Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 12:31 AM
Study NCT ID:
NCT05955560
Status:
COMPLETED
Last Update Posted:
2024-08-27
First Post:
2023-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Male External Catheters' Comparison of Comfort and Efficacy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kirsten.hammitt@bd.com', 'phone': '551-225-1164', 'title': 'Director of Clinical Affairs', 'organization': 'Becton, Dickinson & Company'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The secondary endpoint intended to assess capture rate in men with a buried penis/anatomy not compatible with a traditional sheath-style catheter; however, there were too few men meeting this criteria to make this assessment. Instead, the ITT subpopulation of morbidly obese participants was assessed.'}}, 'adverseEventsModule': {'timeFrame': '24 hours', 'eventGroups': [{'id': 'EG000', 'title': 'PureWick Male External Catheter', 'description': 'PureWick Male External Catheter: The PureWick™ Male External Catheter (MEC) is intended for non-invasive urine output management in male patients. It is a single-use, non-sterile device. The PureWick™ Male External Catheter is a commercially available device which is Class I, 510(K) exempt.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sage PrimoFit', 'description': 'Sage PrimoFit: The PrimoFit External Urine Management for the Male Anatomy is indicated for the non-invasive external collection of urine for adult patients with male anatomy who require urine management. It is a single-use, non-sterile device. The Sage PrimoFit is a commercially available device which is Class I, 510(K) exempt.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Performance of the PureWick MEC Against an Established Comparator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PureWick Male External Catheter', 'description': 'PureWick Male External Catheter: The PureWick™ Male External Catheter (MEC) is intended for non-invasive urine output management in male patients. It is a single-use, non-sterile device. The PureWick™ Male External Catheter is a commercially available device which is Class I, 510(K) exempt.'}, {'id': 'OG001', 'title': 'Sage PrimoFit', 'description': 'Sage PrimoFit: The PrimoFit External Urine Management for the Male Anatomy is indicated for the non-invasive external collection of urine for adult patients with male anatomy who require urine management. It is a single-use, non-sterile device. The Sage PrimoFit is a commercially available device which is Class I, 510(K) exempt.'}], 'classes': [{'title': 'Void 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.8', 'spread': '10.03', 'groupId': 'OG000'}, {'value': '90.7', 'spread': '20.68', 'groupId': 'OG001'}]}]}, {'title': 'Void 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.1', 'spread': '25.84', 'groupId': 'OG000'}, {'value': '85.2', 'spread': '21.67', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A two-sided paired t-test was used and p-value derived. The threshold for statistical significance was p \\< 0.05', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 2 hours after device placement', 'description': 'Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight).\n\nPrior to each void, the weight of the empty urine collection canister and the weight of a dry absorbent pad are collected. Participants void into the device while laying in a bed with the absorbent pad underneath them. After each void, the post-void weight of the urine collection canister and the post-void weight of the absorbent pad are collected.\n\nCapture rate is calculated as the weight of captured urine (post-void canister weight - pre-void canister weight) / total urine volume (captured urine (post-void canister weight - pre-void canister weight) + leaked urine (post-void pad weight - pre-void pad weight)) \\* 100.', 'unitOfMeasure': 'Percentage of urine captured', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled and randomized participants were included in the primary endpoint efficacy analysis'}, {'type': 'SECONDARY', 'title': 'Performance of the PureWick MEC in Morbidly Obese Subpopulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PureWick Male External Catheter', 'description': 'PureWick Male External Catheter: The PureWick™ Male External Catheter (MEC) is intended for non-invasive urine output management in male patients. It is a single-use, non-sterile device. The PureWick™ Male External Catheter is a commercially available device which is Class I, 510(K) exempt.'}, {'id': 'OG001', 'title': 'Sage PrimoFit', 'description': 'Sage PrimoFit: The PrimoFit External Urine Management for the Male Anatomy is indicated for the non-invasive external collection of urine for adult patients with male anatomy who require urine management. It is a single-use, non-sterile device. The Sage PrimoFit is a commercially available device which is Class I, 510(K) exempt.'}], 'classes': [{'title': 'Void 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.7', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '83.5', 'spread': '32.24', 'groupId': 'OG001'}]}]}, {'title': 'Void 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.8', 'spread': '36.94', 'groupId': 'OG000'}, {'value': '79.3', 'spread': '23.