Radiofrequency and pelvic floor exercises for pelvic floor problems after breast cancer

Effectiveness of Radiofrequency and Exercise-based Rehabilitation on Symptoms Associated With Pelvic Floor Dysfunction in Breast Cancer Patients.

This project will test whether radiofrequency, pelvic floor muscle exercises, or both can reduce pelvic floor and genitourinary symptoms in women who had breast cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 117 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Cardenal Herrera University (Academic / other)
• Locations: 1 site (Elche, Spain / Valencia)
• Trial ID: NCT06694519 on ClinicalTrials.gov

What this trial studies

A randomized, double-blind trial at Cardenal Herrera University in Elche, Spain will enroll women with stage 1–2 breast cancer who have pelvic floor dysfunction. Participants will be randomly assigned to pelvic floor muscle training (PFMT), radiofrequency (RF) therapy, or combined PFMT+RF, with treatments delivered onsite. Outcomes include pelvic floor manometry (PHENIX LIBERTY), validated questionnaires (PFIQ-20, ICIQ-SF), Sandvik test, and the vaginal health index to measure symptom and functional change. Key exclusions include recent pelvic therapies or hormones, inability to contract the pelvic floor, pacemakers, active pelvic infections, and major neurological or cardiac conditions.

Who should consider this trial

Good fit: Ideal candidates are adult women with a history of stage 1–2 breast cancer (medical discharge >1 year), a high pelvic floor symptom score (PFDI-20 ≥ 100), and no recent PFMT, RF, laser, or hormonal treatments and no contraindications to therapy.

Not a fit: Patients who cannot contract their pelvic floor, who have recent use of vaginal estrogens or systemic hormones, pacemakers, active pelvic infections, recent pelvic surgery, or significant neurological or cardiac disease are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, these treatments could reduce urinary and vaginal symptoms and improve quality of life for breast cancer survivors who often cannot use local estrogen.

How similar studies have performed: Pelvic floor muscle training has strong evidence for treating incontinence, while vaginal radiofrequency is a newer approach with some promising but limited high-quality evidence.

Eligibility criteria

Inclusion Criteria:

* women of legal age with a clinical history of breast cancer, who agree to participate in the study and who present pelvic dysfunction assessed by the Pelvic Floor Distress Inventory (PFDI20) ≥ 100
* women survivors of stage 1 and 2 breast cancer
* A medical discharge was granted more than one year ago
* A diagnosis of another type of cancer has not been made.

Exclusion Criteria:

* Having performed PMFT or received RF in the last 12 months
* Use of vaginal oestrogens in the last 6 months
* Systemic hormone therapy in the last 6 months
* Laser therapy in the last 6 months
* Absence of pelvic floor contraction according to the Modified Oxford Scale
* Use of pacemaker
* Use of heart pacemaker, decompensated heart or metabolic diseases, cognitive deficits, peripheral or central neurological disorders, previous surgeries in the pelvic region, skin pathologies or wounds in the treatment area or presence of an active urinary tract and/or vaginal infection.

Where this trial is running

Elche, Spain / Valencia

• Cardenal Herrera - Ceu — Elche, Spain / Valencia, Spain (Recruiting)

Study contacts

• Principal investigator: ANA LOZANO, MsC — Cardenal Herrera - Ceu; Ceu Universities
• Study coordinator: SERGIO MONTERO-NAVARRO, PhD

Conditions Breast Cancer; Genitourinary Syndrome; Radiofrequency; Physical Exercise