Postmenopausal PeriodNCT05335317
Treatment of Vaginal Atrophy With Low Intensity Nanosecond 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 study is characteristic of changes in the vaginal wall after treatment of neodymium laser radiation with a wavelength of 1064 nm. To assess the condition of the vaginal walls before and after laser treatment, the following methods will be used: vaginal health index, perineometry, measurement of the vaginal… Read more about this study
- Who is it for?
- Ages 40 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Period, Vaginal Atrophy, Vaginal Prolapse
- 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
- 18 Apr 2022to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age of 40-75 years, inclusive;
- Vaginal atrophy or 1st grade vaginal prolapse with atrophy, or lack of vaginal atrophy in case of control group 2;
- All participants have informed consent to conduct a course of procedures according to protocol, carry out follow-up visits, and conduct studies.
Who cannot join
- Age of under 40 and over 75 years old;
- History of oncological diseases;
- Active tuberculosis;
- Inflammatory diseases of the vulva and vagina including genital herpes in the acute stage;
- Urinary tract infections;
- Damage to the vaginal mucosa;
Show all 19Show fewer
- Pregnancy;
- Tendency to photoallergy including taking photosensitizing drugs (diuretics, antihistamines, antipsychotics);
- Porphyria;
- Cardiac deficiency of 2-3 degrees;
- Chronic renal disease;
- Participants with greater than 1st grade vaginal prolapse;
- Women after childbirth up to 8 weeks;
- Participants who, according to the doctor, are not able to complete the study;
- 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 appearance of contraindications listed in the Exclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
State-Funded Healthcare Institution of the Nizhny Novgorod region "Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko"
Nizhny Novgorod, 603126
Liya Z Sirotina, +79081628760, liya.z.sirotina@bk.ru
Liya Z Sirotina
About this study
Official title: Study of the Efficiency and Safety of Low-Intensity Neodymium Laser Radiation With a Nanosecond Pulse Duration for Treatment of the Vaginal Walls Atrophic Changes
The aim of study is characteristic of changes in the vaginal wall after treatment of neodymium laser radiation with a wavelength of 1064 nm. To assess the condition of the vaginal walls before and after laser treatment, the following methods will be used: vaginal health index, perineometry, measurement of the vaginal wall thickness by ultrasound, Doppler sonography of the vaginal walls vessels, optical coherence tomography, biopsy, cytological and immunocytochemical methods. The King's Health Questionnaire will be used to collect feedback on changes in the participants life quality. Total up to 100 participants with and 20 participants without postmenopausal atrophy will be involved in the study. Participants will be divided into three groups: laser treatment (study group), topical hormones treatment (control group 1) and no treatment (control group 2) by 70, 30 and 20 participants in each group respectively. The time intervals between special tests and the tests themselves will be the same for all groups. Thus, a direct comparison between conventional treatment (topical hormones), laser treatment of the vaginal atrophy and normal condition without treatment will be made. The main hypothesis of the study is improvement in condition of the vaginal walls after laser treatment compared with the initial state of not less than thirty percent of participants, and improvement in condition on average compared with the control 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 100 participants with and 20 participants without postmenopausal atrophy will be involved in the study. Participants will be divided into three groups: laser treatment (study group), topical hormones treatment (control group 1), and no treatment (control group 2) by 70, 30, and 20 participants in each respectively.
The types of examination of each group are the same and include:
- General methods: clinical blood analysis, clinical urine test, vaginal smear for flora, femoflor screen (method is intended for the study of vaginal microbiocenosis), cervical oncocytology test, extended colposcopy, pelvic ultrasound.
- Special methods: filling out the questionnaire (King's Health Questionnaire), Vaginal Health Index, ultrasound for assessing blood vessels (Doppler sonography) and vaginal wall thickness, perineometry, optical coherence tomography (OCT), vaginal smear for immunocytochemical examination and cytology.
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. Three follow-up visits will follow: 1, 3 (mandatory) and 6 (optional) 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,
- d 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.
The CONTROL 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, when the suppository will be used of 2 times a week for 1.5-2 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 special methods only will be performed during the 5th (1 month after the last procedure), 6th (3 months after the last procedure), and 7th (6 months after the last procedure) visits.
For the control group 1 (hormonal treatment): Studies with special methods only will be performed during the 2nd, 3d, and 4th visits. 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 - 3 months after the 4th, the 7th - 6 months after the 4th.
