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

Second-generation Radiofrequency Application and Specific Therapeutic Exercise as a Treatment for Stress Urinary Incontinence Due to Urethral Instability. Randomised Clinical Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07095283
Enrollment
239
Registered
2025-07-31
Start date
2025-08-01
Completion date
2025-09-30
Last updated
2026-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Urinary Incontinence

Keywords

urethral instability, radiofrequency, physical exercise, functional ultrasound, quality of life

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.

Interventions

DIAGNOSTIC_TESTShort 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.

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_TESTUltrasound 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_TESTSandvik 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_TESTOxford's scale

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

DIAGNOSTIC_TESTBiofeedback

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

Sponsors

Cardenal Herrera University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
International Consultation on Incontinence Questionnaire (ICIQ-SF)Pre - post intervention; after 3,6,12 months0 to 21 points, where higher scores indicate greater impact of incontinence
King´s Health Questionnaire (KHQ)Pre - post intervention; after 3,6,12 months0 to 100, where 0 indicates the best quality of life and 100 the worst
ultrasound analysis: Resting aperture (Ar)Pre - post intervention; after 3,6,12 monthsdegrees
ultrasound analysis: Opening during exertion (Ae)Pre - post intervention; after 3,6,12 monthsdegrees
Opening difference (Ae-Ar)Pre - post intervention; after 3,6,12 monthsdegrees
MUSCULAR STRENGTHPre - post intervention; after 3,6,12 monthsdefined 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 musclesPre - post intervention; after 3,6,12 monthsThe 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 STRENGTHPre - post intervention; after 3,6,12 monthsthe 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 EndurancePre - post intervention; after 3,6,12 monthsmaximum 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 ScalePre - post intervention; after 3,6,12 monthsallows 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 IndexPre - post intervention; after 3,6,12 monthsIt 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.

Secondary

MeasureTime frameDescription
age (years)baseline
BMI (Body mass index)baselinekg / m²
smokebaselineyes/no
alcohol consumptionbaselineyes/no
drug usebaselineyes/no
full-term pregnanciesbaselineNumber
natural childbirthbaselineyes/no
cesarean sectionsbaselineyes/no
tearbaselineyes/no
abortionbaselineyes/no
episiotomybaselineyes/no

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026