Erectile Dysfunction
Conditions
Brief 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
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.
Interventions
DEVICETactra 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.
DEVICESpectra™ Concealable 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.
DEVICEAMS Ambicor™ Inflatable Penile Prosthesis
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.
DEVICEAMS 700™ Inflatable Penile Prosthesis w/Momentary Squeeze (MS) Pump
The AMS 700 Inflatable Penile Prosthesis is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence).
DEVICEAMS 700™ Inflatable Penile Prosthesis w/Tenacio™ Pump
The AMS 700 Inflatable Penile Prosthesis is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence).
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. ≥ 18 years of age. 2. Males who are determined to be suitable candidates and scheduled to undergo surgical implantation of a market approved BSC penile prothesis by their physician. 3. Willing and able to complete the informed consent process. 4. Willing and able to comply with the follow-up requirements.
Exclusion criteria
1. Males who are deemed by their physician as not suitable candidates for a penile prosthesis. 2. In the opinion of the investigator, it is not in best interest of the patient or the study for the patient to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to six months in the Erectile Function domain ofthe International Index of Erectile Function (IIEF-EF) questionnaire for Tactra | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | Post-Surgery, 6 months, and 12 months | 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, and 12 months post device implantation compared to baseline as measured by the WPAI:GH Questionnaire. | 6 months, and 12 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, and 12 months post device implantation compared to baseline, as measured by the International Index of Erectile Function Domain (IIEF). | Post-Surgery, and 12 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). |
Countries
China, Saudi Arabia, United States
Contacts
PRINCIPAL_INVESTIGATORMohit Khera, MD
Baylor College of Medicine
Outcome results
None listed