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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT01292941
First Posted: February 10, 2011
Last Update Posted: August 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Coloplast A/S
  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
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Clinical Study Evaluating Safety of a New Catheter for Urinary Intermittent Catheter in Healthy Volunteers

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 ]
    A subject is assesing a VAS scale after each catheterisation.


Secondary Outcome Measures:
  • Safety [ Time Frame: During the investigation 11 Weeks per subject ]
    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 ]
    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 ]
    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 ]
    Ease of use assessed by nurses, measured on a 5 point scale


Enrollment: 0
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01292941


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

Responsible Party: MD,PhD Per Bagi, Rigshospitalet institute/Dept.2112
ClinicalTrials.gov Identifier: NCT01292941     History of Changes
Other Study ID Numbers: CP065CC
First Submitted: February 9, 2011
First Posted: February 10, 2011
Last Update Posted: August 7, 2015
Last Verified: August 2015

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