Actively Recruiting
Multi-stage Urethroplasty with Augmentation Using a Dorsal Graft Inlay Technique Comparing Graft Use in First or Second Stage
Led by University Hospital, Ghent · Updated on 2024-09-19
30
Participants Needed
1
Research Sites
224 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Multi-stage Urethroplasty with Augmentation Using a Dorsal Graft Inlay Technique Comparing Graft Use in First or Second Stage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed written informed consent according to Good Clinical Practice and national regulations
- Age 18 years or older
- Male patient
- Fit for operation as determined by surgeon
- Isolated penile stricture requiring multi-stage urethroplasty with dorsal graft inlay
- Use of oral mucosa as graft material
- Ability and willingness to comply with study protocol
- Prior urethral surgery (dilation, urethrotomy, or urethroplasty) allowed
You will not qualify if you...
- No signed written informed consent
- Age under 18 years
- Female patients
- Transgender patients
- Unfit for operation
- Stricture disease beyond penile urethra or affecting multiple urethral segments
- Use of graft material other than oral mucosa
- Any condition posing significant risk, confounding results, or interfering with participation
- Unwilling or unable to comply with study protocol
- Patients refusing second stage procedure (post-hoc exclusion)
- Patients converted to single-stage procedure intra-operatively (post-hoc exclusion)
- Cases where no graft is needed for retubularization (post-hoc exclusion)
- Patients requiring two-stage Bracka repair with complete urethral plate removal (post-hoc exclusion)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ghent University Hospital
Ghent, Belgium, 9000
Actively Recruiting
Research Team
N
Nicolaas Lumen, MD, PhD
CONTACT
W
Wesley Verla
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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