Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-02-20 @ 10:45 PM
Study NCT ID:
NCT00904969
Status:
COMPLETED
Last Update Posted:
2018-01-30
First Post:
2009-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Pre-Market Study of the American Medical Systems (AMS) Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053825', 'term': 'Suburethral Slings'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'laura.olson2@bsci.com', 'phone': '952-930-6000', 'title': 'Laura Olson, Clinical Project Manager', 'organization': 'American Medical System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected at the implant, 6 weeks, 3 month, 6 month, 12 month, and 24 month visits.', 'description': 'Only adverse events related to the study device or procedure are displayed.', 'eventGroups': [{'id': 'EG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.', 'otherNumAtRisk': 50, 'otherNumAffected': 25, 'seriousNumAtRisk': 50, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Pain/ Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other: Internal'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other: Internal'}, {'term': 'Urinary Incontinence - Persistent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other: Internal'}, {'term': 'Urinary Urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other: Internal'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other: Internal'}, {'term': 'Post-Void Dribbling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other: Internal'}, {'term': 'Pain/ Discomfort With Erections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other: Internal'}, {'term': 'Urinary Incontinence - De Novo Stress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other: Internal'}, {'term': 'Scrotal Pain/ Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other: Internal'}, {'term': 'Groin Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other: Internal'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other: Internal'}, {'term': 'Decreased Penile Sensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other: Internal'}, {'term': 'Edema of Penis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other: Internal'}, {'term': 'Light Post-Op Bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other: Internal'}, {'term': 'Penile Pain with Orgasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other: Internal'}, {'term': 'Worsening Incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other: Internal'}], 'seriousEvents': [{'term': 'Urinary Incontinence - Persistant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other: Internal'}, {'term': 'Intra-operative Bleeding of Aberrant Vessel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other: Internal'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Procedural Endpoint: Procedure Time From First Incision to Closing.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.8', 'spread': '25.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During Procedure, Approximately 60 Minutes', 'description': 'Characterize procedure time from first incision to closing.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Procedural Endpoint: Type of Anesthesia Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.'}], 'classes': [{'title': 'General', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': 'Spinal', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During Procedure, Approximately 60 Minutes', 'description': 'Describe the type of anesthesia used.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Procedural Endpoint: Rate of Foley Catheter Use - Intraoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During Procedure, Approximately 60 Minutes', 'description': 'Number of participants requiring the use of a foley catheter intra-operatively.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Procedural Endpoint: Rate of Foley Catheter Use - Post-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'post-operative to discharge', 'description': 'Number of participants requiring the use of a foley catheter who were able to void prior to discharge.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Procedural Endpoint: Rate of Foley Catheter Use - Post-discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.'}], 'classes': [{'title': 'No instructions', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Intermittent self-catheterization', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Foley catheter', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'post discharge', 'description': 'Number of participants requiring the use of a foley catheter post-discharge following Bladder Management instructions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Procedural Endpoint: Descriptive Procedural Parameters - Use of Tack Sutures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.'}], 'classes': [{'title': 'Tack suture used', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Corpus spongiosum', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'Perineal body', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Other tack suture', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During Procedure, Approximately 60 Minutes', 'description': 'Characterize procedural parameters including the use of tack sutures.