Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-26 @ 1:21 AM
Study NCT ID:
NCT00748033
Status:
COMPLETED
Last Update Posted:
2021-05-06
First Post:
2008-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study Evaluating a Urinary Catheter With Different Activation Times for the Wetting Solution, in Healthy Male Volunteers.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mace@wellspect.com', 'phone': '+46313763000', 'title': 'Head of Medical Affairs', 'organization': 'Wellspect Health Care'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Each subjects visited the clinic during one day. The subjects were catheterized for 3 minutes with each catheter. All subjects were catheterized with 3 catheters each, except one subject, who discontinued after test catheter 1 and was therefore only catheterized twice. At least 2 hours elapsed between each catheterization.', 'description': 'In this study all adverse events will be judged as adverse device effect. Adverse events were not monitored during reference testing.', 'eventGroups': [{'id': 'EG000', 'title': 'LoFric POBE Hydro-Kit II, 5 Seconds', 'description': 'All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.\n\nAfter randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds then LoFric POBE Hydro-Kit II, activation time 24 hours.\n\nAfter randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 2 hours then LoFric POBE Hydro-Kit II, activation time 5 seconds.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 17, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'LoFric POBE Hydro-Kit II, 24 Hours', 'description': 'All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.\n\nAfter randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds then LoFric POBE Hydro-Kit II, activation time 24 hours.\n\nAfter randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 2 hours then LoFric POBE Hydro-Kit II, activation time 5 seconds.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 18, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Discomfort during insertion of test catheter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Discomfort during withdrawal of test catheter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Discomfort during micturition after test catheter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematuria after test catheter is removed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Subjects' Perception at Insertion of Test Catheter Activated for 5 Seconds, Compared to Reference.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LoFric POBE Hydro-Kit II, 5 Seconds', 'description': 'All subjects were first catheterizised with the reference catheter. After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then the test catheter LoFric POBE Hydro-Kit II activation time 24 hours.\n\nThe other group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then test catheter LoFric POBE Hydro-Kit II activation time 24 hours.'}], 'classes': [{'title': 'Very negative', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Slightly negative', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Same', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Slightly positive', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Very positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0650', 'groupIds': ['OG000'], 'groupDescription': 'Wilcoxon signed rank test, two-sided. Testing the hypothesis that the perception is same.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.', 'description': "The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding insertion?'.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was analysed using a per protocol approach only. One subject (Subject ID 125) was catheterized with the reference catheter and the catheter activated 24 hours, but not with the catheter activated 5 seconds. After discussions it has, however, been decided to use all available data. In conclusion all subjects fulfilling the inclusion criteria but none of the exclusion criteria were included in the Per-Protocol (PP) analysis set.'}, {'type': 'PRIMARY', 'title': "Subjects' Perception at Insertion of Test Catheter Activated for 24 Hours, Compared to Reference.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LoFric POBE Hydro-Kit II, 24 Hours', 'description': 'All subjects were first catheterizised with the reference catheter then in a randomized order with the two test catheters.'}], 'classes': [{'title': 'Very negative', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Slightly negative', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Same', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Slightly positive', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Very positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.2487', 'groupIds': ['OG000'], 'groupDescription': 'Wilcoxon signed rank test, two-sided. Testing the hypothesis that the perception is same.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.', 'description': "The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding insertion?'.