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Идёт набор NCT04084938

Artery Embolization vs Operation of Benign Prostate Hyperplasia

Без фазы С лечением Benign Prostatic Hyperplasia Post-Op Complication Embolization Therapeutic Transurethral Resection of Prostate Syndrome

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: Prostate operation or prostate artery embolization.
Кому может быть актуально
Состояния в реестре: Benign Prostatic Hyperplasia, Post-Op Complication, Embolization Therapeutic, Transurethral Resection of Prostate Syndrome. Базовые параметры: Без ограничений · 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
Норвегия
Следующий шаг
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Официальное название

Prostatic Artery Embolization vs Transurethral Resection of the Prostate or Open Prostatectomy in Patients With Symptomatic Benign Prostatic Hyperplasia

Обзор

Aim of the study is to compare prostate artery embolization (PAE) to the established surgical treatment for patient acceptance, morbidity, complications, and the functional outcomes. To compare length of stay, hospital costs and time for recovery. 140 patients will be randomized to PAE or surgery. Patients should suffer from lower urinary tract symptoms (LUTS), be candidates for both treatments and willing to undergo both procedures. Before randomization computed tomography angiography of the pelvic arteries is done to select eligible patients. Magnetic resonance imaging of prostate rules out possible cancer. The PAE is done in the angio suite in the radiology department injecting small particles into the prostate arteries. The surgery is done in the operation room in the urology department according to established procedures. Clinical follow-up include clinical visit after 3 months, 1 and 5 years. Acute as well as long term complications will be recorded.

Подробное описание

Background: Prostatic artery embolization (PAE) has recently been described as a promising alternative to surgery for treatment of lower urinary tract symptoms (LUTS) due to an enlarged, benign prostate. The treatment has not been implemented into international guidelines and has only been introduced to few patients in Norway.

Purpose: To compare PAE to the established surgical treatment for patient acceptance, morbidity, complications, and the functional outcomes. To compare length of stay, hospital costs and time for recovery.

Materials and Methods: 140 patients will be randomized to PAE or surgery. Patients should suffer from LUTS, be candidates for both treatments and willing to undergo both procedures. Before randomization computed tomography angiography of the pelvic arteries is done to select eligible patients. Magnetic resonance imaging of prostate rules out possible cancer. The PAE is done in the angio suite in the radiology department injection small particles into the prostate arteries. The surgery is done in the operation room in the urology department according to established procedures. All patients stay in the urology unit after the procedure. Clinical follow-up include clinical visit after 3 months, 1 and 5 years. Acute as well as long term complications will be recorded. The patients fill in the form of quality of life from urologic disease. Urodynamic examination will record functional outcome. Length of stay, procedure costs and recovery time will be recorded.

Importance of the study: Contribute to establishment of new treatment and help to select the right patients for the alternative treatments. Randomized study will give important information to the international community. It is possible to run this study in Norway because it is still in limited use.

Вмешательства

  • Процедура Prostate operation or prostate artery embolization
    As described above.

Первичные конечные точки

  • Quality of life due to urinary symptoms [Срок оценки: 3 months]
  • Number of patients with Prostate Artery Embolization that did not have prostate operation [Срок оценки: 12 months]
Вторичные конечные точки (3)
  • Number of patients with postoperative complications [Срок оценки: 3 months]
  • Hospital stay [Срок оценки: 3 months]
  • Symptoms [Срок оценки: 3 months, 1 year, 5 years]

Критерии участия

Критерии включения

  • LUTS from Benign Prostate Hyperplasia (BPH) with moderate and severe IPSS score (IPSS > 8) and QoL = or >3
  • and refractory to medical treatment for at least 6 months or the patient is unwilling to accept medical treatment
  • or BPH using permanent or intermittent catheterization
  • Prostate volume > 50 ml
  • Signed informed consent

Критерии исключения

  • Urological disorders: evidence of clinically significant prostate cancer \[as defined by START criteria\] on prostate biopsy (27,28), prostatitis (29,30), detrusor-sphincter dyssynergia or evidence of neurogenic bladder, urethral strictures, bladder neck contracture, bladder stone or bladder cancer
  • Renal insufficiency defined as Glomerular Filtration Rate < 30 ml/min/1,73m2
  • Known severe reactions to iodine-based contrast or gadolinium-based contrast
  • Previous prostate operation
  • CT examination reveals no access to the prostate arteries.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Норвегия · 1 центр
  • Oslo University Hospital, Aker — Oslo

Идентификаторы

NCT: NCT04084938 · 2018/1231

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