Test of Discomfort and Malaise of Two Different Urine Catheters in Healthy Volunteers
NCT ID: NCT01142115
Last Updated: 2011-10-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2010-01-31
2010-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Monza
nonCE marked intermittent catheter
Intermittent catheter CP063CC
intermittent catheterisation
control
SpeediCath coated catheter
Intermittent catheter CP063CC
intermittent catheterisation
SpeediCath
intermittent catheterisation
Interventions
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Intermittent catheter CP063CC
intermittent catheterisation
SpeediCath
intermittent catheterisation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male
* signed informed Consent,
* Neg. urine multistix
Exclusion Criteria
* diseases or surgical procedures performed in the lower urinary-tract
18 Years
MALE
Yes
Sponsors
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Coloplast A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Rikke Otttesen, CTM
Role: STUDY_DIRECTOR
Coloplast A/S
Locations
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Rigshospitalet, dep. 2112
Copenhagen, , Denmark
Countries
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Other Identifiers
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CP063CC
Identifier Type: -
Identifier Source: org_study_id