ClinicalTrials.gg
Enrolling by invitationNCT07185698UVASCUpdated May 19, 2026

Urethral Vascularization and Urodynamics

An interventional study of 3D Ultrasound in Stress Urinary Incontinence, Ultrasound and Vascularisation, sponsored by Insel Gruppe AG, University Hospital Bern. Enrolling by invitation at 1 site in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.

Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Stress Urinary Incontinence
  • Ultrasound
  • Vascularisation
  • Urodynamic Exam
03

In context

Urinary Incontinence, Stress

651 studies on the registry are indexed under Urinary Incontinence, Stress; 120 are open to participants now.

This study's planned enrollment of 70 is close to the median of 68 across 506 interventional studies indexed under Urinary Incontinence, Stress.

Browse Urinary Incontinence, Stress studies →

Lead sponsor

Insel Gruppe AG, University Hospital Bern is the lead sponsor of 741 studies on the registry; 180 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Stress urinary incontinence

    participants with stress urinary incontinence

    Diagnostic Test: 3D Ultrasound

  • Experimental
    NO Stress Urinary Incontinence

    Participants referred to urodynamics without stress urinary incontinence

    Diagnostic Test: 3D Ultrasound

Interventions

  • Diagnostic test3D Ultrasound

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

06

What researchers measure

Primary outcomes

  1. Color histogram index (Vascularity Index)

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

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

07

Study locations

1 site
08

References and documents

Publications

  • 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. PubMed 26243181 ↗
  • 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. PubMed 16752242 ↗

Individual participant data

Plan to share: No — According to the ethics application, the confidentiality measures of the study do not allow the public release of participant data. However, data can be made available upon reasonable request.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Jul 2026, 10 months after the start.

Of 225 non-industry interventional studies with no phase under Urinary Incontinence, Stress, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 10 months is below that.

Counting every sponsor, half of 266 studies reached it within 19 months; a quarter within 9 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 4, 2025
First posted
Sep 22, 2025
StartActual
Sep 1, 2025
Primary completionEst.
Jul 31, 2026
CompletionEst.
Dec 31, 2026
Last update
May 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07185698
Responsible party
Diana Höhn (MD, Insel Gruppe AG, University Hospital Bern) — Principal investigator
First posted
Sep 22, 2025
Start date
Sep 1, 2025
Primary completion
Jul 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
May 19, 2026

Study contacts

Diana Hoehn, MD
principal investigator · Women's Hospital, University Hospital Bern, Inselspital, Switzerland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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