Elastographic Assessment of Suburethral Tissue in Continent and Incontinent Women (SE-inc1)

University of Szeged (SZTE)

Status: Enrolling

Conditions: Urinary Incontinence, Stress; Stress Urinary Incontinence (SUI); Urinary Bladder, Overactive; Urinary Incontinence (UI); Incontinence, Overactive Bladder, Stress Urinary Incontinence; Urinary Incontinence

Treatments: Diagnostic Test: Strain Elastography

Study type: Observational

Funder types: Other

Identifiers

NCT06933407

55/2016

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of stress urinary incontinence (SUI) based on patient history, physical examination, and/or urodynamic assessment.

Exclusion criteria

• Pelvic malignancy or history of pelvic radiation therapy
• Urge urinary incontinence (UUI) or detrusor overactivity
• Pelvic organ prolapse (POP) stage ≥ II (based on POP-Q classification)
• Pregnancy or recent postpartum status (less than 6 months postpartum)
• Neurological disorders affecting bladder function
• Recurrent urinary tract infections (UTIs) or active lower urinary tract infection
• Inability to undergo study procedures
• Cognitive impairment or psychiatric conditions affecting informed consent or compliance

Trial design

80 participants in 6 patient groups

Control group (asymptomatic women)

Description:

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.

Treatment:

Diagnostic Test: Strain Elastography

Stress urinary incontinence (SUI) group

Description:

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.

Treatment:

Diagnostic Test: Strain Elastography

Stress urinary incontinence (SUI) with hypermobile urethra

Description:

This subgroup includes women with stress urinary incontinence and hypermobility of the urethra, which is assessed through clinical examination and/or imaging techniques.

Treatment:

Diagnostic Test: Strain Elastography

Stress urinary incontinence (SUI) without hypermobile urethra

Description:

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.

Treatment:

Diagnostic Test: Strain Elastography

Stress urinary incontinence (SUI) group without estrogen therapy

Description:

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.

Treatment:

Diagnostic Test: Strain Elastography

Stress urinary incontinence (SUI) group with estrogen therapy

Description:

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.

Treatment:

Diagnostic Test: Strain Elastography