Status:
COMPLETED
Post-Operative Imaging After Urethroplasty With Peri-catheter Retrograde Urethrography Or Trial of Voiding With Voiding Cysto-urethrography
Lead Sponsor:
University Hospital, Ghent
Conditions:
Urethral Stricture
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
After a reconstructive procedure of the urethra, a transurethral catheter is usually left in place to allow adequate healing of the tissues without exposure to urine. After 7-21 days, depending on sev...
Detailed Description
After a reconstructive procedure of the urethra, a transurethral catheter is usually left in place to allow adequate healing of the tissues without exposure to urine. After 7-21 days, depending on sev...
Eligibility Criteria
Inclusion
- Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations (Appendix B).
- Age ≥ 18 years.
- Male patient.
- Anterior urethral stricture disease (penile, bulbar, penobulbar and panurethral strictures are allowed).
- Procedure was ended with leaving a transurethral catheter in place with foreseen catheter removal and early postoperative imaging after x days.
Exclusion
- Absence of signed written informed consent (Appendix B).
- Age \< 18 years.
- Female patients.
- Transgender patients.
- Posterior urethral stenosis
- Bladder neck reconstruction
- Patients in which no catheter has been left in place at the end of the procedure.
- Patients in which there is no need for early postoperative imaging, upon discretion of the treating clinician.
Key Trial Info
Start Date :
January 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04307537
Start Date
January 21 2020
End Date
September 1 2021
Last Update
January 4 2023
Active Locations (1)
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1
Dept. of Urology, Ghent University Hospital
Ghent, East-Flanders, Belgium, 9000