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Search / Trial NCT06694519

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

Launched by SERGIO MONTERO NAVARRO · Nov 16, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring how effective two different treatments—radiofrequency (RF) therapy and pelvic floor muscle exercises (PFMT)—are for helping women with breast cancer who are experiencing pelvic floor dysfunction. Many women with breast cancer face problems like vaginal dryness and discomfort, especially after treatment, and this study aims to improve their quality of life. Participants will be divided into three groups: one will do pelvic floor exercises, another will receive RF therapy, and the third will get a combination of both treatments.

To be eligible for the study, women must be at least 18 years old, have a history of breast cancer (stages 1 or 2), and be experiencing pelvic dysfunction. They should also have been medically cleared for more than a year and not have any other types of cancer. Participants can expect to engage in therapy sessions and will be monitored for improvements in their symptoms. This trial is important as it could lead to better, less invasive treatment options for women facing these challenges after breast cancer treatment.

Gender

FEMALE

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.

About Sergio Montero Navarro

Sergio Montero Navarro is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and improving patient outcomes. With a focus on innovative therapeutic solutions, he leads initiatives that facilitate the development of cutting-edge treatments across various medical fields. Leveraging extensive expertise in regulatory compliance and trial management, Navarro ensures that clinical studies are conducted with the highest standards of integrity and scientific rigor. His collaborative approach fosters partnerships with research institutions and healthcare professionals, driving progress and contributing to the evolving landscape of clinical medicine.

Locations

Elche, Spain / Valencia, Spain

Elche, , Spain

Patients applied

0 patients applied

Trial Officials

MERCEDES BLANQUET-ROCHERA, MsC

Principal Investigator

CARDENAL HERRERA - CEU; CEU UNIVERSITIES

CRISTINA ORTS-RUIZ, PhD

Study Director

CARDENAL HERRERA - CEU; CEU UNIVERSITIES

JESÚS SÁNCHEZ-MAS, PhD

Study Director

CARDENAL HERRERA - CEU; CEU UNIVERSITIES

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported