Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT01383018
Status:
COMPLETED
Last Update Posted:
2021-02-12
First Post:
2011-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
PROPPER Prospective Registry of Outcomes With Penile Prosthesis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amanda.vail@bsci.com', 'phone': '612-749-5366', 'title': 'Amanda Vail, Clinical Project Manager', 'organization': 'Boston Scientific'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for all subjects who had the study device implanted through optional 5 year follow-up.', 'description': 'All device and/or procedure related events were collected for this study.', 'eventGroups': [{'id': 'EG000', 'title': 'AMS Penile Prosthesis Receipients', 'description': 'Men for whom an AMS penile prosthesis is recommended\n\nAMS Penile Prosthesis Devices: Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices.', 'otherNumAtRisk': 1380, 'deathsNumAtRisk': 1380, 'otherNumAffected': 72, 'seriousNumAtRisk': 1380, 'deathsNumAffected': 44, 'seriousNumAffected': 36}], 'otherEvents': [{'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Device Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain/Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Reservoir Herniation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Superficial Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Device Cylinder Aneurysm/Bulge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Migration (pump)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urethral Trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Extrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Malposition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain/Discomfort - Groin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Priapism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Adhesion of the Pump/Scrotum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic reaction/Hypersensitivity Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Auto Inflation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bladder Neck Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Device Placement Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema - Penile', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fibrous Capsule Formation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematospermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Incorrect Size - Cylinders too Large', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Blood Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inguinal Hernia Formation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain/Discomfort - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain/Discomfort - Penile', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain/Discomfort With Erections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Patient Dissatisfaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Perforation - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': "Peyronie's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Proximal Corporal Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection - UTI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound Dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain/Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain/Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Migration (Pump)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Migration (Pump)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain/Discomfort - Groin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain/Discomfort - Testicular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain/Discomfort - Testicular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other - Buckling of left cylinder led to left downward curvature', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other - Painful mass in right hemiscrotum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other - Left distal tip migration with pain at tip of penis with intercourse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other - Right cylinder protruding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other - Pinching sensation around the resevoirs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other - Change in curvature of penis (increase in curvature)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other - Proximal cross over during IPP surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other - Incisional drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other - Bilateral corporal aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other - Proximal crossover', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other - Slight separation of penoscrotal wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Device Infection', 'notes': '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.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Erosion', 'notes': '6 Erosion, 6 were device related with 2 being determined to also be procedure related All events were resolved.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Reservoir Herniation', 'notes': '3 Reservoir Herniation, 2 were device related, 1 was procedure related. All events were resolved.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abscess', 'notes': '2 Abscess, 2 were device related with 1 being determined to also be procedure related. All events were resolved.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma', 'notes': '2 Hematoma events, 2 were procedure related, 1 was related to both device and procedure.