Role of Strain Elastography in Assessing Paraurethral Tissue Elasticity in Continent and Incontinent Women and Its Predictive Value Compared to Pelvic Imaging for Urinary Incontinence Treatment Decisions

What this Trial Is About

Researchers are evaluating strain elastography (SE) as a non-invasive imaging method to measure tissue elasticity and biomechanical properties in women with stress urinary incontinence (SUI) compared to women without incontinence. The study aims to find out if SE can detect differences in paraurethral tissue stiffness between these groups, since tissue elasticity plays an important role in SUI. This observational study is conducted at a tertiary referral center and focuses on understanding how tissue elasticity relates to SUI, potentially improving urogynecological diagnoses. Participants will undergo introital two-dimensional ultrasound and SE in three specific regions under the urethra: the internal urethral orifice, midurethra, and external urethral orifice. A reference tissue layer of adipose tissue will be used for comparison. The study groups include women without urinary incontinence, women with SUI, and SUI subgroups based on urethral mobility and estrogen therapy status. SE will be performed following a standardized protocol to maintain accuracy and reproducibility. Participants will have one study visit within two weeks of enrollment for ultrasound and SE assessments. Researchers will analyze paraurethral tissue stiffness differences between groups using statistical methods. The study also aims to explore the potential of SE to support treatment decision-making by distinguishing varying degrees of tissue elasticity. Safety and compliance will be monitored throughout the study period, which continues until 2030.

Elastographic Assessment of Suburethral Tissue in Continent and Incontinent Women