Post-Operative Imaging After Urethroplasty With Peri-catheter Retrograde Urethrography Or Trial of Voiding With Voiding Cysto-urethrography

NCT04307537 | Completed Phase 2

• 1 other identifier: B670201942454
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 several variables (e.g. type of reconstruction, stricture etiology, …), removal of the transurethral catheter is foreseen. However, in order to do so, the clinician first wants to objectify whether the urethra has indeed healed sufficiently and therefore he/she can rely on early postoperative imaging. Up until today, there is no clear standard about when and how to do early postoperative imaging and current practices are mainly based on expert opinion and habit. Basically, two strategies can be found amongst different urethroplasty centers: peri-catheter retrograde urethrography (pcRUG) and voiding cysto-urethrography (VCUG). A pcRUG is performed by placing a small caliber tube (e.g. feeding tube 5 Fr) in the meatus urethrae of the patient, next to the transurethral catheter (which remains in place), and injecting contrast alongside the catheter. With a VCUG, contrast is injected through the transurethral catheter, up to the bladder. Thereafter, the catheter is removed and the patient is asked to urinate and thus to pass contrast through the urethra. The primary end-point of this study is to compare 'the rightful decision to maintain the catheter at the time of imaging' between pcRUG only and pcRUG followed by VCUG in a within-patient fashion.

Conditions

Urethral Stricture

Outcome Measures

Primary Outcomes (1)

• Percentage of 'rightful decision to maintain the catheter at the time of imaging' between pcRUG only and VCUG.

  In other words, the amount of catheters maintained during the investigation divided by the number of significant extravasations requiring perpetuated catheter stay.

  1 day (day of original investigation)

Secondary Outcomes (5)

• Difference in radiation exposure between pcRUG and VCUG expressed in mGy/(cm*cm)

  1 day (moment of original investigation)

• Difference in the amount of significant extravasations that is picked up with pcRUG versus VCUG.

  Results of both pcRUG and VCUG will be shown to the treating clinician at least 4 weeks after the original investigation and the clinician will have to choose between 'no or insignificant contrast leakage' versus 'significant contrast leakage'.

• Intra-observer variability of both pcRUG and VCUG

  First blinded assessment (at least 4 weeks after original investigation) versus second blinded assessment another 4 weeks later.

• Inter-observer variability of both pcRUG and VCUG

  Two experienced clinicians will be compared regarding decision making during the first blinded assessment (at least 4 weeks after the original investigation).

• Amount of patients unable to void while being on the X-ray table

  1 day (moment of original investigation)

Study Arms (2)

pcRUG

EXPERIMENTAL

Peri-catheter retrograde urethrography

Procedure: Post-urethroplasty urethrography

VCUG

ACTIVE COMPARATOR

Voiding cysto-urethrography

Procedure: Post-urethroplasty urethrography

Interventions

Post-urethroplasty urethrography PROCEDURE

Imaging of the urethra after reconstructive surgery to identify contrast leakage (no, insignificant, signficant).

VCUG; pcRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Dept. of Urology, Ghent University Hospital

Ghent, East-Flanders, 9000, Belgium

Location

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 Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within patient comparison

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 13, 2020
• Study Start: January 21, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: January 4, 2023

Record last verified: 2023-01

Locations

BE (1)