NCT00731666已完成不适用
Prospective, Non-randomized, Multi-center Clinical Trial to Assess the Effectiveness of the Coloplast Titan® IPP at Maintaining or Increasing Penile Length After Implantation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- The Study's Primary Objective Will Assess the Change in Penile Length.
研究概览
简要总结
This study is designed to assess the effectiveness of the Coloplast Titan® Inflatable Penile Prosthesis (IPP) at maintaining or increasing penile length after implantation of the device. It will incorporate a modified method of cylinder sizing during implantation and a max-inflate technique after implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Has an estimated life expectancy of more than 5 years
- •Has been diagnosed with erectile dysfunction
- •Is willing to have the Titan IPP implanted
- •Is able and willing to complete all follow-up visits and procedures indicated in this protocol
- •Has been informed of the nature of the study and agrees to its provisions and - Has provided written informed consent as approved by the Institutional Review board of the respective site
排除标准
- •Participant has had a previous penile prosthesis or prior penile enlargement surgeries
- •Participant has a compromised immune system
- •Participant has had a myocardial infarction or coronary artery stent placement within 2 months prior to treatment
- •Participant does not have manual dexterity or mental ability to operate the pump
- •Participant has an active urogenital infection or active skin infection in region of surgery
- •Participant is diagnosed with fibrotic disease, such as priapism or Peyronie's disease
- •Participant is diagnosed with Chordee
- •Participant has neuropathy
- •Participant has a serious bleeding disorder or coagulopathy
结局指标
主要结局
The Study's Primary Objective Will Assess the Change in Penile Length.
时间窗: 12 months
次要结局
- Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire.(12 and 24 months)
- The Rate of Change in Male Stress Urinary Incontinence(SUI).(12 months)
研究者
研究点 (6)
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