Preservation of Penile Tumescence by Cavernous Tissue Preservation During Penile Prosthesis Implantation
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Cavernous tissue thickness postoperatively measured by ultrasound
研究概览
简要总结
Spontaneous penile tumescence after penile prosthesis implantation has been previously reported as sporadically occurring during implant surgery. This study aims at systematically preserving residual erectile function, by the preservation of the patients' spontaneous penile tumescence by systematically sparing cavernous tissue during penile prosthesis implantation.
详细描述
Patients undergoing the cavernous tissue sparing penile implant procedure will be injected intraoperatively with 40µg alprostadil, a prostaglandin E1 agonist intracorporal injection (ICI). The procedure will begin as soon as maximal tumescence is attained.
In the cavernous sparing group, corporal dilation will be done solely with a size 8 dilator. The insertion of the dilator will be carefully inserted in what we call the path of least resistance. To determine the path of least resistance, the corporotomy is spread apart by pulling on previously set stay sutures. The path of least resistance is the plane with maximum outflow of blood from the intraoperatively pharmaceutically dilated and blood filled corpora cavernosa. This plane can also be anticipated with a preoperative penile duplex.
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
- 18 Years 至 81 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Erectile dysfunction not amenable to treatment by approved medical therapy
排除标准
- •Erectile dysfunction amenable to treatment by approved medical therapy
研究组 & 干预措施
Cavernous sparing group
干预措施: Cavernous tissue sparing penile prosthesis implantation (Procedure)
Cavernous sparing group
干预措施: Intracavernosal injection of alprostadil (Procedure)
Conventional technique group
干预措施: Conventional penile prosthesis implantation (Procedure)
结局指标
主要结局
Cavernous tissue thickness postoperatively measured by ultrasound
时间窗: 1 month
次要结局
- Presence of spontaneous penile tumescence post operatively(1 month)
研究者
Adham Zaazaa
Assistant Lecturer
Cairo University