Stress Urinary IncontinenceNCT07095283
Second-generation Radiofrequency Application and Therapeutic Exercise for Stress Urinary Incontinence
A study testing Short International Consultation on Incontinence Questionnaire (ICIQ-SF), King's Health Questionnaire (KHQ) and Ultrasound evaluation in people with Stress Urinary Incontinence, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
Stress urinary incontinence (SUI) is defined as the loss of the ability to hold urine after exertion, i.e., as a result of imbalances in intra-abdominal pressure, which directly affect the lower urinary tract. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Short International Consultation on Incontinence Questionnaire (ICIQ-SF), King's Health Questionnaire (KHQ) and Ultrasound evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 over the age of 18 who meet the International Continence Society (ICS)
- diagnostic criteria for SUI, which consists of involuntary leakage of urine during increased intra-abdominal pressure in the absence of bladder contractions such as coughing, sneezing, and other physical activities.
Who cannot join
- diagnosis of urgent or mixed UI
- diagnosis of pelvic organ prolapse
- taking any treatment for UI
- pregnancy
- history of pelvic surgery, urinary tract infection, or diagnosed psychological disorders
- presence of scars, malformations, abnormal pelvic masses, tissue irritation, or any other condition in the area that could be causing pelvic and urinary function problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Second-generation Radiofrequency Application and Specific Therapeutic Exercise as a Treatment for Stress Urinary Incontinence Due to Urethral Instability. Randomised Clinical Trial
Stress urinary incontinence (SUI) is defined as the loss of the ability to hold urine after exertion, i.e., as a result of imbalances in intra-abdominal pressure, which directly affect the lower urinary tract. SUI has been shown to have a significant impact on the quality of life of those affected, impacting physical, social, and psycho-emotional aspects. Among the proposed treatments is a physiotherapeutic approach, which is offered as a less invasive and painless therapy with fewer adverse effects than pharmacological or surgical treatment. Pelvic floor muscle training (PFMT) is the most effective physiotherapeutic treatment for SUI, increasing the contractile capacity of the muscles and restoring stability throughout the pelvic diaphragm, thereby ensuring proper support of the pelvic organs. Radiofrequency (RF) therapy is currently being proposed as a therapeutic option that may offer certain advantages over those reported for photoplethysmography (PPMT). The potential benefits of RF therapy are attributed to its ability to stimulate collagen metabolism, thereby promoting tissue regeneration. Radiofrequency (RF) is a non-invasive and painless method that has the potential to yield analogous results to pelvic physical therapy (PPMT) as a standalone treatment or enhance the efficacy of PPMT when administered in conjunction with RF for stress urinary incontinence (SUI).
The objective of the present study is to analyse the effectiveness of PFMT and RF as single or combined treatments for SUI in women at Clínica Traña, a clinic specialising in the treatment of pelvic floor dysfunction in Costa Rica. Following the process of obtaining informed consent, patients will be offered a single or combined treatment of RF and/or PFMT. The strength of the pelvic floor muscles, pelvic function and the impact of pelvic dysfunctions on quality of life will be evaluated with a one-year follow-up after the conclusion of treatment.
Read more
The project possesses the facilities, equipment, and personnel necessary to ensure its viability, as well as proven clinical experience.
The scientific and technical impact of the proposed treatment protocol will be achieved by establishing an effective therapeutic strategy to address SUI. The social impact of SUI is significant, given its high prevalence and the fact that it has physical consequences as well as a negative impact on the social activities, work functions and emotions of women who suffer from it.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Short International Consultation on Incontinence Questionnaire (ICIQ-SF), King's Health Questionnaire (KHQ), Ultrasound evaluation, Sandvik Severity Index, Oxford's scale
- Keywords
- urethral instability, radiofrequency, physical exercise, functional ultrasound, quality of life
- Medical subject headings
- Urinary Incontinence, Stress, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short International Consultation on Incontinence Questionnaire (ICIQ-SF)Diagnostic test
This is a self-administered questionnaire with four questions and a total score ranging from 0 [best] to 21 [worst] that identifies people with urinary incontinence and its impact on quality of life.
