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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

239

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2 months study duration

First Submitted

Initial submission to the registry

July 24, 2025

Completed

7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed

1 day until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed

19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2025

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

19 days

First QC Date

July 24, 2025

Last Update Submit

February 9, 2026

Conditions

Stress Urinary Incontinence

Keywords

urethral instabilityradiofrequencyphysical exercisefunctional ultrasoundquality of life

Outcome Measures

Primary Outcomes (11)

International Consultation on Incontinence Questionnaire (ICIQ-SF)
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)
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)
degrees
Pre - post intervention; after 3,6,12 months
ultrasound analysis: Opening during exertion (Ae)
degrees
Pre - post intervention; after 3,6,12 months
Opening difference (Ae-Ar)
degrees
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
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
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.
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.
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.
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.
Pre - post intervention; after 3,6,12 months

Secondary Outcomes (11)

age (years)
baseline
BMI (Body mass index)
baseline
smoke
baseline
alcohol consumption
baseline
drug use
baseline
+6 more secondary outcomes

Study Arms (3)

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).

Diagnostic Test: Short International Consultation on Incontinence Questionnaire (ICIQ-SF)Diagnostic Test: King's Health Questionnaire (KHQ)Diagnostic Test: Ultrasound evaluationDiagnostic Test: Sandvik Severity IndexDiagnostic Test: Oxford's scaleDiagnostic 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).

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).

Interventions

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.