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

This study has been withdrawn prior to enrollment.
(Product development project closed prematurely)
Sponsor:
Information provided by:
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01292941
First received: February 9, 2011
Last updated: April 18, 2011
Last verified: April 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Spinal Cord Injury
 Device: Intermittent catheterisation
Device: NonCE marked intermittent catheter/red
Device: NonCE marked intermittent catheter/green
Device: NonCE marked intermittent catheter/blue
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Clinical Study Evaluating Safety of a New Catheter for Urinary Intermittent Catheter in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • Discomfort during catheterisation measured by VAS-scale (0-10) [ Time Frame: 10 measurements in an 11 week period. 10 min after each catheterisation ] [ Designated as safety issue: No ]
    A subject is assesing a VAS scale after each catheterisation.


Secondary Outcome Measures:
  • Safety [ Time Frame: During the investigation 11 Weeks per subject ] [ Designated as safety issue: Yes ]
    Safety is evalueted continues while the subjects are testing the devices

  • Discomfort during urination post catheterisation [ Time Frame: 10 measurements in an 11 week period. 10 min after each catheterisation ] [ Designated as safety issue: No ]
    Subjects own assesment. Yes or no can be answered to discomfort during urination post catheterisation

  • Haematuria [ Time Frame: 10 measurements in an 11 week period. 10 min after each catheterisation ] [ Designated as safety issue: Yes ]
    Urine test after each catheterisation, and measured on a urine stix

  • Handling during insertion, withdrawal [ Time Frame: 10 measurements in an 11 week period. 10 min after each catheterisation ] [ Designated as safety issue: No ]
    Ease of use assessed by nurses, measured on a 5 point scale


Estimated Enrollment: 55
Study Start Date: March 2011
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active comparator/Yellow catheter
SpeediCath coated catheter
 Device: Intermittent catheterisation
Speedicath, Intermittent catheterisation
Other Name: SpeediCath
Experimental: NonCE marked intermittent catheter/red Device: NonCE marked intermittent catheter/red
Paris, Intermittent catheterisation
Other Name: Paris
Experimental: NonCE marked intermittent catheter/green Device: NonCE marked intermittent catheter/green
Paris, Intermittent catheter
Other Name: Paris
Experimental: NonCE marked intermittent catheter/Blue Device: NonCE marked intermittent catheter/blue
Paris, Intermittent catheter
Other Name: Paris

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292941

Locations
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Coloplast A/S
Investigators
Study Director: Susanne Gürtler, CTM Coloplast A/S
  More Information

No publications provided

Responsible Party: MD,PhD Per Bagi, Rigshospitalet institute/Dept.2112
ClinicalTrials.gov Identifier: NCT01292941     History of Changes
Other Study ID Numbers: CP065CC
Study First Received: February 9, 2011
Last Updated: April 18, 2011
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on June 17, 2013