Intermittent Catheterization in Spinal Cord Injured Men
NCT ID: NCT02230540
Last Updated: 2016-03-15
Study Results
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View full resultsBasic Information
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TERMINATED
NA
8 participants
INTERVENTIONAL
2014-09-30
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Sequence A
Catheterization with SelfCath (comparator) followed by measurement of residual urine.
Then catheterization with Product A in different positions. Measurement of residual urine at different positions.
SelfCath (comparator)
Commercially available CE-marked catheter for urinary drainage.
Product A SelfCath and urine bag, Conveen Security+
SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices).
Sequence B
Based on results from sequence A, sequence B may or may not be initiated.
Catheterization with SelfCath (comparator) followed by measurement of residual urine.
Then catheterization with Product B in different positions. Measurement of residual urine at different positions.
SelfCath (comparator)
Commercially available CE-marked catheter for urinary drainage.
Product B SelfCath and urine bag, Conveen Contour
SelfCath and urine bag, Conveen Contour (both commercially available CE-marked devices).
Interventions
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SelfCath (comparator)
Commercially available CE-marked catheter for urinary drainage.
Product A SelfCath and urine bag, Conveen Security+
SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices).
Product B SelfCath and urine bag, Conveen Contour
SelfCath and urine bag, Conveen Contour (both commercially available CE-marked devices).
Eligibility Criteria
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Inclusion Criteria
* Is at least 18 years of age and has full legal capacity
* Is a male
* Has an Spinal Cord Injury diagnosis
Exclusion Criteria
* Known hypersensitivity toward any of the test products
* Serious abdominal scars
* Symptoms of urinary tract infections
18 Years
MALE
No
Sponsors
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Coloplast A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Per Bagi, MD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Per Bagi
Copenhagen, , Denmark
Countries
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Other Identifiers
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CP250
Identifier Type: -
Identifier Source: org_study_id
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