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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
AgeNot listed
SponsorTanta University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Prostate cancer (current or history).

Previous prostate surgery

Previous urethral surgery.

Neurogenic bladder dysfunction.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP)

    Procedure/Surgery

    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/Surgery

    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/Surgery

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

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: ThuFLEP GroupActive comparator 1 intervention
Group B: HoLEP GroupActive comparator 1 intervention
Group C: Bipolar Enucleation GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
at 1, 3 and 6 months post-surgery
2

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).

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

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.

Time frame
Baseline and at 1, 3, and 6 months post-surgery
4

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.

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

Secondary outcomes

1

Total Operative Time in Minutes

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

Time frame
Intraoperative
2

Enucleation Efficiency in Grams per Minute

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

Time frame
Intraoperative
3

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.

Time frame
Baseline and 24 hours postoperatively
4

Catheterization Duration in Days

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

Time frame
Up to 7 days postoperatively

Other outcomes

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