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

NCT07627178 | Recruiting DMC

• 1 other identifier: 36265MD479/10/25
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lower Urinary Tract Symptom; Bladder Outlet Obstruction; Benign Prostatic Hyperplasia (BPH)

Keywords

Prostate Enucleation; ThuLEP; HOLEP; Bi-TUEP; TFL; BPH Surgery; IPSS; Uroflowmetry

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Total Operative Time in Minutes

  Intraoperative

• Enucleation Efficiency in Grams per Minute

  Intraoperative

• Estimated Blood Loss as Change in Hemoglobin Level

  Baseline and 24 hours postoperatively

• Catheterization Duration in Days

  Up to 7 days postoperatively

• Length of Hospital Stay in Days

  Up to 7 days postoperatively

Study Arms (3)

ThuFLEP Group

ACTIVE COMPARATOR

30 patients undergoing Thulium Fiber Laser Enucleation of the Prostate using Quanta 60W with 550nm Thulium fiber

Procedure: Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP)

HoLEP Group

ACTIVE COMPARATOR

30 patients undergoing Holmium Laser Enucleation of the Prostate using Quanta 150W with 550nm Holmium YAG fiber

Procedure: Holmium Laser Enucleation of the Prostate (HoLEP)

Bipolar Enucleation Group

ACTIVE COMPARATOR

30 patients undergoing Bipolar Transurethral Enucleation of the Prostate using standard bipolar energy

Procedure: Bipolar Transurethral Enucleation of the Prostate (B-TUEP)

Interventions

Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP) PROCEDURE

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.

ThuFLEP Group

Holmium Laser Enucleation of the Prostate (HoLEP) PROCEDURE

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.

HoLEP Group

Bipolar Transurethral Enucleation of the Prostate (B-TUEP) PROCEDURE

Anatomical endoscopic enucleation of the prostate performed transurethrally using standard bipolar electrical energy. Enucleated tissue was removed using a morcellator.

Bipolar Enucleation Group

Eligibility Criteria

• Gender Eligibility Details: Prostate disease - all participants are male by definition.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospital

Tanta, Gharbia Governorate, 31111, Egypt

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms; Urinary Bladder Neck Obstruction

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases

Study Officials

• Hassan Hussein El-Tatawy, MD

  Tanta University Faculty of Medicine

  STUDY DIRECTOR

Central Study Contacts

Abdullah Salah Al Debeiky, MD

CONTACT

+201221430915; abdullah.aldebeiky@med.tanta.edu.eg

Omar Khaled Gad, MSc

CONTACT

+201117837272; omar_khaled@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 4, 2026
• Study Start: October 21, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: June 5, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 6 months after publication of primary results
• 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.

Locations

EG (1)