A Randomised, Cross-over, Open-labelled Test Catheter Acceptance Study
Not Applicable
Completed
- Conditions
- Spinal Cord Injuries
- Interventions
- Device: test intermittent catheterDevice: Intermittent catheterization
- Registration Number
- NCT00990093
- Lead Sponsor
- Coloplast A/S
- Brief Summary
The purpose of this study is to evaluate that the test catheter is no less accepted than the SpeediCath (SC) catheter.
- Detailed Description
See brief summary
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 36
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description test intermittent catheter test intermittent catheter CH 12 hydrophilic coated catheter intermittent catheter Intermittent catheterization CH 12 hydrophilic coated catheter
- Primary Outcome Measures
Name Time Method Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort. 14 days Participants were to test the catheter by self-catheterising a minimum of 4 catheters each day for 14 days.
At the end of each study period participants were asked to indicate how they would rate the discomfort experienced during the catheterisation procedures. Discomfort was measured by the participants own rating of discomfort on a VAS scale from 0 (no discomfort) to 10 (worst imaginable discomfort)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Klinik for Rygmarvsskader
🇩🇰Hornbæk, Denmark