vagina determinationDiagnostic test
Potential of hydrogen (pH) of vagina will be investigated by test-lines paper (to evaluate procedure efficiency).
Physical parameters determinationDiagnostic test
Physical parameters determination (body weight, age, height, body mass index).
| Study group | Role | What they receive |
|---|---|---|
| Genitourinary disorder | Experimental | 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. Receives: Device: Laser treatment; Diagnostic Test: Blood test; Diagnostic Test: Clinical urine test; Diagnostic Test: Vaginal smear; Diagnostic Test: Pelvic ultrasound; Other: Female Sexual Function Index; Other: International Consultation on Incontinence Questionnaire - Short Form; Other: The Short Form Health Survey; Diagnostic Test: Vaginal Health Index; Diagnostic Test: Vital signs determination; Diagnostic Test: pH of vagina determination; Diagnostic Test: Physical parameters determination |
| Relaxation of vagina | Experimental | 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. Receives: Device: Laser treatment; Diagnostic Test: Blood test; Diagnostic Test: Clinical urine test; Diagnostic Test: Vaginal smear; Diagnostic Test: Pelvic ultrasound; Other: Female Sexual Function Index; Other: International Consultation on Incontinence Questionnaire - Short Form; Other: The Short Form Health Survey; Diagnostic Test: Vaginal Health Index; Diagnostic Test: Vital signs determination; Diagnostic Test: pH of vagina determination; Diagnostic Test: Physical parameters determination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change from Baseline of Vaginal Health Index Score
Vaginal Health Index will be investigated by clinical examination for vagina:
- Vaginal elasticity (Characteristic=Points: None=1, Poor=2, Fair=3, Good=4, Excellent=5), B. Vaginal secretions (None=1; Sсant, thin yellow=2; Superficial, thin white=3; Moderate, thin white=4; Normal (white)=5), C. Epithelial mucous membrane (Petechiae noted before contact=1, Bleeding with light contact=2, Bleeds with scraping=3, Not friable thin epithelium=4, Normal=5), D. Vaginal hydration (None, surface inflamed=1, None, surface nod inflamed=2, Minimal=3, Moderate=4, Normal=5), E. pH will be investigated by test-lines paper (≥6.1=1, 5.6-6.0=2, 5.1-5.5=3, 4.7-5.0=4, ≤4.6=5).
Score=A+B+C+D+E
Measured: 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 (11)
Mean Change from Baseline of "Desire" Score on the Female Sexual Function Index Questionnaire
Participants answer questions:
Q1. Over the past 4 weeks, how often did you feel sexual desire or interest? Answers = Points: almost always or always (5), most times (more than half the time) (4), sometimes (about half the time) (3), a few times (less than half the time) (2), almost never or never (1).
Q2. Over the past 4 weeks, how would you rate your level (degree) of sexual desire or interest? Answers = Points: very high (5), high (4), moderate (3), low (2), very low or none at all (1)
Score = (Score to Q1 + Score to Q2)x0.6
Measured: 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)
Mean Change from Baseline of "Arousal" Score on the Female Sexual Function Index Questionnaire
Participants answer questions: Q3. Over the past 4 weeks, how often did you feel sexually aroused during sexual activity or intercourse? Q6. Over the past 4 weeks, how often have you been satisfied with your arousal (excitement) during sexual activity or intercourse? Answers = Points (Q3 and Q6): no sexual activity (0), almost always or always (5), most times (4), sometimes (3), a few times (2), almost never or never (1) Q4. Over the past 4 weeks, how would you rate your level of sexual arousal during sexual activity or intercourse? Answers = Points: no sexual activity (0), very high (5), high (4), moderate (3), low (2), very low or none at all (1) Q5. Over the past 4 weeks, how confident were you about becoming sexually aroused during sexual activity or intercourse? Answers=Points: no sexual activity (0), very high confidence (5), high confidence (4), moderate confidence (3), low confidence (2), very low or no confidence (1) Score=(Score to Q3+Score to Q4+Score to Q5+Score to Q6)x0.3
Measured: 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)
Mean Change from Baseline of "Lubrication" Score on the Female Sexual Function Index Questionnaire
Participants answer questions:Q7. Over the past 4 weeks, how often did you become lubricated ("wet") during sexual activity or intercourse?Q9. Over the past 4 weeks, how often did you maintain your lubrication ("wetness") until completion of sexual activity or intercourse?Answers = Points: no sexual activity (0), almost always or always (5), most times (more than half the time) (4), sometimes (about half the time) (3), a few times (less than half the time) (2), almost never or never (1). Q8. Over the past 4 weeks, how difficult was it to become lubricated ("wet") during sexual activity or intercourse? Q10. Over the past 4 weeks, how difficult was it to maintain your lubrication ("wetness") until completion of sexual activity or intercourse? Answers = Points: no sexual activity (0), extremely difficult or impossible (1), very difficult (2), difficult (3), slightly difficult (4), not difficult (5). Score = (Score to Q7 + Score to Q8 + Score to Q9 + Score to Q10)x0.3
Measured: 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)
Mean Change from Baseline of "Orgasm" Score on the Female Sexual Function Index Questionnaire
Participants answer questions:
Q11. Over the past 4 weeks, when you had sexual stimulation or intercourse, how often did you reach orgasm (climax)? Answers = Points: no sexual activity (0), almost always or always (5), most times (4), sometimes (3), a few times (2), almost never or never (1).
