NCT05814211

Clinical Trial of New Intermittent Single-use Catheter

A Randomized, Open-labelled, Crossover Study Confirming Performance of a New Single-use Compact Intermittent Catheter in a Population of Adult Female Intermittent Catheter Users

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multi-centre, open-labelled, randomised, crossover design. The total study duration for the individual subject will be approximately 4 weeks, consisting of four site visits and two 2-week test periods at home. Visits 0 and 1 can be performed on the same day. For visit 2 and 3, 2 catheterisations will be performed in a hospital setting (one HCP catheterisation and one self-catheterisation) for bladder emptying and user experience assessments. Visit 1 and 2 are followed by a home-use test period, followed by visit 3 which terminates the study.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Investigational device - newly developed intermittent catheter	Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The investigational device is for single use.
DEVICE	Comparator device #1 - SpeediCath Eve	During comparator study period, subjects will only receive one of the comparator products. Randomization will decide which one. Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The comparator device is for single use.
DEVICE	Comparator device #2 - SpeediCath Compact Plus Female	During comparator study period, subjects will only receive one of the comparator products. Randomization will decide which one. Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The comparator device is for single use.

Timeline

• Start date: 2023-08-04
• Primary completion: 2023-11-29
• Completion: 2023-11-29
• First posted: 2023-04-14
• Last updated: 2025-02-20
• Results posted: 2025-02-20

Locations

11 sites across 3 countries: Denmark, France, United Kingdom