Safety and Performance of a New Coating for Urinary Intermittent Catheters

Study Overview
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Brief Summary
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The aim of the study is to evaluate safety and performance of a new catheter coating,compared to the current SpeediCath coating.

Official Title
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Clinical Study Investigating Safety and Performance of a New Coating for Urinary Intermittent Catheters in Healthy Volunteers

Conditions
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Intermittent Urethral Catheterization

Intervention / Treatment
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* Device: ZN-D catheter
* Device: ZN-C catheter
* Device: SpeediCath catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have given written informed consent and signed letter of authority Be at least 18 years of age and have full legal capacity Be a male Willing to refrain from using analgetics up to 24 hours prior to catheterization visits Exclusion Criteria: Abnormalities, diseases or surgical procedures performed in the lower urinary tract Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination) Participating in other interventional clinical investigations during this investigation (inclusion to termination) or have previously participated in this investigation (including run-in period) Known hypersensitivity toward any of the test products -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sequence 1<br>SpeediCath catheter then ZN-D catheter then ZN-C catheter | Device: ZN-D catheter<br>* ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.<br>Device: ZN-C catheter<br>* ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.<br>Device: SpeediCath catheter<br>* The Speedicath cathere is CE-marked and commercially available.<br>|
| Experimental: Sequence 2<br>SpeediCath catheter then ZN-C catheter then ZN-D catheter | Device: ZN-D catheter<br>* ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.<br>Device: ZN-C catheter<br>* ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.<br>Device: SpeediCath catheter<br>* The Speedicath cathere is CE-marked and commercially available.<br>|
| Experimental: Sequence 3<br>ZN-D catheter then SpeediCath catheter then ZN-C catheter | Device: ZN-D catheter<br>* ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.<br>Device: ZN-C catheter<br>* ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.<br>Device: SpeediCath catheter<br>* The Speedicath cathere is CE-marked and commercially available.<br>|
| Experimental: Sequence 4<br>ZN-D catheter then ZN-C catheter then SpeediCath catheter | Device: ZN-D catheter<br>* ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.<br>Device: ZN-C catheter<br>* ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.<br>Device: SpeediCath catheter<br>* The Speedicath cathere is CE-marked and commercially available.<br>|
| Experimental: Sequence 5<br>ZN-C catheter then SpeediCath catheter then ZN-D catheter | Device: ZN-D catheter<br>* ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.<br>Device: ZN-C catheter<br>* ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.<br>Device: SpeediCath catheter<br>* The Speedicath cathere is CE-marked and commercially available.<br>|
| Experimental: Sequence 6<br>ZN-C catheter then ZN-D catheter then SpeediCath catheter | Device: ZN-D catheter<br>* ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.<br>Device: ZN-C catheter<br>* ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.<br>Device: SpeediCath catheter<br>* The Speedicath cathere is CE-marked and commercially available.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Discomfort During Catheterization | Evaluated by the subject on a 10 cm Visual Analog Scale (VAS), where 0 cm is no discomfort and 10 cm is the worst possible discomfort. | 1 day |