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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06758466
Enrollment
180
Registered
2025-01-03
Start date
2025-01-15
Completion date
2028-03-15
Last updated
2025-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia

Keywords

BPH - Bipolar- TURP - Enucleation

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

Interventions

Prostate removal

Sponsors

Kasr El Aini Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
45 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
International Prostate Symptom Score (IPSS)12 months
Qmax12 months

Secondary

MeasureTime frame
PVR12 months
Complications12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026