NCT04633291

Investigation of New Intermittent Catheter Swelling Media in Healthy Volunteers

Clinical Study in Healthy Volunteers Evaluating the Performance and Handling of a Urinary Intermittent Catheter With a Newly Developed Swelling Media.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The CP279 study investigated a novel swelling media for male intermittent urinary catheters. The study was conducted in Denmark and was a single-site, randomized, single blinded, cross-over investigation, testing inferiority of a novel catheter swelling media against a comparator swelling media in 22 adult, healthy, male volunteers. Each participant was randomized to one of two treatment arms, using a randomization sequence of two (i.e., with two different random options for the order in which the participants tested the two swelling media). The study thus contained two test visits, for which the 22 participants tested the two different swelling media, respectively. There was 4-14 days between the test visits and all catheterizations were performed by trained nurses. Due to a visual difference between the products, it was only possible to blind the subjects.

Conditions

• Catheter Site Pain
• Catheter Site Discomfort

Interventions

Type	Name	Description
DEVICE	Novel swelling media	Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.
DEVICE	Comparator swelling media	Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.

Timeline

• Start date: 2019-11-05
• Primary completion: 2019-11-28
• Completion: 2019-11-28
• First posted: 2020-11-18
• Last updated: 2023-07-17
• Results posted: 2023-07-17

Locations

1 site across 1 country: Denmark