Intermittent Catheterisation on the Bladder Mucosa of Healthy Volunteers With a Micro Hole Zone Catheter — CP341  

Urinary Incontinence Clinical Trial

Official title: Exploratory Study Investigating the Acute Effect of Intermittent Catheterisation on the Bladder Mucosa of Healthy Volunteers With a Micro Hole Zone Catheter Compared to a Conventional 2-eyelet Catheter

Status Completed

Clinical Trial Summary

This investigation is a randomized, single-blinded, parallel, single-center investigation. In total, up to 50 subjects (40 completers) will be included and each subject will have two test visits overseen by the Principal Investigator (PI), or designee. Each subject will be enrolled in the investigation, which can be up to 3 days (if Day 0 and Day 1 are not on same day). The subjects will be randomly assigned to test either the test product or the comparator product, with at least 20 subjects assigned to each product.

Clinical Trial Description

This investigation is a randomized, single-blinded, parallel, single-center investigation. Up to 50 subjects (40 completers) will be included and each subject will have two test visits overseen by the Principal Investigator (PI), or designee. Each subject will be enrolled in the investigation, which can be up to 3 days (if Day 0 and Day 1 are not on same day). The subjects will be randomly assigned to test either the test product or the comparator product, with at least 20 subjects assigned to each product. The subjects will undergo cystoscopy and catheterization. ;

Related Conditions & MeSH terms

• Urinary Incontinence

• NCT number: NCT05224544
• Study type: Interventional
• Source: Coloplast A/S
• Status: Completed
• Phase: N/A
• Start date: January 31, 2022
• Completion date: March 31, 2022