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

Recruiting

• Conditions: Urethral Stricture

• Registration Number: NCT04071925
• Lead Sponsor: University Hospital, Ghent

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-08-27
• Study First Posted: 2019-08-28
• Study Start: 2019-09-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-02
• Last Update Posted: 2024-01-03
• Primary Completion: 2029-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Failure-free survival	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	Interval between operation and latest follow-up moment at which the patiënt remains failure-free

Secondary Outcome Measures

Name	Time	Method
Change in erectile function	From the date of preoperative questionnaire completion until 24 months postoperatively.	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).
Change in urinary continence	From the date of preoperative questionnaire completion until 24 months postoperatively.	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).
Change in general quality of life	From the date of preoperative questionnaire completion until 24 months postoperatively.	Assessment preoperatively and postoperatively using the EQ-VAS (Visual Analogue Scale) (a numeric scale ranging from 0 to 100, higher score indicating better quality of life).
Change in ejaculatory function	From the date of preoperative questionnaire completion until 24 months postoperatively.	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)
Change in urinary function	From the date of preoperative questionnaire completion until 24 months postoperatively.	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)
Change in quality of life	From the date of preoperative questionnaire completion until 24 months postoperatively.	Assessment preoperatively and postoperatively using the EQ-5D-3L questionnaire (a 5-item questionnaire generating a digit score, each of the 5 items can be scored with 1, 2 or 3 (e.g. 11213), higher digit score indicating lower quality of life).

Trial Locations

Locations (2)

University Hospital Ghent; 🇧🇪 Ghent, Belgium

Dept. of Urology, Ghent University Hospital; 🇧🇪 Ghent, Belgium