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临床试验/NCT05151380
NCT05151380已完成不适用

Evaluation Clinique Et Cyto-histologique Du Traitement Laser CO2 Fractionné Sur Les Syndromes Génito-Urinaires De La Ménopause Liés À L'atrophie Vaginale

Hopital Nord Franche-Comte1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2021年12月9日最近更新:
适应症
干预措施

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
The main objective of the study is to analyze the evolution of GSM by the use of the MonaLisa Touch ® fractionated laser.

研究概览

简要总结

Estrogen deficiency can occur naturally during menopause or as a secondary effect of various treatments for breast or pelvic cancer and can lead to very disabling vulvovaginal symptoms, since it is associated with an anatomical and functional cellular modification of the urogenital sphere. These changes result in urogenital atrophy responsible for vaginal dryness, painful intercourse (dyspareunia), discomfort, itching and burning sensations, dysuria, urgency and incontinence. These symptoms, which significantly affect quality of life, are found in more than 40% of menopausal women and are grouped under the term Genitourinary Syndrome of Menopause (GSM). General or local estrogen-based treatments improve patients' symptoms, but remain contraindicated in women who have had breast cancer. Non-estrogenic local treatments are less effective, remain restrictive and are therefore often abandoned.

The CO2 laser is currently part of the therapeutic arsenal for the management of patients with GSM. This device prevents and eliminates the effects of low estrogen levels on vaginal tissue by restoring the characteristic conditions of the vaginal mucosa of a woman of childbearing age. This simple treatment, which lasts only a few minutes, is safe and painless and has no serious side effects. It restores the tone and elasticity of the tissues, with positive effects on the quality of life and the couple's relationship. The investigators wish to evaluate the possible changes of the genital sphere in a longitudinal way (before, during and after the treatment), including the induced cytohistological changes, in patients with GSM who can benefit of this therapy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •Women over 40 years of age
  • •Patients with natural menopause or menopause secondary to cancer treatment (breast, pelvis or other)
  • •Patients with vaginal and/or urinary, non-vulvar GSM
  • •Patients for whom CO2 laser therapy is proposed

排除标准

  • •Vulvovaginal infections (vaginosis)
  • •Uninvestigated vaginal hemorrhage
  • •Pregnancy or breastfeeding
  • •Cervico-vaginal pathology (cervical and/or vaginal dysplasia)
  • •Suspected or diagnosed HPV
  • •Significant vaginal prolapse
  • •Patients on hormone replacement therapy

研究组 & 干预措施

Women with CO2 laser MonaLisa Touch ® sessions

Other

Women with 3 sessions of CO2 laser MonaLisa Touch ®

干预措施: CO2 laser MonaLisa Touch ® (Device)

结局指标

主要结局

The main objective of the study is to analyze the evolution of GSM by the use of the MonaLisa Touch ® fractionated laser.

时间窗: 3 months

The primary endpoint is the comparison of the patient's clinical score composed of a visual analogic scale measuring the intensity of symptoms related to vaginal atrophy (i.e., vaginal burning, vaginal pruritus, vaginal dryness, dyspareunia, and dysuria), before and after 3 laser sessions.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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