Ignite Creation Date:
2025-12-24 @ 12:54 PM
Ignite Modification Date:
2025-12-31 @ 6:12 AM
Study NCT ID:
NCT01284361
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2011-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Two Intermittent Urinary Catheters
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016055', 'term': 'Urinary Retention'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'malford.cullum@hollister.com', 'phone': '847-918-3975', 'title': 'Malford Cullum PhD/Sr Clin Res Scientist', 'organization': 'Hollister Incorporated'}, 'certainAgreement': {'otherDetails': 'Variable restriction depends on site.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Male catheter users only in USA only.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control 40 cm Catheter', 'description': 'Commercial 40 cm gel lubricated catheter', 'otherNumAtRisk': 91, 'otherNumAffected': 0, 'seriousNumAtRisk': 91, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Test 30 cm Catheter', 'description': 'Test 30 cm gel lubricated cather similar in all aspects except 10 cm shorter length as control catheter', 'otherNumAtRisk': 91, 'otherNumAffected': 2, 'seriousNumAtRisk': 91, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'bleeding', 'notes': 'reported mild urethral bleeding after using one 30 cm catheter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 91, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'discomfort', 'notes': 'reported mild pain when he used all ten 30 cm catheters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 91, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control and Test Crossover', 'description': 'Control and test intermittent urinary catheters : randomized cross-over'}], 'classes': [{'categories': [{'measurements': [{'value': '91.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '91.5', 'ciLowerLimit': '84.5', 'ciUpperLimit': '97.5', 'estimateComment': 'Seventy five of the 82 subjects (91.5%) preferred the longer commercially available catheter over the experimental 30 cm catheter.', 'groupDescription': 'The sample size of 81 subjects provides a 10.8% margin of error.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 week', 'description': 'Percentage of participants that preferred the 40 cm catheter', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assessment of Ease of Use Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control 40 cm Catheter', 'description': 'Commercial gel lubricated 40 cm catheter'}, {'id': 'OG001', 'title': 'Test 30 cm Catheter', 'description': 'Test gel lubricated 30 cm catheter identical in all aspects to Control catheter except being 10 cm shorter'}], 'classes': [{'title': 'Ease of insertion', 'categories': [{'measurements': [{'value': '84.65', 'groupId': 'OG000'}, {'value': '67.78', 'groupId': 'OG001'}]}]}, {'title': 'Ease of Removal', 'categories': [{'measurements': [{'value': '94.85', 'groupId': 'OG000'}, {'value': '86.34', 'groupId': 'OG001'}]}]}, {'title': 'Ease of Catheter Control Upon Urethral Insertion', 'categories': [{'measurements': [{'value': '86.48', 'groupId': 'OG000'}, {'value': '72.19', 'groupId': 'OG001'}]}]}, {'title': 'Confidence of Complete Bladder Drainage', 'categories': [{'measurements': [{'value': '84.15', 'groupId': 'OG000'}, {'value': '45.80', 'groupId': 'OG001'}]}]}, {'title': 'Ease of Draining into Receptacle', 'categories': [{'measurements': [{'value': '87.00', 'groupId': 'OG000'}, {'value': '58.02', 'groupId': 'OG001'}]}]}, {'title': 'Ease of Connecting Urine Bag', 'categories': [{'measurements': [{'value': '35.68', 'groupId': 'OG000'}, {'value': '31.49', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week', 'description': 'Ease of insertion, removal, and control while catheterizing were assessed using a 5 point Likert scale. The numbers recorded are the percentage of the "top" two responses on a 5 point Likert scale. On one scale this includes 1) Very Easy or 2) Easy, on a scale ranging from 1) Very Easy to 5) Very Difficult. On the other scale this includes 1) Strongly Agree or 2) Agree on a scale ranging from 1) Strongly Agree to 5) Strongly Disagree.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': '82 self-catheterizing wheelchair-using men'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control and Test Crossover', 'description': 'test and control intermittent urinary catheters : randomized cross-over'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Recruitment period: October 10, 2010 - July 21 , 2011 types of locations: private vendor, public rehabilitation center, university'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Control and Test Crossover', 'description': 'test and control intermittent urinary catheters : randomized cross-over'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '82', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.3', 'spread': '11.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '82', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Each subject was given 10 Control catheters and 10 Test catheters to be used consecutively until all 20 catheters were used. Subjects used either the Test catheters (A) first and then the Control catheters (B) or vice versa. Subjects completed questionnaire after using each catheter and a preference questionnaire after all catheters were used.