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Идёт набор NCT06983444

Bipolar Resection vs Enucleation of Prostate

Без фазы С лечением Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection Benign Prostatic Hyperplasia With Outflow Obstruction Benign Prostatic Hyperplasia With Symptomatic Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms

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: TURP, TUEP.
Кому может быть актуально
Состояния в реестре: Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection, Benign Prostatic Hyperplasia With Outflow Obstruction, Benign Prostatic Hyperplasia With Symptomatic Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms. 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
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

Bipolar Trans Urethral Resection of the Prostate (TURP) Versus Bipolar Enucleation of the Prostate in Treatment of Benign Prostatic Hyperplasia (BPH): A Prospective Randomized Comparative Clinical Study

Обзор

The aim of this study is to evaluate efficacy and safety of transurethral resection of the prostate and bipolar enucleation of the prostate.

Подробное описание

Endoscopic management of benign prostatic hyperplasia (BPH), monopolar transurethral resection of the prostate (TURP) has been the gold standard for many years.

Despite its promising efficacy in treating BPH, TURP is associated with a risk of significant complications and clinical limitations, including life-threatening events such as transurethral resection (TUR) syndrome, as well as high cost due to long hospital stay, long catheterization time and difficulty in management of large sized prostate so alternative surgical approaches have been explored.

Minimally invasive approaches achieve equal efficiency to standard resection, but with a more favorable safety and less complications.

Anatomical enucleation of the prostate using Bipolar or Laser-based approaches such as holmium laser have been introduced with success and the efficacy and safety of these procedure has led to the integration into several international guidelines.

Early results of bipolar enucleation resemble those reported for holmium laser procedure, Bipolar transurethral enucleation of the prostate was at least equally effective, and showed less complications, good hemostatic control and both shorter catheterization time and hospital stay than old standard procedure.

A comparison between TURP and Bipolar enucleation of prostate allows us to investigate the true benefits and safety of each modality.

Вмешательства

  • Процедура TURP
    Using bipolar loop diathermy via cystoscopy, excess prostate tissue is resected piecemeal to remove obstruction to the prostatic urethra due to BPH.
  • Процедура TUEP
    Using bipolar enucleation loop diathermy via cystoscopy, to anatomically enucleate prostate.

Первичные конечные точки

  • Catheter and lower urinary tract symptoms free after Bipolar Transurethral resection of prostate (TURP) versus Bipolar Transurethral enucleation of prostate (TUEP) in patient with BPH with lower urinary tract symptoms [Срок оценки: at least 6 months up to one year]
Вторичные конечные точки (7)
  • Operative time in minutes in each group of intervention [Срок оценки: 60 - 90 minutes for each group of intervention]
  • Compare complication rate of TURP versus TUEP [Срок оценки: at least 6 months up to one year]
  • Cost effectiveness of TURP versus TUEP in achieving catheter-free rates in BPH patients with urinary retention [Срок оценки: at least 6 months up to one year]
  • Compare patient reported symptom measures by IPSS questionnaire after TURP versus TUEP [Срок оценки: at least 6 months up to one year]
  • Compare patient reported symptom measures by Michigan Incontinence Symptom Index (M-ISI) questionnaire after TURP versus TUEP [Срок оценки: at least 6 months up to one year]
  • Compare patient reported symptom measures by IIEF-5 questionnaire after TURP versus TUEP [Срок оценки: at least 6 months up to one year]
  • Compare patient reported quality of life by SF-12 questionnaire after TURP versus TUEP [Срок оценки: at least 6 months up to one year]

Критерии участия

Критерии включения

  • Patients with lower urinary tract symptoms (LUTS) due to BPH.
  • Patients with international prostate score system (IPSS) more than 8.
  • Patients with maximal urinary flow rate (Qmax) less than 10ml/second.
  • Patients with Prostatic volume (60 - 100 gm).
  • Patient with indication for surgical intervention.
  • Patient age (50-80 years old)

Критерии исключения

  • Prostatic cancer.
  • Bladder cancer.
  • Urethral stricture.
  • Neurogenic bladder.

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
Простое слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Faculty of Medicine South Valley University — Qina

Публикации

  • Zhang Y, Yuan P, Ma D, Gao X, Wei C, Liu Z, Li R, Wang S, Liu J, Liu X. Efficacy and safety of enucleation vs. resection of prostate for treatment of benign prostatic hyperplasia: a meta-analysis of randomized controlled trials. Prostate Cancer Prostatic Dis. 2019 Dec;22(4):493-508. doi: 10.1038/s41391-019-0135-4. Epub 2019 Feb 28. PMID 30816336
  • Seitz M, Sroka R, Gratzke C, Schlenker B, Steinbrecher V, Khoder W, Tilki D, Bachmann A, Stief C, Reich O. The diode laser: a novel side-firing approach for laser vaporisation of the human prostate--immediate efficacy and 1-year follow-up. Eur Urol. 2007 Dec;52(6):1717-22. doi: 10.1016/j.eururo.2007.06.028. Epub 2007 Jun 26. PMID 17628326
  • Bachmann A, Schurch L, Ruszat R, Wyler SF, Seifert HH, Muller A, Lehmann K, Sulser T. Photoselective vaporization (PVP) versus transurethral resection of the prostate (TURP): a prospective bi-centre study of perioperative morbidity and early functional outcome. Eur Urol. 2005 Dec;48(6):965-71; discussion 972. doi: 10.1016/j.eururo.2005.07.001. Epub 2005 Jul 18. PMID 16126327
  • Gilling PJ, Wilson LC, King CJ, Westenberg AM, Frampton CM, Fraundorfer MR. Long-term results of a randomized trial comparing holmium laser enucleation of the prostate and transurethral resection of the prostate: results at 7 years. BJU Int. 2012 Feb;109(3):408-11. doi: 10.1111/j.1464-410X.2011.10359.x. Epub 2011 Aug 23. PMID 21883820
  • Arcaniolo D, Manfredi C, Veccia A, Herrmann TRW, Lima E, Mirone V, Fusco F, Fiori C, Antonelli A, Rassweiler J, Liatsikos E, Porpiglia F, De Sio M, Autorino R; EAU Section of Uro-Technology (ESUT) Research Group. Bipolar endoscopic enucleation versus bipolar transurethral resection of the prostate: an ESUT systematic review and cumulative analysis. World J Urol. 2020 May;38(5):1177-1186. doi: 10.1 PMID 31346761
  • Ho HS, Yip SK, Lim KB, Fook S, Foo KT, Cheng CW. A prospective randomized study comparing monopolar and bipolar transurethral resection of prostate using transurethral resection in saline (TURIS) system. Eur Urol. 2007 Aug;52(2):517-22. doi: 10.1016/j.eururo.2007.03.038. Epub 2007 Mar 28. PMID 17416453

Идентификаторы

NCT: NCT06983444 · Endoscopic surgery prostate

Первоисточники (государственные реестры)

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