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临床试验/NCT04864301
NCT04864301Unknown不适用

Tumescent Stretching Measurment Technique: A New Technique for Intraoperartive Measurement of Inflatable Penile Implant Size

Cairo University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
24
试验地点
1
主要终点
Number of penile implant insertions and re-insertions needed to arrive to adequate penile implant size

研究概览

简要总结

Introducing and evaluating the accuracy of a novel method for estimating inflatable penile prosthesis cylinders length by stretching the tumesncent penis intraoperatively instead of taking proximla and distal measurement to the corporotomy

详细描述

Objectives:

Introducing and evaluating the accuracy of a novel method for estimating inflatable penile prosthesis cylinders length.

Methods:

24 patients undergoing a Coloplast Titan ® Touch implantation procedure will berandomly divided into two groups.

The "Tumescent Stretching Measurement Technique" (TSMT) group (N=12) will be administered an intracorporal injection (ICI) of 20 microgram Alprostadil. Hegar 7 dilator will be introduced through the corporotomy until reaching a bone stopping point. The tumescent penis will be stretched maximally, and the proximally inserted dilator measured externally to the coronal sulcus.

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
21 Years 至 79 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Males needing Penile implant surgery, not responding to oral pharmacological drugs for ttt of ED -

排除标准

  • Previouys penile surgery Previous implanted penile prosthesis

结局指标

主要结局

Number of penile implant insertions and re-insertions needed to arrive to adequate penile implant size

时间窗: Intraoperative

Number of penile implant insertions and re-insertions needed to arrive to adequate penile implant size

次要结局

未报告次要终点

研究者

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

Adham ZAAZAA

Associate Professor

Cairo University

研究点 (1)

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