At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Exploratory Study Investigating the Acute Effect of Intermittent Catheterization on the Bladder Mucosa of Healthy Volunteers With a Prototype Micro Hole Zone Catheter Compared to a Conventional 2-eyelet Catheter
In Brief
A clinical study evaluating Investigational prototype device and Comparator device for Urinary Incontinence. Completed, enrolled 43 participants across 1 site.
Detailed Summary
This investigation is a randomized, single-blinded, parallel, single-center investigation. In total, up to 50 subjects (40 completers) were included and each subject had two test visits overseen by the Principal Investigator (PI), or designee. Each subject were enrolled in the investigation, which lasted up to 3 days (if Day 0 and Day 1 were not on same day). The subjects were randomly assigned to test either the prototype product or the comparator product, with at least 20 subjects assigned to each product.
Study Details
Timeline
Interventions
The test product is a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.
The comparator is a urinary catheter for bladder drainage through the urethra.