Tumescent Stretching Measurment Technique: A New Technique for Intraoperartive Measurement of Inflatable Penile Implant Size
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
- 是
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
研究组 & 干预措施
Tumescent Stretching Measurement Technique
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 stretched maximally, and the proximally inserted dilator measured externally to the coronal sulcus.
干预措施: Tumescent Stretching Measurement Technique (Procedure)
Conventional Measurement technique
The control group (N=12) will receive no intraoperative ICI. Following maximal corporal dilatation, cylinder length will be estimated conventionally by adding up the internally measured distal and proximal corpora to the length of the corporotomy.
干预措施: Tumescent Stretching Measurement Technique (Procedure)
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
Adham ZAAZAA
Associate Professor
Cairo University