Assessing tissue elasticity in women with urinary incontinence
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.
This study is testing a new way to see if the stiffness of tissue around the urethra can help doctors better diagnose stress urinary incontinence in women.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | Szeged University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Szeged) |
| Trial ID | NCT06933407 on ClinicalTrials.gov |
What this trial studies
This observational study uses strain elastography (SE) to evaluate the elasticity and biomechanical properties of suburethral tissue in women with stress urinary incontinence (SUI) compared to continent controls. Participants will undergo two-dimensional ultrasound and SE in three specific regions of interest around the urethra. The goal is to identify differences in tissue stiffness that could aid in diagnosing SUI. This non-invasive imaging technique aims to enhance urogynecological evaluations.
Who should consider this trial
Good fit: Ideal candidates include women diagnosed with stress urinary incontinence based on clinical assessments.
Not a fit: Patients with pelvic malignancies, urge urinary incontinence, or significant pelvic organ prolapse may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new diagnostic tool for better understanding and managing stress urinary incontinence.
How similar studies have performed: While the use of elastography in this context is relatively novel, similar imaging techniques have shown promise in other areas of urogynecology.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Szeged
- University of szeged — Szeged, Hungary (Recruiting)
Study contacts
- Study coordinator: Lóránt Csákány, Dr.
- Email: md.csakany@gmail.com
- Phone: +36305895619
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.