Urinary Catheterization
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEReference catheter: LoFric PVC, Nelaton 40 cm, CH 12
The subjects were first catheterized with this reference catheter.
DEVICELoFric POBE Hydro-Kit II, 5 seconds
An unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with sodium chloride in wetting solution, activation time 5 seconds
DEVICELoFric POBE Hydro-Kit II, 24 hours
An unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with sodium chloride in wetting solution, activation time 24 hours
Sponsors
Wellspect HealthCare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Provision of written informed consent * Healthy volunteer * Male aged 18 years or over
Exclusion criteria
* Known or suspected, current impairment of and/or decreased urethral sensibility * History of urethral morbidity * History of urinary tract infection within three months, or ongoing symptomatic urinary tract infection * Use of medications that may affect the urethra´s dryness (anti-cholinergic drugs or cortisone) * Current drug, alcohol or other substance abuse * Other significant disease or condition (e.g. benign prostate hypertrophy, other prostatic lesions), which may interfere with treatment and/or evaluation * Allergy to antibiotics suspected poor compliance with the protocol during the complete study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjects' Perception at Insertion of Test Catheter Activated for 5 Seconds, Compared to Reference. | 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. | 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?'. |
| Subjects' Perception at Insertion of Test Catheter Activated for 24 Hours, Compared to Reference. | 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. | 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?'. |
| Subjects' Perception at Withdrawal of Test Catheter Activated for 5 Seconds, Compared to Reference. | 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. | 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' Perception at Withdrawal of Test Catheter Activated for 24 Hours, Compared to Reference. | 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. | 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?'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tension Test System: Ref-24h Mean | The Tension test system was performed while withdrawing the catheters up to 5 seconds. | 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). |
| Tension Test System: Ref-24h Work | The Tension test system was performed while withdrawing the catheters up to 5 seconds. | 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). |
| Comparison of the Perception at Insertion Between 5s and 24h Activation Times. 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. | Comparison of the perception at insertion between the catheters with 5s and 24h activation times. |
| Tension Test System: Ref-5s WORK | The Tension test system was performed while withdrawing the catheters, up to 5 seconds. | 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). |
| Tension Test System: 24h-5s | The Tension test system was performed while withdrawing the catheters, up to 5 seconds. | 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). |
| Tension Test System: Ref-5s MEAN | The Tension test system was performed while withdrawing the catheters, up to 5 seconds. | 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). |
| Comparison of the Perception at Withdrawal Between 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. | Comparison of the perception at withdrawal between the catheters with 5s and 24h activation times. |
| Test of Carry-over Effect at Insertion, Mean Rating of Perception on a Scale of 0 to 5 | 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. | 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. |
| Test of Carry-over Effect at Withdrawal, Mean Rating of Perception on a Scale of 0 to 5 | 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. | 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. |
Countries
Sweden
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 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. | 13 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | LoFric POBE Hydro-Kit II, 24 Hours and Then LoFric POBE Hydro-Kit II, 5 Seconds | LoFric POBE Hydro-Kit II, 5 Seconds and Then LoFric POBE Hydro-Kit II, 24 Hours | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 12 Participants | 25 Participants |
| Age, Continuous | 26.17 years STANDARD_DEVIATION 4.11 | 29.42 years STANDARD_DEVIATION 6.1 | 27 years STANDARD_DEVIATION 5.27 |
| Region of Enrollment Sweden | 13 participants | 12 participants | 25 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 13 Participants | 12 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 25 |
| other Total, other adverse events | 17 / 24 | 18 / 25 |
| serious Total, serious adverse events | 0 / 24 | 0 / 25 |
Outcome results
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?'.
Time frame: 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.
