Pelvic Organ ProlapseNCT05000957
Pelvic Organs Prolapse Treatment Using Neodymium Laser
A study testing Laser Treatment, Blood analysis and Сlinical urine test in people with Pelvic Organ Prolapse and Female Urogenital Diseases, run by MeLSyTech, Ltd at 1 site in Russia.
Trial summary
The aim of this prospective study is investigation of efficiency and safety of medical device "Magic Max" ("Magic Gyno" from August 2024) for preoperative treatment of pelvic organs prolapse I-II degree of severity. Read more about this study
- Who is it for?
- Ages 35 to 50 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Female Urogenital Diseases
- What is being tested?
- Laser Treatment, Blood analysis and Сlinical urine test
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteRussia
- Study dates
- 3 Oct 2021to 1 Apr 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 35 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 35-50 years old;
- Participants diagnosed with pelvic organ prolapse of I-II degree of severity or any non vaginal diseases which require surgical intervention by the method of laparotomy;
- 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
- Age of under 35 and over 50 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 20Show fewer
- Pregnancy;
- Tendency to photoallergy including taking photosensitizing drugs (diuretics, antihistamines, antipsychotics);
- Porphyria;
- Cardiac deficiency of 2-3 degrees;
- Chronic renal disease;
- Diabetes mellitus (type I, II);
- Participants with greater than 2nd 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 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 Budgetary Educational Institution of Higher Education "Privolzhsky Research Medical University" of the Ministry of Health of the Russian Federation
Nizhny Novgorod, 603950
About this study
Official title: Low Intensity Nanosecond Neodymium Laser for Complex Treatment of Pelvic Organs Prolapse
The aim of this prospective study is investigation of efficiency and safety of medical device "Magic Max" ("Magic Gyno" from August 2024) for preoperative treatment of pelvic organs prolapse I-II degree of severity. To assess the condition of the vaginal walls and vulva before and after laser treatment, the following methods will be used: ultrasonography with Doppler ultrasonography, vaginal health index, histological examination, immunohistochemical examination, optical coherence tomography (OCT) (elastography). Pelvic Floor Distress Inventory Questionnaire (PFDI-20), The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), Pelvic Floor Impact Questionnaire (PFIQ-7) will be used to collect feedback on changes in the participants life quality. Genetic testing of 12 gene variants will be carried out. Correlation of genes variants and treatment efficacy will be assessed. Total up to 135 participants with pelvic organs prolapse I-II degree of severity, or any other pathology of pelvic organs, which require surgical intervention will be involved in the study. Participants will be divided into three groups: group with anterior and/or posterior (A/P) colporrhaphy and laser preoperative treatment (laser treatment group), group with A/P colporrhaphy only (control group 1), and group with any other surgical intervention of pelvic area (control group 2), by 45 participants in each. The time intervals between tests will be the same for groups with A/P colporrhaphy, group with any other surgical intervention will be examined before and on the day of surgery without further observation. The main hypothesis of the study is improvement in condition of the vaginal walls after laser preoperative treatment compared with the control group 1.
Read the detailed description
The principle of participant distribution into groups is the type of surgical intervention and preoperative preparation. Total up to 135 participants with pelvic organs prolapse I-II degree of severity, or any other pathology of pelvic organs, which require surgical intervention will be involved in the study. Participants will be divided into three groups: group with anterior and/or posterior (A/P) colporrhaphy and laser preoperative treatment (laser treatment group), group with A/P colporrhaphy only (control group 1), and group with any other surgical intervention of pelvic area with obtaining a biopsy of the vaginal wall (control group 2), by 45 participants in each group.
The types of examination of each group are the same and include:
General methods: physical examination, clinical blood analysis including glucose determination, clinical urine test, vaginal smear for flora and oncocytology, pelvic ultrasound, tests for hepatitis B, C viruses, human immunodeficiency viruses and syphilis, blood clotting tests, blood type and rhesus factor determination, electrocardiography, colposcopy, consultation of a therapist about the absence of contraindications for surgical treatment.
Special methods: filling out the questionnaire (Pelvic Floor Distress Inventory Questionnaire, The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, International Consultation on Incontinence Questionnaire - Short Form, Pelvic Floor Impact Questionnaire), Vaginal Health Index determination, Doppler ultrasonography of vagina, histological examination, immunohistochemical examination, optical coherence tomography (OCT) (elastography).
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.
Genetic testing: genetic testing for the following markers will be carried out:
ESR1 rs2234693 (estrogen receptor 1), ESR1 rs2228480 (estrogen receptor 1), COL3A1 rs1800255 (collagen type III alpha 1 chain), COL14A1 rs4870723 (collagen type XIV alpha 1 chain), MMP9 rs3918253 (matrix metallopeptidase 9), MMP10 rs17435959 (matrix metallopeptidase 10), LOXL1 rs2304719 (lysyl oxidase like 1), WNT4 rs3820282 (Wnt family member 4), MMP2 rs243865 (matrix metalloproteinase type 2), TIMP2 rs2277698 (tissue inhibitor of metalloproteinase-2), CD31 / PECAM1 rs1131012 (platelet-endothelial cell adhesion molecule 1), Ki67 rs11016076 (proliferation marker Ki67).
