Investigation of New Intermittent Catheter Swelling Media in Healthy Volunteers (NCT04633291) | Clinical Trial Compass
CompletedNot Applicable
Investigation of New Intermittent Catheter Swelling Media in Healthy Volunteers
Denmark22 participantsStarted 2019-11-05
Plain-language summary
Investigation of novel swelling media for CE marked intermittent urinary catheters. The study was a randomized, single blinded, cross-over investigation comparing a novel swelling media with a comparator swelling media in 22 adult, healthy, male volunteers.
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:
* Written informed consent given
* Minimum 18 years of age and with full legal capacity
* Male gender
* Willing to refrain from using analgesics up to 24 hours prior to catheterization visits
* Negative urine multistix analysis for erythrocytes (microscopic hematuria)
* Negative urine multistix analysis for leukocytes and nitrite, or if positive, subsequent negative for bacterial growth in urine culture
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 clinical investigations related to urinary tracts system during this investigation (inclusion to termination) or previously participation in this investigation
* Known hypersensitivity toward any of the investigational device
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
1
Overall Discomfort During Nurse Catheterization
Timeframe: Immediately after the procedure/catheterization, up to 5 min.