Urethral Stricture Database

Recruiting

• Conditions: Urethral Stricture

• Registration Number: NCT06362083
• Lead Sponsor: Medical University of Graz

Brief Summary

Establishment of a clinical urethral stricture database for a prospective longitudinal cohort study.

Detailed Description

The aim is to establish a prospective clinical database of patients undergoing urethral surgery due to urethral stricture. In addition to pre-operative basic data, intraoperative and postoperative data, as well as follow-up data through questionnaires, are to be collected. The main objective is the prospective determination of success rates of the performed urethral surgeries in the short, medium, and long term. Furthermore, risk factors leading to failure (recurrence of urethral stricture) should be identified. Ultimately, the quality of life before and after urethral surgery is to be assessed in order to compare the applied procedures.

In today's reconstructive urethral surgery, there are few scientific surveys so far. Many of the applied techniques (therapy options) are based more on the experiences of individual surgeons than on a solid database, hence there are also different approaches. By evaluating prospective data and comparing individually applied surgical methods, the least complication-prone and most successful techniques are to be identified. The planned study aims to create an "efficacy-safety" profile for each urethral surgery technique. This will enable us in the future to not only provide improved (data-based) patient information but also to involve the patient better in the therapy decision. Thus, in the future, counseling and therapy for a young sexually active patient could differ from counseling for an older patient who is no longer sexually active, even with the same stricture length and location.

The analyses of the urethral database will thus enable us to internally validate therapy algorithms and provide personalized patient counseling.

Study Timeline

• Study Start: 2024-01-15
• Status Verified: 2024-04
• Study First Submitted: 2024-04-08
• Study First Submitted QC: 2024-04-08
• Last Update Submitted: 2024-04-08
• Study First Posted: 2024-04-12
• Last Update Posted: 2024-04-12
• Primary Completion: 2034-01-15
• Study Completion: 2034-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 500

Inclusion Criteria

All patients undergoing any of the following urethral surgeries are included:

• Internal urethrotomy according to Sachse (endoscopic transurethral urethrotomy)
• End-to-end anastomosis
• Urethral plastic surgeries with oral mucosa graft (potentially penile skin)
• Urethral plastic surgeries with mesh graft
• Hypospadias corrections
• Boutonniere
• (Self) bougienage of the urethra

Exclusion Criteria

• Lack of capacity to consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success rate of urethral reconstructive surgeries	Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years	Success is defined as a lack of stricture recurrence in the follow-up

Secondary Outcome Measures

Name	Time	Method
Complications of urethral reconstructive surgeries	Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years	Complications are defined as surgical site infection, fistula, problems at the preservation site of buccal mucosa.
Health status after urethral reconstructive surgeries	Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years
Sexual function after urethral reconstructive surgeries	Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years

Trial Locations

Locations (1)

Röthl Martina Anna; 🇦🇹 Graz, Styria, Austria