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

NCT ID: NCT07095283

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2025-09-30

Brief 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. 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.

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Short International Consultation on Incontinence Questionnaire (ICIQ-SF)

Intervention Type: 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)

Intervention Type: 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 evaluation

Intervention Type: DIAGNOSTIC_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 Index

Intervention Type: DIAGNOSTIC_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 scale

Intervention Type: DIAGNOSTIC_TEST

The strength of the Pelvic floor muscles will be evaluated digitally using functional ultrasound and classified according to the Oxford scale.

Biofeedback

Intervention Type: DIAGNOSTIC_TEST

Muscular (mmHg) and static strength (seconds); Fatigability or Dynamic Endurance (% and cmH₂O)

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).

Group Type: EXPERIMENTAL

Short International Consultation on Incontinence Questionnaire (ICIQ-SF)

Intervention Type: 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)

Intervention Type: 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 evaluation

Intervention Type: DIAGNOSTIC_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 Index

Intervention Type: DIAGNOSTIC_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 scale

Intervention Type: DIAGNOSTIC_TEST

The strength of the Pelvic floor muscles will be evaluated digitally using functional ultrasound and classified according to the Oxford scale.

Biofeedback

Intervention Type: DIAGNOSTIC_TEST

Muscular (mmHg) and static strength (seconds); Fatigability or Dynamic Endurance (% and cmH₂O)

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).

Group Type: EXPERIMENTAL

Short International Consultation on Incontinence Questionnaire (ICIQ-SF)

Intervention Type: 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)

Intervention Type: 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 evaluation

Intervention Type: DIAGNOSTIC_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 Index

Intervention Type: DIAGNOSTIC_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 scale

Intervention Type: DIAGNOSTIC_TEST

The strength of the Pelvic floor muscles will be evaluated digitally using functional ultrasound and classified according to the Oxford scale.

Biofeedback

Intervention Type: DIAGNOSTIC_TEST

Muscular (mmHg) and static strength (seconds); Fatigability or Dynamic Endurance (% and cmH₂O)

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Biofeedback

Muscular (mmHg) and static strength (seconds); Fatigability or Dynamic Endurance (% and cmH₂O)

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Muscular and static strength; Fatigability or Dynamic Endurance

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cardenal Herrera University

OTHER

Sponsor Role: lead

Responsible Party

SERGIO MONTERO NAVARRO

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ceu Cardenal Herrera University

Elche, Alicante, Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

CEEI25/646

Identifier Type: -

Identifier Source: org_study_id