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

Ghent University Hospital (UZ)

Status: Enrolling

Conditions: Urethral Stricture

Treatments: Procedure: Urethroplasty

Study type: Observational

Funder types: Other

Identifiers

NCT04071925

B670201940616

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 6 to 100 years old

Volunteers: No Healthy Volunteers

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.