NCT00748033

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Wellspect HealthCare · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Urinary Catheterization

Interventions

Type	Name	Description
DEVICE	Reference catheter: LoFric PVC, Nelaton 40 cm, CH 12	The subjects were first catheterized with this reference catheter.
DEVICE	LoFric POBE Hydro-Kit II, 5 seconds	An unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with sodium chloride in wetting solution, activation time 5 seconds
DEVICE	LoFric POBE Hydro-Kit II, 24 hours	An unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with sodium chloride in wetting solution, activation time 24 hours

Timeline

• Start date: 2008-08-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2008-09-08
• Last updated: 2021-05-06
• Results posted: 2021-05-06

Locations

1 site across 1 country: Sweden