Urethral Stricture Database

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-15

Study Completion Date

2034-03-15

Brief Summary

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

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Detailed Description

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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.

Conditions

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Urethral Stricture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Questionnaires and data collection

It is a non-interventional, single-center, non-randomized, prospective observational study obtaining data and patient-reported outcomes.

Intervention Type OTHER

Eligibility Criteria

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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