HoLEP vs BipolEP in Management of BPH Patients With Large Prostates
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 Laser Enucleation of the Prostate, Bipolar Enucleation of the Prostate.
- 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
- Египет
- 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
Holmium Laser Versus Bipolar Enucleation of the Prostate in Management of Benign Prostatic Hyperplasia Patients With Large Prostates: A Non-inferiority Prospective Randomized Clinical Trial
Обзор
This is a non-inferiority prospective randomized comparative clinical trial aiming to prove the non-inferiority of bipolar enucleation of the prostate in comparison to holmium laser enucleation of the prostate in management of benign prostatic hyperplasia patients with large prostates and in turn its feasibility as an alternative procedure in hospitals with limited resources
Подробное описание
Benign prostatic hyperplasia (BPH) is a prevalent condition among older men. It is characterized by non-cancerous enlargement of the prostate gland often leading to urinary obstruction and significant morbidity. In case of failure of medical treatment, surgical intervention is often required especially in patients with larger prostates. Surgical options in such cases include Holmium Laser Enucleation of the Prostate (HoLEP) and Bipolar Enucleation of the Prostate (BipolEP). These modalities have emerged as promising relatively minimally invasive treatment options in patients with large prostates. HoLEP, utilizing laser technology to enucleate prostatic tissue, has been associated with reduced intraoperative blood loss, shorter catheterization time, and quicker recovery in comparison to open prostatectomy. Likewise, BipolEP, utilizing bipolar energy for enucleation, offers the advantage of reduced bleeding and shorter operative time. Both HoLEP and BipolEP have demonstrated efficacy in improving lower urinary tract symptoms (LUTS) and alleviating obstruction in BPH patients with large prostates, but the comparative efficacy and safety of both techniques remains highly debated. This study aims to compare the efficacy and safety of these two surgical modalities aiming to provide valuable insights that can enhance clinical decision-making and patient care in BPH management.
Вмешательства
- Процедура Holmium Laser Enucleation of the Prostate
Enucleation of the prostate gland using holmium laser energy - Процедура Bipolar Enucleation of the Prostate
Enucleation of the prostate gland using bipolar energy
Первичные конечные точки
- Change in peak flow rate [Срок оценки: At 6 months after the procedure (HoLEP or BipolEP)]
Вторичные конечные точки (1)
- Complications [Срок оценки: At 6 months after the procedure (HoLEP or BipolEP)]
Критерии участия
Критерии включения
- Age >50 years
- Prostate volume >80 ml
- Failure of or noncompliance with medical treatment
- IPSS >15
- Qmax <15 ml/sec
- Urinary retention and fixed catheters with poor results on trial of voiding without catheter
Критерии исключения
- Patients with active UTI
- Prostate cancer
- Bladder carcinoma
- Urethral stricture
- Neurogenic bladder disorders
- Redo cases
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
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Египет · 1 центр
- Assiut University Urology Hospital — Asyut
Публикации
- Becker B, Herrmann TRW, Gross AJ, Netsch C. Thulium vapoenucleation of the prostate versus holmium laser enucleation of the prostate for the treatment of large volume prostates: preliminary 6-month safety and efficacy results of a prospective randomized trial. World J Urol. 2018 Oct;36(10):1663-1671. doi: 10.1007/s00345-018-2321-8. Epub 2018 May 5. PMID 29730838
- Tan AH, Gilling PJ. Holmium laser prostatectomy: current techniques. Urology. 2002 Jul;60(1):152-6. doi: 10.1016/s0090-4295(02)01648-5. PMID 12100945
- Neill MG, Gilling PJ, Kennett KM, Frampton CM, Westenberg AM, Fraundorfer MR, Wilson LC. Randomized trial comparing holmium laser enucleation of prostate with plasmakinetic enucleation of prostate for treatment of benign prostatic hyperplasia. Urology. 2006 Nov;68(5):1020-4. doi: 10.1016/j.urology.2006.06.021. Epub 2006 Nov 7. PMID 17095078
- Shoma AM, Ghobrial FK, El-Tabey N, El-Hefnawy AS, El-Kappany HA. A randomized trial of holmium laser vs thulium laser vs bipolar enucleation of large prostate glands. BJU Int. 2023 Dec;132(6):686-695. doi: 10.1111/bju.16174. Epub 2023 Sep 28. PMID 37667842
Идентификаторы
NCT: NCT06759194 · HoLEP vs BipolEP