NCT05151380

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Hopital Nord Franche-Comte · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Genitourinary Syndrome of Menopause

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2021-12-09
• Primary completion: 2023-09-11
• Completion: 2023-11-10
• First posted: 2021-12-09
• Last updated: 2024-12-27

Locations

1 site across 1 country: France