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

Not Applicable

Not yet recruiting

• Conditions: Benign Prostatic Hyperplasia

• Registration Number: NCT06939062
• Lead Sponsor: Assiut University

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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-15
• Study First Submitted QC: 2025-04-15
• Last Update Submitted: 2025-04-15
• Study First Posted: 2025-04-22
• Last Update Posted: 2025-04-22
• Study Start: 2025-05-01
• Primary Completion: 2027-05-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in international prostate symptom score (IPSS)	At 6 months after the procedure (BipolEP or B-TURP)	Treatment efficacy will be evaluated by comparing the change in international prostate symptom score (IPSS) between the two groups

Secondary Outcome Measures

Name	Time	Method
Complications	At 6 months after the procedure (BipolEP or B-TURP)	Treatment safety will be evaluated by collecting and analyzing any reported complication within the first 6 postoperative months. Complications will be reported using the modified Clavien-Dindo classification system.