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 2 hours after device placement', 'description': 'Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight).', 'unitOfMeasure': 'Percentage of urine captured', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As there were only 2 participants that were assessed as unable to use traditional sheath style condom catheters, the secondary analysis was performed on the ITT subpopulation of morbidly obese participants.'}, {'type': 'SECONDARY', 'title': 'Participant Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PureWick Male External Catheter', 'description': 'PureWick Male External Catheter: The PureWick™ Male External Catheter (MEC) is intended for non-invasive urine output management in male patients. It is a single-use, non-sterile device. The PureWick™ Male External Catheter is a commercially available device which is Class I, 510(K) exempt.'}, {'id': 'OG001', 'title': 'Sage PrimoFit', 'description': 'Sage PrimoFit: The PrimoFit External Urine Management for the Male Anatomy is indicated for the non-invasive external collection of urine for adult patients with male anatomy who require urine management. It is a single-use, non-sterile device. The Sage PrimoFit is a commercially available device which is Class I, 510(K) exempt.'}], 'classes': [{'title': 'Device Placement Comfort', 'categories': [{'measurements': [{'value': '3.85', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '3.69', 'spread': '1.34', 'groupId': 'OG001'}]}]}, {'title': 'Device Voiding Comfort', 'categories': [{'measurements': [{'value': '3.71', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '3.41', 'spread': '1.23', 'groupId': 'OG001'}]}]}, {'title': 'Device Removal Comfort', 'categories': [{'measurements': [{'value': '3.57', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '3.62', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Likelihood to recommend device to a loved one', 'categories': [{'measurements': [{'value': '3.98', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '3.51', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 2 hours after device placement', 'description': 'Overall comfort on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Very Uncomfortable, 2 = Uncomfortable, 3 = Neither Comfortable or Uncomfortable, 4 = Comfortable, and 5 = Very Comfortable.\n\nThe last survey question related to likelihood to recommend the device ranged from 1-5 with higher scores indicating a better outcome, where 1 = Very Unlikely, 2 = Unlikely, 3 = Neither Likely Nor Unlikely, 4 - Likely, and 5 = Very Likely.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled and randomized participants were included in the secondary endpoint analysis (ITT Population)'}, {'type': 'SECONDARY', 'title': 'Participant Comfort Scale Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PureWick Male External Catheter', 'description': 'PureWick Male External Catheter: The PureWick™ Male External Catheter (MEC) is intended for non-invasive urine output management in male patients. It is a single-use, non-sterile device. The PureWick™ Male External Catheter is a commercially available device which is Class I, 510(K) exempt.'}, {'id': 'OG001', 'title': 'Sage PrimoFit', 'description': 'Sage PrimoFit: The PrimoFit External Urine Management for the Male Anatomy is indicated for the non-invasive external collection of urine for adult patients with male anatomy who require urine management. It is a single-use, non-sterile device. The Sage PrimoFit is a commercially available device which is Class I, 510(K) exempt.'}], 'classes': [{'title': 'Device Placement Comfort', 'categories': [{'measurements': [{'value': '4.29', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '3.92', 'spread': '1.24', 'groupId': 'OG001'}]}]}, {'title': 'Device Voiding Comfort', 'categories': [{'measurements': [{'value': '4.0', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '3.58', 'spread': '1.27', 'groupId': 'OG001'}]}]}, {'title': 'Device Removal Comfort', 'categories': [{'measurements': [{'value': '3.84', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '3.92', 'spread': '1.17', 'groupId': 'OG001'}]}]}, {'title': 'Likelihood to recommend device to a loved one', 'categories': [{'measurements': [{'value': '3.97', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '3.58', 'spread': '1.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 2 hours after device placement', 'description': 'Overall comfort on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Very Uncomfortable, 2 = Uncomfortable, 3 = Neither Comfortable or Uncomfortable, 4 = Comfortable, and 5 = Very Comfortable.\n\nThe last survey question related to likelihood to recommend the device ranged from 1-5 with higher scores indicating a better outcome, where 1 = Very Unlikely, 2 = Unlikely, 3 = Neither Likely Nor Unlikely, 4 - Likely, and 5 = Very Likely.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT removing subjects who used source worksheet with typographic errors on Likert scale scoring choices'}, {'type': 'SECONDARY', 'title': 'Ease of Use by Health Care Professional (HCP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PureWick Male External Catheter', 'description': 'PureWick Male External Catheter: The PureWick™ Male External Catheter (MEC) is intended for non-invasive urine output management in male patients. It is a single-use, non-sterile device. The PureWick™ Male External Catheter is a commercially available device which is Class I, 510(K) exempt.'}, {'id': 'OG001', 'title': 'Sage PrimoFit', 'description': 'Sage PrimoFit: The PrimoFit External Urine Management for the Male Anatomy is indicated for the non-invasive external collection of urine for adult patients with male anatomy who require urine management. It is a single-use, non-sterile device. The Sage PrimoFit is a commercially available device which is Class I, 510(K) exempt.'}], 'classes': [{'title': 'Ease of device placement', 'categories': [{'measurements': [{'value': '4.59', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '4.58', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Ease of device removal', 'categories': [{'measurements': [{'value': '4.71', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '4.81', 'spread': '0.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 2 hours after device placement', 'description': 'Ease of use score on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Very Difficult, 2 = Somewhat Difficult, 3 = Average Difficulty, 4 = Somewhat Easy, and 5 = Very Easy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled and randomized participants were included in the secondary endpoint analysis (ITT Population)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PureWick Male, Then Sage PrimoFit', 'description': 'Participants used PureWick MEC for void 1. After consuming fluids to ensure adequate bladder volume, participants completed void 2 using Sage PrimoFit.'}, {'id': 'FG001', 'title': 'Sage PrimoFit, Then PureWick Male', 'description': 'Participants used Sage PrimoFit for void 1. After consuming fluids to ensure adequate bladder volume, participants completed void 2 using PureWick MEC.'}], 'periods': [{'title': 'Void 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Void 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Potential subjects were identified by a third party recruitment vendor. Targeted enrollment included 50 male, healthy volunteer participants in proximity to the clinical site. Participants were excluded if incontinent to urine or feces, or had any pre-existing wound, open lesion or irritation in the device application area.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'This single-blind, controlled, crossover study randomized participants 1:1 to a treatment sequence using two non-invasive urine collection devices (PureWick Male External Catheter or Sage PrimoFit). Participants were followed for 1 day through 2 voids. After void 1 was completed with PureWick MEC or Sage PrimoFit, participants consumed fluids and completed void 2 using the alternative device.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.8', 'spread': '12.44', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Age of overall study population', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '59', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '31.6', 'spread': '8.58', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-16', 'size': 899467, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-06-14T13:14', 'hasProtocol': True}, {'date': '2023-06-01', 'size': 324590, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-06-14T13:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants are blinded to which device is which and will remain blinded to treatment order until study completion. Investigator, Study Personnel and Sponsor will know which device the participant is treated with at any given time.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Each subject acts as his own control, and therefore the difference in treatments is derived from a within-subject comparison.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-02', 'studyFirstSubmitDate': '2023-07-05', 'resultsFirstSubmitDate': '2024-06-14', 'studyFirstSubmitQcDate': '2023-07-13', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-02', 'studyFirstPostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance of the PureWick MEC Against an Established Comparator', 'timeFrame': 'Approximately 2 hours after device placement', 'description': 'Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight).\n\nPrior to each void, the weight of the empty urine collection canister and the weight of a dry absorbent pad are collected. Participants void into the device while laying in a bed with the absorbent pad underneath them. After each void, the post-void weight of the urine collection canister and the post-void weight of the absorbent pad are collected.\n\nCapture rate is calculated as the weight of captured urine (post-void canister weight - pre-void canister weight) / total urine volume (captured urine (post-void canister weight - pre-void canister weight) + leaked urine (post-void pad weight - pre-void pad weight)) \\* 100.'}], 'secondaryOutcomes': [{'measure': 'Performance of the PureWick MEC in Morbidly Obese Subpopulation', 'timeFrame': 'Approximately 2 hours after device placement', 'description': 'Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight).'}, {'measure': 'Participant Comfort', 'timeFrame': 'Approximately 2 hours after device placement', 'description': 'Overall comfort on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Very Uncomfortable, 2 = Uncomfortable, 3 = Neither Comfortable or Uncomfortable, 4 = Comfortable, and 5 = Very Comfortable.\n\nThe last survey question related to likelihood to recommend the device ranged from 1-5 with higher scores indicating a better outcome, where 1 = Very Unlikely, 2 = Unlikely, 3 = Neither Likely Nor Unlikely, 4 - Likely, and 5 = Very Likely.'