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Procedural Endpoint: Descriptive Procedural Parameters - Muscle Dissection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During Procedure, Approximately 60 Minutes', 'description': 'Characterize procedural parameters, including muscle dissection across all participants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Procedural Endpoint: Descriptive Procedural Parameters - Movement of Urethral Bulb While Tensioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.'}], 'classes': [{'title': '2 cm', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': '3 cm', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': '> 3 cm', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During Procedure, Approximately 60 Minutes', 'description': 'Characterize procedural parameters, including the movement of urethral bulb while tensioning in all participants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Device Success as Defined as Successful Placement of the Device in Desired Position Peri-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During Procedure, Approximately 60 Minutes', 'description': 'Summarize device success as defined as a successful placement of the device in a desired position, peri-operatively, in participants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subject Satisfaction Endpoint: 1-Hour Pad Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.4', 'spread': '102.3', 'groupId': 'OG000'}]}]}, {'title': '3 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.9', 'spread': '24.2', 'groupId': 'OG000'}]}]}, {'title': '6 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.6', 'spread': '49.5', 'groupId': 'OG000'}]}]}, {'title': '12 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.8', 'spread': '29.7', 'groupId': 'OG000'}]}]}, {'title': '24 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.0', 'spread': '67.0', 'groupId': 'OG000'}]}]}, {'title': '24 Month LOCF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.2', 'spread': '59.2', 'groupId': 'OG000'}]}]}, {'title': '24 Month WCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.5', 'spread': '76.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 24 month', 'description': 'Summarize subject satisfaction of 1-hour pad weight for participants.', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Last observation carried forward (LOCF) and worst case scenario (WCS) data are derived from data from the 24 month visit'}, {'type': 'SECONDARY', 'title': 'Subject Satisfaction Endpoint: 24-Hour Pad Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '377.2', 'spread': '657.5', 'groupId': 'OG000'}]}]}, {'title': '3 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '108.0', 'spread': '191.7', 'groupId': 'OG000'}]}]}, {'title': '6 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53.7', 'spread': '99.1', 'groupId': 'OG000'}]}]}, {'title': '12 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42.0', 'spread': '92.3', 'groupId': 'OG000'}]}]}, {'title': '24 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38.3', 'spread': '58.8', 'groupId': 'OG000'}]}]}, {'title': '24 Month LOCF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73.0', 'spread': '131.2', 'groupId': 'OG000'}]}]}, {'title': '24 Month WCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '110.0', 'spread': '244.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 24 month', 'description': 'Summarize subject satisfaction with 24-hour pad weight across participants.', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF and WCS data are derived from data from the 24 month visit'}, {'type': 'SECONDARY', 'title': 'Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '3 Month', 'description': '3 Month Follow-Up Visit'}, {'id': 'OG001', 'title': '6 Month', 'description': '6 Month Follow-Up Visit'}, {'id': 'OG002', 'title': '12 Month', 'description': '12 Month Follow-Up Visit'}, {'id': 'OG003', 'title': '24 Month', 'description': '24 Month Follow-Up Visit'}, {'id': 'OG004', 'title': '24 Month LOCF', 'description': '24 Month Visit using Last Observation Carried Forward'}, {'id': 'OG005', 'title': '24 Month WCS', 'description': '24 Month Visit using Worse Case Scenario'}], 'classes': [{'title': '1-Hour ≥ 25% Reduction in Pad Weight', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '34', 'groupId': 'OG005'}]}]}, {'title': '1-Hour ≥ 50% Reduction in Pad Weight', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}]}]}, {'title': '1-Hour ≥ 75% Reduction in Pad Weight', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 24 month', 'description': 'Summarize the percent of subjects that have a decrease of pad weight of 25%, 50%, or 75% at follow-up (1-hour pad weight test used).