A Randomised, Cross-over, Open-labelled Test Catheter Acceptance Study

August 2, 2012 updated by: Coloplast A/S

A Randomised, Cross-over, Open-labelled Study Evaluating the Acceptance of Test Catheters Compared to SpeediCath Catheters

The purpose of this study is to evaluate that the test catheter is no less accepted than the SpeediCath (SC) catheter.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

See brief summary

Study Type

Interventional

Enrollment (Actual)

36

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

  • Denmark
      • Hornbæk, Denmark, 3100
        • Klinik for Rygmarvsskader

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

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • At least 18 years of age
  • Has normal/impaired sensation in the urethra
  • Self-catheterises at least 4 times per day
  • Has used clean self-intermittent catheterisation for at least 14 days
  • Is able to open and prepare the catheters for catheterisation
  • Has signed the informed consent before any study related-activities.

Exclusion Criteria:

  • Has a symptomatic urinary tract infection as assessed by the investigator
  • Is mentally unstable as assessed by the investigator

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: test intermittent catheter
CH 12 hydrophilic coated catheter
Device: test intermittent catheter
CH 12 hydrophilic coated catheter
Other Names:
  • Test catheter
Experimental: intermittent catheter
CH 12 hydrophilic coated catheter
Device: Intermittent catheterization
CH 12 hydrophilic catheter
Other Names:
  • SpeediCath

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort.
Time Frame: 14 days

Participants were to test the catheter by self-catheterising a minimum of 4 catheters each day for 14 days.

At the end of each study period participants were asked to indicate how they would rate the discomfort experienced during the catheterisation procedures. Discomfort was measured by the participants own rating of discomfort on a VAS scale from 0 (no discomfort) to 10 (worst imaginable discomfort)
14 days

Collaborators and Investigators

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

Sponsor

Coloplast A/S

Investigators

  • Principal Investigator: Fin Biering-Sørensen, MD, Klinik for Rygmarvsskader, Rigshospitalet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

October 5, 2009

First Submitted That Met QC Criteria

October 5, 2009

First Posted (Estimate)

October 6, 2009

Study Record Updates

Last Update Posted (Estimate)

September 5, 2012

Last Update Submitted That Met QC Criteria

August 2, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP062CC

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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