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain/Discomfort', 'notes': '1 Pain/Discomfort events, device related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Retention', 'notes': '2 urinary retention events, 1 was procedure related and 1 was device related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Event - Non-specific', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'notes': '1 cellulitis event, procedure related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cylinder Crossover', 'notes': '1 cylinder crossover event, device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Device Cylinder Aneruysm/Bulge', 'notes': '1 device cylinder aneurysm/bulge, device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema - Scrotal', 'notes': '1 edema - scrotal event, procedure and device related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Extrusion', 'notes': '1 extrusion event, device and procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain/Discomfort - Penile', 'notes': '1 pain/discomfort-penile event, device and procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Perforation - Other', 'notes': '1 perforation event, device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': "Peyronie's Disease", 'notes': "1 Peyronie's Disease event, device related", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Proximal Corporal Perforation', 'notes': '1 proximal corporal perforation event, procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Embolus', 'notes': '1 pulmonary embolus event, procedure event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urethral Obstruction', 'notes': '1 urethral obstruction event, device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Would Dehiscence', 'notes': '1 wound dehiscence event, procedure related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other - Substernal Chest Pain', 'notes': '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.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain/Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other - Decreased Oxygen Saturation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Penile Prosthesis Overall Subject Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1082', 'groupId': 'OG000'}, {'value': '1050', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'All AMS Penile Prosthesis Recipients - Total Reponses', 'description': 'Men for whom an AMS penile prosthesis is recommended\n\nAMS Penile Prostheses: Non-interventional device registry. Outcomes for subjects receiving a marketed AMS penile prosthesis.'}, {'id': 'OG001', 'title': 'AMS 700', 'description': 'AMS 700, only\n\nMen for whom an AMS 700 penile prosthesis was recommended'}, {'id': 'OG002', 'title': 'AMS Ambicor', 'description': 'AMS Ambicor, only\n\nMen for whom an AMS Ambicor penile prosthesis was recommended'}, {'id': 'OG003', 'title': 'Spectra', 'description': 'Spectra, only\n\nMen for whom a Spectra penile prosthesis was recommended'}], 'classes': [{'categories': [{'title': 'Very Dissatisfied', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Dissatisfied', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Neither Satisfied nor Dissatisfied', 'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Satisfied', 'measurements': [{'value': '297', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}, {'title': 'Very Satisfied', 'measurements': [{'value': '643', 'groupId': 'OG000'}, {'value': '627', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year, post-implantation', 'description': 'Penile prosthesis overall subject satisfaction (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Penile Prosthesis That Are Using the Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1082', 'groupId': 'OG000'}, {'value': '1050', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'All AMS Penile Prosthesis Recipients - Total Reponses', 'description': 'Men for whom an AMS penile prosthesis is recommended\n\nAMS Penile Prostheses: Non-interventional device registry. Outcomes for subjects receiving a marketed AMS penile prosthesis.'}, {'id': 'OG001', 'title': 'AMS 700', 'description': 'AMS 700, only\n\nMen for whom an AMS 700 penile prosthesis was recommended'}, {'id': 'OG002', 'title': 'AMS Ambicor', 'description': 'AMS Ambicor, only\n\nMen for whom an AMS Ambicor penile prosthesis was recommended'}, {'id': 'OG003', 'title': 'Spectra', 'description': 'Spectra, only\n\nMen for whom a Spectra penile prosthesis was recommended'}], 'classes': [{'categories': [{'measurements': [{'value': '984', 'groupId': 'OG000'}, {'value': '956', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year, post implantation', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Penile Prosthesis That Are Using the Device Indicating How Often Their Use is.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '895', 'groupId': 'OG000'}, {'value': '867', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'All AMS Penile Prosthesis Recipients - Total Reponses', 'description': 'Men for whom an AMS penile prosthesis is recommended\n\nAMS Penile Prostheses: Non-interventional device registry. Outcomes for subjects receiving a marketed AMS penile prosthesis.'}, {'id': 'OG001', 'title': 'AMS 700', 'description': 'AMS 700, only\n\nMen for whom an AMS 700 penile prosthesis was recommended'}, {'id': 'OG002', 'title': 'AMS Ambicor', 'description': 'AMS Ambicor, only\n\nMen for whom an AMS Ambicor penile prosthesis was recommended'}, {'id': 'OG003', 'title': 'Spectra', 'description': 'Spectra, only\n\nMen for whom a Spectra penile prosthesis was recommended'}], 'classes': [{'categories': [{'title': 'Less than once per month', 'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'More than once per month', 'measurements': [{'value': '837', 'groupId': 'OG000'}, {'value': '811', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year, post implantation', 'description': 'Penile prosthesis use at year (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Number of Times Per Month Participants With Penile Prosthesis Are Using the Device.