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

Inclusion Criteria3

  • 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 Criteria1

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

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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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