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was analysed using a per protocol approach only. One subject (Subject ID 125) was catheterized with the reference catheter and the catheter activated 24 hours, but not with the catheter activated 5 seconds. After discussions it has, however, been decided to use all available data. In conclusion all subjects fulfilling the inclusion criteria but none of the exclusion criteria were included in the Per-Protocol (PP) analysis set.'}, {'type': 'PRIMARY', 'title': "Subjects' Perception at Withdrawal of Test Catheter Activated for 5 Seconds, Compared to Reference.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LoFric POBE Hydro-Kit II, 5 Seconds Hours', 'description': 'All subjects were first catheterizised with the reference catheter. After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then the test catheter LoFric POBE Hydro-Kit II activation time 24 hours.\n\nThe other group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then test catheter LoFric POBE Hydro-Kit II activation time 24 hours.'}], 'classes': [{'title': 'Very negative', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Slightly negative', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Same', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Slightly positive', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Very positive', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.7288', 'groupIds': ['OG000'], 'groupDescription': 'Wilcoxon signed rank test, two-sided. Testing the hypothesis that the perception is same.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.', 'description': "The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding withdrawal?'.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects fulfilling the inclusion criteria but none of the exclusion criteria were included in the Per-Protocol (PP) analysis set.'}, {'type': 'PRIMARY', 'title': "Subjects' Perception at Withdrawal of Test Catheter Activated for 24 Hours, Compared to Reference.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LoFric POBE Hydro-Kit II, 24 Hours', 'description': 'All subjects were first catheterizised with the reference catheter. After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then the test catheter LoFric POBE Hydro-Kit II activation time 24 hours.\n\nThe other group was first catheterizised with LoFric POBE Hydro-Kit II activation time 5 seconds, then test catheter LoFric POBE Hydro-Kit II activation time 24 hours.'}], 'classes': [{'title': 'Very negative', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Slightly negative', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Same', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Slightly positive', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Very positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0045', 'groupIds': ['OG000'], 'groupDescription': 'Wilcoxon signed rank test, two-sided. Testing the hypothesis that the perception is same.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.', 'description': "The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding withdrawal?'.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was analysed using a per protocol approach only. One subject (Subject ID 125) was catheterized with the reference catheter and the catheter activated 24 hours, but not with the catheter activated 5 seconds. After discussions it has, however, been decided to use all available data. In conclusion all subjects fulfilling the inclusion criteria but none of the exclusion criteria were included in the Per-Protocol (PP) analysis set.'}, {'type': 'SECONDARY', 'title': 'Comparison of the Perception at Insertion Between 5s and 24h Activation Times. Times', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LoFric POBE Hydro-Kit II, 5 Seconds', 'description': 'All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.\n\nAfter randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds then LoFric POBE Hydro-Kit II, activation time 24 hours.\n\nAfter randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 2 hours then LoFric POBE Hydro-Kit II, activation time 5 seconds.'}, {'id': 'OG001', 'title': 'LoFric POBE Hydro-Kit II, 24 Hours', 'description': 'All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.\n\nAfter randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds then LoFric POBE Hydro-Kit II, activation time 24 hours.\n\nAfter randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 2 hours then LoFric POBE Hydro-Kit II, activation time 5 seconds.'}], 'classes': [{'title': 'Very negative', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Slightly negative', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Same', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Slightly positive', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Very positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4561', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Testing the hypothesis that 5s and 24 h are equal at insertion.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Wilcoxon signed rank test if the difference between 5s and 24h is equal to 0.'