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The purpose of this observational registry is to collect and better understand "real-world" outcomes for men undergoing penile implant surgery to treat erectile dysfunction.
A prospective, multi-center, observational registry to be conducted at multiple sites throughout the United States and Canada, to collect "real-world" penile prosthetic outcomes according to investigators' standard of care. Using questionnaires as well as electronic data collection, investigating physicians will prospectively measure patient responses at regular intervals over a one- to five year period. The physician researchers have identified key metrics for the study including effectiveness, durability, complications, and patient satisfaction; quality of life will also be analyzed, being defined through several validated patient surveys.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMS penile prosthesis receipients | Men for whom an AMS penile prosthesis is recommended |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMS Penile Prosthesis Devices | Device | Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Penile Prosthesis Overall Subject Satisfaction | Penile prosthesis overall subject satisfaction (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis. | 1 year, post-implantation |
| Number of Participants With Penile Prosthesis That Are Using the Device | Number of subjects using penile prosthesis at 1 year (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis. | 1 year, post implantation |
| Number of Participants With Penile Prosthesis That Are Using the Device Indicating How Often Their Use is. | Penile prosthesis use at year (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis. | 1 year, post implantation |
| Number of Times Per Month Participants With Penile Prosthesis Are Using the Device. | Penile prosthesis use at 1 year measured in number of times per month (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis. | 1 year, post implantation |
| Number of Participants With Penile Prosthesis That Were Not Using the Device, Reasons for Non-use | Penile prosthesis reasons for non-use at 1 year (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis. | 1 year, post implantation |
| Number of Participants With Penile Prosthesis Using the Device But Not as Often as Desired |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Subject Reported 5-question International Index of Erectile Function (IIEF-5) Total Score, Baseline Through Five Years | Penile prosthesis International Index of Erectile Function (IIEF-5) score (effectiveness objective 2) measured using a validated, multi-dimensional, self-administered questionnaire. Overall responses are reported. A higher score demonstrates an improvement in erectile function while a lower score indicates a loss of erectile function. The 5-question International Index of Erectile Function (IIEF-5) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0 to 5 is awarded to each of the 5 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. The subscales are summed to calculated the total score. The minimum total score for this questionnaire is 0 with a maximum of 30. |
Inclusion Criteria:
Men diagnosed with erectile dysfunction (ED) for whom an AMS penile prosthesis is recommended by their physician are eligible for inclusion. Potentially eligible men should also meet the following inclusion criteria for study enrollment:
Exclusion Criteria:
- Men who are deemed by their physician to be not suitable for a penile implant will be excluded.
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Men with ED in the United States and Canada.
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| Name | Affiliation | Role |
|---|---|---|
| Gerard Henry, MD | Ark-LA-Tek | Principal Investigator |
| Anthony J. Bella, MD | University of Ottawa | Principal Investigator |
| Edward Karpman, MD | El Camino Urology Medical Group | Principal Investigator |
| LeRoy Jones, MD | Urology San Antonio Research PA | Principal Investigator |
| Bryan T Kansas, MD | The Urology Team | Principal Investigator |
| Brian Christine, MD | Urology Centers of Alabama | Principal Investigator |
| Kevin McVary, MD | SIU School of Medicine | Principal Investigator |
| James Hotaling, MD | University of Utah | Principal Investigator |
| Mohit Khera, MD | Baylor College of Medicine | Principal Investigator |
| Eugene Rhee, MD | Kaiser Permanente |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology Centers of Alabama | Homewood | Alabama | 35209 | United States | ||
| El Camino Urology Medical Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | AMS Penile Prosthesis Recipients | Men for whom an AMS penile prosthesis is recommended AMS Penile Prosthesis Devices: Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
AMS penile prosthesis recipients that completed baseline assessments. Subjects that started the study but did not have implantation are not included.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AMS Penile Prosthesis Recipients | Men for whom an AMS penile prosthesis is recommended AMS Penile Prosthesis Devices: Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Penile Prosthesis Overall Subject Satisfaction | Penile prosthesis overall subject satisfaction (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis. | Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit. | Posted | Count of Participants | Participants | 1 year, post-implantation |
|
Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up.
