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Идёт набор NCT06362083

Urethral Stricture Database

Наблюдательное Urethral Stricture

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Questionnaires and data collection.
Кому может быть актуально
Состояния в реестре: Urethral Stricture. Базовые параметры: от 18 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Австрия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • Success rate of urethral reconstructive surgeries [Срок оценки: Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years]
Вторичные конечные точки (3)
  • Complications of urethral reconstructive surgeries [Срок оценки: Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years]
  • Sexual function after urethral reconstructive surgeries [Срок оценки: Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years]
  • Health status after urethral reconstructive surgeries [Срок оценки: Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years]

Критерии участия

Критерии включения

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

Критерии исключения

  • Lack of capacity to consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Австрия · 1 центр
  • Röthl Martina Anna — Graz

Идентификаторы

NCT: NCT06362083 · 34-317 ex 21/22

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