Randomized Controlled Trial to Evaluate Non-ablative Radiofrequency Combined With Pelvic Floor Muscle Training for Genitourinary Syndrome of Menopause in Breast Cancer Survivors

What this Trial Is About

This research aims to evaluate whether non-ablative radiofrequency (RF) combined with pelvic-floor muscle exercises can relieve vaginal dryness and other symptoms of genitourinary syndrome of menopause (GSM) in women aged 18 to 75 who have survived breast cancer and experience these symptoms. The study compares the effects of active RF plus exercise to sham (inactive) RF plus exercise on vaginal dryness and related symptoms such as pain during intercourse, vaginal health, urinary and sexual function, pelvic-floor strength, and overall satisfaction. Participants will be randomly assigned to receive either six weekly sessions of active non-ablative monopolar capacitive RF therapy or sham RF therapy using the Capenergy C500 device. Each session lasts about 20 minutes and is followed by 20 minutes of guided pelvic-floor muscle training with biofeedback. All participants will also follow a progressive home exercise program and receive education on pelvic-floor anatomy, pain mechanisms after breast cancer, bladder and bowel retraining, breathing techniques, and sexual health if interested. During the study, participants will visit the hospital once a week for 6 weeks to receive treatments and assessments. They will complete questionnaires and tests at the start, immediately after the intervention, and again 3 months later. Researchers will monitor symptoms including vaginal dryness, pain during sexual activity, vaginal health, sexual function, pelvic-floor muscle strength, and urinary symptoms. They will also track adherence to home exercises, adverse events, and breast cancer recurrence over 12 months.

Efficacy of Non-ablative Radiofrequency Combined With Pelvic Floor Muscle Training for Genitourinary Syndrome of Menopause in Breast Cancer Survivors (RF-SGM)