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-02', 'studyFirstSubmitDate': '2011-01-21', 'resultsFirstSubmitDate': '2013-12-02', 'studyFirstSubmitQcDate': '2011-01-25', 'lastUpdatePostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-10-10', 'studyFirstPostDateStruct': {'date': '2011-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants', 'timeFrame': '1 week', 'description': 'Percentage of participants that preferred the 40 cm catheter'}], 'secondaryOutcomes': [{'measure': 'Assessment of Ease of Use Characteristics', 'timeFrame': '1 week', 'description': 'Ease of insertion, removal, and control while catheterizing were assessed using a 5 point Likert scale. The numbers recorded are the percentage of the "top" two responses on a 5 point Likert scale. On one scale this includes 1) Very Easy or 2) Easy, on a scale ranging from 1) Very Easy to 5) Very Difficult. On the other scale this includes 1) Strongly Agree or 2) Agree on a scale ranging from 1) Strongly Agree to 5) Strongly Disagree.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intermittent catheter', 'preference'], 'conditions': ['Urinary Retention']}, 'referencesModule': {'references': [{'pmid': '23896665', 'type': 'RESULT', 'citation': 'Costa JA, Menier M, Doran TJ, Kohler TS. Catheter length preference in wheelchair-using men who perform routine clean intermittent catheterization. Spinal Cord. 2013 Oct;51(10):772-5. doi: 10.1038/sc.2013.76. Epub 2013 Jul 30.'}, {'pmid': '34699062', 'type': 'DERIVED', 'citation': 'Prieto JA, Murphy CL, Stewart F, Fader M. Intermittent catheter techniques, strategies and designs for managing long-term bladder conditions. Cochrane Database Syst Rev. 2021 Oct 26;10(10):CD006008. doi: 10.1002/14651858.CD006008.pub5.'}], 'seeAlsoLinks': [{'url': 'http://www.nature.com/sc/journal/v51/n10/full/sc201376a.html', 'label': 'Catheter length preference in wheelchair-using men who perform routine clean intermittent catheterization'}]}, 'descriptionModule': {'briefSummary': 'This is an unblinded, multi-center, randomized, controlled, cross-over study assessing wheel-chair bound, male user preference and catheter characteristics of two intermittent urinary catheters. Subjects enrolled in the study will be randomized to order of catheter use. Individual participation will consist of approximately 1 week of product use. The null hypothesis to be tested is there no difference between catheters.', 'detailedDescription': "1. is male and at least 18 years of age.\n2. is self-catheterizing at least 3 times a day.\n3. has been performing catheterizations for at least 2 months.\n4. is wheelchair bound.\n5. is able to use a size 12 or 14 French straight catheter.\n6. is willing and able to follow the study protocol and Investigator's instructions.\n7. is in the opinion of the Investigator, qualified to participate."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* is male and at least 18 years of age\n* is self-catheterizing at least 3 times a day\n* has been performing catheterizations for at least 2 months\n* wheelchair bound\n* is able to use a size 12 or 14 French straight catheter\n* is willing and able to follow the study protocol and Investigator's instructions\n* is, in the opinion of the Investigator, qualified to participate\n\nExclusion Criteria:\n\n* has cognitive impairments that preclude completion of study protocol\n* cannot communicate as determined by the Investigator\n* has an existing medical condition that, in the opinion of the investigator, would interfere with the subject's ability to participate or in the interpretation of the results\n* has a symptomatic urinary tract infection determined by interview\n* has a retracted penis\n* has participated in a study during the previous 30 days involving catheterization\n* has been diagnosed with an enlarged prostate\n* has urethral strictures, false passages, or urethral obstruction"}, 'identificationModule': {'nctId': 'NCT01284361', 'briefTitle': 'Comparison of Two Intermittent Urinary Catheters', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hollister Incorporated'}, 'officialTitle': 'User Preference Study to Compare a 40cm Intermittent Catheter to a 30cm Intermittent Catheter', 'orgStudyIdInfo': {'id': '4875-I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '30 cm Intermittent Catheter', 'description': 'Intervention was the test of a 30 cm catheter compared to standard commercial 40 cm catheter in a cross-over design.', 'interventionNames': ['Device: 30 cm Intermittent Catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': '40 cm Intermittent Catheter', 'description': 'Active comparator 40 cm commercial catheter was compared to experimental 30 cm catheter in a cross-over design.', 'interventionNames': ['Device: 40 cm Intermittent Catheter']}], 'interventions': [{'name': '30 cm Intermittent Catheter', 'type': 'DEVICE', 'otherNames': ['Apogee Intermittent Catheter'], 'description': 'Randomized cross-over', 'armGroupLabels': ['30 cm Intermittent Catheter']}, {'name': '40 cm Intermittent Catheter', 'type': 'DEVICE', 'otherNames': ['Apogee Intermittent Catheter'], 'description': 'randomized cross-over', 'armGroupLabels': ['40 cm Intermittent Catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30309-1465', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Shepherd Center and Crawford Research Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60090', 'city': 'Wheeling', 'state': 'Illinois', 'country': 'United States', 'facility': 'Mark Drug Medical Supply', 'geoPoint': {'lat': 42.13919, 'lon': -87.92896}}, {'zip': '64119', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Restored Images', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '37235', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Rita Kaurs, MSHSA MT NMT', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hollister Incorporated'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Published in Spinal Cord (2013) 51, 772-775'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hollister Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}