Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT01009333
Status:
COMPLETED
Last Update Posted:
2013-05-27
First Post:
2009-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
InterStim Therapy Programming Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053202', 'term': 'Urinary Incontinence, Urge'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'maureen.mcguire@medtronic.com', 'phone': '763-526-8425', 'title': 'Maureen McGuire, Sr. Program Manager', 'organization': 'Medtronic Neuromodulation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Low InterStim Rate Setting at 5.2 Hz', 'otherNumAtRisk': 13, 'otherNumAffected': 6, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Medium InterStim Rate Setting at 14 Hz', 'otherNumAtRisk': 12, 'otherNumAffected': 5, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'High InterStim Rate Setting at 25 Hz', 'otherNumAtRisk': 12, 'otherNumAffected': 7, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Bladder discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Change in sensation of stimulation', 'notes': 'Medtronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Faecal incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Hypertonic bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Micturition urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Muscle contractions involuntary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Painful defaecation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA (8.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Urinary Incontinent Episodes Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low InterStim Rate Setting at 5.2 Hz'}, {'id': 'OG001', 'title': 'Medium InterStim Rate Setting at 14 Hz'}, {'id': 'OG002', 'title': 'High InterStim Rate Setting at 25 Hz'}], 'classes': [{'categories': [{'measurements': [{'value': '3.83', 'spread': '2.27', 'groupId': 'OG000'}, {'value': '2.37', 'spread': '1.83', 'groupId': 'OG001'}, {'value': '2.82', 'spread': '2.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'three weeks', 'description': "In a diary, subjects are asked to rate each urine leaking episode at 'None', 'Slight', 'Moderate' or 'Heavy'. The urinary incontinence was counted if there is any degree of leaking, from 'Slight' to 'Heavy'. The total number of urinary incontinence was calculated per day.", 'unitOfMeasure': 'Episodes Per Day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from 12 subjects who completed the study were included in the efficacy analysis; data from 1 subject was excluded because the subject was not compliant with the study protocol and was subsequently withdrawn from the study. Data from all 13 subjects were used for safety reporting.'}, {'type': 'SECONDARY', 'title': 'Number of Voids Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low InterStim Rate Setting at 5.2 Hz'}, {'id': 'OG001', 'title': 'Medium InterStim Rate Setting at 14 Hz'}, {'id': 'OG002', 'title': 'High InterStim Rate Setting at 25 Hz'}], 'classes': [{'categories': [{'measurements': [{'value': '9.33', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '9.36', 'spread': '2.34', 'groupId': 'OG001'}, {'value': '9.57', 'spread': '2.28', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.589', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'three weeks', 'description': "In a diary, subjects are asked clarify each void as 'urine', 'fecal' or 'both'. Either 'urine' or 'both' are counted as void for this analysis. The total number of voids was calculated per day.", 'unitOfMeasure': 'Voids Per Day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from 12 subjects who completed the study were included in the efficacy analysis; data from 1 subject was excluded because the subject was not compliant with the study protocol and was subsequently withdrawn from the study. Data from all 13 subjects were used for safety reporting.'}, {'type': 'SECONDARY', 'title': 'Number of Pads Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low InterStim Rate Setting at 5.2 Hz'}, {'id': 'OG001', 'title': 'Medium InterStim Rate Setting at 14 Hz'}, {'id': 'OG002', 'title': 'High InterStim Rate Setting at 25 Hz'}], 'classes': [{'categories': [{'measurements': [{'value': '2.61', 'spread': '1.64', 'groupId': 'OG000'}, {'value': '1.84', 'spread': '1.43', 'groupId': 'OG001'}, {'value': '1.94', 'spread': '1.61', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'three weeks', 'description': 'In a diary, subjects are asked to provide number of pads they used per day.', 'unitOfMeasure': 'Pads Per Day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Start at 5.2 Hz, Then 14 Hz, Then 25 Hz', 'description': 'Participants started with Low InterStim Rate Setting at 5.2 Hz, then progressed to Medium InterStim Rate Setting at 14 Hz, then High InterStim Rate Settings at 25 Hz until they completed all three settings.'