University of szeged
Szeged, 6725, Hungary
Location status: Recruiting
NCT Number: NCT06933407
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
Interested in participating?
Request Info18 year–99 year
Female
Observational
Szeged, 6725, Hungary
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: At a single study visit, within two weeks of enrollment.
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.
Contact information is provided by the study sponsor or research team.
Szeged University
Other
This Study Investigates the Role of Strain Elastography in Assessing Paraurethral Tissue Elasticity in Continent and Incontinent Pre- and Postmenopausal Women. It Also Evaluates the Predictive Value of Strain Elastography Compared to Other Pelvic Imaging Modalities, Including Conventional Ultrasound Examinations, in Supporting Treatment Decision-making for Urinary Incontinence.
Acronym: SE-inc1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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