Q12. Over the past 4 weeks, when you had sexual stimulation or intercourse, how difficult was it for you to reach orgasm (climax)? Answers = Points: no sexual activity (0), extremely difficult or impossible (1), very difficult (2), difficult (3), slightly difficult (4), not difficult (5).
Q13. Over the past 4 weeks, how satisfied were you with your ability to reach orgasm (climax) during sexual activity or intercourse? Answers = Points: no sexual activity (0), very satisfied (5), moderately satisfied (4), about equally satisfied and dissatisfied (3), moderately dissatisfied (2), very dissatisfied (1).
Score = (Score to Q11 + Score to Q12 + Score to Q13)x0.4
Measured: 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)
Mean Change from Baseline of "Satisfaction" Score on the Female Sexual Function Index Questionnaire
Participants answer questions:
Q14. Over the past 4 weeks, how satisfied have you been with the amount of emotional closeness during sexual activity between you and your partner? Answers = Points: no sexual activity (0), very satisfied (5), moderately satisfied (4), about equally satisfied and dissatisfied (3), moderately dissatisfied (2), very dissatisfied (1).
Q15. Over the past 4 weeks, how satisfied have you been with your sexual relationship with your partner? Answers = Points: no sexual activity (0), very satisfied (5), moderately satisfied (4), about equally satisfied and dissatisfied (3), moderately dissatisfied (2), very dissatisfied (1).
Q16. Over the past 4 weeks, how satisfied have you been with your overall sexual life? Answers = Points: no sexual activity (0), very satisfied (5), moderately satisfied (4), about equally satisfied and dissatisfied (3), moderately dissatisfied (2), very dissatisfied (1).
Score = (Score to Q14 + Score to Q15 + Score to Q16)x0.4
Measured: 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)
Mean Change from Baseline of "Pain" Score on the Female Sexual Function Index Questionnaire
Participants answer questions:
Q17. Over the past 4 weeks, how often did you experience discomfort or pain during vaginal penetration? Answers = Points: did not attempt intercourse (0), almost always or always (1), most times (2), sometimes (3), a few times (4), almost never or never (5).
Q18. Over the past 4 weeks, how often did you experience discomfort or pain following vaginal penetration? Answers = Points: did not attempt intercourse (0), almost always or always (1), most times (2), sometimes (3), a few times (4), almost never or never (5).
Q19. Over the past 4 weeks, how would you rate your level (degree) of discomfort or pain during or following vaginal penetration? Answers = Points: did not attempt intercourse (0)very high (1)high (2)moderate (3)low (4)very low or none at all (5).
Score = (Score to Q17 + Score to Q18 + Score to Q19)x0.4
Measured: 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)
Mean Change from Baseline of Total Score on International Consultation on Incontinence Questionnaire - Short Form
Participants answer questions:
Q1 How often do you leak urine? Answers = Points: never (0), about once a week or less often (1), two or three times a week (2), about once a day (3), several times a day (4), all the time (5).
Q2 How much urine do you usually leak? Answers = Points: none (0), a small amount (2), a moderate amount (4), a large amount (6) Q3 How much does leaking urine interfere with your everyday life? Answers = Visual Analogue Scale, where Not at all (0), A great deal (10).
