Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-29 @ 3:32 AM
Study NCT ID:
NCT00200057
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005242', 'term': 'Fecal Incontinence'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chad.giese@medtronic.com', 'phone': '763-377-5955', 'title': 'Chad Giese', 'organization': 'Medtronic Neuromodulation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.', 'description': 'Adverse events listed below were collected after permanent implant of the device through the data cutoff date.', 'eventGroups': [{'id': 'EG000', 'title': 'Implanted Subjects', 'description': 'Subjects implanted with Sacral Nerve Stimulation (SNS) device.', 'otherNumAtRisk': 120, 'otherNumAffected': 88, 'seriousNumAtRisk': 120, 'seriousNumAffected': 41}], 'otherEvents': [{'term': 'Implant site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Faecal incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 35, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 20, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Implant site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 33, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Laboratory test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 13, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Change in sensation of stimulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}], 'seriousEvents': [{'term': 'Implant site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Perianal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Benign neoplasm of adrenal gland', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Breast cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Eating disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Carotid artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Cervical myelopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Rectal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Volvulus of bowel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Renal failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Vaginal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Implant site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Therapeutic product ineffective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Implant site erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Lead migration/dislodgment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implanted Subjects', 'description': 'Subjects implanted with Sacral Nerve Stimulation (SNS) device.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.73', 'groupId': 'OG000', 'lowerLimit': '0.64', 'upperLimit': '0.81'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '0.64', 'ciUpperLimit': '0.81', 'pValueComment': 'No multiplicity adjustments were made for the primary outcome analysis. Two-tailed p-values were considered statistically significant if they were less than 0.05.', 'groupDescription': 'The exact Binomial test (two-sided) for one-sample proportions was used to test the null hypothesis that the success rate is equal to 0.5.', 'statisticalMethod': 'Exact Binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'The primary efficacy objective was to demonstrate that at least 50% of subjects will achieve at least 50% reduction in the number of fecal incontinent episodes per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of fecal incontinent episodes per week at 12 months post-implant compared to baseline are considered "successes."\n\nThe observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of incontinent episodes per week from baseline to twelve months.', 'unitOfMeasure': 'proportion of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who were successfully implanted were included in the analysis. A modified worst-case analysis was used for missing data, where all subjects who were missing 12-month data were classified as failures, unless there was a subsequent diary available, in which case the subsequent diary was substituted for the missing 12-month data.'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Days Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implanted Subjects', 'description': 'Subjects implanted with Sacral Nerve Stimulation (SNS) device.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.73', 'groupId': 'OG000', 'lowerLimit': '0.64', 'upperLimit': '0.81'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '0.64', 'ciUpperLimit': '0.81', 'pValueComment': 'The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.', 'groupDescription': 'The exact Binomial test (two-sided) for one-sample proportions was used to test the null hypothesis that the success rate is equal to 0.5.', 'statisticalMethod': 'Exact Binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'This secondary objective was to demonstrate that at least 50% of subjects achieved at least 50% reduction in the number of incontinent days per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of fecal incontinent days per week at 12 months post-implant compared to baseline are considered "successes."\n\nThe observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of incontinent days per week from baseline to twelve months.', 'unitOfMeasure': 'proportion of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who were successfully implanted were included in the analysis. A modified worst-case analysis was used for missing data, where all subjects who were missing 12-month data were classified as failures unless there was a subsequent diary available, in which case the subsequent diary was substituted for the missing 12-month data.'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life From Baseline to 12 Months: Scale 1 - Lifestyle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implanted Subjects', 'description': 'Subjects implanted with Sacral Nerve Stimulation (SNS) device.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.92', 'spread': '0.92', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who were successfully implanted were included in the analysis. The modified worst-case analysis was used to account for subjects who did not complete the FIQOL questionnaire at either baseline or 12 months; these subjects were classified as no change from baseline.'