}], 'paramType': 'NUMBER', 'timeFrame': 'A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.', 'description': 'Comparison of the perception at insertion between the catheters with 5s and 24h activation times.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was analysed using a per protocol approach only.'}, {'type': 'SECONDARY', 'title': 'Comparison of the Perception at Withdrawal Between 5s and 24h Activation Times.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LoFric POBE Hydro-Kit II, 5 Seconds', 'description': 'All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.\n\nAfter randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds then LoFric POBE Hydro-Kit II, activation time 24 hours.\n\nAfter randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 2 hours then LoFric POBE Hydro-Kit II, activation time 5 seconds.'}, {'id': 'OG001', 'title': 'LoFric POBE Hydro-Kit II, 24 Hours', 'description': 'All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.\n\nAfter randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds then LoFric POBE Hydro-Kit II, activation time 24 hours.\n\nAfter randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 2 hours then LoFric POBE Hydro-Kit II, activation time 5 seconds.'}], 'classes': [{'title': 'Very negative', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Slightly negative', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Same', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Slightly positive', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Very positive', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1797', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Testing the hypothesis that 5s and 24 h are equal at withdrawal.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Wilcoxon signed rank test if the difference between 5s and 24h is equal to 0.'}], 'paramType': 'NUMBER', 'timeFrame': 'A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.', 'description': 'Comparison of the perception at withdrawal between the catheters with 5s and 24h activation times.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was analysed using a per protocol approach only.'}, {'type': 'SECONDARY', 'title': 'Test of Carry-over Effect at Insertion, Mean Rating of Perception on a Scale of 0 to 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5s Followed by 24h', 'description': 'Both groups were first catheterizied with the reference catheter. One group was then randomised to start with the catheter activated for 5 seconds followed by the catheter activated for 24 hours.\n\nThe other group was randomised to start with the the catheter activated for 24 hours followed by the catheter activated for 5 seconds.'}, {'id': 'OG001', 'title': '24h Followed by 5s', 'description': 'Both groups were first catheterizied with the reference catheter. One group was then randomised to start with the catheter activated for 5 seconds followed by the catheter activated for 24 hours.\n\nThe other group was randomised to start with the the catheter activated for 24 hours followed by the catheter activated for 5 seconds.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.807', 'groupId': 'OG000'}, {'value': '-0.46', 'spread': '0.865', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5171', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The mean perception of the 5s and the 24h catheter is calculated for each patient. The patients are then divided in two groups depending on the order the patients received the two catheters and the hypotheses that the mean of the 5s and the 24h catheter is equal in the two groups are tested. If the test results in a significant p-value it can be concluded that a carry-over effect is present.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Wilcoxon signed rank test if the difference between 5s and 24h is equal to 0.'}], 'paramType': 'MEAN', 'timeFrame': 'A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.', 'description': 'The subjects perception of the catheterization will be classified as very negative, slightly negative, same, slightly positive or very positive.\n\nThe mean perception of the 5s and the 24h catheter is calculated for each subject.\n\nThe perception was measured on a scale from 1 (=very negative compared to the reference catheter) to 5 (=very positive compared to the reference catheter) and a 3 indicating that the perception was the same for the test catheter as for the reference catheter. Before doing any statistics all answers were reduced by 3 resulting in values from -2 (=very negative compared to the reference catheter) to +2 (=very positive compared to the reference catheter) and a 0 indicating that the perception was the same for the test catheter as for the reference catheter.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was analysed using a per protocol approach only. One subject (Subject ID 125) was catheterized with the reference catheter and the catheter activated 24 hours, but not with the catheter activated 5 seconds. After discussions it has, however, been decided to use all available data. In conclusion all subjects fulfilling the inclusion criteria but none of the exclusion criteria were included in the Per-Protocol (PP) analysis set.'