RecruitingNCT04071925

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

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


Sponsor

University Hospital, Ghent

Enrollment

1,000 participants

Start Date

Sep 1, 2019

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 6 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This observational study is prospectively collecting data on patients of all ages and genders — including men, women, transgender men, transgender women, and children — who undergo urethroplasty (surgical repair of a narrowed urethra) or other treatments for urethral stricture disease to better understand real-world outcomes. Urethral stricture, a narrowing of the tube that carries urine out of the body, is commonly treated with surgery, but most existing evidence comes from retrospective studies with significant limitations. Anyone aged 6 or older who consents to participate is eligible; the only exclusion is unwillingness to provide informed consent. Participants will have their surgical and clinical data collected, and those who reach age 18 during the study will be asked to sign a new consent form. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREUrethroplasty

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


Locations(2)

Dept. of Urology, Ghent University Hospital

Ghent, Belgium

University Hospital Ghent

Ghent, Belgium

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NCT04071925


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