Comparative Study : The Effect of Vaginal Estrogen Use, Fractional CO2 LASER and Microablative Fractional Radiofrequency in the Treatment of Vaginal Atrophy: Clinical, Histological, Immunohistochemical and Molecular Biology Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Life's quality questionnaire
研究概览
简要总结
Postmenopausal hypoestrogenism may determine genital atrophy, which may be accompanied by a non-specific inflammatory process and may hinder or even prevent sexual intercourse. In more severe cases, the patient may have local pain that interferes with their daily activities. The best treatment for increasing genital trophism is still estrogen. However, there are women who can not use this therapy or do not want it. Therefore, there is a need for alternatives, such as ablation techniques: use of CO2 LASER and fractional radiofrequency.
The study was carried out at the outpatient clinic of Lower Genital Tract ambulatory of the Discipline of Gynecology, Department of Obstetrics and Gynecology, Clinical Hospital, Faculty of Medicine, University of São Paulo, involving 75 women who were divided after randomization in three groups:
Group 1 - treatment with topical vaginal promestriene (n = 25 patients); Group 2 - treatment with fractional CO2 LASER (n = 25 patients); Group 3 - fractional microablative radiofrequency treatment (n = 25 patients).
An evaluation of the complaints were be performed through questionnaires on sexuality, quality of life and urinary incontinence, as well as biopsies of the vaginal wall for histomorphometric, immunohistochemical and molecular biology study before and after six months of treatment. The duration of the study were fifteen months.
详细描述
After completing the eligibility criteria, patients signed the consent inform.
Division of groups:
Were included in the study 75 patients, divided into three groups:
Group 1 - Treatment with topical vaginal promestriene - 25 patients in this group were included patients free of systemic or topical hormonal treatment for at 3 months
Group 2 - Treatment with CO2 LASER - 25 patients, in this group were included patients free of systemic or topical hormonal treatment for at 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age equal or superior to 40 years and under 65 years
- •Clinical menopause - last menstrual period from 1 to 5 years from the date of recruitment
- •FSH measurement> 25 IU / ml, estrogen <20 æg / ml
- •Patients with vaginal atrophy and clinical and / or sexual symptoms
- •Patients without hormonal treatment for at least five years
排除标准
- •Whole Hymen
- •Altered oncology cytology of the cervix and / or vagina
- •Vaginal infections
- •Connective tissue diseases
- •Immunosuppression
- •Coagulation change
- •Diabetes Mellitus
- •Thyroid diseases
- •Use of systemic or local feminine hormones
- •Use of other substances with estrogenic properties
研究组 & 干预措施
Fractional CO2 LASER
Vaginal fractional CO2 LASER 3 sessions applications
干预措施: Fractional CO2 LASER (Other)
Microablative fractional radiofrequency
Vaginal Microablative fractional radiofrequency 3 sessions application
干预措施: Microablative Fractional radiofrequency (Other)
Promestriene Vaginal
Promestriene vaginal use during 3 months
干预措施: Promestriene Vaginal (Drug)
结局指标
主要结局
Life's quality questionnaire
时间窗: 3-4 months
It was acessed at the beginnig and in the end of the treatment. We used the Short Form Health Survey 36 questionnaire for this parameter. It contains 36 items measuring eight dimensions, that vary the pontuation between 1-5 to 1-6. All but one of the 36 items are used to score the SF-36 eight domains that are aggregated in two summary measures, Physical and Mental components. Among the eight domains, three scales (Physical Functioning, Role-Physical, and Bodily Pain) contributes mostly to the Physical Component Summary (PCS) and three (Mental Health, Role-Emotional, and Social Functioning) contributes to the Mental Component Summary. The domains Vitality, General Health, and Social Functioning present noteworthy correlations with both summary componentNormalized scores below 50 are interpreted as below the generals population. The better is to have a higher pontuation.
次要结局
- Sexuality questionnaire - Female Sexual Function Index(3-4 months)
- score symptoms(3-4 months)
- pH values(3-4 months)