King's Health Questionnaire (KHQ)Diagnostic test
The KHQ is a self-administered instrument specifically designed to assess quality of life in women with UI. It consists of 21 items distributed across 9 dimensions: perception of overall health (1 item), impact of UI (1 item), limitations in daily activities (2 items), physical limitations (2 items), social limitations (2 items), personal relationships (3 items), emotions (3 items), sleep/energy (2 items), and severity of UI (5 items). The score range for each dimension is from 0 (lowest impact of UI and therefore best quality of life) to 100 (highest impact, worst quality of life). This questionnaire provides an overall value for the quality of life of the patient with UI (Overall Score-OS) and another specific value for each dimension on a scale with the following range: 0: Best possible quality of life - 100: Worst possible quality of life.
Ultrasound evaluationDiagnostic test
A two-dimensional (2D) ultrasound system with B-mode capability and cine-loop function, a 3.5 to 6 MHz curved convex probe transducer, was used for the perineal image. The examination will be performed in the dorsal lithotomy position, with the hips flexed and slightly abducted and the heels placed close to the buttocks, or in a standing position if necessary.
Sandvik Severity IndexDiagnostic test
It allows the severity of UI to be determined based on two questions. Interpretation based on the score is classified as follows: 1-2 mild UI, 3-6 moderate UI, 8-9 severe UI, 12 very severe UI.
Oxford's scaleDiagnostic test
The strength of the Pelvic floor muscles will be evaluated digitally using functional ultrasound and classified according to the Oxford scale.
BiofeedbackDiagnostic test
Also called Muscular and static strength; Fatigability or Dynamic Endurance
Muscular (mmHg) and static strength (seconds); Fatigability or Dynamic Endurance (% and cmH₂O)
| Study group | Role | What they receive |
|---|---|---|
| RF Therapy | Experimental | Participants will be placed in the lithotomy position. The treatment temperature will be set at 41°C, with a frequency of 1 MHz and power of 75 kJ. Once the indicated temperature has been reached, the physical therapist will perform small upward and downward movements along the urethral canal, dividing the time equally between both sides. One RF session will be performed every 7 days, as described by the author, for a total of 5 sessions. We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test). Receives: Diagnostic Test: Short International Consultation on Incontinence Questionnaire (ICIQ-SF); Diagnostic Test: King's Health Questionnaire (KHQ); Diagnostic Test: Ultrasound evaluation; Diagnostic Test: Sandvik Severity Index; Diagnostic Test: Oxford's scale; Diagnostic Test: Biofeedback |
| Pelvic floor muscle training (PFMT) | Experimental | The PFMT will consist of a targeted program with a protocol of core and pelvic floor exercises established based on an assessment of the patients' strength, endurance, and fatigue, with a frequency of twice a week led by a physical therapist and a duration of 45 minutes each day for a period of 16 weeks. It will be carried out in groups of 8 people and accompanied by a physical therapist experienced in therapeutic exercise. We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test). Receives: Diagnostic Test: Short International Consultation on Incontinence Questionnaire (ICIQ-SF); Diagnostic Test: King's Health Questionnaire (KHQ); Diagnostic Test: Ultrasound evaluation; Diagnostic Test: Sandvik Severity Index; Diagnostic Test: Oxford's scale; Diagnostic Test: Biofeedback |
| combination of RF Therapy and PFMT | Experimental | We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test). Receives: Diagnostic Test: Short International Consultation on Incontinence Questionnaire (ICIQ-SF); Diagnostic Test: King's Health Questionnaire (KHQ); Diagnostic Test: Ultrasound evaluation; Diagnostic Test: Sandvik Severity Index; Diagnostic Test: Oxford's scale; Diagnostic Test: Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Consultation on Incontinence Questionnaire (ICIQ-SF)
0 to 21 points, where higher scores indicate greater impact of incontinence
Measured: Pre - post intervention; after 3,6,12 months
King´s Health Questionnaire (KHQ)
0 to 100, where 0 indicates the best quality of life and 100 the worst
Measured: Pre - post intervention; after 3,6,12 months
ultrasound analysis: Resting aperture (Ar)
degrees
Measured: Pre - post intervention; after 3,6,12 months
ultrasound analysis: Opening during exertion (Ae)
degrees
Measured: Pre - post intervention; after 3,6,12 months
Opening difference (Ae-Ar)
degrees
Measured: Pre - post intervention; after 3,6,12 months
MUSCULAR STRENGTH
defined as the ability of tissue to generate tension based on its contractile capacity, being the best of three attempts to contract, assessed using the modified OXFORD scale
Measured: Pre - post intervention; after 3,6,12 months
Function of the pelvic floor muscles
The best of the three attempts is selected, graded as follows: 0 = no contraction, 1 = partial contraction, 2 = contraction of the pelvic floor muscles + contraction of related muscles, 3 = isolated contraction of the Pelvic floor muscles
Measured: Pre - post intervention; after 3,6,12 months
STATIC MUSCLE STRENGTH
the ability to maintain optimal contraction (isometric, tonic fibers) for as long as possible, measuring the seconds until fatigue sets in. ORDER: "contract and hold," taking the average of the three assessments.
Measured: Pre - post intervention; after 3,6,12 months
Fatigability or Dynamic Endurance
maximum number of contractions in a unit of time, taking 10 seconds as the average. ORDER: "contract as many times as possible and at the highest speed," with the measurement being the average of the three assessments.
Measured: Pre - post intervention; after 3,6,12 months
Oxford's Scale
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 scored as 0; if the contraction is very weak, it is scored as 1; if the contraction is weak, it is scored as 2; if the contraction is moderate/with tension/and sustained, it is scored as 3; if the contraction is good and maintains tension with resistance, it is scored as 4; and if the contraction is strong and maintains tension against a resistant force, it is scored as 5.
Measured: Pre - post intervention; after 3,6,12 months
Sandvik Severity Index
It allows the severity of UI to be determined based on two questions. Interpretation based on the score is classified as follows: 1-2 mild UI, 3-6 moderate UI, 8-9 severe UI, 12 very severe UI.
Measured: Pre - post intervention; after 3,6,12 months
Secondary outcomes (11)
age (years)
Measured: baseline
BMI (Body mass index)
kg / m²
Measured: baseline
smoke
yes/no
Measured: baseline
alcohol consumption
yes/no
Measured: baseline
drug use
yes/no
Measured: baseline
full-term pregnancies
Number
Measured: baseline
natural childbirth
yes/no
Measured: baseline
cesarean sections
yes/no
Measured: baseline
tear
yes/no
Measured: baseline
abortion
yes/no
Measured: baseline
episiotomy
yes/no
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Aug 2025
- Primary completion20 Aug 2025
- Study completion30 Sep 2025
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 Stress Urinary IncontinenceStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SERGIO MONTERO NAVARRO, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095283
- Sponsor's protocol ID
- CEEI25/646
- Status last verified
- Oct 2026
- First submitted
- 24 Jul 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data associated with this paper will be available in the Zenodo repository
Publications
Trana-Serrano JP, Orts-Ruiz C, Montero-Navarro S, Zamora-Streber A, Ramirez Rivera MJ, Garita Redondo O, Molina-Paya FJ, Fluxa-Juan L, Sanchez-Mas J, Salar-Andreu C. Second-Generation Radiofrequency and Targeted Therapeutic Exercise for Stress Urinary Incontinence Due to Urethral Hypermobility: A Study Protocol. Healthcare (Basel). 2026 Jun 9;14(12):1616. doi: 10.3390/healthcare14121616.
