Clinical Trial of the Safety and Efficacy of Medical Device "Laser Medical Device "Magic Gyno""

  • STATUS
    Recruiting
  • days left to enroll
    89
  • participants needed
    70
  • sponsor
    MeLSyTech, Ltd
Updated on 22 October 2022
body mass index
prolapse
smear
stress urinary incontinence
mixed incontinence

Summary

The aim of this prospective study is investigation of efficiency and safety of medical device "Magic Gyno" in accordance with the stated purpose. To assess the condition of the vaginal walls and vulva before and after laser treatment, the following methods will be used: gynecology examination, vaginal health index, clinical blood test, vaginal flora examination, vaginal pH. International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), Female Sexual Function Index (FSFI) and The Short Form Health Survey (SF-36) will be used to collect feedback on changes in the participants life quality. Total up to 70 participants with pathology of pelvic organs will be involved in the study. Participants will be divided into two groups: group with genitourinary symptoms and group with vaginal relaxation symptoms, by 35 participants in each. The time intervals between tests will be the same for both groups. The main hypothesis of the study is improvement in condition of the vaginal walls after laser treatment compared with the condition before treatment.

Description

The principle of participant distribution into groups is the character of vaginal walls and vulva pathology. Total up to 70 participants will be involved in the study. Participants will be divided into two groups: group with genitourinary symptoms and group with vaginal relaxation symptoms by 35 participants in each.

The types of examination of each group are the same and include:

General methods: demographic data determination, vital signs determination, gynecological examination, physical examination, clinical blood analysis with glucose determination, clinical urine test, vaginal smear for flora and oncocytology, pelvic ultrasound.

Special methods: vaginal smear for flora, vaginal pH determination, filling out the questionnaire (Female Sexual Function Index, International Consultation on Incontinence Questionnaire - Short Form, The Short Form Health Survey), Vaginal Health Index determination.

The treatment procedure of this study is the laser treatment of the vagina and vulva with a "Magic Gyno" laser with subsequent monitoring.

Treatment Technique:

Laser treatment procedure will be carried out in three stages. In total, three procedures will be performed with an interval of 4-6 weeks. One follow-up visit will follow: 90 days after the last procedure.

During the procedure, the following sequence of actions will be performed:

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

Laser radiation is emitted by a series of pulses following each other through a pause. The duration of one pulse is 20-200 nanoseconds (ns), the pause between pulses is 30 microseconds (us). The energy of one pulse is about 1 millijoule (mJ). The procedure is performed without anesthesia. The doctor always focuses on the participant's feeling of warmth.

Participants of all groups will be tested with the general methods necessary to include the participant in the study at the first visit.

For both group: Studies will be carried out using special methods and then laser treatment of the vagina and vulva and paraurethral region will be performed during the 2nd, 3d, and 4th visits. Studies with all special methods will be performed during the 1st (to include participant in the study), 2nd (before the first treatment), 4th (before the last treatment) and 5th (90 days after the last treatment) visits.

Thus, direct comparison between participants condition before and 90 days after treatment within each group will be carried out.

The study will be carried out with the participation of Tver State Medical Academy.

All data obtained during the study will be transferred to the manufacturer of "MeLSyTech" Ltd.

The study will be monitored by "MeLSyTech" Ltd as follows:

In the start of study to ensure awareness of researchers about the plan, the rules for filling in case research forms, work with the device.

Once a 3 month, monitoring of provided documents (copies of individual registration records of participants (case research forms), informed consent, test results) for the complete filling of the forms; the clarity of filling out forms, the possibility of systematizing information from the forms of their assessment. Monitoring will be conducted with a coordinator visit of the research center and analysis activities, such as participants recruitment, data collection, data management, data analysis, reporting for adverse events, and change management.

In the end of study monitoring will be conducted with a coordinator visit of the research center and analysis activities, such as participants recruitment, data collection, data management, data analysis, reporting for adverse events, and change management. The investigator submits a clinical evaluation report to the sponsor.

