Postmenopausal PeriodNCT04735549
Vulvovaginal Atrophy Correction Using Neodymium Laser
A study testing Laser Treatment, Topical hormone estriol and Сlinical blood analysis in people with Postmenopausal Period and Vaginal Atrophy, run by MeLSyTech, Ltd at 1 site in Russia.
Trial summary
The aim of this prospective study is characteristic of changes in the vaginal wall and vulva after treatment of neodymium laser radiation with a wavelength of 1064 nm. To assess the condition of the vaginal walls and vulva before and after laser treatment, the following methods will be used: vaginal health index… Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Postmenopausal Period, Vaginal Atrophy, Female Urogenital Diseases
- What is being tested?
- Laser Treatment, Topical hormone estriol and Сlinical blood analysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2021to 20 Oct 2023
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of over 50 years old, inclusive;
- Participants diagnosed with genitourinary menopausal syndrome with severe signs of vulvovaginal atrophy;
- Participants were examined according to the proposed protocol;
- Participants who signed informed consent and fully informed about the purpose of the study.
Who cannot join
- Tendency to photoallergy including taking photosensitizing drugs (diuretics, antihistamines, antipsychotics);
- Porphyria;
- Active tuberculosis;
- Damage to the vaginal mucosa;
- Urinary tract infections in the acute stage;
- Genital herpes in the acute stage;
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- Inflammatory diseases of the vulva and vagina in the acute stage;
- Oncological diseases of the female reproductive system, including history of oncological diseases;
- Precancerous diseases of the cervix, vagina and vulva;
- The use of drugs and other methods of treatment (including laser) that can affect the result, less than 1 month before the start of the study and during the study (Menopausal hormone therapy, the use of topical estriol; Kegel exercises, physiotherapy, the use of pelvic floor muscle trainers).
- Protocol non-compliance of laser exposure sessions;
- Voluntary refusal to participate in the study;
- Violation of recommendations for the management of the period after laser treatment;
- Adverse events that occurred during laser processing and research, and associated with them.
- The occurrence of adverse events or other symptoms that are contraindications to laser procedures, as well as the occurrence of cases described in the exclusion criteria.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal State Budget Institution "National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov"
Moscow, 117997
About this study
Official title: Correction of Vulvovaginal Atrophy in Postmenopausal Women Using Neodymium Laser Treatment
The aim of this prospective study is characteristic of changes in the vaginal wall and vulva after treatment of neodymium laser radiation with a wavelength of 1064 nm. To assess the condition of the vaginal walls and vulva before and after laser treatment, the following methods will be used: vaginal health index, perineometry, elastography of vulva, cytological methods. Female Sexual Function Index (FSFI), The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), Vulvovaginal Symptoms Questionnaire (VSQ), Visual Analogue Scale (VAS) will be used to collect feedback on changes in the participants life quality. Total up to 120 participants with postmenopausal atrophy will be involved in the study. Participants will be divided into three groups: laser treatment group, topical hormones treatment group, and both laser treatment with topical hormones application group, by 40 participants in each. The time intervals between tests will be the same for all groups. Thus, a direct comparison between conventional treatment (topical hormones), laser treatment and combine laser and topical hormones therapy of the vaginal atrophy will be made. The main hypothesis of the study is improvement in condition of the vaginal walls after laser treatment and laser treatment with hormones application compared with the initial state of not less than thirty percent of participants, and improvement in condition on average compared with the hormones only therapy group.
Read the detailed description
The principle of participant distribution into groups is the main method of treatment of postmenopausal vaginal atrophy. Total up to 120 participants with postmenopausal atrophy will be involved in the study. Participants will be divided into three groups: laser treatment group, topical hormones treatment group, laser treatment with topical hormones application, by 40 participants in each.
The types of examination of each group are the same and include:
General methods: physical examination, clinical blood analysis with glucose determination, clinical urine test, vaginal smear for flora and oncocytology, pelvic ultrasound.
Special methods: filling out the questionnaire (Female Sexual Function Index, The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, Vulvovaginal Symptoms Questionnaire), Vaginal Health Index determination, Visual Analogue Scale (VAS) determination, perineometry, vaginal smear for cytology, elastography of vulva, microbiological vaginal smear stained by Gram.
The treatment procedure of this study is the laser treatment of the vagina and vulva with a "Magic Max" laser ("Magic Gyno" from August 2024) 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. Two follow-up visits will follow: 1 and 6 months 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.
