Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT04445051
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2020-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Investigation of New Intermittent Catheters in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016055', 'term': 'Urinary Retention'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-studies@coloplast.com', 'phone': '+4549111111', 'title': 'Vice President, Medical Affairs', 'organization': 'Coloplast A/S'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Each participant was enrolled for 3 x 4-14 days for the entire investigation, thus a maximum of 42 days.', 'description': 'The relationship to the investigational or comparator products was collected. The safety population constituted the subjects who had given informed consent and were thus 30 participants.\n\nAn adverse event was reported as either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the comparator to the Variant 1 or Variant 2 products.', 'eventGroups': [{'id': 'EG000', 'title': 'Intermittent Catheter; SpeediCath® Standard Female', 'description': 'Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard female (active comparator). The catheterizations were performed by a trained nurses.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'New Intermittent Catheter Variant 1 for Female', 'description': 'Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for females. The catheterizations were performed by a trained nurses.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'New Intermittent Catheter Variant 2 for Female', 'description': 'Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for females. The catheterizations were performed by a trained nurses.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Intermittent Catheter; SpeediCath® Standard Male', 'description': 'Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by a trained nurses.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'New Intermittent Catheter Variant 1 for Male', 'description': 'Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by a trained nurses.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 1, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'New Intermittent Catheter Variant 2 for Male', 'description': 'Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by a trained nurses.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Possibly related', 'notes': 'Urinary tract infection (UTI)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Residual Urine at 1st Flow-stop', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Intermittent Catheter; SpeediCath® Standard Female', 'description': 'Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard female (active comparator). The catheterizations were performed by a trained nurses.'}, {'id': 'OG001', 'title': 'New Intermittent Catheter Variant 1 for Female', 'description': 'Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for females. The catheterizations were performed by a trained nurses.'}, {'id': 'OG002', 'title': 'New Intermittent Catheter Variant 2 for Female', 'description': 'Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for females. The catheterizations were performed by a trained nurses.'}, {'id': 'OG003', 'title': 'Intermittent Catheter; SpeediCath® Standard Male', 'description': 'Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by a trained nurses.'}, {'id': 'OG004', 'title': 'New Intermittent Catheter Variant 1 for Male', 'description': 'Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by a trained nurses.'}, {'id': 'OG005', 'title': 'New Intermittent Catheter Variant 2 for Male', 'description': 'Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by a trained nurses.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.0', 'spread': '71.0', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '2.6', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '37.0', 'spread': '40.0', 'groupId': 'OG003'}, {'value': '2.2', 'spread': '6.2', 'groupId': 'OG004'}, {'value': '1.0', 'spread': '4.0', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.010', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.9', 'ciLowerLimit': '8.3', 'ciUpperLimit': '57.5', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '34.3', 'ciLowerLimit': '9.8', 'ciUpperLimit': '58.8', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.908', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-23.1', 'ciUpperLimit': '25.9', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.006', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.3', 'ciLowerLimit': '10.8', 'ciUpperLimit': '59.8', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.005', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '36.8', 'ciLowerLimit': '11.9', 'ciUpperLimit': '61.8', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.899', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '-23.3', 'ciUpperLimit': '26.5', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after the procedure/catheterization, up to 5 min.', 'description': 'The residual urine at 1st flow-stop during catheterization (performed by a nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying/urination. This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter. Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.'}, {'type': 'SECONDARY', 'title': 'Post-void Residual Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Intermittent Catheter; SpeediCath® Standard Female', 'description': 'Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard female (active comparator). The catheterizations were performed by a trained nurses.'