Clinical trial NCT00748033: A Study Evaluating a Urinary Catheter With Different Activation Times for the Wetting Solution, in Healthy Male Volunteers.
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Catheterization
Lead sponsor: Wellspect HealthCare
Sponsor class: INDUSTRY
First posted: 2008-09-08
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Subjects' Perception at Insertion of Test Catheter Activated for 5 Seconds, Compared to Reference.
timeFrame: 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: Subjects' Perception at Insertion of Test Catheter Activated for 24 Hours, Compared to Reference.
timeFrame: 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: Subjects' Perception at Withdrawal of Test Catheter Activated for 5 Seconds, Compared to Reference.
timeFrame: 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: Subjects' Perception at Withdrawal of Test Catheter Activated for 24 Hours, Compared to Reference.
timeFrame: 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 outcomes:
measure: Comparison of the Perception at Insertion Between 5s and 24h Activation Times. Times
timeFrame: 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: Comparison of the Perception at Withdrawal Between 5s and 24h Activation Times.
timeFrame: 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: Test of Carry-over Effect at Insertion, Mean Rating of Perception on a Scale of 0 to 5
timeFrame: 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: Test of Carry-over Effect at Withdrawal, Mean Rating of Perception on a Scale of 0 to 5
timeFrame: 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: Tension Test System: Ref-24h Mean
timeFrame: The Tension test system was performed while withdrawing the catheters up to 5 seconds.
measure: Tension Test System: Ref-24h Work
timeFrame: The Tension test system was performed while withdrawing the catheters up to 5 seconds.
measure: Tension Test System: Ref-5s MEAN
timeFrame: The Tension test system was performed while withdrawing the catheters, up to 5 seconds.
measure: Tension Test System: Ref-5s WORK
timeFrame: The Tension test system was performed while withdrawing the catheters, up to 5 seconds.
measure: Tension Test System: 24h-5s
timeFrame: The Tension test system was performed while withdrawing the catheters, up to 5 seconds.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Trial Alliance A2:01, Karolinska University Hospital
Study officials:
affiliation: Dentsply Sirona Implants and Consumables
name: Magnus Jacobsson, MD, PhD, Prof.
role: STUDY_DIRECTOR
References: