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

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer; Genitourinary Syndrome; Radiofrequency; Physical Exercise

• Registration Number: NCT06694519
• Lead Sponsor: SERGIO MONTERO NAVARRO

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-11-16
• Last Update Submitted: 2024-11-16
• Study First Posted: 2024-11-19
• Last Update Posted: 2024-11-19
• Study Start: 2025-01-30
• Primary Completion: 2025-12-30
• Study Completion: 2027-01-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 117

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
PFDI-20 questionnaire (300 points)	Pre-intervention / a year post-intervention	This questionnaire assesses the impact over the last 3 months of urinary symptoms (Urinary Impact Questionnaire; UIQ-7), colorectal-anal symptoms (Colorectal-Anal Impact questionnaire, CRAIQ-7) and genital prolapse symptoms (Pelvic Organ Prolapse Impact Questionnaire, POPIQ-7). The maximum possible score is 300 points, with a maximum value of 100 points for each subscale. The higher the score, the greater the negative impact on quality of life.

Secondary Outcome Measures

Name	Time	Method
Age (years)	Pre-intervention	Subject's age (years)
Sex (female or male)	Pre-intervention	Subject's sex (female or male)
Body mass index (Kg /m2)	Pre-intervention	It is a measure of body fat based on height and weight that applies to adult men and women
Pelvic floor muscle strength assessment (oxford scale 0-5 points)	pre-intervention / 15 days post-intervention / 6 months post-intervention / 12 months post-intervention	If there is no contraction it is rated 0, if the contraction is very weak it is rated 1, if the contraction is weak it is 2, if the contraction is moderate/with tension/and maintained it is 3, if the contraction is good and maintains tension with resistance it is 4, and if the contraction is strong and maintains tension against a resistant force it is 5. In addition, this assessment allows the determination of static muscular endurance, fatiguability or dynamic endurance and maximum muscular strength.
neuromuscular stimulation device and PHENIX LIBERTY manometry (mmHg)	pre-intervention / 15 days post-intervention / 6 months post-intervention / 12 months post-intervention
pH (0-14)	pre-intervention / 15 days post-intervention / 6 months post-intervention / 12 months post-intervention	The pH will be quantified using a pH indicator strip between 0 and 14 to be placed directly on the right lateral vaginal wall for one minute, giving 1 point for pH 6.1, 2 for pH 5.6-6.0, 3 for pH 5.1-5.5, 4 for pH 4.7-5.0 and 5 for pH ≤ 4.6. The sum of all items represents the vaginal health score, where 25 represents the best vaginal health.

Trial Locations

Locations (1)

Cardenal Herrera - Ceu; 🇪🇸 Elche, Spain / Valencia, Spain