Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2026-01-05 @ 7:23 PM
Study NCT ID:
NCT03335761
Status:
COMPLETED
Last Update Posted:
2021-01-08
First Post:
2017-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
InterStim® Amplitude Study
Sponsor:
Organization:
Raw JSON
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{'email': 'mylene.champs@medtronic.com', 'phone': '+17635261627', 'title': 'Mylène Champs (Sr Clinical Research Specialist)', 'organization': 'Medtronic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From Post-Neurostimulator device implant to 12 weeks follow-up visit', 'description': 'Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study', 'eventGroups': [{'id': 'EG000', 'title': 'Amplitude Setting #1 = 50% Sensory Threshold', 'description': 'InterStim Therapy will be set to amplitude parameter #1 (50% Sensory Threshold)\n\nInterStim Therapy: Device Programming', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 3, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Amplitude Setting #2 = 80% Sensory Threshold', 'description': 'InterStim Therapy will be set to amplitude parameter #2 (80% Sensory Threshold)\n\nInterStim Therapy: Device Programming', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 1, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Amplitude Setting #3 = Sensory Threshold', 'description': 'InterStim Therapy will be set to amplitude parameter #3 (Sensory Threshold)\n\nInterStim Therapy: Device Programming', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 3, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Medical device site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'seriousEvents': [{'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Urinary Urge Incontinence (UUI) Episodes Per Day From Baseline to 12 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Amplitude Setting #1 = 50% Sensory Threshold', 'description': 'InterStim Therapy will be set to amplitude parameter #1 (50% Sensory Threshold)\n\nInterStim Therapy: Device Programming'}, {'id': 'OG001', 'title': 'Amplitude Setting #2 = 80% Sensory Threshold', 'description': 'InterStim Therapy will be set to amplitude parameter #2 (80% Sensory Threshold)\n\nInterStim Therapy: Device Programming'}, {'id': 'OG002', 'title': 'Amplitude Setting #3 = Sensory Threshold', 'description': 'InterStim Therapy will be set to amplitude parameter #3 (Sensory Threshold)\n\nInterStim Therapy: Device Programming'}], 'classes': [{'title': 'UUI episodes per day at Baseline', 'categories': [{'measurements': [{'value': '4.4', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '3.1', 'groupId': 'OG001'}, {'value': '5.1', 'spread': '4.7', 'groupId': 'OG002'}]}]}, {'title': 'UUI episodes per day at 12 weeks', 'categories': [{'measurements': [{'value': '1.4', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '3.0', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '2.3', 'groupId': 'OG002'}]}]}, {'title': 'Change in UUI episodes per day from baseline to 12 weeks', 'categories': [{'measurements': [{'value': '-3', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '2.9', 'groupId': 'OG001'}, {'value': '-3.6', 'spread': '2.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Symptoms related to OAB were evaluated using paper voiding diaries. Subjects were trained to complete the urinary voiding diaries for 3-days.', 'unitOfMeasure': 'UUI episodes/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete Case Subject Set'}, {'type': 'SECONDARY', 'title': 'Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Amplitude Setting #1 = 50% Sensory Threshold', 'description': 'InterStim Therapy will be set to amplitude parameter #1 (50% Sensory Threshold)\n\nInterStim Therapy: Device Programming'}, {'id': 'OG001', 'title': 'Amplitude Setting #2 = 80% Sensory Threshold', 'description': 'InterStim Therapy will be set to amplitude parameter #2 (80% Sensory Threshold)\n\nInterStim Therapy: Device Programming'}, {'id': 'OG002', 'title': 'Amplitude Setting #3 = Sensory Threshold', 'description': 'InterStim Therapy will be set to amplitude parameter #3 (Sensory Threshold)\n\nInterStim Therapy: Device Programming'}], 'classes': [{'title': 'Change in Coping from baseline to 12 weeks', 'categories': [{'measurements': [{'value': '44.4', 'spread': '30.4', 'groupId': 'OG000'}, {'value': '41.0', 'spread': '26.3', 'groupId': 'OG001'}, {'value': '39.4', 'spread': '27.9', 'groupId': 'OG002'}]}]}, {'title': 'Change in Concern from baseline to 12 weeks', 'categories': [{'measurements': [{'value': '48.2', 'spread': '28.9', 'groupId': 'OG000'}, {'value': '50.3', 'spread': '17', 'groupId': 'OG001'}, {'value': '49.9', 'spread': '30.2', 'groupId': 'OG002'}]}]}, {'title': 'Change in Sleep from baseline to 12 weeks', 'categories': [{'measurements': [{'value': '31.4', 'spread': '26.6', 'groupId': 'OG000'}, {'value': '37.8', 'spread': '22.7', 'groupId': 'OG001'}, {'value': '32.0', 'spread': '31.6', 'groupId': 'OG002'}]}]}, {'title': 'Change in Social from baseline to 12 weeks', 'categories': [{'measurements': [{'value': '20.9', 'spread': '25.0', 'groupId': 'OG000'}, {'value': '28.6', 'spread': '17', 'groupId': 'OG001'}, {'value': '20.6', 'spread': '19.9', 'groupId': 'OG002'}]}]}, {'title': 'Change in HRQL from baseline to 12 weeks', 'categories': [{'measurements': [{'value': '38.1', 'spread': '24.4', 'groupId': 'OG000'}, {'value': '40.5', 'spread': '16.7', 'groupId': 'OG001'}, {'value': '37.1', 'spread': '23.4', 'groupId': 'OG002'}]}]}, {'title': 'Change in Interference from baseline to 12 weeks', 'categories': [{'measurements': [{'value': '-5.2', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '-4.7', 'spread': '3.0', 'groupId': 'OG001'}, {'value': '-4.7', 'spread': '3.