Идёт набор NCT04071925

9000 URETHRA STUDY: a Study About Urethroplasty for Urethral Stricture Disease

— 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: Urethroplasty.
Кому может быть актуально: Состояния в реестре: Urethral Stricture. Базовые параметры: 6 лет — 100 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Бельгия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

9000 URETHRA STUDY: a Prospective, Observational Study About Urethroplasty for Urethral Stricture Disease

Обзор

It has been demonstrated that urethroplasty should be considered the gold standard treatment for urethral stricture disease as it yields higher long-term success rates than endoscopic treatment options such as direct vision internal urethrotomy (DVIU) or dilation. Many data about these procedures exist, although most of the publications about urethroplasty are retrospective and involve a tremendous risk of bias. To address these issues, this study is designed to prospectively gain evidence about this matter in all patient subgroups facing a potential treatment with urethroplasty: native men, native women, transmen, transwomen and children.

Вмешательства

Процедура Urethroplasty
Open reconstructive surgery to restore urethral patency in case of urethral stricture disease.

Первичные конечные точки

Failure-free survival [Срок оценки: From date of surgery until the date of stricture recurrence or date of death from any cause, whichever came first, assessed up to 120 months postoperatively]

Вторичные конечные точки (6)

Change in erectile function [Срок оценки: From the date of preoperative questionnaire completion until 24 months postoperatively.]
Change in ejaculatory function [Срок оценки: From the date of preoperative questionnaire completion until 24 months postoperatively.]
Change in urinary function [Срок оценки: From the date of preoperative questionnaire completion until 24 months postoperatively.]
Change in urinary continence [Срок оценки: From the date of preoperative questionnaire completion until 24 months postoperatively.]
Change in quality of life [Срок оценки: From the date of preoperative questionnaire completion until 24 months postoperatively.]
Change in general quality of life [Срок оценки: From the date of preoperative questionnaire completion until 24 months postoperatively.]

Критерии участия

Критерии включения

Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations.
Patient age ≥ 6 years.
If a patient reaches the age of 18 years, he or she will have to provide a new voluntarily signed written informed consent. All patients reaching the age of 18 years will be contacted by the Principal Investigator or Subinvestigator to provide a new voluntarily signed written informed consent.