Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
Study NCT ID:
NCT04672993
Status:
COMPLETED
Last Update Posted:
2024-02-08
First Post:
2020-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Exploratory Study of a New Urine Collection Device for Men
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}], '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': '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': 'dkmr@coloplast.com', 'phone': '004549112562', 'title': 'Senior Scientific Manager Marianne Raff Dambæk', 'organization': 'Coloplast'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 week', 'description': 'Definition of adverse events are from ISO Standard 14155:2021.\n\nCollection of AEs happened during the 1 week trial and when the subjects terminated their participations by the study nurse and by use of specific forms.', 'eventGroups': [{'id': 'EG000', 'title': 'Urine Collection Device for Men', 'description': 'Test of Urine Collection Device for Men for 7 (+/- 3/0 days).\n\nUrine collection device for men: Use of urine collection device for men', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 13, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'mild skin irritation', 'notes': 'Red and sore skin.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild pain', 'notes': 'Pain in the area of the product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants That Found the Product to be Comfortable to Wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Urine Collection Device for Men', 'description': 'Test of Urine Collection Device for Men for 7 (+/- 3/0 days).\n\nUrine collection device for men: Use of urine collection device for men'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '76'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One week', 'description': 'Questionnaire used to measure the frequency of success in support of "comfortable": "How comfortable was the product to wear?". The question was asked at the end of the trial.', 'unitOfMeasure': 'percentages of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (electronic data from one subject was lost)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Urine Collection Device for Men', 'description': 'Test of Urine Collection Device for Men for 7 (+/- 3/0 days).\n\nUrine collection device for men: Use of urine collection device for men'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '20 participants completed the trial, but data from one participant was lost.', 'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'There was no pre-assignment period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Urine Collection Device for Men', 'description': 'Test of Urine Collection Device for Men for 7 (+/- 3/0 days).\n\nUrine collection device for men: Use of urine collection device for men'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Denmark', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-01', 'size': 1869992, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-02-06T02:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2020-09-03', 'resultsFirstSubmitDate': '2022-11-01', 'studyFirstSubmitQcDate': '2020-12-16', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-06', 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants That Found the Product to be Comfortable to Wear', 'timeFrame': 'One week', 'description': 'Questionnaire used to measure the frequency of success in support of "comfortable": "How comfortable was the product to wear?". The question was asked at the end of the trial.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'The aim of the investigation is to evaluate the subjects experience of a new collection device for men.\n\nAn open-labelled, single arm study design was chosen for this investigation with a duration of 1 week + up to 3 days extra.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Have given written informed consent\n2. Male\n3. Be at least 18 years of age and have full le-gal capacity\n4. Suffering from urinary incontinence equiva-lent to using up to 6 pads or 2 diapers per day\n5. Have had current incontinence issues for at least 3 months\n6. Able to understand patient information and able to change the product himself\n7. Up to 6 of the subjects can be users who are using an intermittent catheter due to re-tention, but who are also dribble inconti-nent in-between catheterizations, and hence need a product to handle the inconti-nence.\n8. Able to fit the test product.\n\nExclusion Criteria:\n\n1. If experiencing incontinence less than once per week\n2. Bedridden, using wheelchair or using a walking aids regularly'}, 'identificationModule': {'nctId': 'NCT04672993', 'briefTitle': 'Exploratory Study of a New Urine Collection Device for Men', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': 'Exploratory Study of a New Urine Collection Device for Men', 'orgStudyIdInfo': {'id': 'CP326'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Urine Collection Device for Men', 'description': 'Test of Urine Collection Device for Men for 7 (+/- 3/0 days).', 'interventionNames': ['Device: Urine collection device for men']}], 'interventions': [{'name': 'Urine collection device for men', 'type': 'DEVICE', 'description': 'Use of urine collection device for men', 'armGroupLabels': ['Urine Collection Device for Men']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3400', 'city': 'Hillerød', 'country': 'Denmark', 'facility': 'Flying Nurses', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}], 'overallOfficials': [{'name': 'Susan Rasmussen', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}