748033
Last Update Posted: 2021-05-06
Recruiting has ended
Males accepted | 18 Years + |
25 Estimated Participants | No Expanded Access |
Interventional Study | Accepts healthy volunteers |
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.
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
Relevant conditions:
Urinary Catheterization
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov