Actively Recruiting
Radiofrequency and Exercise-based Rehabilitation on Symptoms Associated With Pelvic Floor Dysfunctions in Breast Cancer
Led by SERGIO MONTERO NAVARRO · Updated on 2026-01-21
117
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
S
SERGIO MONTERO NAVARRO
Lead Sponsor
C
Cardenal Herrera University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Breast cancer has a high impact, affecting 2.3 million women worldwide in 2022. In Spain, there were 40,203 new cases in 2023. In addition to the economic and social costs, patients suffer genitourinary dysfunctions due to cancer treatments. Genitourinary Menopausal Syndrome (GUS) affects 50% of menopausal women, with a higher prevalence in women with breast cancer. This study aims to compare the effectiveness of radiofrequency (RF) and pelvic floor muscle exercise (PFMT) in the treatment of pelvic dysfunction associated with GUS in breast cancer patients. A randomised, double-blind clinical trial will be conducted in collaboration with the Association of Women Affected by Breast Cancer of Elche and Region) and the CEU Cardenal Herrera University. Women diagnosed with breast cancer and pelvic dysfunction will participate, divided into three groups: one will receive PFMT, one will receive RF and one will receive PFMT+RF therapy. Both techniques are expected to improve the quality of life of patients, where RF could offer additional benefits due to its proven effectiveness in the treatment of vaginal dryness and dyspareunia. The expected results will contribute to more effective and less invasive treatment protocols. The project presented has the potential to positively impact the health and well-being of women with breast cancer, reducing the symptoms associated with the disease and its treatment, and improving their quality of life.
CONDITIONS
Official Title
Radiofrequency and Exercise-based Rehabilitation on Symptoms Associated With Pelvic Floor Dysfunctions in Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 years or older with a history of breast cancer who agree to participate and have pelvic dysfunction with a PFDI-20 score of 100 or higher
- Survivors of stage 1 or 2 breast cancer
- Medical discharge granted more than one year ago
- No diagnosis of any other type of cancer
You will not qualify if you...
- Pelvic floor muscle training or radiofrequency treatment within the last 12 months
- Use of vaginal estrogens in the last 6 months
- Use of systemic hormone therapy in the last 6 months
- Use of laser therapy in the last 6 months
- No pelvic floor muscle contraction according to the Modified Oxford Scale
- Presence of a pacemaker
- Decompensated heart or metabolic diseases
- Cognitive deficits or peripheral/central neurological disorders
- Previous pelvic region surgeries
- Skin conditions or wounds in the treatment area
- Active urinary tract or vaginal infection
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cardenal Herrera - Ceu
Elche, Spain / Valencia, Spain, 46113
Actively Recruiting
Research Team
S
SERGIO MONTERO-NAVARRO, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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