}, {'id': 'OG001', 'title': 'New Intermittent Catheter Variant 1 for Female', 'description': 'Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for females. The catheterizations were performed by a trained nurses.'}, {'id': 'OG002', 'title': 'New Intermittent Catheter Variant 2 for Female', 'description': 'Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for females. The catheterizations were performed by a trained nurses.'}, {'id': 'OG003', 'title': 'Intermittent Catheter; SpeediCath® Standard Male', 'description': 'Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by a trained nurses.'}, {'id': 'OG004', 'title': 'New Intermittent Catheter Variant 1 for Male', 'description': 'Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by a trained nurses.'}, {'id': 'OG005', 'title': 'New Intermittent Catheter Variant 2 for Male', 'description': 'Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by a trained nurses.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '6.1', 'groupId': 'OG001'}, {'value': '27.6', 'spread': '104.1', 'groupId': 'OG002'}, {'value': '5.3', 'spread': '8.9', 'groupId': 'OG003'}, {'value': '24.3', 'spread': '79.1', 'groupId': 'OG004'}, {'value': '16.3', 'spread': '31.9', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.665', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.8', 'ciLowerLimit': '-31.9', 'ciUpperLimit': '49.6', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.375', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.1', 'ciLowerLimit': '-58.7', 'ciUpperLimit': '22.4', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.188', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-27.0', 'ciLowerLimit': '-67.6', 'ciUpperLimit': '13.6', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.361', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.6', 'ciLowerLimit': '-59.3', 'ciUpperLimit': '21.9', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.600', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.9', 'ciLowerLimit': '-52.3', 'ciUpperLimit': '30.5', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.707', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.78', 'ciLowerLimit': '-33.5', 'ciUpperLimit': '49.0', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after the procedure/catheterization, up to 15 min.', 'description': 'The volume of residual urine (urine left in the bladder) post catheterization (performed by the nurse) measured in triplicates using an ultrasound scanner.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.'}, {'type': 'SECONDARY', 'title': 'Catheterization Insertion Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Intermittent Catheter; SpeediCath® Standard Female', 'description': 'Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard female (active comparator). The catheterizations were performed by a trained nurses.'}, {'id': 'OG001', 'title': 'New Intermittent Catheter Variant 1 for Female', 'description': 'Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for females. The catheterizations were performed by a trained nurses.'}, {'id': 'OG002', 'title': 'New Intermittent Catheter Variant 2 for Female', 'description': 'Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for females. The catheterizations were performed by a trained nurses.'}, {'id': 'OG003', 'title': 'Intermittent Catheter; SpeediCath® Standard Male', 'description': 'Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by a trained nurses.'}, {'id': 'OG004', 'title': 'New Intermittent Catheter Variant 1 for Male', 'description': 'Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by a trained nurses.'}, {'id': 'OG005', 'title': 'New Intermittent Catheter Variant 2 for Male', 'description': 'Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by a trained nurses.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.51', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '0.81', 'spread': '0.96', 'groupId': 'OG001'}, {'value': '0.86', 'spread': '1.15', 'groupId': 'OG002'}, {'value': '2.32', 'spread': '2.24', 'groupId': 'OG003'}, {'value': '2.31', 'spread': '1.97', 'groupId': 'OG004'}, {'value': '2.79', 'spread': '2.46', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.615', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-1.08', 'ciUpperLimit': '0.65', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.480', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.31', 'ciLowerLimit': '-1.17', 'ciUpperLimit': '0.56', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.839', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.95', 'ciUpperLimit': '0.77', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.894', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '0.80', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.195', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.58', 'ciLowerLimit': '-1.46', 'ciUpperLimit': '0.30', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.242', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.52', 'ciLowerLimit': '-1.40', 'ciUpperLimit': '0.36', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after the procedure/catheterization, up to 5 min.', 'description': 'Discomfort measured at catheter insertion, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.'}, {'type': 'SECONDARY', 'title': 'Catheterization Urination Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Intermittent Catheter; SpeediCath® Standard Female', 'description': 'Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard female (active comparator). The catheterizations were performed by a trained nurses.'