Explorative Clinical Study on the Performance and Acceptance of New Intermittent Catheters in Healthy Volunteers

Study Overview
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Brief Summary
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Performance and acceptance of new intermittent catheters tested in healthy volunteers

Detailed Description
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This study is a single blinded, randomised, crossover study. The study period consists of an information visit, an inclusion visit, three test visits and a termination visit. Two prototypes of intermittent catheters (Test product 2 and 3) compared to the standard catheter SpeediCath® Flex (Comparator). In the investigation ten subjects will be included. The subjects will be catheterised once per visit. The subjects will be catheterised with the two test catheters and comparator in a randomised order. The order of the catheterisations will be randomised to prevent bias. During the test visits the primary, secondary and explorative endpoints will be registered. Subjects will be asked to participate in an interview in continuation of their last visit (Test Visit 3). The interviews will be performed by a Coloplast representative asking questions related to their experience with the catheter. The subjects must sign a separate consent form for this purpose and can participate in the investigation without participating in the interview. In addition, subjects will be asked for consent to tape recording and filming during the interviews, but can participate in interviews without this. In addition, a Coloplast representative will interview the Investigator and her representatives after LPO with questions related to their experience with the catheters. The investigation is planned to be conducted in August 2018-Januar 2019. The visit window will be minimum five days between the visits (catheterisations), to ensure time for healing of any potential urethral trauma. However, the maximum time between visits should be adjusted to ensure the subject is terminated before LPO. No biobank will be established for this investigation. All urine samples in the clinical investigation (for evaluating in- and exclusion criteria and for evaluating end points) will be destructed immediately after analysis.

Official Title
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Explorative Clinical Study Investigating the Performance and Acceptance of New Intermittent Catheters in Healthy Volunteers

Conditions
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Compliance, Patient

Intervention / Treatment
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* Device: Test product 2
* Device: Test product 3
* Device: Comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has given written informed consent and signed letter of authority Is at least 18 years of age and has full legal capacity Is a male Willing to comply without using analgetica up to 24 hours prior to catheterisation visits Exclusion Criteria: Has a previous history of genitourinary disease including congenital abnormalities and surgical procedures performed in the urinary tract Has symptoms of urinary tract infections (frequent urination, stinging and pain at urination) Are participating in any other clinical investigation related to urinary tract system during this investigation (inclusion to termination) 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test product 2<br>Test catheter 2 | Device: Test product 3<br>* Test catheter 3<br>Device: Comparator<br>* SpeediCath Flex<br>|
| Experimental: Test product 3<br>Test catheter 3 | Device: Test product 2<br>* Test catheter 2<br>Device: Comparator<br>* SpeediCath Flex<br>|
| Active Comparator: Comparator<br>SpeediCath Flex | Device: Test product 2<br>* Test catheter 2<br>Device: Test product 3<br>* Test catheter 3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine flow rate | Average flow rate of urine through the catheter | 4-5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post void residual urine | Urine volume in the bladder post catheterisation | 4-5 weeks | 
| Hematuria | Macroscopic and microscopic hematuria | 4-5 weeks |