Bipolar Resection vs Enucleation of Prostate

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-07-31

Brief Summary

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The aim of this study is to evaluate efficacy and safety of transurethral resection of the prostate and bipolar enucleation of the prostate.

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Detailed Description

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Endoscopic management of benign prostatic hyperplasia (BPH), monopolar transurethral resection of the prostate (TURP) has been the gold standard for many years.

Despite its promising efficacy in treating BPH, TURP is associated with a risk of significant complications and clinical limitations, including life-threatening events such as transurethral resection (TUR) syndrome, as well as high cost due to long hospital stay, long catheterization time and difficulty in management of large sized prostate so alternative surgical approaches have been explored.

Minimally invasive approaches achieve equal efficiency to standard resection, but with a more favorable safety and less complications.

Anatomical enucleation of the prostate using Bipolar or Laser-based approaches such as holmium laser have been introduced with success and the efficacy and safety of these procedure has led to the integration into several international guidelines.

Early results of bipolar enucleation resemble those reported for holmium laser procedure, Bipolar transurethral enucleation of the prostate was at least equally effective, and showed less complications, good hemostatic control and both shorter catheterization time and hospital stay than old standard procedure.

A comparison between TURP and Bipolar enucleation of prostate allows us to investigate the true benefits and safety of each modality.

Conditions

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Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection Benign Prostatic Hyperplasia With Outflow Obstruction Benign Prostatic Hyperplasia With Symptomatic Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A comparison between TURP and Bipolar enucleation of prostate allows us to investigate the true benefits and safety of each modality.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Transurethral resection of prostate

Transurethral resection of prostate (TURP) will be performed under spinal or general anesthesia as per usual care.

Group Type ACTIVE_COMPARATOR

TURP

Intervention Type PROCEDURE

Using bipolar loop diathermy via cystoscopy, excess prostate tissue is resected piecemeal to remove obstruction to the prostatic urethra due to BPH.

Transuretheral enucleation of prostate

Transurethral enucleation of prostate (TUEP) will be performed under spinal or general anesthesia as per usual care.

Group Type ACTIVE_COMPARATOR

TUEP

Intervention Type PROCEDURE

Using bipolar enucleation loop diathermy via cystoscopy, to anatomically enucleate prostate.

Interventions

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TURP

Using bipolar loop diathermy via cystoscopy, excess prostate tissue is resected piecemeal to remove obstruction to the prostatic urethra due to BPH.

Intervention Type PROCEDURE

TUEP

Using bipolar enucleation loop diathermy via cystoscopy, to anatomically enucleate prostate.

Intervention Type PROCEDURE

Other Intervention Names

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Transurethral resection of prostate Bipolar TURP Transurethral enucleation of prostate Bipolar TUEP Anatomical endoscopic enucleation of prostate AEEP

Eligibility Criteria

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Inclusion Criteria

1. Patients with lower urinary tract symptoms (LUTS) due to BPH.
2. Patients with international prostate score system (IPSS) more than 8.
3. Patients with maximal urinary flow rate (Qmax) less than 10ml/second.
4. Patients with Prostatic volume (60 - 100 gm).
5. Patient with indication for surgical intervention.
6. Patient age (50-80 years old)