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '490', 'groupId': 'OG000'}, {'value': '467', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'All AMS Penile Prosthesis Recipients - Total Reponses', 'description': 'Men for whom an AMS penile prosthesis is recommended\n\nAMS Penile Prostheses: Non-interventional device registry. Outcomes for subjects receiving a marketed AMS penile prosthesis.'}, {'id': 'OG001', 'title': 'AMS 700', 'description': 'AMS 700, only\n\nMen for whom an AMS 700 penile prosthesis was recommended'}, {'id': 'OG002', 'title': 'AMS Ambicor', 'description': 'AMS Ambicor, only\n\nMen for whom an AMS Ambicor penile prosthesis was recommended'}, {'id': 'OG003', 'title': 'Spectra', 'description': 'Spectra, only\n\nMen for whom a Spectra penile prosthesis was recommended'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '5.6', 'groupId': 'OG001'}, {'value': '5.4', 'spread': '3.3', 'groupId': 'OG002'}, {'value': '5.2', 'spread': '4.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year, post implantation', 'description': '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.', 'unitOfMeasure': 'Number of times per month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Penile Prosthesis That Were Not Using the Device, Reasons for Non-use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'All AMS Penile Prosthesis Recipients - Total Reponses', 'description': 'Men for whom an AMS penile prosthesis is recommended\n\nAMS Penile Prostheses: Non-interventional device registry. Outcomes for subjects receiving a marketed AMS penile prosthesis.'}, {'id': 'OG001', 'title': 'AMS 700', 'description': 'AMS 700, only\n\nMen for whom an AMS 700 penile prosthesis was recommended'}, {'id': 'OG002', 'title': 'AMS Ambicor', 'description': 'AMS Ambicor, only\n\nMen for whom an AMS Ambicor penile prosthesis was recommended'}, {'id': 'OG003', 'title': 'Spectra', 'description': 'Spectra, only\n\nMen for whom a Spectra penile prosthesis was recommended'}], 'classes': [{'categories': [{'title': 'Loss of partner', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Partner disinterest', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Device problem', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Device dissatisfaction', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Health decline', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Other reason', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year, post implantation', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Penile Prosthesis Using the Device But Not as Often as Desired', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1082', 'groupId': 'OG000'}, {'value': '1050', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'All AMS Penile Prosthesis Recipients - Total Reponses', 'description': 'Men for whom an AMS penile prosthesis is recommended\n\nAMS Penile Prostheses: Non-interventional device registry. Outcomes for subjects receiving a marketed AMS penile prosthesis.'}, {'id': 'OG001', 'title': 'AMS 700', 'description': 'AMS 700, only\n\nMen for whom an AMS 700 penile prosthesis was recommended'}, {'id': 'OG002', 'title': 'AMS Ambicor', 'description': 'AMS Ambicor, only\n\nMen for whom an AMS Ambicor penile prosthesis was recommended'}, {'id': 'OG003', 'title': 'Spectra', 'description': 'Spectra, only\n\nMen for whom a Spectra penile prosthesis was recommended'}], 'classes': [{'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year, post implantation', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Penile Prosthesis That Are Using the Device Less Than Desired or Dissatisfied - Reason Device Used Less Than Desired or Dissatisfied', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'All AMS Penile Prosthesis Recipients - Total Reponses', 'description': 'Men for whom an AMS penile prosthesis is recommended\n\nAMS Penile Prostheses: Non-interventional device registry. Outcomes for subjects receiving a marketed AMS penile prosthesis.'}, {'id': 'OG001', 'title': 'AMS 700', 'description': 'AMS 700, only\n\nMen for whom an AMS 700 penile prosthesis was recommended'}, {'id': 'OG002', 'title': 'AMS Ambicor', 'description': 'AMS Ambicor, only\n\nMen for whom an AMS Ambicor penile prosthesis was recommended'}, {'id': 'OG003', 'title': 'Spectra', 'description': 'Spectra, only\n\nMen for whom a Spectra penile prosthesis was recommended'}], 'classes': [{'categories': [{'title': 'Loss of partner', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Partner disinterest', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Device problem', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Device dissatisfaction', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Health decline', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Other reason', 'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year, post implantation', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Subject Reported 5-question International Index of Erectile Function (IIEF-5) Total Score, Baseline Through Five Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1194', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All AMS Penile Prosthesis Recipients - Total Reponses', 'description': 'Men for whom an AMS penile prosthesis was recommended\n\nAMS Penile Prosthesis Devices: Non-interventional device registry. Outcomes for patients receiving a marketed AMS penile prosthesis.