N/A
Completed N=36
Safety and Performance of a New Coating for Urinary Intermittent Catheters
Intermittent Urethral Catheterization
Source: ClinicalTrials.gov NCT01800903 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: Overall Discomfort During Catheterization — 2.6; 2.4; 1.8 cm
Summary
The aim of the study is to evaluate safety and performance of a new catheter coating,compared to the current SpeediCath coating.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Discomfort During Catheterization |
2.6; 2.4; 1.8 | — |
Eligibility Criteria
Inclusion Criteria
- Have given written informed consent and signed letter of authority
- Be at least 18 years of age and have full legal capacity
- Be a male
- Willing to refrain from using analgetics up to 24 hours prior to catheterization visits
Exclusion Criteria
- Abnormalities, diseases or surgical procedures performed in the lower urinary tract
- Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination)
- Participating in other interventional clinical investigations during this investigation (inclusion to termination) or have previously participated in this investigation (including run-in period)
- Known hypersensitivity toward any of the test products -
Data sourced from ClinicalTrials.gov (NCT01800903). 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.