Comparing two approaches for urethroplasty using grafts

MAGIC I TRIAL - Multi-stage Urethroplasty with Augmentation Using a Dorsal Graft Inlay Technique Comparing Graft Use in First or Second Stage: a Randomized Controlled Pilot Study

This study is testing two different ways to do surgery for men with a specific type of urethra narrowing to see which method works better over a year.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: University Hospital, Ghent (other)
• Locations: 1 site (Ghent)
• Trial ID: NCT04965025 on ClinicalTrials.gov

What this trial studies

This pilot study aims to compare two different approaches to multi-stage urethroplasty involving a dorsal graft inlay technique. The study will analyze the failure rates of these approaches after one year of follow-up, providing critical data for future larger trials. The procedures involve either performing the graft inlay during the first or second stage of the urethroplasty, depending on the patient's specific condition. The study focuses on male patients with isolated penile stricture requiring surgical intervention.

Who should consider this trial

Good fit: Ideal candidates are male patients aged 18 and older with isolated penile stricture requiring multi-stage urethroplasty.

Not a fit: Patients with stricture disease extending beyond the penile urethra or those unfit for surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and lower failure rates for patients undergoing urethroplasty.

How similar studies have performed: There are currently no studies that directly compare the outcomes of the two approaches being tested in this trial, making it a novel investigation.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 this trial is running

Ghent

• Ghent University Hospital — Ghent, Belgium (RECRUITING)

Study contacts

• Principal investigator: Nicolaas Lumen — University Hospital, Ghent
• Study coordinator: Nicolaas Lumen, MD, PhD

Conditions: Urethra Stenosis, Urethral Stricture