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LoFric POBE Hydro-Kit II, 5 Seconds | Subjects' Perception at Insertion of Test Catheter Activated for 24 Hours, Compared to Reference. | Very negative | 4 Participants |
| LoFric POBE Hydro-Kit II, 5 Seconds | Subjects' Perception at Insertion of Test Catheter Activated for 24 Hours, Compared to Reference. | Slightly negative | 8 Participants |
| LoFric POBE Hydro-Kit II, 5 Seconds | Subjects' Perception at Insertion of Test Catheter Activated for 24 Hours, Compared to Reference. | Same | 5 Participants |
| LoFric POBE Hydro-Kit II, 5 Seconds | Subjects' Perception at Insertion of Test Catheter Activated for 24 Hours, Compared to Reference. | Slightly positive | 7 Participants |
| LoFric POBE Hydro-Kit II, 5 Seconds | Subjects' Perception at Insertion of Test Catheter Activated for 24 Hours, Compared to Reference. | Very positive | 1 Participants |
Comparison: Wilcoxon signed rank test, two-sided. Testing the hypothesis that the perception is same.p-value: 0.2487Wilcoxon (Mann-Whitney)
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?'.
Time frame: 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.
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LoFric POBE Hydro-Kit II, 5 Seconds | Subjects' Perception at Insertion of Test Catheter Activated for 5 Seconds, Compared to Reference. | Very negative | 3 participants |
| LoFric POBE Hydro-Kit II, 5 Seconds | Subjects' Perception at Insertion of Test Catheter Activated for 5 Seconds, Compared to Reference. | Slightly negative | 10 participants |
| LoFric POBE Hydro-Kit II, 5 Seconds | Subjects' Perception at Insertion of Test Catheter Activated for 5 Seconds, Compared to Reference. | Same | 5 participants |
| LoFric POBE Hydro-Kit II, 5 Seconds | Subjects' Perception at Insertion of Test Catheter Activated for 5 Seconds, Compared to Reference. | Slightly positive | 6 participants |
| LoFric POBE Hydro-Kit II, 5 Seconds | Subjects' Perception at Insertion of Test Catheter Activated for 5 Seconds, Compared to Reference. | Very positive | 0 participants |
Comparison: Wilcoxon signed rank test, two-sided. Testing the hypothesis that the perception is same.p-value: 0.065Wilcoxon (Mann-Whitney)
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?'.
Time frame: 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.
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LoFric POBE Hydro-Kit II, 5 Seconds | Subjects' Perception at Withdrawal of Test Catheter Activated for 24 Hours, Compared to Reference. | Very negative | 6 participants |
| LoFric POBE Hydro-Kit II, 5 Seconds | Subjects' Perception at Withdrawal of Test Catheter Activated for 24 Hours, Compared to Reference. | Slightly negative | 6 participants |
| LoFric POBE Hydro-Kit II, 5 Seconds | Subjects' Perception at Withdrawal of Test Catheter Activated for 24 Hours, Compared to Reference. | Same | 11 participants |
| LoFric POBE Hydro-Kit II, 5 Seconds | Subjects' Perception at Withdrawal of Test Catheter Activated for 24 Hours, Compared to Reference. | Slightly positive | 2 participants |
| LoFric POBE Hydro-Kit II, 5 Seconds | Subjects' Perception at Withdrawal of Test Catheter Activated for 24 Hours, Compared to Reference. | Very positive | 0 participants |
Comparison: Wilcoxon signed rank test, two-sided. Testing the hypothesis that the perception is same.p-value: 0.0045Wilcoxon (Mann-Whitney)
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?'.
Time frame: 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.
Population: Subjects fulfilling the inclusion criteria but none of the exclusion criteria were included in the Per-Protocol (PP) analysis set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LoFric POBE Hydro-Kit II, 5 Seconds | Subjects' Perception at Withdrawal of Test Catheter Activated for 5 Seconds, Compared to Reference. | Very negative | 4 Participants |
| LoFric POBE Hydro-Kit II, 5 Seconds | Subjects' Perception at Withdrawal of Test Catheter Activated for 5 Seconds, Compared to Reference. | Slightly negative | 6 Participants |
| LoFric POBE Hydro-Kit II, 5 Seconds | Subjects' Perception at Withdrawal of Test Catheter Activated for 5 Seconds, Compared to Reference. | Same | 4 Participants |
| LoFric POBE Hydro-Kit II, 5 Seconds | Subjects' Perception at Withdrawal of Test Catheter Activated for 5 Seconds, Compared to Reference. | Slightly positive | 8 Participants |
| LoFric POBE Hydro-Kit II, 5 Seconds | Subjects' Perception at Withdrawal of Test Catheter Activated for 5 Seconds, Compared to Reference. | Very positive | 2 Participants |
Comparison: Wilcoxon signed rank test, two-sided. Testing the hypothesis that the perception is same.p-value: 0.7288Wilcoxon (Mann-Whitney)
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.
