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Completed

NCT Number: NCT05151380

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

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.

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Key information

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Nord Franche-Comté

Trévenans, 90400, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 to the vaginal walls with a 360° scan, between 800 and 1100µs, to the vaginal orifice

Primary outcomes

  1. The main objective of the study is to analyze the evolution of GSM by the use of the MonaLisa Touch ® fractionated laser.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hopital Nord Franche-Comte

Other

Registry information

Official study title

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

Acronym: ATROVENANS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 9, 2021
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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