}, {'measure': 'Participant Comfort Scale Survey', 'timeFrame': 'Approximately 2 hours after device placement', 'description': 'Overall comfort on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Very Uncomfortable, 2 = Uncomfortable, 3 = Neither Comfortable or Uncomfortable, 4 = Comfortable, and 5 = Very Comfortable.\n\nThe last survey question related to likelihood to recommend the device ranged from 1-5 with higher scores indicating a better outcome, where 1 = Very Unlikely, 2 = Unlikely, 3 = Neither Likely Nor Unlikely, 4 - Likely, and 5 = Very Likely.'}, {'measure': 'Ease of Use by Health Care Professional (HCP)', 'timeFrame': 'Approximately 2 hours after device placement', 'description': 'Ease of use score on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Very Difficult, 2 = Somewhat Difficult, 3 = Average Difficulty, 4 = Somewhat Easy, and 5 = Very Easy.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Non-invasive Urine Output Management']}, 'descriptionModule': {'briefSummary': 'A Prospective, Randomized, Crossover, Single-blind, Single Center Healthy Volunteer Study conducted over 1 day, with 2 voids using the PureWick (PW) Male external catheter (MEC) vs. comparator Sage PrimoFit™. This study is designed to assess the performance, comfort, and ease of use of the PW Male external catheter as compared to the comparator product.', 'detailedDescription': 'In this prospective, post-market, crossover, single-blind, single center healthy volunteer study, healthy males will be randomized 1:1 to a treatment sequence using two devices (PureWick™ Male External Catheter and Sage PrimoFit™) and followed for 1 day through 2 voids. Approximately 50 participants will be enrolled in this study to obtain 44 evaluable subjects. This study is designed to assess the performance, comfort, and ease of use of the PW Male external catheter.\n\nThe purpose of this study is to provide clinical evidence to compare the effectiveness and comfort of PureWick™ Male against a comparator for non-invasive urine output management in patients with varying male anatomy. Specifically, the study will collect data about how the male external catheters perform when participants are positioned on their side using a turning wedge with the head of the bed elevated, mimicking common patient positioning in the hospital setting.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult Male Patient ≥ 18 years old\n2. Male anatomy at time of enrollment\n3. Ability to speak and understand English\n4. Willing to comply with all study procedures in this protocol\n5. Able to independently void urine\n6. Provision of signed and dated informed consent form\n\nExclusion Criteria:\n\n1. Urinary incontinence which does not allow the subject to spontaneously void\n2. Frequent episodes of bowel incontinence\n3. Has Urinary Retention\n4. Has any irritation, wound, open lesion, at the application site, on the genitalia, perineum, or sacrum\n5. Recent surgery of the external urogenital tract, penis, or pubic area\n6. Not able to comply with study procedures independently without required assistance\n7. Any other condition that, in the opinion of the investigator, would preclude them from participating in the study'}, 'identificationModule': {'nctId': 'NCT05955560', 'acronym': 'MECCE', 'briefTitle': "Male External Catheters' Comparison of Comfort and Efficacy", 'organization': {'class': 'INDUSTRY', 'fullName': 'C. R. Bard'}, 'officialTitle': 'Evaluating the Efficacy and Comfort of the PureWick Male External Catheter Against a Comparator in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'UCC-23AC022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Treatment Sequence 1', 'description': 'PureWick™ Male External Catheter is used first, followed by cross-over to Sage PrimoFit.', 'interventionNames': ['Device: PureWick Male External Catheter', 'Device: Sage PrimoFit']}, {'type': 'OTHER', 'label': 'Treatment Sequence 2', 'description': 'The Sage PrimoFit™ is used first, followed by cross-over to PureWick MEC.', 'interventionNames': ['Device: PureWick Male External Catheter', 'Device: Sage PrimoFit']}], 'interventions': [{'name': 'PureWick Male External Catheter', 'type': 'DEVICE', 'otherNames': ['PureWick MEC'], 'description': 'The PureWick™ Male External Catheter (MEC) is intended for non-invasive urine output management in male patients. It is a single-use, non-sterile device. The PureWick™ Male External Catheter is a commercially available device which is Class I, 510(K) exempt.', 'armGroupLabels': ['Treatment Sequence 1', 'Treatment Sequence 2']}, {'name': 'Sage PrimoFit', 'type': 'DEVICE', 'description': 'The PrimoFit External Urine Management for the Male Anatomy is indicated for the non-invasive external collection of urine for adult patients with male anatomy who require urine management. It is a single-use, non-sterile device. The Sage PrimoFit is a commercially available device which is Class I, 510(K) exempt.', 'armGroupLabels': ['Treatment Sequence 1', 'Treatment Sequence 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '336020', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'USF Health Center for Advanced Medical Learning and Simulation (CAMLS)', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Maria-Victoria Sena, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tampa General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'C. R. Bard', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}