Total Score = Scores(Q1+Q2+Q3)
Measured: 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)
Mean Change from Baseline of "Physical Health Component Score" on The Short Form Health Survey
Participants fill out a survey form (SF-36 Health Survey Standard Scoring). Calculations of final scores (PCS and MCS) will be carried out using Mean and SD from US adult population (PCS-US and MCS-US respectively).
Measured: 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)
Mean Change from Baseline of "Mental Health Component Score" on The Short Form Health Survey
Participants fill out a survey form (SF-36 Health Survey Standard Scoring). Calculations of final scores (PCS and MCS) will be carried out using Mean and SD form US adult population (PCS-US and MCS-US respectively).
Measured: 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)
Mean Change from Baseline of pH of vagina
Potential of hydrogen (pH) will be investigated by test-lines paper.
Measured: 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)
Mean Change from Baseline of Lactobacilli quantity
Smear will be sampled from the posterior wall of vagina and stained according to Gram. Evaluation of the Lactobacilli quantity will be performed for each participant with light microscope in field of view. Score depends on the number of bacteria: low - 1, average - 2, normal - 3.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start5 Aug 2022
- Primary completion22 Jan 2024
- Study completion22 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Urogenital DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- MeLSyTech, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vladislav V Dubenskij, Ph.D., Principal investigator, Tver State Medical Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463081
- Sponsor's protocol ID
- CTMGLD-2022
- Status last verified
- Dec 2024
- First submitted
- 14 Jul 2022
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The following data can be shared with researchers upon an official request: The final version of the Study Protocol approved by the Local Ethics Committee; Copies of anonymized filled Individual Registration Cards (IRC); Informed Consent Form (ICF); Clinical Study Report (CSR) and/or published article (if not contradict the rules and conditions of a journal); Supplement files systematizing data.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of the Safety and Efficacy of Medical Device "Laser Medical Device "Magic Gyno""
- ClinicalTrials.gov ID
- NCT05463081
- Acronym / sponsor ID
- CTMGLD-2022
- Conditions
- Female Urogenital Diseases, Urinary Incontinence, Prolapse Genital, Menopausal Syndrome, Postmenopausal Period, Vaginal Atrophy
- Keywords
- Laser, Vaginal, Neodymium Laser, Laser Treatment, Nanosecond, Female Urogenital Diseases, Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- MeLSyTech, LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 22 Jan 2024 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- st Stage - vaginal processing with a conical mirror handpiece,
- nd Stage - vaginal processing with a corner mirror handpiece,
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genitourinary disorder | Experimental | Device: Laser treatment, Diagnostic Test: Blood test, Diagnostic Test: Clinical urine test, Diagnostic Test: Vaginal smear, Diagnostic Test: Pelvic ultrasound, Other: Female Sexual Function Index, Other: International Consultation on Incontinence Questionnaire - Short Form, Other: The Short Form Health Survey, Diagnostic Test: Vaginal Health Index, Diagnostic Test: Vital signs determination, Diagnostic Test: pH of vagina determination, Diagnostic Test: Physical parameters determinationParticipants 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. |
| Relaxation of vagina | Experimental | Device: Laser treatment, Diagnostic Test: Blood test, Diagnostic Test: Clinical urine test, Diagnostic Test: Vaginal smear, Diagnostic Test: Pelvic ultrasound, Other: Female Sexual Function Index, Other: International Consultation on Incontinence Questionnaire - Short Form, Other: The Short Form Health Survey, Diagnostic Test: Vaginal Health Index, Diagnostic Test: Vital signs determination, Diagnostic Test: pH of vagina determination, Diagnostic Test: Physical parameters determinationParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
- Stress urinary incontinence,
- Mixed urinary incontinence with a predominance of the stress component,
- Genitourinary menopausal syndrome,
Key exclusion criteria (28 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser treatmentLaser 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. | Device | Genitourinary disorder, Relaxation of vagina |
| Blood testTaking 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 | Genitourinary disorder, Relaxation of vagina |
| Clinical urine testUrine sampling for Clinical urine test (to include the participant in the study). | Diagnostic test | Genitourinary disorder, Relaxation of vagina |
| Vaginal smearVaginal smear for flora investigation (to include the participant in the study and evaluate procedure efficiency) | Diagnostic test | Genitourinary disorder, Relaxation of vagina |
