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

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

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.

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