Breast CancerNCT06694519
Radiofrequency and Exercise-based Rehabilitation on Symptoms Associated With Pelvic Floor Dysfunctions in Breast Cancer
A study testing manometry through the PHENIX series device (model: PHENIX LIBERTY; manufacturer: ELECTRONIC CONCEPT LIGNON INNOVATION, Montpelier, France)., PFIQ-20 questionnaire (Pelvic Floor Impact Questionnaire Short Form) and ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form) in people with Breast Cancer and Genitourinary Syndrome, run by SERGIO MONTERO NAVARRO at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Genitourinary Syndrome, Radiofrequency
- What is being tested?
- manometry through the PHENIX series device (model: PHENIX LIBERTY; manufacturer: ELECTRONIC CONCEPT LIGNON INNOVATION, Montpelier, France)., PFIQ-20 questionnaire (Pelvic Floor Impact Questionnaire Short Form) and ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jan 2025to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Cardenal Herrera - Ceu
Elche, Spain / Valencia, 46113
SERGIO MONTERO-NAVARRO, PhD, +34 965426486 ext. 67406, sergio.montero@uchceu.es
ANA LOZANO-RUBIO, MsC
About this study
Official title: Effectiveness of Radiofrequency and Exercise-based Rehabilitation on Symptoms Associated With Pelvic Floor Dysfunction in Breast Cancer Patients.
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.
- Being tested
- manometry through the PHENIX series device (model: PHENIX LIBERTY; manufacturer: ELECTRONIC CONCEPT LIGNON INNOVATION, Montpelier, France)., PFIQ-20 questionnaire (Pelvic Floor Impact Questionnaire Short Form), ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form), Sandvik's test, vaginal health index (VHI)
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manometry through the PHENIX series device (model: PHENIX LIBERTY; manufacturer: ELECTRONIC CONCEPT LIGNON INNOVATION, Montpelier, France).Device
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'.
PFIQ-20 questionnaire (Pelvic Floor Impact Questionnaire Short Form)Diagnostic test
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.
ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form)Diagnostic test
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.
Sandvik's testDiagnostic 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.
vaginal health index (VHI)Diagnostic test
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
Visual analogue scale (VAS)Diagnostic test
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.
Body Image Scale (S-BIS)Diagnostic test
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.
Likert's scale questionnaireDiagnostic test
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).
Oxford's ScaleDiagnostic test
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.
Sexual function and self-esteemDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Temperature after apply RF in capacitive electrical transfer mode (Capernergy® device model C500) | Experimental | 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. Receives: 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 |
| PFMT | Experimental | The PFMT will consist of a targeted programme, with a protocol of CORE and pelvic floor exercises established based on the assessment of the patients' strength, endurance and fatigue, with a frequency of twice a week led by a physiotherapist and a duration of 45 minutes each day and a period of 16 weeks.It will be carried out in groups of 8 people and accompanied by a physiotherapist experienced in therapeutic exercise.
Each session will consist of exercises to activate the pelvic floor muscles in isolation and in association with the CORE muscles, both static and dynamic. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFDI-20 questionnaire (300 points)
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.
Measured: Pre-intervention / a year post-intervention
Secondary outcomes (6)
Age (years)
Subject's age (years)
Measured: Pre-intervention
Sex (female or male)
Subject's sex (female or male)
Measured: Pre-intervention
Body mass index (Kg /m2)
It is a measure of body fat based on height and weight that applies to adult men and women
Measured: Pre-intervention
Pelvic floor muscle strength assessment (oxford scale 0-5 points)
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.
Measured: pre-intervention / 15 days post-intervention / 6 months post-intervention / 12 months post-intervention
neuromuscular stimulation device and PHENIX LIBERTY manometry (mmHg)
Measured: pre-intervention / 15 days post-intervention / 6 months post-intervention / 12 months post-intervention
pH (0-14)
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.
Measured: pre-intervention / 15 days post-intervention / 6 months post-intervention / 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start30 Jan 2025
- Primary completion30 Dec 2025
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SERGIO MONTERO NAVARRO
- Sponsor type
- University, hospital or other
- Collaborators
- Cardenal Herrera University, CAPENERGY MEDICAL, SL
- Responsible party
- Sponsor-investigator, SERGIO MONTERO NAVARRO, Cardenal Herrera University
- Investigators
- ANA LOZANO, MsC, Principal investigator, CARDENAL HERRERA - CEU; CEU UNIVERSITIESCRISTINA ORTS-RUIZ, PhD, Study director, CARDENAL HERRERA - CEU; CEU UNIVERSITIESJESÚS SÁNCHEZ-MAS, PhD, Study director, CARDENAL HERRERA - CEU; CEU UNIVERSITIES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694519
- Sponsor's protocol ID
- CEEI24/540
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The general data of the subject will be collected (name, age, sex, physical variables and clinical history). You must come to participate in our study with comfortable clothes. 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. An alpha-numeric code will be assigned to each participant. The study is double-blind. Only this code will be recorded by the evaluators. This study was approved by the Research and Ethics Committee of CEU Cardenal Herrera University (CEEI24/540).
