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临床试验/NCT03939078
NCT03939078已完成不适用

Fractional Ablative CO2 Laser in the Treatment of the Genitourinary Syndrome of Menopause

Universidade Federal Fluminense1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2018年4月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
1
主要终点
Reversion of vaginal atrophy

研究概览

简要总结

Menopause is a woman's hormonal status one year after her ovulatory failure, when the decrease of circulating estrogen levels leads to a group of symptoms named Genitourinary Syndrome of Menopause (GSM), such as: vaginal dryness, dyspareunia, dysuria, epithelial fragility with recurrent bleedings, loss of genital elasticity and pH alterations causing recurrent infections. The CO2 laser is a fractional ablative source of light, capable of inducing neocollagenesis within the skin, reversing atrophies, increasing blood supply and reorganizing the architectural structure of the treated epithelium. Recent studies in the laser field show great improvement of the SGM, with satisfying results in female's sexual disfunction. Nevertheless, there is still a lack of studies that show, at the same time, the improvement in both patient's subjective reports and objective measurements, such as cytology, histology and immunohistochemistry. This study aims to thoroughly analyze the benefits of the CO2 laser in the treatment of the GMS, comparing the improvement found in questionnaires to the results of cytology, histology and immunohistochemistry for collagen I and III from vaginal biopsies before and after the laser treatment. Therefore, fourteen women after menopause complaining of symptoms of the GSM were selected from the ambulatory of the Hospital Universitário Antônio Pedro. The patients will be submitted to three CO2 intravaginal laser (Femilift®), with a 30-days interval between them. Biopsies of the vaginal wall will be taken one month before the start and one month after the end of the laser sessions, and material will be sent to histology, cytology and immunohistochemistry analysis. Results obtained will be compared to the patients' reports, in order to evaluate subjective and objective improvement due to the treatment.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women from 40 to 70 years old;
  • Post- menopausa (at least one year after cessation of periods);
  • Experimenting any symptom related to the Genitourinary Syndrome of Menopause (GSM), such as: vaginal dryness, dyspareunia, urinary incontinence, dysuria, recurrent urinary infections;
  • Regular follow up in gynecologist, with recent normal pap smear.

排除标准

  • The volunteers must not be under any treatment for this syndrome;
  • Volunteers cannot be using hormones or any vaginal treatment;
  • Volunteers cannot have previous history of vaginal / uterine cancer;
  • Volunteers cannot have previous surgery for urinary incontinence;
  • Uterine prolapse;
  • Recent altered pap smear.

结局指标

主要结局

Reversion of vaginal atrophy

时间窗: 1 month after the last (3rd) laser section

Reversion of vaginal atrophy by the laser stimulation, with increasing layers of epithelial cells, increased collagen deposition and improvement in vascularization.

Improvement in urinary incontinence

时间窗: 1 month after the third and last laser section

Improvement in urine involuntary loss, the so called stress incontinence

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Claudia Almeida Issa

Professor

Universidade Federal Fluminense

研究点 (1)

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