Multi-stage Urethroplasty with Augmentation Using a Dorsal Graft Inlay Technique Comparing Graft Use in First or Second Stage

Recruiting now · Not applicable

Conditions studied: Urethra Stenosis, Urethral Stricture

In brief

The principal aim of this pilot study is to directly compare both approaches and analyze the failure rate after one year of follow-up. These data will serve as the basis to design a larger phase II or III trial in the future with failure rate as the primary end-point. Other study objectives are thoroughly described underneath.

Key facts

Study ID

NCT04965025

Run by

University Hospital, Ghent

People needed

30

Starts

2020-11-11

Expected to finish

2025-03-01

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations.
• Age ≥ 18 years.
• Male patient.
• Fit for operation, upon surgeon's discretion.
• Isolated penile stricture that requires a multi-stage urethroplasty with dorsal inlay of a graft (upon surgeon's discretion).
• Use of oral mucosa as graft material.
• Patient is able and willing to comply with protocol.
• Prior urethral surgery (dilation, urethrotomy of urethroplasty) is allowed.

You may not qualify if…

• Absence of signed written informed consent.
• Age < 18 years.
• Female patients.
• Transgender patients.
• Patients unfit for operation.
• Stricture disease extending beyond the penile urethra or concomitant stricture at a different urethral segment.
• Use of graft other than oral mucosa.
• Any condition or situation, which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the patient's participation in the study.
• Unwilling or unable to comply with study protocol.
• Patients deciding not to undergo the second stage will be excluded post-hoc.
• When the surgeon intra-operatively decides to carry out a single-stage procedure after all, the patient will also be excluded post-hoc.
• If the surgeon decides that no graft is needed to retubularize the urethra, the patient will also be excluded post-hoc.
• If the surgeon decides that a two-stage Bracka repair is needed, where the urethral plate is entirely cut away during the first stage and grafted, the patient will also be excluded post-hoc.

Where it is running

• Ghent University Hospital — Ghent, Belgium (enrolling)

Full record on ClinicalTrials.gov

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