}, {'type': 'SECONDARY', 'title': 'Test of Carry-over Effect at Withdrawal, Mean Rating of Perception on a Scale of 0 to 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5s Followed by 24h', 'description': 'Both groups were first catheterizied with the reference catheter. One group was then randomised to start with the catheter activated for 5 seconds followed by the catheter activated for 24 hours.\n\nThe other group was randomised to start with the the catheter activated for 24 hours followed by the catheter activated for 5 seconds.'}, {'id': 'OG001', 'title': '24h Followed by 5s', 'description': 'Both groups were first catheterizied with the reference catheter. One group was then randomised to start with the catheter activated for 5 seconds followed by the catheter activated for 24 hours.\n\nThe other group was randomised to start with the the catheter activated for 24 hours followed by the catheter activated for 5 seconds.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.835', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '0.807', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7105', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The mean perception of the 5s and the 24h catheter is calculated for each patient. The patients are then divided in two groups depending on the order the patients received the two catheters and the hypotheses that the mean of the 5s and the 24h catheter is equal in the two groups are tested. If the test results in a significant p-value it can be concluded that a carry-over effect is present.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.', 'description': 'They had five alternative answers.The subjects perception of the catheterization will be classified as very negative, slightly negative, same, slightly positive or very positive.\n\nThe mean perception of the 5s and the 24h catheter is calculated for each subject.\n\nThe perception was measured on a scale from 1 (=very negative compared to the reference catheter) to 5 (=very positive compared to the reference catheter) and a 3 indicating that the perception was the same for the test catheter as for the reference catheter. Before doing any statistics all answers were reduced by 3 resulting in values from -2 (=very negative compared to the reference catheter) to +2 (=very positive compared to the reference catheter) and a 0 indicating that the perception was the same for the test catheter as for the reference catheter.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was analysed using a per protocol approach only. One subject (Subject ID 125) was catheterized with the reference catheter and the catheter activated 24 hours, but not with the catheter activated 5 seconds. After discussions it has, however, been decided to use all available data. In conclusion all subjects fulfilling the inclusion criteria but none of the exclusion criteria were included in the Per-Protocol (PP) analysis set.'}, {'type': 'SECONDARY', 'title': 'Tension Test System: Ref-24h Mean', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MEAN Friction Value', 'description': 'Tension test system at withdrawal'}], 'classes': [{'categories': [{'measurements': [{'value': '0.077', 'spread': '0.088', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'The Tension test system was performed while withdrawing the catheters up to 5 seconds.', 'description': 'Tension test system (friction) at withdrawal. Comparison between the reference catheter and the 24 hours activation time. The MEAN for the withdrawal friction was measured in Newton (N).', 'unitOfMeasure': 'Newton', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was analysed using a per protocol approach only.'}, {'type': 'SECONDARY', 'title': 'Tension Test System: Ref-24h Work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mean Friction Value', 'description': 'Mean Tension test system at withdrawal'}], 'classes': [{'categories': [{'measurements': [{'value': '0.011', 'spread': '0.024', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0346', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'The Tension test system was performed while withdrawing the catheters up to 5 seconds.', 'description': 'Tension test system (friction) at withdrawal. Comparison between the reference catheter and the 24 hours activation time. The WORK for the withdrawal friction was measured in Joule (J).', 'unitOfMeasure': 'Joule', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was analysed using a per protocol approach only.'}, {'type': 'SECONDARY', 'title': 'Tension Test System: Ref-5s MEAN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MEAN Friction Value', 'description': 'Tension test system at withdrawal'}], 'classes': [{'categories': [{'measurements': [{'value': '0.073', 'spread': '0.122', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0016', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'The Tension test system was performed while withdrawing the catheters, up to 5 seconds.', 'description': 'Tension test system (friction) at withdrawal. Comparison between the reference catheter and the 5 seconds activation time. The MEAN for the withdrawal friction was measured in Newton (N).', 'unitOfMeasure': 'Newton', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was analysed using a per protocol approach only.'