Comparison of Microtrauma in Urethra After Usage of Different Catheters

January 31, 2014 updated by: Wellspect HealthCare

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

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%.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, 221 85
        • Clinical Trial Unit, R&D Centre Skåne, Skåne University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion criteria:

  1. Provision of informed consent
  2. Healthy male volunteers aged 18 years and over (half of the included subjects shall be 18-50 years and the other half >50 years old)
  3. Negative urine dipstick test (no blood in the urine) before randomization

Exclusion Criteria:

  1. Intake of anticoagulants at enrolment and during the study period
  2. Intake of antibiotics at enrolment and during the study period
  3. Urinary tract infection (UTI) at enrolment and during the study period
  4. Known abnormalities or diseases of the lower urinary tract with the exception of BPH
  5. Kidney stones
  6. Tumour in the urinary tract
  7. Known Sexually transferable diseases in the urinary tract during the study period
  8. Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
  9. Previous enrolment or randomisation of treatment in the present study
  10. Simultaneous participation in another clinical study that might interfere with the endpoints of the study, as deemed by the investigator
  11. Severe non-compliance to protocol as judged by the investigator and/or Astra Tech

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LoFric - SC - SCCM
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.
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.
EXPERIMENTAL: LoFric - SCCM - SC
Study period 1: LoFric Study period 2: SpeediCath Compact Male Study period 3: SpeediCath In each study period three catheterizations are made, separated by at least 2 hours.
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.
EXPERIMENTAL: SC - SCCM - LoFric
Study period 1: SpeediCath Study period 2: SpeediCath Compact Male Study period 3: LoFric In each study period three catheterizations are made, separated by at least 2 hours.
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.
EXPERIMENTAL: SC - LoFric - SCCM
Study period 1: SpeediCath Study period 2: LoFric Study period 3: SpeediCath Compact Male In each study period three catheterizations are made, separated by at least 2 hours.
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.
EXPERIMENTAL: SCCM - LoFric - SC
Study period 1: SpeediCath Compact Male Study period 2: LoFric Study period 3: SpeediCath In each study period three catheterizations are made, separated by at least 2 hours.
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.
EXPERIMENTAL: SCCM - SC - LoFric
Study period 1: SpeediCath Compact Male Study period 2: SpeediCath Study period 3: LoFric In each study period three catheterizations are made, separated by at least 2 hours.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hematuria
Time Frame: Approximately 2 hours after last catheterization
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hematuria
Time Frame: At first, second and third catheterization, approximately 2 hours apart
Blood in urine (measured by microscopic urine sediment evaluation). Comparison will be made between study catheter/visit days.
At first, second and third catheterization, approximately 2 hours apart
Pyuria
Time Frame: At first, second and third catheterization, approximately 2 hours apart
White blood cells in urine (measured by microscopic urine sediment evaluation). Comparison will be made between study catheter/visit days.
At first, second and third catheterization, approximately 2 hours apart
Pyuria
Time Frame: Approximately 2 hours after last catheterization
White blood cells in urine (measured by microscopic urine sediment evaluation) will be assessed at first normal micturition after three catheterizations. Comparison will be made between study catheter/visit days.
Approximately 2 hours after last catheterization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wellspect HealthCare

Investigators

  • Principal Investigator: Ulf Malmkvist, Assoc Prof, Skåne University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

April 24, 2012

First Submitted That Met QC Criteria

May 15, 2012

First Posted (ESTIMATE)

May 17, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 3, 2014

Last Update Submitted That Met QC Criteria

January 31, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOF-0022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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