Investigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for males with a comparator catheter
The CP323 study investigated a novel non-CE marked intermittent catheter, designed in two different variants, Variant 1 and Variant 2, respectively, and was conducted in Denmark. The study was a randomized, single blinded, cross-over investigation, comparing the two new variant catheters with a comparator catheter in 15 male IC users. For each participant, the study thus contains three test visits/treatment arms (Comparator, Variant 1 and Variant 2, respectively), to which the 15 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
16
Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male.
Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 catheter.
Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 catheter.
Blegdamsvej 9, Urologisk klinik Afsnit 2112, Rigshospitalet
Copenhagen, Denmark
Residual Urine at 1st Flow-stop During Nurse Catheterization
The residual urine at 1st flow-stop during nurse catheterization (i.e., catheterization performed by the 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.
Residual Urine at 1st Flow-stop During Self-catheterization
The residual urine at 1st flow-stop during nurse catheterization (i.e., catheterization performed by the participant) 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 After Nurse Catheterization
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.
Post-void Residual Urine After Self-catheterization
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The volume of residual urine (urine left in the bladder) post catheterization (performed by the participant) measured in triplicates using an ultrasound scanner.
Time frame: Immediately after the procedure/catheterization, up to 15 min.
Insertion Discomfort During Nurse Catheterization
Discomfort measured at catheter insertion (performed by nurse), 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.
Urination Discomfort During Nurse Catheterization
Discomfort measured during catheter urination/emptying (performed by nurse), 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.
Withdrawal Discomfort During Nurse Catheterization
Discomfort measured during catheter withdrawal (performed by nurse), 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 Discomfort During Nurse Catheterization
Discomfort measured for the entire catheterization procedure (performed by nurse), 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.
Insertion Discomfort During Self-catheterization
Discomfort measured at catheter insertion (performed by participant), 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.
Urination Discomfort During Self-catheterization
Discomfort measured during catheter urination/emptying (performed by participant), 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.
Withdrawal Discomfort During Self-catheterization
Discomfort measured during catheter withdrawal (performed by participant), 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 Discomfort During Self-catheterization
Discomfort measured for the entire catheterization procedure (performed by participant), 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.