Clinical trial NCT06933407: Elastographic Assessment of Suburethral Tissue in Continent and Incontinent Women
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urinary Incontinence
Urinary Incontinence, Stress
Urinary Incontinence (UI)
Urinary Bladder, Overactive
Incontinence, Overactive Bladder, Stress Urinary Incontinence
Stress Urinary Incontinence (SUI)
Keywords: Urinary Incontinence
Bladder dysfunction
Urine leakage
Stress urinary incontinence (SUI)
Lead sponsor: Szeged University
Sponsor class: OTHER
Collaborators: name: Capio Specialized Center for Gynecology, Solna, 182 88 Stockholm, Sweden
First posted: 2025-04-18
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include adult women in Hungary diagnosed with stress urinary incontinence (SUI), along with a control group of continent women. Participants will be recruited from urogynecology outpatient clinics, tertiary referral centers, and gynecology departments.

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

Primary outcomes:
measure: Assessment of Paraurethral Tissue Elasticity in Women with Stress Urinary Incontinence Using Strain Elastography
timeFrame: At a single study visit, within two weeks of enrollment.
Secondary outcomes:
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: University of szeged
Study officials:
References:
citation: Falconer C, Ekman-Ordeberg G, Ulmsten U, Westergren-Thorsson G, Barchan K, Malmstrom A. Changes in paraurethral connective tissue at menopause are counteracted by estrogen. Maturitas. 1996 Jul;24(3):197-204. doi: 10.1016/s0378-5122(96)82010-x.
citation: Tunn R, Petri E. Introital and transvaginal ultrasound as the main tool in the assessment of urogenital and pelvic floor dysfunction: an imaging panel and practical approach. Ultrasound Obstet Gynecol. 2003 Aug;22(2):205-13. doi: 10.1002/uog.189.
citation: DeLancey JO. Structural support of the urethra as it relates to stress urinary incontinence: the hammock hypothesis. Am J Obstet Gynecol. 1994 Jun;170(6):1713-20; discussion 1720-3. doi: 10.1016/s0002-9378(94)70346-9.
citation: Kreutzkamp JM, Schafer SD, Amler S, Strube F, Kiesel L, Schmitz R. Strain Elastography as a New Method for Assessing Pelvic Floor Biomechanics. Ultrasound Med Biol. 2017 Apr;43(4):868-872. doi: 10.1016/j.ultrasmedbio.2016.12.004. Epub 2017 Jan 17.
citation: Zhao B, Wen L, Chen W, Qing Z, Liu D, Liu M. A Preliminary Study on Quantitative Quality Measurements of the Urethral Rhabdosphincter Muscle by Supersonic Shear Wave Imaging in Women With Stress Urinary Incontinence. J Ultrasound Med. 2020 Aug;39(8):1615-1621. doi: 10.1002/jum.15255. Epub 2020 Mar 3.
citation: Falah-Hassani K, Reeves J, Shiri R, Hickling D, McLean L. The pathophysiology of stress urinary incontinence: a systematic review and meta-analysis. Int Urogynecol J. 2021 Mar;32(3):501-552. doi: 10.1007/s00192-020-04622-9. Epub 2021 Jan 8.
citation: Patel UJ, Godecker AL, Giles DL, Brown HW. Updated Prevalence of Urinary Incontinence in Women: 2015-2018 National Population-Based Survey Data. Female Pelvic Med Reconstr Surg. 2022 Apr 1;28(4):181-187. doi: 10.1097/SPV.0000000000001127. Epub 2022 Jan 12.