PubMed 42354475
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second-generation Radiofrequency Application and Specific Therapeutic Exercise as a Treatment for Stress Urinary Incontinence Due to Urethral Instability. Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT07095283
- Acronym / sponsor ID
- CEEI25/646
- Conditions
- Stress Urinary Incontinence
- Keywords
- urethral instability, radiofrequency, physical exercise, functional ultrasound, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 31 Jul 2025 (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.
Stress urinary incontinence (SUI) is defined as the loss of the ability to hold urine after exertion, i.e., as a result of imbalances in intra-abdominal pressure, which directly affect the lower urinary tract. SUI has been shown to have a significant impact on the quality of life of those affected, impacting physical, social, and psycho-emotional aspects. Among the proposed treatments is a physiotherapeutic approach, which is offered as a less invasive and painless therapy with fewer adverse effects than pharmacological or surgical treatment. Pelvic floor muscle training (PFMT) is the most effective physiotherapeutic treatment for SUI, increasing the contractile capacity of the muscles and restoring stability throughout the pelvic diaphragm, thereby ensuring proper support of the pelvic organs. Radiofrequency (RF) therapy is currently being proposed as a therapeutic option that may offer certain advantages over those reported for photoplethysmography (PPMT). The potential benefits of RF therapy are attributed to its ability to stimulate collagen metabolism, thereby promoting tissue regeneration. Radiofrequency (RF) is a non-invasive and painless method that has the potential to yield analogous results to pelvic physical therapy (PPMT) as a standalone treatment or enhance the efficacy of PPMT when administered in conjunction with RF for stress urinary incontinence (SUI).
The objective of the present study is to analyse the effectiveness of PFMT and RF as single or combined treatments for SUI in women at Clínica Traña, a clinic specialising in the treatment of pelvic floor dysfunction in Costa Rica. Following the process of obtaining informed consent, patients will be offered a single or combined treatment of RF and/or PFMT. The strength of the pelvic floor muscles, pelvic function and the impact of pelvic dysfunctions on quality of life will be evaluated with a one-year follow-up after the conclusion of treatment.
The project possesses the facilities, equipment, and personnel necessary to ensure its viability, as well as proven clinical experience.
The scientific and technical impact of the proposed treatment protocol will be achieved by establishing an effective therapeutic strategy to address SUI. The social impact of SUI is significant, given its high prevalence and the fact that it has physical consequences as well as a negative impact on the social activities, work functions and emotions of women who suffer from it.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RF Therapy | Experimental | Diagnostic Test: Short International Consultation on Incontinence Questionnaire (ICIQ-SF), Diagnostic Test: King's Health Questionnaire (KHQ), Diagnostic Test: Ultrasound evaluation, Diagnostic Test: Sandvik Severity Index, Diagnostic Test: Oxford's scale, Diagnostic Test: BiofeedbackParticipants will be placed in the lithotomy position. The treatment temperature will be set at 41°C, with a frequency of 1 MHz and power of 75 kJ. Once the indicated temperature has been reached, the physical therapist will perform small upward and downward movements along the urethral canal, dividing the time equally between both sides. One RF session will be performed every 7 days, as described by the author, for a total of 5 sessions. We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test). |
| Pelvic floor muscle training (PFMT) | Experimental | Diagnostic Test: Short International Consultation on Incontinence Questionnaire (ICIQ-SF), Diagnostic Test: King's Health Questionnaire (KHQ), Diagnostic Test: Ultrasound evaluation, Diagnostic Test: Sandvik Severity Index, Diagnostic Test: Oxford's scale, Diagnostic Test: BiofeedbackThe PFMT will consist of a targeted program with a protocol of core and pelvic floor exercises established based on an assessment of the patients' strength, endurance, and fatigue, with a frequency of twice a week led by a physical therapist and a duration of 45 minutes each day for a period of 16 weeks. It will be carried out in groups of 8 people and accompanied by a physical therapist experienced in therapeutic exercise. We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test). |
| combination of RF Therapy and PFMT | Experimental | Diagnostic Test: Short International Consultation on Incontinence Questionnaire (ICIQ-SF), Diagnostic Test: King's Health Questionnaire (KHQ), Diagnostic Test: Ultrasound evaluation, Diagnostic Test: Sandvik Severity Index, Diagnostic Test: Oxford's scale, Diagnostic Test: BiofeedbackWe divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women over the age of 18 who meet the International Continence Society (ICS)
- diagnostic criteria for SUI, which consists of involuntary leakage of urine during increased intra-abdominal pressure in the absence of bladder contractions such as coughing, sneezing, and other physical activities.
