Multi-stage Urethroplasty with Augmentation Using a Dorsal Graft Inlay Technique Comparing Graft Use in First or Second Stage
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
University Hospital, Ghent
30 participants
Nov 11, 2020
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria8
- 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 Criteria13
- 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.
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Interventions
Herein, the graft will be used in the first stage and the second stage will solely consist of retubularizing the urethra.
Herein, the graft will be used in the second stage and the first stage will solely consist of opening the urethra longitudinally.
Locations(1)
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NCT04965025