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Trial record 1 of 2 for:    The Erectile Restoration Registry
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IT Matters: The Erectile Restoration Registry (It MATTERS)

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
Recruitment Status : Enrolling by invitation
First Posted : December 16, 2019
Last Update Posted : July 25, 2022
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
The primary objective of the It MATTERS registry is to assess erectile function at 6 months, post implantation of an It MATTERS Study Penile Prosthesis, demonstrating an improvement in quality of life from baseline.

Condition or disease Intervention/treatment
Erectile Dysfunction Device: Tactra Malleable Device: Spectra Penile Prothesis Device: AMS Ambicor

Detailed Description:
The study is a post-market study on a newly released device and is part of the planned postmarket clinical follow-up (PMCF) of the device. Adult males with moderate to severe erectile dysfunction (IIEF-EF domain score 1-16) who meet the indications for surgical correction of erectile dysfunction will be included. The purpose of this study will be to assess the impact of the Tactra malleable prosthesis on quality of life in men with erectile dysfunction through use of the International Index of Erectile Function, Erectile Function Score (IIEF-EF).

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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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
BSC Penile Prothesis Recipients
Men for whom BSC Penile Prothesis is recommended.
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.




Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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).



Other Outcome Measures:
  1. 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.

  2. 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.



Information from the National Library of Medicine

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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
Study Population
Adult males who meet the indications for surgical correction of erectile dysfunction will be enrolled.
Criteria

Inclusion Criteria:

  1. Males who are >/= 18 years of age.
  2. Males with chronic, organic, erectile dysfunction (impotence) who are determined to be suitable candidates for implantation surgery by their physician.
  3. Willing and able to undergo surgical implantation of a study BSC penile prothesis device.
  4. Willing and able to complete the informed consent process.
  5. 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).


Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Mohit Khera, MD Baylor College of Medicine
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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

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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
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders