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

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.

Study Overview

• Status: Recruiting
• Conditions: Bladder Outlet Obstruction; Lower Urinary Tract Symptom; Benign Prostatic Hyperplasia (BPH)
• Intervention / Treatment: Procedure: Endoscopic Enucleation of the Prostate; Procedure: Endoscopic Enucleation of the Prostate; Procedure: Endoscopic Enucleation of the Prostate

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abdullah Salah Al Debeiky, MD; Phone Number: +201221430915; Email: abdullah.aldebeiky@med.tanta.edu.eg
• Study Contact Backup: Name: Omar Khaled Gad, MSc; Phone Number: +201117837272; Email: omar_khaled@med.tanta.edu.eg

Study Locations

• Egypt
  • Gharbia Governorate
    • Tanta, Gharbia Governorate, Egypt, 31111
      • Recruiting
      • Tanta University Hospital
      • Contact: Abdullah Salah Al Debeiky, MD; Phone Number: +201221430915; Email: abdullah.aldebeiky@med.tanta.edu.eg
      • Contact: Omar Khaled Gad, MSc; Phone Number: +201117837272; Email: omar_khaled@med.tanta.edu.eg
      • Principal Investigator: Omar Khaled Gad, MSc
      • Sub-Investigator: Hassan Hussein El-Tatawy, MD
      • Sub-Investigator: Mohamed Hassan Radwan, MD
      • Sub-Investigator: Mohamed Osama Abou Farha, MD
      • Sub-Investigator: Abdullah Salah Al Debeiky, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ThuFLEP Group; 30 patients undergoing Thulium Fiber Laser Enucleation of the Prostate using Quanta 60W with 550nm Thulium fiber	Procedure: Endoscopic Enucleation of the Prostate; Transurethral endoscopic enucleation of the prostate performed by: Thulium fiber laser; Procedure: Endoscopic Enucleation of the Prostate; Transurethral endoscopic enucleation of the prostate performed by: Holmium laser; Procedure: Endoscopic Enucleation of the Prostate; Transurethral endoscopic enucleation of the prostate performed by: Bipolar energy
Active Comparator: HoLEP Group; 30 patients undergoing Holmium Laser Enucleation of the Prostate using Quanta 150W with 550nm Holmium YAG fiber	Procedure: Endoscopic Enucleation of the Prostate; Transurethral endoscopic enucleation of the prostate performed by: Thulium fiber laser; Procedure: Endoscopic Enucleation of the Prostate; Transurethral endoscopic enucleation of the prostate performed by: Holmium laser; Procedure: Endoscopic Enucleation of the Prostate; Transurethral endoscopic enucleation of the prostate performed by: Bipolar energy
Active Comparator: Bipolar Enucleation Group; 30 patients undergoing Bipolar Transurethral Enucleation of the Prostate using standard bipolar energy	Procedure: Endoscopic Enucleation of the Prostate; Transurethral endoscopic enucleation of the prostate performed by: Thulium fiber laser; Procedure: Endoscopic Enucleation of the Prostate; Transurethral endoscopic enucleation of the prostate performed by: Holmium laser; Procedure: Endoscopic Enucleation of the Prostate; Transurethral endoscopic enucleation of the prostate performed by: Bipolar energy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Prostate Symptom Score (IPSS)	Change from baseline in IPSS total score (0-35 scale; higher scores indicate worse urinary symptoms). Scores compared across ThuFLEP, HoLEP, and bipolar enucleation groups.	at 1, 3 and 6 months post-surgery
Quality of Life Score (QoL)	Change from baseline in the IPSS-linked Quality of Life index (0-6 scale; higher scores indicate worse quality of life due to urinary symptoms).	Baseline and at 1, 3, and 6 months post-surgery
Maximum Urinary Flow Rate (Qmax)	Change from baseline in maximum urinary flow rate in mL/s as measured by uroflowmetry. Higher values indicate better voiding function.	Baseline and at 1, 3, and 6 months post-surgery
Post-Void Residual Urine Volume (PVR)	Change from baseline in post-void residual urine volume in mL as measured by transabdominal ultrasound. Lower values indicate better bladder emptying.	Baseline and at 1, 3, and 6 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Operative Time in Minutes	Total surgical time from start of procedure to completion, including enucleation and morcellation phases.	Intraoperative
Enucleation Efficiency in Grams per Minute	Weight of enucleated prostatic tissue (grams) divided by enucleation time (minutes), reflecting surgical speed and effectiveness.	Intraoperative
Estimated Blood Loss as Change in Hemoglobin Level	Difference between preoperative and 24-hour postoperative serum hemoglobin levels (g/dL). Greater decrease indicates more blood loss.	Baseline and 24 hours postoperatively
Catheterization Duration in Days	Number of days from end of surgery until urethral catheter removal, based on resolution of hematuria and clinical assessment.	Up to 7 days postoperatively
Length of Hospital Stay in Days	Total number of days from surgery to hospital discharge.	Up to 7 days postoperatively
Number of Participants with Postoperative Complications as Assessed by Clavien-Dindo Classification	Rate and severity of complications including urinary incontinence, urinary tract infection, urethral stricture, and need for reoperation, graded using the Clavien-Dindo classification system (Grade I-V; higher grade indicates more severe complication).	Up to 6 months postoperatively
Erectile Function Score (IIEF-5)	Change from baseline in International Index of Erectile Function-5 (IIEF-5) questionnaire score (range 5-25; higher scores indicate better erectile function).	Baseline and at 1, 3, and 6 months postoperatively

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Study Director: Hassan Hussein El-Tatawy, MD, Tanta University Faculty of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: May 26, 2026
• First Submitted That Met QC Criteria: May 29, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: IPSS; TFL; HOLEP; ThuLEP; Uroflowmetry; Prostate Enucleation; Bi-TUEP; BPH Surgery
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urological Manifestations; Urinary Bladder Diseases; Urethral Diseases; Urethral Obstruction; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Prostatic Hyperplasia; Lower Urinary Tract Symptoms; Urinary Bladder Neck Obstruction
• Other Study ID Numbers: 36265MD479/10/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data underlying published results will be shared after de-identification, including data for primary and secondary outcome measures. Data will be available upon reasonable request to the corresponding author following publication.
• IPD Sharing Time Frame: Beginning 6 months after publication of primary results
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal approved by the study team. Requests should be directed to the corresponding author. Data will be shared for individual participant meta-analyses or systematic reviews.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No