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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
25
The subjects were first catheterized with this reference catheter.
An unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with sodium chloride in wetting solution, activation time 5 seconds
An unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with sodium chloride in wetting solution, activation time 24 hours
Karolinska Trial Alliance A2:01, Karolinska University Hospital
Stockholm, Sweden
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.
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.
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.
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.
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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.
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.
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.
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.
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.
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.
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.
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.
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.