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临床试验/NCT05531877
NCT05531877Unknown不适用

Penile Implant Intraoperative Measurements Planning Chart

Cairo University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
2
主要终点
No oversizing

研究概览

简要总结

This is a chart of penile size measurements where penile length and width are recorded intra-operatively prior to penile prosthesis implantation to guide the surgeon to the correct and adequate post-operative penile size

详细描述

The chart records preoperative penile dimensions as penile length and circumference both relaxed and stretched, both in a de-tumescent and erect state, before after intra-operative injection of 1cc Prostaglandin E1 respectively, to enhance pharmacological tumescence.

The implantation of the penile implant will resume with the cavernosal sparing technique.

After the penile prosthesis has been implanted, penile length and girth will be measured and the penile implant dimensions will be recorded in the chart.

The PIMP chart will assist the surgeon in assuring he sized the penis most adequately with the implant by taking the penile dimensions ( Length and Circumference). To assure that the penis was not oversized with the implant, the post-operative penile length should not exceed the pre-operative penile tumescent stretched length.

To assure that the penis was not undersized, the postoperative penile length should not be less than the pre-operative tumescent non-stretched penile length..

研究设计

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

入排标准

年龄范围
21 Years 至 99 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Erectile dysfunction not responding to medical treatment

排除标准

  • Patients refusing penile prosthesis implantation as a treatment modality for their erectile dysfunction

结局指标

主要结局

No oversizing

时间窗: Intraoperative

Post-operative Penile Length did not exceed pre-operative pharmacologically induced erect stretched length

No undersizing

时间窗: Intraoperative

Post-operative penile length not less than pre-operative pharmacologically induced erect non-stretched penile length

次要结局

  • Adequate Girth(Intraoperative)

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 (2)

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