IT Matters: The Erectile Restoration Registry

Erectile Dysfunction Clinical Trial

— It MATTERS  

Official title:

IT Matters: The Erectile Restoration Registry

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04200937
• Other study ID #: U0670
• Status: Enrolling by invitation
• Start date: August 5, 2021
• Est. completion date: December 2031

Study information

• Verified date: June 2024
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 450
• Est. completion date: December 2031
• Est. primary completion date: January 2031
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Willis-Knighton Medical Center	Bossier City	Louisiana
United States	University of Chicago	Chicago	Illinois
United States	Baylor College of Medicine	Houston	Texas
United States	Houston Methodist Hospital	Houston	Texas
United States	Indiana University Medical Center	Indianapolis	Indiana
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	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Duke University Medical Center	Raleigh	North Carolina
United States	Washington University in St. Louis	Saint Louis	Missouri
United States	W.G. Hefner VA Medical Center	Salisbury	North Carolina
United States	University of Utah	Salt Lake City	Utah
United States	University of Washington Medical Center	Seattle	Washington
United States	SIU School of Medicine	Springfield	Illinois
United States	USF Health South Tampa Center for Advanced Healthcare	Tampa	Florida
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Device satisfaction at post-surgery, 6 months, 12 months and annually thereafter measured by the Likert scale.	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, 12 months and annually thereafter through study completion, an average of 10 years
Other	Assess for outcomes and adverse events on AMS Tools at Post Procedure.	AMS tools will be assess by a physician survey as part of the post-procedure case report form.	Collected only at Post-Procedure
Primary	Change from baseline to six months in the Erectile Function domain of the International Index of Erectile Function (IIEF-EF) questionnaire	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
Secondary	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.	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, 12 months and annually thereafter through study completion, an average of 10 years
Secondary	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.	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, 12 months and 24 months
Secondary	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).	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, 12 months and annually thereafter through study completion, an average of 10 years