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

Assiut University

Status: Not yet enrolling

Conditions: Benign Prostatic Hyperplasia

Treatments: Procedure: Bipolar transurethral resection of the prostate (B-TURP); Procedure: Bipolar enucleation of the prostate (BipolEP)

Study type: Interventional

Funder types: Other

Identifiers

NCT06939062

B-TURP vs BipolEP

Details and patient eligibility

About

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

Full description

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.

Enrollment: 44 estimated patients

Sex: Male

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Bipolar enucleation of the prostate (BipolEP) patients

Active Comparator group

Description:

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

Treatment:

Procedure: Bipolar enucleation of the prostate (BipolEP)

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

Active Comparator group

Description:

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

Treatment:

Procedure: Bipolar transurethral resection of the prostate (B-TURP)