}, {'id': 'FG001', 'title': 'Start at 5.2 Hz, Then 25 Hz, Then 14 Hz', 'description': 'Participants started with Low InterStim Rate Setting at 5.2 Hz, then progressed to High InterStim Rate Setting at 25 Hz, then Medium InterStim Rate Settings at 14 Hz until they completed all three settings.'}, {'id': 'FG002', 'title': 'Start at 14 Hz, Then 5.2 Hz, Then 25 Hz', 'description': 'Participants started with Medium InterStim Rate Setting at 14 Hz, then progressed to Low InterStim Rate setting at 5.2 Hz, then High InterStim Rate Settings at 25 Hz until they completed all three settings.'}, {'id': 'FG003', 'title': 'Start at 14 Hz, Then 25 Hz, Then 5.2 Hz', 'description': 'Participants started with Medium InterStim Rate Setting at 14 Hz, then progressed to High InterStim Rate setting at 25 Hz, then Low InterStim Rate Settings at 5.2 Hz until they completed all three settings.'}, {'id': 'FG004', 'title': 'Start at 25 Hz, Then 5.2 Hz, Then 14 Hz', 'description': 'Participants started with High InterStim Rate Setting at 25 Hz, then progressed to Low InterStim Rate setting at 5.2 Hz, then Medium InterStim Rate Settings at 14 Hz until they completed all three settings.'}, {'id': 'FG005', 'title': 'Start at 25 Hz, Then 14 Hz, Then 5.2 Hz', 'description': 'Participants started with High InterStim Rate Setting at 25 Hz, then progressed to Medium InterStim Rate setting at 14 Hz, then Low InterStim Rate Settings at 5.2 Hz until they completed all three settings.'}], 'periods': [{'title': 'Week 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'comment': '1 participant did not progress to the second period due to a protocol violation.', 'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Week 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Week 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.9', 'spread': '6.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-17', 'studyFirstSubmitDate': '2009-11-02', 'resultsFirstSubmitDate': '2011-11-28', 'studyFirstSubmitQcDate': '2009-11-05', 'lastUpdatePostDateStruct': {'date': '2013-05-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-04-05', 'studyFirstPostDateStruct': {'date': '2009-11-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Urinary Incontinent Episodes Per Day', 'timeFrame': 'three weeks', 'description': "In a diary, subjects are asked to rate each urine leaking episode at 'None', 'Slight', 'Moderate' or 'Heavy'. The urinary incontinence was counted if there is any degree of leaking, from 'Slight' to 'Heavy'. The total number of urinary incontinence was calculated per day."}], 'secondaryOutcomes': [{'measure': 'Number of Voids Per Day', 'timeFrame': 'three weeks', 'description': "In a diary, subjects are asked clarify each void as 'urine', 'fecal' or 'both'. Either 'urine' or 'both' are counted as void for this analysis. The total number of voids was calculated per day."}, {'measure': 'Number of Pads Per Day', 'timeFrame': 'three weeks', 'description': 'In a diary, subjects are asked to provide number of pads they used per day.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['urgency frequency', 'urinary urge incontinence', 'InterStim Therapy'], 'conditions': ['Urgency Frequency', 'Urinary Urge Incontinence']}, 'descriptionModule': {'briefSummary': 'This study assessed the effect of different InterStim rate settings on voiding diary outcomes. Specifically, the study evaluated how 3 different rate settings affected the number of urinary incontinent episodes per day collected through a voiding diary. The study also evaluated how the 3 different rate settings affected other voiding diary measures including number of voids per day, degree of urgency before each void, number of pads used per day, and number of fecal incontinent episodes, questionnaires, and adverse events.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Implanted with either Neurostimulator Model 3023 (InterStim) or Neurostimulator Model 3058 (InterStim II) for at least 3 months - Implanted with tined lead models 3889 or 3093\n* Tined lead is located in S2, S3, or S4\n* Diagnosis before InterStim implant included urgency frequency (an average of 8 or more voids per day) and any amount of urinary urge incontinence over the voiding diary reporting period. The diary reporting period must be at least 2 days.