Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-05 @ 5:45 PM
Study NCT ID:
NCT03522766
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2018-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Urine Samples and Their Relation to Urinary Tract Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'urine samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-31', 'studyFirstSubmitDate': '2018-05-01', 'studyFirstSubmitQcDate': '2018-05-01', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Type of bacteria present in the urine', 'timeFrame': '1 year', 'description': 'The different bacteria isolated present in the urine will be identified'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urinary Tract Infections']}, 'descriptionModule': {'briefSummary': 'The aim is to explore the human urine composition and its relation to urine tract infections'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of danish subjects and will consist of healthy volunteers as well as users of intermittent catheter (neurogenic bladder or enlarged prostate) with and without reoccurring urine tract infections.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Have given written informed consent\n2. Be at least 18 years of age and have full legal capacity\n3. For the 2 patient populations: Use intermittent catheter on a daily basis due to neurogenic bladder or enlarged prostate and have used IC for at least 2 months\n4. For healthy volunteers without UTIs: No diag-nosed UTIs within the last year\n5. For healthy volunteers with recurrent UTIs: 3 or more UTIs within the last year or 2 UTIs within the last 6 months (treated with antibiotics)\n\nExclusion Criteria:\n\n1. Be treated for urinary tract infection at time of enrolment\n2. May not take prophylactic treatment for urinary tract infections (antibiotics only)'}, 'identificationModule': {'nctId': 'NCT03522766', 'briefTitle': 'Evaluation of Urine Samples and Their Relation to Urinary Tract Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': 'Evaluation of Urine Samples and Their Relation to Urinary Tract Infection', 'orgStudyIdInfo': {'id': 'CP287'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy volunteers with no urinary tract infections', 'description': "people who don't experience urinary tract infections", 'interventionNames': ['Other: urine sample']}, {'label': 'Healthy volunteers with urinary tract infections', 'description': 'people who frequently experience urinary tract infections', 'interventionNames': ['Other: urine sample']}, {'label': 'Intermittent catheter users with neurogenic bladder', 'interventionNames': ['Other: urine sample']}, {'label': 'Intermittent catheter users with enlarged prostate', 'interventionNames': ['Other: urine sample']}], 'interventions': [{'name': 'urine sample', 'type': 'OTHER', 'description': 'The subjects are asked to give a maximum of 15 urine samples during the study', 'armGroupLabels': ['Healthy volunteers with no urinary tract infections', 'Healthy volunteers with urinary tract infections', 'Intermittent catheter users with enlarged prostate', 'Intermittent catheter users with neurogenic bladder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3050', 'city': 'Humlebæk', 'country': 'Denmark', 'facility': 'Coloplast A/S', 'geoPoint': {'lat': 55.9618, 'lon': 12.5341}}], 'overallOfficials': [{'name': 'Lene F Nielsen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Coloplast A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}