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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2024
  • participants needed
    120
  • sponsor
    MeLSyTech, Ltd
Updated on 20 October 2022
cancer
smear
estriol
Accepts healthy volunteers

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 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 50, 50 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.

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 50, 50, 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 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:

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

Laser 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:

  1. Privolzhsky Research Medical University (main scientific coordinator, information for participant recruiting),
  2. 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),
  3. Municipal Hospital №35 of the Soviet District of Nizhny Novgorod (cytological and immunocytochemical analysis),
  4. 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),
  5. 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),
  6. Medical Center "Imidzh Lab" (information for participant recruiting, general tests to include participants in the study),
  7. 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.

Details
Condition Postmenopausal Period, Vaginal Atrophy, Vaginal Prolapse
Treatment biopsy, Optical Coherence Tomography, Laser treatment, pelvic ultrasound, Topical hormone estriol, Сlinical blood analysis, Сlinical urine test, Vaginal smear, Vaginal Health Index, Perineometry, Cervical oncocytology test., Extended colposcopy, King's Health Questionnaire, Ultrasound investigation, Femoflor screen
Clinical Study IdentifierNCT05335317
SponsorMeLSyTech, Ltd
Last Modified on20 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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
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