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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This study has been withdrawn prior to enrollment.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

February 9, 2011
April 18, 2011
March 2011
June 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01292941 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Clinical Study Evaluating Safety of a New Catheter for Urinary Intermittent Catheter in Healthy Volunteers
Clinical Study Evaluating Safety of a New Catheter for Urinary Intermittent Catheter in Healthy Volunteers

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Spinal Cord Injury
  • Device: Intermittent catheterisation
    Speedicath, Intermittent catheterisation
    Other Name: SpeediCath
  • Device: NonCE marked intermittent catheter/red
    Paris, Intermittent catheterisation
    Other Name: Paris
  • Device: NonCE marked intermittent catheter/green
    Paris, Intermittent catheter
    Other Name: Paris
  • Device: NonCE marked intermittent catheter/blue
    Paris, Intermittent catheter
    Other Name: Paris
  • Active Comparator: Active comparator/Yellow catheter
    SpeediCath coated catheter
    Intervention: Device: Intermittent catheterisation
  • Experimental: NonCE marked intermittent catheter/red
    Intervention: Device: NonCE marked intermittent catheter/red
  • Experimental: NonCE marked intermittent catheter/green
    Intervention: Device: NonCE marked intermittent catheter/green
  • Experimental: NonCE marked intermittent catheter/Blue
    Intervention: Device: NonCE marked intermittent catheter/blue
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
55
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01292941
CP065CC
No
MD,PhD Per Bagi, Rigshospitalet institute/Dept.2112
Coloplast A/S
Not Provided
Study Director: Susanne Gürtler, CTM Coloplast A/S
Coloplast A/S
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP