CompletedNot Applicable

Safety and Performance of a New Coating for Urinary Intermittent Catheters

Denmark40 participantsStarted 2013-02

Plain-language summary

The aim of the study is to evaluate safety and performance of a new catheter coating,compared to the current SpeediCath coating.

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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 -

Overall Discomfort During Catheterization

Timeframe: 1 day

NCT IDNCT01800903

SponsorColoplast A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-04

Results submitted2013-11-29