Bipolar Resection vs Enucleation of Prostate

Not Applicable

Recruiting

• Conditions: Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection; Benign Prostatic Hyperplasia With Outflow Obstruction; Benign Prostatic Hyperplasia With Symptomatic Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms

• Registration Number: NCT06983444
• Lead Sponsor: South Valley University

Brief Summary

The aim of this study is to evaluate efficacy and safety of transurethral resection of the prostate and bipolar enucleation of the prostate.

Detailed Description

Endoscopic management of benign prostatic hyperplasia (BPH), monopolar transurethral resection of the prostate (TURP) has been the gold standard for many years.

Despite its promising efficacy in treating BPH, TURP is associated with a risk of significant complications and clinical limitations, including life-threatening events such as transurethral resection (TUR) syndrome, as well as high cost due to long hospital stay, long catheterization time and difficulty in management of large sized prostate so alternative surgical approaches have been explored.

Minimally invasive approaches achieve equal efficiency to standard resection, but with a more favorable safety and less complications.

Anatomical enucleation of the prostate using Bipolar or Laser-based approaches such as holmium laser have been introduced with success and the efficacy and safety of these procedure has led to the integration into several international guidelines.

Early results of bipolar enucleation resemble those reported for holmium laser procedure, Bipolar transurethral enucleation of the prostate was at least equally effective, and showed less complications, good hemostatic control and both shorter catheterization time and hospital stay than old standard procedure.

A comparison between TURP and Bipolar enucleation of prostate allows us to investigate the true benefits and safety of each modality.

Study Timeline

• Study First Submitted: 2025-04-29
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-17
• Last Update Submitted: 2025-05-17
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21
• Study Start: 2025-06-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

1. Patients with lower urinary tract symptoms (LUTS) due to BPH.
2. Patients with international prostate score system (IPSS) more than 8.
3. Patients with maximal urinary flow rate (Qmax) less than 10ml/second.
4. Patients with Prostatic volume (60 - 100 gm).
5. Patient with indication for surgical intervention.
6. Patient age (50-80 years old)

Exclusion Criteria

1. Prostatic cancer.
2. Bladder cancer.
3. Urethral stricture.
4. Neurogenic bladder.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Catheter and lower urinary tract symptoms free after Bipolar Transurethral resection of prostate (TURP) versus Bipolar Transurethral enucleation of prostate (TUEP) in patient with BPH with lower urinary tract symptoms	at least 6 months up to one year	To determine number of patients in each group that will be Catheter and lower urinary tract symptoms free with changes in IPPS \< 20 score after intervention and follow up at 1 month, 3 months and 6 months.

Secondary Outcome Measures

Name	Time	Method
Operative time in minutes in each group of intervention	60 - 90 minutes for each group of intervention	To determine operative time in minutes in each group of intervention
Compare complication rate of TURP versus TUEP	at least 6 months up to one year	To determine the percentage and severity of complications after each intervention (according to the Clavien-Dindo classification).; * Minimum score is class I: No intervention needed; * Maximum score is class V: Death of a patient
Cost effectiveness of TURP versus TUEP in achieving catheter-free rates in BPH patients with urinary retention	at least 6 months up to one year	To determine the cost required to achieve catheter free patients for each intervention (including hospitalization, anesthetic costs, equipment, consumables, etc)
Compare patient reported symptom measures by IPSS questionnaire after TURP versus TUEP	at least 6 months up to one year	sing International prostate symptom score (IPSS) questionnaire to determine patient reported symptom measure after each intervention; minimal score: 0, maximum score is 35 higher score means worse outcome
Compare patient reported symptom measures by Michigan Incontinence Symptom Index (M-ISI) questionnaire after TURP versus TUEP	at least 6 months up to one year	Using the Michigan Incontinence Symptom Index (M-ISI) questionnaire to determine patient reported symptom measure after each intervention; * Minimum score: 1; * Maximum score: 12; * The higher the score means worse outcome
Compare patient reported symptom measures by IIEF-5 questionnaire after TURP versus TUEP	at least 6 months up to one year	Using the International index of erectile function- 5 items (IIEF-5) questionnaire to determine patient reported symptom measure after each intervention; minimum score: 1, maximum score: 25 higher score means better outcome
Compare patient reported quality of life by SF-12 questionnaire after TURP versus TUEP	at least 6 months up to one year	sing the Short Form 12 (SF-12) questionnaire to determine patient reported quality of life measures after each intervention; minimum score: 0, maximum score: 100 higher score means better outcome

Trial Locations

Locations (1)

Faculty of Medicine South Valley University; 🇪🇬 Qinā, Qena, Egypt