Treatment Technique:
Laser treatment procedure will be carried out in three stages. In total, three procedures will be performed with an interval of 4 weeks. Colporrhaphy will be carried out 1 month after last treatment. Three follow-up visits will follow: 1, 6 and 12 months after colporrhaphy.
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 1.5 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.
Control Technique:
In the control groups general surgery preparation protocol (sanitation of vagina) will be used as a therapeutic tool. After completing of preparation course, the operation will be performed.
Operation technique:
A part of the stretched vaginal wall in the posterior fornix area including the mucous membrane and muscle layer will be excised with its further suturing during colporrhaphy surgery (the excised material will be examined). This will allow comparing the vaginal walls state at the time of surgery after laser treatment and without it, and with the age norm.
Participants of all groups will be tested with the general methods necessary to include the patient in the study at the first visit.
For the laser treatment group: Studies will be carried out using filling out the questionnaires, Vaginal Health Index determination, and Doppler ultrasonography, and then laser treatment of the vagina, vulva and paraurethral region will be performed during the 2nd, 3d, and 4th visits. Filling out the questionnaires, Vaginal Health Index determination, and Doppler ultrasonography will be repeated during the 5th visit (1 month after last laser treatment and 1 day before colporrhaphy). Vaginal biopsy for histological examination, immunohistochemical examination, and optical coherence tomography (elastography) will be carried out during A/P colporrhaphy in the 6th visit. Physical examination only will be carried out during the 7th (follow-up) visit - 1 month after colporrhaphy. Filling out the questionnaires, Vaginal Health Index determination, and Doppler ultrasonography will be carried out during 8th and 9th (follow-up) visits - 6 and 12 months after colporrhaphy.
For control group 1: Studies will be carried out using filling out the questionnaires, Vaginal Health Index determination, and Doppler ultrasonography during the 1st visit after including patient. Vaginal biopsy for histological examination, immunohistochemical examination, and optical coherence tomography (elastography) will be carried out during A/P colporrhaphy in the 2nd visit. Physical examination only will be carried out during the 3th (follow-up) visit - 1 month after colporrhaphy. Filling out the questionnaire, Vaginal Health Index determination, and Doppler ultrasonography will be carried out during 4th and 5th (follow-up) visits - 6 and 12 months after colporrhaphy. Buccal smear collection will be carried out during 4th follow up visit (6 months after colporrhaphy).
Thus, a direct comparison between laser preoperational treatment and lack of preoperational treatment will be made during the investigation, 6 and 12 months after the end of each type of treatment.
For control group 2: Studies will be carried out using filling out the questionnaires, Vaginal Health Index determination, and Doppler ultrasonography during the 1st visit after including participant. Vaginal biopsy for histological examination, immunohistochemical examination, and optical coherence tomography (elastography) will be carried out during A/P colporrhaphy in the 2nd visit (no more than 1 month after 1st visit). The obtained data will allow to study the tissues of the vaginal wall in normal conditions.
The study will be carried out with the participation of several clinics:
(recruting, filling out IRC - Individual Registration Cards, buccal smear collection) (colporrhaphy and biopsy)
- Privolzhsky Research Medical University (main scientific coordinator, histological examination, immunohistochemical examination, and optical coherence tomography (elastography)), genetic examination,
- LLC "Medical Center" AIST "" (location of laser equipment, recruiting, filling out IRC - Individual Registration Cards laser treatment, special tests, buccal smear collection),
- State Budgetary Institution of Health Care of the Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Oncological Dispensary" (colporrhaphy and biopsy, buccal smear collection),
- Clinic "Preventamed", LLC "Aesthetic Medicine" (recruting, filling out IRC - Individual Registration Cards, buccal smear collection),
- State-Funded Healthcare Institution of the Nizhny Novgorod region "Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko" (recruting, filling out IRC - Individual Registration Cards, buccal smear collection),
- Birth house №4 of the Leninskiy District of Nizhny Novgorod named after A.F. Dobrotina (colporrhaphy and biopsy) All data obtained during the study will be transferred to the manufacturer of laser equipment "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.
- Conditions
- Pelvic Organ Prolapse, Female Urogenital Diseases
- Being tested
- Laser Treatment, Blood analysis, Сlinical urine test, Electrocardiography, Vaginal smear
- Keywords
- Pelvic Organ Prolapse, Colporrhaphy, Neodymium Laser, Laser Treatment, Nanosecond, Laser, Vaginal, Female Urogenital Diseases
- Medical subject headings
- Pelvic Organ Prolapse, 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 1.5 mJ.
General laser radiation parameters for 1st and 2nd stages are: beam with diameter of 4 millimeters (mm) scans treatment area by 4 circles with step of 2 mm (50 percentage (%) overlap), average power of 10-25 Watt (W), treatment time in one point of 1-10 seconds (s), treatment step of 5 mm, from 1 to 5 repetitions of total vagina treatment. General laser radiation parameters for 3d stage are: beam diameter of 6 mm, average power of 15-30 W, duration of ns-pulses packet of 50-100 milliseconds (ms), pause between packets of 50-100 ms, treatment duration up to 65 s, treatment in permanent motion with speed of 10-50 mm/s.
The procedure is performed without anesthesia. The doctor always focuses on the participant's feeling of warmth.
