At a glance
ClinicalIndex Comparison RecordN/ACompleted· 22 enrolled
Drug / intervention
Novel swelling media +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Study in Healthy Volunteers Evaluating the Performance and Handling of a Urinary Intermittent Catheter With a Newly Developed Swelling Media.
In Brief
A clinical study evaluating Novel swelling media and Comparator swelling media for Catheter Site Pain and Catheter Site Discomfort. Completed, enrolled 22 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCatheter Site Pain, Catheter Site Discomfort
CountriesDenmark
Collaborators--
Timeline
N/ACompletedFinished
2020202120222023202420252026
Enrollment StartNov 2019
Primary CompletionNov 2019
First PostedNov 2020
TodayJul 2026
First PostedNov 18, 2020
Enrollment StartNov 5, 2019
Primary CompletionNov 28, 2019
TodayJul 2, 2026
Enrollment to primary: 23 daysPosted 5.6 years ago
Interventions
Novel swelling mediadevice
Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.
Comparator swelling mediadevice
Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.