Actively Recruiting
Multi-stage Urethroplasty with Dorsal Graft Inlay Comparing Graft Use in First or Second Stage: A Randomized Controlled Pilot Study
Led by University Hospital, Ghent · Updated on 2024-09-19
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Urethral stricture disease affects the male urethra and can be treated with urethroplasty, a reconstructive surgery to restore urethral opening. This research compares two multi-stage urethroplasty approaches using a dorsal graft inlay technique, either applied in the first or second surgery stage. The study aims to assess failure rates after one year of follow-up to guide future larger trials. The trial involves two groups: one receiving the graft during the first stage where the urethra is opened and graft inserted, followed later by retubularization; the other group has the graft applied in the second stage after initial urethral opening. Both use oral mucosa grafts. The study also evaluates additional outcomes such as complications, erectile and ejaculatory function, urinary symptoms, continence, quality of life, patient satisfaction, and urine flow rates at various times before and after surgeries. Participants are adult males with isolated penile urethral strictures needing multi-stage repair with graft. They will have follow-up assessments including clinical evaluations and questionnaires at pre-surgery, 3 months after first stage, 3 months after second stage, and one year post-second stage. The main result is the graft failure rate after one year. Safety and feasibility of randomization are monitored. Total participation lasts at least one year after the second surgery.
CONDITIONS
Brief 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.
- Male aged 18 years or older.
- Fit for surgery as determined by the surgeon.
- Isolated penile urethral stricture requiring multi-stage urethroplasty with dorsal graft inlay.
- Use of oral mucosa as graft material.
- Able and willing to comply with study protocol.
- Prior urethral surgeries (dilation, urethrotomy, or urethroplasty) allowed.
You will not qualify if you...
- No signed informed consent.
- Female or transgender patients.
- Under 18 years of age.
- Unfit for surgery.
- Stricture extending beyond penile urethra or multiple urethral segments involved.
- Use of graft material other than oral mucosa.
- Any condition posing significant risk or interfering with participation as judged by investigator.
- Unwilling or unable to comply with study protocol.
- Patients who decide not to undergo second stage surgery or require single-stage or Bracka repair excluded post-hoc.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure
Participants undergo the first stage of multi-stage urethroplasty, which involves opening the urethra longitudinally. Depending on their assigned group, a graft is either placed during this first stage or reserved for the second stage.
1 visit (in-person)
Duration - Up to 90 days after first stage
Participants receive immediate care following the first stage surgery, including monitoring for complications and recovery.
Visits as needed within 90 days after first stage
Duration - At least 3 months
Participants experience a urethral rest period of at least 3 months between the first and second stage surgeries to allow healing.
Visits may occur as part of routine care; no specific study visits required
Duration - Single day procedure
Participants undergo the second stage of urethroplasty, which involves retubularizing the urethra. If the graft was not placed in the first stage, it is used during this surgery.
1 visit (in-person)
Duration - Up to 90 days after second stage
Participants receive immediate care following the second stage surgery, including monitoring for complications and recovery.
Visits as needed within 90 days after second stage
Duration - 1 year after second stage
Participants are followed for one year after the second stage surgery to monitor for surgical failure, changes in urinary and sexual function, quality of life, and patient satisfaction.
Visits at 3 months, and 1 year after second stage; additional assessments preoperative and 3 months after first stage
Trial Site Locations
Total: 1 location
1
Ghent University Hospital
Ghent, Belgium, 9000
Actively Recruiting
Research Team
N
Nicolaas Lumen, MD, PhD
W
Wesley Verla
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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