NCT06758466

Bipolar TURP Versus Bipolar Enucleation for BPH Management

A Prospective Randomized Controlled Trial Comparing Bipolar TURP and Bipolar Enucleation of the Prostate for Benign Prostatic Hyperplasia (BPH) With Prostate Volumes Between 30-80 Grams

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Kasr El Aini Hospital · Academic / Other
• Sex: Male
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To compare the surgical outcomes at 12 months post-surgery between Bipolar TURP and BipoLEP in men with BPH and prostate volumes between 30-80 grams.

Detailed description

Create a research protocol in a prospective study to compare bipolar transurethral resection of prostate vs bipolar enucleation of prostate between 30 and 80 gm in management of BPH Okay, here's a detailed research protocol for a prospective study comparing Bipolar Transurethral Resection of the Prostate (TURP) and Bipolar Enucleation of the Prostate (BipoLEP) for BPH, specifically focusing on prostates between 30-80 grams: Study Title: A Prospective Randomized Controlled Trial Comparing Bipolar TURP and Bipolar Enucleation of the Prostate for Benign Prostatic Hyperplasia (BPH) with Prostate Volumes between 30-80 grams 1\. Introduction Background: Briefly introduce Benign Prostatic Hyperplasia (BPH), its prevalence, and the associated lower urinary tract symptoms (LUTS). Highlight the common surgical interventions: TURP and, more recently, enucleation techniques. Problem Statement: State that while both bipolar TURP and BipoLEP are established treatments, there's a need for a direct comparison, especially for moderate-sized prostates (30-80g). There's an ongoing debate regarding which approach offers superior outcomes and a better balance of efficacy and safety. Rationale: Explain why this study is necessary. This can be because there is limited direct Primary Objective: To compare the International Prostate Symptom Score (IPSS) at 12 months post-surgery between Bipolar TURP and BipoLEP in men with BPH and prostate volumes between 30-80 grams. Secondary Objectives: To compare perioperative outcomes including: Operative time (minutes) Catheterization time (days) Length of hospital stay (days) Blood loss (change in hemoglobin) Requirement of blood transfusion Incidence of perioperative complications (e.g., TUR syndrome, bleeding, infection, clot retention) To compare postoperative functional outcomes including: Peak urinary flow rate (Qmax) at 3, 6, and 12 months Post-void residual (PVR) volume at 3, 6, and 12 months Quality of life (QoL) using a validated questionnaire at 3, 6, and 12 months To compare the incidence of postoperative complications including: Urinary tract infection (UTI) Urinary incontinence (UI) Urethral stricture Bladder neck contracture Need for re-operation within 12 months. To compare overall patient satisfaction using a visual analog scale (VAS) at 3, 6, and 12 months

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
PROCEDURE	Prostate surgery	Prostate removal

Timeline

• Start date: 2025-01-15
• Primary completion: 2027-12-15
• Completion: 2028-03-15
• First posted: 2025-01-03
• Last updated: 2025-01-03