Time frame: 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.
Population: The study was analysed using a per protocol approach only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LoFric POBE Hydro-Kit II, 5 Seconds | Comparison of the Perception at Insertion Between 5s and 24h Activation Times. Times | Slightly negative | 10 participants |
| LoFric POBE Hydro-Kit II, 5 Seconds | Comparison of the Perception at Insertion Between 5s and 24h Activation Times. Times | Slightly positive | 6 participants |
| LoFric POBE Hydro-Kit II, 5 Seconds | Comparison of the Perception at Insertion Between 5s and 24h Activation Times. Times | Same | 5 participants |
| LoFric POBE Hydro-Kit II, 5 Seconds | Comparison of the Perception at Insertion Between 5s and 24h Activation Times. Times | Very positive | 0 participants |
| LoFric POBE Hydro-Kit II, 5 Seconds | Comparison of the Perception at Insertion Between 5s and 24h Activation Times. Times | Very negative | 3 participants |
| LoFric POBE Hydro-Kit II, 24 Hours | Comparison of the Perception at Insertion Between 5s and 24h Activation Times. Times | Very positive | 1 participants |
| LoFric POBE Hydro-Kit II, 24 Hours | Comparison of the Perception at Insertion Between 5s and 24h Activation Times. Times | Very negative | 3 participants |
| LoFric POBE Hydro-Kit II, 24 Hours | Comparison of the Perception at Insertion Between 5s and 24h Activation Times. Times | Slightly negative | 8 participants |
| LoFric POBE Hydro-Kit II, 24 Hours | Comparison of the Perception at Insertion Between 5s and 24h Activation Times. Times | Same | 5 participants |
| LoFric POBE Hydro-Kit II, 24 Hours | Comparison of the Perception at Insertion Between 5s and 24h Activation Times. Times | Slightly positive | 7 participants |
Comparison: Testing the hypothesis that 5s and 24 h are equal at insertion.p-value: 0.4561Wilcoxon (Mann-Whitney)
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.
Time frame: 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.
Population: The study was analysed using a per protocol approach only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LoFric POBE Hydro-Kit II, 5 Seconds | Comparison of the Perception at Withdrawal Between 5s and 24h Activation Times. | Slightly negative | 6 participants |
| LoFric POBE Hydro-Kit II, 5 Seconds | Comparison of the Perception at Withdrawal Between 5s and 24h Activation Times. | Slightly positive | 8 participants |
| LoFric POBE Hydro-Kit II, 5 Seconds | Comparison of the Perception at Withdrawal Between 5s and 24h Activation Times. | Same | 4 participants |
| LoFric POBE Hydro-Kit II, 5 Seconds | Comparison of the Perception at Withdrawal Between 5s and 24h Activation Times. | Very positive | 2 participants |
| LoFric POBE Hydro-Kit II, 5 Seconds | Comparison of the Perception at Withdrawal Between 5s and 24h Activation Times. | Very negative | 4 participants |
| LoFric POBE Hydro-Kit II, 24 Hours | Comparison of the Perception at Withdrawal Between 5s and 24h Activation Times. | Very positive | 0 participants |
| LoFric POBE Hydro-Kit II, 24 Hours | Comparison of the Perception at Withdrawal Between 5s and 24h Activation Times. | Very negative | 5 participants |
| LoFric POBE Hydro-Kit II, 24 Hours | Comparison of the Perception at Withdrawal Between 5s and 24h Activation Times. | Slightly negative | 6 participants |
| LoFric POBE Hydro-Kit II, 24 Hours | Comparison of the Perception at Withdrawal Between 5s and 24h Activation Times. | Same | 11 participants |
| LoFric POBE Hydro-Kit II, 24 Hours | Comparison of the Perception at Withdrawal Between 5s and 24h Activation Times. | Slightly positive | 2 participants |
Comparison: Testing the hypothesis that 5s and 24 h are equal at withdrawal.p-value: 0.1797Wilcoxon (Mann-Whitney)
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).
