Clinical Trial of New Single-use Compact Intermittent Catheter

Not Applicable

Completed

Brief Summary: The study is a randomised, single-blinded, controlled crossover study. The total study duration for the individual subject will be between two days - two weeks, consisting of three site visits. Visits 0 and 1 can be performed on the same day. Visit 2 can be performed the day after visit 1. For visit 1 and 2, catheterizations will be performed in a hospital setting by a health care professional for bladder emptying assessment and collection of urine samples for haematuria assessment. A sub-group of subjects (all enrolled subjects at DK sites) will be asked to conduct a self-catheterization at visit 2 after hcp catheterization and evaluate discomfort and PVR.

The total study duration for the individual subject will be up to 14 days.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Hollister Infyna Chic	Comparator device	The comparator is Hollister Infyna Chic, a CE-marked single-use compact catheter.
Investigational device - newly developed intermittent compact catheter	Comparator device	Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (CH12 and CH14) for urinary drainage. The investigational device is for single use.
Investigational device - newly developed intermittent compact catheter	Investigational device	Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (CH12 and CH14) for urinary drainage. The investigational device is for single use.
Hollister Infyna Chic	Investigational device	The comparator is Hollister Infyna Chic, a CE-marked single-use compact catheter.

Primary Outcome Measures

Name	Time	Method
Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP)	At Visit 1 and Visit 2	Measure residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile, \[mL\]

Secondary Outcome Measures

Name	Time	Method
Number of Flowstops (Catheterisation Performed by a Healthcare Professional)	At Visit 1 and Visit 2	Measure number of flow-stop episodes derived from a catheterisation profile (catheterisation performed by a healthcare professional), \[number\].
Residual Volume Post Catheterisation	At Visit 1 and Visit 2	Measure average residual volume post catheterisation (PVR) measured with a bladder scanner (triplicate measurements), \[mL\],
Number of Adverse Events	At Visit 1 and Visit 2	Count number of Adverse events, \[number\]