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life From Baseline to 12 Months: Scale 2 - Coping/Behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implanted Subjects', 'description': 'Subjects implanted with Sacral Nerve Stimulation (SNS) device.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.12', 'spread': '0.99', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 Months', 'description': 'This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who were successfully implanted were included in the analysis. The modified worst-case analysis was used to account for subjects who did not complete the FIQOL questionnaire at either baseline or 12 months; these subjects were classified as no change from baseline.'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life From Baseline to 12 Months: Scale 3 - Depression/Self-Perception', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implanted Subjects', 'description': 'Subjects implanted with Sacral Nerve Stimulation (SNS) device.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.86', 'spread': '0.96', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 Months', 'description': 'This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who were successfully implanted were included in the analysis. The modified worst-case analysis was used to account for subjects who did not complete the FIQOL questionnaire at either baseline or 12 months; these subjects were classified as no change from baseline.'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life From Baseline to 12 Months: Scale 4 - Embarrassment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implanted Subjects', 'description': 'Subjects implanted with Sacral Nerve Stimulation (SNS) device.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.06', 'spread': '1.00', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 Months', 'description': 'This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who were successfully implanted were included in the analysis. The modified worst-case analysis was used to account for subjects who did not complete the FIQOL questionnaire at either baseline or 12 months; these subjects were classified as no change from baseline.'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With at Least 50% Reduction in Number of Urgent Incontinent Episodes Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implanted Subjects', 'description': 'Subjects implanted with Sacral Nerve Stimulation (SNS) device.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.71', 'groupId': 'OG000', 'lowerLimit': '0.62', 'upperLimit': '0.79'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.62', 'ciUpperLimit': '0.79', 'pValueComment': 'The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.', 'groupDescription': 'The exact Binomial test (two-sided) for one-sample proportions was used to test the null hypothesis that the success rate is equal to 0.5.', 'statisticalMethod': 'Exact Binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'This secondary objective was to demonstrate that at least 50% of subjects achieved at least 50% reduction in the number of urgent incontinent episodes per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of urgent fecal incontinent episodes per week at 12 months post-implant compared to baseline are considered "successes."\n\nThe observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of urgent incontinent episodes per week from baseline to 12 months.', 'unitOfMeasure': 'proportion of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who were successfully implanted were included in this analysis. The modified worst-case analysis for missing data was used, so that all subjects with missing 12-month data were classified as failures, unless there was a subsequent diary available, in which case the subsequent diary was substituted for the missing 12-month data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Implanted Subjects', 'description': 'Subjects implanted with Sacral Nerve Stimulation (SNS) device.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}]}, {'type': '1 Month Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '117'}]}, {'type': '3 Month Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}]}, {'type': '6 Month Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}]}, {'type': '12 Month Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Exited due to terminal illness of PI', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Change in medical condition', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Infection', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The clinical investigation began on January 14, 2002, and the first implant occurred on May 03, 2002. The study was closed to enrollments on June 15, 2006, and the last implant occurred on August 04, 2006.', 'preAssignmentDetails': 'All patients who signed an informed consent were considered enrolled in the study. Of the 285 subjects who enrolled in the study, 132 subjects underwent acute test stimulation with 129 proceeding to the sub-chronic test stimulation phase. Of these, 120 subjects qualified for permanent implant. All 120 patients were successfully implanted.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Implanted Subjects', 'description': 'Subjects implanted with Sacral Nerve Stimulation (SNS) device.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '71', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.5', 'spread': '12.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '110', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weekly Fecal Incontinent Episodes', 'classes': [{'categories': [{'measurements': [{'value': '9.39', 'spread': '7.27', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'A bowel diary was used by subjects to record information about their bowel elimination frequency. Over the 14-day diary period, subjects recorded the date and time of each bowel episode and responded to questions related to each bowel episode, including amount of incontinence (none, staining, minor soiling, major soiling) and urgency (no, yes). A bowel movement was considered incontinent if the amount of incontinence was minor or major soiling.', 'unitOfMeasure': 'incontinent episodes per week', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weekly Fecal Incontinent Days', 'classes': [{'categories': [{'measurements': [{'value': '4.51', 'spread': '1.61', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'A