Time frame: The Tension test system was performed while withdrawing the catheters, up to 5 seconds.
Population: The study was analysed using a per protocol approach only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LoFric POBE Hydro-Kit II, 5 Seconds | Tension Test System: 24h-5s | -0.013 Newton | Standard Deviation 0.4092 |
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).
Time frame: The Tension test system was performed while withdrawing the catheters up to 5 seconds.
Population: The study was analysed using a per protocol approach only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LoFric POBE Hydro-Kit II, 5 Seconds | Tension Test System: Ref-24h Mean | 0.077 Newton | Standard Deviation 0.088 |
p-value: 0.0003Wilcoxon (Mann-Whitney)
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).
Time frame: The Tension test system was performed while withdrawing the catheters up to 5 seconds.
Population: The study was analysed using a per protocol approach only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LoFric POBE Hydro-Kit II, 5 Seconds | Tension Test System: Ref-24h Work | 0.011 Joule | Standard Deviation 0.024 |
p-value: 0.0346Wilcoxon (Mann-Whitney)
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).
Time frame: The Tension test system was performed while withdrawing the catheters, up to 5 seconds.
Population: The study was analysed using a per protocol approach only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LoFric POBE Hydro-Kit II, 5 Seconds | Tension Test System: Ref-5s MEAN | 0.073 Newton | Standard Deviation 0.122 |
p-value: 0.0016Wilcoxon (Mann-Whitney)
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).
Time frame: The Tension test system was performed while withdrawing the catheters, up to 5 seconds.
Population: The study was analysed using a per protocol approach only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LoFric POBE Hydro-Kit II, 5 Seconds | Tension Test System: Ref-5s WORK | 0.009 Joule | Standard Deviation 0.03 |
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.
Time frame: 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.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LoFric POBE Hydro-Kit II, 5 Seconds | Test of Carry-over Effect at Insertion, Mean Rating of Perception on a Scale of 0 to 5 | -0.17 Scores on a scale | Standard Deviation 0.807 |
| LoFric POBE Hydro-Kit II, 24 Hours | Test of Carry-over Effect at Insertion, Mean Rating of Perception on a Scale of 0 to 5 | -0.46 Scores on a scale | Standard Deviation 0.865 |
Comparison: The mean perception of the 5s and the 24h catheter is calculated for each patient. The patients are then divided in two groups depending on the order the patients received the two catheters and the hypotheses that the mean of the 5s and the 24h catheter is equal in the two groups are tested. If the test results in a significant p-value it can be concluded that a carry-over effect is present.p-value: 0.5171Wilcoxon (Mann-Whitney)
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.
Time frame: 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.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LoFric POBE Hydro-Kit II, 5 Seconds | Test of Carry-over Effect at Withdrawal, Mean Rating of Perception on a Scale of 0 to 5 | -0.33 Score on a scale | Standard Deviation 0.835 |
| LoFric POBE Hydro-Kit II, 24 Hours | Test of Carry-over Effect at Withdrawal, Mean Rating of Perception on a Scale of 0 to 5 | -0.33 Score on a scale | Standard Deviation 0.807 |
Comparison: The mean perception of the 5s and the 24h catheter is calculated for each patient. The patients are then divided in two groups depending on the order the patients received the two catheters and the hypotheses that the mean of the 5s and the 24h catheter is equal in the two groups are tested. If the test results in a significant p-value it can be concluded that a carry-over effect is present.p-value: 0.7105Wilcoxon (Mann-Whitney)