All device and/or procedure related events were collected for this study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AMS Penile Prosthesis Receipients | Men for whom an AMS penile prosthesis is recommended AMS Penile Prosthesis Devices: Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device Infection | Infections and infestations | Non-systematic Assessment | 13 Device Infections, 10 were device related, 5 were procedure related, 3 of these were related to both device and procedure. All events were resolved. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amanda Vail, Clinical Project Manager | Boston Scientific | 612-749-5366 | amanda.vail@bsci.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 17, 2016 | Dec 13, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
Not provided
Not provided
Not provided
Not provided
Not provided
|
Number of penile prosthesis subjects using the device but indicated that they were not using as often as desired (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis. |
| 1 year, post implantation |
| Number of Participants With Penile Prosthesis That Are Using the Device Less Than Desired or Dissatisfied - Reason Device Used Less Than Desired or Dissatisfied | Reason why subject is using penile prosthesis less than desired or dissatisfied (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis. | 1 year, post implantation |
| Baseline through 5 years |
| Erection Hardness Scale Over Five Years | The Erection Hardness Scale (EHS), an easy-to-use, four-point scale for erectile dysfunction, provides a reliable measure of erection hardness and an indicator of other health and wellbeing outcomes, according to new data reported at the European Association of Urology. EHS rates the hardness of erection on a scale of zero to four, with four being the maximal score. A higher score indicates a harder penis while a lower score indicates greater dysfunction. | Baseline through 5 years |
| American Urology Association - Symptom Index Over Five Years | The AUA-SI contains seven symptoms questions which include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 for a total score of maximum 35 points from "non-missing" items. The lower score means a better quality of life. | Baseline through 5 years |
| UCLA Prostate Cancer Index Over Five Years | The University of California Los Angeles-Prostate Cancer Index -UCLA-PCI is a validated, twenty question questionnaire to asses impact of treatment for early stage prostate cancer on quality of life. The UCLA-PCI is analyzed in six sections, Sexual Function and Sexual Bother, Urinary Function and Urinary Bother, and Bowel Function and Bowel Bother. This is to measure not just the impact on function but also the quality of life impact. The UCLA PCI domain is scored on a scale of 0-100 points with higher values representing better outcomes. | Baseline through 5 years |
| Principal Investigator |
| Mountain View |
| California |
| 94040 |
| United States |
| Kaiser Permanente | San Diego | California | 92154 | United States |
| SIU School of Medicine | Springfield | Illinois | 62794-9664 | United States |
| Ark-LA-Tek | Bossier City | Louisiana | 71111 | United States |
| Lahey Clinic | Burlington | Massachusetts | 01805 | United States |
| The Urology Team | Austin | Texas | 78715 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Urology San Antonio Research, PA | San Antonio | Texas | 78229 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| University of Ottawa | Ottawa | Ontario | K1H 8L6 | Canada |
| Physician Decision |
|
| Withdrawal by Subject |
|
| Subject not implanted |
|
| Missed Visit |
|
| Site closed early-not compliance related |
|
| Patient moved away from site |
|
| Subject Incarcerated |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Primary ED etiology | Count of Participants | Participants |
|
AMS 700, only
Men for whom an AMS 700 penile prosthesis was recommended
| OG002 | AMS Ambicor | AMS Ambicor, only Men for whom an AMS Ambicor penile prosthesis was recommended |
| OG003 | Spectra | Spectra, only Men for whom a Spectra penile prosthesis was recommended |
|
|
| Primary | Number of Participants With Penile Prosthesis That Are Using the Device | Number of subjects using penile prosthesis at 1 year (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis. | Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit. | Posted | Count of Participants | Participants | 1 year, post implantation |
|
|
|
| Primary | Number of Participants With Penile Prosthesis That Are Using the Device Indicating How Often Their Use is. | Penile prosthesis use at year (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis. | Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit who answered that they were using the device and responded to how often they were using it. | Posted | Count of Participants | Participants | 1 year, post implantation |
|
|
|
| Primary | Number of Times Per Month Participants With Penile Prosthesis Are Using the Device. | Penile prosthesis use at 1 year measured in number of times per month (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis. | Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit who hand answered that they were using the device and responded to how many times per month they were using it. | Posted | Mean | Standard Deviation | Number of times per month | 1 year, post implantation |
|
|
|
| Primary | Number of Participants With Penile Prosthesis That Were Not Using the Device, Reasons for Non-use | Penile prosthesis reasons for non-use at 1 year (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis. | Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit who had answered that they were not using the device and responded to the reason for non-use. | Posted | Count of Participants | Participants | 1 year, post implantation |
|
|
|
| Primary | Number of Participants With Penile Prosthesis Using the Device But Not as Often as Desired | Number of penile prosthesis subjects using the device but indicated that they were not using as often as desired (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis. | Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit. | Posted | Count of Participants | Participants | 1 year, post implantation |
