NCT04965025 Multi-stage Urethroplasty with Augmentation Using a Dorsal Graft Inlay Technique Comparing Graft Use in First or Second Stage
| NCT ID | NCT04965025 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Ghent |
| Condition | Urethra Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2020-11-11 |
| Primary Completion | 2025-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2020-11-11 with a primary completion date of 2025-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Nicolaas Lumen
PRINCIPAL INVESTIGATOR
University Hospital, Ghent
Frequently Asked Questions
Who can join the NCT04965025 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Urethra Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04965025 currently recruiting?
Yes, NCT04965025 is actively recruiting participants. Contact the research team at nicolaas.lumen@uzgent.be for enrollment information.
Where is the NCT04965025 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT04965025 clinical trial?
NCT04965025 is sponsored by University Hospital, Ghent. The principal investigator is Nicolaas Lumen at University Hospital, Ghent. The trial plans to enroll 30 participants.