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1194', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.4', 'spread': '5.2', 'groupId': 'OG000'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '853', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.6', 'spread': '6.4', 'groupId': 'OG000'}]}]}, {'title': '2 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '777', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.4', 'spread': '6.6', 'groupId': 'OG000'}]}]}, {'title': '3 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '595', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.2', 'spread': '6.1', 'groupId': 'OG000'}]}]}, {'title': '4 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '457', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.6', 'spread': '6.8', 'groupId': 'OG000'}]}]}, {'title': '5 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.2', 'spread': '6.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through 5 years', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects analyzed reduced over time due to attrition. Also, follow-up after 1 year was optional.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Erection Hardness Scale Over Five Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1209', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All AMS Penile Prosthesis Recipients - Total Reponses', 'description': 'Men for whom an AMS penile prosthesis was recommended\n\nAMS Penile Prosthesis Devices: Non-interventional device registry. Outcomes for patients receiving a marketed AMS penile prosthesis.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1209', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '855', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': '2 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '779', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': '3 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '594', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': '4 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': '5 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through 5 years', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects analyzed reduced over time due to attrition. Also, follow-up after 1 year was optional.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'American Urology Association - Symptom Index Over Five Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1114', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All AMS Penile Prosthesis Recipients - Total Reponses', 'description': 'Men for whom an AMS penile prosthesis was recommended\n\nAMS Penile Prosthesis Devices: Non-interventional device registry. Outcomes for patients receiving a marketed AMS penile prosthesis.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1114', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.0', 'spread': '6.9', 'groupId': 'OG000'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '805', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.9', 'spread': '6.6', 'groupId': 'OG000'}]}]}, {'title': '2 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '741', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.8', 'spread': '7.0', 'groupId': 'OG000'}]}]}, {'title': '3 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '564', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.2', 'spread': '6.5', 'groupId': 'OG000'}]}]}, {'title': '4 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.1', 'spread': '6.3', 'groupId': 'OG000'}]}]}, {'title': '5 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.1', 'spread': '5.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through 5 years', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects analyzed reduced over time due to attrition. Also, follow-up after 1 year was optional.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'UCLA Prostate Cancer Index Over Five Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '833', 'groupId': 'OG000'}, {'value': '814', 'groupId': 'OG001'}, {'value': '804', 'groupId': 'OG002'}, {'value': '820', 'groupId': 'OG003'}, {'value': '812', 'groupId': 'OG004'}, {'value': '802', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'UCLA-PCI Sexual Function', 'description': 'Sexual function measure'}, {'id': 'OG001', 'title': 'UCLA-PCI Urinary Function', 'description': 'Urinary function measure'}, {'id': 'OG002', 'title': 'UCLA-PCI Bowel Function', 'description': 'Bowel function measure'}, {'id': 'OG003', 'title': 'UCLA-PCI Sexual Bother', 'description': 'Sexual bother measure'}, {'id': 'OG004', 'title': 'UCLA-PCI Urinary Bother', 'description': 'Urinary bother measure'}, {'id': 'OG005', 'title': 'UCLA-PCI Bowel Bother', 'description': 'Bowel bother measure'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '833', 'groupId': 'OG000'}, {'value': '814', 'groupId': 'OG001'}, {'value': '804', 'groupId': 'OG002'}, {'value': '820', 'groupId': 'OG003'}, {'value': '812', 'groupId': 'OG004'}, {'value': '802', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '21.5', 'spread': '16.9', 'groupId': 'OG000'}, {'value': '79.9', 'spread': '24.3', 'groupId': 'OG001'}, {'value': '85.0', 'spread': '15.5', 'groupId': 'OG002'}, {'value': '10.8', 'spread': '22.8', 'groupId': 'OG003'}, {'value': '76.7', 'spread': '31.6', 'groupId': 'OG004'}, {'value': '85.5', 'spread': '24.1', 'groupId': 'OG005'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '619', 'groupId': 'OG000'}, {'value': '616', 'groupId': 'OG001'}, {'value': '613', 'groupId': 'OG002'}, {'value': '614', 'groupId': 'OG003'}, {'value': '615', 'groupId': 'OG004'}, {'value': '614', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '70.9', 'spread': '20.9', 'groupId': 'OG000'}, {'value': '82.6', 'spread': '20.9', 'groupId': 'OG001'}, {'value': '88.4', 'spread': '14.3', 'groupId': 'OG002'}, {'value': '77.3', 'spread': '32.7', 'groupId': 