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'International Consultation on Incontinence Modular Questionnaire - Overactive Bladder Symptoms Quality of Life Questionnaire The questionnaire consists of 4 subscales and a single item on urinary symptom interference.\n\nThe four subscales of Concern (7 items), Coping (8 items), Sleep (5 items), and Social (5 items) are measured on a scale from 0-100 using a range percentile transformation on the summed value from individual listed items. The Health-Related Quality of Life (HRQL) score is a calculated score with a range from 0 to 100 using a range percentile transformation on the summed value from the subscales. Subjects were asked a urinary symptom interference question. "Interference" was measured on a scale from 0-10.\n\nA positive change in Concern, Coping, Sleep, Social, and HRQL indicates improvement in Quality of Life; a negative change in Interference indicates improvement in Quality of Life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete Case Subject Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Amplitude Setting #1 = 50% Sensory Threshold', 'description': 'InterStim Therapy will be set to amplitude parameter #1 (50% Sensory Threshold)\n\nInterStim Therapy: Device Programming'}, {'id': 'FG001', 'title': 'Amplitude Setting #2 = 80% Sensory Threshold', 'description': 'InterStim Therapy will be set to amplitude parameter #2 (80% Sensory Threshold)\n\nInterStim Therapy: Device Programming'}, {'id': 'FG002', 'title': 'Amplitude Setting #3 = Sensory Threshold', 'description': 'InterStim Therapy will be set to amplitude parameter #3 (Sensory Threshold)\n\nInterStim Therapy: Device Programming'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'Implanted With a Neurostimulator Device', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Out of 97 subjects enrolled in the study, 48 were randomized, 46 were implanted with a neurostimulator device, and 43 completed their 12 week follow-up visit before exiting the study. Nineteen were randomized to 50% of sensory threshold, 14 were randomized to 80% of sensory threshold, and 15 were randomized to sensory threshold.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Amplitude Setting #1 = 50% Sensory Threshold', 'description': 'InterStim Therapy will be set to amplitude parameter #1 (50% Sensory Threshold)\n\nInterStim Therapy: Device Programming'}, {'id': 'BG001', 'title': 'Amplitude Setting #2 = 80% Sensory Threshold', 'description': 'InterStim Therapy will be set to amplitude parameter #2 (80% Sensory Threshold)\n\nInterStim Therapy: Device Programming'}, {'id': 'BG002', 'title': 'Amplitude Setting #3 = Sensory Threshold', 'description': 'InterStim Therapy will be set to amplitude parameter #3 (Sensory Threshold)\n\nInterStim Therapy: Device Programming'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '64.1', 'spread': '16', 'groupId': 'BG000'}, {'value': '57.9', 'spread': '16.1', 'groupId': 'BG001'}, {'value': '56.7', 'spread': '14.9', 'groupId': 'BG002'}, {'value': '60', 'spread': '15.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '30.0', 'spread': '5.7', 'groupId': 'BG000'}, {'value': '36.3', 'spread': '11.2', 'groupId': 'BG001'}, {'value': '33.1', 'spread': '6.4', 'groupId': 'BG002'}, {'value': '32.8', 'spread': '8.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'This summarizes demographics for subjects in the Randomized Subject Set.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-23', 'size': 1429509, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-10-30T10:41', 'hasProtocol': True}, {'date': '2019-03-05', 'size': 518346, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-10-30T10:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-14', 'studyFirstSubmitDate': '2017-10-23', 'resultsFirstSubmitDate': '2020-11-03', 'studyFirstSubmitQcDate': '2017-11-03', 'lastUpdatePostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-14', 'studyFirstPostDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Urinary Urge Incontinence (UUI) Episodes Per Day From Baseline to 12 Weeks.', 'timeFrame': '12 weeks', 'description': 'Symptoms related to OAB were evaluated using paper voiding diaries. Subjects were trained to complete the urinary voiding diaries for 3-days.'}], 'secondaryOutcomes': [{'measure': 'Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks.', 'timeFrame': '12 weeks', 'description': 'International Consultation on Incontinence Modular Questionnaire - Overactive Bladder Symptoms Quality of Life Questionnaire The questionnaire consists of 4 subscales and a single item on urinary symptom interference.\n\nThe four subscales of Concern (7 items), Coping (8 items), Sleep (5 items), and Social (5 items) are measured on a scale from 0-100 using a range percentile transformation on the summed value from individual listed items. The Health-Related Quality of Life (HRQL) score is a calculated score with a range from 0 to 100 using a range percentile transformation on the summed value from the subscales. Subjects were asked a urinary symptom interference question. "Interference" was measured on a scale from 0-10.\n\nA positive change in Concern, Coping, Sleep, Social, and HRQL indicates improvement in Quality of Life; a negative change in Interference indicates improvement in Quality of Life.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Urinary', 'Incontinence'], 'conditions': ['Urinary Urge Incontinence']}, 'descriptionModule': {'briefSummary': 'This feasibility study will explore the effects of three different InterStim amplitude settings on overactive bladder symptoms (OAB).', 'detailedDescription': 'This is a prospective, randomized, multicenter, single-blinded study to explore the efficacy and quality of life (QoL) of 3 different amplitude settings.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Primary diagnosis of urinary urge incontinence (UUI) as demonstrated on a 3-day baseline voiding diary demonstrating at least 3 UUI episodes\n2. Female subjects 18 years of age or older\n3. Candidate for InterStim Lead Placement\n4. Willing and able to accurately complete voiding diaries, questionnaires, attend visits, and comply with the study protocol (which includes maintenance of InterStim II programming settings over the course of the study)\n5. Willing and able to provide signed and dated informed consent\n6. Willing to maintain current regimen (dosage and frequency) of any overactive bladder (OAB) medication\n\nExclusion Criteria:\n\n1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury\n2. History of diabetes unless the diabetes is well-controlled through diet and/or medications\n3. Symptomatic urinary tract infection (UTI)\n4. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component\n5. Treatment of urinary symptoms with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study\n6. Implanted with a neurostimulator, pacemaker, or defibrillator\n7. Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or radio frequency (RF) energy exposure not included within the scanning conditions provided with the MRI Guidelines for InterStim Therapy\n8. Women who are pregnant or planning to become pregnant\n9. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.\n10. Currently enrolled or planning to enroll in a potentially confounding clinical study during the course of the study (co-enrollment in concurrent studies is only allowed when documented pre-approval is obtained from the Medtronic study manager (or designee).'}, 'identificationModule': {'nctId': 'NCT03335761', 'briefTitle': 'InterStim® Amplitude Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedtronicNeuro'}, 'officialTitle': 'InterStim® Amplitude Study', 'orgStudyIdInfo': {'id': 'MDT17030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amplitude Setting #1', 'description': 'InterStim Therapy will be set to amplitude parameter #1.', 'interventionNames': ['Device: InterStim Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Amplitude Setting #2', 'description': 'InterStim Therapy will be set to amplitude parameter #2.', 'interventionNames': ['Device: InterStim Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Amplitude Setting #3', 'description': 'InterStim Therapy will be set to amplitude parameter #3.', 'interventionNames': ['Device: InterStim Therapy']}], 'interventions': [{'name': 'InterStim Therapy', 'type': 'DEVICE', 'description': 'Device Programming', 'armGroupLabels': ['Amplitude Setting #1', 'Amplitude Setting #2', 'Amplitude Setting #3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85027', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Academic Urology & Urogynecology of Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'East Coast Institute for Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33710', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Pinellas Urology', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Urology Partners', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '55432', 'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Urology Fridley', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'zip': '55125', 'city': 'Woodbury', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Urology Woodbury', 'geoPoint': {'lat': 44.92386, 'lon': -92.95938}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Adult Pediatric Urology and Urogynecology', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '07631', 'city': 'Englewood', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Urologic Research & Consulting', 'geoPoint': {'lat': 40.89288, 'lon': -73.97264}}, {'zip': '28025', 'city': 'Concord', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Urology Partners', 'geoPoint': {'lat': 35.40888, 'lon': -80.58158}}, {'zip': '37421', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Chattanooga Hamilton County Hospital Authority d/b/a Erlanger Health System', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37232-2765', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '53227', 'city': 'West Allis', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Aurora Research Institute - Aurora West Allis Women's Pavilion", 'geoPoint': {'lat': 43.01668, 'lon': -88.00703}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven - Campus Gasthuisberg - Department Urology', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Urology Associates, Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Rouen', 'country': 'France', 'facility': 'CHU Hôpitaux de Rouen - Hôpital Charles Nicolle', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '37126', 'city': 'Verona', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Integrata Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'zip': '3015 GD', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': 'W1G 8PH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'University College London Hospitals NHS Foundation Trust - University College Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedtronicNeuro', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}