Thus, a direct comparison between conventional treatment (topical hormones) and laser treatment of the vaginal atrophy will be made during the treatment, as well as on follow-up visits in 1, 3 and 6 months after the end of each type of treatment.
For the control group 2 Vaginal Health Index will be estimated only and OCT investigation with biopsy.
The study will be carried out with the participation of several clinics:
- Privolzhsky Research Medical University (main scientific coordinator, information for participant recruiting),
- State-Funded Healthcare Institution of the Nizhny Novgorod region "Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko" (location of laser equipment, laser treatment and participant consultation, special tests, collection of material for cytological and immunocytochemical analysis, recruiting),
- Municipal Hospital №35 of the Soviet District of Nizhny Novgorod (cytological and immunocytochemical analysis),
- State-Funded Healthcare Institution of the Nizhny Novgorod region "Municipal Clinical Hospital №29" (information for participant recruiting, general tests to include participants in the study),
- LLC "Clinic of modern technologies "SADKO" (recruiting, general tests to include participants in the study, location of laser equipment, laser treatment and participant consultation, special tests, collection of material for cytological and immunocytochemical analysis),
- Medical Center "Imidzh Lab" (information for participant recruiting, general tests to include participants in the study),
- LLC "Tonus" (information for participant recruiting, general tests to include participants in the study).
All data obtained during the study will be transferred to the manufacturer of "MeLSyTech" Ltd.
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.
- Conditions
- Postmenopausal Period, Vaginal Atrophy, Vaginal Prolapse
- Being tested
- Laser Treatment, Topical hormone estriol, Сlinical blood analysis, Сlinical urine test, Vaginal smear
- Keywords
- Vaginal Atrophy, Vaginal Prolapse, Neodymium Laser, Laser Treatment, Nanosecond, Laser, Vaginal, Postmenopausal
- Medical subject headings
- Uterine 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% overlap), average power of 10-25 Watt (W), treatment time in one point of 1-10 seconds (s), treatment step of 5 mm (total handpiece length of 10 centimeter (cm), 20 treatment points along vagina), 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 100 milliseconds (ms), pause between packets of 50 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 suppository ((17 beta)-estra-1,3,5 (10)-trien-3,17-diol). Active ingredient of 0.5 milligram in 1 suppository. Daily dose will be 1 suppository.
Сlinical blood analysisDiagnostic test
Taking blood from a vein for Clinical blood analysis (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), immunocytochemical examination and cytology (to evaluate procedure efficiency).
Cervical oncocytology test.Diagnostic test
Cervical smear for oncocytology test (to include the participant in the study).
Extended colposcopyDiagnostic test
Extended colposcopy is performed under a microscope using a Lugol to determine external changes in the epithelium in order to determine atrophy and pathologies of the cervix and vaginal vault (dysplasia, erosion, cancer, etc.) (to include the participant in the study).
Pelvic ultrasoundDiagnostic test
Pelvic ultrasound investigation to determine pathologies of the pelvic through a gynecological probe (to include the participant in the study).
King's Health QuestionnaireOther
The King's Health 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. pH (potential of hydrogen) will be investigated by test-lines paper (to evaluate procedure efficiency).
Ultrasound investigationDiagnostic test
Ultrasound investigation with General Electric Voluson E8 Expert for assessing blood vessels (Doppler sonography) and vaginal wall thickness measurement (to evaluate procedure efficiency).
PerineometryDiagnostic test
Pressure force of vaginal walls measurement with IEASE device (to evaluate procedure efficiency).
Optical coherence tomographyDiagnostic test
Optical non-invasive method of investigation vaginal mucus morphological and functional condition.
BiopsyDiagnostic test
Biopsy of the vaginal wall to assess the condition of the vaginal wall and compare the obtained data with the data of optical coherence tomography.
Femoflor screenDiagnostic test
Femoflor screen for the study of vaginal microbiocenosis, specifically for the detection of the pathogens, opportunistic flora and normal flora and their qualitative and quantitative evaluation (to include the participant in the study).
