Radiofrequency and Exercise-based Rehabilitation on Symptoms Associated With Pelvic Floor Dysfunctions in Breast Cancer

Recruiting · NCT06694519 · Interventional (participants receive a specific treatment)

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Interventions studied

Body Image Scale (S-BIS)ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form)Likert's scale questionnaireOxford's ScalePFIQ-20 questionnaire (Pelvic Floor Impact Questionnaire Short Form)Sandvik's testSexual function and self-esteemVisual analogue scale (VAS)manometry through the PHENIX series device (model: PHENIX LIBERTY; manufacturer: ELECTRONIC CONCEPT LIGNON INNOVATION, Montpelier, France).vaginal health index (VHI)

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.

Who can take part

Age range

18 Years and older

Sex

Female

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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 it is running

1 location listed.

Cardenal Herrera - Ceu - Elche, Spain / Valencia, Spain

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →