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临床试验/NCT06939062
NCT06939062已完成不适用

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

Assiut University1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
63
试验地点
1
主要终点
Change in international prostate symptom score (IPSS)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Change in international prostate symptom score (IPSS)

时间窗: 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

次要结局

  • Complications(At 6 months after the procedure (BipolEP or B-TURP))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mostafa Mohamed Atef Abdelaziz Mostafa

Lecturer of Urology

Assiut University

研究点 (1)

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