N/A
Completed N=36
A Randomised, Cross-over, Open-labelled Test Catheter Acceptance Study
Spinal Cord Injuries
Source: ClinicalTrials.gov NCT00990093 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcomePrimary: Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort. — 1.59; 1.94 units on a scale
Summary
The purpose of this study is to evaluate that the test catheter is no less accepted than the SpeediCath (SC) catheter.
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 | — |
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. Informational only — not medical advice.