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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Urethral Stricture
• Intervention / Treatment: Procedure: Urethroplasty

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Wesley Verla; Phone Number: +32 9 332 22 76; Email: wesley.verla@uzgent.be
• Study Contact Backup: Name: Nicolaas Lumen; Phone Number: +32 9 332 22 76; Email: nicolaas.lumen@uzgent.be

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Recruiting
    • University Hospital Ghent
    • Contact: Wesley Verla; Phone Number: +32 332 22 83; Email: wesley.verla@uzgent.be
  • Ghent, Belgium, 9000
    • Not yet recruiting
    • Dept. of Urology, Ghent University Hospital
    • Contact: Wesley Verla; Phone Number: +32 9 332 22 76; Email: wesley.verla@uzgent.be
    • Contact: Nicolaas Lumen; Phone Number: +32 9 332 22 76; Email: nicolaas.lumen@uzgent.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Native men, native women, transmen, transwomen and children with urethral stricture disease.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Nicolaas Lumen, University Hospital, Ghent; Study Director: Wesley Verla, University Hospital, Ghent; Study Chair: Marjan Waterloos, University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: urethra; urethral stricture; urethroplasty; urethral stricture disease
• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Urethral Diseases; Urethral Obstruction; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Constriction, Pathologic; Urethral Stricture
• Other Study ID Numbers: B670201940616

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No