82
Participants
Start Date
August 4, 2023
Primary Completion Date
November 29, 2023
Study Completion Date
November 29, 2023
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.
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."
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."
Rigshopsitalet, Copenhagen
Odense Universitetshospital, Odense
Sanos Clinic Vejle, Vejle
Sanos Clinic, Gandrup
Hôpital Tenon, Paris
Hôpital Saint- Philibert, Lille
CHU Toulouse Rangueil, Toulouse
Synexus Birmingham, Birmingham
North Bristol NHS Trust, Bristol
Addenbrookes, Cambridge
Synexus Merseyside, Liverpool
Lead Sponsor
Coloplast A/S
INDUSTRY