Stress Urinary IncontinenceUVASCNCT07185698
Urethral Vascularization and Urodynamics
A study testing 3D Ultrasound in people with Stress Urinary Incontinence and Ultrasound, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence, Ultrasound, Vascularisation
- What is being tested?
- 3D Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Urodynamic examination
- Written informed consent
- Understanding of the German language
- Indicated urodynamic assessment
- Endovaginal and perineal ultrasound feasible
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
University Hospital Bern, Inselspital
Bern, Canton of Bern, 3013
About this study
Official title: UVASC Urethral Vascularization and Urodynamics
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.
- Being tested
- 3D Ultrasound
- Medical subject headings
- Urinary Incontinence, Stress, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D UltrasoundDiagnostic test
Virtual Organ Computer-aided AnaLysis (VOCAL) to assess flow and velocity characteristics of the urethral blood supply
| Study group | Role | What they receive |
|---|---|---|
| Stress urinary incontinence | Experimental | participants with stress urinary incontinence Receives: Diagnostic Test: 3D Ultrasound |
| NO Stress Urinary Incontinence | Experimental | Participants referred to urodynamics without stress urinary incontinence Receives: Diagnostic Test: 3D Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color histogram index (Vascularity Index)
Doppler Indices (Vascularity Index) generated by Virtual Organ Computer-aided AnaLysis (VOCAL)
Measured: Enrollment by the urodynamic examination until the ultrasound measurement (VOCAL) up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Sep 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana Höhn, Insel Gruppe AG, University Hospital Bern
- Investigators
- Diana Hoehn, MD, Principal investigator, Women's Hospital, University Hospital Bern, Inselspital, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185698
- Sponsor's protocol ID
- 2024-01776
- Other IDs
- 2024-01776
- Acronym
- UVASC
- Status last verified
- May 2026
- First submitted
- 4 Sep 2025
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 26243181Liang 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
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UVASC Urethral Vascularization and Urodynamics
- ClinicalTrials.gov ID
- NCT07185698
- Acronym / sponsor ID
- UVASC / 2024-01776
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress urinary incontinence | Experimental | Diagnostic Test: 3D Ultrasoundparticipants with stress urinary incontinence |
| NO Stress Urinary Incontinence | Experimental | Diagnostic Test: 3D UltrasoundParticipants referred to urodynamics without stress urinary incontinence |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Urodynamic examination
- Written informed consent
- Understanding of the German language
- Indicated urodynamic assessment
- Endovaginal and perineal ultrasound feasible
Key exclusion criteria (7 listed)
- Urinary tract infections
- Transgender Population
- Pregnancy
- History of incontinence or prolapse surgery
- Pelvic prolapse higher than second degree
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D UltrasoundVirtual Organ Computer-aided AnaLysis (VOCAL) to assess flow and velocity characteristics of the urethral blood supply | Diagnostic test | NO Stress Urinary Incontinence, Stress urinary incontinence |
Primary outcome
Color histogram index (Vascularity Index)
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Background: PubMed 26243181Lone 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.
- Background: PubMed 16752242Liang 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.
- UniBE Forschungsstiftung GrantLink provided by the sponsor.
- Grant from Vontobel StiftungLink provided by the sponsor.
- Grant from Ruth und Arthur Scherbarth StiftungLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diana Hoehn, MD principal investigator
Women's Hospital, University Hospital Bern, Inselspital, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Ultrasound in people with Stress Urinary Incontinence and Ultrasound, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Color histogram index (Vascularity Index) (time frame: Enrollment by the urodynamic examination until the ultrasound measurement (VOCAL) up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07185698, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.