Blood analysisDiagnostic test
Taking blood from a vein for clinical blood analysis, glucose test, hepatitis B, C viruses, human immunodeficiency viruses and syphilis test, blood clotting tests, blood type and rhesus factor determination (to include the participant in the study).
Сlinical urine testDiagnostic test
Urine sampling for Clinical urine test (to include the participant in the study).
ElectrocardiographyDiagnostic test
Electrocardiography investigation to determine cardiac abnormalities (to include the participant in the study).
Vaginal smearDiagnostic test
Vaginal smear for flora investigation, oncocytology (to include the participant in the study).
ColposcopyDiagnostic test
Colposcopy investigation to determine pre-malignant and malignant lesions of cervix, vagina or vulva (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).
Doppler ultrasonographyDiagnostic test
Ultrasound investigation for assessing blood flow in the tissues of vulva region (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).
Biopsy of the vaginal wallDiagnostic test
Sampling of the vaginal wall material in the posterior fornix area including the mucous membrane and muscle layer will be performed during colporrhaphy or any pelvic surgical procedure for histological, immunohistochemical studies, and optical coherence tomography (elastography) (to evaluate procedure efficiency)
The Pelvic Organ Prolapse/Urinary Incontinence Sexual QuestionnaireDiagnostic test
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).
Pelvic Floor Distress Inventory QuestionnaireDiagnostic test
Pelvic Floor Distress Inventory Questionnaire will be used to collect feedback on changes in the participants' life quality (to evaluate procedure efficiency).
International Consultation on Incontinence Questionnaire - Short FormDiagnostic test
International Consultation on Incontinence Questionnaire will be used to collect feedback on changes in the participants' life quality (to evaluate procedure efficiency).
Pelvic Floor Impact QuestionnaireDiagnostic test
Pelvic Floor Impact Questionnaire will be used to collect feedback on changes in the participants' life quality (to evaluate procedure efficiency).
Anterior and/or posterior colporrhaphyProcedure or surgery
Surgical procedure to repair pelvic organ prolapse followed by biopsy for histological, immunohistochemical studies, and optical coherence tomography (elastography).
Pelvic surgical procedureProcedure or surgery
Any pelvic surgical procedure which do not affect condition of vagina, vulva and paraurethral region followed by biopsy for histological, immunohistochemical studies, and optical coherence tomography (elastography).
Physical examinationOther
Pelvic examination (to include the participant in the study and observe throughout the study)
СonsultationOther
Сonsultation of a therapist about the absence of contraindications for surgical treatment (to include the participant in the study)
Buccal smearGenetic
Buccal smear to performing genetic testing.
The following markers will be analyzed:
ESR1 rs2234693, ESR1 rs2228480, COL3A1 rs1800255, COL14A1 rs4870723, MMP9 rs3918253, MMP10 rs17435959, LOXL1 rs2304719, WNT4 rs3820282, MMP2 rs243865, TIMP2 rs2277698, CD31 / PECAM1 rs1131012, Ki67 rs11016076.
| Study group | Role | What they receive |
|---|---|---|
| "Magic Max" ("Magic Gyno") Laser Treatment + Colporrhaphy | Experimental | Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" ("Magic Gyno") laser. In total, three procedures will be performed with an interval of 4 weeks.
During the procedure, the following sequence of actions will be performed:
1. st Stage - vaginal processing with a conical mirror handpiece,
2. nd Stage - vaginal processing with a corner mirror handpiece,
3. d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
A/R colporrhaphy will be performed 1 month after last laser treatment. Receives: Device: Laser Treatment; Diagnostic Test: Blood analysis; Diagnostic Test: Сlinical urine test; Diagnostic Test: Electrocardiography; Diagnostic Test: Vaginal smear; Diagnostic Test: Colposcopy; Diagnostic Test: Pelvic ultrasound; Diagnostic Test: Doppler ultrasonography; Diagnostic Test: Vaginal Health Index; Diagnostic Test: Biopsy of the vaginal wall; Diagnostic Test: The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire; Diagnostic Test: Pelvic Floor Distress Inventory Questionnaire; Diagnostic Test: International Consultation on Incontinence Questionnaire - Short Form; Diagnostic Test: Pelvic Floor Impact Questionnaire; Procedure: Anterior and/or posterior colporrhaphy; Other: Physical examination; Other: Сonsultation; Genetic: Buccal smear |
| Colporrhaphy (control group 1) | Active comparator | A/R colporrhaphy only will be performed. Receives: Diagnostic Test: Blood analysis; Diagnostic Test: Сlinical urine test; Diagnostic Test: Electrocardiography; Diagnostic Test: Vaginal smear; Diagnostic Test: Colposcopy; Diagnostic Test: Pelvic ultrasound; Diagnostic Test: Doppler ultrasonography; Diagnostic Test: Vaginal Health Index; Diagnostic Test: Biopsy of the vaginal wall; Diagnostic Test: The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire; Diagnostic Test: Pelvic Floor Distress Inventory Questionnaire; Diagnostic Test: International Consultation on Incontinence Questionnaire - Short Form; Diagnostic Test: Pelvic Floor Impact Questionnaire; Procedure: Anterior and/or posterior colporrhaphy; Other: Physical examination; Other: Сonsultation |