'OG003'}, {'value': '81.1', 'spread': '26.6', 'groupId': 'OG004'}, {'value': '87.3', 'spread': '22.3', 'groupId': 'OG005'}]}]}, {'title': '2 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '619', 'groupId': 'OG000'}, {'value': '616', 'groupId': 'OG001'}, {'value': '614', 'groupId': 'OG002'}, {'value': '611', 'groupId': 'OG003'}, {'value': '617', 'groupId': 'OG004'}, {'value': '614', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '70.0', 'spread': '21.6', 'groupId': 'OG000'}, {'value': '83.4', 'spread': '20.8', 'groupId': 'OG001'}, {'value': '87.8', 'spread': '15.9', 'groupId': 'OG002'}, {'value': '77.9', 'spread': '33.2', 'groupId': 'OG003'}, {'value': '80.5', 'spread': '27.3', 'groupId': 'OG004'}, {'value': '86.5', 'spread': '23.5', 'groupId': 'OG005'}]}]}, {'title': '3 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '487', 'groupId': 'OG001'}, {'value': '486', 'groupId': 'OG002'}, {'value': '488', 'groupId': 'OG003'}, {'value': '487', 'groupId': 'OG004'}, {'value': '486', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '71.7', 'spread': '20.8', 'groupId': 'OG000'}, {'value': '83.8', 'spread': '21.2', 'groupId': 'OG001'}, {'value': '87.5', 'spread': '17.1', 'groupId': 'OG002'}, {'value': '78.8', 'spread': '32.2', 'groupId': 'OG003'}, {'value': '79.0', 'spread': '28.3', 'groupId': 'OG004'}, {'value': '86.8', 'spread': '23.7', 'groupId': 'OG005'}]}]}, {'title': '4 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}, {'value': '404', 'groupId': 'OG002'}, {'value': '401', 'groupId': 'OG003'}, {'value': '402', 'groupId': 'OG004'}, {'value': '403', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '70.3', 'spread': '22.2', 'groupId': 'OG000'}, {'value': '86.0', 'spread': '19.6', 'groupId': 'OG001'}, {'value': '87.8', 'spread': '17.3', 'groupId': 'OG002'}, {'value': '80.7', 'spread': '31.9', 'groupId': 'OG003'}, {'value': '79.9', 'spread': '27.3', 'groupId': 'OG004'}, {'value': '86.6', 'spread': '24.3', 'groupId': 'OG005'}]}]}, {'title': '5 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}, {'value': '261', 'groupId': 'OG002'}, {'value': '261', 'groupId': 'OG003'}, {'value': '262', 'groupId': 'OG004'}, {'value': '261', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '71.2', 'spread': '21.3', 'groupId': 'OG000'}, {'value': '85.9', 'spread': '21.5', 'groupId': 'OG001'}, {'value': '86.7', 'spread': '19.3', 'groupId': 'OG002'}, {'value': '83.1', 'spread': '29.4', 'groupId': 'OG003'}, {'value': '80.5', 'spread': '28.3', 'groupId': 'OG004'}, {'value': '84.8', 'spread': '26.0', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through 5 years', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects analyzed reduced over time due to attrition. Also, follow-up after 1 year was optional.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AMS Penile Prosthesis Recipients', 'description': 'Men for whom an AMS penile prosthesis is recommended\n\nAMS Penile Prosthesis Devices: Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1457'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1082'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '375'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Subject not implanted', 'reasons': [{'groupId': 'FG000', 'numSubjects': '76'}]}, {'type': 'Missed Visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '247'}]}, {'type': 'Site closed early-not compliance related', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Patient moved away from site', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Subject Incarcerated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1380', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'AMS Penile Prosthesis Recipients', 'description': 'Men for whom an AMS penile prosthesis is recommended\n\nAMS Penile Prosthesis Devices: Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.8', 'spread': '9.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1380', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '77', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1303', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '187', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '1152', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Primary ED etiology', 'classes': [{'categories': [{'title': 'Radical prostatectomy (RP)', 'measurements': [{'value': '369', 'groupId': 'BG000'}]}, {'title': 'Diabetes', 'measurements': [{'value': '283', 'groupId': 'BG000'}]}, {'title': 'Cardiovascular disease', 'measurements': [{'value': '251', 'groupId': 'BG000'}]}, {'title': 'Peyronies disease', 'measurements': [{'value': '123', 'groupId': 'BG000'}]}, {'title': 'Priaprism', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '335', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'AMS penile prosthesis recipients that completed baseline assessments. Subjects that started the study but did not have implantation are not included.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-17', 'size': 603692, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-12-13T18:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1457}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2018-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-25', 'studyFirstSubmitDate': '2011-06-24', 'resultsFirstSubmitDate': '2019-12-16', 'studyFirstSubmitQcDate': '2011-06-27', 'lastUpdatePostDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-05', 'studyFirstPostDateStruct': {'date': '2011-06-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Subject Reported 5-question International Index of Erectile Function (IIEF-5) Total Score, Baseline Through Five Years', 'timeFrame': 'Baseline through 5 years', 'description': '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.'