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

RecruitingNAAges 18 Years - anyFemaleSERGIO MONTERO NAVARRO
NCT06694519 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 receiv

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📋 Eligibility rules (as published)
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.
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What it tests

  • manometry through the PHENIX series device (model: PHENIX LIBERTY; manufacturer: ELECTRONIC CONCEPT LIGNON INNOVATION, Montpelier, France).
  • PFIQ-20 questionnaire (Pelvic Floor Impact Questionnaire Short Form)
  • ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form)
  • Sandvik's test
  • vaginal health index (VHI)
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Where

1 site
Cardenal Herrera - Ceu
Elche, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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