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 range18 Years
SexMALE
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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
What they're measuring
1
Overall Discomfort During Nurse Catheterization
Timeframe: Immediately after the procedure/catheterization, up to 5 min.