Low Intensity Nanosecond Neodymium Laser for Complex Treatment of Pelvic Organs Prolapse
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- Mean Difference from Control Groups of Collagen Fibers Thickness in Vaginal Wall
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 35 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •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.
结局指标
主要结局
Mean Difference from Control Groups of Collagen Fibers Thickness in Vaginal Wall
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
- 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).)