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Test of Discomfort and Malaise of Two Different Urine Catheters in Healthy Volunteers

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Intermittent catheter CP063CC
SpeediCath
Sponsored by
Coloplast A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years or older
  • Male
  • signed informed Consent,
  • Neg. urine multistix

Exclusion Criteria:

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

Sites / Locations

  • Rigshospitalet, dep. 2112

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Monza

control

Arm Description

nonCE marked intermittent catheter

SpeediCath coated catheter

Outcomes

Primary Outcome Measures

Discomfort Measured on the Visual Analog Scale (VAS)
Outcome measured on a 10 cm Visual Analog Scale ranging from "no discomfort" (0cm) to "worst thinkable discomfort" (10cm).

Secondary Outcome Measures

Irritation During Voiding After Catheterization
After each catheterization subjects were asked if they felt any irritation during voiding with answer option yes or no. Yes - they experienced irritation. No - they did not experience irritation.
Ease of Use Measured on a 5 Point Scale: Insertion Effort
After each catheterization the nurse who conducted the catheterization answered how the catheter insertion had been. There were 5 answer categories: very difficult - difficult - neither easy nor difficult - easy - very easy
Ease of Use Measured on a 5 Point Scale: Withdrawal Effort
After each catheterization the nurse who conducted the catheterization answered how the catheter withdrawal had been. There were 5 answer categories: very difficult - difficult - neither easy nor difficult - easy - very easy
Visible Blood
Visual blood observed on the catheter or in the urine in connection to catheterization. The nurse who conducted the catheterization could answer yes or no as follows: Yes = visible blood observed. No = no visible blood observed.
Haematuria
Negative or positive result on a multistix urin analysis. Negative haematuria: 10 erythrocytes/microliter or less. Positive haematuria: above 10 erythrocytes/microliter.

Full Information

First Posted
May 4, 2010
Last Updated
October 4, 2011
Sponsor
Coloplast A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01142115
Brief Title
Test of Discomfort and Malaise of Two Different Urine Catheters in Healthy Volunteers
Official Title
Comparative Study of Two Different Urine Catheters.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coloplast A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety of a new developed catheter in comparison with an catheter on the market. The study is randomised.
Detailed Description
Intermittent catheterization is the preferred method for emptying the bladder in patients with spinal cord injury and neurogenic bladder dysfunction. Coloplast has developed a new intermittent catheter. In this investigation this new test catheter will be compared with SpeediCath 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. 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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monza
Arm Type
Experimental
Arm Description
nonCE marked intermittent catheter
Arm Title
control
Arm Type
Active Comparator
Arm Description
SpeediCath coated catheter
Intervention Type
Device
Intervention Name(s)
Intermittent catheter CP063CC
Other Intervention Name(s)
Intermittent catheter,
Intervention Description
intermittent catheterisation
Intervention Type
Device
Intervention Name(s)
SpeediCath
Other Intervention Name(s)
Intermittent catheter
Intervention Description
intermittent catheterisation
Primary Outcome Measure Information:
Title
Discomfort Measured on the Visual Analog Scale (VAS)
Description
Outcome measured on a 10 cm Visual Analog Scale ranging from "no discomfort" (0cm) to "worst thinkable discomfort" (10cm).
Time Frame
10 minutes after each catheterisation at visit 1 and at visit 2 which is 5-25 days after visit 1
Secondary Outcome Measure Information:
Title
Irritation During Voiding After Catheterization
Description
After each catheterization subjects were asked if they felt any irritation during voiding with answer option yes or no. Yes - they experienced irritation. No - they did not experience irritation.
Time Frame
10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
Title
Ease of Use Measured on a 5 Point Scale: Insertion Effort
Description
After each catheterization the nurse who conducted the catheterization answered how the catheter insertion had been. There were 5 answer categories: very difficult - difficult - neither easy nor difficult - easy - very easy
Time Frame
10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
Title
Ease of Use Measured on a 5 Point Scale: Withdrawal Effort
Description
After each catheterization the nurse who conducted the catheterization answered how the catheter withdrawal had been. There were 5 answer categories: very difficult - difficult - neither easy nor difficult - easy - very easy
Time Frame
10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
Title
Visible Blood
Description
Visual blood observed on the catheter or in the urine in connection to catheterization. The nurse who conducted the catheterization could answer yes or no as follows: Yes = visible blood observed. No = no visible blood observed.
Time Frame
10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
Title
Haematuria
Description
Negative or positive result on a multistix urin analysis. Negative haematuria: 10 erythrocytes/microliter or less. Positive haematuria: above 10 erythrocytes/microliter.
Time Frame
2 hours after catheterisation at visits 1 and 2

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years or older Male signed informed Consent, Neg. urine multistix Exclusion Criteria: Abnormalities, diseases or surgical procedures performed in the lower urinary-tract
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rikke Otttesen, CTM
Organizational Affiliation
Coloplast A/S
Official's Role
Study Director
Facility Information:
Facility Name
Rigshospitalet, dep. 2112
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

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Test of Discomfort and Malaise of Two Different Urine Catheters in Healthy Volunteers

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