}, {'measure': 'Erection Hardness Scale Over Five Years', 'timeFrame': 'Baseline through 5 years', 'description': '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.'}, {'measure': 'American Urology Association - Symptom Index Over Five Years', 'timeFrame': 'Baseline through 5 years', 'description': '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.'}, {'measure': 'UCLA Prostate Cancer Index Over Five Years', 'timeFrame': 'Baseline through 5 years', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Penile Prosthesis Overall Subject Satisfaction', 'timeFrame': '1 year, post-implantation', 'description': 'Penile prosthesis overall subject satisfaction (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.'}, {'measure': 'Number of Participants With Penile Prosthesis That Are Using the Device', 'timeFrame': '1 year, post implantation', 'description': '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.'}, {'measure': 'Number of Participants With Penile Prosthesis That Are Using the Device Indicating How Often Their Use is.', 'timeFrame': '1 year, post implantation', 'description': 'Penile prosthesis use at year (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.'}, {'measure': 'Number of Times Per Month Participants With Penile Prosthesis Are Using the Device.', 'timeFrame': '1 year, post implantation', 'description': '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.'}, {'measure': 'Number of Participants With Penile Prosthesis That Were Not Using the Device, Reasons for Non-use', 'timeFrame': '1 year, post implantation', 'description': '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.'}, {'measure': 'Number of Participants With Penile Prosthesis Using the Device But Not as Often as Desired', 'timeFrame': '1 year, post implantation', 'description': '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.'}, {'measure': 'Number of Participants With Penile Prosthesis That Are Using the Device Less Than Desired or Dissatisfied - Reason Device Used Less Than Desired or Dissatisfied', 'timeFrame': '1 year, post implantation', 'description': '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.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Erectile Dysfunction (ED)', 'Penile Implant', 'Impotence', 'Penile Prosthesis', 'Registry'], 'conditions': ['Erectile Dysfunction', 'Impotence']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men with ED in the United States and Canada.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMen 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:\n\n* Willing and able to provide written informed consent prior to enrollment (if applicable).\n* Willing to be seen or contacted by phone by the investigator and answer at least 2 questions related to satisfaction and device use 1 year following implantation of an AMS penile prosthesis.\n\nExclusion Criteria:\n\n\\- Men who are deemed by their physician to be not suitable for a penile implant will be excluded.'}, 'identificationModule': {'nctId': 'NCT01383018', 'acronym': 'PROPPER', 'briefTitle': 'PROPPER Prospective Registry of Outcomes With Penile Prosthesis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Prospective Registry of Outcomes With Penile Prosthesis for Erectile Restoration (PROPPER)', 'orgStudyIdInfo': {'id': 'U0552'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AMS penile prosthesis receipients', 'description': 'Men for whom an AMS penile prosthesis is recommended', 'interventionNames': ['Device: AMS Penile Prosthesis Devices']}], 'interventions': [{'name': 'AMS Penile Prosthesis Devices', 'type': 'DEVICE', 'otherNames': ['AMS 700', 'AMS Ambicor', 'AMS Spectra'], 'description': 'Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices.', 'armGroupLabels': ['AMS penile prosthesis receipients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Homewood', 'state': 'Alabama', 'country': 'United States', 'facility': 'Urology Centers of Alabama', 'geoPoint': {'lat': 33.47177, 'lon': -86.80082}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'El Camino Urology Medical Group', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '92154', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '62794-9664', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'SIU School of Medicine', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '71111', 'city': 'Bossier City', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ark-LA-Tek', 'geoPoint': {'lat': 32.51599, 'lon': -93.73212}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Clinic', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '78715', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'The Urology Team', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Urology San Antonio Research, PA', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Ottawa', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Gerard Henry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ark-LA-Tek'}, {'name': 'Anthony J. Bella, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ottawa'}, {'name': 'Edward Karpman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'El Camino Urology Medical Group'}, {'name': 'LeRoy Jones, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Urology San Antonio Research PA'}, {'name': 'Bryan T Kansas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Urology Team'}, {'name': 'Brian Christine, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Urology Centers of Alabama'}, {'name': 'Kevin McVary, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SIU School of Medicine'}, {'name': 'James Hotaling, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}, {'name': 'Mohit Khera, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}, {'name': 'Eugene Rhee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}