|
|
|
| Primary | Number of Participants With Penile Prosthesis That Are Using the Device Less Than Desired or Dissatisfied - Reason Device Used Less Than Desired or Dissatisfied | Reason why subject is using penile prosthesis less than desired or dissatisfied (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis. | Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit and responded that they were using the device less than desired or dissatisfied. | Posted | Count of Participants | Participants | 1 year, post implantation |
|
|
|
| Other Pre-specified | Subject Reported 5-question International Index of Erectile Function (IIEF-5) Total Score, Baseline Through Five Years | Penile prosthesis International Index of Erectile Function (IIEF-5) score (effectiveness objective 2) measured using a validated, multi-dimensional, self-administered questionnaire. Overall responses are reported. A higher score demonstrates an improvement in erectile function while a lower score indicates a loss of erectile function. The 5-question International Index of Erectile Function (IIEF-5) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0 to 5 is awarded to each of the 5 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. The subscales are summed to calculated the total score. The minimum total score for this questionnaire is 0 with a maximum of 30. | Number of subjects analyzed reduced over time due to attrition. Also, follow-up after 1 year was optional. | Posted | Mean | Standard Deviation | score on a scale | Baseline through 5 years |
|
|
|
| Other Pre-specified | Erection Hardness Scale Over Five Years | The Erection Hardness Scale (EHS), an easy-to-use, four-point scale for erectile dysfunction, provides a reliable measure of erection hardness and an indicator of other health and wellbeing outcomes, according to new data reported at the European Association of Urology. EHS rates the hardness of erection on a scale of zero to four, with four being the maximal score. A higher score indicates a harder penis while a lower score indicates greater dysfunction. | Number of subjects analyzed reduced over time due to attrition. Also, follow-up after 1 year was optional. | Posted | Mean | Standard Deviation | score on a scale | Baseline through 5 years |
|
|
|
| Other Pre-specified | American Urology Association - Symptom Index Over Five Years | The AUA-SI contains seven symptoms questions which include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 for a total score of maximum 35 points from "non-missing" items. The lower score means a better quality of life. | Number of subjects analyzed reduced over time due to attrition. Also, follow-up after 1 year was optional. | Posted | Mean | Standard Deviation | score on a scale | Baseline through 5 years |
|
|
|
| Other Pre-specified | UCLA Prostate Cancer Index Over Five Years | The University of California Los Angeles-Prostate Cancer Index -UCLA-PCI is a validated, twenty question questionnaire to asses impact of treatment for early stage prostate cancer on quality of life. The UCLA-PCI is analyzed in six sections, Sexual Function and Sexual Bother, Urinary Function and Urinary Bother, and Bowel Function and Bowel Bother. This is to measure not just the impact on function but also the quality of life impact. The UCLA PCI domain is scored on a scale of 0-100 points with higher values representing better outcomes. | Number of subjects analyzed reduced over time due to attrition. Also, follow-up after 1 year was optional. | Posted | Mean | Standard Deviation | score on a scale | Baseline through 5 years |
|
|
|
| 44 |
| 1,380 |
| 36 |
| 1,380 |
| 72 |
| 1,380 |
|
| Erosion | Injury, poisoning and procedural complications | Non-systematic Assessment | 6 Erosion, 6 were device related with 2 being determined to also be procedure related All events were resolved. |
|
| Reservoir Herniation | Injury, poisoning and procedural complications | Non-systematic Assessment | 3 Reservoir Herniation, 2 were device related, 1 was procedure related. All events were resolved. |
|
| Abscess | Infections and infestations | Non-systematic Assessment | 2 Abscess, 2 were device related with 1 being determined to also be procedure related. All events were resolved. |
|
| Hematoma | Injury, poisoning and procedural complications | Non-systematic Assessment | 2 Hematoma events, 2 were procedure related, 1 was related to both device and procedure. |
|
| Pain/Discomfort | Injury, poisoning and procedural complications | Non-systematic Assessment | 1 Pain/Discomfort events, device related. |
|
| Urinary Retention | Renal and urinary disorders | Non-systematic Assessment | 2 urinary retention events, 1 was procedure related and 1 was device related. |
|
| Cardiac Event - Non-specific | Vascular disorders | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | Non-systematic Assessment | 1 cellulitis event, procedure related. |
|
| Cylinder Crossover | Injury, poisoning and procedural complications | Non-systematic Assessment | 1 cylinder crossover event, device related |
|
| Device Cylinder Aneruysm/Bulge | Product Issues | Non-systematic Assessment | 1 device cylinder aneurysm/bulge, device related |
|
| Edema - Scrotal | Skin and subcutaneous tissue disorders | Non-systematic Assessment | 1 edema - scrotal event, procedure and device related. |
|
| Extrusion | Injury, poisoning and procedural complications | Non-systematic Assessment | 1 extrusion event, device and procedure related |
|
| Pain/Discomfort - Penile | General disorders | Non-systematic Assessment | 1 pain/discomfort-penile event, device and procedure related |
|
| Perforation - Other | Injury, poisoning and procedural complications | Non-systematic Assessment | 1 perforation event, device related |
|
| Peyronie's Disease | Reproductive system and breast disorders | Non-systematic Assessment | 1 Peyronie's Disease event, device related |
|
| Proximal Corporal Perforation | Injury, poisoning and procedural complications | Non-systematic Assessment | 1 proximal corporal perforation event, procedure related |
|
| Pulmonary Embolus | Vascular disorders | Non-systematic Assessment | 1 pulmonary embolus event, procedure event |
|
