Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 1:18 AM
Study NCT ID:
NCT00324233
Status:
COMPLETED
Last Update Posted:
2013-01-01
First Post:
2006-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of Residual Urine After Intermittent Catheterisation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006417', 'term': 'Hematuria'}], 'ancestors': [{'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': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dkkg@coloplast.com', 'phone': '+4549113557', 'title': 'Kristine Gjødsbøl, PhD', 'organization': 'Coloplast A/S'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'SC Then SCCM', 'description': 'SpeediCath (SC)catheter in first period then SpeediCath Compact Male (SCCM)catheter in second period', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'SCCM Then SC', 'description': 'SpeediCath Compact Male (SCCM)catheter in the first period then SpeediCath(SC)catheter in second period', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Residual Urine Measured by Ultra Sound', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SpeediCath'}, {'id': 'OG001', 'title': 'SpediCath Compact Male'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'spread': '30', 'groupId': 'OG000'}, {'value': '6', 'spread': '23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.56', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'equivalence testing', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjectively Measured Handling', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Subjectively Measured Insertion of the Catheter', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SC Then SCCM', 'description': 'SpeediCath (SC)catheter in first period then SpeediCath Compact Male (SCCM)catheter in second period'}, {'id': 'FG001', 'title': 'SCCM Then SC', 'description': 'SpeediCath Compact Male (SCCM)catheter in the first period then SpeediCath(SC)catheter in second period'}], 'periods': [{'title': 'First Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'unable to insert catheter', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'unable to insert catheter', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SC Then SCCM', 'description': 'SpeediCath (SC)catheter in first period then SpeediCath Compact Male (SCCM)catheter in second period'}, {'id': 'BG001', 'title': 'SCCM Then SC', 'description': 'SpeediCath Compact Male (SCCM)catheter in the first period then SpeediCath(SC)catheter in second period'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23.6', 'spread': '3.0', 'groupId': 'BG000'}, {'value': '23.9', 'spread': '2.9', 'groupId': 'BG001'}, {'value': '23.7', 'spread': '2.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Denmark', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-29', 'studyFirstSubmitDate': '2006-05-09', 'resultsFirstSubmitDate': '2012-01-09', 'studyFirstSubmitQcDate': '2006-05-09', 'lastUpdatePostDateStruct': {'date': '2013-01-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-11-29', 'studyFirstPostDateStruct': {'date': '2006-05-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Residual Urine Measured by Ultra Sound', 'timeFrame': '2'}], 'secondaryOutcomes': [{'measure': 'Subjectively Measured Handling'}, {'measure': 'Subjectively Measured Insertion of the Catheter'}]}, 'conditionsModule': {'keywords': ['Residual urine', 'Hematuria', 'Ultra sound'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Intermittent catheterization is a well-known method used for emptying the bladder. The objective of this study is to compare the residual urine after intermittent catheterisation with 2 different, hydrophilic coated, intermittent catheters. The study is a randomized, single blinded, crossover study including 24 healthy males.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* 18 years and above\n* A negative urine dip-stick\n* Have signed informed written consent to participate\n\nExclusion Criteria:\n\n* The test participant has previous or current congenital deformity, diseases or operation in the lower urinary tract'}, 'identificationModule': {'nctId': 'NCT00324233', 'briefTitle': 'Evaluation of Residual Urine After Intermittent Catheterisation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': 'Evaluation of Residual Urine After Intermittent Catheterisation - Comparison of 2 Hydrophilic Coated, Intermittent Catheters', 'orgStudyIdInfo': {'id': 'DK052CC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SC', 'description': 'Speedicath (SC) catheter is a catheter for intermittent catherisation', 'interventionNames': ['Device: Intermittent catheter']}, {'type': 'EXPERIMENTAL', 'label': 'SCCM', 'description': 'SpeediCath Compact Male (SCCM) is a compact catheter for intermittent catherisation to be used by males', 'interventionNames': ['Device: Compact intermittent catheter']}], 'interventions': [{'name': 'Intermittent catheter', 'type': 'DEVICE', 'description': 'SpeediCath catherter (SC) for intermittent catherisation', 'armGroupLabels': ['SC']}, {'name': 'Compact intermittent catheter', 'type': 'DEVICE', 'description': 'SpeediCath Compact Male catheter (SCCM) is a compact intermittent catheter for males', 'armGroupLabels': ['SCCM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'København Ø', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Per Bagi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}