A Study Evaluating a Urinary Catheter With Different Activation Times for the Wetting Solution, in Healthy Male Volunteers.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Single-blind, Cross-over, Single-centre Study in Healthy Volunteers Evaluating Subject Perception and Friction at Withdrawal of Catheters With Different Activation Times Compared to a Reference Catheter

Conditions
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Urinary Catheterization

Intervention / Treatment
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* Device: Reference catheter: LoFric PVC, Nelaton 40 cm, CH 12
* Device: LoFric POBE Hydro-Kit II, 5 seconds
* Device: LoFric POBE Hydro-Kit II, 24 hours


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LoFric POBE Hydro-Kit II, 5 seconds and then LoFric POBE Hydro-Kit II, 24 hours<br>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. | Device: Reference catheter: LoFric PVC, Nelaton 40 cm, CH 12<br>* The subjects were first catheterized with this reference catheter.<br>Device: LoFric POBE Hydro-Kit II, 5 seconds<br>* An unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with sodium chloride in wetting solution, activation time 5 seconds<br>Device: LoFric POBE Hydro-Kit II, 24 hours<br>* An unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with sodium chloride in wetting solution, activation time 24 hours<br>|
| Experimental: LoFric POBE Hydro-Kit II, 24 hours and then LoFric POBE Hydro-Kit II, 5 seconds<br>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. | Device: Reference catheter: LoFric PVC, Nelaton 40 cm, CH 12<br>* The subjects were first catheterized with this reference catheter.<br>Device: LoFric POBE Hydro-Kit II, 5 seconds<br>* An unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with sodium chloride in wetting solution, activation time 5 seconds<br>Device: LoFric POBE Hydro-Kit II, 24 hours<br>* An unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with sodium chloride in wetting solution, activation time 24 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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. |