Study Results
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View full resultsBasic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2020-10-03
2021-01-31
Brief Summary
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Detailed Description
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For each participant, the study thus contains three test visits/treatment arms (Comparator, Variant 1 and Variant 2, respectively), to which the 15 participants were randomized using a randomization sequence of six (i.e., there were six different random options for the order in which the participants tested the three catheters). There were 4-14 days between the test visits.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
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Intermittent catheter; SpeediCath® Standard male
Participants underwent two catheterizations with standard of care intermittent catheter: The first was performed by a trained nurse, the second by the participant later the same day.
SpeediCath® Standard male
Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male.
New intermittent catheter Variant 1 for males
Participants underwent two catheterizations with the new intermittent catheter Variant 1 for males: The first was performed by a trained nurse, the second by the participant later the same day.
New intermittent Variant 1 catheter for males
Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 catheter.
New intermittent catheter Variant 2 for males
Participants underwent two catheterizations with the new intermittent catheter Variant 2 for males: The first was performed by a trained nurse, the second by the participant later the same day.
New intermittent Variant 2 catheter for males
Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 catheter.
Interventions
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SpeediCath® Standard male
Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male.
New intermittent Variant 1 catheter for males
Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 catheter.
New intermittent Variant 2 catheter for males
Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 catheter.
Eligibility Criteria
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Inclusion Criteria
* Minimum 18 years of age and with full legal capacity
* Daily intermittent catheterization for bladder management, with at least two catheters used on average pr. day, during the last 3 months
* Ability to self-catheterize
* Written informed consent, signed letter of authority and signed secrecy agreement given
Exclusion Criteria
* Symptoms of urinary tract infection as judged by the investigator
* Any know allergies towards ingredients in the products
* Relevant medical history that would prevent the subject from participation in the investigation (investigators judgement)
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
Blegdamsvej 9, Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark
Locations
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Blegdamsvej 9, Urologisk klinik Afsnit 2112, Rigshospitalet
Copenhagen, , Denmark
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CP323
Identifier Type: -
Identifier Source: org_study_id
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