NCT00731939已完成不适用
Titan® One Touch Release Inflatable Penile Prosthesis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 16
- 主要终点
- Assess the Ease of Deflation of the Titan® OTR Pump
研究概览
简要总结
The purpose of this study is to assess the ease of deflation of the Titan® OTR pump.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Participant has an estimated life expectancy of more than 5 years
- •Participant has been diagnosed with erectile dysfunction (impotence)
- •participant is willing to have the Titan OTR IPP implanted
- •Participant is able and willing to complete all follow-up visits and procedures indicated in the protocol
排除标准
- •Participant is unable or unwilling to sign the Informed Consent Form and /or comply with all follow-up requirements according to the study protocol
- •Participant had a previous penile prosthesis or prior penile enlargement surgeries
- •Participant has a compromised immune system, such as systemic lupus erythematosus, discoid lupus, or scleroderma
- •Participant has had a myocardial infarction or coronary artery stent placement within 2 months prior to treatment
- •Participant currently has uncontrolled or severe diabetes or other disease significantly reducing wound healing ability
- •Participant does not have the manual dexterity or mental ability to operate the pump
- •Participant has chordee or priapism
- •Participant has penile sensory neuropathy
- •Participant has serious bleeding disorder
研究组 & 干预措施
Titan® OTR IPP
Other
Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
干预措施: Inflatable Penile Prosthesis (Device)
结局指标
主要结局
Assess the Ease of Deflation of the Titan® OTR Pump
时间窗: 6 months
The study's primary endpoint was to demonstrate that at least 64% of subjects were mostly or completely satisfied with the ability to deflate the device at the 6-month follow-up. The study's primary objective was to assess the ease of deflation of the Titan® OTR pump via subject questionnaire at 6-month follow-up. Subjects were asked via questionnaire how satisfied they were with ease of deflation of their implant. Success criteria was a response of "satisfactory" or "somewhat satisfactory". Other possible responses were "neither satisfactory nor unsatisfactory", "somewhat unsatisfactory", and "very unsatisfactory".
次要结局
- Evaluate User Acceptance of Titan® OTR - Question 8(12 months post-surgery)
- Evaluate User Acceptance of Titan® OTR - Question 1(12 months post-surgery)
- Evaluate User Acceptance of Titan® OTR - Question 2(12 months post-surgery)
- Evaluate User Acceptance of Titan® OTR - Question 6(12 months post-surgery)
- Assess the Ease of Training for Titan® OTR - Question 6(6 weeks)
- Evaluate User Acceptance of Titan® OTR - Question 3(12 months post-surgery)
- Evaluate User Acceptance of Titan® OTR - Question 7(12 months post-surgery)
- Evaluate User Acceptance of Titan® OTR - Question 10(12 months post-surgery)
- Assess the Ease of Implant of the Titan® OTR Question 1(At implant)
- Assess the Ease of Training for Titan® OTR - Question 7(6 weeks)
- Assess the Ease of Training for Titan® OTR - Question 8(6 weeks)
- Evaluate User Acceptance of Titan® OTR - Question 4(12 months post-surgery)
- Evaluate User Acceptance of Titan® OTR - Question 5(12 months post-surgery)
- Assess the Ease of Implant of the Titan® OTR - Question 3(At implant)
- Assess the Ease of Training for Titan® OTR - Question 1(6 weeks)
- Assess the Ease of Training for Titan® OTR - Question 2(6 weeks)
- Assess the Ease of Training for Titan® OTR - Question 9(6 weeks)
- Assess the Ease of Training for Titan® OTR - Question 3(6 weeks)
- Assess the Ease of Training for Titan® OTR - Question 4(6 weeks)
- Assess the Ease of Training for Titan® OTR - Question 5(6 weeks)
- Assess Partner Satisfaction (Where Applicable)(6 months)
- Evaluate User Acceptance of Titan® OTR - Question 9(12 months post-surgery)
- Assess the Ease of Implant of the Titan® OTR - Question 2(At implant)
研究者
研究点 (16)
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