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.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

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

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 -

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall Discomfort During Catheterization

Timeframe: 1 day

Trial details

NCT IDNCT01800903

SponsorColoplast A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-04

Results submitted2013-11-29

View on ClinicalTrials.gov More Intermittent Urethral Catheterization trials