跳至主要内容
临床试验/NCT01378559
NCT01378559已完成不适用

Patient Satisfaction and Complications With the New Titan® One Touch Release (OTR) Penis Prosthesis

Copenhagen University Hospital at Herlev1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
26
试验地点
1
主要终点
Patient satisfaction assessed by EDITS question 1

研究概览

简要总结

The purpose of this study is to assess patient satisfaction with the Titan one touch release penis prosthesis and to register complications with this prosthesis. This will regard the first prostheses inserted at Herlev Hospital/Frederikssund Hospital.

Patient satisfaction will be assessed by mailing out the "Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire" and recording the patient answers. The most important question will be "Overall how satisfied are you with penile prosthesis?".

Complications (including infection, bleeding, and mechanical failure) will be assessed by a patient chart review and confirmed by a brief phone interview.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • Men who have had a Titan one touch release penis prosthesis implanted at Herlev Hospital.

排除标准

  • Inability to read Danish

结局指标

主要结局

Patient satisfaction assessed by EDITS question 1

时间窗: Satisfaction will be assessed when questionnaires are returned - expected avarage 2 months

Patient satisfaction assesed by the "Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire", Question 1: 1. Overall how satisfied are you with penile prosthesis? Very satisfied Somewhat satisfied Neither satisfied or dissatisfied Somewhat dissatisfied Very dissatisfied

次要结局

  • Complications(At the beginning of study when the chart review is conducted)
  • Patient satisfaction assessed by EDITS questions 2-13(Satisfaction will be assessed when questionnaires are returned - expected avarage 2 months)

研究者

发起方
Copenhagen University Hospital at Herlev
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Patient Satisfaction and Complications With the New... | 临床试验