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

NCT ID: NCT05151380

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-09

Study Completion Date

2023-11-10

Brief Summary

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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

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Conditions

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Genitourinary Syndrome of Menopause

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Women with CO2 laser MonaLisa Touch ® sessions

Women with 3 sessions of CO2 laser MonaLisa Touch ®

Group Type OTHER

CO2 laser MonaLisa Touch ®

Intervention Type DEVICE

3 sessions of SmartXide fractional CO2 laser via the MonaLisa Touch® device, spaced 4 weeks apart, will be performed. An additional comfort session will be performed at 1 year if needed.

The handpiece of the MonaLisa Touch® device is applied to the vaginal walls with a 360° scan, between 800 and 1100µs, to the vaginal orifice

Interventions

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CO2 laser MonaLisa Touch ®

3 sessions of SmartXide fractional CO2 laser via the MonaLisa Touch® device, spaced 4 weeks apart, will be performed. An additional comfort session will be performed at 1 year if needed.

The handpiece of the MonaLisa Touch® device is applied to the vaginal walls with a 360° scan, between 800 and 1100µs, to the vaginal orifice

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hopital Nord Franche-Comte

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Nord Franche-Comté

Trévenans, , France

Site Status

Countries

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France

Other Identifiers

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2021-A01625-36

Identifier Type: -

Identifier Source: org_study_id