Non-ablative radiofrequency plus pelvic-floor exercises for menopausal vaginal dryness in breast cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Women who are disease-free breast cancer survivors with bothersome menopausal genitourinary symptoms will receive six weekly sessions of either active or sham non-ablative radiofrequency alongside guided pelvic-floor muscle training. Each visit includes about 20 minutes of intra-/extra-vaginal radiofrequency (or sham) and about 20 minutes of pelvic-floor exercises. The main outcome is change in a 0–10 vaginal dryness score at the end of treatment (6 weeks) and at 3 months, with additional measures of pain with intercourse, Vaginal Health Index, urinary and sexual function, pelvic-floor strength, and overall satisfaction. Researchers compare the active device (Capenergy C500 UpGradeC200) to a placebo-mode sham device to determine added benefit beyond exercises alone.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Universitario Ramón y Cajal
  Madrid, Madrid, Spain Recruiting

Study contacts

• Study coordinator: Irene Lázaro Navas, PhD, MSc, PT
• Email: ilazaro@salud.madrid.org
• Phone: +34 91 336 83 22

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.