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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
Dept. of Urology, Ghent University Hospital
NOT_YET_RECRUITING
Ghent
University Hospital Ghent
RECRUITING
Ghent
Contact Information
Primary
Nicolaas Lumen
nicolaas.lumen@uzgent.be
+32 9 332 22 76
Backup
Wesley Verla
wesley.verla@uzgent.be
+32 9 332 22 76
Time Frame
Start Date: 2019-09-01
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 1000
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Ghent

This content was sourced from clinicaltrials.gov