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

NARecruitingINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

June 15, 2025

Primary Completion Date

June 1, 2028

Study Completion Date

June 1, 2028

Conditions
Vaginal DrynessBreast CancerVulvovaginal Atrophy
Interventions
DEVICE

GynWave-360

"For patients randomized to the experimental group:~3 sessions of 20 minutes each, spaced 4 to 6 weeks apart (M0, M1, M2) ideally, with +/- 1 maintenance session between 8 and 12 months after the first session (M8-12)."

OTHER

Local hydratation

Reference treatment combining local hydration (hyaluronic acid-based treatment, 3 times a week), with the possibility of using associated measures at the investigator's discretion (physiotherapy, vaginal dilators, etc.).

Trial Locations (1)

59020

RECRUITING

Centre Oscar Lambret, Lille

All Listed Sponsors
collaborator

MATMATECH

UNKNOWN

lead

Centre Oscar Lambret

OTHER