Erectile DysfunctionNCT04200937
IT Matters: The Erectile Restoration Registry
An observational study of Erectile Dysfunction, run by Boston Scientific Corporation at 25 sites in 3 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Tactra Malleable, Spectra™ Concealable Penile Prothesis and AMS Ambicor™ Inflatable Penile Prosthesis
- Type of treatment
- Medical device
- How many people
- 450 participants
- Where
- 25 sitesin 3 countries
- Study dates
- 5 Aug 2021to Dec 2031
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult males who meet the indications for surgical correction of erectile dysfunction will be enrolled.
Who may be able to join
- ≥ 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.
Who cannot join
- 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.
Trial locations and contacts
25 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
25 sites in 3 countries
United States21 sites
Willis-Knighton Medical Center
Bossier City, Louisiana, 71111
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio State University Wexner Medical Center
Columbus, Ohio, 43212
Baylor College of Medicine
Houston, Texas, 77030
Houston Methodist Hospital
Houston, Texas, 77030
Indiana University Medical Center
Indianapolis, Indiana, 46202
USC Medical Center
Los Angeles, California, 90033
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Tower Urology-Research Facility
Los Angeles, California, 99048
University of Miami Hospital
Miami, Florida, 33136
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Duke University Medical Center
Raleigh, North Carolina, 27609
W.G. Hefner VA Medical Center
Salisbury, North Carolina, 28144
University of Utah
Salt Lake City, Utah, 84132
University of Washington Medical Center
Seattle, Washington, 98195
SIU School of Medicine
Springfield, Illinois, 62702
Washington University in St. Louis
St Louis, Missouri, 63110
USF Health South Tampa Center for Advanced Healthcare
Tampa, Florida, 33606
Wake Forest University
Winston-Salem, North Carolina, 27103
China3 sites
Peking University First Hospital
Beijing, 100034
Shanghai General Hospital
Shanghai, 200080
Shanghai Jiaotong University School of Medicine Renji Hospital
Shanghai, 200127
About this study
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
Read the 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.
- Conditions
- Erectile Dysfunction
- Being tested
- Tactra Malleable, Spectra™ Concealable Penile Prothesis, AMS Ambicor™ Inflatable Penile Prosthesis, AMS 700™ Inflatable Penile Prosthesis w/Momentary Squeeze (MS) Pump, AMS 700™ Inflatable Penile Prosthesis w/Tenacio™ Pump
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tactra MalleableDevice
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.
Spectra™ Concealable Penile ProthesisDevice
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.
AMS Ambicor™ Inflatable Penile ProsthesisDevice
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.
AMS 700™ Inflatable Penile Prosthesis w/Momentary Squeeze (MS) PumpDevice
The AMS 700 Inflatable Penile Prosthesis is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence).
AMS 700™ Inflatable Penile Prosthesis w/Tenacio™ PumpDevice
The AMS 700 Inflatable Penile Prosthesis is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence).
| Study group | Role | What they receive |
|---|---|---|
| BSC Penile Prothesis Recipients | Men for whom BSC Penile Prothesis is recommended. Receives: Device: Tactra Malleable; Device: Spectra™ Concealable Penile Prothesis; Device: AMS Ambicor™ Inflatable Penile Prosthesis; Device: AMS 700™ Inflatable Penile Prosthesis w/Momentary Squeeze (MS) Pump; Device: AMS 700™ Inflatable Penile Prosthesis w/Tenacio™ Pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to six months in the Erectile Function domain ofthe International Index of Erectile Function (IIEF-EF) questionnaire for Tactra
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).
Measured: Baseline to 6 months
Secondary outcomes (3)
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.
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).
Measured: 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.
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.
Measured: 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).
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).
Measured: Post-Surgery, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start5 Aug 2021
- Primary completionJan 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohit Khera, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200937
- Sponsor's protocol ID
- U0670
- Status last verified
- Oct 2026
- First submitted
- 11 Dec 2019
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No