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

Summary

The goal of this clinical trial is to find out whether non-ablative radiofrequency (RF) applied together with pelvic-floor muscle exercises can ease vaginal dryness and other symptoms of genitourinary syndrome of menopause (GSM) in women aged 18-75 years who have survived breast cancer and currently experience those symptoms.

The main questions it aims to answer are:

Does the combination of RF + exercise lower the 0-to-10 vaginal-dryness score more than sham (inactive) RF + exercise at 6 weeks (end of treatment) and 3 months?

What other changes (pain during intercourse, Vaginal Health Index, urinary and sexual function, pelvic-floor strength, overall satisfaction) are seen in each group?

Researchers will compare six sessions of active RF with six sessions of sham (inactive) RF to see whether the active treatment works better.

Participants will:

Visit the hospital once a week for 6 weeks. Each visit includes about 20 minutes of intra-/extra-vaginal RF (or sham) and 20 minutes of guided pelvic-floor training whose content is adapted and progressed throughout the study.

Carry out a structured, progressive home-exercise programme, recording any discomfort in a diary.

Complete questionnaires and tests at baseline, after session 6, and 3 months later.

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.

Sponsors & Collaborators

• Hospital Universitario Ramon y Cajal

  collaborator OTHER

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-01

Primary Completion

2026-12-31

Completion

2027-12-31

Countries

• Spain

Study Locations