| Urethral Obstruction | Product Issues | Non-systematic Assessment | 1 urethral obstruction event, device related |
|
| Would Dehiscence | Skin and subcutaneous tissue disorders | Non-systematic Assessment | 1 wound dehiscence event, procedure related |
|
| Other - Substernal Chest Pain | Cardiac disorders | Non-systematic Assessment | The event was reported by the site as not procedure or device related which does not fit the definition of a reportable SADE or UADE per the protocol. |
|
| Pain/Discomfort | General disorders | Non-systematic Assessment |
|
| Other - Decreased Oxygen Saturation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Urinary Retention | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Device Infection | Infections and infestations | Non-systematic Assessment |
|
| Erosion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Pain/Discomfort | General disorders | Non-systematic Assessment |
|
| Reservoir Herniation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Superficial Wound Infection | Infections and infestations | Non-systematic Assessment |
|
| Device Cylinder Aneurysm/Bulge | Product Issues | Non-systematic Assessment |
|
| Migration (pump) | General disorders | Non-systematic Assessment |
|
| Urethral Trauma | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Extrusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Malposition | Product Issues | Non-systematic Assessment |
|
| Pain/Discomfort - Groin | General disorders | Non-systematic Assessment |
|
| Priapism | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Adhesion of the Pump/Scrotum | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Allergic reaction/Hypersensitivity Reaction | Immune system disorders | Non-systematic Assessment |
|
| Auto Inflation | Product Issues | Non-systematic Assessment |
|
| Bladder Neck Obstruction | Renal and urinary disorders | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | Non-systematic Assessment |
|
| Device Placement Failure | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Edema - Penile | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Fever | Investigations | Non-systematic Assessment |
|
| Fibrosis | Product Issues | Non-systematic Assessment |
|
| Fibrous Capsule Formation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hematospermia | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Incorrect Size - Cylinders too Large | Product Issues | Non-systematic Assessment |
|
| Increased Blood Loss | Vascular disorders | Non-systematic Assessment |
|
| Inguinal Hernia Formation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain/Discomfort - Other | General disorders | Non-systematic Assessment |
|
| Pain/Discomfort - Penile | General disorders | Non-systematic Assessment |
|
| Pain/Discomfort With Erections | General disorders | Non-systematic Assessment |
|
| Patient Dissatisfaction | General disorders | Non-systematic Assessment |
|
| Perforation - Other | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Peyronie's Disease | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Proximal Corporal Perforation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Urinary Tract Infection - UTI | Infections and infestations | Non-systematic Assessment |
|
| Wound Dehiscence | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | Non-systematic Assessment |
|
| Pain/Discomfort | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain/Discomfort | Product Issues | Non-systematic Assessment |
|
| Migration (Pump) | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Migration (Pump) | Product Issues | Non-systematic Assessment |
|
| Pain/Discomfort - Groin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Pain/Discomfort - Testicular | General disorders | Non-systematic Assessment |
|
| Pain/Discomfort - Testicular | Product Issues | Non-systematic Assessment |
|
| Other - Buckling of left cylinder led to left downward curvature | Product Issues | Non-systematic Assessment |
|
| Other - Painful mass in right hemiscrotum | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Other - Left distal tip migration with pain at tip of penis with intercourse | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Other - Right cylinder protruding | Product Issues | Non-systematic Assessment |
|
| Other - Pinching sensation around the resevoirs | General disorders | Non-systematic Assessment |
|
| Other - Change in curvature of penis (increase in curvature) | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Other - Proximal cross over during IPP surgery | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Other - Incisional drainage | Infections and infestations | Non-systematic Assessment |
|
| Other - Bilateral corporal aneurysm | Product Issues | Non-systematic Assessment |
|
| Other - Proximal crossover | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Other - Slight separation of penoscrotal wound | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| More than once per month |
|
| Partner disinterest |
|
| Device problem |
|
| Device dissatisfaction |
|
| Health decline |
|
| Other reason |
|
| Partner disinterest |
|
| Device problem |
|
| Device dissatisfaction |
|
| Health decline |
|
| Other reason |
|
|
| 2 year |
|
|
| 3 year |
|
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| 4 year |
|
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| 5 year |
|
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| 2 year |
|
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| 3 year |
|
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| 4 year |
|
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| 5 year |
|
|
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| 2 year |
|
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| 3 year |
|
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| 4 year |
|
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| 5 year |
|
|
|
| 1 year |
|
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| 2 year |
|
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| 3 year |
|
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| 4 year |
|
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| 5 year |
|
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