| No Treatment (control group 2) | Other | Any surgery which do not affect condition of vagina, vulva and paraurethral region will be performed. Receives: Diagnostic Test: Blood analysis; Diagnostic Test: Сlinical urine test; Diagnostic Test: Electrocardiography; Diagnostic Test: Vaginal smear; Diagnostic Test: Colposcopy; Diagnostic Test: Pelvic ultrasound; Diagnostic Test: Doppler ultrasonography; Diagnostic Test: Vaginal Health Index; Diagnostic Test: Biopsy of the vaginal wall; Diagnostic Test: The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire; Diagnostic Test: Pelvic Floor Distress Inventory Questionnaire; Diagnostic Test: International Consultation on Incontinence Questionnaire - Short Form; Diagnostic Test: Pelvic Floor Impact Questionnaire; Procedure: Pelvic surgical procedure; Other: Physical examination; Other: Сonsultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Difference from Control Groups of Collagen Fibers Thickness in Vaginal Wall
Measurement is a part of histological examination. The quantitative assessment of collagen fibers thickness will be carried out using the ImageJ Fiji (version 1.2) software package on histological samples stained with Van Gieson's picrofuchsin. To obtain images, a light microscope with 20x objective magnification and CMOS APS-C camera will be used. The value of the collagen fiber thickness will be determined throughout the entire depth of the submucosa in 5 non-overlapping fields of view for each participant. The average value of the collagen fibers thickness will be determined based on 5 measurements in each field of view (25 measurements in total). Collagen Fibers Thickness will be measured in micrometers.
Measured: day of colporrhaphy or any surgery (laser treatment group: 1 month after last laser treatment - visit 6, control groups - no more than a month after the participant was included in the study - visit 2).
Mean Difference from Control Groups of Collagen Fibers Length in Vaginal Wall
Measurement is a part of histological examination. The quantitative assessment of collagen fibers length will be carried out using the ImageJ Fiji (version 1.2) software package on histological samples stained with Van Gieson's picrofuchsin. To obtain images, a light microscope with 20x objective magnification and CMOS APS-C camera will be used. The value of the collagen fiber length will be determined throughout the entire depth of the submucosa in 5 non-overlapping fields of view for each participant. The average value of the collagen fiber length will be determined based on 5 measurements in each field of view (25 measurements in total). Collagen Fibers Length will be measured in micrometers.
Measured: day of colporrhaphy or any surgery (laser treatment group: 1 month after last laser treatment - visit 6, control groups - no more than a month after the participant was included in the study - visit 2).
Mean Difference from Control Groups of Thickness of the Vaginal Wall
Measurement is a part of histological examination. Thickness of the Vaginal Wall will be measured using the ImageJ Fiji software package (version 1.2) on histological samples stained with hematoxylin and eosin. To obtain images, a light microscope with 4x objective magnification and CMOS APS-C camera will be used. The measurement will be carried out at three points of the histological section perpendicular to the surface of the epithelium. The thickness will be measured from the surface layer of the epithelium to the border of the submucosa and muscle layer. Zones of tissue deformation will not be considered. An average vaginal wall thickness will be determined for each participant. Thickness of the Vaginal Wall will be measured in millimeters (mm).
Measured: day of colporrhaphy or any surgery (laser treatment group: 1 month after last laser treatment - visit 6, control groups - no more than a month after the participant was included in the study - visit 2).
Secondary outcomes (2)
Mean Change from Baseline of Artery Perfusion Index
Measurement is a part of ultrasonography. Perfusion Index will be measured with US-device. Artery Perfusion Index (API) is the total volumetric blood flow of both uterine arteries per 1 cubic centimeter (cm^3) of the uterine body. API will be calculated in percentages (%). Artery Perfusion Index is calculated by the following equation: API = (VvolRUA + VvolLUA)/Vu*100, where VvolRUA - right uterine artery volumetric blood flow (cm^3 per cardiac cycle), VvolLUA - left uterine artery volumetric blood flow (cm^3 per cardiac cycle), Vu - uterus volume (cm^3).
Measured: before any intervention: laser treatment, colporrhaphy, or any surgery; before colporrhaphy - 1 month after last laser treatment (for laser treatment group); 6 and 12 months after any colporrhaphy or any surgery.
Mean Difference from Control Groups of Number of Fibroblasts in Vaginal Wall
Measurement is a part of histological examination. The quantitative assessment of fibroblasts will be carried out visually in histological samples stained with hematoxylin and eosin. The number of fibroblasts will be counted for each participant in five non-overlapping fields of view at 400x magnification in view field diameter of 0.5 millimeter (mm) with light microscope. The average value will be calculated. Number of Fibroblasts will be measured in units per field of view.