}, {'id': 'OG001', 'title': 'New Intermittent Catheter Variant 1 for Female', 'description': 'Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for females. The catheterizations were performed by a trained nurses.'}, {'id': 'OG002', 'title': 'New Intermittent Catheter Variant 2 for Female', 'description': 'Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for females. The catheterizations were performed by a trained nurses.'}, {'id': 'OG003', 'title': 'Intermittent Catheter; SpeediCath® Standard Male', 'description': 'Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by a trained nurses.'}, {'id': 'OG004', 'title': 'New Intermittent Catheter Variant 1 for Male', 'description': 'Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by a trained nurses.'}, {'id': 'OG005', 'title': 'New Intermittent Catheter Variant 2 for Male', 'description': 'Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by a trained nurses.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.18', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '0.83', 'groupId': 'OG001'}, {'value': '0.55', 'spread': '0.93', 'groupId': 'OG002'}, {'value': '0.93', 'spread': '1.62', 'groupId': 'OG003'}, {'value': '0.74', 'spread': '0.86', 'groupId': 'OG004'}, {'value': '1.51', 'spread': '2.77', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.639', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-1.20', 'ciUpperLimit': '0.74', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.492', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-1.30', 'ciUpperLimit': '0.63', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.828', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-1.07', 'ciUpperLimit': '0.86', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.744', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-0.81', 'ciUpperLimit': '1.13', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.208', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.63', 'ciLowerLimit': '-1.62', 'ciUpperLimit': '0.36', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.116', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.79', 'ciLowerLimit': '-1.77', 'ciUpperLimit': '0.20', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after the procedure/catheterization, up to 5 min.', 'description': 'Discomfort measured during catheter emptying/urination, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.'}, {'type': 'SECONDARY', 'title': 'Withdrawal Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Intermittent Catheter; SpeediCath® Standard Female', 'description': 'Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard female (active comparator). The catheterizations were performed by a trained nurses.'}, {'id': 'OG001', 'title': 'New Intermittent Catheter Variant 1 for Female', 'description': 'Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for females. The catheterizations were performed by a trained nurses.'}, {'id': 'OG002', 'title': 'New Intermittent Catheter Variant 2 for Female', 'description': 'Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for females. The catheterizations were performed by a trained nurses.'}, {'id': 'OG003', 'title': 'Intermittent Catheter; SpeediCath® Standard Male', 'description': 'Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by a trained nurses.'}, {'id': 'OG004', 'title': 'New Intermittent Catheter Variant 1 for Male', 'description': 'Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by a trained nurses.'}, {'id': 'OG005', 'title': 'New Intermittent Catheter Variant 2 for Male', 'description': 'Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by a trained nurses.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.79', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '0.94', 'groupId': 'OG001'}, {'value': '1.11', 'spread': '1.32', 'groupId': 'OG002'}, {'value': '2.05', 'spread': '2.55', 'groupId': 'OG003'}, {'value': '1.42', 'spread': '1.86', 'groupId': 'OG004'}, {'value': '2.28', 'spread': '2.39', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.798', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '0.96', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.556', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-1.10', 'ciUpperLimit': '0.60', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.399', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-1.21', 'ciUpperLimit': '0.49', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.198', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '1.41', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.365', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.40', 'ciLowerLimit': '-1.27', 'ciUpperLimit': '0.48', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.033', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.95', 'ciLowerLimit': '-1.82', 'ciUpperLimit': '-0.08', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after the procedure/catheterization, up to 5 min.', 'description': 'Discomfort measured during catheter withdrawal, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.'}, {'type': 'SECONDARY', 'title': 'Overall Catheterization Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Intermittent Catheter; SpeediCath® Standard Female', 'description': 'Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard female (active comparator). The catheterizations were performed by a trained nurses.'