Clinical Trial of New Single-use Compact Intermittent Catheter

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Crossover Study Confirming Performance of a New Single-use Compact Intermittent Catheter vs. Infyna Chic in a Pop-ulation of Adult Female Intermittent Catheter Users.

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Device: Investigational device
* Device: Comparator device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: controlled crossover study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational device - newly developed intermittent compact catheter<br>Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (CH12 and CH14) for urinary drainage. The investigational device is for single use. | Device: Investigational device<br>* Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The investigational device is for single use.<br>Device: Comparator device<br>* Hollister Infyna Chic, single-use compact catheter.<br>|
| Active Comparator: Hollister Infyna Chic<br>The comparator is Hollister Infyna Chic, a CE-marked single-use compact catheter. | Device: Investigational device<br>* Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The investigational device is for single use.<br>Device: Comparator device<br>* Hollister Infyna Chic, single-use compact catheter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual volume at 1st flow-stop (catheterisation performed by HCP) | 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] | From June 2023 - October 2023 (Up to 5 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of flowstops (catheterisation performed by a healthcare professional) | Measure number of flow-stop episodes derived from a catheterisation profile (catheterisation performed by a healthcare professional), [number]. | From June 2023 - October 2023 (Up to 5 months) | 
| Resdiual volume post catheterisation | Measure average residual volume post catheterisation (PVR) measured with a bladder scanner (triplicate measurements), [mL], | From June 2023 - October 2023 (Up to 5 months) | 
| Number of Adverse events | Count number of Adverse events, [number] | From June 2023 - October 2023 (Up to 5 months) |