Urethral Stricture
Conditions
Keywords
urethral stricture disease, urethral stricture, urethra, urethroplasty
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.
Interventions
PROCEDUREUrethroplasty
Open reconstructive surgery to restore urethral patency in case of urethral stricture disease.
Sponsors
University Hospital, Ghent
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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). |
| 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 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). |
Countries
Belgium
Contacts
Primary ContactNicolaas Lumen
Backup ContactWesley Verla
Outcome results
None listed