Urethral Stricture Database

Urethral Stricture Clinical Trial

Official title:

Construction of a Clinical Urethral Stricture Database for a Prospective Longitudinal Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06362083
• Other study ID #: 34-317 ex 21/22
• Status: Recruiting
• Start date: January 15, 2024
• Est. completion date: March 15, 2034

Study information

• Verified date: April 2024
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 15, 2034
• Est. primary completion date: January 15, 2034
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Urethral Stricture

Intervention

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

Locations

Country	Name	City	State
Austria	Röthl Martina Anna	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Sexual function after urethral reconstructive surgeries		Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years
Secondary	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