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Compares treatment options for Urethra Stenosis
Official title Multi-stage Urethroplasty with Augmentation Using a Dorsal Graft Inlay Technique Comparing Graft Use in First or Second Stage
ClinicalTrials.gov ID: NCT04965025
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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).
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Ghent, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ghent, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.