bowel diary was used by subjects to record information about their bowel elimination frequency. Over the 14-day diary period, subjects recorded the date and time of each bowel episode and responded to questions related to each bowel episode, including amount of incontinence (none, staining, minor soiling, major soiling) and urgency (no, yes). A bowel movement was considered incontinent if the amount of incontinence was minor or major soiling. A day in a diary period was considered as an incontinent day if there was at least one incontinent episode during that day.', 'unitOfMeasure': 'incontinent days per week', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weekly Urgent Fecal Incontinent Episodes', 'classes': [{'categories': [{'measurements': [{'value': '4.95', 'spread': '4.88', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'A bowel diary was used by subjects to record information about their bowel elimination frequency. Over the 14-day diary period, subjects recorded the date and time of each bowel episode and responded to questions related to each episode, including amount of incontinence (none, staining, minor soiling, major soiling) and urgency (no, yes). A bowel movement was considered incontinent if the amount of incontinence was minor or major soiling. A bowel movement was considered urgent if the answer to the urgency question was yes and it was associated with incontinence.', 'unitOfMeasure': 'urgent incontinent episodes per week', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fecal Incontinence Quality of Life (FIQOL) Scale 1 - Lifestyle', 'classes': [{'categories': [{'measurements': [{'value': '2.31', 'spread': '0.85', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline measure from all subjects who were successfully implanted and completed the Fecal Incontinence Quality of Life (FIQOL) at baseline, n=119. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FIQOL Scale 2 - Coping/Behavior', 'classes': [{'categories': [{'measurements': [{'value': '1.49', 'spread': '0.53', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline measure from all subjects who were successfully implanted and completed the FIQOL at baseline, n=119. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FIQOL Scale 3 - Depression/Self-Perception', 'classes': [{'categories': [{'measurements': [{'value': '2.53', 'spread': '0.81', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline measure from all subjects who were successfully implanted and completed the FIQOL at baseline, n=119. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FIQOL Scale 4 - Embarrassment', 'classes': [{'categories': [{'measurements': [{'value': '1.60', 'spread': '0.63', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline measure from all subjects who were successfully implanted and completed the FIQOL at baseline, n=119. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 285}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'dispFirstSubmitDate': '2010-05-07', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-17', 'studyFirstSubmitDate': '2005-09-12', 'dispFirstSubmitQcDate': '2011-03-29', 'resultsFirstSubmitDate': '2011-04-13', 'studyFirstSubmitQcDate': '2005-09-12', 'dispFirstPostDateStruct': {'date': '2011-04-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-01-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-29', 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week', 'timeFrame': 'Baseline and 12 months', 'description': 'The primary efficacy objective was to demonstrate that at least 50% of subjects will achieve at least 50% reduction in the number of fecal incontinent episodes per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of fecal incontinent episodes per week at 12 months post-implant compared to baseline are considered "successes."\n\nThe observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of incontinent episodes per week from baseline to twelve months.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Days Per Week', 'timeFrame': 'Baseline and 12 months', 'description': 'This secondary objective was to demonstrate that at least 50% of subjects achieved at least 50% reduction in the number of incontinent days per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of fecal incontinent days per week at 12 months post-implant compared to baseline are considered "successes."\n\nThe observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of incontinent days per week from baseline to twelve months.'}, {'measure': 'Change in Quality of Life From Baseline to 12 Months: Scale 1 - Lifestyle', 'timeFrame': 'Baseline and 12 months', 'description': 'This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.'}, {'measure': 'Change in Quality of Life From Baseline to 12 Months: Scale 2 - Coping/Behavior', 'timeFrame': 'Baseline and 12 Months', 'description': 'This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.'}, {'measure': 'Change in Quality of Life From Baseline to 12 Months: Scale 3 - Depression/Self-Perception', 'timeFrame': 'Baseline and 12 Months', 'description': 'This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.'}, {'measure': 'Change in Quality of Life From Baseline to 12 Months: Scale 4 - Embarrassment', 'timeFrame': 'Baseline and 12 Months', 'description': 'This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.'}, {'measure': 'Proportion of Subjects With at Least 50% Reduction in Number of Urgent Incontinent Episodes Per Week', 'timeFrame': 'Baseline and 12 months', 'description': 'This secondary objective was to demonstrate that at least 50% of subjects achieved at least 50% reduction in the number of urgent incontinent episodes per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of urgent fecal incontinent episodes per week at 12 months post-implant compared to baseline are considered "successes."\n\nThe observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of urgent incontinent episodes per week from baseline to 12 months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fecal Incontinence', 'InterStim'], 'conditions': ['Fecal Incontinence']}, 'referencesModule': {'references': [{'pmid': '20160636', 'type': 'RESULT', 'citation': 'Wexner SD, Coller JA, Devroede G, Hull T, McCallum R, Chan M, Ayscue JM, Shobeiri AS, Margolin D, England M, Kaufman H, Snape WJ, Mutlu E, Chua H, Pettit P, Nagle D, Madoff RD, Lerew DR, Mellgren A. Sacral nerve stimulation for fecal incontinence: results of a 120-patient prospective multicenter study. Ann Surg. 2010 Mar;251(3):441-9. doi: 10.1097/SLA.0b013e3181cf8ed0.'