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NCT Number: NCT04071925

9000 URETHRA STUDY: a 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.

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Key information

Conditions

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

Age range

6 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept. of Urology, Ghent University Hospital, Ghent, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Urethroplasty

Procedure

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

Primary outcomes

  1. Failure-free survival

    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 postoperatively

    Interval between operation and latest follow-up moment at which the patiënt remains failure-free

Secondary outcomes

  1. Change in erectile function

    Time frame: 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).

  2. Change in ejaculatory function

    Time frame: 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)

  3. Change in urinary function

    Time frame: 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)

  4. Change in urinary continence

    Time frame: 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).

  5. Change in quality of life

    Time frame: 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).

  6. Change in general quality of life

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Nicolaas Lumen

CONTACT

[email protected]

+32 9 332 22 76

Wesley Verla

CONTACT

[email protected]

+32 9 332 22 76

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2029
Study completion
2029
First posted
Aug 28, 2019
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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