Actively Recruiting
Efficacy of Non-ablative Radiofrequency Combined With Pelvic Floor Muscle Training for Genitourinary Syndrome of Menopause in Breast Cancer Survivors (RF-SGM)
Led by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Updated on 2025-09-15
50
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
Sponsors
F
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Lead Sponsor
H
Hospital Universitario Ramon y Cajal
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Efficacy of Non-ablative Radiofrequency Combined With Pelvic Floor Muscle Training for Genitourinary Syndrome of Menopause in Breast Cancer Survivors (RF-SGM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
You will not qualify if you...
- 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.
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Trial Site Locations
Total: 1 location
1
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain, 28034
Actively Recruiting
Research Team
I
Irene Lázaro Navas, PhD, MSc, PT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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