Correction of Vulvovaginal Atrophy in Postmenopausal Women Using Neodymium Laser Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Mean Change from Baseline of Vaginal Health Index Score
研究概览
简要总结
The aim of this prospective study is characteristic of changes in the vaginal wall and vulva after treatment of neodymium laser radiation with a wavelength of 1064 nm. To assess the condition of the vaginal walls and vulva before and after laser treatment, the following methods will be used: vaginal health index, perineometry, elastography of vulva, cytological methods. Female Sexual Function Index (FSFI), The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), Vulvovaginal Symptoms Questionnaire (VSQ), Visual Analogue Scale (VAS) will be used to collect feedback on changes in the participants life quality. Total up to 120 participants with postmenopausal atrophy will be involved in the study. Participants will be divided into three groups: laser treatment group, topical hormones treatment group, and both laser treatment with topical hormones application group, by 40 participants in each. The time intervals between tests will be the same for all groups. Thus, a direct comparison between conventional treatment (topical hormones), laser treatment and combine laser and topical hormones therapy of the vaginal atrophy will be made. The main hypothesis of the study is improvement in condition of the vaginal walls after laser treatment and laser treatment with hormones application compared with the initial state of not less than thirty percent of participants, and improvement in condition on average compared with the hormones only therapy group.
详细描述
The principle of participant distribution into groups is the main method of treatment of postmenopausal vaginal atrophy. Total up to 120 participants with postmenopausal atrophy will be involved in the study. Participants will be divided into three groups: laser treatment group, topical hormones treatment group, laser treatment with topical hormones application, by 40 participants in each.
The types of examination of each group are the same and include:
General methods: physical examination, clinical blood analysis with glucose determination, clinical urine test, vaginal smear for flora and oncocytology, pelvic ultrasound.
Special methods: filling out the questionnaire (Female Sexual Function Index, The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, Vulvovaginal Symptoms Questionnaire), Vaginal Health Index determination, Visual Analogue Scale (VAS) determination, perineometry, vaginal smear for cytology, elastography of vulva, microbiological vaginal smear stained by Gram.
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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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 and the use of local hormones on their own. However, the specialists involved in the study (cytologist and ultrasound specialist) will not know which group the participant belongs to. The researcher will refer participants (or their materials) to these specialists, indicating their name and visit number. The Researcher will keep a document matching the participant's name and number.
The conversation will be held with participants. A participant must not disclose his group when visiting an ultrasound specialist.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age of over 50 years old, inclusive;
- •Participants diagnosed with genitourinary menopausal syndrome with severe signs of vulvovaginal atrophy;
- •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
- •Tendency to photoallergy including taking photosensitizing drugs (diuretics, antihistamines, antipsychotics);
- •Porphyria;
- •Active tuberculosis;
- •Damage to the vaginal mucosa;
- •Urinary tract infections in the acute stage;
- •Genital herpes in the acute stage;
- •Inflammatory diseases of the vulva and vagina in the acute stage;
- •Oncological diseases of the female reproductive system, including history of oncological diseases;
- •Precancerous diseases of the cervix, vagina and vulva;
- •The use of drugs and other methods of treatment (including laser) that can affect the result, less than 1 month before the start of the study and during the study (Menopausal hormone therapy, the use of topical estriol; Kegel exercises, physiotherapy, the use of pelvic floor muscle trainers).
- •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.
研究组 & 干预措施
Laser Treatment
Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks.
During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Laser Treatment (Device)
Laser Treatment
Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks.
During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Сlinical blood analysis (Diagnostic Test)
Laser Treatment
Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks.
During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Сlinical urine test (Diagnostic Test)
Laser Treatment
Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks.
During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Vaginal smear (Diagnostic Test)
Laser Treatment
Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks.
During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Pelvic ultrasound (Diagnostic Test)
Laser Treatment
Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks.
During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Female Sexual Function Index (Other)
Laser Treatment
Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks.
During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (Other)
Laser Treatment
Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks.
During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Vulvovaginal Symptoms Questionnaire (Other)
Laser Treatment
Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks.
During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Vaginal Health Index (Diagnostic Test)
Laser Treatment
Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks.
During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Elastography (ultrasound investigation) (Diagnostic Test)
Topical hormone
Local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms.
干预措施: Perineometry (Diagnostic Test)
Laser Treatment
Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks.
