Benign Prostatic Hyperplasia (BPH), Bladder Outlet Obstruction, Lower Urinary Tract Symptom
Conditions
Keywords
Prostate Enucleation, ThuLEP, HOLEP, Bi-TUEP, TFL, BPH Surgery, IPSS, Uroflowmetry
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.
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
PROCEDUREThulium 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.
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.
PROCEDUREBipolar 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.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Prostate Symptom Score (IPSS) | 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. |
| Quality of Life Score (QoL) | 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). |
| Maximum Urinary Flow Rate (Qmax) | 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. |
| Post-Void Residual Urine Volume (PVR) | 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
| Measure | Time frame | Description |
|---|---|---|
| Total Operative Time in Minutes | Intraoperative | Total surgical time from start of procedure to completion, including enucleation and morcellation phases. |
| Enucleation Efficiency in Grams per Minute | Intraoperative | Weight of enucleated prostatic tissue (grams) divided by enucleation time (minutes), reflecting surgical speed and effectiveness. |
| Estimated Blood Loss as Change in Hemoglobin Level | Baseline and 24 hours postoperatively | Difference between preoperative and 24-hour postoperative serum hemoglobin levels (g/dL). Greater decrease indicates more blood loss. |
| Catheterization Duration in Days | Up to 7 days postoperatively | Number of days from end of surgery until urethral catheter removal, based on resolution of hematuria and clinical assessment. |
| Length of Hospital Stay in Days | Up to 7 days postoperatively | Total number of days from surgery to hospital discharge. |
| Number of Participants with Postoperative Complications as Assessed by Clavien-Dindo Classification | 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). |
| Erectile Function Score (IIEF-5) | 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). |
Countries
Egypt
Contacts
CONTACTAbdullah Salah Al Debeiky, MD
CONTACTOmar Khaled Gad, MSc
STUDY_DIRECTORHassan Hussein El-Tatawy, MD
Tanta University Faculty of Medicine
Outcome results
None listed