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

NARecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Genitourinary Syndrome of Menopause (GSM)Breast Cancer
Interventions
DEVICE

Active Radiofrequency (Capenergy C500 UpGradeC200)

"Non-ablative radiofrequency is applied using a Capenergy C500 device at a target tissue temperature of ≤ 45 °C, once a week for 6 consecutive weeks. Treatment is delivered through two channels simultaneously: a capacitive plate placed on the suprapubic area and an intracavitary vaginal probe. Each session lasts 20 minutes and is followed by 20 minutes of pelvic-floor muscle training guided by biofeedback. Participants will also follow a progressive home exercise programme and record adherence and events.~In addition, all participants will receive education on pelvic-floor anatomy and function, underlying mechanisms of pain after breast cancer, bladder and bowel retraining, respiratory pattern re-education, and-if interested-information on sexual health."

DEVICE

Sham Radiofrequency (Capenergy C500 UpGrade C200 - Placebo Mode)

"Participants will receive one session per week for 6 weeks of sham (placebo) radiofrequency using the Capenergy C500 in Placebo Mode (no temperature increase), designed to simulate active treatment. The screen will display a simulated delivered energy value; temperature and energy readings will be hidden; LED indicators will activate sequentially; and a suprapubic capacitive plate and intracavitary probe will be used with the same protocol as in the intervention group. This will be followed by 20 minutes of pelvic-floor muscle training guided by biofeedback, identical to the intervention group. Participants will also follow a progressive home exercise programme and record adherence and events. All participants will receive education on pelvic-floor function, pain mechanisms after breast cancer, bladder/bowel retraining, breathing pattern correction, and-if interested-sexual health."

Trial Locations (1)

28034

RECRUITING

Hospital Universitario Ramón y Cajal, Madrid

All Listed Sponsors
collaborator

Hospital Universitario Ramon y Cajal

OTHER

lead

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

OTHER

NCT07034976 - Efficacy of Non-ablative Radiofrequency Combined With Pelvic Floor Muscle Training for Genitourinary Syndrome of Menopause in Breast Cancer Survivors (RF-SGM) | Biotech Hunter | Biotech Hunter