| 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: Cervical oncocytology test.; Diagnostic Test: Extended colposcopy; Diagnostic Test: Pelvic ultrasound; Other: King's Health Questionnaire; Diagnostic Test: Vaginal Health Index; Diagnostic Test: Ultrasound investigation; Diagnostic Test: Perineometry; Diagnostic Test: Optical coherence tomography; Diagnostic Test: Biopsy; Diagnostic Test: Femoflor screen |
| 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, when the suppository will be used of 2 times a week for 1.5-2 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: Cervical oncocytology test.; Diagnostic Test: Extended colposcopy; Diagnostic Test: Pelvic ultrasound; Other: King's Health Questionnaire; Diagnostic Test: Vaginal Health Index; Diagnostic Test: Ultrasound investigation; Diagnostic Test: Perineometry; Diagnostic Test: Femoflor screen |
| No treatment | Other | Participants without vaginal atrophy (no complaints of vaginal health and a vaginal health index greater than 20) and not receiving any treatment. Receives: Diagnostic Test: Vaginal Health Index; Diagnostic Test: Optical coherence tomography; Diagnostic Test: Biopsy |
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 (potential of hydrogen) 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: 2nd visit (before any treatment); 3d visit (4-6 weeks after 2nd visit); 4th visit (4-6 weeks after 3d visit) - the end of any treatment; 1 month after 4th visit, 3 months after 4th visit, and 6 months after 4th visit
Mean Change from Baseline of Periodic Acid Schiff Reaction Percentage in Vaginal Smear
Part of a cytological test. Histological preparation prepared by liquid-based cytology and stained according to the instructions of the Periodic Acid Schiff kit. The investigator counts 100 cells in field of view with 400x magnification and records the proportion of cells with diffuse and granular staining. Parameter will be measured in percentages (%).
Measured: 2nd visit (before any treatment); 3d visit (4-6 weeks after 2nd visit); 1 month after 4th visit (after the end of any treatment), 3 months after 4th visit
Mean Change from Baseline of Resistive Index by Doppler Sonography
Measurement is a part of ultrasonography. Resistive Index will be measured with US-device. The Resistive Index (RI) is calculated by the following equation: RI = (PSV - EDV) / PSV, where PSV is peak systolic velocity and EDV is end-diastolic velocity, in relative units.
Measured: 2nd visit (before any treatment);1 month after 4th visit (after the end of any treatment), 3 months 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 posted19 Apr 2022
- Study start18 Apr 2022
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MeLSyTech, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liya Z Sirotina, Principal investigator, Privolzhsky Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335317
- Sponsor's protocol ID
- TVALINNL-2019
- Status last verified
- Dec 2024
- First submitted
- 13 Apr 2022
- 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
- Study of the Efficiency and Safety of Low-Intensity Neodymium Laser Radiation With a Nanosecond Pulse Duration for Treatment of the Vaginal Walls Atrophic Changes
- ClinicalTrials.gov ID
- NCT05335317
- Acronym / sponsor ID
- TVALINNL-2019
- Conditions
- Postmenopausal Period, Vaginal Atrophy, Vaginal Prolapse
- Keywords
- Vaginal Atrophy, Vaginal Prolapse, Neodymium Laser, Laser Treatment, Nanosecond, Laser, Vaginal, Postmenopausal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- MeLSyTech, LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 19 Apr 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 study is characteristic of changes in the vaginal wall after treatment of neodymium laser radiation with a wavelength of 1064 nm. To assess the condition of the vaginal walls before and after laser treatment, the following methods will be used: vaginal health index, perineometry, measurement of the vaginal wall thickness by ultrasound, Doppler sonography of the vaginal walls vessels, optical coherence tomography, biopsy, cytological and immunocytochemical methods. The King's Health Questionnaire will be used to collect feedback on changes in the participants life quality. Total up to 100 participants with and 20 participants without postmenopausal atrophy will be involved in the study. Participants will be divided into three groups: laser treatment (study group), topical hormones treatment (control group 1) and no treatment (control group 2) by 70, 30 and 20 participants in each group respectively. The time intervals between special tests and the tests themselves will be the same for all groups. Thus, a direct comparison between conventional treatment (topical hormones), laser treatment of the vaginal atrophy and normal condition without treatment will be made. The main hypothesis of the study is improvement in condition of the vaginal walls after laser treatment compared with the initial state of not less than thirty percent of participants, and improvement in condition on average compared with the control group.
Detailed description
The principle of participant distribution into groups is the main method of treatment of postmenopausal vaginal atrophy. Total up to 100 participants with and 20 participants without postmenopausal atrophy will be involved in the study. Participants will be divided into three groups: laser treatment (study group), topical hormones treatment (control group 1), and no treatment (control group 2) by 70, 30, and 20 participants in each respectively.
The types of examination of each group are the same and include:
- General methods: clinical blood analysis, clinical urine test, vaginal smear for flora, femoflor screen (method is intended for the study of vaginal microbiocenosis), cervical oncocytology test, extended colposcopy, pelvic ultrasound.
