Investigation of Non-CE Marked Intermittent Catheters.

Coloplast

Status: Completed

Conditions: Retention, Urinary

Treatments: Device: New intermittent Variant 1 catheter for males; Device: SpeediCath® Standard male; Device: New intermittent Variant 2 catheter for males

Study type: Interventional

Funder types: Industry

Identifiers

NCT04543136

CP323

Details and patient eligibility

About

Investigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for males with a comparator catheter

Full description

The CP323 study investigated a novel non-CE marked intermittent catheter, designed in two different variants, Variant 1 and Variant 2, respectively, and was conducted in Denmark. The study was a randomized, single blinded, cross-over investigation, comparing the two new variant catheters with a comparator catheter in 15 male IC users.

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.

Enrollment: 16 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male
• 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

• Participation in any other clinical study during this investigation
• 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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16 participants in 3 patient groups

Intermittent catheter; SpeediCath® Standard male

Active Comparator group

Description:

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.

Treatment:

Device: SpeediCath® Standard male

New intermittent catheter Variant 1 for males

Experimental group

Description:

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.

Treatment:

Device: New intermittent Variant 1 catheter for males

New intermittent catheter Variant 2 for males

Experimental group

Description:

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.

Treatment:

Device: New intermittent Variant 2 catheter for males