9000 URETHRA STUDY: a Study About Urethroplasty for Urethral Stricture Disease
ConditionUrethral Stricture
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-100
SponsorUniversity Hospital, Ghent
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Native men, native women, transmen, transwomen and children with urethral stricture disease.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Urethroplasty
Procedure/SurgeryOpen reconstructive surgery to restore urethral patency in case of urethral stricture disease.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Failure-free survival
Interval between operation and latest follow-up moment at which the patiënt remains failure-free
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 postoperativelySecondary outcomes
1
Change in erectile function
Assessment preoperatively and postoperatively using the IIEF-5 (International Index of Erectile Function) questionnaire (a 5-item questionnaire, total score on 25, higher score indicating better erectile function).
Time frame
From the date of preoperative questionnaire completion until 24 months postoperatively.2
Change in ejaculatory function
Assessment preoperatively and postoperatively using the MSHQ-EjD (Male Sexual Health Questionnaire - Ejaculatory Dysfunction) short form questionnaire (a 3-item questionnaire, total score on 15, higher score indicating better ejaculatory function)
Time frame
From the date of preoperative questionnaire completion until 24 months postoperatively.3
Change in urinary function
Assessment preoperatively and postoperatively using the ICIQ-MLUTS (International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms) module questionnaire (a 6-item questionnaire, total score on 24, higher score indicating more urinary bother)
Time frame
From the date of preoperative questionnaire completion until 24 months postoperatively.4
Change in urinary continence
Assessment preoperatively and postoperatively using the ICIQ-UI (International Consultation on Incontinence Questionnaire - Urinary Incontinence) short form questionnaire (a 3-item questionnaire, total score on 21, higher score indicating more incontinence).
Time frame
From the date of preoperative questionnaire completion until 24 months postoperatively.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov