Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2026-02-19 @ 10:12 AM
Study NCT ID:
NCT02602132
Status:
TERMINATED
Last Update Posted:
2021-08-30
First Post:
2015-11-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clamping vs. Free Drainage Before the Removal of Short-term Indwelling Urethral Catheters in Internal Medicine Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003250', 'term': 'Constriction'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'whyStopped': 'Not enough participants. very slow and poor recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-24', 'studyFirstSubmitDate': '2015-11-04', 'studyFirstSubmitQcDate': '2015-11-10', 'lastUpdatePostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of recatheterization', 'timeFrame': '24h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['INDWELLING URINARY CATHETER', 'CLAMPING', 'REMOVAL'], 'conditions': ['Complication of Urinary Catheter']}, 'referencesModule': {'references': [{'pmid': '34184246', 'type': 'DERIVED', 'citation': 'Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.'}]}, 'descriptionModule': {'briefSummary': 'The study will be conducted at University Hospital Alcorcón Foundation, belonging to the public network of hospitals of Madrid Health Service.\n\nThe aim of this study is to evaluate the effects of clamping the urethral catheter prior to removal and determine which of the two options (clamping or free drainage) is the most recommended for removal of bladder catheterization in adults.\n\nThe interest of this study is given by the importance of proper handling of catheterization in the health of patients admitted to a hospital and are subjected to this technique. Increase its interest the need for implementation of evidence-based care, and limited scientific literature on the subject.\n\nThe study population will be patients undergoing short-term urethral catheterization at the Internal Medicine Service in the University Hospital Alcorcón Foundation.\n\nThe methodology of the study is experimental, randomized clinical trial without drug type. Interventions (prior clamped and free drainage) will be assigned in a randomized manner.\n\nInterventions and data collection of patients who met the inclusion criteria to join the study will be conducted during 2016 and the first quarter of 2017. It is planned to present results at the end of 2017.\n\nKeywords: BLADDER TRAINING, INDWELLING CATHETER, URINARY CATHETER, URETHRAL CATHETER, CLAMPING, REMOVAL, ACUTE URINARY RETENTION.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients of both sexes, aged between 18 and 85 years who require IUC 18 short-term (1 to 14 days) in the units of internal medicine at University Hospital Alcorcón Foundation.\n\nPatients who express a desire to participate in the study by signing the informed consent.\n\nExclusion Criteria:\n\n* Patients with permanent long-term (15 days or more) urinary catheter. Patients with recurrent episodes of UTI, which has submitted episodes of urinary retention in the last month, or who have urologic pathology.\n\nPatients with cognitive impairments that hinder communication with the medical staff.\n\nDisoriented patients in person, time and place. Anatomical and physiological genito-urinary system Alterations Patients taking a drug that affects the bladder and kidney function the week prior to catheterization.\n\nPregnant patients. Patients with a known history of benign prostatic hyperplasia.'}, 'identificationModule': {'nctId': 'NCT02602132', 'briefTitle': 'Clamping vs. Free Drainage Before the Removal of Short-term Indwelling Urethral Catheters in Internal Medicine Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Fundación Alcorcón'}, 'officialTitle': 'Clamping vs. Free Drainage Before the Removal of Short-term Indwelling Urethral Catheters in Internal Medicine Patients.', 'orgStudyIdInfo': {'id': '15/63'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clamping group', 'description': 'Indwelling urinary catheter is clamped before removal and unclamped when the patient expresses his desire to urinate.', 'interventionNames': ['Procedure: Clamping']}, {'type': 'NO_INTERVENTION', 'label': 'Free drainage group', 'description': 'The urinary catheter will be removed without prior clamping.'}], 'interventions': [{'name': 'Clamping', 'type': 'PROCEDURE', 'description': 'To clamp before the removal of short-term indwelling urethral catheters', 'armGroupLabels': ['Clamping group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28922', 'city': 'Alcorcón', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Fundación Alcorcón', 'geoPoint': {'lat': 40.34582, 'lon': -3.82487}}], 'overallOfficials': [{'name': 'David Guadarrama Ortega, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HUFA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'David Guadarrama-Ortega', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Registered Nurse', 'investigatorFullName': 'David Guadarrama-Ortega', 'investigatorAffiliation': 'Hospital Universitario Fundación Alcorcón'}}}}