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Идёт набор NCT05240001

Thulium Fiber Laser (TFL) vs Holmium MOSES for Treatment of Benign Prostatic Hyperplasia (BPH)

Без фазы С лечением 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: Thulium Fibre Laser, MOSES Holmium Laser.
Кому может быть актуально
Состояния в реестре: Benign Prostatic Hyperplasia. Базовые параметры: от 50 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
Канада
Следующий шаг
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Официальное название

Thulium Fiber Laser (TFL) Versus Holmium MOSES Laser Enucleation of the Prostate for Treatment of Benign Prostatic Hyperplasia (BPH): A Randomized Prospective Clinical Study

Обзор

Benign prostatic hyperplasia (BPH), the non-cancerous enlargement of the prostate, places pressure on the urethra and causes urination and bladder problems. Transurethral Resection of the Prostate (TURP) remains the gold standard treatment in most centres for BPH. However, morbidity after TURP is high, especially bleeding requiring blood transfusion and late postoperative bleeding. Holmium laser enucleation of the prostate (HoLEP) is a safe and effective procedure which has demonstrated comparable results to TURP. HOLEP also offers patients the alternative of being treated endoscopically with minimal blood loss, short catheterization time, and decreased hospital stay. The main reason HoLEP has yet to become the new standard for treatment of symptomatic BPH is due the complexity of this procedure as compared to TURP. Furthermore, the HoLEP can be used with the MOSESTM system, a system that allows for more efficiency and ease of use of the HoLEP. Thulium fiber laser (TFL) enucleation of the prostate is an emerging technology for endoscopic prostate enucleation that is notable for its high wavelength and pulsed mode of action. Recent studies have shown TFL enucleation of the prostate to be a safe and highly efficacious treatment modality for the management of large volume (\> 80 cm3) glands in BPH. Due to its novelty, further studies are needed to broaden the investigators' understanding of the TFL and comprehend the full implications and benefits of this new technology, as well its limitations. The aim of this study is to whether Thulium Fiber laser enucleation of the prostate (ThuFLEP) and Holmium laser enucleation using MOSES™ (M-HoLEP) have comparable length of hospital stay, as well as intraoperative and postoperative outcomes.

Вмешательства

  • Устройство Thulium Fibre Laser
    Participants will undergo treatment using the TFL
  • Устройство MOSES Holmium Laser
    Participants will undergo treatment using the MOSES Holmium laser.

Первичные конечные точки

  • Length of stay in the hospital [Срок оценки: within 6 hours]
Вторичные конечные точки (10)
  • Incidence of bleeding [Срок оценки: Intra-Op]
  • Incidence of blood transfusion [Срок оценки: Intra-Op]
  • Operative time [Срок оценки: Intra-Op]
  • International Prostate Symptom Score [Срок оценки: 1,3,6,12 months post-op]
  • Quality of Life (QOL) as scored on the International Prostate Symptom Score (IPSS) [Срок оценки: 1,3,6,12 months post-op]
  • Peak flow rate [Срок оценки: 1,3,6,12 months post-op]
  • Post-void residual [Срок оценки: 1,3,6,12 months post-op]
  • Prostate specific antigen [Срок оценки: 1,3,6,12 months post-op]
  • Change in size [Срок оценки: 6 months]
  • Time to Catheter Removal [Срок оценки: within 4 hours]

Критерии участия

Критерии включения

  • Males over 50 years of age at the time of enrollment
  • Referred to urology for refractory LUTS or urinary retention secondary to BPH
  • Failed medical (non-surgical) treatment
  • Prostate size on preoperative TRUS of≥80 ml
  • IPSS >15 and QOL score ≥3 and Qmax <15 ml/sec
  • Written informed consent to participate in the study
  • Ability to comply with the requirements of the study procedures

Критерии исключения

  • Previous surgical treatment for BPH
  • History of prostate cancer
  • Prostate size < 80 mL
  • History of urethral stenosis or its management
  • Known or suspected neurogenic bladder
  • Participants with active urinary tract infection until appropriately treated
  • Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study
  • Participants who lack the capacity, or cannot speak English, in order to provide free and informed written consent

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

Канада · 1 центр
  • Thunder Bay Regional Health Sciences Centre — Thunder Bay

Идентификаторы

NCT: NCT05240001 · RP-775

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