Effectiveness of Radiofrequency and Exercise-based Rehabilitation on Symptoms Associated With Pelvic Floor Dysfunction in Breast Cancer Patients.
Phase: NA
Conditions: Breast Cancer, Genitourinary Syndrome, Radiofrequency, Physical Exercise
Sponsor: SERGIO MONTERO NAVARRO

 
 
 
 
 
 
 
 
 
 
 
 
 
STUDY PROTOCOL PLAN AND STADISTICAL ANALYSIS PLAN (SAP)  
 
UNIVERSITY CEU CARDENAL HERRERA  
 
Principal investigator: Dra. Cristina Orts Ruiz 
 
TITLE: Effectiveness of radiofrequency and exercise-based rehabilitation on 
symptoms associated with pelvic floor dysfunction in breast cancer patients.  
 
Research and Ethics Committee of CEU Cardenal Herrera University Number: CEEI24/540 
 
NCT ID: 
DATE: 11-14-2024 
 
 
 
 

 
STUDY PROTOCOL PLAN 
 
Objectives: 
 
The objectives of our study have been the following: 
 
The aim of the study is to compare the effectiveness of radiofrecuency (RF)-based 
treatment with pelvic floor muscle treatment (PFMT)-based treatment on genitourinary 
menopausal syndrome (GUS)-related pelvic dysfunction in breast cancer patients.   
 
Specific objectives  
 
To evaluate the effect of RF, PFMT and the combination of both therapies on urinary 
incontinence (UI), fecal incontinence (FI) and prolapse in women diagnosed with breast 
cancer.  
 
To evaluate the effect of RF therapy and PFMT on the quality of life of women diagnosed 
with breast cancer.  
 
To analyse the effect of RF and PFMT on sexual function in women diagnosed with 
breast cancer.  
 
Protocol 
 
To find out the impact of RF therapy and PFMT on the perception of body self-image in 
women diagnosed with breast cancer. 
 
The recruitment of breast cancer survivors will be carried out at the facilities of two 
associations of patients diagnosed with breast cancer in the province of Alicante: 
Asociación de Mujeres Afectadas por el Cáncer de Mama de Elche y Comarca 
(AMACMEC, Elche) and Asociación de cáncer de Mama Vinalopó (AcMAVI, Petrel). 
Both associations have signed a collaboration agreement with the CEU Cardenal 
Herrera University for the development of the study. The evaluation and intervention will 
be carried out at the facilities of the Department of Nursing and Physiotherapy of the 
Faculty of Health Sciences of the CEU Cardenal Herrera University (Elche, Spain).   
 

 
Volunteers who want to participate in the study will read the general information of the 
study and sign the informed consent to participate in the study. 
 
Interventions 
Group 1. Treatment based on radiofrequency.   
The proposed therapeutic process will consist of applying RF in the modality of 
capacitive electrical transfer (Capernergy® device model C500 Urogyne, Capenergy 
Medical, Barcelona, Spain). This is a device designed primarily for addressing 
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. 
The protocol to be performed is based on a previous treatment shown to be 
effective for the treatment of UGS in postmenopausal women45. Participants will be 
placed in a lithotomic position, with lower limbs flexed and supported. The treatment 
temperature will be set at 41°C, with a frequency of 1Mhz and power of 75KJ. Once the 
indicated temperature has been reached, the physiotherapist will perform semicircular 
movements on the vaginal wall for 2 minutes on the anterior vaginal side and for 4 
minutes on the posterior vaginal wall. A total of 5 sessions will be carried out with an 
interval of 7 days between each one of them, for a total of 4 weeks of treatment. Patients 
will be instructed to contact the investigators if they experience any discomfort or notice 
any change in vaginal discharge.   
 
Group 2. PFMT-based treatment  
 
Patients in the PFMT group will be assisted during the sessions by experienced 
physiotherapists. PFMT will consist of a programme where the participants, in groups of 
8, will perform a programme of CORE and pelvic floor exercises established based on 
an assessment of the patients' strength, endurance and fatigability. The aim is to activate 
the pelvic floor muscles in isolation and in association with the CORE muscles, both 
statically and dynamically.   
 

 
The design of the exercise protocol and sequences is based on an adaptation of 
the programme described in a previous study carried out in 117 climacteric women with 
pelvic dysfunction, which showed significant improvement in UI symptoms, vaginal 
symptoms and sexual function similar to what we intend to analyse in this project, and 
on previous studies on therapeutic exercise in the prevention and treatment of pelvic 
floor pathologies based on PFMT, hypopressive technique, CORE work and the use of 
unstable bases. 
 
The PFMT will take place twice a week, with each session lasting 45 minutes and 
a total training period of 16 weeks. The PFMT will expand goals by month and will have 
different sessions per week, to encourage adherence and motivation from the variability 
of the exercises. The first four weeks will include a first day of CORE and pelvic floor 
training in a cabin and individual session to ensure understanding of concepts and 
correct technique. After this, the therapeutic exercise protocol will focus on 
proprioception, mobilisation and activation of the structures responsible for the CORE, 
isometric work, voluntary activation of the CORE musculature, pelvic floor and synergic 
musculature such as the gluteus, both static and dynamic, as well as the performance of 
exercises in resisted expiration and apnoea to facilitate the activation of the lumbopelvic 
complex, as previous programmes aimed at patients with abdominopelvic dysfunctions 
have demonstrated their efficacy.  
 
