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

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Status: Enrolling

Conditions: Breast Cancer; Genitourinary Syndrome of Menopause (GSM)

Treatments: Device: Sham Radiofrequency (Capenergy C500 UpGrade C200 - Placebo Mode); Device: Active Radiofrequency (Capenergy C500 UpGradeC200)

Study type: Interventional

Funder types: Other

Identifiers

NCT07034976

069/25

IMP24_B01 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

50 participants in 2 patient groups

Active Non-ablative Radiofrequency + Pelvic-Floor Muscle Training

Experimental group

Description:

Participants in this group will receive non-ablative monopolar capacitive radiofrequency therapy combined with pelvic-floor muscle training guided by biofeedback.

Treatment:

Device: Active Radiofrequency (Capenergy C500 UpGradeC200)

Sham Radiofrequency + Pelvic-Floor Muscle Training

Sham Comparator group

Description:

Participants in this group will receive sham radiofrequency treatment combined with pelvic-floor muscle training guided by biofeedback.

Treatment:

Device: Sham Radiofrequency (Capenergy C500 UpGrade C200 - Placebo Mode)