9000 URETHRA STUDY: a Study About Urethroplasty for Urethral Stricture Disease

NCT ID: NCT04071925

Last Updated: 2024-01-03

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2029-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

It has been demonstrated that urethroplasty should be considered the gold standard treatment for urethral stricture disease as it yields higher long-term success rates than endoscopic treatment options such as direct vision internal urethrotomy (DVIU) or dilation. Many data about these procedures exist, although most of the publications about urethroplasty are retrospective and involve a tremendous risk of bias. To address these issues, this study is designed to prospectively gain evidence about this matter in all patient subgroups facing a potential treatment with urethroplasty: native men, native women, transmen, transwomen and children.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urethral Stricture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Urethroplasty

Open reconstructive surgery to restore urethral patency in case of urethral stricture disease.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations.
* Patient age ≥ 6 years.
* If a patient reaches the age of 18 years, he or she will have to provide a new voluntarily signed written informed consent. All patients reaching the age of 18 years will be contacted by the Principal Investigator or Subinvestigator to provide a new voluntarily signed written informed consent.

Exclusion Criteria

\- Absence of signed written informed consent and thus a patient unwilling to participate.
Minimum Eligible Age

6 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nicolaas Lumen

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Marjan Waterloos

Role: STUDY_CHAIR

University Hospital, Ghent

Wesley Verla

Role: STUDY_DIRECTOR

University Hospital, Ghent

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dept. of Urology, Ghent University Hospital

Ghent, , Belgium

Site Status NOT_YET_RECRUITING

University Hospital Ghent

Ghent, , Belgium

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nicolaas Lumen

Role: CONTACT

+32 9 332 22 76

Wesley Verla

Role: CONTACT

+32 9 332 22 76

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nicolaas Lumen

Role: primary

+32 9 332 22 76

Wesley Verla

Role: backup

+32 9 332 22 76

Wesley Verla

Role: primary

+32 332 22 83

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B670201940616

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Urethral Vascularization and Urodynamics
NCT07185698 ENROLLING_BY_INVITATION NA
Urodynamics: Prone Vs. Seated Position
NCT06864117 NOT_YET_RECRUITING NA