N/A
Completed N=25
Test Catheter Pilot Study in Healthy Volunteers
Healthy
Source: ClinicalTrials.gov NCT00832078 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcomePrimary: Discomfort — 2.25; 2.52 units on a scale
Summary
The purpose of this study is to evaluate the safety of an intermittent catheter in comparison with an already existing catheter on the market. The study is a randomised, single blinded, cross-over study including 25 healthy males.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Discomfort |
2.25; 2.52 | — |
| SECONDARY Handling |
— | — |
| SECONDARY Preference |
— | — |
| SECONDARY Haematuria |
— | — |
Eligibility Criteria
Inclusion Criteria
- 18 years or older
- Male
- Signed informed consent
- Negative urine multistix
Exclusion Criteria
- Abnormalities, diseases or surgical procedures performed in the lower urinary tract
Data sourced from ClinicalTrials.gov (NCT00832078). 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.