}, {'type': 'SECONDARY', 'title': 'Tension Test System: Ref-5s WORK', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MEAN Friction Value', 'description': 'Tension test system at withdrawal'}], 'classes': [{'categories': [{'measurements': [{'value': '0.009', 'spread': '0.030', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The Tension test system was performed while withdrawing the catheters, up to 5 seconds.', 'description': 'Tension test system (friction) at withdrawal. Comparison between the reference catheter and the 5 seconds activation time. The WORK for the withdrawal friction was measured in Joule (J).', 'unitOfMeasure': 'Joule', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was analysed using a per protocol approach only.'}, {'type': 'SECONDARY', 'title': 'Tension Test System: 24h-5s', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MEAN Friction Value', 'description': 'Tension test system at withdrawal'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.013', 'spread': '0.4092', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The Tension test system was performed while withdrawing the catheters, up to 5 seconds.', 'description': 'Tension test system (friction) at withdrawal. Comparison between the catheters with 24h activation time and the 5 seconds activation time.\n\nThe MEAN for the withdrawal friction was measured in Newton (N).', 'unitOfMeasure': 'Newton', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was analysed using a per protocol approach only.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LoFric POBE Hydro-Kit II, 5 Seconds and Then LoFric POBE Hydro-Kit II, 24 Hours', 'description': 'Catheterizasion order:\n\n1. Reference Catheter, then washout for 2 hours\n2. LoFric POBE Hydro-Kit II activation time 5 seconds, then washout for 2 hours\n3. LoFric POBE Hydro-Kit II activation time 24 hours'}, {'id': 'FG001', 'title': 'LoFric POBE Hydro-Kit II, 24 Hours and Then LoFric POBE Hydro-Kit II, 5 Seconds', 'description': 'Catheterizasion order:\n\n1. Reference Catheter, then washout for 2 hours\n2. LoFric POBE Hydro-Kit II activation time 24 hours, then washout for 2 hours\n3. LoFric POBE Hydro-Kit II activation time 5 seconds'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'comment': 'One subject participated only in 2 arms due to an adverse event.', 'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This is a study with a crossover design between the test catheters. The subjects were first catheterized with a reference catheter and then catheterisized in a randomized order with the two test catheters.\n\nAll subjects participated in all arms except one that participated only in 2 arms due to an adverse event.\n\nThe subjects were catheterized three times during one day.. A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'LoFric POBE Hydro-Kit II, 5 Seconds and Then LoFric POBE Hydro-Kit II, 24 Hours', 'description': 'All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.\n\nAfter randomisation this group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds.\n\nThen the next test catheter was used, LoFric POBE Hydro-Kit II, activation time 24 hours.'}, {'id': 'BG001', 'title': 'LoFric POBE Hydro-Kit II, 24 Hours and Then LoFric POBE Hydro-Kit II, 5 Seconds', 'description': 'All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12.\n\nAfter randomisation this group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 24 hours.\n\nThen the next test catheter was used LoFric POBE Hydro-Kit II, activation time 5 seconds.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.42', 'spread': '6.10', 'groupId': 'BG000'}, {'value': '26.17', 'spread': '4.11', 'groupId': 'BG001'}, {'value': '27', 'spread': '5.27', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Two different activation times for the wetting solution for a urinary catheter will be used in healthy volunteers, compared to the use of a registered urinary catheter.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-09', 'studyFirstSubmitDate': '2008-09-05', 'resultsFirstSubmitDate': '2021-02-04', 'studyFirstSubmitQcDate': '2008-09-05', 'lastUpdatePostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-09', 'studyFirstPostDateStruct': {'date': '2008-09-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Subjects' Perception at Insertion of Test Catheter Activated for 5 Seconds, Compared to Reference.", 'timeFrame': 'A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.', 'description': "The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding insertion?'."}, {'measure': "Subjects' Perception at Insertion of Test Catheter Activated for 24 Hours, Compared to Reference.", 'timeFrame': 'A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.', 'description': "The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding insertion?'."}, {'measure': "Subjects' Perception at Withdrawal of Test Catheter Activated for 5 Seconds, Compared to Reference.", 'timeFrame': 'A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.', 'description': "The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding withdrawal?'