Hormone treatment procedure. Local hormone therapy with estriol will be used as a therapeutic tool for the control group. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy will be used of 2 times a week for 12 months to prevent symptoms.
Participants of all groups will be tested with the general methods necessary to include the participant in the study at the first visit.
For the laser treatment 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 (before the start of treatment) visit. Vaginal health index, pH-measurement, perineometry, and filling of questionnaires will be performed during 3d-6th visits. Cytological investigation and elastography of vulva will be performed during 5th (1 month after the last procedure) and 6th (6 months after the last procedure).
For the hormone treatment group: Studies with all special methods will be performed during the 1st (before the start of treatment) visit. Vaginal health index, pH-measurement, perineometry, and filling of questionnaires will be performed during 3d-6th visits. Cytological investigation and Doppler sonography will be performed during 5th (1 month after the last procedure) and 6th (6 months after the last procedure). Hormone therapy will begin from the 2nd visit. All subsequent visits will be carried out at the same time intervals as for the laser treatment group, using studies with special methods. The 3d visit will be in 4-6 weeks after the start of treatment, the 4th will be in 4-6 weeks after the 3d visit, the 5th - 1 month after the 4th, the 6th - 6 months after the 4th.
For the combine laser treatment with topical hormones application group: laser treatment of the vagina and vulva and paraurethral region will be performed during the 2nd, 3d, and 4th visits. At the same time, starting from 2nd visit hormone therapy will be started. All subsequent visits will be carried out at the same time intervals as for the laser treatment group and hormone treatment group, using studies with special methods.
Thus, a direct comparison between conventional treatment (topical hormones), laser treatment and combine therapy of the vaginal atrophy will be made during the treatment, as well as on follow-up visits in 1 and 6 months after the end of each type of treatment.
The study will be carried out with the participation of FSBI "National Medical Research Center For Obstetrics, Gynecology And Perinatology Named After Academician V.I.Kulakov" MINISTRY OF HEALTHCARE OF THE RUSSIAN FEDERATION
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:
- Once a month, monitoring of provided documents (copies of individual registration records of participants, 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;
- Once every six months, 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;
- Once a year, the investigator submits a clinical evaluation report to the sponsor.
Statistics
The analysis will be carried out both between groups of participants receiving different types of therapy (analysis of independent groups) and 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 and unpaired 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 Kruskal-Wallis test (ANOVA tests) for independent groups and the Friedman test for matched groups. Dunn's multiple comparison test will be used to assess intergroup differences.
Before assessing intergroup differences, the initial samples (1 visit) will be analyzed for identity using ANOVA or nonparametric Kruskal-Wallis tests (depending on the type of data). In case of significant differences in the samples, the search and removal of extremely deviating values (outliers) will be carried out.
Differences will be considered statistically significant if the significance P values are <0.05.
- Being tested
- Laser Treatment, Topical hormone estriol, Сlinical blood analysis, Сlinical urine test, Vaginal smear
- Keywords
- Vaginal Atrophy, Female Urogenital Diseases, Neodymium Laser, Laser Treatment, Nanosecond, Laser, Vaginal, Postmenopausal
- Medical subject headings
- Female Urogenital Diseases
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.
Topical hormone estriolDrug
Estriol ((17 beta)-estra-1,3,5 (10)-trien-3,17-diol). Daily dose will be 0.5 gram daily for 2 weeks, later 0.5 gram twice a week for 12 months.
Сlinical blood analysisDiagnostic test
Taking blood from a vein for Clinical blood analysis, 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).
Сlinical 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), cytology, microbiological analysis with Gram staining (to 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).
The Pelvic Organ Prolapse/Urinary Incontinence Sexual QuestionnaireOther
The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency).
Vulvovaginal Symptoms QuestionnaireOther
Vulvovaginal Symptoms Questionnaire 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).
Elastography (ultrasound investigation)Diagnostic test
Ultrasound investigation for assessing elasticity / stiffness of tissues of vulva region with Mindray device (head L14-6WU) (to evaluate procedure efficiency).
PerineometryDiagnostic test
Pressure force of vaginal walls measurement with EmbaGYN device (to evaluate procedure efficiency).
Visual Analogue Scale (VAS)Other
Visual Analogue Scale will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency).
| Study group | Role | What they receive |
|---|---|---|
| Laser Treatment | Experimental | Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks.