- Special methods: filling out the questionnaire (King's Health Questionnaire), Vaginal Health Index, ultrasound for assessing blood vessels (Doppler sonography) and vaginal wall thickness, perineometry, optical coherence tomography (OCT), vaginal smear for immunocytochemical examination and cytology.
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. Three follow-up visits will follow: 1, 3 (mandatory) and 6 (optional) 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,
- d 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.
The CONTROL 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, when the suppository will be used of 2 times a week for 1.5-2 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 special methods only will be performed during the 5th (1 month after the last procedure), 6th (3 months after the last procedure), and 7th (6 months after the last procedure) visits.
For the control group 1 (hormonal treatment): Studies with special methods only will be performed during the 2nd, 3d, and 4th visits. 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 - 3 months after the 4th, the 7th - 6 months after the 4th.
Thus, a direct comparison between conventional treatment (topical hormones) and laser treatment of the vaginal atrophy will be made during the treatment, as well as on follow-up visits in 1, 3 and 6 months after the end of each type of treatment.
For the control group 2 Vaginal Health Index will be estimated only and OCT investigation with biopsy.
The study will be carried out with the participation of several clinics:
- Privolzhsky Research Medical University (main scientific coordinator, information for participant recruiting),
- State-Funded Healthcare Institution of the Nizhny Novgorod region "Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko" (location of laser equipment, laser treatment and participant consultation, special tests, collection of material for cytological and immunocytochemical analysis, recruiting),
- Municipal Hospital №35 of the Soviet District of Nizhny Novgorod (cytological and immunocytochemical analysis),
- State-Funded Healthcare Institution of the Nizhny Novgorod region "Municipal Clinical Hospital №29" (information for participant recruiting, general tests to include participants in the study),
- LLC "Clinic of modern technologies "SADKO" (recruiting, general tests to include participants in the study, location of laser equipment, laser treatment and participant consultation, special tests, collection of material for cytological and immunocytochemical analysis),
- Medical Center "Imidzh Lab" (information for participant recruiting, general tests to include participants in the study),
- LLC "Tonus" (information for participant recruiting, general tests to include participants in the study).
All data obtained during the study will be transferred to the manufacturer of "MeLSyTech" Ltd.
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
- Non-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: Cervical oncocytology test., Diagnostic Test: Extended colposcopy, Diagnostic Test: Pelvic ultrasound, Other: King's Health Questionnaire, Diagnostic Test: Vaginal Health Index, Diagnostic Test: Ultrasound investigation, Diagnostic Test: Perineometry, Diagnostic Test: Optical coherence tomography, Diagnostic Test: Biopsy, Diagnostic Test: Femoflor screenLaser 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: Cervical oncocytology test., Diagnostic Test: Extended colposcopy, Diagnostic Test: Pelvic ultrasound, Other: King's Health Questionnaire, Diagnostic Test: Vaginal Health Index, Diagnostic Test: Ultrasound investigation, Diagnostic Test: Perineometry, Diagnostic Test: Femoflor screenLocal hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy, when the suppository will be used of 2 times a week for 1.5-2 months to prevent symptoms. |
| No treatment | Other | Diagnostic Test: Vaginal Health Index, Diagnostic Test: Optical coherence tomography, Diagnostic Test: BiopsyParticipants without vaginal atrophy (no complaints of vaginal health and a vaginal health index greater than 20) and not receiving any treatment. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of 40-75 years, inclusive;
- Vaginal atrophy or 1st grade vaginal prolapse with atrophy, or lack of vaginal atrophy in case of control group 2;
- All participants have informed consent to conduct a course of procedures according to protocol, carry out follow-up visits, and conduct studies.
