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临床试验/NCT05199727
NCT05199727Unknown不适用

Comparison of the Efficacy and Safety of Low Intensity Extracorporeal Shock Wave Therapy Versus On-demand Tadalafil for Erectile Dysfunction

Menoufia University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Erectile function assessed by International Index of Erectile Function-5

研究概览

简要总结

The objective of this study is to evaluate the effectiveness and safety of focused Li-ESWT on 25 participants complaining of ED compared to 25 participants complaining of ED on medical treatment on a prospective clinical trial for 12 weeks.

详细描述

Penile erection is a very complex process which requires a delicate and coordinated equilibrium among the neurological, vascular and the tissue compartments. It also includes arterial dilation, trabecular smooth muscle relaxation, and activation of the corporeal veno occlusive mechanism.Erectile dysfunction is defined as persistent inability to achieve or maintain the erection that is sufficient to permit satisfactory sexual intercours. It has a multifactorial pathogenesis, one of them is vasculogenic ED that occurs due to diseases such as diabetes mellitus, hypertension, hyperlipidemia, smoking, or vascular occlusive disease.

ED is also the most commonly treated sexual disorder and it affects approximately 20% of adult males over the age of 20. Nowadays, there are several treatment solutions for patients with ED, either non-invasive or invasive but the phosphodiesterase 5 inhibitors are still the first-line therapy for ED.

However, PDE5-Is effect is limited due to their inability to improve penile blood flow for a time period that is sufficient to allow optimal oxygenation and recovery of Cavernosal vasculature. Also, they cannot improve spontaneous erections. Moreover, several patients ranging from 40% to 50% will not respond to drug therapy even after optimization approaches such as treatment combinations have been implemented.

Also, it was proven that the effect of long-term daily use of PDE5-Is on endothelial function has induced a short-term improvement in erectile function but probably not a longstanding one.

Another option for ED patients is the use of intracavernosal injections which is considered the second line of treatment. Although PDE5-Is and intracavernosal injections are effective and safe vasodilating agents, they are unable to alter the underlying predominant pathology in patients with vasculogenic ED (eg, cavernosal artery insufficiency).

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
25 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Male patients
  • ED at least for 6 months
  • vasculogenic ED
  • from 25-60 years old

排除标准

  • psychological patents
  • neurological patients
  • younger than 25 years old
  • older than 60 years old

研究组 & 干预措施

Shockwave group

Experimental

This group will receive 6 sessions (2 per week) with average 6,000 shocks per session with the PiezoWave2 unit

干预措施: LI-ESWT (Device)

Medical Treatment Group

Active Comparator

This group will receive self-administered Tadalafil on-demand

干预措施: Tadalafil 20Mg Oral Tablet (Drug)

结局指标

主要结局

Erectile function assessed by International Index of Erectile Function-5

时间窗: 3 months

We will asessess erectile function using International Index of Erectile Function-5 (IIEF-5) where scores ≤6, severe; 8-16, moderate; 17-21, mild; and 22-25, none.

次要结局

  • Erection hardness score(3 months)

研究者

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

Hosam Kotb

Principal investigator

Menoufia University

研究点 (1)

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