Clinical Trial of New Intermittent Single-use Catheter

Study Overview
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Brief Summary
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A multi-centre, open-labelled, randomised, crossover design. The total study duration for the individual subject will be approximately 4 weeks, consisting of four site visits and two 2-week test periods at home. Visits 0 and 1 can be performed on the same day. For visit 2 and 3, 2 catheterisations will be performed in a hospital setting (one HCP catheterisation and one self-catheterisation) for bladder emptying and user experience assessments. Visit 1 and 2 are followed by a home-use test period, followed by visit 3 which terminates the study.

Official Title
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A Randomized, Open-labelled, Crossover Study Confirming Performance of a New Single-use Compact Intermittent Catheter in a Population of Adult Female Intermittent Catheter Users

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Device: Investigational device - newly developed intermittent catheter
* Device: Comparator device #1 - SpeediCath Eve
* Device: Comparator device #2 - SpeediCath Compact Plus Female


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 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational device - newly developed intermittent 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. Randomization will decide the order of investigational device/comparator device and which of the two comparator devices the subject will receive in the comparator study period. | Device: Investigational device - newly developed intermittent catheter<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>|
| Active Comparator: Comparator device (#1 OR #2)<br>SpeediCath Eve or SpeediCath Compact Plus Female (CH12 and CH14). Both comparators are CE marked Coloplast products. Randomization will decide the order of investigational device/comparator device and which of the two comparator devices the subject will receive in the comparator study period. | Device: Comparator device #1 - SpeediCath Eve<br>* During comparator study period, subjects will only receive one of the comparator products. Randomization will decide which one. Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The comparator device is for single use.<br>Device: Comparator device #2 - SpeediCath Compact Plus Female<br>* During comparator study period, subjects will only receive one of the comparator products. Randomization will decide which one. Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The comparator device is for single use.<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) | Residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile (catheterisation performed by a healthcare professional) | Week 2 and 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of flow-stops (catheterisation profile, catheterisation performed by HCP) | Number of flow-stop episodes derived from a catheterisation profile (catheterisation performed by a healthcare professional) | Week 2 and 4 | 
| Number of flow-stops (catheterisation profile, self-catheterisation) | Number of flow-stop episodes derived from a catheterisation profile (self-catheterisation) | Week 2 and 4 | 
| Residual volume at 1st flow-stop | Residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile (self-catheterisation) | Week 2 and 4 | 
| Average residual volume post catheterisation (bladder scan) | Average residual volume post catheterisation measured with the BladderScanner (triplicate measurements) | Week 2 and 4 | 
| Number of Adverse events | Number of Adverse events (number) | From Week 0-4 |