Urethral Vascularization and Urodynamics

NCT ID: NCT07185698

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-06-30

Brief Summary

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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

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Conditions

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Stress Urinary Incontinence Ultrasound Vascularisation Urodynamic Exam

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Stress urinary incontinence

participants with stress urinary incontinence

Group Type EXPERIMENTAL

3D Ultrasound

Intervention Type DIAGNOSTIC_TEST

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

NO Stress Urinary Incontinence

Participants referred to urodynamics without stress urinary incontinence

Group Type EXPERIMENTAL

3D Ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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3D Ultrasound

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Diana Höhn

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diana Hoehn, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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University Hospital Bern, Inselspital

Bern, Canton of Bern, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 26243181 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16752242 (View on PubMed)

Related Links

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Other Identifiers

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2024-01776

Identifier Type: OTHER

Identifier Source: secondary_id

2024-01776

Identifier Type: -

Identifier Source: org_study_id

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