NCT05626686

An Exploratory Investigation of the Effects of Single Use vs. Reuse Catheters in Intermittent Catheterization

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall aim of the investigation is to investigate the effect of repeated reuse of intermittent urinary catheters and to observe the impact of switch from single use to multiple reuse catheters.

Detailed description

Throughout the investigation, the impact of switch from single use to multiple reuse catheters will be observed and compared with respect to health-related quality of life (HR-QoL), satisfaction, perception, and preference in female and male catheter-users, who use clean intermittent catheterization (CIC) for bladder management. Furthermore, the investigation intends to identify microbial contamination of reused catheters and compare proportions to a control single use catheter.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	CLINY catheter	Subjects using a single use catheter for bladder management at inclusion. During the study period, subjects will use the reusable CLINY catheter for 28 test-days

Timeline

• Start date: 2022-08-12
• Primary completion: 2023-03-30
• Completion: 2023-03-30
• First posted: 2022-11-25
• Last updated: 2024-04-15
• Results posted: 2024-04-15

Locations

1 site across 1 country: Denmark