Efficacy of Non-ablative Radiofrequency Combined With Pelvic Floor Muscle Training for Genitourinary Syndrome of Menopause in Breast Cancer Survivors (RF-SGM)
NCT ID: NCT07034976
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-09-01
2027-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active Non-ablative Radiofrequency + Pelvic-Floor Muscle Training
Participants in this group will receive non-ablative monopolar capacitive radiofrequency therapy combined with pelvic-floor muscle training guided by biofeedback.
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.
Sham Radiofrequency + Pelvic-Floor Muscle Training
Participants in this group will receive sham radiofrequency treatment combined with pelvic-floor muscle training guided by biofeedback.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
FEMALE
No
Sponsors
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Hospital Universitario Ramon y Cajal
OTHER
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
OTHER
Responsible Party
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Irene Lázaro Navas
PhD Physiotherapist, Department of Rehabilitation Medicine, Hospital Universitario Ramón y Cajal
Locations
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Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IMP24_B01
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
069/25
Identifier Type: -
Identifier Source: org_study_id
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