Measured: day of colporrhaphy or any surgery (laser treatment group: 1 month after last laser treatment - visit 6, control groups - no more than a month after the participant was included in the study - visit 2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start3 Oct 2021
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- MeLSyTech, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gennadij O Grechkanev, M.D., Principal investigator, Privolzhsky Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000957
- Sponsor's protocol ID
- POPTUNL-2021
- Status last verified
- Dec 2024
- First submitted
- 30 Jul 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
- Low Intensity Nanosecond Neodymium Laser for Complex Treatment of Pelvic Organs Prolapse
- ClinicalTrials.gov ID
- NCT05000957
- Acronym / sponsor ID
- POPTUNL-2021
- Conditions
- Pelvic Organ Prolapse, Female Urogenital Diseases
- Keywords
- Pelvic Organ Prolapse, Colporrhaphy, Neodymium Laser, Laser Treatment, Nanosecond, Laser, Vaginal, Female Urogenital Diseases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 129 participants (actual)
- Lead sponsor
- MeLSyTech, LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2021 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 11 Aug 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 investigation of efficiency and safety of medical device "Magic Max" ("Magic Gyno" from August 2024) for preoperative treatment of pelvic organs prolapse I-II degree of severity. To assess the condition of the vaginal walls and vulva before and after laser treatment, the following methods will be used: ultrasonography with Doppler ultrasonography, vaginal health index, histological examination, immunohistochemical examination, optical coherence tomography (OCT) (elastography). Pelvic Floor Distress Inventory Questionnaire (PFDI-20), The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), Pelvic Floor Impact Questionnaire (PFIQ-7) will be used to collect feedback on changes in the participants life quality. Genetic testing of 12 gene variants will be carried out. Correlation of genes variants and treatment efficacy will be assessed. Total up to 135 participants with pelvic organs prolapse I-II degree of severity, or any other pathology of pelvic organs, which require surgical intervention will be involved in the study. Participants will be divided into three groups: group with anterior and/or posterior (A/P) colporrhaphy and laser preoperative treatment (laser treatment group), group with A/P colporrhaphy only (control group 1), and group with any other surgical intervention of pelvic area (control group 2), by 45 participants in each. The time intervals between tests will be the same for groups with A/P colporrhaphy, group with any other surgical intervention will be examined before and on the day of surgery without further observation. The main hypothesis of the study is improvement in condition of the vaginal walls after laser preoperative treatment compared with the control group 1.
Detailed description
The principle of participant distribution into groups is the type of surgical intervention and preoperative preparation. Total up to 135 participants with pelvic organs prolapse I-II degree of severity, or any other pathology of pelvic organs, which require surgical intervention will be involved in the study. Participants will be divided into three groups: group with anterior and/or posterior (A/P) colporrhaphy and laser preoperative treatment (laser treatment group), group with A/P colporrhaphy only (control group 1), and group with any other surgical intervention of pelvic area with obtaining a biopsy of the vaginal wall (control group 2), by 45 participants in each group.
The types of examination of each group are the same and include:
General methods: physical examination, clinical blood analysis including glucose determination, clinical urine test, vaginal smear for flora and oncocytology, pelvic ultrasound, tests for hepatitis B, C viruses, human immunodeficiency viruses and syphilis, blood clotting tests, blood type and rhesus factor determination, electrocardiography, colposcopy, consultation of a therapist about the absence of contraindications for surgical treatment.
Special methods: filling out the questionnaire (Pelvic Floor Distress Inventory Questionnaire, The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, International Consultation on Incontinence Questionnaire - Short Form, Pelvic Floor Impact Questionnaire), Vaginal Health Index determination, Doppler ultrasonography of vagina, histological examination, immunohistochemical examination, optical coherence tomography (OCT) (elastography).
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.
Genetic testing: genetic testing for the following markers will be carried out:
ESR1 rs2234693 (estrogen receptor 1), ESR1 rs2228480 (estrogen receptor 1), COL3A1 rs1800255 (collagen type III alpha 1 chain), COL14A1 rs4870723 (collagen type XIV alpha 1 chain), MMP9 rs3918253 (matrix metallopeptidase 9), MMP10 rs17435959 (matrix metallopeptidase 10), LOXL1 rs2304719 (lysyl oxidase like 1), WNT4 rs3820282 (Wnt family member 4), MMP2 rs243865 (matrix metalloproteinase type 2), TIMP2 rs2277698 (tissue inhibitor of metalloproteinase-2), CD31 / PECAM1 rs1131012 (platelet-endothelial cell adhesion molecule 1), Ki67 rs11016076 (proliferation marker Ki67).
Treatment Technique:
Laser treatment procedure will be carried out in three stages. In total, three procedures will be performed with an interval of 4 weeks. Colporrhaphy will be carried out 1 month after last treatment. Three follow-up visits will follow: 1, 6 and 12 months after colporrhaphy.
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 1.5 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.
Control Technique:
In the control groups general surgery preparation protocol (sanitation of vagina) will be used as a therapeutic tool. After completing of preparation course, the operation will be performed.
Operation technique:
A part of the stretched vaginal wall in the posterior fornix area including the mucous membrane and muscle layer will be excised with its further suturing during colporrhaphy surgery (the excised material will be examined). This will allow comparing the vaginal walls state at the time of surgery after laser treatment and without it, and with the age norm.
Participants of all groups will be tested with the general methods necessary to include the patient in the study at the first visit.
For the laser treatment group: Studies will be carried out using filling out the questionnaires, Vaginal Health Index determination, and Doppler ultrasonography, and then laser treatment of the vagina, vulva and paraurethral region will be performed during the 2nd, 3d, and 4th visits. Filling out the questionnaires, Vaginal Health Index determination, and Doppler ultrasonography will be repeated during the 5th visit (1 month after last laser treatment and 1 day before colporrhaphy). Vaginal biopsy for histological examination, immunohistochemical examination, and optical coherence tomography (elastography) will be carried out during A/P colporrhaphy in the 6th visit. Physical examination only will be carried out during the 7th (follow-up) visit - 1 month after colporrhaphy. Filling out the questionnaires, Vaginal Health Index determination, and Doppler ultrasonography will be carried out during 8th and 9th (follow-up) visits - 6 and 12 months after colporrhaphy.
For control group 1: Studies will be carried out using filling out the questionnaires, Vaginal Health Index determination, and Doppler ultrasonography during the 1st visit after including patient. Vaginal biopsy for histological examination, immunohistochemical examination, and optical coherence tomography (elastography) will be carried out during A/P colporrhaphy in the 2nd visit. Physical examination only will be carried out during the 3th (follow-up) visit - 1 month after colporrhaphy. Filling out the questionnaire, Vaginal Health Index determination, and Doppler ultrasonography will be carried out during 4th and 5th (follow-up) visits - 6 and 12 months after colporrhaphy. Buccal smear collection will be carried out during 4th follow up visit (6 months after colporrhaphy).
Thus, a direct comparison between laser preoperational treatment and lack of preoperational treatment will be made during the investigation, 6 and 12 months after the end of each type of treatment.
For control group 2: Studies will be carried out using filling out the questionnaires, Vaginal Health Index determination, and Doppler ultrasonography during the 1st visit after including participant. Vaginal biopsy for histological examination, immunohistochemical examination, and optical coherence tomography (elastography) will be carried out during A/P colporrhaphy in the 2nd visit (no more than 1 month after 1st visit). The obtained data will allow to study the tissues of the vaginal wall in normal conditions.
The study will be carried out with the participation of several clinics:
(recruting, filling out IRC - Individual Registration Cards, buccal smear collection) (colporrhaphy and biopsy)
- Privolzhsky Research Medical University (main scientific coordinator, histological examination, immunohistochemical examination, and optical coherence tomography (elastography)), genetic examination,
- LLC "Medical Center" AIST "" (location of laser equipment, recruiting, filling out IRC - Individual Registration Cards laser treatment, special tests, buccal smear collection),
- State Budgetary Institution of Health Care of the Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Oncological Dispensary" (colporrhaphy and biopsy, buccal smear collection),
- Clinic "Preventamed", LLC "Aesthetic Medicine" (recruting, filling out IRC - Individual Registration Cards, buccal smear collection),
- State-Funded Healthcare Institution of the Nizhny Novgorod region "Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko" (recruting, filling out IRC - Individual Registration Cards, buccal smear collection),
- Birth house №4 of the Leninskiy District of Nizhny Novgorod named after A.F. Dobrotina (colporrhaphy and biopsy) All data obtained during the study will be transferred to the manufacturer of laser equipment "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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| "Magic Max" ("Magic Gyno") Laser Treatment + Colporrhaphy | Experimental | Device: Laser Treatment, Diagnostic Test: Blood analysis, Diagnostic Test: Сlinical urine test, Diagnostic Test: Electrocardiography, Diagnostic Test: Vaginal smear, Diagnostic Test: Colposcopy, Diagnostic Test: Pelvic ultrasound, Diagnostic Test: Doppler ultrasonography, Diagnostic Test: Vaginal Health Index, Diagnostic Test: Biopsy of the vaginal wall, Diagnostic Test: The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, Diagnostic Test: Pelvic Floor Distress Inventory Questionnaire, Diagnostic Test: International Consultation on Incontinence Questionnaire - Short Form, Diagnostic Test: Pelvic Floor Impact Questionnaire, Procedure: Anterior and/or posterior colporrhaphy, Other: Physical examination, Other: Сonsultation, Genetic: Buccal smearLaser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" ("Magic Gyno") laser. In total, three procedures will be performed with an interval of 4 weeks. During the procedure, the following sequence of actions will be performed: 1. st Stage - vaginal processing with a conical mirror handpiece, 2. nd Stage - vaginal processing with a corner mirror handpiece, 3. d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece. A/R colporrhaphy will be performed 1 month after last laser treatment. |
| Colporrhaphy (control group 1) | Active comparator | Diagnostic Test: Blood analysis, Diagnostic Test: Сlinical urine test, Diagnostic Test: Electrocardiography, Diagnostic Test: Vaginal smear, Diagnostic Test: Colposcopy, Diagnostic Test: Pelvic ultrasound, Diagnostic Test: Doppler ultrasonography, Diagnostic Test: Vaginal Health Index, Diagnostic Test: Biopsy of the vaginal wall, Diagnostic Test: The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, Diagnostic Test: Pelvic Floor Distress Inventory Questionnaire, Diagnostic Test: International Consultation on Incontinence Questionnaire - Short Form, Diagnostic Test: Pelvic Floor Impact Questionnaire, Procedure: Anterior and/or posterior colporrhaphy, Other: Physical examination, Other: СonsultationA/R colporrhaphy only will be performed. |
