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临床试验/NCT07566689
NCT07566689已完成不适用

A Comparative Study of the Effect of Holmium Laser Enucleation of the Prostate Versus Water Vapor Therapy of the Prostate on Sexual Function and Ejaculation

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年4月3日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1

研究概览

简要总结

This study aims to compare the effect of holmium laser enucleation of the prostate (HoLEP) versus water vapor therapy (Rezum) on sexual function and ejaculation in patients with benign prostatic hyperplasia (BPH).

Benign prostatic hyperplasia is a common condition affecting aging men and may lead to lower urinary tract symptoms requiring surgical intervention. While both HoLEP and Rezum are effective minimally invasive treatments, their impact on sexual function, particularly ejaculation, remains an important concern.

Participants will be assigned to undergo either HoLEP or Rezum therapy. Sexual function and ejaculatory outcomes will be evaluated using validated questionnaires before and after treatment. The study aims to determine which modality provides better preservation of sexual function while maintaining clinical efficacy.

详细描述

Benign prostatic hyperplasia (BPH) is a prevalent condition in aging males and is commonly associated with lower urinary tract symptoms (LUTS) that significantly affect quality of life. Surgical intervention is indicated in patients who fail medical therapy or present with complications.

Holmium laser enucleation of the prostate (HoLEP) is considered a gold standard surgical treatment for BPH, offering durable outcomes and effective removal of prostatic adenoma. However, it is frequently associated with postoperative retrograde ejaculation.

Water vapor thermal therapy (Rezum) is a minimally invasive treatment that uses convective water vapor energy to ablate prostatic tissue, with the potential advantage of preserving sexual and ejaculatory function.

This prospective comparative study aims to evaluate and compare the effects of HoLEP and Rezum on sexual function and ejaculatory outcomes. Eligible patients with BPH will be allocated to one of the two treatment groups according to the study protocol.

Primary outcomes include changes in sexual function and ejaculatory status assessed using validated questionnaires. Secondary outcomes include improvement in urinary symptoms and treatment-related complications.

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
None

入排标准

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

入选标准

  • Male patients aged 50 years or older
  • Diagnosed with benign prostatic hyperplasia (BPH)
  • Presence of lower urinary tract symptoms (LUTS)
  • International Prostate Symptom Score (IPSS) ≥ 13
  • Peak urinary flow rate (Qmax) ≤ 15 mL/s
  • Failure of medical therapy for BPH
  • Sexually active and in a stable relationship

排除标准

  • History of prostate cancer
  • Prior prostate surgery
  • Neurogenic bladder dysfunction
  • Urethral stricture disease
  • Active urinary tract infection
  • Severe comorbidities contraindicating surgery

研究者

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

Mahmoud Abdallah

lecturer of urology

Beni-Suef University

研究点 (1)

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