Key exclusion criteria (6 listed)
- diagnosis of urgent or mixed UI
- diagnosis of pelvic organ prolapse
- taking any treatment for UI
- pregnancy
- history of pelvic surgery, urinary tract infection, or diagnosed psychological disorders
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 |
|---|---|---|
| Short International Consultation on Incontinence Questionnaire (ICIQ-SF)This is a self-administered questionnaire with four questions and a total score ranging from 0 [best] to 21 [worst] that identifies people with urinary incontinence and its impact on quality of life. | Diagnostic test | Pelvic floor muscle training (PFMT), RF Therapy, combination of RF Therapy and PFMT |
| King's Health Questionnaire (KHQ)The KHQ is a self-administered instrument specifically designed to assess quality of life in women with UI. It consists of 21 items distributed across 9 dimensions: perception of overall health (1 item), impact of UI (1 item), limitations in daily activities (2 items), physical limitations (2 items), social limitations (2 items), personal relationships (3 items), emotions (3 items), sleep/energy (2 items), and severity of UI (5 items). The score range for each dimension is from 0 (lowest impact of UI and therefore best quality of life) to 100 (highest impact, worst quality of life). This questionnaire provides an overall value for the quality of life of the patient with UI (Overall Score-OS) and another specific value for each dimension on a scale with the following range: 0: Best possible quality of life - 100: Worst possible quality of life. | Diagnostic test | Pelvic floor muscle training (PFMT), RF Therapy, combination of RF Therapy and PFMT |
| Ultrasound evaluationA two-dimensional (2D) ultrasound system with B-mode capability and cine-loop function, a 3.5 to 6 MHz curved convex probe transducer, was used for the perineal image. The examination will be performed in the dorsal lithotomy position, with the hips flexed and slightly abducted and the heels placed close to the buttocks, or in a standing position if necessary. | Diagnostic test | Pelvic floor muscle training (PFMT), RF Therapy, combination of RF Therapy and PFMT |
| Sandvik Severity IndexIt allows the severity of UI to be determined based on two questions. Interpretation based on the score is classified as follows: 1-2 mild UI, 3-6 moderate UI, 8-9 severe UI, 12 very severe UI. | Diagnostic test | Pelvic floor muscle training (PFMT), RF Therapy, combination of RF Therapy and PFMT |
| Oxford's scaleThe strength of the Pelvic floor muscles will be evaluated digitally using functional ultrasound and classified according to the Oxford scale. | Diagnostic test | Pelvic floor muscle training (PFMT), RF Therapy, combination of RF Therapy and PFMT |
| BiofeedbackAlso: Muscular and static strength; Fatigability or Dynamic EnduranceMuscular (mmHg) and static strength (seconds); Fatigability or Dynamic Endurance (% and cmH₂O) | Diagnostic test | Pelvic floor muscle training (PFMT), RF Therapy, combination of RF Therapy and PFMT |
Primary outcome
International Consultation on Incontinence Questionnaire (ICIQ-SF)
Time frame: Pre - post intervention; after 3,6,12 months
0 to 21 points, where higher scores indicate greater impact of incontinence
King´s Health Questionnaire (KHQ)
Time frame: Pre - post intervention; after 3,6,12 months
0 to 100, where 0 indicates the best quality of life and 100 the worst
ultrasound analysis: Resting aperture (Ar)
Time frame: Pre - post intervention; after 3,6,12 months
degrees
ultrasound analysis: Opening during exertion (Ae)
Time frame: Pre - post intervention; after 3,6,12 months
degrees
Opening difference (Ae-Ar)
