Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-26 @ 1:56 AM
Study NCT ID:
NCT05560594
Status:
COMPLETED
Last Update Posted:
2022-10-18
First Post:
2022-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigate Bladder and Prostate During Emptying With Intermittent Catheter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-04-24', 'releaseDate': '2025-04-07'}], 'estimatedResultsFirstSubmitDate': '2025-04-07'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Explore the behavior of the urinary bladder and prostate during emptying the bladder with an intermittent catheter.\n\nBy use of 3D scanning techniques and dynamic MRI, the objective is to investigate behavior of bladder emptying using an intermittent catheter compared to the voluntary bladder emptying.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-17', 'studyFirstSubmitDate': '2022-08-02', 'studyFirstSubmitQcDate': '2022-09-26', 'lastUpdatePostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bladder morphology', 'timeFrame': 'Within 1 year after termination', 'description': 'Evaluate bladder morphology and behavior during emptying of the bladder by performance of 3D and dynamic MRI'}, {'measure': 'Bladder behavior', 'timeFrame': 'Within 1 year after termination', 'description': 'Evaluate bladder behavior when emptying the bladder with an intermittent catheter evaluated by performance of 3D and dynamic MRI'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urinary Function']}, 'descriptionModule': {'briefSummary': 'Explorative study investigating the urinary bladder and prostate during intermittent catheterization in healthy male adults by use of MR-scanning.', 'detailedDescription': '12 healthy male adults will be enrolled in the investigation. The study includes one study visit where MR-scans of the bladder and prostate will be performed during normal voiding as baseline measurement followed by measurements during emptying of the bladder with an intermittent catheter (SpeediCath CH12 standard male intermittent catheter).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Healthy male adults', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* Has given written informed consent\n* Be at least 18 years of age and have full legal capacity\n\nExclusion Criteria:\n\n* Participate in any other clinical investigation\n* Has symptoms of UTI (Investigator\'s judgement)\n* Has known abnormalities and/or diseases in the bladder and/ or the lower urinary tract\n* Has had previous disease or surgery in lower urinary tract\n* Has any MR-scanning contraindication - according to "MR check list"'}, 'identificationModule': {'nctId': 'NCT05560594', 'briefTitle': 'Investigate Bladder and Prostate During Emptying With Intermittent Catheter', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': 'Explorative Study Investigating the Urinary Bladder and Prostate During Intermittent Catheterization in Healthy Male Adults by Use of MR-scanning.', 'orgStudyIdInfo': {'id': 'CP336'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intermittent catheter', 'description': 'Coloplast SpeediCath CH12 male intermittent catheter', 'interventionNames': ['Device: Coloplast SpeediCath CH12 standard male intermittent catheter']}], 'interventions': [{'name': 'Coloplast SpeediCath CH12 standard male intermittent catheter', 'type': 'DEVICE', 'description': 'Drainage of the bladder through the urethra when using the SpeediCath standard male intermittent catheter.', 'armGroupLabels': ['Intermittent catheter']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Per Bagi, PI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Per.bagi@regionh.dk /+45 35 45 83 10'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-04-07', 'type': 'RELEASE'}, {'date': '2025-04-24', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Coloplast A/S'}}}}