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

Official title

Randomized, Controlled Trial to Evaluate the Efficacy of Non-ablative Radiofrequency Combined With Pelvic Floor Muscle Training on Symptoms of Genitourinary Syndrome of Menopause in Breast Cancer Survivors

Overview

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.

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 an
• 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

Primary outcome measures

• Subjective sensation of vaginal dryness [Time frame: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)]

Secondary outcome measures (12)

• Subjective sensation of pain during sexual activity (NRS 0-10) [Time frame: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)]
• Subjective sensation of vaginal itching (NRS 0-10) [Time frame: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)]
• Vaginal Health Index Score [Time frame: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)]
• Female Sexual Function Index total score [Time frame: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)]
• Vaginal pH level [Time frame: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)]
• Pelvic organ support parameters measured by POP-Q system [Time frame: T0 (baseline, before intervention); T2 (3 months after T1)]
• International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF total score) [Time frame: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)]
• ICIQ-FLUTS [Time frame: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)]
• Pelvic-floor muscle strength (Modified Oxford Scale, 0-5) [Time frame: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)]
• Pelvic-floor muscle activity measured by surface electromyography (μV) [Time frame: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)]
• Subjective global impression of improvement (7-point Likert scale) [Time frame: T1 (immediately after completing the intervention); T2 (3 months after T1)]
• Incidence of adverse events related to the intervention [Time frame: T1 (immediately after completing the intervention); T2 (3 months after T1)]

Eligibility criteria

Inclusion criteria

• Women who are breast cancer survivors and clinically confirmed to be disease-free by their physician.
• Amenorrhea for more than 12 months and vaginal pH ≥ 5, with symptoms related to genitourinary syndrome of menopause (GSM), as diagnosed by a physician. Symptoms must be bothersome and not better explained by another clinical condition.
• Negative urine culture at baseline.
• Moderate to severe vaginal dryness, defined as a score > 4 on the Numeric Rating Scale (NRS 0-10)

Exclusion criteria

• Age over 75 years.
• Current or past diagnosis of any cancer other than breast cancer.
• Pelvic surgery, chemotherapy, or radiotherapy in the past 3 months.
• Use of local estrogen therapy within the past month.
• Active genital infections.
• Diagnosis of HIV infection or severe immunosuppression.
• Presence of pacemakers, metallic implants, or electromagnetic devices.
• Coagulation disorders or current use of anticoagulants.
• Pelvic organ prolapse stage > III (POP-Q classification).
• Unexplained abnormal vaginal bleeding.
• History of pelvic anti-incontinence surgery, with or without mesh.
• Inflammatory dermatoses of the vulva.
• Pelvic-floor muscle strength score of 0/5 on the Modified Oxford Scale.
• Nickel allergy.
• Previous treatment with radiofrequency in the pelvic or genital area.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Hospital Universitario Ramón y Cajal — Madrid

Identifiers

NCT: NCT07034976 · 069/25 · IMP24_B01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