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临床试验/NCT06983444
NCT06983444招募中不适用

Bipolar Trans Urethral Resection of the Prostate (TURP) Versus Bipolar Enucleation of the Prostate in Treatment of Benign Prostatic Hyperplasia (BPH): A Prospective Randomized Comparative Clinical Study

South Valley University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Catheter and lower urinary tract symptoms free after Bipolar Transurethral resection of prostate (TURP) versus Bipolar Transurethral enucleation of prostate (TUEP) in patient with BPH with lower urinary tract symptoms

研究概览

简要总结

The aim of this study is to evaluate efficacy and safety of transurethral resection of the prostate and bipolar enucleation of the prostate.

详细描述

Endoscopic management of benign prostatic hyperplasia (BPH), monopolar transurethral resection of the prostate (TURP) has been the gold standard for many years.

Despite its promising efficacy in treating BPH, TURP is associated with a risk of significant complications and clinical limitations, including life-threatening events such as transurethral resection (TUR) syndrome, as well as high cost due to long hospital stay, long catheterization time and difficulty in management of large sized prostate so alternative surgical approaches have been explored.

Minimally invasive approaches achieve equal efficiency to standard resection, but with a more favorable safety and less complications.

Anatomical enucleation of the prostate using Bipolar or Laser-based approaches such as holmium laser have been introduced with success and the efficacy and safety of these procedure has led to the integration into several international guidelines.

Early results of bipolar enucleation resemble those reported for holmium laser procedure, Bipolar transurethral enucleation of the prostate was at least equally effective, and showed less complications, good hemostatic control and both shorter catheterization time and hospital stay than old standard procedure.

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 (Participant)

入排标准

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

入选标准

  • •Patients with lower urinary tract symptoms (LUTS) due to BPH.
  • •Patients with international prostate score system (IPSS) more than
  • •Patients with maximal urinary flow rate (Qmax) less than 10ml/second.
  • •Patients with Prostatic volume (60 - 100 gm).
  • •Patient with indication for surgical intervention.
  • •Patient age (50-80 years old)

排除标准

  • •Prostatic cancer.
  • •Bladder cancer.
  • •Urethral stricture.
  • •Neurogenic bladder.

研究组 & 干预措施

Transurethral resection of prostate

Active Comparator

Transurethral resection of prostate (TURP) will be performed under spinal or general anesthesia as per usual care.

干预措施: TURP (Procedure)

Transuretheral enucleation of prostate

Active Comparator

Transurethral enucleation of prostate (TUEP) will be performed under spinal or general anesthesia as per usual care.

干预措施: TUEP (Procedure)

结局指标

主要结局

Catheter and lower urinary tract symptoms free after Bipolar Transurethral resection of prostate (TURP) versus Bipolar Transurethral enucleation of prostate (TUEP) in patient with BPH with lower urinary tract symptoms

时间窗: at least 6 months up to one year

To determine number of patients in each group that will be Catheter and lower urinary tract symptoms free with changes in IPPS \< 20 score after intervention and follow up at 1 month, 3 months and 6 months.

次要结局

  • Operative time in minutes in each group of intervention(60 - 90 minutes for each group of intervention)
  • Compare complication rate of TURP versus TUEP(at least 6 months up to one year)
  • Cost effectiveness of TURP versus TUEP in achieving catheter-free rates in BPH patients with urinary retention(at least 6 months up to one year)
  • Compare patient reported symptom measures by IPSS questionnaire after TURP versus TUEP(at least 6 months up to one year)
  • Compare patient reported symptom measures by Michigan Incontinence Symptom Index (M-ISI) questionnaire after TURP versus TUEP(at least 6 months up to one year)
  • Compare patient reported symptom measures by IIEF-5 questionnaire after TURP versus TUEP(at least 6 months up to one year)
  • Compare patient reported quality of life by SF-12 questionnaire after TURP versus TUEP(at least 6 months up to one year)

研究者

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

Ahmed Abdelfattah Hamed Abdelraheem

Assistant Lecturer

South Valley University

研究点 (1)

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