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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.
The study is designed as a randomized, single-blind, cross-over, single-centre, study in healthy male volunteers.
All 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.
When 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.
During each catheterization, the friction at withdrawal will be measured for the catheter using a Tension Test System.
The subjects will be blinded. 25 healthy volunteers will be recruited from a single centre in Sweden.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LoFric POBE Hydro-Kit II, 5 seconds and then LoFric POBE Hydro-Kit II, 24 hours | Experimental | 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. Then the next test catheter was used LoFric POBE Hydro-Kit II, activation time 24 hours. |
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| LoFric POBE Hydro-Kit II, 24 hours and then LoFric POBE Hydro-Kit II, 5 seconds | Experimental | 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. Then the next test catheter was used LoFric POBE Hydro-Kit II, activation time 5 seconds. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reference catheter: LoFric PVC, Nelaton 40 cm, CH 12 | Device | The subjects were first catheterized with this reference catheter. |
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| Measure | Description | Time Frame |
|---|---|---|
| Subjects' Perception at Insertion of Test Catheter Activated for 5 Seconds, Compared to Reference. | 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?'. | 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. |
| Subjects' Perception at Insertion of Test Catheter Activated for 24 Hours, Compared to Reference. | 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?'. | 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. |
| Subjects' Perception at Withdrawal of Test Catheter Activated for 5 Seconds, Compared to Reference. | 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?'. | 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. |
| Subjects' Perception at Withdrawal of Test Catheter Activated for 24 Hours, Compared to Reference. | 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?'. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the Perception at Insertion Between 5s and 24h Activation Times. Times | Comparison of the perception at insertion between the catheters with 5s and 24h activation times. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magnus Jacobsson, MD, PhD, Prof. | Dentsply Sirona Implants and Consumables | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Trial Alliance A2:01, Karolinska University Hospital | Stockholm | SE-171 76 | Sweden |
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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.
All subjects participated in all arms except one that participated only in 2 arms due to an adverse event.
The subjects were catheterized three times during one day.. A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes.
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| ID | Title | Description |
|---|---|---|
| FG000 | LoFric POBE Hydro-Kit II, 5 Seconds and Then LoFric POBE Hydro-Kit II, 24 Hours | Catheterizasion order:
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| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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.
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| LoFric POBE Hydro-Kit II, 5 seconds | Device | An unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with sodium chloride in wetting solution, activation time 5 seconds |
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| LoFric POBE Hydro-Kit II, 24 hours | Device | An unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with sodium chloride in wetting solution, activation time 24 hours |
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| Comparison of the Perception at Withdrawal Between 5s and 24h Activation Times. | Comparison of the perception at withdrawal between the catheters with 5s and 24h activation times. | 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. |
| Test of Carry-over Effect at Insertion, Mean Rating of Perception on a Scale of 0 to 5 | The subjects perception of the catheterization will be classified as very negative, slightly negative, same, slightly positive or very positive. The mean perception of the 5s and the 24h catheter is calculated for each subject. The 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. | 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. |
| Test of Carry-over Effect at Withdrawal, Mean Rating of Perception on a Scale of 0 to 5 | 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. The mean perception of the 5s and the 24h catheter is calculated for each subject. The 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. | 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. |
| Tension Test System: Ref-24h Mean | 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). | The Tension test system was performed while withdrawing the catheters up to 5 seconds. |
| Tension Test System: Ref-24h Work | 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). | The Tension test system was performed while withdrawing the catheters up to 5 seconds. |
| Tension Test System: Ref-5s MEAN | 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). | The Tension test system was performed while withdrawing the catheters, up to 5 seconds. |
| Tension Test System: Ref-5s WORK | 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). | The Tension test system was performed while withdrawing the catheters, up to 5 seconds. |
| Tension Test System: 24h-5s | Tension test system (friction) at withdrawal. Comparison between the catheters with 24h activation time and the 5 seconds activation time. The MEAN for the withdrawal friction was measured in Newton (N). | The Tension test system was performed while withdrawing the catheters, up to 5 seconds. |
| LoFric POBE Hydro-Kit II, 24 Hours and Then LoFric POBE Hydro-Kit II, 5 Seconds |
Catheterizasion order:
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | LoFric POBE Hydro-Kit II, 5 Seconds and Then LoFric POBE Hydro-Kit II, 24 Hours | All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12. After randomisation this group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds. Then the next test catheter was used, LoFric POBE Hydro-Kit II, activation time 24 hours. |
| BG001 | LoFric POBE Hydro-Kit II, 24 Hours and Then LoFric POBE Hydro-Kit II, 5 Seconds | All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12. After randomisation this group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 24 hours. Then the next test catheter was used LoFric POBE Hydro-Kit II, activation time 5 seconds. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subjects' Perception at Insertion of Test Catheter Activated for 5 Seconds, Compared to Reference. | 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?'. | 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. | Posted | Number | participants | 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. |
