Actively Recruiting
9000 URETHRA STUDY: a Prospective, Observational Study About Urethroplasty for Urethral Stricture Disease
Led by University Hospital, Ghent · Updated on 2024-01-03
1000
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating urethroplasty as a treatment option for urethral stricture disease across all patient groups, including native men, native women, transmen, transwomen, and children. This prospective observational study aims to gather unbiased evidence on urethroplasty's outcomes compared to other treatments like direct vision internal urethrotomy or dilation, which have shown lower long-term success rates. The study is sponsored by the University Hospital, Ghent, and focuses on understanding treatment effectiveness and patient experience over time. The study observes patients undergoing urethroplasty, an open reconstructive surgery designed to restore normal urine flow by repairing urethral strictures. There are no intervention groups or comparators since it is an observational study. The study tracks patient outcomes over several years to measure the surgery's success and impact on various aspects of health and quality of life. Participants will be monitored from the time of surgery up to 10 years to assess failure-free survival, meaning the time until stricture recurrence or death. Additionally, patients will complete questionnaires before surgery and at regular intervals for up to two years afterward to track changes in erectile function, ejaculatory function, urinary function, continence, and quality of life. This long-term follow-up allows researchers to understand both the clinical and personal effects of urethroplasty.
CONDITIONS
Brief Title
9000 URETHRA STUDY: a Study About Urethroplasty for Urethral Stricture Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed written informed consent according to Good Clinical Practice rules
- Patient age 6 years or older
- Patients reaching 18 years must provide new written informed consent
You will not qualify if you...
- Absence of signed written informed consent indicating unwillingness to participate
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 - Up to 1 week
Participants undergo urethroplasty surgery to restore urethral patency followed by immediate post-operative care.
1 surgery visit and approximately 3 post-operative visits
Duration - Up to 24 months
Participants are monitored to assess functional outcomes and quality of life after surgery.
Regular visits during the 24-month follow-up period
Duration - Up to 120 months
Participants are followed for failure-free survival up to 120 months postoperatively.
Annual visits up to 10 years
Trial Site Locations
Total: 2 locations
1
Dept. of Urology, Ghent University Hospital
Ghent, Belgium, 9000
Not Yet Recruiting
2
University Hospital Ghent
Ghent, Belgium, 9000
Actively Recruiting
Research Team
N
Nicolaas Lumen
W
Wesley Verla
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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