}, {'id': 'OG001', 'title': 'New Intermittent Catheter Variant 1 for Female', 'description': 'Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for females. The catheterizations were performed by a trained nurses.'}, {'id': 'OG002', 'title': 'New Intermittent Catheter Variant 2 for Female', 'description': 'Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for females. The catheterizations were performed by a trained nurses.'}, {'id': 'OG003', 'title': 'Intermittent Catheter; SpeediCath® Standard Male', 'description': 'Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by a trained nurses.'}, {'id': 'OG004', 'title': 'New Intermittent Catheter Variant 1 for Male', 'description': 'Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by a trained nurses.'}, {'id': 'OG005', 'title': 'New Intermittent Catheter Variant 2 for Male', 'description': 'Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by a trained nurses.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.66', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '0.72', 'spread': '0.63', 'groupId': 'OG001'}, {'value': '1.04', 'spread': '1.63', 'groupId': 'OG002'}, {'value': '1.99', 'spread': '2.19', 'groupId': 'OG003'}, {'value': '1.71', 'spread': '1.57', 'groupId': 'OG004'}, {'value': '2.58', 'spread': '2.56', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.882', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.83', 'ciUpperLimit': '0.96', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.478', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.32', 'ciLowerLimit': '-1.21', 'ciUpperLimit': '0.57', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.391', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.38', 'ciLowerLimit': '-1.27', 'ciUpperLimit': '0.51', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.657', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '-0.69', 'ciUpperLimit': '1.09', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.125', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.71', 'ciLowerLimit': '-1.62', 'ciUpperLimit': '0.20', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.051', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.91', 'ciLowerLimit': '-1.81', 'ciUpperLimit': '0.00', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after the procedure/catheterization, up to 5 min.', 'description': 'Discomfort measured for the overall/entire catheterization procedure, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.'}, {'type': 'SECONDARY', 'title': 'Post-catheterization Urination Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Intermittent Catheter; SpeediCath® Standard Female', 'description': 'Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard female (active comparator). The catheterizations were performed by a trained nurses.'}, {'id': 'OG001', 'title': 'New Intermittent Catheter Variant 1 for Female', 'description': 'Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for females. The catheterizations were performed by a trained nurses.'}, {'id': 'OG002', 'title': 'New Intermittent Catheter Variant 2 for Female', 'description': 'Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for females. The catheterizations were performed by a trained nurses.'}, {'id': 'OG003', 'title': 'Intermittent Catheter; SpeediCath® Standard Male', 'description': 'Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by a trained nurses.'}, {'id': 'OG004', 'title': 'New Intermittent Catheter Variant 1 for Male', 'description': 'Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by a trained nurses.'}, {'id': 'OG005', 'title': 'New Intermittent Catheter Variant 2 for Male', 'description': 'Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by a trained nurses.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.29', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '0.35', 'spread': '0.72', 'groupId': 'OG002'}, {'value': '0.66', 'spread': '1.56', 'groupId': 'OG003'}, {'value': '0.66', 'spread': '0.84', 'groupId': 'OG004'}, {'value': '1.88', 'spread': '2.70', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.877', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.83', 'ciUpperLimit': '0.97', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.351', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.42', 'ciLowerLimit': '-1.31', 'ciUpperLimit': '0.47', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.278', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.49', 'ciLowerLimit': '-1.38', 'ciUpperLimit': '0.40', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.711', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '1.06', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.024', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.06', 'ciLowerLimit': '-1.97', 'ciUpperLimit': '-0.15', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}, {'pValue': '0.009', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.23', 'ciLowerLimit': '-2.14', 'ciUpperLimit': '-0.31', 'pValueComment': 'The P-values were not adjusted for multiple comparisons.', 'groupDescription': 'Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\\*Gender (male and females)'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after the first normal void following the procedure/catheterization, up to 5 min.', 'description': 'Discomfort measured for the first normal void/urination after the catheterization procedure, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Comparator, Then Variant 2, Then Variant 1', 'description': 'On three separate visits and in the listed random order, the participants underwent three interventions:\n\nFirst intervention: Day of catheterization with Comparator. