Clinical Trial of New Single-use Compact Intermittent Catheter
Urinary Incontinence
About this trial
This is an interventional prevention trial for Urinary Incontinence
Eligibility Criteria
Inclusion Criteria: Is Female Is at least 18 years of age and has full legal capacity Has signed an informed consent form Has used clean intermittent self-catheterisation (CISC) (CH12 or CH14) for at least one month up to inclusion Is using intermittent self-catheterisation for a minimum of 3 times per day for bladder emptying Has used a compact catheter 50% of the time (or more) for the last two weeks prior to entering the study Has the ability (assessed by investigator) and willingness to follow study procedures or is able to use a compact catheter assessed by investigator Exclusion Criteria: Is participating in any other clinical study during this investigation Has previously participated in this study Has symptoms of urinary tract infection at time of inclusion, as judged by the investigator (if the patient recovers within the recruitment period, a second inclusion is allowed, under a different subject id) Is an individual with a history of - suspected to be - or showing signs of producing an excessive amount of mucus or large/clustered sediments or debris Has any known allergies towards ingredients in the investigational device Is pregnant Is breastfeeding
Sites / Locations
- Odense UniversitetshospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Investigational device - newly developed intermittent compact catheter
Hollister Infyna Chic
Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (CH12 and CH14) for urinary drainage. The investigational device is for single use.
The comparator is Hollister Infyna Chic, a CE-marked single-use compact catheter.