N/A
N=36
A Randomised, Cross-over, Open-labelled Test Catheter Acceptance Study
Spinal Cord Injuries
Bottom Line
View on ClinicalTrials.gov: NCT00990093 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcome: Primary: Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort. — 1.59; 1.94 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- test intermittent catheter (Device); Intermittent catheterization (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Coloplast A/S
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort. |
1.59; 1.94 | — |
Summary
The purpose of this study is to evaluate that the test catheter is no less accepted than the SpeediCath (SC) catheter.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00990093). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.