Study on urethroplasty for urethral stricture disease
Official title: 9000 URETHRA STUDY: a Prospective, Observational Study About Urethroplasty for Urethral Stricture Disease
Run by University Hospital, Ghent · NCT04071925 · Data updated 2026-11-12
This study is testing how well urethroplasty works for treating urethral stricture disease in different groups of people, including men, women, transgender individuals, and children.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 6 Years to 100 Years |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 2 sites (Ghent and 1 other locations) |
| Status | Recruiting |
| Started | September 1, 2019 |
| Main results expected | December 31, 2029 |
| Study ends | December 31, 2029 |
| Registry record updated | January 3, 2024 |
| Trial ID | NCT04071925 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals aged 6 years and older who are facing potential treatment for urethral stricture disease.
✕Probably not a fit
Patients who are unwilling to provide informed consent will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to gather prospective evidence on the effectiveness of urethroplasty as a treatment for urethral stricture disease, which is considered the gold standard due to its higher long-term success rates compared to other treatments. It will include diverse patient groups, such as native men, native women, transmen, transwomen, and children, to ensure comprehensive data collection. The study will focus on understanding outcomes across these subgroups to address biases present in previous retrospective studies.
Why it matters
Potential benefit: If successful, this study could provide robust evidence supporting urethroplasty as the preferred treatment for urethral stricture disease, leading to improved patient outcomes.
How similar studies have gone: While many studies have focused on urethroplasty, this study's prospective approach aims to fill gaps left by previous retrospective analyses, making it a novel contribution to the field.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
University Hospital Ghent
Ghent, Belgium Recruiting -
Dept. of Urology, Ghent University Hospital
Ghent, Belgium Not yet recruiting
Study contacts
- Principal investigator: Nicolaas Lumen — University Hospital, Ghent
- Study coordinator: Nicolaas Lumen
- Email: nicolaas.lumen@uzgent.be
- Phone: +32 9 332 22 76
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Intraoperative Lidocaine or Dexmedetomidine to Help Postoperative Pain After Urethral Reconstruction
This study tests whether giving lidocaine or dexmedetomidine during urethral reconstruction can reduce pain after surgery and lower the chance of long-lasting pain.
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Urethral Resistive Index (URI) as a non-invasive test for urethral blockage
This project tests a new, painless urine-flow measure called the Urethral Resistive Index (URI) to see if it can detect urethral strictures in men.
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Comparing cheek (buccal) tissue versus penile skin grafts for repairing long anterior urethral strictures
This will test whether cheek (buccal) tissue or penile skin works better to repair long anterior urethral strictures in men who need urethroplasty.
-
Paclitaxel-coated versus standard dilatation balloon for recurrent urethral stricture
This trial tests if a paclitaxel-coated dilatation balloon (Optilume) reduces the chance of urethral stricture coming back compared with a non-coated balloon in adults who have had previous dilations or DVIU.
-
Database for patients with urethral stricture undergoing surgery
This study is trying to gather information from patients with urethral stricture who are having surgery to see how well different surgical methods work and how they affect quality of life.
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Using engineered urethral constructs to treat urethral strictures in men
This study is testing a new way to treat urethral strictures in men by using specially grown tissue from their own bladder to see if it helps them feel better over time.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.