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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSERGIO MONTERO NAVARRO

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • 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)
  • Visual analogue scale (VAS)
  • Body Image Scale (S-BIS)
  • Likert's scale questionnaire
  • Oxford's Scale
  • Sexual function and self-esteem

Treatment groups

117 Participants
are divided into 2 treatment groups

Sponsors and collaborators

SERGIO MONTERO NAVARRO

Lead sponsor

Cardenal Herrera University

Sponsor institution

Cardenal Herrera University

Collaborator

CAPENERGY MEDICAL, SL

Collaborator