9000 URETHRA STUDY: a Study About Urethroplasty for Urethral Stricture Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Urethroplasty.
- Who it may be relevant to
- Registry conditions: Urethral Stricture. Basic parameters: 6 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
9000 URETHRA STUDY: a Prospective, Observational Study About Urethroplasty for Urethral Stricture Disease
Overview
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.
Interventions
- Procedure Urethroplasty
Open reconstructive surgery to restore urethral patency in case of urethral stricture disease.
Primary outcome measures
- Failure-free survival [Time frame: From date of surgery until the date of stricture recurrence or date of death from any cause, whichever came first, assessed up to 120 months postoperatively]
Secondary outcome measures (6)
- Change in erectile function [Time frame: From the date of preoperative questionnaire completion until 24 months postoperatively.]
- Change in ejaculatory function [Time frame: From the date of preoperative questionnaire completion until 24 months postoperatively.]
- Change in urinary function [Time frame: From the date of preoperative questionnaire completion until 24 months postoperatively.]
- Change in urinary continence [Time frame: From the date of preoperative questionnaire completion until 24 months postoperatively.]
- Change in quality of life [Time frame: From the date of preoperative questionnaire completion until 24 months postoperatively.]
- Change in general quality of life [Time frame: From the date of preoperative questionnaire completion until 24 months postoperatively.]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 2 centers
- Dept. of Urology, Ghent University Hospital — Ghent
- University Hospital Ghent — Ghent
Identifiers
NCT: NCT04071925 · B670201940616