Breast Cancer, Genitourinary Syndrome, Radiofrequency, Physical Exercise
Conditions
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.
Interventions
DEVICEmanometry 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 maximum pressure held for 10 seconds in three measurements, the average of the three being calculated at the command, 'contract as hard as you can for as long as possible'.
DIAGNOSTIC_TESTPFIQ-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.
DIAGNOSTIC_TESTICIQ-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.
DIAGNOSTIC_TESTSandvik'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.
DIAGNOSTIC_TESTvaginal 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 inspection) and 5 (non-friable tissue and normal mucosa). Moisture ranges from 1 (no moisture detected on inspection and presence of inflamed mucosa) to 5 (normal moisture). The pH will be quantified using a pH indicator strip between 0 and 14 (MColorpHast™-PH indicator strips) 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
DIAGNOSTIC_TESTVisual 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. The intensity is expressed in centimetres or millimetres. The rating will be: 1 Mild pain if the patient scores the pain as less than 3; 2 Moderate pain if the rating is between 4 and 7; 3 Severe pain if the rating is equal to or greater than 8.
DIAGNOSTIC_TESTBody 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 with high reliability (Cronbach's alpha=0.93), suggesting that it is a suitable and useful measure for assessing body image in breast cancer patients.
DIAGNOSTIC_TESTLikert'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).
DIAGNOSTIC_TESTOxford'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.
DIAGNOSTIC_TESTSexual 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.
Sponsors
SERGIO MONTERO NAVARRO
Cardenal Herrera University
CAPENERGY MEDICAL, SL
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Spain
Contacts
CONTACTSERGIO MONTERO-NAVARRO, PhD
PRINCIPAL_INVESTIGATORANA LOZANO, MsC
CARDENAL HERRERA - CEU; CEU UNIVERSITIES
STUDY_DIRECTORCRISTINA ORTS-RUIZ, PhD
CARDENAL HERRERA - CEU; CEU UNIVERSITIES
STUDY_DIRECTORJESÚS SÁNCHEZ-MAS, PhD
CARDENAL HERRERA - CEU; CEU UNIVERSITIES
Outcome results
None listed