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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство manometry through the PHENIX series device (model: PHENIX LIBERTY; manufacturer: ELECTRONIC CONCEPT LIGNON INNOVATION, Montpelier, France).
  For this manometry the air probe, connected to the Phenix biofeedback system, covered by a latex probe cover lubricated with gel, will be used. In the procedure, the labia majora are opened with one hand and slowly rotated into the vagina while holding the back of the manometric probe with the other hand. Basal tone in g will be measured prior to pelvic floor muscles force measurements. The manometry probe will extract pelvic floor pressure signals by measuring both your basal tone and the maxim
• Диагностический тест PFIQ-20 questionnaire (Pelvic Floor Impact Questionnaire Short Form)
  This questionnaire allows assessment of the impact of urinary symptoms, colo-rectal-anal symptoms and genital prolapse symptoms. This questionnaire will also be used as an inclusion criterion, to homogenise the characteristics of the population in terms of pelvic dysfunction prior to the intervention, as indicated above.
• Диагностический тест ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form)
  a four-question self-administered questionnaire that identifies individuals with urinary incontinence by assessing frequency, severity and impact on quality of life. It is composed of five questions assessing frequency, severity and impact of UI, plus a set of eight self-diagnostic items related to UI situations experienced by patients. The maximum sum of the response values indicates a score of 21 points, referring to the high impact of UI on an individual's life.
• Диагностический тест Sandvik's test
  It provides information on the severity of the UI by means of two questions. The interpretation based on the score is classified as: 1-2 mild UI, 3-6 moderate UI, 8-9 severe UI, 12 very severe UI.
• Диагностический тест vaginal health index (VHI)
  this index consists of a graduated scale from 1 to 5 for each item (vaginal elasticity, fluid volume, pH, epithelial integrity and moisture).Vaginal elasticity ranges from 1 (no elasticity) to 5 (excellent elasticity), assessed by distension of the mucosa on palpation and speculum placement. The volume of fluid, assessed during inspection, varies between 1 (no discharge) and 5 (normal discharge) (white flocculent). The integrity of the epithelium varies between 1 (petechiae already detected on i
• Диагностический тест Visual analogue scale (VAS)
  This scale allows the intensity of pain described by the patient to be measured with maximum reproducibility between observers. It consists of a horizontal line of 10 centimetres, at the ends of which are the extreme expressions of a symptom. At the left end is the absence or lowest intensity and at the right end the highest intensity. The patient is asked to mark on the line the point that indicates the intensity of the pain during sexual intercourse and it is measured with a millimetres ruler.
• Диагностический тест Body Image Scale (S-BIS)
  It consists of 10 items assessing various dimensions of body image in cancer patients, evaluating: affective, behavioural and cognitive. The items are scored on a four-point scale (0: not at all; 1: a little; 2: quite a lot; 3: a lot) with a maximum possible score of 3 points. The higher the score, the higher the body image problem. Its brevity facilitates rapid assessment in both clinical and research settings. It shows a stable factor structure between samples, and good psychometric properties
• Диагностический тест Likert's scale questionnaire
  five-point Likert scale for satisfaction with treatment to be classified as: 1 (very dissatisfied), 2 (dissatisfied), 3 (no change), 4 (satisfied), 5 (very satisfied). Women who miss any of the RF sessions and/or whose attendance at the face-to-face physiotherapy sessions (RF and/or PFMT) does not reach 80% will be considered as not complying with the study protocol and their participation will be terminated, although they will be included in the analysis (by intention to treat).
• Диагностический тест Oxford's Scale
  It allows the contractile capacity of the pelvic floor muscles to be assessed. It scores from 0 to 5, as follows: if there is no contraction it is 0, if the contraction is very weak it is 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.
• Диагностический тест Sexual function and self-esteem
  The Female Sexual Function Index (FSFI) questionnaire consists of 19 items that assess sexual function over the past 4 weeks and performance in six domains: sexual desire, arousal, lubrication, orgasm, satisfaction and pain. A cut-off point ≤ 26.5 is considered sexual dysfunction and an increase in score is considered an improvement.

Первичные конечные точки

• PFDI-20 questionnaire (300 points) [Срок оценки: Pre-intervention / a year post-intervention]

Вторичные конечные точки (6)

• Age (years) [Срок оценки: Pre-intervention]
• Sex (female or male) [Срок оценки: Pre-intervention]
• Body mass index (Kg /m2) [Срок оценки: Pre-intervention]
• Pelvic floor muscle strength assessment (oxford scale 0-5 points) [Срок оценки: pre-intervention / 15 days post-intervention / 6 months post-intervention / 12 months post-intervention]
• neuromuscular stimulation device and PHENIX LIBERTY manometry (mmHg) [Срок оценки: pre-intervention / 15 days post-intervention / 6 months post-intervention / 12 months post-intervention]
• pH (0-14) [Срок оценки: pre-intervention / 15 days post-intervention / 6 months post-intervention / 12 months post-intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Cardenal Herrera - Ceu — Elche

Публикации

• Salar-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. eCollectio PMID 40880350

Идентификаторы

NCT: NCT06694519 · CEEI24/540

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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