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

What this trial studies

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.

Conditions in scope

• Genitourinary Syndrome of Menopause (GSM)
• Breast Cancer

Interventions

• Active Radiofrequency (Capenergy C500 UpGradeC200) (Device) — Non-ablative radiofrequency is applied using a Capenergy C500 device at a target tissue temperature of ≤ 45 °C, once a week for 6 consecutive weeks. Treatment is delivered through two channels simultaneously: a capacitive plate placed on the suprapubic area…
• Sham Radiofrequency (Capenergy C500 UpGrade C200 - Placebo Mode) (Device) — Participants will receive one session per week for 6 weeks of sham (placebo) radiofrequency using the Capenergy C500 in Placebo Mode (no temperature increase), designed to simulate active treatment. The screen will display a simulated "delivered energy" value; temperature and…

Who can join

Women only · Ages 18 Years to 75 Years

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.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2025-09-01
• Primary completion: 2026-12-31
• Last update posted: 2025-09-15
• First posted: 2025-06-24

Sponsor & contact

Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal (Other)

Collaborators: Hospital Universitario Ramon y Cajal

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Subjective sensation of vaginal dryness (T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1))
  Measured using a 0-10 Numeric Rating Scale (NRS), where 0 indicates "no dryness" and 10 indicates "maximum dryness". The NRS is a self-reported, single-item scale commonly used for subjective symptom intensity.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.