During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece. Receives: Device: Laser Treatment; Diagnostic Test: Сlinical blood analysis; Diagnostic Test: Сlinical urine test; Diagnostic Test: Vaginal smear; Diagnostic Test: Pelvic ultrasound; Other: Female Sexual Function Index; Other: The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire; Other: Vulvovaginal Symptoms Questionnaire; Diagnostic Test: Vaginal Health Index; Diagnostic Test: Elastography (ultrasound investigation); Diagnostic Test: Perineometry; Other: Visual Analogue Scale (VAS) |
| Topical hormone | Active comparator | Local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms. Receives: Drug: Topical hormone estriol; Diagnostic Test: Сlinical blood analysis; Diagnostic Test: Сlinical urine test; Diagnostic Test: Vaginal smear; Diagnostic Test: Pelvic ultrasound; Other: Female Sexual Function Index; Other: The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire; Other: Vulvovaginal Symptoms Questionnaire; Diagnostic Test: Vaginal Health Index; Diagnostic Test: Elastography (ultrasound investigation); Diagnostic Test: Perineometry; Other: Visual Analogue Scale (VAS) |
| Laser Treatment + Topical hormone | Experimental | Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks. During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
At the same time local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms. Receives: Device: Laser Treatment; Drug: Topical hormone estriol; Diagnostic Test: Сlinical blood analysis; Diagnostic Test: Сlinical urine test; Diagnostic Test: Vaginal smear; Diagnostic Test: Pelvic ultrasound; Other: Female Sexual Function Index; Other: The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire; Other: Vulvovaginal Symptoms Questionnaire; Diagnostic Test: Vaginal Health Index; Diagnostic Test: Elastography (ultrasound investigation); Diagnostic Test: Perineometry; Other: Visual Analogue Scale (VAS) |
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: Non=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, 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: [Time Frame: 1st visit (before any treatment); 3d visit (4-6 weeks after 2nd visit); 4th visit (4-6 weeks after 3d visit) - the end of laser treatment; 1 month after 4th visit and 6 months after 4th visit]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start1 Sep 2021
- Primary completion20 Oct 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal PeriodStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- MeLSyTech, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Inna A Apolikhina, Ph.D., Principal investigator, Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735549
- Sponsor's protocol ID
- VACUNL-2020
- Status last verified
- Dec 2024
- First submitted
- 28 Jan 2021
- Last updated
- 12 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 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correction of Vulvovaginal Atrophy in Postmenopausal Women Using Neodymium Laser Treatment
- ClinicalTrials.gov ID
- NCT04735549
- Acronym / sponsor ID
- VACUNL-2020
- Keywords
- Vaginal Atrophy, Female Urogenital Diseases, Neodymium Laser, Laser Treatment, Nanosecond, Laser, Vaginal, Postmenopausal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- MeLSyTech, LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 3 Feb 2021 (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 characteristic of changes in the vaginal wall and vulva after treatment of neodymium laser radiation with a wavelength of 1064 nm. To assess the condition of the vaginal walls and vulva before and after laser treatment, the following methods will be used: vaginal health index, perineometry, elastography of vulva, cytological methods. Female Sexual Function Index (FSFI), The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), Vulvovaginal Symptoms Questionnaire (VSQ), Visual Analogue Scale (VAS) will be used to collect feedback on changes in the participants life quality. Total up to 120 participants with postmenopausal atrophy will be involved in the study. Participants will be divided into three groups: laser treatment group, topical hormones treatment group, and both laser treatment with topical hormones application group, by 40 participants in each. The time intervals between tests will be the same for all groups. Thus, a direct comparison between conventional treatment (topical hormones), laser treatment and combine laser and topical hormones therapy of the vaginal atrophy will be made. The main hypothesis of the study is improvement in condition of the vaginal walls after laser treatment and laser treatment with hormones application compared with the initial state of not less than thirty percent of participants, and improvement in condition on average compared with the hormones only therapy group.
Detailed description
The principle of participant distribution into groups is the main method of treatment of postmenopausal vaginal atrophy. Total up to 120 participants with postmenopausal atrophy will be involved in the study. Participants will be divided into three groups: laser treatment group, topical hormones treatment group, laser treatment with topical hormones application, by 40 participants in each.
The types of examination of each group are the same and include:
General methods: physical examination, clinical blood analysis with glucose determination, clinical urine test, vaginal smear for flora and oncocytology, pelvic ultrasound.
