A Confirmatory Study Confirming Performance of a New Intermittent Catheter

Study Overview
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Brief Summary
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A multi-centre, randomised, controlled crossover design. The total study duration for the individual subject was approximately 9 weeks, consisting of four site visits and two 4-week test periods at home. Visits 0 and 1 could be performed on the same day. For visit 2 and 3, catheterisations were performed in a hospital setting for bladder emptying assessment and collection of urine samples (the latter only in Denmark). Visit 1 and 2 were followed by a home-use test period, followed by visit 3 which terminated the study.

Detailed Description
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This investigation was a multi-centre, randomised, controlled crossover study including 73 male CIC users. The study consisted of four study visits (V0-V3) and two 4-week test periods at home (T1 and T2). Visit 0 and 1 were performed on the same day if subjects allowed. Visit 0 included the screening-, inclusion-, and randomization phase of subjects and at visit 1 subjects performed a self-catheterisation with the device according to their respective randomization scheme. This was followed by a dipstick test for haematuria. In the two 4-week test periods (T1 and T2, respectively) the subjects catheterised at home with the specified catheter according to their randomization scheme. Both 4-week periods started with a 2-week run-in period followed by a 2-week period during which a dipstick test for haematuria was performed daily. For Visit 2 and 3, a sub-group of subjects was invited for a clinical test visit during which subjects were catheterised with the same device applied during the preceding home-test period. First a healthcare professional (HCP)-led catheterisation was performed followed by a self-catheterisation, and endpoints related to bladder emptying (residual urine and number of urinary flow-stop episodes) were measured. After each catheterisation, any residual urine left in the bladder was measured with a bladder scanner and haematuria was assessed with a dip-stick test. After the self-catheterisation process, subjects at clinic visit V2 and V3 completed a questionnaire related to discomfort. Finally, all subjects completed a perception questionnaire and a HRQoL questionnaire associated with the catheter during the last two weeks of the home test period. For subjects not part of visits V2 and V3, a nurse assisted with the questionnaires after each home-test period during a remote home visit. Thereafter, all subjects were introduced to the second device to be tested for the next home-test period. After the second home-test period, the study was terminated with a test visit 3 (V3), either in the clinic (for the subset group) or a home visit by the nurse (the remaining subjects).

Official Title
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A Confirmatory, Multi-centre, Randomised, Open Label, Controlled Study Confirming Performance of a Single-use Intermittent Micro-holes Zone Catheter in a Population of Adult Male Intermittent Catheter Users.

Conditions
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Urinary Retention

Intervention / Treatment
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* Device: Investigational device - intermittent catheter with micro-hole zone
* Device: Comparator - standard intermittent catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male Is at least 18 years of age and has full legal capacity Has given written informed consent Has signed letter of authority (only DK) Has used clean intermittent self-catheterisation (CISC) for at least the last 3 months Has used intermittent catheterisation as the only bladder emptying method for at least the last 3 months Self-catheterise using Coloplast SpeediCath Flex or Hollister VaPro catheters, CH12 or CH14, for at least 3 months prior to inclusion Ability (assessed by investigator) and willingness to adhere to a 2-month study period Exclusion Criteria Participation in any other clinical study during this investigation Previous participation in this study Symptoms of urinary tract infection as judged by the investigator (rescheduling allowed within recruitment period for LPI) Individuals with history, suspected or showing signs of producing urine with excessive amount of mucus or large/clustered sediments or debris Any known allergies towards ingredients in the investigational device

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Male

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 - intermittent catheter with micro-hole zone<br>Ready-to-use, sterile, hydrophilic coated intermittent male catheter (sizes CH12 and CH14) with a flexible tip and a micro-hole zone for urinary drainage. The investigational device is for single use. | Device: Investigational device - intermittent catheter with micro-hole zone<br>* Intermittent male catheter with micro-hole zone for urinary drainage<br>|
| Active Comparator: Comparator device - standard intermittent catheter<br>Single-use, hydrophilic coated intermittent male catheters (sizes CH12 and CH14) with sleeves: SpeediCath Flex, VaPro, VaPro Pocket, VaPro Plus and VaPor Plus Pocket. | Device: Comparator - standard intermittent catheter<br>* SpeediCath Flex, VaPro Pocket, VaPro Plus and VaPro Plus Pocket.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual urine at 1st flow stop (HCP-led catheterisation) | Residual urine at 1st flow stop, i.e. post catheterisation volume minus volume at 1st flow stop after HCP-led catheterisation. | 4 weeks | 
| Residual urine at 1st flow stop (HCP-led catheterisation) | Residual urine at 1st flow stop, i.e. post catheterisation volume minus volume at 1st flow stop after HCP-led catheterisation. | 8 weeks | 
| Flow-stop episodes (HCP-led catheterisation) | Number of flow-stop episodes during a HCP-led catheterization. | 4 weeks | 
| Flow-stop episodes (HCP-led catheterisation) | Number of flow-stop episodes during a HCP-led catheterization | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Red blood cells | Red blood cell concentration based on a dipstick test, collected during the final two weeks of two home test period T1 and T2 [Erythrocytes/µL]. | From week 3-4 | 
| Red blood cells | Red blood cell concentration based on a dipstick test, collected during the final two weeks of two home test period T1 and T2 [Erythrocytes/µL]. | From week 6-8 | 
| Hematuria | Number of positive hematuria occurrences based on a dipstick test, collected during the final two weeks of two home test period T1 and T2 [positive/negative scale]. | From week 2-4 | 
| Hematuria | Number of positive hematuria occurrences based on a dipstick test, collected during the final two weeks of two home test period T1 and T2 [positive/negative scale]. | From week 6-8 |