In the second month, mobility, proprioception and PFMT exercises facilitated by 
posture and breathing will be maintained, and the load will be increased with positions 
against gravity, activation in movement and activation against resistance of the 
accessory musculature. 
 
In the third month, mobility, proprioception and PFMT exercises will be continued 
with an increase in load through posture and movement, and external loads will be 
introduced at 60% of their RM according to the progression of the loads in terms of 
strength, endurance and health.   
 
In the fourth month, after reassessing the RM for load management, the load will 
be increased to 75% and we will focus on the work and activation of the CORE and pelvic 
floor in a dynamic way, with normalised breathing and introducing impact and fatigue, 
demonstrable risk factors in pelvic pathology. The aim is to achieve the automation of 
the abdominopelvic synergy and its competence in situations both in daily life and in 

 
physical exercise. 
 
Primary outcomes  
 
The primary outcome will be the indication of improvement in pelvic function after 
the proposed interventions as assessed through the PFDI-20 questionnaire. This 
questionnaire allows assessment of the impact in the last 3 months of urinary symptoms 
(Urinary Impact Questionnaire; UIQ-7), colo-rectal-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 outcomes  
 
The determinations indicated in this section will be made before starting the 
intervention, fifteen days after the end of the intervention, six months after the end of the 
intervention and twelve months after the end of the intervention.    
 
Assessment of the strength of the pelvic floor musculature  
 
Prior to the measurement, participants will be asked to go to the toilet to urinate, 
thus allowing the bladder volume to be standardised as far as possible. They will 
complete a resting period of 3 minutes in a seated position prior to the measurement, as 
this time corresponds to twice the duration of sympathetic system deactivation. For the 
force recording, the women will be placed in a lithotomic position, with the genital region 
and legs unclothed, covered by a sheet. They will then be instructed to remain relaxed.    
 
The first examination will consist of a bidigital palpation to estimate the strength 
of the pelvic floor musculature during maximal contraction using the Oxford scale based 
on previous studies indicating the influence of strength, endurance and fatigability on 
pelvic floor competence and its relationship to the synergistic musculature. The Oxford 
scale assesses the contractile capacity of the pelvic floor muscles. It is scored from 0 to 
5 as follows: no contraction is 0, very weak contraction is 1, weak contraction is 2, 
moderate/tension/and maintained contraction is 3, good contraction and maintaining 
tension with resistance is 4, and strong contraction and maintaining tension against a 

 
resistant force is 5. In addition, this assessment allows determination of static muscular 
endurance, fatiguability or dynamic endurance and maximal muscular strength. 
 
Strength and endurance will also be determined by using a pelvimeter consisting 
of an inflatable vaginal probe connected to the PHENIX LIBERTY therapeutic 
neuromuscular stimulation and manometry device (ELECTRONIC CONCEPT LIGNON 
INNOVATION, Montpeilier, France). 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 by holding 
the back of the manometric probe with the other hand. Pelvic floor pressure signals will 
be collected by measuring both the basal tone of the pelvic floor and the maximum 
pressure maintained for 10 seconds in three measurements, with the average of the 
three being calculated at the command, ‘contract as hard as you can for as long as 
possible. 
Pelvic function and quality of life  
Pelvic function will be assessed with the PFDI-20 questionnaire described above, and in 
addition with the following questionnaires:  
The International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) is 
a four-question self-administered questionnaire that identifies individuals with urinary 
incontinence by assessing frequency, severity and impact on quality of life. It consists 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.  
The Sandvik severity test provides insight into the severity of 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. 
Vaginal symptoms  
Physical examination will assess the vaginal health index (VHI), which consists of a 
graded scale of 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 distending the mucosa on palpation and on placement of the VHI. Vaginal 

 
elasticity ranges from 1 (no elasticity) to 5 (excellent elasticity), assessed by distension 
of the mucosa on palpation and speculum placement. Fluid volume, assessed during 
inspection, varies between 1 (no discharge) and 5 (normal discharge, white flocculent). 
The integrity of the epithelium ranges from 1 (petechiae already detected on inspection) 
to 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 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.  
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.  
Dyspareunia will be assessed using the Visual Analogue Scale (VAS), which 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 is 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 millimetre 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.  
The Body Image Scale (S-BIS) consists of 10 items assessing various dimensions of 
body image in cancer patients, evaluating: affective, behavioural and 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.  
Baseline and follow-up period assessment  
After signing the informed consent, patients will undergo an anamnesis that includes 

