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

NCT04071925 | Recruiting DMC

• 1 other identifier: B670201940616
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Urethral Stricture

Keywords

urethral stricture disease; urethral stricture; urethra; urethroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in erectile function

  From the date of preoperative questionnaire completion until 24 months postoperatively.

• Change in ejaculatory function

  From the date of preoperative questionnaire completion until 24 months postoperatively.

• Change in urinary function

  From the date of preoperative questionnaire completion until 24 months postoperatively.

• Change in urinary continence

  From the date of preoperative questionnaire completion until 24 months postoperatively.

• Change in quality of life

  From the date of preoperative questionnaire completion until 24 months postoperatively.

Interventions

Urethroplasty PROCEDURE

Open reconstructive surgery to restore urethral patency in case of urethral stricture disease.

Eligibility Criteria

• Age: 6 Years - 100 Years
• Gender Eligibility Details: Native male and female + transman and transwomen + boys and girls \< 18 years old
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• \- Absence of signed written informed consent and thus a patient unwilling to participate.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (2)

Dept. of Urology, Ghent University Hospital

Ghent, 9000, Belgium

NOT YET RECRUITING

University Hospital Ghent

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Nicolaas Lumen

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

• Marjan Waterloos

  University Hospital, Ghent

  STUDY CHAIR

• Wesley Verla

  University Hospital, Ghent

  STUDY DIRECTOR

Central Study Contacts

Nicolaas Lumen

CONTACT

+32 9 332 22 76; nicolaas.lumen@uzgent.be

Wesley Verla

CONTACT

+32 9 332 22 76; wesley.verla@uzgent.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 28, 2019
• Study Start: September 1, 2019
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)