}, {'pmid': '20354809', 'type': 'RESULT', 'citation': 'Wexner SD, Hull T, Edden Y, Coller JA, Devroede G, McCallum R, Chan M, Ayscue JM, Shobeiri AS, Margolin D, England M, Kaufman H, Snape WJ, Mutlu E, Chua H, Pettit P, Nagle D, Madoff RD, Lerew DR, Mellgren A. Infection rates in a large investigational trial of sacral nerve stimulation for fecal incontinence. J Gastrointest Surg. 2010 Jul;14(7):1081-9. doi: 10.1007/s11605-010-1177-z. Epub 2010 Mar 31.'}]}, 'descriptionModule': {'briefSummary': 'Fecal incontinence (FI) is a difficulty in storing gas, liquid stool or solid stool (bowel movement) in order to expel it at a proper time and place. Patients who suffer from FI may experience passive FI (difficulty in sensing stool in the rectum) or urgency (able to sense a bowel movement but cannot hold the stool until an acceptable time and place). FI is not a life-threatening disease, but it is often profoundly distressing and socially incapacitating.\n\nIf a patient is suffering with symptoms of chronic FI despite trying oral medications, biofeedback and/or other more conservative treatments, a patient may be eligible to participate in a clinical research study to evaluate the safety and effectiveness of sacral nerve stimulation for the treatment of chronic fecal incontinence. One hundred-twenty (120) patients will be implanted with medical devices and followed closely for twelve months, and then once a year after that until the study closes. There are up to 20 centers in the United States.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed and dated informed consent.\n* 18 years of age or older.\n* Patient is diagnosed with chronic fecal incontinence of a duration greater than 6 months (\\>12 months post-vaginal childbirth) and defined as \\> 2 incontinent episodes on average per week of more than staining recorded during the baseline diary period.\n* Failed or are not candidates for more conservative treatments.\n* Willing and competent to completely and accurately fill out bowel diaries and questionnaires throughout the study.\n\nExclusion Criteria:\n\n* Congenital anorectal malformations.\n* Active participation in another bowel disorder investigational study.\n* Present rectal prolapse.\n* Previous rectal surgery (such as rectopexy or resection) or sphincteroplasty done \\< 12 months prior to study enrollment (24 months for cancer).\n* Neurological diseases such as clinically significant peripheral neuropathy or complete spinal cord injury (i.e. paraplegia).\n* Grade III hemorrhoids.\n* Known or suspected organic disorders of the bowel (i.e. Inflammatory bowel disease such as Crohn's or ulcerative colitis).\n* Chronic watery diarrhea, unmanageable by drugs or diet, as primary cause of fecal incontinence. (Incontinent episodes with a Bristol stool consistency of \\> 6 for \\> 4 days during the baseline diary period will be exclusionary, unless the investigator determines that the diary is not indicative of chronic watery diarrhea.)\n* Pregnancy or planned pregnancy.\n* Patients for whom patient materials are not available in a language understood by the patient.\n* Life expectancy of less than one year.\n* Patient characteristics indicating a poor understanding of the study or poor compliance with the study protocol (i.e., patients unable to adequately operate equipment, patients unwilling or unable to return for scheduled follow-up visits).\n* Patients with a history of pelvic irradiation who present with visible or functional effects of irradiation.\n* Patients with active anal abscesses or fistulas.\n* Patients with anatomical limitations that would prevent the successful placement of an electrode.\n* Patients with knowledge of planned MRIs, diathermy, microwave, or RF energy.\n* Patients with other implantable neurostimulators, pacemakers or defibrillators.\n* Defect of external anal sphincter of \\>60 degrees or amenable to surgical repair."}, 'identificationModule': {'nctId': 'NCT00200057', 'briefTitle': 'Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedtronicNeuro'}, 'officialTitle': 'Medtronic InterStim® Sacral Nerve Stimulation Therapy for Bowel Control: Fecal Incontinence Study', 'orgStudyIdInfo': {'id': 'G010206'}}, 'armsInterventionsModule': {'interventions': [{'name': 'InterStim Sacral Nerve Stimulation Therapy', 'type': 'DEVICE', 'description': 'Open label study. All subjects that qualify for the study will be implanted.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Contact Medtronic for specific site information', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Contact Medtronic for specific site information', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Contact Medtronic for specific site information', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'facility': 'Contact Medtronic for specific site information', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Contact Medtronic for specific site information', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Contact Medtronic for specific site information', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Contact Medtronic for specific site information', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Contact Medtronic for specific site information', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Contact Medtronic for specific site information', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Contact Medtronic for specific site information', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Contact Medtronic for specific site information', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Contact Medtronic for specific site information', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'city': 'Fleurimont', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Contact Medtronic for specific site information', 'geoPoint': {'lat': 45.40842, 'lon': -71.83796}}], 'overallOfficials': [{'name': 'Sudha Iyer, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medtronic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedtronicNeuro', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Sudha Iyer, Clinical Research Manager', 'oldOrganization': 'Medtronic'}}}}