 
questions related to a questionnaire designed ad hoc that will allow to know the 
sociodemographic characteristics, as well as information related to the diagnosis and 
treatment of breast cancer. They will complete the questionnaires described above on 
pelvic function and quality of life, vaginal health, sexual function and self-esteem. 
Subsequently, patients will be referred for a physical examination consisting of pelvic 
floor muscle strength assessment. Questionnaires will be self-completed by participants 
and collected at the end of the baseline assessment. These procedures will be performed 
at the initial assessment (first visit). 
Patients will be followed up in 3 periods after the interventions: first follow-up (15 days 
after the intervention), second follow-up (6 months after the intervention) and third follow-
up (12 months after the intervention). The same assessment procedures will be 
performed at follow-up as at baseline.  
Data collection and management  
A researcher will assist participants in completing the questionnaires and will check that 
all questionnaires are completed and signed. A physiotherapist with more than 15 years 
of pelvic floor experience will assess the pelvic floor muscle strength and vaginal health 
of all participants. Two physiotherapists with more than 15 years of experience in 
rehabilitation will perform the PFMT interventions. One physiotherapist with more than 
10 years of experience will perform radiofrequency intervention.  
The data collected for this study will be included in a computerised database of a 
personal nature of the CEU Cardenal Herrera University, to which access will only be 
granted to the researcher responsible for the analysis, extraction and handling of the 
data, by means of an access code, being subject to the secrecy inherent to their 
profession or derived from a confidentiality agreement. 
 
 
 

 
Statistical Analysis Plan (SAP) 
 
The Kolmogorov-Smirnov test will be used to assess the normality of the sample. 
Comparative analyses between groups will be performed by analysis of variance 
(ANOVA) or Kruskal-Wallis test. Associations of categorical variables will be 
analysed using the Chi-square test and Fisher's exact test. Intra-group 
assessment will be performed using the Wilcoxon test or Student's t-test for 
paired samples for continuous variables, and McNemar's test for categorical 
variables.  
 
The data will also be evaluated using ANOVA for repeated measures in order to 
simultaneously verify the influence of the three study groups (between-group 
effect), the two assessments (within-group effect) and to estimate the group × 
time interaction effect for each of the variables. The results will be analysed by 
intention-to-treat. The significance level will be 5%. IBM SPSS Statistics for 
Windows, version 29.0 (SPSS Inc., Chicago, IL, USA) will be used.  
 
Statistical analysis of the data collected will be performed by a researcher blinded 
for the intervention and for data collection. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
GENERAL STUDY INFORMATION AND INFORMED CONSENT 
 
UNIVERSITY CEU CARDENAL HERRERA  
 
Principal investigator: Dra. Cristina Orts Ruiz 
 
TITLE: Effectiveness of radiofrequency and exercise-based rehabilitation on 
symptoms associated with pelvic floor dysfunction in breast cancer patients.  
 
Research and Ethics Committee of CEU Cardenal Herrera University Number: CEEI24/540 
 
NCT ID: 
DATE: 11-14-2024 
 
 
 

 
 
GENERAL STUDY INFORMATION 
 
TITLE: Effectiveness of radiofrequency and exercise-based rehabilitation on 
symptoms associated with pelvic floor dysfunction in breast cancer patients 
 
Mrs. Cristina Orts Ruiz, Physiotherapist, principal investigator and researcher reports that: 
The study in which will be part of rehabilitation on symptoms associated with pelvic floor 
dysfunction in breast cancer patients. In this way we can contribute to promote the health 
status of people with this pathology. 
 
The tests performed are simple and in no case involve difficulty, fatigue, danger, injury, 
pain or adverse reaction.  
 
They will be carried out by collegiate physiotherapists in the School of Physiotherapists of 
the Valencian Community. 
 
The general data of the subject will be collected (name, age, sex, physical variables and 
clinical history). The subject should come with comfortable clothes. The day that you were 
cited by the researcher, previous notice. Personal data is recognized in this study.  
 
The personal data are confidential, apply to the protection of personal data. The study will 
be carried out in accordance with the Declaration of Helsinki and in accordance with 
current Spanish legislation (Royal Decree 223/2004 and the Biomedical Research Act 2007) 
and any other thing that may be applicable. 
 
This study was approved by the Research and Ethics Committee of CEU Cardenal Herrera 
University (CEEI24/540). 
 
 
 
 

 
INFORMED CONSENT 
  
Mr/Mrs................................................................................................... with Number 
identification ....................................... .. freely and voluntarily, I DECLARE: 
 
That I have read the information contained in this document about the general information 
of the study. 
 
I have been informed that all tests are simple to perform and do not produce harmful effects 
on health. They will be carried out in appropriate facilities and will be carried out by 
qualified and specialized personnel. 
 
I have also been informed that, the data collected in this study will be treated confidentially, 
applying the current legislation on protection of personal data (Royal Decree 223/2004 and 
the Biomedical Research Act 2007) and any other applicable. 
 
Therefore, I give my consent, and I authorize Mrs. Cristina Orts Ruiz, to carry out the 
detailed study in this document with the help of the necessary personnel with the 
appropriate qualification and specialization. 
 
In Elche, to ...... of .......................................... of 201 
 
SIGNED