Time frame: Pre - post intervention; after 3,6,12 months
degrees
MUSCULAR STRENGTH
Time frame: Pre - post intervention; after 3,6,12 months
defined as the ability of tissue to generate tension based on its contractile capacity, being the best of three attempts to contract, assessed using the modified OXFORD scale
Function of the pelvic floor muscles
Time frame: Pre - post intervention; after 3,6,12 months
The best of the three attempts is selected, graded as follows: 0 = no contraction, 1 = partial contraction, 2 = contraction of the pelvic floor muscles + contraction of related muscles, 3 = isolated contraction of the Pelvic floor muscles
STATIC MUSCLE STRENGTH
Time frame: Pre - post intervention; after 3,6,12 months
the ability to maintain optimal contraction (isometric, tonic fibers) for as long as possible, measuring the seconds until fatigue sets in. ORDER: "contract and hold," taking the average of the three assessments.
Fatigability or Dynamic Endurance
Time frame: Pre - post intervention; after 3,6,12 months
maximum number of contractions in a unit of time, taking 10 seconds as the average. ORDER: "contract as many times as possible and at the highest speed," with the measurement being the average of the three assessments.
Oxford's Scale
Time frame: Pre - post intervention; after 3,6,12 months
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 scored as 0; if the contraction is very weak, it is scored as 1; if the contraction is weak, it is scored as 2; if the contraction is moderate/with tension/and sustained, it is scored as 3; if the contraction is good and maintains tension with resistance, it is scored as 4; and if the contraction is strong and maintains tension against a resistant force, it is scored as 5.
Sandvik Severity Index
Time frame: Pre - post intervention; after 3,6,12 months
It allows the severity of UI to be determined based on two questions. Interpretation based on the score is classified as follows: 1-2 mild UI, 3-6 moderate UI, 8-9 severe UI, 12 very severe UI.
11 secondary outcomes
age (years)
Time frame: baseline
BMI (Body mass index)
Time frame: baseline
smoke
Time frame: baseline
alcohol consumption
Time frame: baseline
drug use
Time frame: baseline
full-term pregnancies
Time frame: baseline
natural childbirth
Time frame: baseline
cesarean sections
Time frame: baseline
tear
Time frame: baseline
abortion
Time frame: baseline
episiotomy
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Derived from this study: PubMed 42354475Trana-Serrano JP, Orts-Ruiz C, Montero-Navarro S, Zamora-Streber A, Ramirez Rivera MJ, Garita Redondo O, Molina-Paya FJ, Fluxa-Juan L, Sanchez-Mas J, Salar-Andreu C. Second-Generation Radiofrequency and Targeted Therapeutic Exercise for Stress Urinary Incontinence Due to Urethral Hypermobility: A Study Protocol. Healthcare (Basel). 2026 Jun 9;14(12):1616. doi: 10.3390/healthcare14121616.
- Individual participant dataSharing planned: Yes. The data associated with this paper will be available in the Zenodo repository
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short International Consultation on Incontinence Questionnaire (ICIQ-SF), King's Health Questionnaire (KHQ) and Ultrasound evaluation in people with Stress Urinary Incontinence, run by Cardenal Herrera University 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 20 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Consultation on Incontinence Questionnaire (ICIQ-SF) (time frame: Pre - post intervention; after 3,6,12 months). The study lists 11 primary outcomes in all. 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 NCT07095283, 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 20 Oct 2026.