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '3 Month', 'description': '3 Month Follow-Up Visit'}, {'id': 'OG001', 'title': '6 Month', 'description': '6 Month Follow-Up Visit'}, {'id': 'OG002', 'title': '12 Month', 'description': '12 Month Follow-Up Visit'}, {'id': 'OG003', 'title': '24 Month', 'description': '24 Month Follow-Up Visit'}, {'id': 'OG004', 'title': '24 Month LOCF', 'description': '24 Month Visit using Last Observation Carried Forward'}, {'id': 'OG005', 'title': '24 Month WCS', 'description': '24 Month Visit using Worse Case Scenario'}], 'classes': [{'title': '24-Hour ≥ 25% Reduction in Pad Weight', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}]}]}, {'title': '24-Hour ≥ 50% Reduction in Pad Weight', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '34', 'groupId': 'OG005'}]}]}, {'title': '24-Hour ≥ 75% Reduction in Pad Weight', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 24 Month', 'description': 'Summarize the percent of subjects that have a decrease of pad weight of 25%, 50%, or 75% at follow-up (24-hour pad weight test used).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subject Satisfaction Endpoint: Pads Per Day Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '0-1 PPD', 'description': '0-1 Pads per Day Use'}, {'id': 'OG001', 'title': '2-3 PPD', 'description': '2-3 Pads per Day Use'}, {'id': 'OG002', 'title': '4-5 PPD', 'description': '4-5 Pads per Day Use'}, {'id': 'OG003', 'title': '6-7 PPD', 'description': '6-7 Pads per Day Use'}, {'id': 'OG004', 'title': '>= 10 PPD', 'description': 'Greater than or equal to 10 Pads per Day Use'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '6 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': '3 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '6 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '12 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '24 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '24 Month LOCF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': '24 Month WCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to 24 Months', 'description': 'Summarize the subject satisfaction using pads per day use collected in follow-up in participants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF and WCS data are derived from data from the 24 month visit'}, {'type': 'SECONDARY', 'title': 'Subject Satisfaction Endpoint: Quality of Life I-QOL Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.3', 'spread': '22.4', 'groupId': 'OG000'}]}]}, {'title': '3 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.2', 'spread': '20.9', 'groupId': 'OG000'}]}]}, {'title': '6 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.4', 'spread': '21.6', 'groupId': 'OG000'}]}]}, {'title': '12 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.9', 'spread': '22.9', 'groupId': 'OG000'}]}]}, {'title': '24 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82.4', 'spread': '18.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 24 Months', 'description': "The Incontinence Quality of Life (I-QOL) questionnaire contains 22 items, each with a 5-point Likert-type response scale, evaluating a subject's quality of life with respect to his urinary problems or incontinence. A possible total score can be 0-100, with a higher score meaning less problems.", 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects that did not have test performed at follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Subject Satisfaction Endpoint: Quality of Life International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.7', 'spread': '4.1', 'groupId': 'OG000'}]}]}, {'title': '3 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.6', 'spread': '5.6', 'groupId': 'OG000'}]}]}, {'title': '6 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.6', 'spread': '5.7', 'groupId': 'OG000'}]}]}, {'title': '12 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.3', 'spread': '5.8', 'groupId': 'OG000'}]}]}, {'title': '24 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.5', 'spread': '5.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 24 Months', 'description': "The ICIQ-SF questionnaire evaluates the impact of urinary incontinence on quality of life through four questions that evaluate the frequency, severity and impact of urinary incontinence. A set of eight self-diagnosis items related to the causes or situations of urinary incontinence experienced by the subject are also assessed. Scores may range from 0 to 21. Improvement in the subject's quality of life from baseline to follow-up is indicated by a decrease in the ICIQ-SF score.", 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects that did not have test performed at follow-up visit.'}, {'type': 'POST_HOC', 'title': 'Uroflow Studies: Peak Flow Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.8', 'spread': '11.3', 'groupId': 'OG000'}]}]}, {'title': '3 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.9', 'spread': '13.5', 'groupId': 'OG000'}]}]}, {'title': '6 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.8', 'spread': '13.8', 'groupId': 'OG000'}]}]}, {'title': '12 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.4', 'spread': '8.4', 'groupId': 'OG000'}]}]}, {'title': '24 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.1', 'spread': '8.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 24 month', 'description': 'Baseline uroflow measurements including peak flow rates, average flow rates, voided volume, and post-void residual were compared to follow-up results at 3, 6, 12, and 24 months.', 'unitOfMeasure': 'ml/sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects that did not have test performed at follow-up visit.'