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| Primary | Subjects' Perception at Insertion of Test Catheter Activated for 24 Hours, Compared to Reference. | 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?'. | 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. | Posted | Count of Participants | Participants | 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. |
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| Primary | Subjects' Perception at Withdrawal of Test Catheter Activated for 5 Seconds, Compared to Reference. | 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?'. | Subjects fulfilling the inclusion criteria but none of the exclusion criteria were included in the Per-Protocol (PP) analysis set. | Posted | Count of Participants | Participants | 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. |
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| Primary | Subjects' Perception at Withdrawal of Test Catheter Activated for 24 Hours, Compared to Reference. | 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?'. | 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. | Posted | Number | participants | 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. |
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| Secondary | Comparison of the Perception at Insertion Between 5s and 24h Activation Times. Times | Comparison of the perception at insertion between the catheters with 5s and 24h activation times. | The study was analysed using a per protocol approach only. | Posted | Number | participants | 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. |
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| Secondary | Comparison of the Perception at Withdrawal Between 5s and 24h Activation Times. | Comparison of the perception at withdrawal between the catheters with 5s and 24h activation times. | The study was analysed using a per protocol approach only. | Posted | Number | participants | 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. |
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| Secondary | Test of Carry-over Effect at Insertion, Mean Rating of Perception on a Scale of 0 to 5 | The subjects perception of the catheterization will be classified as very negative, slightly negative, same, slightly positive or very positive. The mean perception of the 5s and the 24h catheter is calculated for each subject. The 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. | 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. | Posted | Mean | Standard Deviation | Scores on a scale | 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. |
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| Secondary | Test of Carry-over Effect at Withdrawal, Mean Rating of Perception on a Scale of 0 to 5 | 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. The mean perception of the 5s and the 24h catheter is calculated for each subject. The 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | 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. |
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| Secondary | Tension Test System: Ref-24h Mean | 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). | The study was analysed using a per protocol approach only. | Posted | Mean | Standard Deviation | Newton | The Tension test system was performed while withdrawing the catheters up to 5 seconds. |
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| Secondary | Tension Test System: Ref-24h Work | 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). | The study was analysed using a per protocol approach only. | Posted | Mean | Standard Deviation | Joule | The Tension test system was performed while withdrawing the catheters up to 5 seconds. |
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| Secondary | Tension Test System: Ref-5s MEAN | 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). | The study was analysed using a per protocol approach only. | Posted | Mean | Standard Deviation | Newton | The Tension test system was performed while withdrawing the catheters, up to 5 seconds. |
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| Secondary | Tension Test System: Ref-5s WORK | 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). | The study was analysed using a per protocol approach only. | Posted | Mean | Standard Deviation | Joule | The Tension test system was performed while withdrawing the catheters, up to 5 seconds. |
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| Secondary | Tension Test System: 24h-5s | Tension test system (friction) at withdrawal. Comparison between the catheters with 24h activation time and the 5 seconds activation time. The MEAN for the withdrawal friction was measured in Newton (N). | The study was analysed using a per protocol approach only. | Posted | Mean | Standard Deviation | Newton | The Tension test system was performed while withdrawing the catheters, up to 5 seconds. |
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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.
In this study all adverse events will be judged as adverse device effect. Adverse events were not monitored during reference testing.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LoFric POBE Hydro-Kit II, 5 Seconds | All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12. After 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. After 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. | 0 | 24 | 0 | 24 | 17 | 24 |
| EG001 | LoFric POBE Hydro-Kit II, 24 Hours | All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12. After 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. After 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. | 0 | 25 | 0 | 25 | 18 | 25 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Discomfort during insertion of test catheter | Renal and urinary disorders | Systematic Assessment |
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| Discomfort during withdrawal of test catheter | Renal and urinary disorders | Systematic Assessment |
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| Discomfort during micturition after test catheter | Renal and urinary disorders | Systematic Assessment |
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| Hematuria after test catheter is removed | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Medical Affairs | Wellspect Health Care | +46313763000 | mace@wellspect.com |
| >=65 years |
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| Male |
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| Title | Measurements |
|---|---|
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| Slightly positive |
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| Very positive |
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| OG001 | 24h Followed by 5s | 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. The other group was randomised to start with the the catheter activated for 24 hours followed by the catheter activated for 5 seconds. |
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| OG001 | 24h Followed by 5s | 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. The other group was randomised to start with the the catheter activated for 24 hours followed by the catheter activated for 5 seconds. |
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