Urethral Stricture Database
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Questionnaires and data collection.
- Who it may be relevant to
- Registry conditions: Urethral Stricture. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Construction of a Clinical Urethral Stricture Database for a Prospective Longitudinal Cohort Study
Overview
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.
Interventions
- Other Questionnaires and data collection
It is a non-interventional, single-center, non-randomized, prospective observational study obtaining data and patient-reported outcomes.
Primary outcome measures
- Success rate of urethral reconstructive surgeries [Time frame: Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years]
Secondary outcome measures (3)
- Complications of urethral reconstructive surgeries [Time frame: 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 [Time frame: 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 [Time frame: Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Austria · 1 center
- Röthl Martina Anna — Graz
Identifiers
NCT: NCT06362083 · 34-317 ex 21/22