Investigation of New Intermittent Catheters in Healthy Volunteers

Study Overview
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Brief Summary
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Investigation of non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters with a comparator catheter in 30 adult healthy volunteers.

Detailed Description
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The CP322 study investigated a novel non-CE marked intermittent catheter for males and females, designed in two different variants, Variant 1 and Variant 2, respectively. The study was conducted in Denmark and was a randomized, single blinded, cross-over investigation comparing the two new variant catheters with a comparator catheter in 30 adult healthy volunteers. For each participant, the study thus contained three test visits/treatment arms (Comparator, Variant 1 and Variant 2, respectively), to which the 30 participants were randomized using a randomization sequence of six (i.e., there were six different random options for the order in which the participants tested the three catheters). There were 4-14 days between the test visits.

Official Title
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Exploratory Investigation on Performance and Safety of New Intermittent Catheters in Healthy Volunteers

Conditions
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Retention, Urinary

Intervention / Treatment
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* Device: SpeediCath® Standard male or female
* Device: New intermittent Variant 1 catheter for male or female
* Device: New intermittent Variant 2 catheter for male or female


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum 18 years of age and with full legal capacity Written informed consent and signed letter of authority and secrecy agreement given Willing to comply with not using analgesics 1 up to 24 hours prior to catheterization visits Urine Multistix negative for erythrocytes (hematuria) Exclusion Criteria: Participation in any other clinical investigations during this investigation Known hypersensitivity towards any of the test products Symptoms of urinary tract infection (UTI) (Investigators judgement) Pregnancy or 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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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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intermittent catheter; SpeediCath® Standard male or female<br>Participants underwent catheterization with standard of care intermittent catheter. The catheterization was performed by a trained nurse. | Device: SpeediCath® Standard male or female<br>* Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male or female.<br>|
| Experimental: New intermittent catheter Variant 1 for male or female<br>Participants underwent catheterization with the new intermittent catheter Variant 1 for males or females. The catheterization was performed by a trained nurse. | Device: New intermittent Variant 1 catheter for male or female<br>* Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 for male or female.<br>|
| Experimental: New intermittent catheter Variant 2 for male or female<br>Participants underwent catheterization with the new intermittent catheter Variant 2 for males or females. The catheterization was performed by a trained nurse. | Device: New intermittent Variant 2 catheter for male or female<br>* Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 for male or female.<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 | The residual urine at 1st flow-stop during catheterization (performed by a nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying/urination. This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter. Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop. | Immediately after the procedure/catheterization, up to 5 min. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-void Residual Urine | The volume of residual urine (urine left in the bladder) post catheterization (performed by the nurse) measured in triplicates using an ultrasound scanner. | Immediately after the procedure/catheterization, up to 15 min. | 
| Catheterization Insertion Discomfort | Discomfort measured at catheter insertion, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score. | Immediately after the procedure/catheterization, up to 5 min. | 
| Catheterization Urination Discomfort | Discomfort measured during catheter emptying/urination, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score. | Immediately after the procedure/catheterization, up to 5 min. | 
| Withdrawal Discomfort | Discomfort measured during catheter withdrawal, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score. | Immediately after the procedure/catheterization, up to 5 min. | 
| Overall Catheterization Discomfort | Discomfort measured for the overall/entire catheterization procedure, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score. | Immediately after the procedure/catheterization, up to 5 min. | 
| Post-catheterization Urination Discomfort | Discomfort measured for the first normal void/urination after the catheterization procedure, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score. | Immediately after the first normal void following the procedure/catheterization, up to 5 min. |