During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Perineometry (Diagnostic Test)
Laser Treatment
Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks.
During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Visual Analogue Scale (VAS) (Other)
Topical hormone
Local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms.
干预措施: Topical hormone estriol (Drug)
Topical hormone
Local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms.
干预措施: Сlinical blood analysis (Diagnostic Test)
Topical hormone
Local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms.
干预措施: Сlinical urine test (Diagnostic Test)
Topical hormone
Local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms.
干预措施: Vaginal smear (Diagnostic Test)
Topical hormone
Local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms.
干预措施: Pelvic ultrasound (Diagnostic Test)
Topical hormone
Local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms.
干预措施: Female Sexual Function Index (Other)
Topical hormone
Local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms.
干预措施: The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (Other)
Topical hormone
Local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms.
干预措施: Vulvovaginal Symptoms Questionnaire (Other)
Topical hormone
Local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms.
干预措施: Vaginal Health Index (Diagnostic Test)
Topical hormone
Local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms.
干预措施: Elastography (ultrasound investigation) (Diagnostic Test)
Topical hormone
Local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms.
干预措施: Visual Analogue Scale (VAS) (Other)
Laser Treatment + Topical hormone
Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks. During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
At the same time local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms.
干预措施: Laser Treatment (Device)
Laser Treatment + Topical hormone
Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks. During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
At the same time local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms.
干预措施: Topical hormone estriol (Drug)
Laser Treatment + Topical hormone
Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks. During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
At the same time local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms.
干预措施: Сlinical blood analysis (Diagnostic Test)
Laser Treatment + Topical hormone
Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks. During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
At the same time local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms.
干预措施: Сlinical urine test (Diagnostic Test)
Laser Treatment + Topical hormone
Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks. During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
At the same time local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms.
干预措施: Vaginal smear (Diagnostic Test)
Laser Treatment + Topical hormone
Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks. During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
At the same time local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms.
干预措施: Pelvic ultrasound (Diagnostic Test)
Laser Treatment + Topical hormone
Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks. During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
At the same time local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms.
干预措施: Female Sexual Function Index (Other)
Laser Treatment + Topical hormone
Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks. During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
At the same time local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms.
干预措施: The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (Other)
Laser Treatment + Topical hormone
Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks. During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
At the same time local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms.
干预措施: Vulvovaginal Symptoms Questionnaire (Other)
Laser Treatment + Topical hormone
Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks. During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
At the same time local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms.
干预措施: Vaginal Health Index (Diagnostic Test)
Laser Treatment + Topical hormone
Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks. During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
At the same time local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms.
干预措施: Elastography (ultrasound investigation) (Diagnostic Test)
Laser Treatment + Topical hormone
Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks. During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
At the same time local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms.
干预措施: Perineometry (Diagnostic Test)
Laser Treatment + Topical hormone
Laser treatment of the vagina, vulva, and paraurethral region with a "Magic Max" laser ("Magic Gyno"). In total, three procedures will be performed with an interval of 4-6 weeks. During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
At the same time local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy for 12 months to prevent symptoms.
干预措施: Visual Analogue Scale (VAS) (Other)
结局指标
主要结局
Mean Change from Baseline of Vaginal Health Index Score
时间窗: [Time Frame: 1st visit (before any treatment); 3d visit (4-6 weeks after 2nd visit); 4th visit (4-6 weeks after 3d visit) - the end of laser treatment; 1 month after 4th visit and 6 months after 4th visit]
Vaginal Health Index will be investigated by clinical examination for vagina: A. Vaginal elasticity (Characteristic=Points: Non=1, Poor=2, Fair=3, Good=4, Excellent=5), B. Vaginal secretions (None=1; Sсant, thin yellow=2; Superficial, thin white=3; Moderate, thin white=4; Normal (white)=5), C. Epithelial mucous membrane (Petechiae noted before contact=1, Bleeding with light contact=2, Bleeds with scraping, Not friable thin epithelium=4, Normal=5), D. Vaginal hydration (None, surface inflamed=1, None, surface nod inflamed=2, Minimal=3, Moderate=4, Normal=5), E. pH will be investigated by test-lines paper (≥6.1=1, 5.6-6.0=2, 5.1-5.5=3, 4.7-5.0=4, ≤4.6=5). Score=A+B+C+D+E
次要结局
未报告次要终点