Study on urethroplasty for urethral stricture disease
9000 URETHRA STUDY: a Prospective, Observational Study About Urethroplasty for Urethral Stricture Disease
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 |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 6 Years to 100 Years |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 2 sites (Ghent and 1 other locations) |
| Trial ID | NCT04071925 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 6 years and older who are facing potential treatment for urethral stricture disease.
Not a fit: Patients who are unwilling to provide informed consent will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Ghent and 1 other locations
- Dept. of Urology, Ghent University Hospital — Ghent, Belgium (Not_yet_recruiting)
- University Hospital Ghent — Ghent, Belgium (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.