Röthl Martina Anna
Graz, Styria, 8036, Austria
Location status: Recruiting
Location contact
Marianne Leitsmann, Prof. Dr.
CONTACT
Marianne Leitsmann, Prof. Dr.
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06362083
Establishment of a clinical urethral stricture database for a prospective longitudinal cohort study.
Interested in participating?
Request Info18 year and older
Male
Observational
Graz, Styria, 8036, Austria
Location status: Recruiting
Marianne Leitsmann, Prof. Dr.
CONTACT
Marianne Leitsmann, Prof. Dr.
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All patients undergoing any of the following urethral surgeries are included:
Exclusion criteria
It is a non-interventional, single-center, non-randomized, prospective observational study obtaining data and patient-reported outcomes.
Time frame: 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
Time frame: 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.
Time frame: Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years
Time frame: Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years
Medical University of Graz
Other
Construction of a Clinical Urethral Stricture Database for a Prospective Longitudinal Cohort Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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