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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
30
Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male or female.
Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 for male or female.
Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 for male or female.
Urologisk klinik, Afsnit 2112, Rigshospitalet
Copenhagen, Copenhagen Ø, Denmark
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.
Time frame: Immediately after the procedure/catheterization, up to 5 min.
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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Immediately after the first normal void following the procedure/catheterization, up to 5 min.