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Completed

NCT Number: NCT00748033

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

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.

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Key information

Conditions

Urinary Catheterization

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Trial Alliance A2:01, Karolinska University Hospital

Stockholm, SE-171 76, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reference catheter: LoFric PVC, Nelaton 40 cm, CH 12

Device

The subjects were first catheterized with this reference catheter.

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

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

Primary outcomes

  1. Subjects' Perception at Insertion of Test Catheter Activated for 5 Seconds, Compared to Reference.

    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.

    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?'.

  2. Subjects' Perception at Insertion of Test Catheter Activated for 24 Hours, Compared to Reference.

    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.

    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?'.

  3. Subjects' Perception at Withdrawal of Test Catheter Activated for 5 Seconds, Compared to Reference.

    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.

    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?'.

  4. Subjects' Perception at Withdrawal of Test Catheter Activated for 24 Hours, Compared to Reference.

    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.

    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 outcomes

  1. Comparison of the Perception at Insertion Between 5s and 24h Activation Times. 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 insertion between the catheters with 5s and 24h activation times.

  2. Comparison of the Perception at Withdrawal Between 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 the catheters with 5s and 24h activation times.

  3. Test of Carry-over Effect at Insertion, Mean Rating of Perception on a Scale of 0 to 5

    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.

    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.

  4. Test of Carry-over Effect at Withdrawal, Mean Rating of Perception on a Scale of 0 to 5

    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.

    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.

  5. Tension Test System: Ref-24h Mean

    Time frame: 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).

  6. Tension Test System: Ref-24h Work

    Time frame: 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).

  7. Tension Test System: Ref-5s MEAN

    Time frame: 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).

  8. Tension Test System: Ref-5s WORK

    Time frame: 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).

  9. Tension Test System: 24h-5s

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Wellspect HealthCare

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Sep 8, 2008
Registry last updated
May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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