Efficacy of Non-ablative Radiofrequency Combined With Pelvic Floor Muscle Training for Genitourin… (NCT07034976) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy of Non-ablative Radiofrequency Combined With Pelvic Floor Muscle Training for Genitourinary Syndrome of Menopause in Breast Cancer Survivors (RF-SGM)
Spain50 participantsStarted 2025-09-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Subjective sensation of vaginal dryness
Timeframe: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)
Trial details
NCT IDNCT07034976
SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal