Elastographic Assessment of Suburethral Tissue in Continent and Incontinent Women

Sponsor
Szeged University
Study ID
NCT06933407
Status
Recruiting
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Conditions

  • Incontinence, Overactive Bladder, Stress Urinary Incontinence
  • Stress Urinary Incontinence (SUI)
  • Urinary Bladder, Overactive
  • Urinary Incontinence
  • Urinary Incontinence (UI)
  • Urinary Incontinence, Stress

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

  • Strain Elastography — DIAGNOSTIC_TEST
    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.

Study Details

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): * internal urethral orifice (IUO) level * midurethra (MU) level * external urethral orifice (EUO) level 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: * Weakened bladder neck support * Impaired urethral stabilization due to increased tissue elasticity and collagen degradation * While conventional 2D ultrasound provides anatomical information, it does not directly evaluate tissue biomechanics. In contrast, SE enables real-time visualization of tissue elasticity, offering a promising adjunct to traditional urogynecological assessment methods. Standardization and Protocol The study will follow a standardized protocol to ensure reproducibility and high-quality data. Key methodological elements include: * Minimal probe compression during introital ultrasound to avoid artifacts * Bladder emptying prior to examination to eliminate confounding effects * Carefully standardized ROI placement across all patients * Controlled image acquisition conditions to reduce variability Future Directions * Future research based on this study will aim to: * Optimize SE protocols and refine ROI placement strategies * Establish clinical cutoff values for differentiating tissue stiffness in SUI vs. continent women * Assess the long-term effects of pelvic floor muscle training (PFMT) and vaginal estrogen therapy on paraurethral biomechanics * Facilitate the integration of SE into routine urogynecological practice to support early diagnosis and personalized treatment strategies for SUI

Key Dates

First listed
Apr 18, 2025
Start date
Aug 16, 2024
Status verified
Apr 2025
Primary completion
Mar 30, 2025
Completion
Jan 1, 2030

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: Control group (asymptomatic women)
    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.
  • Arm: Stress urinary incontinence (SUI) group
    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.
  • Arm: Stress urinary incontinence (SUI) with hypermobile urethra
    This subgroup includes women with stress urinary incontinence and hypermobility of the urethra, which is assessed through clinical examination and/or imaging techniques.
  • Arm: Stress urinary incontinence (SUI) without hypermobile urethra
    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.
  • Arm: Stress urinary incontinence (SUI) group without estrogen therapy
    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.
  • Arm: Stress urinary incontinence (SUI) group with estrogen therapy
    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.

Primary Outcome Measure

Assessment of Paraurethral Tissue Elasticity in Women with Stress Urinary Incontinence Using Strain Elastography [ Time Frame: At a single study visit, within two weeks of enrollment. ]

Central Contacts

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