An Exploratory Investigation of the Effects of Single Use vs. Reuse Catheters in Intermittent Catheterization

Study Overview
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Brief Summary
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The overall aim of the investigation is to investigate the effect of repeated reuse of intermittent urinary catheters and to observe the impact of switch from single use to multiple reuse catheters.

Detailed Description
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Throughout the investigation, the impact of switch from single use to multiple reuse catheters will be observed and compared with respect to health-related quality of life (HR-QoL), satisfaction, perception, and preference in female and male catheter-users, who use clean intermittent catheterization (CIC) for bladder management. Furthermore, the investigation intends to identify microbial contamination of reused catheters and compare proportions to a control single use catheter.

Official Title
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An Exploratory Investigation of the Effects of Single Use vs. Reuse Catheters in Intermittent Catheterization

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Device: CLINY catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years of age and has full legal capacity Signed informed consent form Use clean intermittent catheterization to the greatest extent possible (at least three times daily) for at least the last 1 month prior to inclusion Ability (assessed by the investigator) and willingness to participate in a 4-week study period with at least three catheterizations a day using the investigational test product Self-catheterize using a single use hydrophilic coated catheter for at least 1 month prior to inclusion Exclusion Criteria: Participation in any other clinical intervention study during this investigation Previous participation in this investigation Any known allergies towards ingredients in the investigational device Symptoms of UTI at time of inclusion, as judged by the investigator Antibiotic treatment within 2 weeks prior to the Baseline visit (V1) Pregnancy Breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Other
Intervention Model: Single Group Assignment
Interventional Model Description: The investigation is designed as an open-labelled, single-arm investigation including subjects currently using single use catheters.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLINY reusable catheter 28 days<br>The investigation is designed as an open-labelled, single-arm investigation, in which the reuse CLINY catheter will be compared to single use catheters at baseline. | Device: CLINY catheter<br>* Subjects using a single use catheter for bladder management at inclusion. During the study period, subjects will use the reusable CLINY catheter for 28 test-days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life (HR-QoL) measured by the intermittent self-catheterization questionnaire, (ISC-Q) index score | Subjects will complete the questionnaire at inclusion and termination | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Number of Adverse Events during the study | 28 days |