Clinical and Cyto-histological Evaluation of Fractional CO2 Laser Treatment on Genito-Urinary Syndromes of Menopause Related to Vaginal Atrophy (ATROVENANS)
Primary Purpose
Genitourinary Syndrome of Menopause
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CO2 laser MonaLisa Touch ®
Sponsored by
About this trial
This is an interventional treatment trial for Genitourinary Syndrome of Menopause
Eligibility Criteria
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
Sites / Locations
- Hôpital Nord Franche-Comté
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Women with CO2 laser MonaLisa Touch ® sessions
Arm Description
Women with 3 sessions of CO2 laser MonaLisa Touch ®
Outcomes
Primary Outcome Measures
The main objective of the study is to analyze the evolution of GSM by the use of the MonaLisa Touch ® fractionated laser.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05151380
First Posted
November 26, 2021
Last Updated
June 20, 2023
Sponsor
Hopital Nord Franche-Comte
1. Study Identification
Unique Protocol Identification Number
NCT05151380
Brief Title
Clinical and Cyto-histological Evaluation of Fractional CO2 Laser Treatment on Genito-Urinary Syndromes of Menopause Related to Vaginal Atrophy
Acronym
ATROVENANS
Official Title
Evaluation Clinique et Cyto-histologique du Traitement Laser CO2 fractionné Sur Les Syndromes Génito-Urinaires de la Ménopause liés à l'Atrophie Vaginale
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 9, 2021 (Actual)
Primary Completion Date
September 13, 2024 (Anticipated)
Study Completion Date
January 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Nord Franche-Comte
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genitourinary Syndrome of Menopause
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Women with CO2 laser MonaLisa Touch ® sessions
Arm Type
Other
Arm Description
Women with 3 sessions of CO2 laser MonaLisa Touch ®
Intervention Type
Device
Intervention Name(s)
CO2 laser MonaLisa Touch ®
Intervention Description
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
Primary Outcome Measure Information:
Title
The main objective of the study is to analyze the evolution of GSM by the use of the MonaLisa Touch ® fractionated laser.
Description
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.
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hôpital Nord Franche-Comté
City
Trévenans
ZIP/Postal Code
90400
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical and Cyto-histological Evaluation of Fractional CO2 Laser Treatment on Genito-Urinary Syndromes of Menopause Related to Vaginal Atrophy
We'll reach out to this number within 24 hrs