Urethral Vascularization and Urodynamics

NCT07185698 | Enrolling By Invitation

• 1 other identifier: 2024-01776
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence; Ultrasound; Vascularisation; Urodynamic Exam

Outcome Measures

Primary Outcomes (1)

• Color histogram index (Vascularity Index)

  Doppler Indices (Vascularity Index) generated by Virtual Organ Computer-aided AnaLysis (VOCAL)

  Enrollment by the urodynamic examination until the ultrasound measurement (VOCAL) up to 4 weeks

Study Arms (2)

Stress urinary incontinence

EXPERIMENTAL

participants with stress urinary incontinence

Diagnostic Test: 3D Ultrasound

NO Stress Urinary Incontinence

EXPERIMENTAL

Participants referred to urodynamics without stress urinary incontinence

Diagnostic Test: 3D Ultrasound

Interventions

3D Ultrasound DIAGNOSTIC_TEST

Virtual Organ Computer-aided AnaLysis (VOCAL) to assess flow and velocity characteristics of the urethral blood supply

NO Stress Urinary Incontinence; Stress urinary incontinence

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

University Hospital Bern, Inselspital

Bern, Canton of Bern, 3013, Switzerland

Location

Related Publications (2)

• Lone F, Thakar R, Wieczorek AP, Sultan AH, Stankiewicz A. Assessment of urethral vascularity using 2D colour Doppler high-frequency endovaginal ultrasonography in women treated for symptomatic stress urinary incontinence: 1-year prospective follow-up study. Int Urogynecol J. 2016 Jan;27(1):85-92. doi: 10.1007/s00192-015-2800-z. Epub 2015 Aug 5.

  PMID: 26243181 BACKGROUND

• Liang CC, Chang SD, Chang YL, Wei TY, Wu HM, Chao AS. Three-dimensional power Doppler measurement of perfusion of the periurethral tissue in incontinent women -- a preliminary report. Acta Obstet Gynecol Scand. 2006;85(5):608-13. doi: 10.1080/00016340500342920.

  PMID: 16752242 BACKGROUND

Related Links

• UniBE Forschungsstiftung Grant
• Grant from the Burgergemeinde Bern
• Grant from Vontobel Stiftung
• Grant from Ruth und Arthur Scherbarth Stiftung

MeSH Terms

Conditions

Urinary Incontinence, Stress; Neovascularization, Pathologic

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Metaplasia; Pathologic Processes

Study Officials

• Diana Hoehn, MD

  Women's Hospital, University Hospital Bern, Inselspital, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 22, 2025
• Study Start: September 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)