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

  • STATUS
    Recruiting
  • End date
    Jan 15, 2025
  • participants needed
    75
  • sponsor
    Hopital Nord Franche-Comte
Updated on 25 March 2022

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.

Details
Condition Genitourinary Syndrome of Menopause
Treatment CO2 laser MonaLisa Touch ®
Clinical Study IdentifierNCT05151380
SponsorHopital Nord Franche-Comte
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

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
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