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Набор скоро начнётся NCT07350005

Comparison of Holmium, Thulium:YAG, and Thulium Fiber Lasers in Prostate Enucleation

Без фазы С лечением BPH (Benign Prostatic Hyperplasia)

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: Holmium:YAG Laser Prostate Enucleation, Thulium:YAG Laser Prostate Enucleation, Thulium Fiber Laser Prostate Enucleation.
Кому может быть актуально
Состояния в реестре: BPH (Benign Prostatic Hyperplasia). Базовые параметры: 50 лет — 80 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
Turkey (Türkiye)
Следующий шаг
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Официальное название

A Prospective Randomized Study Comparing the Efficiency and Safety of Holmium:YAG, Thulium:YAG, and Thulium Fiber Lasers in Anatomical Prostate Enucleation

Обзор

Benign prostatic hyperplasia (BPH) is a common condition in aging men and may require surgical treatment when medical therapy is ineffective. Anatomical prostate enucleation using different laser technologies is a well-established surgical approach for the treatment of BPH. The purpose of this prospective randomized study is to compare the efficiency and safety of three commonly used laser systems-Holmium:YAG, Thulium:YAG, and Thulium Fiber Laser (TFL)-during anatomical prostate enucleation. The primary objective of the study is to evaluate laser efficiency by measuring grams of enucleated prostate tissue per joule (g/J) using intraoperative laser device data. Secondary outcomes include changes in International Prostate Symptom Score (IPSS) and the occurrence of postoperative urinary incontinence. All laser systems used in this study are part of routine clinical practice, and no additional diagnostic procedures or treatments will be performed for study purposes

Подробное описание

This is a prospective, randomized, single-center clinical study designed to compare the efficiency and safety of three different laser systems used in anatomical prostate enucleation for the surgical treatment of benign prostatic hyperplasia (BPH).

Eligible patients will be randomly assigned to undergo prostate enucleation using one of the following laser technologies: Holmium:YAG laser, Thulium:YAG laser, or Thulium Fiber Laser (TFL). All procedures will be performed according to standard surgical techniques routinely used in clinical practice.

The primary outcome of the study is laser efficiency, which will be evaluated using intraoperative laser system data,including grams of enucleated prostate tissue per joule (g/J). Preoperative prostate volume and intraoperative laser parameters are routinely recorded and will be used for analysis. No additional diagnostic procedures or treatments will be performed specifically for study purposes.

Secondary outcomes include changes in the International Prostate Symptom Score (IPSS) from preoperative assessment to postoperative follow-up and the presence of postoperative urinary incontinence. Safety assessment will be based on perioperative and postoperative adverse events recorded during routine clinical care.

The study will be conducted in accordance with ethical principles and applicable regulatory requirements, and patient confidentiality will be maintained throughout the study period.

Вмешательства

  • Процедура Holmium:YAG Laser Prostate Enucleation
    Anatomical prostate enucleation performed using a Holmium:YAG laser system as part of standard surgical treatment for benign prostatic hyperplasia.
  • Процедура Thulium:YAG Laser Prostate Enucleation
    Anatomical prostate enucleation performed using a Thulium:YAG laser system as part of standard surgical treatment for benign prostatic hyperplasia.
  • Процедура Thulium Fiber Laser Prostate Enucleation
    Anatomical prostate enucleation performed using a Thulium Fiber Laser (TFL) system as part of standard surgical treatment for benign prostatic hyperplasia.

Первичные конечные точки

  • Laser Enucleation Efficiency (g/J) [Срок оценки: Intraoperative]
Вторичные конечные точки (2)
  • Change in International Prostate Symptom Score (IPSS) [Срок оценки: Baseline (preoperative) and 3 months postoperatively]
  • Postoperative Urinary Incontinence [Срок оценки: Up to 3 months postoperatively]

Критерии участия

Критерии включения

  • Patients diagnosed with benign prostatic hyperplasia (BPH) and scheduled for anatomical prostate enucleation
  • Presence of a prostate and clinical indication for surgical treatment
  • Age between 50 and 80 years

Критерии исключения

  • History or suspicion of prostate cancer
  • Previous prostate surgery
  • Presence of neurogenic bladder or significant lower urinary tract dysfunction unrelated to BPH
  • Active urinary tract infection at the time of surgery
  • Severe comorbid conditions contraindicating surgery or anesthesia

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

Turkey (Türkiye) · 1 центр
  • Ankara University — Ankara

Идентификаторы

NCT: NCT07350005 · AUTF-TRI-LASER-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