Phase
Condition
Enuresis
Urinary Incontinence
Treatment
Investigational device
Comparator device
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
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 leastone month up to inclusion
Is using intermittent self-catheterisation for a minimum of 3 times per day forbladder emptying
Has used a compact catheter 50% of the time (or more) for the last two weeks priorto entering the study
Has the ability (assessed by investigator) and willingness to follow studyprocedures or is able to use a compact catheter assessed by investigator
Exclusion
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 theinvestigator (if the patient recovers within the recruitment period, a secondinclusion is allowed, under a different subject id)
Is an individual with a history of - suspected to be - or showing signs of producingan excessive amount of mucus or large/clustered sediments or debris
Has any known allergies towards ingredients in the investigational device
Is pregnant
Is breastfeeding
Study Design
Connect with a study center
Odense Universitetshospital
Odense, 5000
DenmarkSite Not Available
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