NCT06933407 Elastographic Assessment of Suburethral Tissue in Continent and Incontinent Women
| NCT ID | NCT06933407 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Szeged University |
| Condition | Urinary Incontinence |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-08-16 |
| Primary Completion | 2025-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2024-08-16 with a primary completion date of 2025-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06933407 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 99 Years, studying Urinary Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06933407 currently recruiting?
Yes, NCT06933407 is actively recruiting participants. Contact the research team at md.csakany@gmail.com for enrollment information.
Where is the NCT06933407 trial being conducted?
This trial is being conducted at Szeged, Hungary.
Who is sponsoring the NCT06933407 clinical trial?
NCT06933407 is sponsored by Szeged University. The trial plans to enroll 80 participants.