Intermittent Catheterisation on the Bladder Mucosa of Healthy Volunteers With a Micro Hole Zone Catheter

Study Overview
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Brief Summary
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This investigation is a randomized, single-blinded, parallel, single-center investigation. In total, up to 50 subjects (40 completers) will be included and each subject will have two test visits overseen by the Principal Investigator (PI), or designee. Each subject will be enrolled in the investigation, which can be up to 3 days (if Day 0 and Day 1 are not on same day). The subjects will be randomly assigned to test either the test product or the comparator product, with at least 20 subjects assigned to each product.

Detailed Description
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This investigation is a randomized, single-blinded, parallel, single-center investigation. Up to 50 subjects (40 completers) will be included and each subject will have two test visits overseen by the Principal Investigator (PI), or designee. Each subject will be enrolled in the investigation, which can be up to 3 days (if Day 0 and Day 1 are not on same day). The subjects will be randomly assigned to test either the test product or the comparator product, with at least 20 subjects assigned to each product. The subjects will undergo cystoscopy and catheterization.

Official Title
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Exploratory Study Investigating the Acute Effect of Intermittent Catheterisation on the Bladder Mucosa of Healthy Volunteers With a Micro Hole Zone Catheter Compared to a Conventional 2-eyelet Catheter

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Device: Nautilus Catheter
* Device: Comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has given written informed consent Is at least 18 years and have full legal capacity Is female Has a negative urine Multistix dipstick test for erythrocytes (haematuria) Exclusion Criteria: Has used an internal urinary catheter or cystoscopy within the past month Has prior history of bladder surgery Is symptomatic and/or on medication for overactive bladder Has evidence of ongoing, active, symptomatic UTI (assessed by PI, or delegate) Is pregnant and/or breast-feeding Is participating in other clinical investigations during this investigation Is menstruating during study period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Catheter<br>Healthy volunteers to test the investigational intermittent catheter. | Device: Nautilus Catheter<br>* The test product is a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.<br>|
| Active Comparator: Comparator Catheter<br>Healthy volunteers to test the comparator. | Device: Comparator<br>* The comparator is a urinary catheter for bladder drainage through the urethra.<br>* Other names: Infyna Chic - Hollister;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in appearance of the bladder mucosa (pre- and post-catheterization) (∆), rated on a 4-point scale following visit 2 (Day 2). | Change in appearance of the bladder mucosa (pre- and post-catheterization) (∆), rated on a 4-point scale following visit 2 (Day 2). The 4-point scale defined as such: no lesions evident; minor mucosal and blood vessel lesions; major blood vessel lesions, and major mucosal and blood vessel lesions, | Day 2 |