."}, {'measure': "Subjects' Perception at Withdrawal of Test Catheter Activated for 24 Hours, Compared to Reference.", 'timeFrame': 'A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.', 'description': "The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding withdrawal?'."}], 'secondaryOutcomes': [{'measure': 'Comparison of the Perception at Insertion Between 5s and 24h Activation Times. Times', 'timeFrame': 'A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.', 'description': 'Comparison of the perception at insertion between the catheters with 5s and 24h activation times.'}, {'measure': 'Comparison of the Perception at Withdrawal Between 5s and 24h Activation Times.', 'timeFrame': 'A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.', 'description': 'Comparison of the perception at withdrawal between the catheters with 5s and 24h activation times.'}, {'measure': 'Test of Carry-over Effect at Insertion, Mean Rating of Perception on a Scale of 0 to 5', 'timeFrame': 'A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.', 'description': 'The subjects perception of the catheterization will be classified as very negative, slightly negative, same, slightly positive or very positive.\n\nThe mean perception of the 5s and the 24h catheter is calculated for each subject.\n\nThe perception was measured on a scale from 1 (=very negative compared to the reference catheter) to 5 (=very positive compared to the reference catheter) and a 3 indicating that the perception was the same for the test catheter as for the reference catheter. Before doing any statistics all answers were reduced by 3 resulting in values from -2 (=very negative compared to the reference catheter) to +2 (=very positive compared to the reference catheter) and a 0 indicating that the perception was the same for the test catheter as for the reference catheter.'}, {'measure': 'Test of Carry-over Effect at Withdrawal, Mean Rating of Perception on a Scale of 0 to 5', 'timeFrame': 'A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.', 'description': 'They had five alternative answers.The subjects perception of the catheterization will be classified as very negative, slightly negative, same, slightly positive or very positive.\n\nThe mean perception of the 5s and the 24h catheter is calculated for each subject.\n\nThe perception was measured on a scale from 1 (=very negative compared to the reference catheter) to 5 (=very positive compared to the reference catheter) and a 3 indicating that the perception was the same for the test catheter as for the reference catheter. Before doing any statistics all answers were reduced by 3 resulting in values from -2 (=very negative compared to the reference catheter) to +2 (=very positive compared to the reference catheter) and a 0 indicating that the perception was the same for the test catheter as for the reference catheter.'}, {'measure': 'Tension Test System: Ref-24h Mean', 'timeFrame': 'The Tension test system was performed while withdrawing the catheters up to 5 seconds.', 'description': 'Tension test system (friction) at withdrawal. Comparison between the reference catheter and the 24 hours activation time. The MEAN for the withdrawal friction was measured in Newton (N).'}, {'measure': 'Tension Test System: Ref-24h Work', 'timeFrame': 'The Tension test system was performed while withdrawing the catheters up to 5 seconds.', 'description': 'Tension test system (friction) at withdrawal. Comparison between the reference catheter and the 24 hours activation time. The WORK for the withdrawal friction was measured in Joule (J).'}, {'measure': 'Tension Test System: Ref-5s MEAN', 'timeFrame': 'The Tension test system was performed while withdrawing the catheters, up to 5 seconds.', 'description': 'Tension test system (friction) at withdrawal. Comparison between the reference catheter and the 5 seconds activation time. The MEAN for the withdrawal friction was measured in Newton (N).'}, {'measure': 'Tension Test System: Ref-5s WORK', 'timeFrame': 'The Tension test system was performed while withdrawing the catheters, up to 5 seconds.', 'description': 'Tension test system (friction) at withdrawal. Comparison between the reference catheter and the 5 seconds activation time. The WORK for the withdrawal friction was measured in Joule (J).'}, {'measure': 'Tension Test System: 24h-5s', 'timeFrame': 'The Tension test system was performed while withdrawing the catheters, up to 5 seconds.', 'description': 'Tension test system (friction) at withdrawal. Comparison between the catheters with 24h activation time and the 5 seconds activation time.\n\nThe MEAN for the withdrawal friction was measured in Newton (N).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urinary Catheterization']}, 'descriptionModule': {'briefSummary': "The primary purpose of this study is to compare the subject's perception (separately for each randomized catheter) of practicing catheterization when using catheters with sodium chloride in wetting solution (using two different activation times) with a standard reference catheter. The hypothesis is that the subjects' perception of catheterization is the same or more positive when using the test catheters compared to the reference catheter.", 'detailedDescription': 'The study is designed as a randomized, single-blind, cross-over, single-centre, study in healthy male volunteers.\n\nAll subjects will first be catheterized with a reference catheter, which is proven to be well tolerated by most subjects. This catheter will be used as a reference catheter to be compared with the randomized catheters. One more reason for this first test is to withdraw subjects who cannot tolerate catheterizations. Subjects will qualify for the randomized part of the study only if the first catheterization could be performed without significant discomfort.\n\nWhen the subject is randomized he will be catheterized with two urinary catheters in a randomized order during one day. The activation times for the wetting solution will be 5 seconds and 24 (± 2h) hours.\n\nDuring each catheterization, the friction at withdrawal will be measured for the catheter using a Tension Test System.\n\nThe subjects will be blinded. 25 healthy volunteers will be recruited from a single centre in Sweden.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of written informed consent\n* Healthy volunteer\n* Male aged 18 years or over\n\nExclusion Criteria:\n\n* Known or suspected, current impairment of and/or decreased urethral sensibility\n* History of urethral morbidity\n* History of urinary tract infection within three months, or ongoing symptomatic urinary tract infection\n* Use of medications that may affect the urethra´s dryness (anti-cholinergic drugs or cortisone)\n* Current drug, alcohol or other substance abuse\n* Other significant disease or condition (e.g. benign prostate hypertrophy, other prostatic lesions), which may interfere with treatment and/or evaluation\n* Allergy to antibiotics suspected poor compliance with the protocol during the complete study period'}, 'identificationModule': {'nctId': 'NCT00748033', 'briefTitle': 'A Study Evaluating a Urinary Catheter With Different Activation Times for the Wetting Solution, in Healthy Male Volunteers.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wellspect HealthCare'}, 'officialTitle': 'A Randomized, Single-blind, Cross-over, Single-centre Study in Healthy Volunteers Evaluating Subject Perception and Friction at Withdrawal of Catheters With Different Activation Times Compared to a Reference Catheter', 'orgStudyIdInfo': {'id': 'YA-CLO-0005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LoFric POBE Hydro-Kit II, 5 seconds and then LoFric POBE Hydro-Kit II, 24 hours', 'description': 'All subjects were first catheterizised with the reference catheter. After randomisation this group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds.\n\nThen the next test catheter was used LoFric POBE Hydro-Kit II, activation time 24 hours.', 'interventionNames': ['Device: Reference catheter: LoFric PVC, Nelaton 40 cm, CH 12', 'Device: LoFric POBE Hydro-Kit II, 5 seconds', 'Device: LoFric POBE Hydro-Kit II, 24 hours']}, {'type': 'EXPERIMENTAL', 'label': 'LoFric POBE Hydro-Kit II, 24 hours and then LoFric POBE Hydro-Kit II, 5 seconds', 'description': 'All subjects were first catheterizised with the reference catheter. After randomisation this group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 24 hours.\n\nThen the next test catheter was used LoFric POBE Hydro-Kit II, activation time 5 seconds.', 'interventionNames': ['Device: Reference catheter: LoFric PVC, Nelaton 40 cm, CH 12', 'Device: LoFric POBE Hydro-Kit II, 5 seconds', 'Device: LoFric POBE Hydro-Kit II, 24 hours']}], 'interventions': [{'name': 'Reference catheter: LoFric PVC, Nelaton 40 cm, CH 12', 'type': 'DEVICE', 'description': 'The subjects were first catheterized with this reference catheter.', 'armGroupLabels': ['LoFric POBE Hydro-Kit II, 24 hours and then LoFric POBE Hydro-Kit II, 5 seconds', 'LoFric POBE Hydro-Kit II, 5 seconds and then LoFric POBE Hydro-Kit II, 24 hours']}, {'name': 'LoFric POBE Hydro-Kit II, 5 seconds', 'type': 'DEVICE', 'description': 'An unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with sodium chloride in wetting solution, activation time 5 seconds', 'armGroupLabels': ['LoFric POBE Hydro-Kit II, 24 hours and then LoFric POBE Hydro-Kit II, 5 seconds', 'LoFric POBE Hydro-Kit II, 5 seconds and then LoFric POBE Hydro-Kit II, 24 hours']}, {'name': 'LoFric POBE Hydro-Kit II, 24 hours', 'type': 'DEVICE', 'description': 'An unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with sodium chloride in wetting solution, activation time 24 hours', 'armGroupLabels': ['LoFric POBE Hydro-Kit II, 24 hours and then LoFric POBE Hydro-Kit II, 5 seconds', 'LoFric POBE Hydro-Kit II, 5 seconds and then LoFric POBE Hydro-Kit II, 24 hours']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-171 76', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Trial Alliance A2:01, Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Magnus Jacobsson, MD, PhD, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dentsply Sirona Implants and Consumables'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wellspect HealthCare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}