}, {'type': 'POST_HOC', 'title': 'Uroflow Studies: Average Flow Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.0', 'spread': '6.0', 'groupId': 'OG000'}]}]}, {'title': '3 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.1', 'spread': '7.0', 'groupId': 'OG000'}]}]}, {'title': '6 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.3', 'spread': '9.8', 'groupId': 'OG000'}]}]}, {'title': '12 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.9', 'spread': '4.9', 'groupId': 'OG000'}]}]}, {'title': '24 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.5', 'spread': '5.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 24 Month', 'description': 'Baseline uroflow measurements including peak flow rates, average flow rates, voided volume, and post-void residual were compared to follow-up results at 3, 6, 12, and 24 months.', 'unitOfMeasure': 'ml/sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects that did not have test performed at follow-up visit.'}, {'type': 'POST_HOC', 'title': 'Uroflow Studies: Voided Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '280.8', 'spread': '112.4', 'groupId': 'OG000'}]}]}, {'title': '3 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '263.0', 'spread': '142.6', 'groupId': 'OG000'}]}]}, {'title': '6 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '244.2', 'spread': '114.3', 'groupId': 'OG000'}]}]}, {'title': '12 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '248.7', 'spread': '134.4', 'groupId': 'OG000'}]}]}, {'title': '24 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '298.6', 'spread': '147.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 24 Months', 'description': 'Baseline uroflow measurements including peak flow rates, average flow rates, voided volume, and post-void residual were compared to follow-up results at 3, 6, 12, and 24 months.', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects that did not have test performed at follow-up visit.'}, {'type': 'POST_HOC', 'title': 'Uroflow Studies: Post-Void Residual', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.0', 'spread': '27.8', 'groupId': 'OG000'}]}]}, {'title': '3 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.7', 'spread': '31.1', 'groupId': 'OG000'}]}]}, {'title': '6 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.8', 'spread': '41.7', 'groupId': 'OG000'}]}]}, {'title': '12 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.1', 'spread': '30.0', 'groupId': 'OG000'}]}]}, {'title': '24 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.2', 'spread': '28.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 24 Months', 'description': 'Baseline uroflow measurements including peak flow rates, average flow rates, voided volume, and post-void residual were compared to follow-up results at 3, 6, 12, and 24 months.', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects that did not have test performed at follow-up visit.'}, {'type': 'POST_HOC', 'title': 'Urodynamic Results: Bladder Capacity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '323.5', 'spread': '130.8', 'groupId': 'OG000'}]}]}, {'title': '6 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '349.4', 'spread': '136.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 Months Post implant', 'description': 'Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects that did not have test performed at follow-up visit.'}, {'type': 'POST_HOC', 'title': 'Urodynamics Results: Maximum Detrusor Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.9', 'spread': '27.4', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.3', 'spread': '21.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 Months Post Implant', 'description': 'Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.\n\nMaximum detrusor pressure is measured during a urodynamic study when tension is applied to the bladder wall (detrusor muscles) by filling the bladder to capacity with saline water and observing the detrusor muscle during filling of the bladder and voiding of the saline water.', 'unitOfMeasure': 'cm H2O', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects that did not have test performed at follow-up visit.'}, {'type': 'POST_HOC', 'title': 'Urodynamics Results: Pdet at Qmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.2', 'spread': '19.3', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.2', 'spread': '17.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 Months Post Implant', 'description': 'Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.\n\nMaximum detrusor pressure is measured during a urodynamic study when tension is applied to the bladder wall (detrusor muscles) by filling the bladder to capacity with saline water and observing the detrusor muscle during filling of the bladder and voiding of the saline water. Pdet at Qmax is the detrusor pressure at maximal flow rate when the bladder is full and the patient begins voiding.', 'unitOfMeasure': 'cm H20', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects that did not have test performed at follow-up visit.'}, {'type': 'POST_HOC', 'title': 'Urodynamics Results: Detrusor Instability, Started at Filling Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '225.8', 'spread': '159.9', 'groupId': 'OG000'}]}]}, {'title': '6 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '170.8', 'spread': '32.