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

Primary Purpose

Spinal Cord Injury

Status
Withdrawn
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Intermittent catheterisation
NonCE marked intermittent catheter/red
NonCE marked intermittent catheter/green
NonCE marked intermittent catheter/blue
Sponsored by
Coloplast A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinal Cord Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Active comparator/Yellow catheter

NonCE marked intermittent catheter/red

NonCE marked intermittent catheter/green

NonCE marked intermittent catheter/Blue

Arm Description

SpeediCath coated catheter

Outcomes

Primary Outcome Measures

Discomfort during catheterisation measured by VAS-scale (0-10)
A subject is assesing a VAS scale after each catheterisation.

Secondary Outcome Measures

Safety
Safety is evalueted continues while the subjects are testing the devices
Discomfort during urination post catheterisation
Subjects own assesment. Yes or no can be answered to discomfort during urination post catheterisation
Haematuria
Urine test after each catheterisation, and measured on a urine stix
Handling during insertion, withdrawal
Ease of use assessed by nurses, measured on a 5 point scale

Full Information

First Posted
February 9, 2011
Last Updated
August 6, 2015
Sponsor
Coloplast A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01292941
Brief Title
Clinical Study Evaluating Safety of a New Catheter for Urinary Intermittent Catheter in Healthy Volunteers
Official Title
Clinical Study Evaluating Safety of a New Catheter for Urinary Intermittent Catheter in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Product development project closed prematurely
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Coloplast A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate discomfort of a new coating and catheter material compared to SpeediCath (SC)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active comparator/Yellow catheter
Arm Type
Active Comparator
Arm Description
SpeediCath coated catheter
Arm Title
NonCE marked intermittent catheter/red
Arm Type
Experimental
Arm Title
NonCE marked intermittent catheter/green
Arm Type
Experimental
Arm Title
NonCE marked intermittent catheter/Blue
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Intermittent catheterisation
Other Intervention Name(s)
SpeediCath
Intervention Description
Speedicath, Intermittent catheterisation
Intervention Type
Device
Intervention Name(s)
NonCE marked intermittent catheter/red
Other Intervention Name(s)
Paris
Intervention Description
Paris, Intermittent catheterisation
Intervention Type
Device
Intervention Name(s)
NonCE marked intermittent catheter/green
Other Intervention Name(s)
Paris
Intervention Description
Paris, Intermittent catheter
Intervention Type
Device
Intervention Name(s)
NonCE marked intermittent catheter/blue
Other Intervention Name(s)
Paris
Intervention Description
Paris, Intermittent catheter
Primary Outcome Measure Information:
Title
Discomfort during catheterisation measured by VAS-scale (0-10)
Description
A subject is assesing a VAS scale after each catheterisation.
Time Frame
10 measurements in an 11 week period. 10 min after each catheterisation
Secondary Outcome Measure Information:
Title
Safety
Description
Safety is evalueted continues while the subjects are testing the devices
Time Frame
During the investigation 11 Weeks per subject
Title
Discomfort during urination post catheterisation
Description
Subjects own assesment. Yes or no can be answered to discomfort during urination post catheterisation
Time Frame
10 measurements in an 11 week period. 10 min after each catheterisation
Title
Haematuria
Description
Urine test after each catheterisation, and measured on a urine stix
Time Frame
10 measurements in an 11 week period. 10 min after each catheterisation
Title
Handling during insertion, withdrawal
Description
Ease of use assessed by nurses, measured on a 5 point scale
Time Frame
10 measurements in an 11 week period. 10 min after each catheterisation

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Gürtler, CTM
Organizational Affiliation
Coloplast A/S
Official's Role
Study Director
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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