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NCT06933407: SE-inc1
Elastographic Assessment of Suburethral Tissue in Continent and Incontinent Women
trial testing Strain Elastography in Urinary Incontinence in 80 participants. Currently enrolling.
30 March 2025
Quick facts
| Lead sponsor | Szeged University |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 80 |
| Start date | 16 August 2024 |
| Primary completion | 30 March 2025 |
| Estimated completion | 1 January 2030 |
| Sites | 1 location across Hungary |
Drugs / interventions tested
- Strain Elastography
Conditions studied
- Urinary Incontinence — all drugs for Urinary Incontinence →
- Urinary Incontinence, Stress — all drugs for Urinary Incontinence, Stress →
- Urinary Incontinence (UI) — all drugs for Urinary Incontinence (UI) →
- Urinary Bladder, Overactive — all drugs for Urinary Bladder, Overactive →
Sponsor
Szeged University
Who can join
Adults 18 to 99, female only, with Urinary Incontinence or Urinary Incontinence, Stress. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06933407
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06933407 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Szeged University
- Last refreshed: 18 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06933407.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing