IT Matters: The Erectile Restoration Registry (It MATTERS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04200937 |
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Recruitment Status :
Enrolling by invitation
First Posted : December 16, 2019
Last Update Posted : July 25, 2022
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| Condition or disease | Intervention/treatment |
|---|---|
| Erectile Dysfunction | Device: Tactra Malleable Device: Spectra Penile Prothesis Device: AMS Ambicor |
| Study Type : | Observational |
| Estimated Enrollment : | 450 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | IT Matters: The Erectile Restoration Registry |
| Actual Study Start Date : | August 5, 2021 |
| Estimated Primary Completion Date : | January 2024 |
| Estimated Study Completion Date : | December 2031 |
| Group/Cohort | Intervention/treatment |
|---|---|
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BSC Penile Prothesis Recipients
Men for whom BSC Penile Prothesis is recommended.
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Device: Tactra Malleable
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. Device: Spectra Penile Prothesis 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. Device: AMS Ambicor 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. |
- Change from baseline to six months in the Erectile Function domain of the International Index of Erectile Function (IIEF-EF) questionnaire [ Time Frame: 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).
- 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. [ Time Frame: 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. [ Time Frame: 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.
- 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). [ Time Frame: 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).
- Device satisfaction at post-surgery, 6 months, 12 months and annually thereafter measured by the Likert scale. [ Time Frame: Post-surgery, 6 months, 12 months and annually thereafter through study completion, an average of 10 years ]The Likert scale has the options of Very Satisfied, Dissatisfied, Neither Satisfied nor Dissatisfied, Satisfied and Very Satisfied. Responses will be evaluated categorically.
- Assess for outcomes and adverse events on AMS Tools at Post Procedure. [ Time Frame: Collected only at Post-Procedure ]AMS tools will be assess by a physician survey as part of the post-procedure case report form.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
1. 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04200937
| United States, California | |
| Ronald Reagan UCLA Medical Center | |
| Los Angeles, California, United States, 90095 | |
| United States, Florida | |
| University of Miami Hospital | |
| Miami, Florida, United States, 33136 | |
| USF Health South Tampa Center for Advanced Healthcare | |
| Tampa, Florida, United States, 33606 | |
| United States, Illinois | |
| SIU School of Medicine | |
| Springfield, Illinois, United States, 62702 | |
| United States, Indiana | |
| Indiana University Medical Center | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Louisiana | |
| Willis-Knighton Medical Center | |
| Bossier City, Louisiana, United States, 71111 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Raleigh, North Carolina, United States, 27609 | |
| Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| University of Utah | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Washington | |
| University of Washington Medical Center | |
| Seattle, Washington, United States, 98195 | |
| Principal Investigator: | Mohit Khera, MD | Baylor College of Medicine |
| Responsible Party: | Boston Scientific Corporation |
| ClinicalTrials.gov Identifier: | NCT04200937 |
| Other Study ID Numbers: |
U0670 |
| First Posted: | December 16, 2019 Key Record Dates |
| Last Update Posted: | July 25, 2022 |
| Last Verified: | July 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Product Manufactured in and Exported from the U.S.: | Yes |
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Erectile Dysfunction Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Mental Disorders |