临床试验/NCT03466619

NCT03466619招募中不适用

Assessment of Safety and Efficacy of Inflatable Penile Prothesis in Patients With Erectile Dysfunction

Tanta University1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2014年11月1日最近更新: 2018年3月15日

适应症

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方: Tanta University
入组人数: 100
试验地点: 1
主要终点: Number of patients with improved erectile dysfunction

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Erectile dysfunction (ED) is defined as the persistent inability to attain and or maintain an erection sufficient to permit satisfactory sexual performance

详细描述

In the literature, well- designed studies evaluating safety and efficacy of inflatable penile prosthesis (IPP) is lacking. So, this series aimed at investigating this prospectively.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 80 Years（Adult, Older Adult）
性别: Male
接受健康志愿者: 否

入选标准

•Patients complaining of ED with contraindication or failure of medical treatment

排除标准

•Patients lacking manual dexterity or mental abilities necessary to operate the pump
•General contraindications as uncorrectable bleeding tendency

研究组 & 干预措施

inflatable penile prosthesis (IPP)

Experimental

inflatable penile prosthesis (IPP)

干预措施: inflatable penile prosthesis (IPP) (Device)

结局指标

主要结局

Number of patients with improved erectile dysfunction

时间窗: 3 years

The number of patients with improved erectile dysfunction

次要结局

未报告次要终点

研究者

发起方

Tanta University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Sherief Abd-Elsalam

Investigator

Tanta University

研究点 (1)

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