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Establishment of a clinical urethral stricture database for a prospective longitudinal cohort study.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires and data collection | Other | It is a non-interventional, single-center, non-randomized, prospective observational study obtaining data and patient-reported outcomes. |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of urethral reconstructive surgeries | Success is defined as a lack of stricture recurrence in the follow-up | Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Complications of urethral reconstructive surgeries | Complications are defined as surgical site infection, fistula, problems at the preservation site of buccal mucosa. | 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 |
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Inclusion Criteria:
All patients undergoing any of the following urethral surgeries are included:
Exclusion Criteria:
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Patients undergoing urethral surgeries or interventions. All patients meeting the inclusion and exclusion criteria of the study should be informed about the possibility of participating in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Röthl Martina Anna | Recruiting | Graz | Styria | 8036 | Austria |
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| ID | Term |
|---|---|
| D014525 | Urethral Stricture |
| ID | Term |
|---|---|
| D014524 | Urethral Obstruction |
| D014522 | Urethral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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| Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years |
| 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 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |