NCT01600443

Comparison of Microtrauma in Urethra After Usage of Different Catheters

A Randomized Cross-over Study on Urethral Microtrauma After Intermittent Catheterization.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Wellspect HealthCare · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study is undertaken to investigate if the urethral microtrauma, caused by intermittent catheterization, differs between three hydrophilic catheters for intermittent catheterization, LoFric; SpeediCath (SC) and SpeediCath Compact Male (SCCM). The study is a prospective, randomised, cross-over, single-centre study. Each subject will be randomized to use three different catheter types. Three catheterizations will be performed with each catheter type during one day, with at least two hours between each catheterization. The washout period between catheter switch will be at least one week. The primary objective is to evaluate urethral microtrauma for three hydrophilic catheters with regards to hematuria after intermittent catheterization. The secondary objectives are to evaluate urethral microtrauma for three hydrophilic catheters with regards to pyuria and subjective evaluation after intermittent catheterization. The safety of the three catheters will be evaluated in terms of adverse advents, non-serious and serious, rated for causality. The hypothesis that level of hematuria is equal after using different catheters will be tested using Wilcoxon signed rank test. The hypothesis will be rejected if the p-value is less than 5%.

Conditions

• Hematuria

Interventions

Type	Name	Description
DEVICE	LoFric	Three catheterizations at least two hours apart using LoFric Primo 40 cm CH14.
DEVICE	SpeediCath	Three catheterizations at least two hours apart using SpeediCath 40 cm CH14.
DEVICE	SpeediCath Compact Male	Three catheterizations at least two hours apart using SpeediCath Compact Male 30 cm.

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2012-05-17
• Last updated: 2014-02-03

Locations

1 site across 1 country: Sweden