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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BSC Penile Prothesis Recipients | Men for whom BSC Penile Prothesis is recommended. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tactra Malleable | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to six months in the Erectile Function domain ofthe International Index of Erectile Function (IIEF-EF) questionnaire for Tactra | 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 |
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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Adult males who meet the indications for surgical correction of erectile dysfunction will be enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Mohit Khera, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Medical Center | Los Angeles | California | 90033 | United States | ||
| Ronald Reagan UCLA Medical Center |
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| Spectra™ Concealable Penile Prothesis | Device | 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™ Inflatable Penile Prosthesis | Device | 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. |
|
| AMS 700™ Inflatable Penile Prosthesis w/Momentary Squeeze (MS) Pump | Device | The AMS 700 Inflatable Penile Prosthesis is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence). |
|
| AMS 700™ Inflatable Penile Prosthesis w/Tenacio™ Pump | Device | The AMS 700 Inflatable Penile Prosthesis is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence). |
|
| 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 |
| 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 |
| Los Angeles |
| California |
| 90095 |
| United States |
| Tower Urology-Research Facility | Los Angeles | California | 99048 | United States |
| University of Miami Hospital | Miami | Florida | 33136 | United States |
| USF Health South Tampa Center for Advanced Healthcare | Tampa | Florida | 33606 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| SIU School of Medicine | Springfield | Illinois | 62702 | United States |
| Indiana University Medical Center | Indianapolis | Indiana | 46202 | United States |
| Willis-Knighton Medical Center | Bossier City | Louisiana | 71111 | United States |
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
| Duke University Medical Center | Raleigh | North Carolina | 27609 | United States |
| W.G. Hefner VA Medical Center | Salisbury | North Carolina | 28144 | United States |
| Wake Forest University | Winston-Salem | North Carolina | 27103 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Ohio State University Wexner Medical Center | Columbus | Ohio | 43212 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Peking University First Hospital | Beijing | 100034 | China |
| Shanghai General Hospital | Shanghai | 200080 | China |
| Shanghai Jiaotong University School of Medicine Renji Hospital | Shanghai | 200127 | China |
| Johns Hopkins Aramco Healthcare | Dhahran | 34465 | Saudi Arabia |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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