A Prospective Comparative Study Evaluating the Safety and Efficacy of Transurethral Thulium Fiber Laser, Holmium Laser and Bipolar Enucleation of Large Sized Prostate

Обзор

This study compares the safety and efficacy of three endoscopic enucleation techniques for large prostates (\>100 mL) in patients with benign prostatic hyperplasia (BPH): Thulium Fiber Laser Enucleation (ThuFLEP), Holmium Laser Enucleation (HoLEP), and Bipolar Enucleation (B-TUEP). Ninety male patients with severe lower urinary tract symptoms (IPSS ≥20, Qmax ≤10 mL/s) who failed medical therapy will be randomized 1:1:1 into three groups of 30. Primary outcomes include IPSS, quality of life score, maximum flow rate (Qmax), and post-void residual at 1, 3, and 6 months postoperatively. Secondary outcomes include operative time, enucleation efficiency, blood loss, catheterization duration, hospital stay, and complication rates assessed by the Clavien-Dindo classification.

Подробное описание

Benign prostatic hyperplasia (BPH) is a progressive condition causing lower urinary tract symptoms (LUTS) that significantly impairs quality of life in aging men. While medical therapy with alpha-blockers and 5-alpha reductase inhibitors represents first-line management, surgical intervention becomes necessary when symptoms are severe or complications arise.

Anatomical endoscopic enucleation of the prostate has emerged as the size-independent gold standard surgical approach. This prospective randomized controlled trial will be conducted at the Urology Department, Tanta University Hospital (October 2025 - October 2027) following IRB approval (Code: 36265MD479/10/25).

Patients will undergo preoperative evaluation including IPSS, QoL index, IIEF-5, uroflowmetry, transrectal ultrasound, PSA, CBC, coagulation profile, and renal/liver function tests. Intraoperative data will include total operative time, enucleation time, morcellation time, enucleation efficiency (g/min), and estimated blood loss. Postoperative follow-up at 1, 3, and 6 months will assess IPSS, QoL, IIEF-5, Qmax, and post-void residual. Complications will be graded using the Clavien-Dindo classification. Randomization will use the sealed opaque envelope method with 1:1:1 allocation.

Вмешательства

• Процедура Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP)
  Anatomical endoscopic enucleation of the prostate performed transurethrally using a Quanta thulium fiber laser at 60 watts with a 550 μm thulium fiber. Enucleated tissue was removed using a morcellator.
• Процедура Holmium Laser Enucleation of the Prostate (HoLEP)
  Anatomical endoscopic enucleation of the prostate performed transurethrally using a Quanta holmium YAG laser at 150 watts with a 550 μm holmium fiber. Enucleated tissue was removed using a morcellator.
• Процедура Bipolar Transurethral Enucleation of the Prostate (B-TUEP)
  Anatomical endoscopic enucleation of the prostate performed transurethrally using standard bipolar electrical energy. Enucleated tissue was removed using a morcellator.

Первичные конечные точки

• International Prostate Symptom Score (IPSS) [Срок оценки: at 1, 3 and 6 months post-surgery]
• Quality of Life Score (QoL) [Срок оценки: Baseline and at 1, 3, and 6 months post-surgery]
• Maximum Urinary Flow Rate (Qmax) [Срок оценки: Baseline and at 1, 3, and 6 months post-surgery]
• Post-Void Residual Urine Volume (PVR) [Срок оценки: Baseline and at 1, 3, and 6 months post-surgery]

Вторичные конечные точки (7)

• Total Operative Time in Minutes [Срок оценки: Intraoperative]
• Enucleation Efficiency in Grams per Minute [Срок оценки: Intraoperative]
• Estimated Blood Loss as Change in Hemoglobin Level [Срок оценки: Baseline and 24 hours postoperatively]
• Catheterization Duration in Days [Срок оценки: Up to 7 days postoperatively]
• Length of Hospital Stay in Days [Срок оценки: Up to 7 days postoperatively]
• Number of Participants with Postoperative Complications as Assessed by Clavien-Dindo Classification [Срок оценки: Up to 6 months postoperatively]
• Erectile Function Score (IIEF-5) [Срок оценки: Baseline and at 1, 3, and 6 months postoperatively]

Критерии участия

Критерии включения

• Male patients diagnosed with BPH
• Clinical diagnosis of BPH with lower urinary tract symptoms.
• IPSS ≥ 20 (severe symptoms)
• Maximum urinary flow rate (Qmax) ≤ 10 mL/s
• Prostate volume >100 mL (measured by transrectal ultrasound)
• Failed medical therapy and fit for operation

Критерии исключения

• Prostate cancer (current or history).
• Previous prostate surgery
• Previous urethral surgery.
• Neurogenic bladder dysfunction.
• Active urinary tract infection.
• Severe cardiovascular disease (ASA Class IV).
• Previous pelvic radiation.
• Urethral stricture
• Urinary bladder stones.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Tanta University Hospital — Tanta

Публикации

• Giulianelli R, Gentile BC, Mirabile G, Tema G, Nacchia A, Albanesi L, Tariciotti P, Mavilla L, Bellangino M, Lopes Mendes L, Rizzo G, Aloisi P, Vincenti G, Lombardo R. Bipolar Plasma Enucleation of the Prostate: 5 Years Outcomes. J Endourol. 2019 May;33(5):396-399. doi: 10.1089/end.2019.0050. PMID 30816063
• Chen YY, Hua WX, Huang YH, Shen XY, You JN, Ding X. The safety and efficacy of five surgical treatments in prostate enucleation: a network meta-analysis. BMC Urol. 2024 Jun 17;24(1):128. doi: 10.1186/s12894-024-01517-5. PMID 38886739
• Kosiba M, Filzmayer M, Welte MN, Hugenell L, Keller AC, Traumann MI, Muller MJ, Kluth LA, Mandel PC, Chun FK, Becker A. Thulium fiber laser vs. holmium laser enucleation of the prostate: results of a prospective randomized non-inferiority trial. World J Urol. 2024 Jan 20;42(1):49. doi: 10.1007/s00345-023-04748-7. PMID 38244076
• Herrmann TRW, Gravas S, de la Rosette JJ, Wolters M, Anastasiadis AG, Giannakis I. Lasers in Transurethral Enucleation of the Prostate-Do We Really Need Them. J Clin Med. 2020 May 10;9(5):1412. doi: 10.3390/jcm9051412. PMID 32397634
• 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: NCT07627178 · 36265MD479/10/25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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