HoLEP Vs BipolEP in Management of BPH Patients with Large Prostates

Not Applicable

Not yet recruiting

• Conditions: Benign Prostatic Hyperplasia

• Registration Number: NCT06759194
• Lead Sponsor: Assiut University

Brief Summary

This is a non-inferiority prospective randomized comparative clinical trial aiming to prove the non-inferiority of bipolar enucleation of the prostate in comparison to holmium laser enucleation of the prostate in management of benign prostatic hyperplasia patients with large prostates and in turn its feasibility as an alternative procedure in hospitals with limited resources

Detailed Description

Benign prostatic hyperplasia (BPH) is a prevalent condition among older men. It is characterized by non-cancerous enlargement of the prostate gland often leading to urinary obstruction and significant morbidity. In case of failure of medical treatment, surgical intervention is often required especially in patients with larger prostates. Surgical options in such cases include Holmium Laser Enucleation of the Prostate (HoLEP) and Bipolar Enucleation of the Prostate (BipolEP). These modalities have emerged as promising relatively minimally invasive treatment options in patients with large prostates. HoLEP, utilizing laser technology to enucleate prostatic tissue, has been associated with reduced intraoperative blood loss, shorter catheterization time, and quicker recovery in comparison to open prostatectomy. Likewise, BipolEP, utilizing bipolar energy for enucleation, offers the advantage of reduced bleeding and shorter operative time. Both HoLEP and BipolEP have demonstrated efficacy in improving lower urinary tract symptoms (LUTS) and alleviating obstruction in BPH patients with large prostates, but the comparative efficacy and safety of both techniques remains highly debated. This study aims to compare the efficacy and safety of these two surgical modalities aiming to provide valuable insights that can enhance clinical decision-making and patient care in BPH management.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-30
• Study Start: 2025-01
• Study First Submitted QC: 2025-01-03
• Last Update Submitted: 2025-01-03
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06
• Primary Completion: 2026-06
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 98

Inclusion Criteria

• Age >50 years
• Prostate volume >80 ml
• Failure of or noncompliance with medical treatment
• IPSS >15
• Qmax <15 ml/sec
• Urinary retention and fixed catheters with poor results on trial of voiding without catheter

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Exclusion Criteria

• Patients with active UTI
• Prostate cancer
• Bladder carcinoma
• Urethral stricture
• Neurogenic bladder disorders
• Redo cases

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in peak flow rate	At 6 months after the procedure (HoLEP or BipolEP)	Treatment efficacy will be evaluated by comparing the change in peak flow rate (Qmax) on uroflowmetry between the two groups

Secondary Outcome Measures

Name	Time	Method
Complications	At 6 months after the procedure (HoLEP or BipolEP)	Treatment safety will be evaluated by collecting and analyzing any reported complication within the first 6 postoperative months. Complications will be reported using the modified Clavien-Dindo classification system.