Clinical trial · Interventional
Radiofrequency and Exercise-based Rehabilitation on Symptoms Associated With Pelvic Floor Dysfunctions in Breast Cancer
Effectiveness of Radiofrequency and Exercise-based Rehabilitation on Symptoms Associated With Pelvic Floor Dysfunction in Breast Cancer Patients.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Genitourinary Syndrome | — | UNRESOLVED | — |
| Physical Exercise | — | UNRESOLVED | — |
| Radiofrequency | — | UNRESOLVED | — |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Body Image Scale (S-BIS) | Diagnostic Test | — | UNRESOLVED |
| ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form) | Diagnostic Test | — | UNRESOLVED |
| Likert's scale questionnaire | Diagnostic Test | — | UNRESOLVED |
| manometry through the PHENIX series device (model: PHENIX LIBERTY; manufacturer: ELECTRONIC CONCEPT LIGNON INNOVATION, Montpelier, France). | Device | — | UNRESOLVED |
| Oxford's Scale | Diagnostic Test | — | UNRESOLVED |
| PFIQ-20 questionnaire (Pelvic Floor Impact Questionnaire Short Form) | Diagnostic Test | — | UNRESOLVED |
| Sandvik's test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Temperature after apply RF in capacitive electrical transfer mode (Capernergy® device model C500)
- 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.
- interventionNames
- Device: manometry through the PHENIX series device (model: PHENIX LIBERTY; manufacturer: ELECTRONIC CONCEPT LIGNON INNOVATION, Montpelier, France).
- Diagnostic Test: PFIQ-20 questionnaire (Pelvic Floor Impact Questionnaire Short Form)
- Diagnostic Test: ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form)
- Diagnostic Test: Sandvik's test
- Diagnostic Test: vaginal health index (VHI)
- Diagnostic Test: Visual analogue scale (VAS)
- Diagnostic Test: Body Image Scale (S-BIS)
- Diagnostic Test: Likert's scale questionnaire
- Diagnostic Test: Oxford's Scale
- Diagnostic Test: Sexual function and self-esteem
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDSalar-Andreu C, Montero-Navarro S, Lozano-Rubio A, Del Rio-Medina S, Botella-Rico JM, Torres-Lacomba M, Benitez-Martinez JC, Sanchez-Mas J, Orts-Ruiz C. Effectiveness of radiofrequency and exercise-based rehabilitation on symptoms associated with pelvic floor dysfunction in breast cancer patients: A study protocol. PLoS One. 2025 Aug 29;20(8):e0330156. doi: 10.1371/journal.pone.0330156. eCollection 2025. PMID 40880350