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Recruiting NCT07627178

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

No phase Interventional Benign Prostatic Hyperplasia (BPH) Lower Urinary Tract Symptom Bladder Outlet Obstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP), Holmium Laser Enucleation of the Prostate (HoLEP), Bipolar Transurethral Enucleation of the Prostate (B-TUEP).
Who it may be relevant to
Registry conditions: Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptom, Bladder Outlet Obstruction. Basic parameters: No limits · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

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.

Interventions

  • Procedure 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.
  • Procedure 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.
  • Procedure 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.

Primary outcome measures

  • International Prostate Symptom Score (IPSS) [Time frame: at 1, 3 and 6 months post-surgery]
  • Quality of Life Score (QoL) [Time frame: Baseline and at 1, 3, and 6 months post-surgery]
  • Maximum Urinary Flow Rate (Qmax) [Time frame: Baseline and at 1, 3, and 6 months post-surgery]
  • Post-Void Residual Urine Volume (PVR) [Time frame: Baseline and at 1, 3, and 6 months post-surgery]
Secondary outcome measures (7)
  • Total Operative Time in Minutes [Time frame: Intraoperative]
  • Enucleation Efficiency in Grams per Minute [Time frame: Intraoperative]
  • Estimated Blood Loss as Change in Hemoglobin Level [Time frame: Baseline and 24 hours postoperatively]
  • Catheterization Duration in Days [Time frame: Up to 7 days postoperatively]
  • Length of Hospital Stay in Days [Time frame: Up to 7 days postoperatively]
  • Number of Participants with Postoperative Complications as Assessed by Clavien-Dindo Classification [Time frame: Up to 6 months postoperatively]
  • Erectile Function Score (IIEF-5) [Time frame: Baseline and at 1, 3, and 6 months postoperatively]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Tanta University Hospital — Tanta

Publications

  • 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

Identifiers

NCT: NCT07627178 · 36265MD479/10/25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