| Pelvic ultrasoundPelvic ultrasound investigation to determine pathologies of the pelvic through a gynecological probe (to include the participant in the study). | Diagnostic test | Genitourinary disorder, Relaxation of vagina |
| Female Sexual Function IndexFemale Sexual Function Index will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency). | Other | Genitourinary disorder, Relaxation of vagina |
| International Consultation on Incontinence Questionnaire - Short FormInternational Consultation on Incontinence Questionnaire will be used to collect feedback on changes in the participants' life quality (to evaluate procedure efficiency). | Other | Genitourinary disorder, Relaxation of vagina |
| The Short Form Health SurveyThe Short Form Health Survey will be used to collect feedback on changes in the participants' life quality (to evaluate procedure efficiency). | Other | Genitourinary disorder, Relaxation of vagina |
| Vaginal Health IndexVaginal 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 | Genitourinary disorder, Relaxation of vagina |
| Vital signs determinationVital signs determination (respiration rate, blood pressure, pulse rate, body temperature). | Diagnostic test | Genitourinary disorder, Relaxation of vagina |
| pH of vagina determinationPotential of hydrogen (pH) of vagina will be investigated by test-lines paper (to evaluate procedure efficiency). | Diagnostic test | Genitourinary disorder, Relaxation of vagina |
| Physical parameters determinationPhysical parameters determination (body weight, age, height, body mass index). | Diagnostic test | Genitourinary disorder, Relaxation of vagina |
Primary outcome
Mean Change from Baseline of Vaginal Health Index Score
Time frame: 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)
Vaginal Health Index will be investigated by clinical examination for vagina: A. Vaginal elasticity (Characteristic=Points: None=1, Poor=2, Fair=3, Good=4, Excellent=5), B. Vaginal secretions (None=1; Sсant, thin yellow=2; Superficial, thin white=3; Moderate, thin white=4; Normal (white)=5), C. Epithelial mucous membrane (Petechiae noted before contact=1, Bleeding with light contact=2, Bleeds with scraping=3, Not friable thin epithelium=4, Normal=5), D. Vaginal hydration (None, surface inflamed=1, None, surface nod inflamed=2, Minimal=3, Moderate=4, Normal=5), E. pH will be investigated by test-lines paper (≥6.1=1, 5.6-6.0=2, 5.1-5.5=3, 4.7-5.0=4, ≤4.6=5). Score=A+B+C+D+E
11 secondary outcomes
Mean Change from Baseline of "Desire" Score on the Female Sexual Function Index Questionnaire
Time frame: 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)
Mean Change from Baseline of "Arousal" Score on the Female Sexual Function Index Questionnaire
Time frame: 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)
Mean Change from Baseline of "Lubrication" Score on the Female Sexual Function Index Questionnaire
Time frame: 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)
Mean Change from Baseline of "Orgasm" Score on the Female Sexual Function Index Questionnaire
Time frame: 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)
Mean Change from Baseline of "Satisfaction" Score on the Female Sexual Function Index Questionnaire
Time frame: 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)
Mean Change from Baseline of "Pain" Score on the Female Sexual Function Index Questionnaire
Time frame: 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)
Mean Change from Baseline of Total Score on International Consultation on Incontinence Questionnaire - Short Form
Time frame: 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)
Mean Change from Baseline of "Physical Health Component Score" on The Short Form Health Survey
Time frame: 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)
Mean Change from Baseline of "Mental Health Component Score" on The Short Form Health Survey
Time frame: 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)
Mean Change from Baseline of pH of vagina
Time frame: 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)
Mean Change from Baseline of Lactobacilli quantity
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: Yes. The following data can be shared with researchers upon an official request: The final version of the Study Protocol approved by the Local Ethics Committee; Copies of anonymized filled Individual Registration Cards (IRC); Informed Consent Form (ICF); Clinical Study Report (CSR) and/or published article (if not contradict the rules and conditions of a journal); Supplement files systematizing data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladislav V Dubenskij, Ph.D. principal investigator
Tver State Medical Academy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser treatment, Blood test and Clinical urine test in people with Female Urogenital Diseases and Urinary Incontinence, run by MeLSyTech, Ltd at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change from Baseline of Vaginal Health Index Score (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.