Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-02-18 @ 2:15 PM
Study NCT ID:
NCT03897959
Status:
UNKNOWN
Last Update Posted:
2019-04-01
First Post:
2019-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COMPARISON OF KOHLI AND FOLEY CATHETERS IN SUPRAPUBIC CATHETER PATIENTS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients will utilize existing urinary drainage catheter for 30 days and then switch to alternative for 30 days. Patient will repeat this cycle once more.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-28', 'studyFirstSubmitDate': '2019-03-25', 'studyFirstSubmitQcDate': '2019-03-28', 'lastUpdatePostDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Suprapubic catheter blockage - failure to drain', 'timeFrame': '1 year', 'description': 'To determine whether an indwelling suprapubic low profile Kohli Atraumatic Catheter causes less patient-reported mucous plugging than a traditional indwelling suprapubic Foley catheter.'}], 'secondaryOutcomes': [{'measure': 'Suprapubic catheter pain', 'timeFrame': '1 year', 'description': 'To determine whether an indwelling suprapubic low profile Kohli Atraumatic Catheter causes less patient-defined discomfort than a traditional indwelling suprapubic Foley catheter. Pain will be accessed using a Visual Analog Pain scale.'}, {'measure': 'Suprapubic catheter urinary tract infection (UTI)', 'timeFrame': '1 year', 'description': "To determine whether an indwelling suprapubic low profile Kohli Atraumatic Catheter reduces catheter-associated urinary tract infections (CAUTI's) than a traditional indwelling suprapubic Foley catheter. Patient symptoms such as hematuria, lower abdomen discomfort, frequent, painful urination, and pelvic pressure will be used to diagnose the presence of UTI."}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['suprapubic, urinary catheter'], 'conditions': ['Catheter Infection', 'Complications; Catheter']}, 'descriptionModule': {'briefSummary': 'The purpose of this medical research study is to compare two different urinary drainage catheters to see which has fewer problems with blockages and pain. The study involves completing 16 weekly 3-question surveys either online or by phone. The new catheters are FDA-approved and will be provided for FREE. No medications will be given.', 'detailedDescription': 'The purpose of this study is to see if a redesign of the catheter to remove the extended tip of the conventional urinary catheter will reduce problems with catheter blockage or catheter-associated discomfort. By eliminating the extended tip, the bladder wall will no longer be subject to the tip rubbing on the bladder wall. This could lead to fewer problems with blockages and less irritation and trauma to the bladder lining. A reduction in trauma to the bladder wall could reduce pain, bladder inflammation/irritation and the risk of urinary tract infections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indwelling suprapubic Foley urinary catheter for at least 30 days prior to entry with anticipation for continued indwelling urinary catheterization for at least 30 days after entry into the study.\n* Catheter associated discomfort or difficulty with mucous plugging of the catheter.\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* No catheter associated discomfort or problems with mucous plugging'}, 'identificationModule': {'nctId': 'NCT03897959', 'briefTitle': 'COMPARISON OF KOHLI AND FOLEY CATHETERS IN SUPRAPUBIC CATHETER PATIENTS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nellie Medical, LLC'}, 'officialTitle': 'FOLEY VERSUS KOHLI FOR SUPRAPUBIC CATHETER ASSOCIATED PROBLEMS STUDY', 'orgStudyIdInfo': {'id': 'KVF2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Kohli vs Foley Study', 'description': 'Compare various performance characteristics of two urinary catheters.', 'interventionNames': ['Device: Kohli vs Foley catheter']}], 'interventions': [{'name': 'Kohli vs Foley catheter', 'type': 'DEVICE', 'description': 'Alternative suprapubic catheter used for bladder drainage.', 'armGroupLabels': ['Kohli vs Foley Study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02481', 'city': 'Wellesley', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Neeraj Kohli, MD', 'role': 'CONTACT', 'email': 'nkohli@bostonurogyn.com', 'phone': '617-340-6446'}, {'name': 'Ronald D Adams, MS', 'role': 'CONTACT', 'email': 'info@kohlicatheter.com', 'phone': '775-800-7300'}], 'facility': 'Boston Urogynecology', 'geoPoint': {'lat': 42.29649, 'lon': -71.29256}}], 'centralContacts': [{'name': 'Ronald D Adams, MS', 'role': 'CONTACT', 'email': 'info@kohlicatheter.com', 'phone': '7758007300'}, {'name': 'Neeraj Kohli, MD', 'role': 'CONTACT', 'email': 'nkohli@bostonurogyn.com', 'phone': '617-340-6446'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nellie Medical, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}