\n* Able to tolerate (ie, no complaint of pain or discomfort) acute high InterStim rate setting\n* Able to tolerate (ie, no complaint of pain or discomfort) acute medium InterStim rate setting\n* Able to tolerate (ie, no complaint of pain or discomfort) acute low InterStim rate setting\n* Must be willing to maintain their current regimen (dosage and frequency) of any overactive bladder medication (anticholinergic or antimuscarinic) or tricyclic antidepression medication over the study duration\n* Female subject 18 years of age or older\n* Willing and able to accurately complete voiding diaries and questionnaires, attend visits, and comply with the study protocol that includes maintenance of InterStim programming settings over the course of the study.\n* Able to consent to participate by signing the Informed Consent Form\n\nExclusion Criteria:\n\n* Multiple sclerosis\n* Reiter\'s syndrome\n* Exclude diabetics unless the subject\'s diabetes is well-controlled with diet or medication\n* History of spinal cord injury or a cerebral vascular accident (CVA)\n* Active symptomatic urinary tract infection (UTI)\n* Stress incontinence as the primary diagnosis\n* Pelvic pain of uncertain etiology that is not associated with a voiding dysfunction or where pelvic pain is the primary complaint/diagnosis\n* Interstitial cystitis as the primary diagnosis\n* Urinary retention as the primary diagnosis\n* Treatment of urinary symptoms with botulinum toxin in the past 12 months or any plan to have botulinum toxin treatment during the study\n* Bilateral lead placement\n* Have other implantable neurostimulator, pacemaker, or defibrillator\n* Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or RF energy exposure\n* Have an anticipated system modification within the next 1 month\n* Women who are pregnant or planning to become pregnant or women of child-bearing potential who are not using a medically-acceptable method of birth control. Women of child-bearing age potential must undergo a pregnancy test, with a clear negative result, no more than 7 days prior to randomization visit.\n* Subjects who frequently use the patient programmer to change device program settings. "Frequently" is defined as at least once a day and does not include shutting off the device for safety purposes.\n* Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol\n* Study site personnel will contact the Medtronic Study Manager to determine if a potential subject who plans to enroll in another investigational device or drug trial, or is currently enrolled in an investigational device or drug trial is eligible for this study.'}, 'identificationModule': {'nctId': 'NCT01009333', 'briefTitle': 'InterStim Therapy Programming Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedtronicNeuro'}, 'officialTitle': 'InterStim Therapy Programming Study', 'orgStudyIdInfo': {'id': '1650'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low InterStim rate setting at 5.2 Hz', 'interventionNames': ['Device: InterStim Therapy at rate 5.2 Hz']}, {'type': 'EXPERIMENTAL', 'label': 'Medium InterStim rate setting at 14 Hz', 'interventionNames': ['Device: InterStim Therapy at rate 14 Hz']}, {'type': 'EXPERIMENTAL', 'label': 'High InterStim rate setting at 25 Hz', 'interventionNames': ['Device: InterStim Therapy']}], 'interventions': [{'name': 'InterStim Therapy at rate 5.2 Hz', 'type': 'DEVICE', 'description': 'All subjects enrolled in this study were programmed to this rate setting for a 1-week period.', 'armGroupLabels': ['Low InterStim rate setting at 5.2 Hz']}, {'name': 'InterStim Therapy at rate 14 Hz', 'type': 'DEVICE', 'description': 'All subjects enrolled in this study were programmed to this rate setting for a 1-week period.', 'armGroupLabels': ['Medium InterStim rate setting at 14 Hz']}, {'name': 'InterStim Therapy', 'type': 'DEVICE', 'description': 'All subjects enrolled in this study were programmed to each rate setting (low, medium, high) for a 1-week period.', 'armGroupLabels': ['High InterStim rate setting at 25 Hz']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Kenneth Peters, MD', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}], 'overallOfficials': [{'name': 'Maureen McGuire, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MedtronicNeuro'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedtronicNeuro', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}