Key exclusion criteria (19 listed)
- Age of under 40 and over 75 years old;
- History of oncological diseases;
- Active tuberculosis;
- Inflammatory diseases of the vulva and vagina including genital herpes in the acute stage;
- Urinary tract infections;
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% overlap), average power of 10-25 Watt (W), treatment time in one point of 1-10 seconds (s), treatment step of 5 mm (total handpiece length of 10 centimeter (cm), 20 treatment points along vagina), 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 100 milliseconds (ms), pause between packets of 50 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 |
| Topical hormone estriolEstriol suppository ((17 beta)-estra-1,3,5 (10)-trien-3,17-diol). Active ingredient of 0.5 milligram in 1 suppository. Daily dose will be 1 suppository. | Drug | Topical hormone |
| Сlinical blood analysisTaking blood from a vein for Clinical blood analysis (to include the participant in the study). | Diagnostic test | Laser Treatment, Topical hormone |
| Сlinical urine testUrine sampling for Clinical urine test (to include the participant in the study). | Diagnostic test | Laser Treatment, Topical hormone |
| Vaginal smearVaginal smear for flora investigation (to include the participant in the study), immunocytochemical examination and cytology (to evaluate procedure efficiency). | Diagnostic test | Laser Treatment, Topical hormone |
| Cervical oncocytology test.Cervical smear for oncocytology test (to include the participant in the study). | Diagnostic test | Laser Treatment, Topical hormone |
| Extended colposcopyExtended colposcopy is performed under a microscope using a Lugol to determine external changes in the epithelium in order to determine atrophy and pathologies of the cervix and vaginal vault (dysplasia, erosion, cancer, etc.) (to include the participant in the study). | Diagnostic test | Laser Treatment, 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, Topical hormone |
| King's Health QuestionnaireThe King's Health Questionnaire will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency). | Other | Laser Treatment, Topical hormone |
| Vaginal Health IndexVaginal Health Index will be investigated by clinical examination for vaginal elasticity, vaginal secretions, epithelial mucous membrane, vaginal hydration. pH (potential of hydrogen) will be investigated by test-lines paper (to evaluate procedure efficiency). | Diagnostic test | Laser Treatment, No treatment, Topical hormone |
| Ultrasound investigationUltrasound investigation with General Electric Voluson E8 Expert for assessing blood vessels (Doppler sonography) and vaginal wall thickness measurement (to evaluate procedure efficiency). | Diagnostic test | Laser Treatment, Topical hormone |
| PerineometryPressure force of vaginal walls measurement with IEASE device (to evaluate procedure efficiency). | Diagnostic test | Laser Treatment, Topical hormone |
| Optical coherence tomographyOptical non-invasive method of investigation vaginal mucus morphological and functional condition. | Diagnostic test | Laser Treatment, No treatment |
| BiopsyBiopsy of the vaginal wall to assess the condition of the vaginal wall and compare the obtained data with the data of optical coherence tomography. | Diagnostic test | Laser Treatment, No treatment |
| Femoflor screenFemoflor screen for the study of vaginal microbiocenosis, specifically for the detection of the pathogens, opportunistic flora and normal flora and their qualitative and quantitative evaluation (to include the participant in the study). | Diagnostic test | Laser Treatment, Topical hormone |
Primary outcome
Mean Change from Baseline of Vaginal Health Index Score
Time frame: 2nd visit (before any treatment); 3d visit (4-6 weeks after 2nd visit); 4th visit (4-6 weeks after 3d visit) - the end of any treatment; 1 month after 4th visit, 3 months 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 (potential of hydrogen) 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
Mean Change from Baseline of Periodic Acid Schiff Reaction Percentage in Vaginal Smear
Time frame: 2nd visit (before any treatment); 3d visit (4-6 weeks after 2nd visit); 1 month after 4th visit (after the end of any treatment), 3 months after 4th visit
Part of a cytological test. Histological preparation prepared by liquid-based cytology and stained according to the instructions of the Periodic Acid Schiff kit. The investigator counts 100 cells in field of view with 400x magnification and records the proportion of cells with diffuse and granular staining. Parameter will be measured in percentages (%).
Mean Change from Baseline of Resistive Index by Doppler Sonography
Time frame: 2nd visit (before any treatment);1 month after 4th visit (after the end of any treatment), 3 months after 4th visit, and 6 months after 4th visit
Measurement is a part of ultrasonography. Resistive Index will be measured with US-device. The Resistive Index (RI) is calculated by the following equation: RI = (PSV - EDV) / PSV, where PSV is peak systolic velocity and EDV is end-diastolic velocity, in relative units.
Results and safety
This study is still under way. Results are not available in the source record yet.
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.
Liya Z Sirotina principal investigator
Privolzhsky Research Medical University
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 3 inclusion and 19 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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ksenia V Shatilova, Ph.D. (+79262792700, shatilova@melsytech.com), or a site near the patient. 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: 2nd visit (before any treatment); 3d visit (4-6 weeks after 2nd visit); 4th visit (4-6 weeks after 3d visit) - the end of any treatment; 1 month after 4th visit, 3 months after 4th visit, and 6 months after 4th visit). The study lists 3 primary outcomes in all. 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.