Investigation of Non-CE Marked Intermittent Catheters.

Not Applicable

Completed

Conditions: Retention, Urinary

Interventions: Device: SpeediCath® Standard male
Device: New intermittent Variant 1 catheter for males
Device: New intermittent Variant 2 catheter for males

Registration Number: NCT04543136

Lead Sponsor: Coloplast A/S

Brief Summary: 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

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 16

Inclusion Criteria

Male
Minimum 18 years of age and with full legal capacity
Daily intermittent catheterization for bladder management, with at least two catheters used on average pr. day, during the last 3 months
Ability to self-catheterize
Written informed consent, signed letter of authority and signed secrecy agreement given

Exclusion Criteria

Participation in any other clinical study during this investigation
Symptoms of urinary tract infection as judged by the investigator
Any know allergies towards ingredients in the products
Relevant medical history that would prevent the subject from participation in the investigation (investigators judgement)

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intermittent catheter; SpeediCath® Standard male	SpeediCath® Standard male	Participants underwent two catheterizations with standard of care intermittent catheter: The first was performed by a trained nurse, the second by the participant later the same day.
New intermittent catheter Variant 1 for males	New intermittent Variant 1 catheter for males	Participants underwent two catheterizations with the new intermittent catheter Variant 1 for males: The first was performed by a trained nurse, the second by the participant later the same day.
New intermittent catheter Variant 2 for males	New intermittent Variant 2 catheter for males	Participants underwent two catheterizations with the new intermittent catheter Variant 2 for males: The first was performed by a trained nurse, the second by the participant later the same day.

Primary Outcome Measures

Name	Time	Method
Residual Urine at 1st Flow-stop During Self-catheterization	Immediately after the procedure/catheterization, up to 5 min.	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.
Residual Urine at 1st Flow-stop During Nurse Catheterization	Immediately after the procedure/catheterization, up to 5 min.	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.

Secondary Outcome Measures

Name	Time	Method
Urination Discomfort During Nurse Catheterization	Immediately after the procedure/catheterization, up to 5 min.	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.
Post-void Residual Urine After Self-catheterization	Immediately after the procedure/catheterization, up to 15 min.	The volume of residual urine (urine left in the bladder) post catheterization (performed by the participant) measured in triplicates using an ultrasound scanner.
Withdrawal Discomfort During Nurse Catheterization	Immediately after the procedure/catheterization, up to 5 min.	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.
Overall Discomfort During Nurse Catheterization	Immediately after the procedure/catheterization, up to 5 min.	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.
Post-void Residual Urine After Nurse Catheterization	Immediately after the procedure/catheterization, up to 15 min.	The volume of residual urine (urine left in the bladder) post catheterization (performed by the nurse) measured in triplicates using an ultrasound scanner.
Insertion Discomfort During Self-catheterization	Immediately after the procedure/catheterization, up to 5 min.	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.
Insertion Discomfort During Nurse Catheterization	Immediately after the procedure/catheterization, up to 5 min.	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.
Overall Discomfort During Self-catheterization	Immediately after the procedure/catheterization, up to 5 min.	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.
Urination Discomfort During Self-catheterization	Immediately after the procedure/catheterization, up to 5 min.	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.
Withdrawal Discomfort During Self-catheterization	Immediately after the procedure/catheterization, up to 5 min.	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.