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 Type
OBSERVATIONAL
Enrollment
1,000
Open reconstructive surgery to restore urethral patency in case of urethral stricture disease.
Dept. of Urology, Ghent University Hospital
Ghent, Belgium
NOT_YET_RECRUITINGUniversity Hospital Ghent
Ghent, Belgium
RECRUITINGFailure-free survival
Interval between operation and latest follow-up moment at which the patiënt remains failure-free
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
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).
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: From the date of preoperative questionnaire completion until 24 months postoperatively.
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