Efficacy and Safety of Vaginal Radiofrequency for Vulvovaginal Atrophy in Breast Cancer Patients

Launched by CENTRE OSCAR LAMBRET · Mar 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called vaginal radiofrequency to help women with vaginal dryness caused by breast cancer treatments. Specifically, it focuses on patients who are experiencing significant vaginal dryness despite using regular moisturizing treatments. The trial will compare the effects of vaginal radiofrequency therapy with a standard hydration treatment over six months. Women aged 40 and older who have been on specific breast cancer medications for at least three months may be eligible to join the study.

If you participate, you will be randomly placed in one of two groups. One group will receive a hyaluronic acid-based hydration treatment, while the other group will receive this treatment along with vaginal radiofrequency therapy during three sessions. This trial is not yet recruiting participants, but it’s important to know that certain health conditions or current treatments may exclude you from joining. If you’re interested or think you might qualify, discussing this with your doctor could be a good next step.

Gender

FEMALE

Eligibility criteria

• INCLUSION CRITERIA :
• • Patient over 40 years
• • Presenting disabling vaginal dryness symptoms despite well-administered local moisturizing treatment, attested by a vaginal dryness score ≥3
• • Patient undergoing adjuvant treatment for breast cancer
• • Patient treated with aromatase inhibitors +/- LHRH agonist for at least 3 months with a planned remaining duration of at least 12 months
• • Patient affiliated to a social security organization
• • Patient having signed the informed consent for the present study
• EXCLUSION CRITERIA:
• * Contraindications related to the radiofrequency technique:
• • Ongoing urinary tract infection
• • Pacemaker
• • IUD intrauterine device
• • Pregnancy
• • Mucocutaneous disease with vulvovaginal localization: infection, sore, scleratrophic lichen, psoriasis, eczema, etc.
• • Neurodegenerative disease with perineal involvement
• • Current or recent treatment (within the last 12 months) with other physical methods: vaginal laser, photobiomodulation, PRP injection, hyaluronic acid injection or lipo-modeling.
• • Pregnant or breast-feeding women
• • Patients under guardianship or trusteeship.