Urethral Vascularization and Urodynamics

Not Applicable

• Conditions: Stress Urinary Incontinence; Ultrasound; Vascularisation; Urodynamic Exam

• Registration Number: NCT07185698
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

The urethra plays a crucial role in maintaining urinary continence. Its complex blood supply is still not well understood. Particularly in the context of urethral pressure. Urethral pressure can be measured by bladder and urethral pressure studies (urodynamic).

This study aims to use advanced imaging techniques to analyse the blood supply of the urethra and correlate it to urethral pressure measurements.

Elucidating these relationships will improve our understanding of urethral function and malfunction, and ultimately optimise diagnosis and treatment of stress urinary incontinence. A total of 35 participants with stress urinary incontinence and 35 without stress urinary incontinence will be asked to participate in this study.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-04
• Study First Submitted QC: 2025-09-17
• Last Update Submitted: 2025-09-17
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22
• Primary Completion: 2026-04-01
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• Urodynamic examination
• Written informed consent
• Understanding of the German language
• Indicated urodynamic assessment
• Endovaginal and perineal ultrasound feasible

Exclusion Criteria

• Urinary tract infections
• Transgender Population
• Pregnancy
• History of incontinence or prolapse surgery
• Pelvic prolapse higher than second degree
• Prior pelvic radiotherapy
• Prior history of gynecologic tumor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Color histogram index (Vascularity Index)	Enrollment by the urodynamic examination until the ultrasound measurement (VOCAL) up to 4 weeks	Doppler Indices (Vascularity Index) generated by Virtual Organ Computer-aided AnaLysis (VOCAL)

Trial Locations

Locations (1)

University Hospital Bern, Inselspital; 🇨🇭 Bern, Canton of Bern, Switzerland