Second-generation Radiofrequency Application and Therapeutic Exercise for Stress Urinary Incontinence

February 9, 2026 updated by: SERGIO MONTERO NAVARRO, Cardenal Herrera University

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.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
239

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alicante
      • Elche, Alicante, Spain, 03204
        • CEU Cardenal Herrera University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Study Population

women who attended pelvic floor physiotherapy consultations with symptoms of UI

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: RF Therapy
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).
Diagnostic test: 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: 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: Ultrasound evaluation
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.
Diagnostic test: 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.
Diagnostic test: Oxford's scale
The strength of the Pelvic floor muscles will be evaluated digitally using functional ultrasound and classified according to the Oxford scale.
Diagnostic test: Biofeedback
Muscular (mmHg) and static strength (seconds); Fatigability or Dynamic Endurance (% and cmH₂O)
Other Names:
  • Muscular and static strength; Fatigability or Dynamic Endurance
Experimental: Pelvic floor muscle training (PFMT)
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).
Diagnostic test: 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: 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: Ultrasound evaluation
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.
Diagnostic test: 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.
Diagnostic test: Oxford's scale
The strength of the Pelvic floor muscles will be evaluated digitally using functional ultrasound and classified according to the Oxford scale.
Diagnostic test: Biofeedback
Muscular (mmHg) and static strength (seconds); Fatigability or Dynamic Endurance (% and cmH₂O)
Other Names:
  • Muscular and static strength; Fatigability or Dynamic Endurance
Experimental: combination of RF Therapy and PFMT
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).
Diagnostic test: 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: 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: Ultrasound evaluation
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.
Diagnostic test: 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.
Diagnostic test: Oxford's scale
The strength of the Pelvic floor muscles will be evaluated digitally using functional ultrasound and classified according to the Oxford scale.
Diagnostic test: Biofeedback
Muscular (mmHg) and static strength (seconds); Fatigability or Dynamic Endurance (% and cmH₂O)
Other Names:
  • Muscular and static strength; Fatigability or Dynamic Endurance

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Pre - post intervention; after 3,6,12 months
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
Pre - post intervention; after 3,6,12 months
ultrasound analysis: Resting aperture (Ar)
Time Frame: Pre - post intervention; after 3,6,12 months
degrees
Pre - post intervention; after 3,6,12 months
ultrasound analysis: Opening during exertion (Ae)
Time Frame: Pre - post intervention; after 3,6,12 months
degrees
Pre - post intervention; after 3,6,12 months
Opening difference (Ae-Ar)
Time Frame: Pre - post intervention; after 3,6,12 months
degrees
Pre - post intervention; after 3,6,12 months
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
Pre - post intervention; after 3,6,12 months
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
Pre - post intervention; after 3,6,12 months
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.
Pre - post intervention; after 3,6,12 months
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.
Pre - post intervention; after 3,6,12 months
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.
Pre - post intervention; after 3,6,12 months
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.
Pre - post intervention; after 3,6,12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
age (years)
Time Frame: baseline
baseline
BMI (Body mass index)
Time Frame: baseline
kg / m²
baseline
smoke
Time Frame: baseline
yes/no
baseline
alcohol consumption
Time Frame: baseline
yes/no
baseline
drug use
Time Frame: baseline
yes/no
baseline
full-term pregnancies
Time Frame: baseline
Number
baseline
natural childbirth
Time Frame: baseline
yes/no
baseline
cesarean sections
Time Frame: baseline
yes/no
baseline
tear
Time Frame: baseline
yes/no
baseline
abortion
Time Frame: baseline
yes/no
baseline
episiotomy
Time Frame: baseline
yes/no
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cardenal Herrera University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 20, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CEEI25/646

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data associated with this paper will be available in the Zenodo repository

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stress Urinary Incontinence

Clinical Trials on Short International Consultation on Incontinence Questionnaire (ICIQ-SF)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings