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

Urethral Stricture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04071925
• Other study ID #: B670201940616
• Status: Recruiting
• Start date: September 1, 2019
• Est. completion date: December 31, 2029

Study information

• Verified date: January 2024
• Source: University Hospital, Ghent
• Contact: Nicolaas Lumen
• Phone: +32 9 332 22 76
• Email: nicolaas.lumen[@]uzgent.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Urethral Stricture

Intervention

Procedure:
• Urethroplasty
Open reconstructive surgery to restore urethral patency in case of urethral stricture disease.

Locations

Country	Name	City	State
Belgium	Dept. of Urology, Ghent University Hospital	Ghent
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure-free survival	Interval between operation and latest follow-up moment at which the patiënt remains failure-free	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	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).	From the date of preoperative questionnaire completion until 24 months postoperatively.
Secondary	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)	From the date of preoperative questionnaire completion until 24 months postoperatively.
Secondary	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)	From the date of preoperative questionnaire completion until 24 months postoperatively.
Secondary	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).	From the date of preoperative questionnaire completion until 24 months postoperatively.
Secondary	Change in quality of life	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).	From the date of preoperative questionnaire completion until 24 months postoperatively.
Secondary	Change in general quality of life	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).	From the date of preoperative questionnaire completion until 24 months postoperatively.