Brief 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%.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Apr 2012

Shorter than P25 for not_applicable

Geographic Reach

1 country

1 active site

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1 month study duration

Study Start

First participant enrolled

April 1, 2012

Completed

23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2012

Completed

7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed

16 days until next milestone

First Posted

Study publicly available on registry

May 17, 2012

Completed

Last Updated

February 3, 2014

Status Verified

January 1, 2014

Enrollment Period

1 month

First QC Date

April 24, 2012

Last Update Submit

January 31, 2014

Conditions

Hematuria

Outcome Measures

Primary Outcomes (1)

Hematuria
Blood in urine (measured by microscopic urine sediment evaluation) will be assessed at the first normal micturition after three catheterizations. Comparison will be made between study catheter/visit days.
Approximately 2 hours after last catheterization

Secondary Outcomes (3)

Hematuria
At first, second and third catheterization, approximately 2 hours apart
Pyuria
At first, second and third catheterization, approximately 2 hours apart
Pyuria
Approximately 2 hours after last catheterization

Study Arms (6)

LoFric - SC - SCCM

EXPERIMENTAL

Study period 1: LoFric Study period 2: SpeediCath Study period 3: SpeediCath Compact Male In each study period three catheterizations are made, separated by at least 2 hours.