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 1.'}, {'id': 'FG001', 'title': 'Variant 2, Then Variant 1, Then Comparator', 'description': 'On three separate visits and in the listed random order, the participants underwent three interventions:\n\nFirst intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Third intervention: Day of catheterization with Comparator.'}, {'id': 'FG002', 'title': 'Comparator, Then Variant 1, Then Variant 2', 'description': 'On three separate visits and in the listed random order, the participants underwent three interventions:\n\nFirst intervention: Day of catheterization with Comparator. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 2.'}, {'id': 'FG003', 'title': 'Variant 1, Then Comparator, Then Variant 2', 'description': 'On three separate visits and in the listed random order, the participants underwent three interventions:\n\nFirst intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Second intervention: Day of catheterization with Comparator. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 2.'}, {'id': 'FG004', 'title': 'Variant 1, Then Variant 2, Then Comparator', 'description': 'On three separate visits and in the listed random order, the participants underwent three interventions:\n\nFirst intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Third intervention: Day of catheterization with Comparator.'}, {'id': 'FG005', 'title': 'Variant 2, Then Comparator, Then Variant 1', 'description': 'On three separate visits and in the listed random order, the participants underwent three interventions:\n\nFirst intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Second intervention: Day of catheterization with Comparator. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Between March 2020 and September 2020, 30 users were recruited for the study from one site (Denmark) and encompassed the safety population.', 'preAssignmentDetails': "The 30 recruited participant were randomized into the three treatment arms, using a randomization sequence of six. No participants were excluded, one was discontinued after Visit 2 due to an adverse event.\n\nTwo participants total had an adverse event, both were classified as mild, non-serious, 'Possibly related' and 'Not related' (for details; see Adverse Events section).\n\nThus, 30 participants constituted the intention to treat (ITT) population."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Female ITT Population', 'description': 'Each treatment arm consisted of three test visits with 4-14 days between each crossover. On each visit, the participants underwent intermittent catheterization through the urethra, draining the bladder, and tested a different intermittent catheter: The comparator catheter (SpeediCath® Standard female), the new Variant 1 female catheter, or the new Variant 2 female catheter.'}, {'id': 'BG001', 'title': 'Male ITT Population', 'description': 'Each treatment arm consisted of three test visits with 4-14 days between each crossover. On each visit, the participants underwent intermittent catheterization through the urethra, draining the bladder, and tested a different intermittent catheter: The comparator catheter (SpeediCath® Standard male), the new Variant 1 male catheter, or the new Variant 2 male catheter.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], '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': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', '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': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31', 'spread': '12', 'groupId': 'BG000'}, {'value': '32', 'spread': '8', 'groupId': 'BG001'}, {'value': '32', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Denmark', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hematuria positive', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Blood in the urine; dipstick analysis positive.', 'unitOfMeasure': 'Participants'}, {'title': 'Hematuria negative', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Blood in the urine; dipstick analysis negative.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-23', 'size': 1935400, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-08-04T06:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-08', 'studyFirstSubmitDate': '2020-05-28', 'resultsFirstSubmitDate': '2022-02-04', 'studyFirstSubmitQcDate': '2020-06-23', 'lastUpdatePostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-08', 'studyFirstPostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Residual Urine at 1st Flow-stop', 'timeFrame': 'Immediately after the procedure/catheterization, up to 5 min.', 'description': 'The residual urine at 1st flow-stop during catheterization (performed by a nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying/urination. This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter. Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop.'}], 'secondaryOutcomes': [{'measure': 'Post-void Residual Urine', 'timeFrame': 'Immediately after the procedure/catheterization, up to 15 min.', 'description': 'The volume of residual urine (urine left in the bladder) post catheterization (performed by the nurse) measured in triplicates using an ultrasound scanner.'}, {'measure': 'Catheterization Insertion Discomfort', 'timeFrame': 'Immediately after the procedure/catheterization, up to 5 min.', 'description': 'Discomfort measured at catheter insertion, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.'