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 Months Post Implant', 'description': 'Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.\n\nDetrusor instability occurs when the detrusor muscle is unstable and spontaneously contracts the bladder.\n\nThe measure data table shows the mean volume at the start of the urodynamic measurement study for patients with detrusor instability.', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects that did not have test performed at follow-up visit.'}, {'type': 'POST_HOC', 'title': 'Urodynamics Results: Detrusor Instability, Max Pdet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.5', 'spread': '31.3', 'groupId': 'OG000'}]}]}, {'title': '6 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41.0', 'spread': '37.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 Months Post Implant', 'description': 'Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.\n\nMaximum detrusor pressure is measured during a urodynamic study when tension is applied to the bladder wall (detrusor muscles) by filling the bladder to capacity with saline water and observing the detrusor muscle during filling of the bladder and voiding of the saline water. Pdet at Qmax is the detrusor pressure at maximal flow rate when the bladder is full and the patient begins voiding.\n\nDetrusor instability occurs when the detrusor muscle is unstable and spontaneously contracts the bladder.\n\nThe outcome measure data table shows the Pdet for patients with detrusor instability.', 'unitOfMeasure': 'cm H2O', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects that did not have test performed at follow-up visit.'}, {'type': 'POST_HOC', 'title': 'Urodynamics Results: Abnormal Cystometrogram, Abnormal End Fill Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.0', 'spread': '8.3', 'groupId': 'OG000'}]}]}, {'title': '6 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.0', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 Months Post Implant', 'description': 'Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.\n\nAbnormal graphical representation of bladder pressure during urodynamics testing which is when the bladder is filled with saline water.', 'unitOfMeasure': 'cm H2O', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects that did not have test performed at follow-up visit.'}, {'type': 'POST_HOC', 'title': 'Urodynamic Results: Abdominal Leak Point Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.'}], 'classes': [{'title': 'Improved: leaked @ baseline, improved @ 6 months', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Improved: leaked @ baseline, no leak @ 6 months', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Unchanged: leaked same at baseline and 6 months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Unchanged: no leak @ baseline, no leak @ 6 months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Worsened: leaked @ baseline, leaked more at 6 mo', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Worsened: no leak @ baseline, leak @ 6 months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 6 Months Post Implant', 'description': 'Abdominal leak point pressure (ALPP) is one indicator of improvement in continence symptoms. Abdominal leak point pressure was collected at baseline and 6-month follow-up as part of the urodynamic assessment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '18 participants did not have 6-month follow-up data'}, {'type': 'SECONDARY', 'title': 'Subject Satisfaction Endpoint: Quality of Life UCLA (University of California Los Angeles) / RAND (RAND Corporation) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.1', 'spread': '14.3', 'groupId': 'OG000'}]}]}, {'title': '3 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.7', 'spread': '28.7', 'groupId': 'OG000'}]}]}, {'title': '6 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.9', 'spread': '28.8', 'groupId': 'OG000'}]}]}, {'title': '12 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57.4', 'spread': '29.1', 'groupId': 'OG000'}]}]}, {'title': '24 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57.3', 'spread': '27.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 24 Months', 'description': "Improvement in the subject's quality of life from baseline to follow-up is indicated by an increase in the UCLA/RAND urinary function score. Scores may range from 0 to 100.", 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects that did not have test performed at follow-up visit.'}, {'type': 'SECONDARY', 'title': "Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status", 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Completely Dry', 'description': 'Defined as "No leakage".'}, {'id': 'OG001', 'title': 'Substantially Improved', 'description': 'Defined as "May have periodic leakage of small amounts but additional protection not needed".'}, {'id': 'OG002', 'title': 'Some Additional Protection May be Required', 'description': 'Defined as "Up to three pads per day may be needed or may wet themselves not more than once weekly".'}, {'id': 'OG003', 'title': 'Substantially or Totally Incontinent', 'description': 'Defined as "Will require more than three pads per day or may wet themselves two or more times per week".'