Clinical and Cyto-histological Evaluation of Fractional CO2 Laser Treatment on Genito-Urinary Syndromes of Menopause Related to Vaginal Atrophy

Not Applicable

Completed

• Conditions: Genitourinary Syndrome of Menopause
• Interventions: Device: CO2 laser MonaLisa Touch ®

• Registration Number: NCT05151380
• Lead Sponsor: Hopital Nord Franche-Comte

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-26
• Study First Submitted QC: 2021-11-26
• Study Start: 2021-12-09
• Study First Posted: 2021-12-09
• Primary Completion: 2023-09-11
• Study Completion: 2023-11-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Women with CO2 laser MonaLisa Touch ® sessions	CO2 laser MonaLisa Touch ®	Women with 3 sessions of CO2 laser MonaLisa Touch ®

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Nord Franche-Comté; 🇫🇷 Trévenans, France