跳至主要内容
临床试验/NCT06759194
NCT06759194招募中不适用

Holmium Laser Versus Bipolar Enucleation of the Prostate in Management of Benign Prostatic Hyperplasia Patients With Large Prostates: A Non-inferiority Prospective Randomized Clinical Trial

Assiut University1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2025年1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
98
试验地点
1
主要终点
Change in peak flow rate

研究概览

简要总结

This is a non-inferiority prospective randomized comparative clinical trial aiming to prove the non-inferiority of bipolar enucleation of the prostate in comparison to holmium laser enucleation of the prostate in management of benign prostatic hyperplasia patients with large prostates and in turn its feasibility as an alternative procedure in hospitals with limited resources

详细描述

Benign prostatic hyperplasia (BPH) is a prevalent condition among older men. It is characterized by non-cancerous enlargement of the prostate gland often leading to urinary obstruction and significant morbidity. In case of failure of medical treatment, surgical intervention is often required especially in patients with larger prostates. Surgical options in such cases include Holmium Laser Enucleation of the Prostate (HoLEP) and Bipolar Enucleation of the Prostate (BipolEP). These modalities have emerged as promising relatively minimally invasive treatment options in patients with large prostates. HoLEP, utilizing laser technology to enucleate prostatic tissue, has been associated with reduced intraoperative blood loss, shorter catheterization time, and quicker recovery in comparison to open prostatectomy. Likewise, BipolEP, utilizing bipolar energy for enucleation, offers the advantage of reduced bleeding and shorter operative time. Both HoLEP and BipolEP have demonstrated efficacy in improving lower urinary tract symptoms (LUTS) and alleviating obstruction in BPH patients with large prostates, but the comparative efficacy and safety of both techniques remains highly debated. This study aims to compare the efficacy and safety of these two surgical modalities aiming to provide valuable insights that can enhance clinical decision-making and patient care in BPH management.

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
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •Age >50 years
  • •Prostate volume >80 ml
  • •Failure of or noncompliance with medical treatment
  • •IPSS >15
  • •Qmax <15 ml/sec
  • •Urinary retention and fixed catheters with poor results on trial of voiding without catheter

排除标准

  • •Patients with active UTI
  • •Prostate cancer
  • •Bladder carcinoma
  • •Urethral stricture
  • •Neurogenic bladder disorders
  • •Redo cases

研究组 & 干预措施

Holmium Laser Enucleation of the Prostate (HoLEP)

Active Comparator

Half of the BPH patients with large prostate admitted to the study will undergo Holmium Laser Enucleation of the Prostate (HoLEP)

干预措施: Holmium Laser Enucleation of the Prostate (Procedure)

Bipolar Enucleation of the Prostate (BipolEP)

Active Comparator

Half of the BPH patients with large prostate admitted to the study will undergo Bipolar Enucleation of the Prostate (BipolEP)

干预措施: Bipolar Enucleation of the Prostate (Procedure)

结局指标

主要结局

Change in peak flow rate

时间窗: At 6 months after the procedure (HoLEP or BipolEP)

Treatment efficacy will be evaluated by comparing the change in peak flow rate (Qmax) on uroflowmetry between the two groups

次要结局

  • Complications(At 6 months after the procedure (HoLEP or BipolEP))

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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