An observational study in Urinary Incontinence, Urinary Incontinence, Stress and Urinary Incontinence (UI), sponsored by Szeged University. Recruiting at 1 site in Hungary. Open to female participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-18.
Sponsored by Szeged University · Observational
Strain elastography (SE) will be utilized as a non-invasive imaging technique to evaluate tissue elasticity and biomechanical properties in women with stress urinary incontinence (SUI) and in continent controls. The primary aim is to determine whether SE can detect differences in paraurethral tissue stiffness between these groups. Given the established role of tissue elasticity in the pathophysiology of SUI, SE will be investigated as a potential diagnostic tool in urogynecological evaluations.
This prospective cohort study will be conducted at a tertiary referral center. All participants will undergo introital two-dimensional (2D) ultrasound in the midsagittal plane at rest. SE will be performed in three predefined suburethral regions of interest (ROIs):
The adipose layer (AL) between the external urethral meatus and the pubic symphysis will serve as the reference tissue, representing the softest anatomical structure in the region.
Descriptive and comparative statistical analyses will be conducted to assess differences in paraurethral tissue stiffness between the study groups.
It is hypothesized that SE will be able to detect differences in paraurethral tissue elasticity, with SUI being associated with increased tissue compliance. The study also aims to determine whether SE can reliably distinguish between varying degrees of tissue stiffness in women with SUI and continent controls.
Pathophysiological focus:
The study will explore key mechanisms underlying SUI, including:
Standardization and Protocol
The study will follow a standardized protocol to ensure reproducibility and high-quality data. Key methodological elements include:
Future Directions
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's planned enrollment of 80 is below the median of 120 across 305 observational studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Szeged University is the lead sponsor of 53 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study will include adult women in Hungary diagnosed with stress urinary incontinence (SUI), along with a control group of continent women. Participants will be recruited from urogynecology outpatient clinics, tertiary referral centers, and gynecology departments.
Exclusion Criteria:
This group consists of women without any symptoms of urinary incontinence. They serve as a baseline for comparison with the affected groups. No specific intervention is applied to this group.
Diagnostic Test: Strain Elastography
This group includes women diagnosed with stress urinary incontinence (SUI), characterized by involuntary urine leakage during physical exertion, coughing, sneezing, or other activities that increase intra-abdominal pressure.
Diagnostic Test: Strain Elastography
This subgroup includes women with stress urinary incontinence and hypermobility of the urethra, which is assessed through clinical examination and/or imaging techniques.
Diagnostic Test: Strain Elastography
This subgroup consists of women with stress urinary incontinence but without significant urethral hypermobility. The absence of hypermobility may suggest intrinsic sphincter deficiency (ISD) as a primary factor in incontinence.
Diagnostic Test: Strain Elastography
Women diagnosed with stress urinary incontinence (SUI) who do not receive vaginal estrogen therapy. This group will serve as a reference to assess the natural biomechanical properties of paraurethral tissues in SUI patients.
Diagnostic Test: Strain Elastography
Women diagnosed with stress urinary incontinence (SUI) who undergo vaginal estrogen therapy as part of their treatment. This group will be evaluated to determine the effects of vaginal estrogen on paraurethral tissue elasticity and its potential role in improving urethral support and biomechanical properties.
Diagnostic Test: Strain Elastography
Strain elastography (SE) is a parametric imaging modality that assesses tissue deformation in response to externally applied pressure, providing qualitative and semi-quantitative information on tissue elasticity and mechanical properties. Unlike conventional 2D ultrasound, SE enables the objective evaluation of paraurethral tissue stiffness, which may play a role in the pathophysiology of stress urinary incontinence (SUI). SE will be performed on three predefined paraurethral regions to assess pelvic floor elasticity and biomechanical characteristics. A standardized protocol will be implemented to ensure high reproducibility, with controlled probe compression and precisely defined regions of interest. SE may improve the diagnostic accuracy and therapeutic decision-making for SUI by identifying differences in tissue compliance among affected women.
Assessment of Paraurethral Tissue Elasticity in Women with Stress Urinary Incontinence Using Strain Elastography
Detection of a statistically significant difference in paraurethral tissue elasticity between women with stress urinary incontinence (SUI) and continent controls using strain elastography (SE), with high measurement reproducibility across predefined regions of interest.
Time frame: At a single study visit, within two weeks of enrollment.
Plan to share: Yes — Quantitative strain elastography measurements of periurethral tissue elasticity.
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