Effectiveness of Radiofrequency and Exercise-based Rehabilitation on Symptoms Associated With Pelvic Floor Dysfunction in Breast Cancer Patients.

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Cardenal Herrera - Ceu
RECRUITING
Elche
Contact Information
Primary
SERGIO MONTERO-NAVARRO, PhD
sergio.montero@uchceu.es
+34 965426486
Time Frame
Start Date: 2025-01-30
Estimated Completion Date: 2027-01-30
Participants
Target number of participants: 117
Treatments
Experimental: Temperature after apply RF in capacitive electrical transfer mode (Capernergy® device model C500)
It is a device designed mainly to address dysfunctions in the urogynecological area, where the increase in tissue temperature is regulated by a temperature sensor, with 3 frequencies (0.8MHz, 1MHz and 1.2 MHz) that will allow different tissue depths to be addressed, and a power of 310w. This device consists of two electrodes: an active capacitive electrode to be placed in the vaginal area with a probe cover and water-soluble gel and another dispersive electrode or return plate to be positioned in the lumbosacral region.
Experimental: PFMT
The PFMT will consist of a targeted programme, with a protocol of CORE and pelvic floor exercises established based on the assessment of the patients' strength, endurance and fatigue, with a frequency of twice a week led by a physiotherapist and a duration of 45 minutes each day and a period of 16 weeks.It will be carried out in groups of 8 people and accompanied by a physiotherapist experienced in therapeutic exercise.~Each session will consist of exercises to activate the pelvic floor muscles in isolation and in association with the CORE muscles, both static and dynamic.
Sponsors
Collaborators: CAPENERGY MEDICAL, SL, Cardenal Herrera University
Leads: SERGIO MONTERO NAVARRO

This content was sourced from clinicaltrials.gov