IT Matters: The Erectile Restoration Registry
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 450
- 试验地点
- 38
- 主要终点
- Change from baseline to six months in the Erectile Function domain ofthe International Index of Erectile Function (IIEF-EF) questionnaire for Tactra
研究概览
简要总结
The objective of the It MATTERS registry is to collect Real-World Data (RWD) to monitor the safe and effective use of commercially available Boston Scientific Corporation (BSC) penile prostheses
详细描述
IT MATTERS is a prospective, multicenter, observational registry that is part of planned, active post market clinical follow-up (PMCF) activity associated with each device.
The study will include adult males who undergo penile prothesis implantation with a market approved BSC device to treat erectile dysfunction.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •≥ 18 years of age.
- •Males who are determined to be suitable candidates and scheduled to undergo surgical implantation of a market approved BSC penile prothesis by their physician.
- •Willing and able to complete the informed consent process.
- •Willing and able to comply with the follow-up requirements.
排除标准
- •Males who are deemed by their physician as not suitable candidates for a penile prosthesis.
- •In the opinion of the investigator, it is not in best interest of the patient or the study for the patient to participate.
研究组 & 干预措施
BSC Penile Prothesis Recipients
Men for whom BSC Penile Prothesis is recommended.
干预措施: AMS Ambicor™ Inflatable Penile Prosthesis (Device)
BSC Penile Prothesis Recipients
Men for whom BSC Penile Prothesis is recommended.
干预措施: AMS 700™ Inflatable Penile Prosthesis w/Tenacio™ Pump (Device)
BSC Penile Prothesis Recipients
Men for whom BSC Penile Prothesis is recommended.
干预措施: Tactra Malleable (Device)
BSC Penile Prothesis Recipients
Men for whom BSC Penile Prothesis is recommended.
干预措施: Spectra™ Concealable Penile Prothesis (Device)
BSC Penile Prothesis Recipients
Men for whom BSC Penile Prothesis is recommended.
干预措施: AMS 700™ Inflatable Penile Prosthesis w/Momentary Squeeze (MS) Pump (Device)
结局指标
主要结局
Change from baseline to six months in the Erectile Function domain ofthe International Index of Erectile Function (IIEF-EF) questionnaire for Tactra
时间窗: Baseline to 6 months
The International Index of Erectile Function (IIEF) is a validated, widely used, multidimensional self-report instrument for the evaluation of erectile function. It consists of 15 items that assess sexual function in five domains: erectile function (Q1, 2, 3, 4, 5,15), orgasmic function (Q9,10), sexual desire (Q11,12), intercourse satisfaction (Q 6,7,8) and overall satisfaction (Q 13,14). A score of 0-5 is awarded to each of the 15 questions. The IIEF-15 total score is the sum of the ordinal responses to the 5 domains. The erectile function (EF) domain is the most sensitive domain of the IIEF. IIEF-EF score ranges from 1 to 30 and is derived by scoring 0 (poorest function) to 5 (best function) on each of six questions function (Q1, 2, 3, 4, 5, 15). There are five categories of erectile function based on EF domain score: severe (1-10), moderate (11-16), mild to moderate (17-21), mild (22-25) and no ED (26-30).
次要结局
- Change in erectile function at post-surgery, 12 months and annually post device implantation compared to baseline, as measured by the International Index of Erectile Function Domain (IIEF).(Post-Surgery, 12 months and annually thereafter through study completion, an average of 10 years)
- Change in depressive symptoms and overall sexual function at Post-Surgery, 6 months, 12 months and annually thereafter post device implantation compared to baseline, as measured by the PHQ-9 Depression Questionnaire and the IIEF: Total Score.(Post-Surgery, 6 months, 12 months and annually thereafter through study completion, an average of 10 years)
- Change in quality of life at 6 months, 12 months, and 24 months post device implantation compared to baseline as measured by the WPAI:GH Questionnaire.(6 months, 12 months and 24 months)
- Change in depressive symptoms and overall sexual function at Post-Surgery, 6 months, and 12 months post device implantation compared to baseline, as measured by the PHQ-9 Depression Questionnaire and the IIEF: Total Score.(Post-Surgery, 6 months, and 12 months)
- Change in quality of life at 6 months, and 12 months post device implantation compared to baseline as measured by the WPAI:GH Questionnaire.(6 months, and 12 months)
- Change in erectile function at post-surgery, and 12 months post device implantation compared to baseline, as measured by the International Index of Erectile Function Domain (IIEF).(Post-Surgery, and 12 months)