IT Matters: The Erectile Restoration Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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IT Matters: The Erectile Restoration Registry

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Device: Tactra Malleable
* Device: Spectra Penile Prothesis
* Device: AMS Ambicor


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BSC Penile Prothesis Recipients<br>Men for whom BSC Penile Prothesis is recommended. | Device: Tactra Malleable<br>* 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.<br>Device: Spectra Penile Prothesis<br>* 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.<br>Device: AMS Ambicor<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |