IT 事项：勃起恢复登记处
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
研究概览
地位
条件
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习地点
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Beijing、中国、100034
- Peking University First Hospital
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Shanghai、中国、200080
- Shanghai General Hospital
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Shanghai、中国、200127
- Shanghai Jiaotong University School of Medicine Renji Hospital
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Dhahran、沙特阿拉伯、34465
- Johns Hopkins Aramco Healthcare
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California
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Los Angeles、California、美国、90095
- Ronald Reagan UCLA Medical Center
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Los Angeles、California、美国、90033
- USC Medical Center
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Los Angeles、California、美国、99048
- Tower Urology-Research Facility
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Florida
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Miami、Florida、美国、33136
- University of Miami Hospital
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Tampa、Florida、美国、33606
- USF Health South Tampa Center for Advanced Healthcare
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Illinois
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Chicago、Illinois、美国、60637
- University of Chicago
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Springfield、Illinois、美国、62702
- SIU School of Medicine
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Indiana
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Indianapolis、Indiana、美国、46202
- Indiana University Medical Center
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Louisiana
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Bossier City、Louisiana、美国、71111
- Willis-Knighton Medical Center
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Missouri
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St Louis、Missouri、美国、63110
- Washington University in St. Louis
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North Carolina
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Raleigh、North Carolina、美国、27609
- Duke University Medical Center
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Salisbury、North Carolina、美国、28144
- W.G. Hefner VA Medical Center
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Winston-Salem、North Carolina、美国、27103
- Wake Forest University
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Ohio
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Cleveland、Ohio、美国、44195
- Cleveland Clinic
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Columbus、Ohio、美国、43212
- Ohio State University Wexner Medical Center
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19107
- Thomas Jefferson University Hospital
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Texas
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Houston、Texas、美国、77030
- Baylor College of Medicine
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Houston、Texas、美国、77030
- Houston Methodist Hospital
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Utah
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Salt Lake City、Utah、美国、84132
- University of Utah
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Washington
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Seattle、Washington、美国、98195
- University of Washington Medical Center
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Wisconsin
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Milwaukee、Wisconsin、美国、53226
- Medical College of Wisconsin
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Adult males who meet the indications for surgical correction of erectile dysfunction will be enrolled.
描述
Inclusion Criteria:
- ≥ 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
BSC Penile Prothesis Recipients
Men for whom BSC Penile Prothesis is recommended. |
The Tactra™ Penile Prosthesis is a sterile, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in adult males who are suitable candidates for implantation procedure. The Spectra Penile Prothesis is a sterile, non-pyrogenic, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in men who are determined to be suitable candidates for implantation surgery. The AMS Ambicor inflatable penile prothesis intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence) in adult men who are determined to be suitable candidates for implantation surgery. The AMS 700 Inflatable Penile Prosthesis is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence). The AMS 700 Inflatable Penile Prosthesis is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence). |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from baseline to six months in the Erectile Function domain ofthe International Index of Erectile Function (IIEF-EF) questionnaire for Tactra
大体时间：Baseline to 6 months
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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). |
Baseline to 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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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.
大体时间：Post-Surgery, 6 months, and 12 months
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The Patient Health Questionnaire (PHQ) is a diagnostic tool for mental health disorders used by health care professionals. The PHQ contains: mood anxiety, alcohol, eating, and somatoform modules. The PHQ-9, is a validated tool specific to depression, scoring each of the 9 DSM-IV criteria. Scored from 0-27, the PHQ-9 is separated into five different diagnoses: minimal depression (0-4), mild depression (5-9), moderate depression (10-14), moderately severe depression (15-19), and severe depression (20-27). |
Post-Surgery, 6 months, and 12 months
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Change in quality of life at 6 months, and 12 months post device implantation compared to baseline as measured by the WPAI:GH Questionnaire.
大体时间：6 months, and 12 months
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The WPAI:GH (Work Productivity and Activity Impairment Questionnaire: General Health) is a validated tool that asks a series of questions about the effect of subject health problems, both physical and emotional, on their ability to work and perform regular activities. The WPAI:GH outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, as following 6 questions: 1 = currently employed, 2 = hours missed due to health problems, 3 = hours missed other reasons, 4 = hours actually worked, 5 = degree health affected productivity while working, 6 = degree health affected regular activities. Scores are then multiplied by 100 to be expressed in percentages. |
6 months, and 12 months
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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).
大体时间：Post-Surgery, and 12 months
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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). |
Post-Surgery, and 12 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Device satisfaction at post-surgery, 6 months, and 12 months a measured by the Likert scale.
大体时间：Post-surgery, 6 months, and 12 months
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The Likert scale has the options of Very Satisfied, Dissatisfied, Neither Satisfied nor Dissatisfied, Satisfied and Very Satisfied. Responses will be evaluated categorically. |
Post-surgery, 6 months, and 12 months
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Assess for outcomes and adverse events on AMS Tools at Post Procedure.
大体时间：Collected only at Post-Procedure
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AMS tools will be assess by a physician survey as part of the post-procedure case report form. |
Collected only at Post-Procedure
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合作者和调查者
调查人员
- 首席研究员：Mohit Khera, MD、Baylor College of Medicine
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.