Special methods: filling out the questionnaire (Female Sexual Function Index, The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, Vulvovaginal Symptoms Questionnaire), Vaginal Health Index determination, Visual Analogue Scale (VAS) determination, perineometry, vaginal smear for cytology, elastography of vulva, microbiological vaginal smear stained by Gram.
The treatment procedure of this study is the laser treatment of the vagina and vulva with a "Magic Max" laser ("Magic Gyno" from August 2024) 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. Two follow-up visits will follow: 1 and 6 months 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.
Hormone treatment procedure. Local hormone therapy with estriol will be used as a therapeutic tool for the control group. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy will be used of 2 times a week for 12 months to prevent symptoms.
Participants of all groups will be tested with the general methods necessary to include the participant in the study at the first visit.
For the laser treatment 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 (before the start of treatment) visit. Vaginal health index, pH-measurement, perineometry, and filling of questionnaires will be performed during 3d-6th visits. Cytological investigation and elastography of vulva will be performed during 5th (1 month after the last procedure) and 6th (6 months after the last procedure).
For the hormone treatment group: Studies with all special methods will be performed during the 1st (before the start of treatment) visit. Vaginal health index, pH-measurement, perineometry, and filling of questionnaires will be performed during 3d-6th visits. Cytological investigation and Doppler sonography will be performed during 5th (1 month after the last procedure) and 6th (6 months after the last procedure). Hormone therapy will begin from the 2nd visit. All subsequent visits will be carried out at the same time intervals as for the laser treatment group, using studies with special methods. The 3d visit will be in 4-6 weeks after the start of treatment, the 4th will be in 4-6 weeks after the 3d visit, the 5th - 1 month after the 4th, the 6th - 6 months after the 4th.
For the combine laser treatment with topical hormones application group: laser treatment of the vagina and vulva and paraurethral region will be performed during the 2nd, 3d, and 4th visits. At the same time, starting from 2nd visit hormone therapy will be started. All subsequent visits will be carried out at the same time intervals as for the laser treatment group and hormone treatment group, using studies with special methods.
Thus, a direct comparison between conventional treatment (topical hormones), laser treatment and combine therapy of the vaginal atrophy will be made during the treatment, as well as on follow-up visits in 1 and 6 months after the end of each type of treatment.
The study will be carried out with the participation of FSBI "National Medical Research Center For Obstetrics, Gynecology And Perinatology Named After Academician V.I.Kulakov" MINISTRY OF HEALTHCARE OF THE RUSSIAN FEDERATION
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:
- Once a month, monitoring of provided documents (copies of individual registration records of participants, 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;
- Once every six months, 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;
- Once a year, the investigator submits a clinical evaluation report to the sponsor.
Statistics
The analysis will be carried out both between groups of participants receiving different types of therapy (analysis of independent groups) and 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 and unpaired 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 Kruskal-Wallis test (ANOVA tests) for independent groups and the Friedman test for matched groups. Dunn's multiple comparison test will be used to assess intergroup differences.
Before assessing intergroup differences, the initial samples (1 visit) will be analyzed for identity using ANOVA or nonparametric Kruskal-Wallis tests (depending on the type of data). In case of significant differences in the samples, the search and removal of extremely deviating values (outliers) will be carried out.
Differences will be considered statistically significant if the significance P values are <0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laser Treatment | Experimental | Device: Laser Treatment, Diagnostic Test: Сlinical blood analysis, Diagnostic Test: Сlinical urine test, Diagnostic Test: Vaginal smear, Diagnostic Test: Pelvic ultrasound, Other: Female Sexual Function Index, Other: The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, Other: Vulvovaginal Symptoms Questionnaire, Diagnostic Test: Vaginal Health Index, Diagnostic Test: Elastography (ultrasound investigation), Diagnostic Test: Perineometry, Other: Visual Analogue Scale (VAS)Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks. During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece. |
| Topical hormone | Active comparator | Drug: Topical hormone estriol, Diagnostic Test: Сlinical blood analysis, Diagnostic Test: Сlinical urine test, Diagnostic Test: Vaginal smear, Diagnostic Test: Pelvic ultrasound, Other: Female Sexual Function Index, Other: The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, Other: Vulvovaginal Symptoms Questionnaire, Diagnostic Test: Vaginal Health Index, Diagnostic Test: Elastography (ultrasound investigation), Diagnostic Test: Perineometry, Other: Visual Analogue Scale (VAS)Local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms. |
| Laser Treatment + Topical hormone | Experimental | Device: Laser Treatment, Drug: Topical hormone estriol, Diagnostic Test: Сlinical blood analysis, Diagnostic Test: Сlinical urine test, Diagnostic Test: Vaginal smear, Diagnostic Test: Pelvic ultrasound, Other: Female Sexual Function Index, Other: The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, Other: Vulvovaginal Symptoms Questionnaire, Diagnostic Test: Vaginal Health Index, Diagnostic Test: Elastography (ultrasound investigation), Diagnostic Test: Perineometry, Other: Visual Analogue Scale (VAS)Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks. During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece. At the same time local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age of over 50 years old, inclusive;
- Participants diagnosed with genitourinary menopausal syndrome with severe signs of vulvovaginal atrophy;
- Participants were examined according to the proposed protocol;
- Participants who signed informed consent and fully informed about the purpose of the study.
