CP356 Investigation of new compact female intermittent self catheter
Research type
Research Study
Full title
CP356 -A randomized, crossover study confirming performance of a new single-use compact intermittent catheter vs. Infyna Chic in a population of adult female intermittent catheter users.
IRAS ID
326970
Contact name
Lesley Gjelstrup Kristensen
Contact email
Sponsor organisation
Coloplast A/S
Duration of Study in the UK
0 years, 4 months, 27 days
Research summary
Coloplast is in the process of developing a new intermittent catheter for females.
The aim of this investigation is to demonstrate superiority of the new compact catheter in terms of improved bladder emptying, to support CE marking.The investigation will be conducted from June 2023 to Oct 2023, enrolling 72 subjects with equal split in DK and UK. In UK we expect up to 4 sites in total. Once enrolled the subjects will be in the study approximately 14 days and required to attend upto 3 visits. During the visits, catheterisation will be performed by a HCP with both the new catheter test product and the second investigational catheter. During the catheterisations urine flow-stops will be counted and urine volume will be measured. A dipstick test will also be performed to determine presence of haematuria (blood in the urine), specific gravity (concentration of the urine) and leukocyturia (white blood cells in the urine).
Between visits subjects will use their usual catheter. At visit 3 the subject will be completed.
REC name
HSC REC A
REC reference
23/NI/0055
Date of REC Opinion
2 Jun 2023
REC opinion
Further Information Favourable Opinion