Bipolar TURP Versus Bipolar Enucleation for BPH Management

January 2, 2025 updated by: Samer Morsy, Kasr El Aini Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bipolar enucleation
Procedure: Prostate surgery
Prostate removal
Active Comparator: Bipolar resection
Procedure: Prostate surgery
Prostate removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
International Prostate Symptom Score (IPSS)
Time Frame: 12 months
12 months
Qmax
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Complications
Time Frame: 12 months
12 months
PVR
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 15, 2025

Primary Completion (Estimated)

December 15, 2027

Study Completion (Estimated)

March 15, 2028

Study Registration Dates

First Submitted

December 27, 2024

First Submitted That Met QC Criteria

January 2, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 2, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kasr Alainy- Cairo University

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Benign Prostatic Hyperplasia

Clinical Trials on Prostate surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe