NCT05224544

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: Female
• Age: 18 Years – 110 Years
• Healthy volunteers: Accepted

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.

Detailed description

This investigation was 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 prototype product or the comparator product, with at least 20 subjects assigned to each product. The subjects will undergo cystoscopy and catheterization.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Investigational prototype device	The test product is a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.
DEVICE	Comparator device	The comparator is a urinary catheter for bladder drainage through the urethra.

Timeline

• Start date: 2022-01-31
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2022-02-04
• Last updated: 2025-12-12
• Results posted: 2025-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study