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

SERGIO MONTERO NAVARRO

Status

Enrolling

Conditions

Breast Cancer

Physical Exercise

Radiofrequency

Genitourinary Syndrome

Treatments

Diagnostic Test: PFIQ-20 questionnaire (Pelvic Floor Impact Questionnaire Short Form)

Diagnostic Test: Sandvik's test

Diagnostic Test: Visual analogue scale (VAS)

Diagnostic Test: vaginal health index (VHI)

Diagnostic Test: Likert's scale questionnaire

Diagnostic Test: Oxford's Scale

Diagnostic Test: Sexual function and self-esteem

Diagnostic Test: Body Image Scale (S-BIS)

Diagnostic Test: ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form)

Device: manometry through the PHENIX series device (model: PHENIX LIBERTY; manufacturer: ELECTRONIC CONCEPT LIGNON INNOVATION, Montpelier, France).

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06694519

CEEI24/540

Details and patient eligibility

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.

Enrollment

117 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

117 participants in 2 patient groups

Temperature after apply RF in capacitive electrical transfer mode (Capernergy® device model C500)

Experimental group

Description:

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.

Treatment:

Diagnostic Test: ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form)

Device: manometry through the PHENIX series device (model: PHENIX LIBERTY; manufacturer: ELECTRONIC CONCEPT LIGNON INNOVATION, Montpelier, France).

Diagnostic Test: Sexual function and self-esteem

Diagnostic Test: Body Image Scale (S-BIS)

Diagnostic Test: Oxford's Scale

Diagnostic Test: Likert's scale questionnaire

Diagnostic Test: vaginal health index (VHI)

Diagnostic Test: Visual analogue scale (VAS)

Diagnostic Test: Sandvik's test

Diagnostic Test: PFIQ-20 questionnaire (Pelvic Floor Impact Questionnaire Short Form)

PFMT

Experimental group

Description:

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.

Treatment:

Diagnostic Test: ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form)

Device: manometry through the PHENIX series device (model: PHENIX LIBERTY; manufacturer: ELECTRONIC CONCEPT LIGNON INNOVATION, Montpelier, France).

Diagnostic Test: Sexual function and self-esteem

Diagnostic Test: Body Image Scale (S-BIS)

Diagnostic Test: Oxford's Scale

Diagnostic Test: Likert's scale questionnaire

Diagnostic Test: vaginal health index (VHI)

Diagnostic Test: Visual analogue scale (VAS)

Diagnostic Test: Sandvik's test

Diagnostic Test: PFIQ-20 questionnaire (Pelvic Floor Impact Questionnaire Short Form)

Trial documents