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NCT Number: NCT06362083

Urethral Stricture Database

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

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Röthl Martina Anna

Graz, Styria, 8036, Austria

Location status: Recruiting

Location contact

Marianne Leitsmann, Prof. Dr.

CONTACT

[email protected]

+43 316 385 80550

Marianne Leitsmann, Prof. Dr.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

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:

  • 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

Treatment and study plan

Questionnaires and data collection

Other

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

Primary outcomes

  1. 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

    Success is defined as a lack of stricture recurrence in the follow-up

Secondary outcomes

  1. 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

    Complications are defined as surgical site infection, fistula, problems at the preservation site of buccal mucosa.

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2034
Study completion
2034
First posted
Apr 12, 2024
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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