Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-28 @ 6:38 PM
Study NCT ID:
NCT04897932
Status:
UNKNOWN
Last Update Posted:
2021-05-24
First Post:
2021-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation Trial of Handheld Urinal for Adult Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'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'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-05-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-18', 'studyFirstSubmitDate': '2021-04-16', 'studyFirstSubmitQcDate': '2021-05-18', 'lastUpdatePostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in fluid intake', 'timeFrame': '28 days', 'description': 'Quantitative analysis of levels of daily fluid intake i) when using the device and ii) not using the device.'}, {'measure': 'Change in incidence of falls associated with urinary toileting', 'timeFrame': "28 days (3 months reported number of falls based on participant's recollection of incidence during that period)", 'description': 'Quantitative analysis of the number of falls incurred going to and from toilet while using the device over the 28 day study period compared to the number of falls recalled by participants going to and from the toilet during the 3 months prior to the study when not using the device.\n\nTool: user diary and questionairre'}, {'measure': 'Change in level of user independence', 'timeFrame': '28 days', 'description': 'Quantitative assessment of number of carer interventions required to assist users with urinary toileting when using and not using the device.\n\nTool: user diary and questionairre'}, {'measure': 'Levels of user confidence', 'timeFrame': '28 days', 'description': 'Qualitative self-assessments, on a three-point scale of "Not at all confident", "Reasonably confident" and "Very confident", by users of their confidence in their ability to manage urinary incontinence when using the device in a range of different orientations.\n\nTool: questionairre'}, {'measure': 'Convenience in use', 'timeFrame': '28 days', 'description': 'Qualitative self-assessment by users of the convenience in use of the device relative to other continence aids used on a three-point scale: "More convenient", "Neither more nor less convenient", and "Less convenient".\n\nTool: questionairre'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'Usability and efficacy evaluation of a prototype handheld urinal for adult use', 'detailedDescription': '28 day usability and efficacy evaluation by 154 adults in domestic settings who suffer one or more of nocturia, urge, frequency or functional incontinence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suffers from nocturia urge, frequency, or funnctional incontinence\n\nExclusion Criteria:\n\n* Suffers only from stress UI'}, 'identificationModule': {'nctId': 'NCT04897932', 'briefTitle': 'Evaluation Trial of Handheld Urinal for Adult Use', 'organization': {'class': 'INDUSTRY', 'fullName': 'Binding Sciences Limited'}, 'officialTitle': 'An Evaluation of the Usability and Efficacy of a Prototype Handheld Urinal for Adults Who Suffer From Nocturia, Urge, Frequency, and/or Functional Incontinence', 'orgStudyIdInfo': {'id': 'BSL BHT IRAS 291714'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Adult nocturia', 'description': 'Use of device over 28 days', 'interventionNames': ['Device: RS - WP06']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adult urge urinary incontinence', 'description': 'Use of device over 28 days', 'interventionNames': ['Device: RS - WP06']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adult frequency urinary incontinence', 'description': 'Use of device over 28 days', 'interventionNames': ['Device: RS - WP06']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adult functional incontinence', 'description': 'Use of device over 28 days', 'interventionNames': ['Device: RS - WP06']}], 'interventions': [{'name': 'RS - WP06', 'type': 'DEVICE', 'description': 'Ad hoc use of handheld urinal', 'armGroupLabels': ['Adult frequency urinary incontinence', 'Adult functional incontinence', 'Adult nocturia', 'Adult urge urinary incontinence']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX17 1PX', 'city': 'Cropredy', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'Binding Sciences Limited', 'geoPoint': {'lat': 52.11745, 'lon': -1.31764}}], 'centralContacts': [{'name': 'Keith A Binding, MBA', 'role': 'CONTACT', 'email': 'keith@bindingsciences.com', 'phone': '+441295 408029'}, {'name': 'Melissa Odling, MEng', 'role': 'CONTACT', 'email': 'melissa@bindingsciences.com', 'phone': '+441295 408029'}], 'overallOfficials': [{'name': 'Piers Clifford, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Buckinghamshire Healthcare NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Binding Sciences Limited', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Buckinghamshire Healthcare NHS Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}