Clinical trial NCT06939062: B-TURP vs BipolEP in Management of BPH Patients With Medium-sized Prostates
Official title: Efficacy and Safety of Bipolar Resection Versus Enucleation of the Prostate in Management of Benign Prostatic Hyperplasia Patients With Medium-sized Prostates: A Prospective Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign Prostatic Hyperplasia (BPH)
Bipolar enucleation of the prostate (BipolEP)
Bipolar Transurethral reaction of the prostate (B-TURP)
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 44
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in international prostate symptom score (IPSS)
timeFrame: At 6 months after the procedure (BipolEP or B-TURP)
Secondary outcomes:
measure: Complications
timeFrame: At 6 months after the procedure (BipolEP or B-TURP)
Other outcomes:
Locations:
Study officials:
References:
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