Clinical Study Evaluating Safety of a New Catheter for Urinary Intermittent Catheter in Healthy Volunteers

August 6, 2015 updated by: Coloplast A/S
To evaluate discomfort of a new coating and catheter material compared to SpeediCath (SC)

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Intermittent catheterization is the preferred method for emptying the bladder in patients with spinal cord injury and neurogenic bladder dysfunction.

Coloplast have developed a new intermittent catheters. In this investigation this new test catheter will be compared with SpeediCat by assessing discomfort and pain associated with catheterization of healthy men. The reason for choosing healthy men is that many catheter users do not have full feeling in their urethra and therefore can not assess the discomfort.

55 healthy men who are ≥ 18 years and have no signs of urinary tract infection and do not have abnormalities, disease or have had operational interventions in the urinary tract will be included. They are recruited through advertisements on the website www.forsoegsperson.dk.

Study Type

Interventional

Phase

  • Phase 1

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
      • Copenhagen, Denmark, 2100
        • Rigshospitalet

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:

  • • ≥18 years

    • Male
    • Signed informed consent
    • Negative urine stix (erythrocytes, leucocytes and nitrite)

Exclusion Criteria:

  • • Abnormalities, diseases or surgical procedures performed in the lower urinary tract

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active comparator/Yellow catheter
SpeediCath coated catheter
Device: Intermittent catheterisation
Speedicath, Intermittent catheterisation
Other Names:
  • SpeediCath
Experimental: NonCE marked intermittent catheter/red
Device: NonCE marked intermittent catheter/red
Paris, Intermittent catheterisation
Other Names:
  • Paris
Experimental: NonCE marked intermittent catheter/green
Device: NonCE marked intermittent catheter/green
Paris, Intermittent catheter
Other Names:
  • Paris
Experimental: NonCE marked intermittent catheter/Blue
Device: NonCE marked intermittent catheter/blue
Paris, Intermittent catheter
Other Names:
  • Paris

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discomfort during catheterisation measured by VAS-scale (0-10)
Time Frame: 10 measurements in an 11 week period. 10 min after each catheterisation
A subject is assesing a VAS scale after each catheterisation.
10 measurements in an 11 week period. 10 min after each catheterisation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: During the investigation 11 Weeks per subject
Safety is evalueted continues while the subjects are testing the devices
During the investigation 11 Weeks per subject
Discomfort during urination post catheterisation
Time Frame: 10 measurements in an 11 week period. 10 min after each catheterisation
Subjects own assesment. Yes or no can be answered to discomfort during urination post catheterisation
10 measurements in an 11 week period. 10 min after each catheterisation
Haematuria
Time Frame: 10 measurements in an 11 week period. 10 min after each catheterisation
Urine test after each catheterisation, and measured on a urine stix
10 measurements in an 11 week period. 10 min after each catheterisation
Handling during insertion, withdrawal
Time Frame: 10 measurements in an 11 week period. 10 min after each catheterisation
Ease of use assessed by nurses, measured on a 5 point scale
10 measurements in an 11 week period. 10 min after each catheterisation

Collaborators and Investigators

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

Sponsor

Coloplast A/S

Investigators

  • Study Director: Susanne Gürtler, CTM, Coloplast A/S

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

March 1, 2011

Primary Completion (Anticipated)

June 1, 2011

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

February 9, 2011

First Submitted That Met QC Criteria

February 9, 2011

First Posted (Estimate)

February 10, 2011

Study Record Updates

Last Update Posted (Estimate)

August 7, 2015

Last Update Submitted That Met QC Criteria

August 6, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP065CC

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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