Pelvic Organs Prolapse Treatment Using Neodymium Laser
Low Intensity Nanosecond Neodymium Laser for Complex Treatment of Pelvic Organs Prolapse
1 other identifier
interventional
129
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2021
CompletedFirst Posted
Study publicly available on registry
August 11, 2021
CompletedStudy Start
First participant enrolled
October 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedDecember 12, 2024
December 1, 2024
3.5 years
July 30, 2021
December 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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).
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
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
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).
Other Outcomes (32)
Mean Change from Baseline of Thickness of the Vaginal Wall
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 Change from Baseline of Pulsatility Index of Uterine Arteries
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 Change from Baseline of Volumetric Blood Flow of Uterine Arteries
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.
- +29 more other outcomes
Study Arms (3)
"Magic Max" ("Magic Gyno") Laser Treatment + Colporrhaphy
EXPERIMENTALLaser 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 COMPARATORA/R colporrhaphy only will be performed.
No Treatment (control group 2)
OTHERAny surgery which do not affect condition of vagina, vulva and paraurethral region will be performed.
Interventions
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.
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).
Urine sampling for Clinical urine test (to include the participant in the study).
Electrocardiography investigation to determine cardiac abnormalities (to include the participant in the study).
Vaginal smear for flora investigation, oncocytology (to include the participant in the study).
Colposcopy investigation to determine pre-malignant and malignant lesions of cervix, vagina or vulva (to include the participant in the study).
Pelvic ultrasound investigation to determine pathologies of the pelvic through a gynecological probe (to include the participant in the study).
Ultrasound investigation for assessing blood flow in the tissues of vulva region (to evaluate procedure efficiency).
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).
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 Questionnaire will be used to collect feedback on changes in the participants' life quality (to evaluate procedure efficiency).
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 will be used to collect feedback on changes in the participants' life quality (to evaluate procedure efficiency).
Pelvic Floor Impact Questionnaire will be used to collect feedback on changes in the participants' life quality (to evaluate procedure efficiency).
Surgical procedure to repair pelvic organ prolapse followed by biopsy for histological, immunohistochemical studies, and optical coherence tomography (elastography).
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).
Pelvic examination (to include the participant in the study and observe throughout the study)
Сonsultation of a therapist about the absence of contraindications for surgical treatment (to include the participant in the study)
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- 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;
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MeLSyTech, Ltdlead
Study Sites (1)
Federal State Budgetary Educational Institution of Higher Education "Privolzhsky Research Medical University" of the Ministry of Health of the Russian Federation
Nizhny Novgorod, 603950, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gennadij O Grechkanev, M.D.
Privolzhsky Research Medical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The treatment method cannot be hidden from the participants and the researcher because of the very different method of treatment: laser treatment followed by colporrhaphy and colporrhaphy only. However, the histologists involved in the study will not know which group the participant belongs to. The researcher will refer participants (or their materials) to these specialists, indicating their name. The Researcher will keep a document matching the participant's name and identification number.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2021
First Posted
August 11, 2021
Study Start
October 3, 2021
Primary Completion
April 1, 2025
Study Completion
April 1, 2025
Last Updated
December 12, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Time Frame
- IPD can be shared with researchers starting 3 months after CSR or article publication for five years.
- Access Criteria
- IPD can be shared with researchers only upon an official request from researcher's affiliation institution in the letter form on organization's letterhead paper signed by an authorized person. Official request must be directed by e-mail to the contact person (Ksenia Shatilova, shatilova@melsytech.com). The letter must contain the request purpose and statement of internal IPD use as confidential information only. IPD will be shared after approval by CEO of "MeLSyTech" Ltd according to the company internal rules. A requester will be notified of the decision by official letter. Depending on the decision, a requester will receive a link to the repository, or a justified rejection.
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.