B-TURP vs BipolEP in Management of BPH Patients With Medium-sized Prostates

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

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2025-07-01

Brief Summary

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This is a comparative study of the efficacy and safety of endoscopic bipolar transurethral resection and enucleation of the prostate in management of benign prostatic hyperplasia patients with medium-sized prostates

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Detailed Description

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Benign prostatic hyperplasia (BPH) is a highly prevalent condition among aging males, with incidence rates escalating progressively with age. Epidemiological data indicate that approximately 8% of men in their fourth decade are affected, a proportion that rises to 50% by the sixth decade and exceeds 80% in individuals reaching their ninth decade. BPH may induce bladder outlet obstruction (BOO), leading to lower urinary tract symptoms (LUTS). LUTS are one of the most frequent urological complaints in aging males. LUTS are typically categorized into obstructive and storage subtypes, with clinical BPH representing the predominant underlying etiology.

Approximately 20% of men with BPH will eventually require surgical intervention. Transurethral resection of the prostate (TURP) remains the gold-standard surgical treatment, offering both immediate relief of intravesical obstruction and durable improvement in voiding parameters and symptoms. However, the procedure carries significant risks, including perioperative bleeding and transurethral resection syndrome (TUR syndrome), with complication rates increasing proportionally to prostate size.

The recent technological advancements in urological equipment have led to increased adoption of bipolar transurethral resection of the prostate (B-TURP) for BPH management. This technique employs a plasma kinetic system that provides superior coagulation capabilities. A significant advantage of B-TURP is its use of normal saline irrigation, which substantially reduces the risk of TUR syndrome compared to conventional methods. Clinical studies have demonstrated B-TURP's efficacy in relieving bladder outlet obstruction secondary to BPH, with outcomes comparable to traditional approaches.

Despite advancements in TURP technology, incidence of complications such as postoperative recurrence remained unchanged, necessitating surgical innovation. In this context, bipolar enucleation of the prostate (BipoLEP) has emerged as an alternative technique designed to address these challenges. Our study was designed to conduct a comparative analysis of BipoLEP versus bipolar B-TURP in the treatment of medium-sized BPH patients.

Conditions

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Benign Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Bipolar enucleation of the prostate (BipolEP) patients

Benign prostatic hyperplasia patients with medium -sized prostates who will undergo Bipolar enucleation of the prostate (BipolEP)

Group Type ACTIVE_COMPARATOR

Bipolar enucleation of the prostate (BipolEP)

Intervention Type PROCEDURE

Endoscopic transurethral enucleation of the prostate using bipolar energy

Bipolar transurethral resection of the prostate (B-TURP) patients

Benign prostatic hyperplasia patients with medium -sized prostates who will undergo Bipolar transurethral resection of the prostate (B-TURP)

Group Type ACTIVE_COMPARATOR

Bipolar transurethral resection of the prostate (B-TURP)

Intervention Type PROCEDURE

Endoscopic transurethral resection of the prostate using bipolar energy

Interventions

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Bipolar enucleation of the prostate (BipolEP)

Endoscopic transurethral enucleation of the prostate using bipolar energy

Intervention Type PROCEDURE

Bipolar transurethral resection of the prostate (B-TURP)

Endoscopic transurethral resection of the prostate using bipolar energy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Male patients aged 45-80 years with symptomatic BPH (IPSS ≥8).
* Prostate volume between 40-80 cc as determined by transrectal ultrasound (TRUS).
* Failure of medical management.
* Written informed consent.

Exclusion Criteria

* Prostate cancer (suspected on PSA/DRE or confirmed by biopsy).
* Previous prostate/urethral surgery.
* Neurogenic bladder or urethral strictures.
* 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