Key exclusion criteria (15 listed)
- Tendency to photoallergy including taking photosensitizing drugs (diuretics, antihistamines, antipsychotics);
- Porphyria;
- Active tuberculosis;
- Damage to the vaginal mucosa;
- Urinary tract infections in the acute stage;
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 | Laser Treatment, Laser Treatment + Topical hormone |
| Topical hormone estriolEstriol ((17 beta)-estra-1,3,5 (10)-trien-3,17-diol). Daily dose will be 0.5 gram daily for 2 weeks, later 0.5 gram twice a week for 12 months. | Drug | Laser Treatment + Topical hormone, Topical hormone |
| Сlinical blood analysisTaking blood from a vein for Clinical blood analysis, 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). | Diagnostic test | Laser Treatment, Laser Treatment + Topical hormone, Topical hormone |
| Сlinical urine testUrine sampling for Clinical urine test (to include the participant in the study). | Diagnostic test | Laser Treatment, Laser Treatment + Topical hormone, Topical hormone |
| Vaginal smearVaginal smear for flora investigation (to include the participant in the study), cytology, microbiological analysis with Gram staining (to evaluate procedure efficiency). | Diagnostic test | Laser Treatment, Laser Treatment + Topical hormone, Topical hormone |
| Pelvic ultrasoundPelvic ultrasound investigation to determine pathologies of the pelvic through a gynecological probe (to include the participant in the study). | Diagnostic test | Laser Treatment, Laser Treatment + Topical hormone, Topical hormone |
| 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 | Laser Treatment, Laser Treatment + Topical hormone, Topical hormone |
| The Pelvic Organ Prolapse/Urinary Incontinence Sexual QuestionnaireThe Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency). | Other | Laser Treatment, Laser Treatment + Topical hormone, Topical hormone |
| Vulvovaginal Symptoms QuestionnaireVulvovaginal Symptoms Questionnaire will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency). | Other | Laser Treatment, Laser Treatment + Topical hormone, Topical hormone |
| 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 | Laser Treatment, Laser Treatment + Topical hormone, Topical hormone |
| Elastography (ultrasound investigation)Ultrasound investigation for assessing elasticity / stiffness of tissues of vulva region with Mindray device (head L14-6WU) (to evaluate procedure efficiency). | Diagnostic test | Laser Treatment, Laser Treatment + Topical hormone, Topical hormone |
| PerineometryPressure force of vaginal walls measurement with EmbaGYN device (to evaluate procedure efficiency). | Diagnostic test | Laser Treatment, Laser Treatment + Topical hormone, Topical hormone |
| Visual Analogue Scale (VAS)Visual Analogue Scale will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency). | Other | Laser Treatment, Laser Treatment + Topical hormone, Topical hormone |
Primary outcome
Mean Change from Baseline of Vaginal Health Index Score
Time frame: [Time Frame: 1st visit (before any treatment); 3d visit (4-6 weeks after 2nd visit); 4th visit (4-6 weeks after 3d visit) - the end of laser treatment; 1 month after 4th visit and 6 months after 4th visit]
Vaginal Health Index will be investigated by clinical examination for vagina: A. Vaginal elasticity (Characteristic=Points: Non=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, 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
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 12 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.
Inna A Apolikhina, Ph.D. principal investigator
Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov
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, Topical hormone estriol and Сlinical blood analysis in people with Postmenopausal Period and Vaginal Atrophy, 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 4 inclusion and 15 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 12 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: [Time Frame: 1st visit (before any treatment); 3d visit (4-6 weeks after 2nd visit); 4th visit (4-6 weeks after 3d visit) - the end of laser treatment; 1 month after 4th visit and 6 months after 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 12 Dec 2024.