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
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.
• 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.