The pathophysiology of stress urinary incontinence: a systematic review and meta-analysis.
Kobra Falah-Hassani, Joanna Reeves, Rahman Shiri...
https://pubmed.ncbi.nlm.nih.gov/33416968/Actively Recruiting
Led by Szeged University · Updated on 2025-04-18
80
Participants Needed
1
Research Sites
248 weeks
Total Duration
Researchers are evaluating strain elastography SE as a non-invasive imaging method to measure tissue elasticity and biomechanical properties in women with stress urinary incontinence SUI compared to women without incontinence. The study aims to find out if SE can detect differences in paraurethral tissue stiffness between these groups, since tissue elasticity plays an important role in SUI. This observational study is conducted at a tertiary referral center and focuses on understanding how tissue elasticity relates to SUI, potentially improving urogynecological diagnoses. Participants will undergo introital two-dimensional ultrasound and SE in three specific regions under the urethra the internal urethral orifice, midurethra, and external urethral orifice. A reference tissue layer of adipose tissue will be used for comparison. The study groups include women without urinary incontinence, women with SUI, and SUI subgroups based on urethral mobility and estrogen therapy status. SE will be performed following a standardized protocol to maintain accuracy and reproducibility. Participants will have one study visit within two weeks of enrollment for ultrasound and SE assessments. Researchers will analyze paraurethral tissue stiffness differences between groups using statistical methods. The study also aims to explore the potential of SE to support treatment decision-making by distinguishing varying degrees of tissue elasticity. Safety and compliance will be monitored throughout the study period, which continues until 2030.
CONDITIONS
Elastographic Assessment of Suburethral Tissue in Continent and Incontinent Women
L
Lóránt Csákány, Dr.
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Szeged University
Lead Sponsor
Capio Specialized Center for Gynecology, Solna, 182 88 Stockholm, Sweden
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within two weeks of enrollment
Participants undergo strain elastography to assess paraurethral tissue elasticity and biomechanical properties related to stress urinary incontinence.
1 visit (in-person)
Duration - Up to the study completion date
Participants are observed to evaluate the relationship between tissue elasticity and clinical outcomes without active intervention.
1 to 2 visits depending on cohort assignment
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
Have more questions? Get in touch with our team for quick support
Kobra Falah-Hassani, Joanna Reeves, Rahman Shiri...
https://pubmed.ncbi.nlm.nih.gov/33416968/J O DeLancey
https://pubmed.ncbi.nlm.nih.gov/8203431/R Tunn, E Petri
https://pubmed.ncbi.nlm.nih.gov/12905521/Jana Marie Kreutzkamp, Sebastian Daniel Schäfer, Susanne Amler...
https://pubmed.ncbi.nlm.nih.gov/28108041/Baihua Zhao, Lieming Wen, Wenjie Chen...
https://pubmed.ncbi.nlm.nih.gov/32125001/Ushma J Patel, Amy L Godecker, Dobie L Giles...
https://pubmed.ncbi.nlm.nih.gov/35030139/C Falconer, G Ekman-Ordeberg, U Ulmsten...
https://pubmed.ncbi.nlm.nih.gov/8844634/Szeged University
Lead Sponsor
Capio Specialized Center for Gynecology, Solna, 182 88 Stockholm, Sweden
Collaborating Sponsor