}], 'classes': [{'title': '6 Week', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': '3 Month', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': '6 Month', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': '12 Month', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': '24 Month', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 Weeks post implant to 24 Months', 'description': "Physician evaluation of subject's incontinence status at 6 weeks and subsequent follow-up evaluations", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Procedural and Device Complication Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Procedure to 24 Months Post implant', 'description': 'Percentage of participants with serious and non-serious adverse events.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Number of patients with an attempted implant; 1 subject with procedure aborted', 'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '\\# of Implanted Subjects Who Completed the Study', 'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Additional Treatments', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Case Aborted; Subject Exited', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '10 clinical Sites enrolled and implanted subjects. All subjects gave informed consent prior to enrollment and all implanted subjects met the inclusion / exclusion criteria. Enrollment into the study began in February 2006 and ended April 2007.', 'preAssignmentDetails': 'Subjects who meet the inclusion / exclusion criteria and were good surgical candidates were enrolled into the single arm study and were eligible to be implanted.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treated Participants', 'description': 'Participants in which a device placement was attempted.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.6', 'spread': '8.7', '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': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Primary etiology of intrinsic sphincter deficiency (ISD)', 'classes': [{'title': 'Post-Transurethral Resection of Prostate (TURP)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Radical Prostatectomy', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Years Since Surgery', 'classes': [{'title': '<=1995', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': '1996 - 2001', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': '2002-2004', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': '2005', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': '2006', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Duration of Incontinence Symptoms', 'classes': [{'categories': [{'measurements': [{'value': '57.2', 'spread': '76.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-03', 'studyFirstSubmitDate': '2009-05-18', 'resultsFirstSubmitDate': '2017-01-22', 'studyFirstSubmitQcDate': '2009-05-19', 'lastUpdatePostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-03', 'studyFirstPostDateStruct': {'date': '2009-05-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedural Endpoint: Procedure Time From First Incision to Closing.', 'timeFrame': 'During Procedure, Approximately 60 Minutes', 'description': 'Characterize procedure time from first incision to closing.'}, {'measure': 'Procedural Endpoint: Type of Anesthesia Used', 'timeFrame': 'During Procedure, Approximately 60 Minutes', 'description': 'Describe the type of anesthesia used.'}, {'measure': 'Procedural Endpoint: Rate of Foley Catheter Use - Intraoperative', 'timeFrame': 'During Procedure, Approximately 60 Minutes', 'description': 'Number of participants requiring the use of a foley catheter intra-operatively.'}, {'measure': 'Procedural Endpoint: Rate of Foley Catheter Use - Post-operative', 'timeFrame': 'post-operative to discharge', 'description': 'Number of participants requiring the use of a foley catheter who were able to void prior to discharge.'}, {'measure': 'Procedural Endpoint: Rate of Foley Catheter Use - Post-discharge', 'timeFrame': 'post discharge', 'description': 'Number of participants requiring the use of a foley catheter post-discharge following Bladder Management instructions.'}, {'measure': 'Procedural Endpoint: Descriptive Procedural Parameters - Use of Tack Sutures', 'timeFrame': 'During Procedure, Approximately 60 Minutes', 'description': 'Characterize procedural parameters including the use of tack sutures.'}, {'measure': 'Procedural Endpoint: Descriptive Procedural Parameters - Muscle Dissection', 'timeFrame': 'During Procedure, Approximately 60 Minutes', 'description': 'Characterize procedural parameters, including muscle dissection across all participants.'}, {'measure': 'Procedural Endpoint: Descriptive Procedural Parameters - Movement of Urethral Bulb While Tensioning', 'timeFrame': 'During Procedure, Approximately 60 Minutes', 'description': 'Characterize procedural parameters, including the movement of urethral bulb while tensioning in all participants.'}, {'measure': 'Device Success as Defined as Successful Placement of the Device in Desired Position Peri-operatively', 'timeFrame': 'During Procedure, Approximately 60 Minutes', 'description': 'Summarize device success as defined as a successful placement of the device in a desired position, peri-operatively, in participants.'