Statistics The analysis will be carried out within groups at different time intervals (analysis of matched groups).

Before performing statistical analysis of the data, the distribution type of the variables will be assessed. To assess the normality of distribution for each variable, histograms of frequency distributions will be visually evaluated, indicators of skewness, kurtosis, and the D'Agostino-Pearson normality test will be used.

In addition to checking the type of distribution of variables, the equality of variances of the studied groups will be assessed using the methods of analysis of variance, in particular the Brown-Forsythe test.

Methods of descriptive analysis will be used depending on the type of distribution of the variable. With a normal distribution, the mean (M) and standard deviation (SD) will be calculated. In case of an nongaussian distribution, the median (Me) and interquartile range will be calculated. Different algorithms of statistical analysis will be applied depending on the type of distribution of variables.

Comparison of the paired groups with a normal distribution, in case of the equality of the variances, will be carried out by the methods of analysis of variance ANOVA. Comparison of groups in pairs will be performed using the post-hoc method of posterior multiple comparisons (Tukey test).

Comparison of groups in which variables do not follow the normal distribution will be carried out using the methods of nonparametric analysis of variations: the Friedman test for matched groups.

Differences will be considered statistically significant if the significance P values are <0.05.

Details
Condition Female Urogenital Diseases, Urinary Incontinence, Prolapse Genital, Menopausal Syndrome, Postmenopausal Period, Vaginal Atrophy, Vaginal Prolapse, Postpartum Period, Sexual Dysfunction, Preoperative Care, Postoperative Care
Treatment Blood test, Laser treatment, pelvic ultrasound, Vaginal smear, Female Sexual Function Index, Vaginal Health Index, International Consultation on Incontinence Questionnaire - Short Form, Clinical urine test, The Short Form Health Survey, Vital signs determination, pH of vagina determination, Physical parameters determination
Clinical Study IdentifierNCT05463081
SponsorMeLSyTech, Ltd
Last Modified on22 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Women from 18 years old in conditions caused by collagen deficiency in the treated area, women in premenopause and menopause
Participants who signed informed consent and fully informed about the purpose of the study
Following disorders
Stress urinary incontinence
Mixed urinary incontinence with a predominance of the stress component
Genitourinary menopausal syndrome
Dystrophic and atrophic processes in the genital area
Scleroatrophic changes in the urogenital region
Prolapse of the genitals I-II degree
Vaginal relaxation syndrome
Postpartum recovery
Sexual dysfunctions
Restoration of tone, turgor and tissue density of the urogenital area (Intimate rejuvenation, correction of age-related changes)
Preoperative preparation for genital prolapse surgery and postoperative rehabilitation

Exclusion Criteria

Age up to 18 years
Inability or unwillingness to give informed consent to participate in a trial or to fulfill the requirements of a clinical trial
The presence of contraindications to the use of a medical device
Pregnancy
Bleeding disorders accompanied by a violation of blood clotting
Use of anticoagulant medicines (post-infarction and post-stroke conditions)
Autoimmune diseases
Emerging infection diseases of any etiology
Damage to the skin (mucous membranes) in the area of laser treatment
Oncological diseases, cancer alertness
Decompensated diabetes
Photosensitizing drug administration
Decompensated somatic diseases
Decompensated cardiovascular disease, and other decompensated common diseases
Severe somatic diseases (heart failure, chronic renal failure, hepatitis, liver cirrhosis)
Severe autoimmune diseases (including hemorrhagic vasculitis)
Immunodeficiency (including HIV infection and AIDS)
Severe mental and neurological disorders
Bedridden and immobile patients
COVID 19
Acute inflammatory diseases of the urogenital area
Acute purulent processes of the urogenital region
Bleeding of a natural nature (menstruation) and any other types of bleeding in the urogenital area
Postoperative scars up to 6 months
Lateral cysts of the vagina
Growing uterine fibroid
Fillers / suture in the area of laser exposure
The presence of varicose veins of the urogenital region and dilated capillary plexuses of the mucosa
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note