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Urethral Stricture Database

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06362083
Enrollment
500
Registered
2024-04-12
Start date
2024-01-15
Completion date
2034-03-15
Last updated
2024-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urethral Stricture

Keywords

Reconstructive surgery, Quality of life, Perioperative Outcomes

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.

Interventions

OTHERQuestionnaires and data collection

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

Sponsors

Medical University of Graz
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Success rate of urethral reconstructive surgeriesQuestionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 yearsSuccess is defined as a lack of stricture recurrence in the follow-up

Secondary

MeasureTime frameDescription
Complications of urethral reconstructive surgeriesQuestionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 yearsComplications are defined as surgical site infection, fistula, problems at the preservation site of buccal mucosa.
Sexual function after urethral reconstructive surgeriesQuestionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years
Health status after urethral reconstructive surgeriesQuestionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026