}, {'measure': 'Catheterization Urination Discomfort', 'timeFrame': 'Immediately after the procedure/catheterization, up to 5 min.', 'description': 'Discomfort measured during catheter emptying/urination, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.'}, {'measure': 'Withdrawal Discomfort', 'timeFrame': 'Immediately after the procedure/catheterization, up to 5 min.', 'description': 'Discomfort measured during catheter withdrawal, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.'}, {'measure': 'Overall Catheterization Discomfort', 'timeFrame': 'Immediately after the procedure/catheterization, up to 5 min.', 'description': 'Discomfort measured for the overall/entire catheterization procedure, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.'}, {'measure': 'Post-catheterization Urination Discomfort', 'timeFrame': 'Immediately after the first normal void following the procedure/catheterization, up to 5 min.', 'description': 'Discomfort measured for the first normal void/urination after the catheterization procedure, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Retention, Urinary']}, 'referencesModule': {'references': [{'pmid': '37966080', 'type': 'DERIVED', 'citation': 'Landauro MH, Tentor F, Pedersen T, Jacobsen L, Bagi P. Improved Performance With the Micro-Hole Zone Intermittent Catheter: A Combined Analysis of 3 Randomized Controlled Studies Comparing the New Catheter Technology With a Conventional Eyelet Catheter. J Wound Ostomy Continence Nurs. 2023 Nov-Dec 01;50(6):504-511. doi: 10.1097/WON.0000000000001029.'}]}, 'descriptionModule': {'briefSummary': 'Investigation of non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters with a comparator catheter in 30 adult healthy volunteers.', 'detailedDescription': 'The CP322 study investigated a novel non-CE marked intermittent catheter for males and females, designed in two different variants, Variant 1 and Variant 2, respectively. The study was conducted in Denmark and was a randomized, single blinded, cross-over investigation comparing the two new variant catheters with a comparator catheter in 30 adult healthy volunteers.\n\nFor each participant, the study thus contained three test visits/treatment arms (Comparator, Variant 1 and Variant 2, respectively), to which the 30 participants were randomized using a randomization sequence of six (i.e., there were six different random options for the order in which the participants tested the three catheters). There were 4-14 days between the test visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimum 18 years of age and with full legal capacity\n* Written informed consent and signed letter of authority and secrecy agreement given\n* Willing to comply with not using analgesics 1 up to 24 hours prior to catheterization visits\n* Urine Multistix negative for erythrocytes (hematuria)\n\nExclusion Criteria:\n\n* Participation in any other clinical investigations during this investigation\n* Known hypersensitivity towards any of the test products\n* Symptoms of urinary tract infection (UTI) (Investigators judgement)\n* Pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT04445051', 'briefTitle': 'Investigation of New Intermittent Catheters in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': 'Exploratory Investigation on Performance and Safety of New Intermittent Catheters in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'CP322'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intermittent catheter; SpeediCath® Standard male or female', 'description': 'Participants underwent catheterization with standard of care intermittent catheter. The catheterization was performed by a trained nurse.', 'interventionNames': ['Device: SpeediCath® Standard male or female']}, {'type': 'EXPERIMENTAL', 'label': 'New intermittent catheter Variant 1 for male or female', 'description': 'Participants underwent catheterization with the new intermittent catheter Variant 1 for males or females. The catheterization was performed by a trained nurse.', 'interventionNames': ['Device: New intermittent Variant 1 catheter for male or female']}, {'type': 'EXPERIMENTAL', 'label': 'New intermittent catheter Variant 2 for male or female', 'description': 'Participants underwent catheterization with the new intermittent catheter Variant 2 for males or females. The catheterization was performed by a trained nurse.', 'interventionNames': ['Device: New intermittent Variant 2 catheter for male or female']}], 'interventions': [{'name': 'SpeediCath® Standard male or female', 'type': 'DEVICE', 'description': 'Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male or female.', 'armGroupLabels': ['Intermittent catheter; SpeediCath® Standard male or female']}, {'name': 'New intermittent Variant 1 catheter for male or female', 'type': 'DEVICE', 'description': 'Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 for male or female.', 'armGroupLabels': ['New intermittent catheter Variant 1 for male or female']}, {'name': 'New intermittent Variant 2 catheter for male or female', 'type': 'DEVICE', 'description': 'Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 for male or female.', 'armGroupLabels': ['New intermittent catheter Variant 2 for male or female']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'Copenhagen Ø', 'country': 'Denmark', 'facility': 'Urologisk klinik, Afsnit 2112, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Per Bagi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Blegdamsvej 9, Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}