Investigation of New Intermittent Catheters in Healthy Volunteers

Retention, Urinary Clinical Trial

Official title: Exploratory Investigation on Performance and Safety of New Intermittent Catheters in Healthy Volunteers

Status Completed

Clinical Trial Summary

Investigation of non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters with a comparator catheter in 30 adult healthy volunteers.

Clinical Trial Description

The CP322 study investigated a novel non-CE marked intermittent catheter for males and females, designed in two different variants, Variant 1 and Variant 2, respectively. The study was conducted in Denmark and was a randomized, single blinded, cross-over investigation comparing the two new variant catheters with a comparator catheter in 30 adult healthy volunteers.

For each participant, the study thus contained three test visits/treatment arms (Comparator, Variant 1 and Variant 2, respectively), to which the 30 participants were randomized using a randomization sequence of six (i.e., there were six different random options for the order in which the participants tested the three catheters). There were 4-14 days between the test visits. ;

Related Conditions & MeSH terms

• Retention, Urinary
• Urinary Retention

• NCT number: NCT04445051
• Study type: Interventional
• Source: Coloplast A/S
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Completion date: September 1, 2020