Publications
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. eCollection 2025.
PubMed 40880350
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Radiofrequency and Exercise-based Rehabilitation on Symptoms Associated With Pelvic Floor Dysfunction in Breast Cancer Patients.
- ClinicalTrials.gov ID
- NCT06694519
- Acronym / sponsor ID
- CEEI24/540
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- SERGIO MONTERO NAVARROUniversity, hospital or other
- Collaborators
- Cardenal Herrera University, CAPENERGY MEDICAL, SL
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temperature after apply RF in capacitive electrical transfer mode (Capernergy® device model C500) | Experimental | 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-esteemIt 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. |
| PFMT | Experimental | 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-esteemThe PFMT will consist of a targeted programme, with a protocol of CORE and pelvic floor exercises established based on the assessment of the patients' strength, endurance and fatigue, with a frequency of twice a week led by a physiotherapist and a duration of 45 minutes each day and a period of 16 weeks.It will be carried out in groups of 8 people and accompanied by a physiotherapist experienced in therapeutic exercise. Each session will consist of exercises to activate the pelvic floor muscles in isolation and in association with the CORE muscles, both static and dynamic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 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'. | Device | PFMT, Temperature after apply RF in capacitive electrical transfer mode (Capernergy® device model C500) |
| 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. | Diagnostic test | PFMT, Temperature after apply RF in capacitive electrical transfer mode (Capernergy® device model C500) |
| 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. | Diagnostic test | PFMT, Temperature after apply RF in capacitive electrical transfer mode (Capernergy® device model C500) |
| Sandvik's testIt 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 test | PFMT, Temperature after apply RF in capacitive electrical transfer mode (Capernergy® device model C500) |
| 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 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 test | PFMT, Temperature after apply RF in capacitive electrical transfer mode (Capernergy® device model C500) |
| 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. 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 test | PFMT, Temperature after apply RF in capacitive electrical transfer mode (Capernergy® device model C500) |
| 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 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 test | PFMT, Temperature after apply RF in capacitive electrical transfer mode (Capernergy® device model C500) |
| Likert's scale questionnairefive-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 test | PFMT, Temperature after apply RF in capacitive electrical transfer mode (Capernergy® device model C500) |
| Oxford's ScaleIt 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 test | PFMT, Temperature after apply RF in capacitive electrical transfer mode (Capernergy® device model C500) |
| Sexual function and self-esteemThe 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. | Diagnostic test | PFMT, Temperature after apply RF in capacitive electrical transfer mode (Capernergy® device model C500) |
Primary outcome
PFDI-20 questionnaire (300 points)
Time frame: 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.
6 secondary outcomes
Age (years)
Time frame: Pre-intervention
Sex (female or male)
Time frame: Pre-intervention
Body mass index (Kg /m2)
Time frame: Pre-intervention
Pelvic floor muscle strength assessment (oxford scale 0-5 points)
Time frame: pre-intervention / 15 days post-intervention / 6 months post-intervention / 12 months post-intervention
neuromuscular stimulation device and PHENIX LIBERTY manometry (mmHg)
Time frame: pre-intervention / 15 days post-intervention / 6 months post-intervention / 12 months post-intervention
pH (0-14)
Time frame: pre-intervention / 15 days post-intervention / 6 months post-intervention / 12 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Derived from this study: PubMed 40880350Salar-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.
- Individual participant dataSharing planned: Yes. The general data of the subject will be collected (name, age, sex, physical variables and clinical history). You must come to participate in our study with comfortable clothes. 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. An alpha-numeric code will be assigned to each participant. The study is double-blind. Only this code will be recorded by the evaluators. This study was approved by the Research and Ethics Committee of CEU Cardenal Herrera University (CEEI24/540).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ANA LOZANO, MsC principal investigator
CARDENAL HERRERA - CEU; CEU UNIVERSITIES
CRISTINA ORTS-RUIZ, PhD study director
CARDENAL HERRERA - CEU; CEU UNIVERSITIES
JESÚS SÁNCHEZ-MAS, PhD study director
CARDENAL HERRERA - CEU; CEU UNIVERSITIES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manometry through the PHENIX series device (model: PHENIX LIBERTY; manufacturer: ELECTRONIC CONCEPT LIGNON INNOVATION, Montpelier, France)., PFIQ-20 questionnaire (Pelvic Floor Impact Questionnaire Short Form) and ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form) in people with Breast Cancer and Genitourinary Syndrome, run by SERGIO MONTERO NAVARRO at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SERGIO MONTERO-NAVARRO, PhD (+34 965426486 ext. 67406, sergio.montero@uchceu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFDI-20 questionnaire (300 points) (time frame: Pre-intervention / a year post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06694519, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.