}], 'secondaryOutcomes': [{'measure': 'Subject Satisfaction Endpoint: 1-Hour Pad Weight', 'timeFrame': 'Baseline to 24 month', 'description': 'Summarize subject satisfaction of 1-hour pad weight for participants.'}, {'measure': 'Subject Satisfaction Endpoint: 24-Hour Pad Weight', 'timeFrame': 'Baseline to 24 month', 'description': 'Summarize subject satisfaction with 24-hour pad weight across participants.'}, {'measure': 'Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test)', 'timeFrame': 'Baseline to 24 month', 'description': 'Summarize the percent of subjects that have a decrease of pad weight of 25%, 50%, or 75% at follow-up (1-hour pad weight test used).'}, {'measure': 'Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test)', 'timeFrame': 'Baseline to 24 Month', 'description': 'Summarize the percent of subjects that have a decrease of pad weight of 25%, 50%, or 75% at follow-up (24-hour pad weight test used).'}, {'measure': 'Subject Satisfaction Endpoint: Pads Per Day Use', 'timeFrame': 'Baseline to 24 Months', 'description': 'Summarize the subject satisfaction using pads per day use collected in follow-up in participants.'}, {'measure': 'Subject Satisfaction Endpoint: Quality of Life I-QOL Scores', 'timeFrame': 'Baseline to 24 Months', 'description': "The Incontinence Quality of Life (I-QOL) questionnaire contains 22 items, each with a 5-point Likert-type response scale, evaluating a subject's quality of life with respect to his urinary problems or incontinence. A possible total score can be 0-100, with a higher score meaning less problems."}, {'measure': 'Subject Satisfaction Endpoint: Quality of Life International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) Scores', 'timeFrame': 'Baseline to 24 Months', 'description': "The ICIQ-SF questionnaire evaluates the impact of urinary incontinence on quality of life through four questions that evaluate the frequency, severity and impact of urinary incontinence. A set of eight self-diagnosis items related to the causes or situations of urinary incontinence experienced by the subject are also assessed. Scores may range from 0 to 21. Improvement in the subject's quality of life from baseline to follow-up is indicated by a decrease in the ICIQ-SF score."}, {'measure': 'Subject Satisfaction Endpoint: Quality of Life UCLA (University of California Los Angeles) / RAND (RAND Corporation) Scores', 'timeFrame': 'Baseline to 24 Months', 'description': "Improvement in the subject's quality of life from baseline to follow-up is indicated by an increase in the UCLA/RAND urinary function score. Scores may range from 0 to 100."}, {'measure': "Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status", 'timeFrame': '6 Weeks post implant to 24 Months', 'description': "Physician evaluation of subject's incontinence status at 6 weeks and subsequent follow-up evaluations"}, {'measure': 'Procedural and Device Complication Rates', 'timeFrame': 'Procedure to 24 Months Post implant', 'description': 'Percentage of participants with serious and non-serious adverse events.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Urinary Incontinence, Stress', 'Intrinsic sphincter deficiency', 'Secondary', 'Transurethral Resection (TUR)', 'Transurethral Resection of the Prostate (TURP)', 'Radical prostatectomy', 'Open prostatectomy', 'Post-suprapubic prostatectomy'], 'conditions': ['Urinary Incontinence, Stress']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to obtain surgical technique data for use in physician education and training and to collect early clinical outcomes data for future publication.', 'detailedDescription': 'A multi-center study conducted under a common implant and follow-up protocol. The study will collect pre-operative urologic testing, medical history and subject quality of life (Incontinence Quality of Life Questionnaire). Intra-operative procedural data will be collected.\n\nPad weight and incontinence severity rating (using the International Consultation on Incontinence Questionnaire (ICIQ)) will be used to characterize continence status.\n\nPost-operative complications, urologic testing, and subject quality of life will be collected at six weeks and three, six, 12, and 24 months.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The subject has agreed to be implanted with the AMS Male Transobturator Sling System.\n2. The subject is willing and able to give valid informed consent.\n3. The subject is \\> 40 years of age.\n4. The subject has confirmed stress urinary incontinence for at least 6 months and uses no more than 8 pads per day for incontinence management.\n5. The subject has any of the following: an observable degree of incontinence during stress related activities, more than one pad is used in a 24 hour period, has more than two episodes of incontinence per day.\n6. Internal sphincter contractility confirmed by endoscopic view.\n7. The subject's primary etiology is TUR, TURP, radical prostatectomy, open prostatectomy, or suprapubic prostatectomy\n8. Pre-existing urological conditions, other than incontinence have been treated and are under control.\n9. The subject is willing and able to return for follow-up evaluations and questionnaire completion according to the study protocol.\n10. The subject is a good surgical candidate.\n\nExclusion Criteria:\n\n1. The subject has a neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods.\n2. The subject has an atonic bladder.\n3. The subject has a post-void residual \\> 75 cc.\n4. The subject has detrusor-external sphincter dyssynergia.\n5. The subject has a urinary tract infection (UTI).\n6. The subject was treated with pelvic radiation within the last 6 months.\n7. The subject currently has an inflatable penile prosthesis.\n8. The subject self-catheterizes.\n9. The subject has symptomatic or unstable bladder neck stricture disease.\n10. The subject has a history of urethral strictures that may require repetitive instrumentation.\n11. The subject has previously had a urethral Sling System, an AMS Sphincter 800™, or any implanted device for the treatment of urinary incontinence (not including bulking agents).\n12. The subject has a history of connective tissue or autoimmune conditions.\n13. The subject has a compromised immune system.\n14. The subject has renal insufficiency, and upper and/or lower urinary tract relative obstruction.\n15. The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials."}, 'identificationModule': {'nctId': 'NCT00904969', 'acronym': 'AMS051', 'briefTitle': 'A Pre-Market Study of the American Medical Systems (AMS) Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence', 'organization': {'class': 'INDUSTRY', 'fullName': 'American Medical Systems'}, 'officialTitle': 'A Pre-Market Study of the AMS Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence', 'orgStudyIdInfo': {'id': 'AMS051'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AMS Transobturator Male Sling System', 'interventionNames': ['Device: The AMS Male Transobturator Sling System', 'Device: AdVance Male Sling']}], 'interventions': [{'name': 'The AMS Male Transobturator Sling System', 'type': 'DEVICE', 'description': 'The AMS Male Transobturator Sling System was developed to treat urinary stress incontinence in men resulting from intrinsic sphincter deficiency (ISD) secondary to radical prostatectomy. The Male Transobturator Sling System procedure is minimally invasive and consists of using two single-use needle passers and passing them through two small incisions over the obturator foramen. The needles are pushed in an arc through the tissue and exited at a perineal incision. Once the passers are through the perineal incision, the Sling System mesh arms are attached to the needles which are then pulled back through the needle track to their points of origin over the obturator foramen. The Sling System is subsequently tensioned and all incisions are closed.', 'armGroupLabels': ['AMS Transobturator Male Sling System']}, {'name': 'AdVance Male Sling', 'type': 'DEVICE', 'otherNames': ['Male TO', 'transobturator sling', 'suburethral sling', 'retrourethral sling'], 'description': 'A transobturator sling for the treatment of post-prostatectomy incontinence', 'armGroupLabels': ['AMS Transobturator Male Sling System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90067', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Century City Docotrs Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80262', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'The University of Michigan HS', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'CHCS - Carolinas Medical Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '29572', 'city': 'Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Urologic Research Center', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Centennial Hospital', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'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': 'Christus Santa Rosa Hospital', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Norfolk General', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Gregory Bales, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago Hospital'}, {'name': 'Timothy Boone, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}, {'name': 'Karyn Eilber, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Century City Doctors Hospital'}, {'name': 'Brian J. Flynn, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado Health'}, {'name': 'Michael Guralnick, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wisconsin'}, {'name': 'Sender Herschorn, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Health Sciences Centre'}, {'name': 'LeRoy Jones, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRISTUS Health'}, {'name': 'Gerald Jordan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norfolk General'}, {'name': 'Michael Kennelly, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHCS - Carolinas Medical Center'}, {'name': 'Dean L. Knoll, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centennial Hospital'}, {'name': 'Edward McGuire, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Michigan HS'}, {'name': 'Brian Roberts, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carolina Urologic Research Center'}, {'name': 'George D. Webster, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data generated from this study may be used to support clinical publications, internal device documents for marketing and/or instructional manuals, etc.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American Medical Systems', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}