Evaluation Clinique et Cyto-histologique du Traitement Laser CO2 fractionné Sur Les Syndromes Génito-Urinaires de la Ménopause liés à l'Atrophie Vaginale

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 40
Healthy Volunteers: No
View:

• 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

Locations
Other Locations
France
Hôpital Nord Franche-Comté
Recruiting
Trévenans
Contact Information
Primary
Elodie BOUVIER
elodie.bouvier@hnfc.fr
+33384983570
Time Frame
Start Date: December 9, 2021
Estimated Completion Date: January 15, 2025
Participants
Target number of participants: 75
Treatments
Other: Women with CO2 laser MonaLisa Touch ® sessions
Women with 3 sessions of CO2 laser MonaLisa Touch ®
Related Therapeutic Areas
Sponsors
Leads: Hopital Nord Franche-Comte

This content was sourced from clinicaltrials.gov

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