| No Treatment (control group 2) | Other | Diagnostic Test: Blood analysis, Diagnostic Test: Сlinical urine test, Diagnostic Test: Electrocardiography, Diagnostic Test: Vaginal smear, Diagnostic Test: Colposcopy, Diagnostic Test: Pelvic ultrasound, Diagnostic Test: Doppler ultrasonography, Diagnostic Test: Vaginal Health Index, Diagnostic Test: Biopsy of the vaginal wall, Diagnostic Test: The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, Diagnostic Test: Pelvic Floor Distress Inventory Questionnaire, Diagnostic Test: International Consultation on Incontinence Questionnaire - Short Form, Diagnostic Test: Pelvic Floor Impact Questionnaire, Procedure: Pelvic surgical procedure, Other: Physical examination, Other: СonsultationAny surgery which do not affect condition of vagina, vulva and paraurethral region will be performed. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 35-50 years old;
- Participants diagnosed with pelvic organ prolapse of I-II degree of severity or any non vaginal diseases which require surgical intervention by the method of laparotomy;
- 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 (20 listed)
- Age of under 35 and over 50 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 1.5 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 | "Magic Max" ("Magic Gyno") Laser Treatment + Colporrhaphy |
| Blood analysisTaking blood from a vein for clinical blood analysis, glucose test, hepatitis B, C viruses, human immunodeficiency viruses and syphilis test, blood clotting tests, blood type and rhesus factor determination (to include the participant in the study). | Diagnostic test | "Magic Max" ("Magic Gyno") Laser Treatment + Colporrhaphy, Colporrhaphy (control group 1), No Treatment (control group 2) |
| Сlinical urine testUrine sampling for Clinical urine test (to include the participant in the study). | Diagnostic test | "Magic Max" ("Magic Gyno") Laser Treatment + Colporrhaphy, Colporrhaphy (control group 1), No Treatment (control group 2) |
| ElectrocardiographyElectrocardiography investigation to determine cardiac abnormalities (to include the participant in the study). | Diagnostic test | "Magic Max" ("Magic Gyno") Laser Treatment + Colporrhaphy, Colporrhaphy (control group 1), No Treatment (control group 2) |
| Vaginal smearVaginal smear for flora investigation, oncocytology (to include the participant in the study). | Diagnostic test | "Magic Max" ("Magic Gyno") Laser Treatment + Colporrhaphy, Colporrhaphy (control group 1), No Treatment (control group 2) |
| ColposcopyColposcopy investigation to determine pre-malignant and malignant lesions of cervix, vagina or vulva (to include the participant in the study). | Diagnostic test | "Magic Max" ("Magic Gyno") Laser Treatment + Colporrhaphy, Colporrhaphy (control group 1), No Treatment (control group 2) |
| Pelvic ultrasoundPelvic ultrasound investigation to determine pathologies of the pelvic through a gynecological probe (to include the participant in the study). | Diagnostic test | "Magic Max" ("Magic Gyno") Laser Treatment + Colporrhaphy, Colporrhaphy (control group 1), No Treatment (control group 2) |
| Doppler ultrasonographyUltrasound investigation for assessing blood flow in the tissues of vulva region (to evaluate procedure efficiency). | Diagnostic test | "Magic Max" ("Magic Gyno") Laser Treatment + Colporrhaphy, Colporrhaphy (control group 1), No Treatment (control group 2) |
| 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 | "Magic Max" ("Magic Gyno") Laser Treatment + Colporrhaphy, Colporrhaphy (control group 1), No Treatment (control group 2) |
| Biopsy of the vaginal wallSampling of the vaginal wall material in the posterior fornix area including the mucous membrane and muscle layer will be performed during colporrhaphy or any pelvic surgical procedure for histological, immunohistochemical studies, and optical coherence tomography (elastography) (to evaluate procedure efficiency) | Diagnostic test | "Magic Max" ("Magic Gyno") Laser Treatment + Colporrhaphy, Colporrhaphy (control group 1), No Treatment (control group 2) |
| 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). | Diagnostic test | "Magic Max" ("Magic Gyno") Laser Treatment + Colporrhaphy, Colporrhaphy (control group 1), No Treatment (control group 2) |
| Pelvic Floor Distress Inventory QuestionnairePelvic Floor Distress Inventory Questionnaire will be used to collect feedback on changes in the participants' life quality (to evaluate procedure efficiency). | Diagnostic test | "Magic Max" ("Magic Gyno") Laser Treatment + Colporrhaphy, Colporrhaphy (control group 1), No Treatment (control group 2) |
| International Consultation on Incontinence Questionnaire - Short FormInternational Consultation on Incontinence Questionnaire will be used to collect feedback on changes in the participants' life quality (to evaluate procedure efficiency). | Diagnostic test | "Magic Max" ("Magic Gyno") Laser Treatment + Colporrhaphy, Colporrhaphy (control group 1), No Treatment (control group 2) |
| Pelvic Floor Impact QuestionnairePelvic Floor Impact Questionnaire will be used to collect feedback on changes in the participants' life quality (to evaluate procedure efficiency). | Diagnostic test | "Magic Max" ("Magic Gyno") Laser Treatment + Colporrhaphy, Colporrhaphy (control group 1), No Treatment (control group 2) |
| Anterior and/or posterior colporrhaphySurgical procedure to repair pelvic organ prolapse followed by biopsy for histological, immunohistochemical studies, and optical coherence tomography (elastography). | Procedure or surgery | "Magic Max" ("Magic Gyno") Laser Treatment + Colporrhaphy, Colporrhaphy (control group 1) |
