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

RecruitingNAAges 18 Years - 75 YearsFemaleFundacion para la Investigacion Biomedica del Hosโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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.
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What it tests

  • Active Radiofrequency (Capenergy C500 UpGradeC200)
  • Sham Radiofrequency (Capenergy C500 UpGrade C200 - Placebo Mode)
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Where

1 site
Hospital Universitario Ramรณn y Cajal
Madrid, Spain
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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