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

What this trial studies

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.

Conditions in scope

• Genitourinary Syndrome of Menopause

Interventions

• CO2 laser MonaLisa Touch ® (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…

Who can join

Women only · Ages 40 Years and up

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: N/A
• Start date: 2021-12-09
• Primary completion: 2023-09-11
• Last update posted: 2024-12-27
• First posted: 2021-12-09

Sponsor & contact

Lead sponsor: Hopital Nord Franche-Comte (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• The main objective of the study is to analyze the evolution of GSM by the use of the MonaLisa Touch ® fractionated laser. (3 months)
  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.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.