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