Bipolar TURP Versus Bipolar Enucleation for BPH Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prostate surgery.
- Who it may be relevant to
- Registry conditions: Benign Prostatic Hyperplasia. Basic parameters: 45 years — 80 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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
Interventions
- Procedure Prostate surgery
Prostate removal
Primary outcome measures
- International Prostate Symptom Score (IPSS) [Time frame: 12 months]
- Qmax [Time frame: 12 months]
Secondary outcome measures (2)
- PVR [Time frame: 12 months]
- Complications [Time frame: 12 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06758466 · Kasr Alainy- Cairo University