Actively Recruiting
Construction of a Clinical Urethral Stricture Database for a Prospective Longitudinal Cohort Study
Led by Medical University of Graz · Updated on 2024-04-12
500
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are creating a clinical database to study patients who have urethral strictures and undergo various types of urethral surgeries. The study aims to collect detailed information before, during, and after surgery, including follow-up data from questionnaires. The goal is to determine the success rates of these surgeries over short, medium, and long terms and to identify risk factors that may lead to surgical failure or stricture recurrence. Additionally, the study will assess quality of life changes before and after surgery to compare different surgical techniques. The study is observational and non-interventional, collecting data from patients who undergo procedures such as internal urethrotomy, end-to-end anastomosis, urethral plastic surgeries using grafts, hypospadias corrections, Boutonniere procedures, and self-bougienage. Patient-reported outcomes and clinical data are gathered through questionnaires at set intervals starting from 3 months after surgery, continuing at 6 and 12 months, and then annually up to 10 years. Participants will provide information via questionnaires on surgery success, complications, sexual function, and overall health status at multiple follow-up points. These data will help researchers analyze and improve surgical techniques and personalize patient counseling based on factors like age and sexual activity. The total follow-up period can last up to 10 years to monitor long-term outcomes comprehensively.
CONDITIONS
Brief Title
Urethral Stricture Database
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 18 years or older
- Patients undergoing one of the following urethral surgeries: internal urethrotomy (Sachse), end-to-end anastomosis, urethral plastic surgeries with oral mucosa or mesh graft, hypospadias corrections, Boutonniere procedure, or (self) bougienage of the urethra
You will not qualify if you...
- Lack of capacity to give informed consent
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.
Duration - Varies by individual surgical procedure
Participants undergo urethral surgery and immediate post-operative care.
Duration - Up to 10 years
Participants complete questionnaires to assess success rates, complications, sexual function, and health status after surgery.
Questionnaires at 3, 6, and 12 months after surgery, then annually up to 10 years
Trial Site Locations
Total: 1 location
1
Röthl Martina Anna
Graz, Styria, Austria, 8036
Actively Recruiting
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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