Bipolar TURP Versus Bipolar Enucleation for BPH Management

NCT ID: NCT06758466

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-15
• Study Completion Date: 2028-03-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bipolar enucleation

Group Type: ACTIVE_COMPARATOR

Prostate surgery

Intervention Type: PROCEDURE

Prostate removal

Bipolar resection

Group Type: ACTIVE_COMPARATOR

Prostate surgery

Intervention Type: PROCEDURE

Prostate removal

Interventions

Prostate surgery

Prostate removal

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Male patients aged 45-80 years diagnosed with symptomatic BPH.
• Prostate volume between 30-80 grams as determined by transrectal ultrasound (TRUS) performed within 4 weeks before randomization.
• Moderate to severe LUTS with an IPSS of ≥ 8.
• Failure of medical management.
• Patients able to provide written informed consent.

Exclusion Criteria

• History of prostate cancer.
• History of previous prostate surgery (including any procedure for BPH or prostate cancer).
• History of urethral stricture or bladder neck contracture.
• Neurogenic bladder dysfunction.
• Significant coagulopathy.
• Uncontrolled urinary tract infection.
• Patient on anticoagulant medication.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Samer Morsy

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Kasr Alainy- Cairo University

Identifier Type: -

Identifier Source: org_study_id