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

Randomized, Controlled Trial to Evaluate the Efficacy of Non-ablative Radiofrequency Combined With Pelvic Floor Muscle Training on Symptoms of Genitourinary Syndrome of Menopause in Breast Cancer Survivors

This trial will test whether adding non-ablative radiofrequency to pelvic-floor exercises helps ease vaginal dryness and related genitourinary symptoms in breast cancer survivors.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Madrid, Madrid)
• Trial ID: NCT07034976 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are disease-free breast cancer survivors aged 18–75 with amenorrhea >12 months, vaginal pH ≥5, a bothersome vaginal dryness score >4, and no active genital infection or recent use of local estrogen.

Not a fit: Patients with contraindications such as pacemakers or metallic implants, active infections, recent pelvic surgery/chemotherapy/radiotherapy, severe immunosuppression, coagulation disorders, or very advanced pelvic organ prolapse may not benefit or be eligible.

Why it matters

Potential benefit: If successful, the combination could reduce vaginal dryness and improve sexual and urinary symptoms in breast cancer survivors without using local hormones.

How similar studies have performed: Small prior studies of vaginal radiofrequency in postmenopausal women have reported short-term symptom improvements, but evidence is limited and results have been mixed.

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.

Where this trial is running

Madrid, Madrid

• Hospital Universitario Ramón y Cajal — Madrid, Madrid, Spain (Recruiting)

Study contacts

• Study coordinator: Irene Lázaro Navas, PhD, MSc, PT

Conditions Genitourinary Syndrome of Menopause; Breast Cancer; genitourinary syndrome of menopause; vaginal atrophy; vaginal dryness; breast cancer survivors; non-ablative radiofrequency; pelvic floor muscle training