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NCT Number: NCT07627178

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.

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Key information

Conditions

Benign Prostatic Hyperplasia (BPH) Bladder Outlet Obstruction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptom Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urethral Diseases Urethral Obstruction Urinary Bladder Diseases Urinary Bladder Neck Obstruction Urogenital Diseases Urologic Diseases Urological Manifestations

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University Hospital

Tanta, Gharbia Governorate, 31111, Egypt

Location status: Recruiting

Location contact

Abdullah Salah Al Debeiky, MD

CONTACT

[email protected]

+201221430915

Abdullah Salah Al Debeiky, MD

SUB_INVESTIGATOR

Hassan Hussein El-Tatawy, MD

SUB_INVESTIGATOR

Mohamed Hassan Radwan, MD

SUB_INVESTIGATOR

Mohamed Osama Abou Farha, MD

SUB_INVESTIGATOR

Omar Khaled Gad, MSc

CONTACT

[email protected]

+201117837272

Omar Khaled Gad, MSc

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. International Prostate Symptom Score (IPSS)

    Time frame: at 1, 3 and 6 months post-surgery

    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.

  2. Quality of Life Score (QoL)

    Time frame: Baseline and at 1, 3, and 6 months post-surgery

    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).

  3. Maximum Urinary Flow Rate (Qmax)

    Time frame: Baseline and at 1, 3, and 6 months post-surgery

    Change from baseline in maximum urinary flow rate in mL/s as measured by uroflowmetry. Higher values indicate better voiding function.

  4. Post-Void Residual Urine Volume (PVR)

    Time frame: Baseline and at 1, 3, and 6 months post-surgery

    Change from baseline in post-void residual urine volume in mL as measured by transabdominal ultrasound. Lower values indicate better bladder emptying.

Secondary outcomes

  1. Total Operative Time in Minutes

    Time frame: Intraoperative

    Total surgical time from start of procedure to completion, including enucleation and morcellation phases.

  2. Enucleation Efficiency in Grams per Minute

    Time frame: Intraoperative

    Weight of enucleated prostatic tissue (grams) divided by enucleation time (minutes), reflecting surgical speed and effectiveness.

  3. Estimated Blood Loss as Change in Hemoglobin Level

    Time frame: Baseline and 24 hours postoperatively

    Difference between preoperative and 24-hour postoperative serum hemoglobin levels (g/dL). Greater decrease indicates more blood loss.

  4. Catheterization Duration in Days

    Time frame: Up to 7 days postoperatively

    Number of days from end of surgery until urethral catheter removal, based on resolution of hematuria and clinical assessment.

  5. Length of Hospital Stay in Days

    Time frame: Up to 7 days postoperatively

    Total number of days from surgery to hospital discharge.

  6. Number of Participants with Postoperative Complications as Assessed by Clavien-Dindo Classification

    Time frame: Up to 6 months postoperatively

    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).

  7. Erectile Function Score (IIEF-5)

    Time frame: Baseline and at 1, 3, and 6 months postoperatively

    Change from baseline in International Index of Erectile Function-5 (IIEF-5) questionnaire score (range 5-25; higher scores indicate better erectile function).

Study contacts

Contact information is provided by the study sponsor or research team.

Abdullah Salah Al Debeiky, MD

CONTACT

[email protected]

+201221430915

Omar Khaled Gad, MSc

CONTACT

[email protected]

+201117837272

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 4, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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