| Pelvic surgical procedureAny pelvic surgical procedure which do not affect condition of vagina, vulva and paraurethral region followed by biopsy for histological, immunohistochemical studies, and optical coherence tomography (elastography). | Procedure or surgery | No Treatment (control group 2) |
| Physical examinationPelvic examination (to include the participant in the study and observe throughout the study) | Other | "Magic Max" ("Magic Gyno") Laser Treatment + Colporrhaphy, Colporrhaphy (control group 1), No Treatment (control group 2) |
| СonsultationСonsultation of a therapist about the absence of contraindications for surgical treatment (to include the participant in the study) | Other | "Magic Max" ("Magic Gyno") Laser Treatment + Colporrhaphy, Colporrhaphy (control group 1), No Treatment (control group 2) |
| Buccal smearBuccal smear to performing genetic testing. The following markers will be analyzed: ESR1 rs2234693, ESR1 rs2228480, COL3A1 rs1800255, COL14A1 rs4870723, MMP9 rs3918253, MMP10 rs17435959, LOXL1 rs2304719, WNT4 rs3820282, MMP2 rs243865, TIMP2 rs2277698, CD31 / PECAM1 rs1131012, Ki67 rs11016076. | Genetic | "Magic Max" ("Magic Gyno") Laser Treatment + Colporrhaphy |
Primary outcome
Mean Difference from Control Groups of Collagen Fibers Thickness in Vaginal Wall
Time frame: day of colporrhaphy or any surgery (laser treatment group: 1 month after last laser treatment - visit 6, control groups - no more than a month after the participant was included in the study - visit 2).
Measurement is a part of histological examination. The quantitative assessment of collagen fibers thickness will be carried out using the ImageJ Fiji (version 1.2) software package on histological samples stained with Van Gieson's picrofuchsin. To obtain images, a light microscope with 20x objective magnification and CMOS APS-C camera will be used. The value of the collagen fiber thickness will be determined throughout the entire depth of the submucosa in 5 non-overlapping fields of view for each participant. The average value of the collagen fibers thickness will be determined based on 5 measurements in each field of view (25 measurements in total). Collagen Fibers Thickness will be measured in micrometers.
Mean Difference from Control Groups of Collagen Fibers Length in Vaginal Wall
Time frame: day of colporrhaphy or any surgery (laser treatment group: 1 month after last laser treatment - visit 6, control groups - no more than a month after the participant was included in the study - visit 2).
Measurement is a part of histological examination. The quantitative assessment of collagen fibers length will be carried out using the ImageJ Fiji (version 1.2) software package on histological samples stained with Van Gieson's picrofuchsin. To obtain images, a light microscope with 20x objective magnification and CMOS APS-C camera will be used. The value of the collagen fiber length will be determined throughout the entire depth of the submucosa in 5 non-overlapping fields of view for each participant. The average value of the collagen fiber length will be determined based on 5 measurements in each field of view (25 measurements in total). Collagen Fibers Length will be measured in micrometers.
Mean Difference from Control Groups of Thickness of the Vaginal Wall
Time frame: day of colporrhaphy or any surgery (laser treatment group: 1 month after last laser treatment - visit 6, control groups - no more than a month after the participant was included in the study - visit 2).
Measurement is a part of histological examination. Thickness of the Vaginal Wall will be measured using the ImageJ Fiji software package (version 1.2) on histological samples stained with hematoxylin and eosin. To obtain images, a light microscope with 4x objective magnification and CMOS APS-C camera will be used. The measurement will be carried out at three points of the histological section perpendicular to the surface of the epithelium. The thickness will be measured from the surface layer of the epithelium to the border of the submucosa and muscle layer. Zones of tissue deformation will not be considered. An average vaginal wall thickness will be determined for each participant. Thickness of the Vaginal Wall will be measured in millimeters (mm).
2 secondary outcomes
Mean Change from Baseline of Artery Perfusion Index
Time frame: before any intervention: laser treatment, colporrhaphy, or any surgery; before colporrhaphy - 1 month after last laser treatment (for laser treatment group); 6 and 12 months after any colporrhaphy or any surgery.
Mean Difference from Control Groups of Number of Fibroblasts in Vaginal Wall
Time frame: day of colporrhaphy or any surgery (laser treatment group: 1 month after last laser treatment - visit 6, control groups - no more than a month after the participant was included in the study - visit 2).
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.
Related trials for Pelvic Organ Prolapse
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
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.
Gennadij O Grechkanev, M.D. 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, Blood analysis and Сlinical urine test in people with Pelvic Organ Prolapse and Female Urogenital Diseases, 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 20 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: under way, not looking for participants, 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?
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 Difference from Control Groups of Collagen Fibers Thickness in Vaginal Wall (time frame: day of colporrhaphy or any surgery (laser treatment group: 1 month after last laser treatment - visit 6, control groups - no more than a month after the participant was included in the study - visit 2).). 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.