IT Matters: The Erectile Restoration Registry
- Conditions
- Erectile Dysfunction
- Interventions
- Device: Tactra MalleableDevice: Spectra™ Concealable Penile ProthesisDevice: AMS Ambicor™ Inflatable Penile ProsthesisDevice: AMS 700™ Inflatable Penile Prosthesis w/Momentary Squeeze (MS) PumpDevice: AMS 700™ Inflatable Penile Prosthesis w/Tenacio™ Pump
- Registration Number
- NCT04200937
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- Male
- Target Recruitment
- 450
- Males who are >/= 18 years of age.
- Males with chronic, organic, erectile dysfunction (impotence) who are determined to be suitable candidates for implantation surgery by their physician.
- Willing and able to undergo surgical implantation of a study BSC penile prothesis device.
- Willing and able to complete the informed consent process.
- Willing and able to comply with the follow-up requirement.
- Men who are deemed by their physician as not suitable for a penile prothesis will be excluded per the contraindications in each study device's Instructions for Use (IFU).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description BSC Penile Prothesis Recipients Tactra Malleable Men for whom BSC Penile Prothesis is recommended. BSC Penile Prothesis Recipients AMS 700™ Inflatable Penile Prosthesis w/Momentary Squeeze (MS) Pump Men for whom BSC Penile Prothesis is recommended. BSC Penile Prothesis Recipients AMS 700™ Inflatable Penile Prosthesis w/Tenacio™ Pump Men for whom BSC Penile Prothesis is recommended. BSC Penile Prothesis Recipients Spectra™ Concealable Penile Prothesis Men for whom BSC Penile Prothesis is recommended. BSC Penile Prothesis Recipients AMS Ambicor™ Inflatable Penile Prosthesis Men for whom BSC Penile Prothesis is recommended.
- Primary Outcome Measures
Name Time Method Change from baseline to six months in the Erectile Function domain ofthe International Index of Erectile Function (IIEF-EF) questionnaire for Tactra 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).
- Secondary Outcome Measures
Name Time Method 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 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).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 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).
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 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.
Trial Locations
- Locations (22)
USC Medical Center
🇺🇸Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
🇺🇸Los Angeles, California, United States
Tower Urology-Research Facility
🇺🇸Los Angeles, California, United States
University of Miami Hospital
🇺🇸Miami, Florida, United States
USF Health South Tampa Center for Advanced Healthcare
🇺🇸Tampa, Florida, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
SIU School of Medicine
🇺🇸Springfield, Illinois, United States
Indiana University Medical Center
🇺🇸Indianapolis, Indiana, United States
Willis-Knighton Medical Center
🇺🇸Bossier City, Louisiana, United States
Washington University in St. Louis
🇺🇸St. Louis, Missouri, United States
Duke University Medical Center
🇺🇸Raleigh, North Carolina, United States
W.G. Hefner VA Medical Center
🇺🇸Salisbury, North Carolina, United States
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Peking University First Hospital
🇨🇳Beijing, China
Johns Hopkins Aramco Healthcare
🇸🇦Dhahran, Saudi Arabia