NCT07034976 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 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal |
| Condition | Genitourinary Syndrome of Menopause (GSM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-09-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07034976 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Genitourinary Syndrome of Menopause (GSM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07034976 currently recruiting?
Yes, NCT07034976 is actively recruiting participants. Contact the research team at ilazaro@salud.madrid.org for enrollment information.
Where is the NCT07034976 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT07034976 clinical trial?
NCT07034976 is sponsored by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal. The trial plans to enroll 50 participants.