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Comparison of Microtrauma in Urethra After Usage of Different Catheters

NCT01600443 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2014-02-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Wellspect HealthCare

    lead INDUSTRY

Principal Investigators

  • Ulf Malmkvist, Assoc Prof · Skane University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01600443 on ClinicalTrials.gov