Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-02-28 @ 11:15 AM
Study NCT ID:
NCT03801720
Status:
TERMINATED
Last Update Posted:
2023-12-21
First Post:
2018-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UltraWee: Ultrasound Bladder Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Study was suspended due to COVID. Investigators no long feel that completion of the study is feasible and have permanently terminated the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-15', 'studyFirstSubmitDate': '2018-12-14', 'studyFirstSubmitQcDate': '2019-01-10', 'lastUpdatePostDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of miturition', 'timeFrame': 'Less than 5 minutes', 'description': 'Recorded act of successfully initiating miturition/urination'}, {'measure': 'Time to Miturition', 'timeFrame': '0-5 minutes', 'description': 'Recorded time to miturition'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clean Catch Urine (CCU)', 'Catherterization', 'Ultrasound', 'Micturition', 'Urine Collection', 'Pre-Continent Children', 'Pediatrics'], 'conditions': ['Urinalysis']}, 'descriptionModule': {'briefSummary': 'The UltraWee study is a prospective randomized controlled trial used to compare the success rate of and time to obtaining a urine sample in pre-continent children between standard clean catch urine (CCU) method and using ultrasound stimulation clean catch methods. The objectives of this study are to see if ultrasound stimulation increases success rate of micturition, decreases time to micturition, and decreases the use of more invasive techniques for urine collection.', 'detailedDescription': 'Standard procedure for obtaining urine samples in the pediatrics emergency department consists of a clean catch urine (CCU). For those patients who are still pre-continent, this involves cleaning the genitourinary (GU) area with betadine followed with waiting with a specimen cup for the patient to produce urine.\n\nCurrently, the CCU technique has had mixed success rates of micturition, some studies showing as low as 12% success rate. Because of the mixed success rates, often times these patients are subjected to the discomfort and trauma of a urinary catheter. Catheterization also occurs in patients with clinical conditions that require urine samples under time sensitive conditions.\n\nLess invasive ways of urine collections have been recently studied. The Quick-Wee study was a novel study that showed a promising alternative to obtaining urine samples in pre-continent children when compared to the CCU sample. This method served as a noninvasive way to obtain a urine sample, thus preventing uncomfortable and traumatic urinary catheterizations and improving parent satisfaction scores.\n\nThe investigators hope to study the effectiveness of another technique for obtaining a urine sample without urinary catheterization: ultrasound stimulation. By incorporating ultrasound evaluation of the bladder, the UltraWee study hopes to decrease the number of failed attempts at obtaining a urine sample in pre-continent children less than thirty-six months of age.\n\nThe UltraWee study will be a prospective randomized controlled trial comparing success rate of and time to obtaining a urine sample in pre-continent children between standard clean catch urine method and using ultrasound stimulation clean catch methods. The objective of this study is to see if ultrasound stimulation increases success rate and decreases time to micturition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pre-continent children\n* Children between the ages of 1 month and 36 months\n* Children who require a urine sample as part of their workup\n* Children who are seen in the emergency department at University Hospital Downtown Campus\n\nExclusion Criteria:\n\n* Children who are continent\n* Children who are in foster care or who are wards of the state'}, 'identificationModule': {'nctId': 'NCT03801720', 'briefTitle': 'UltraWee: Ultrasound Bladder Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York - Upstate Medical University'}, 'officialTitle': 'UltraWee: Ultrasound Bladder Stimulation to Help With Clean Catch Urine in Pre-Continent Children', 'orgStudyIdInfo': {'id': '1190457'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Utilize standard practice for obtaining a CCU in pre-continent children; this consists of cleaning the GU area with betadine and waiting 5 minutes for micturition to occur.'}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Consists of cleaning the GU area with betadine followed by using an ultrasound probe to apply cool ultrasound gel and subprapubic pressure to the patient to induce micturition.', 'interventionNames': ['Other: Ultrasound']}], 'interventions': [{'name': 'Ultrasound', 'type': 'OTHER', 'description': 'Using ultrasound stimulation to induce micturition.', 'armGroupLabels': ['Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}], 'overallOfficials': [{'name': 'Vincent Calleo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'State University of New York - Upstate Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York - Upstate Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Vincent Calleo', 'investigatorAffiliation': 'State University of New York - Upstate Medical University'}}}}