Clinical trial NCT06362083: Urethral Stricture Database
Official title: Construction of a Clinical Urethral Stricture Database for a Prospective Longitudinal Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urethral Stricture
Keywords: Reconstructive surgery
Quality of life
Perioperative Outcomes
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 500
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: Success rate of urethral reconstructive surgeries
timeFrame: Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years
Secondary outcomes:
measure: Complications of urethral reconstructive surgeries
timeFrame: Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years
measure: Sexual function after urethral reconstructive surgeries
timeFrame: Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years
measure: Health status after urethral reconstructive surgeries
timeFrame: Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Röthl Martina Anna
state: Styria
Study officials:
References: