A Randomised, Cross-over, Open-labelled Test Catheter Acceptance Study

Coloplast

Status: Completed

Conditions: Spinal Cord Injuries

Treatments: Device: Intermittent catheterization; Device: test intermittent catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT00990093

CP062CC

Details and patient eligibility

About

The purpose of this study is to evaluate that the test catheter is no less accepted than the SpeediCath (SC) catheter.

Full description

See brief summary

Enrollment: 36 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years of age
• Has normal/impaired sensation in the urethra
• Self-catheterises at least 4 times per day
• Has used clean self-intermittent catheterisation for at least 14 days
• Is able to open and prepare the catheters for catheterisation
• Has signed the informed consent before any study related-activities.

Exclusion criteria

• Has a symptomatic urinary tract infection as assessed by the investigator
• Is mentally unstable as assessed by the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

test intermittent catheter

Experimental group

Description:

CH 12 hydrophilic coated catheter

Treatment:

Device: test intermittent catheter

intermittent catheter

Experimental group

Description:

CH 12 hydrophilic coated catheter

Treatment:

Device: Intermittent catheterization