Investigation of New Intermittent Catheters in Healthy Volunteers

Not Applicable

Completed

Conditions: Retention, Urinary

Interventions: 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

Registration Number: NCT04445051

Lead Sponsor: Coloplast A/S

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intermittent catheter; SpeediCath® Standard male or female	SpeediCath® Standard male or female	Participants underwent catheterization with standard of care intermittent catheter. The catheterization was performed by a trained nurse.
New intermittent catheter Variant 1 for male or female	New intermittent Variant 1 catheter for male or female	Participants underwent catheterization with the new intermittent catheter Variant 1 for males or females. The catheterization was performed by a trained nurse.
New intermittent catheter Variant 2 for male or female	New intermittent Variant 2 catheter for male or female	Participants underwent catheterization with the new intermittent catheter Variant 2 for males or females. The catheterization was performed by a trained nurse.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Post-void Residual Urine	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.
Withdrawal Discomfort	Immediately after the procedure/catheterization, up to 5 min.	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.
Post-catheterization Urination Discomfort	Immediately after the first normal void following the procedure/catheterization, up to 5 min.	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.
Catheterization Insertion Discomfort	Immediately after the procedure/catheterization, up to 5 min.	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.
Catheterization Urination Discomfort	Immediately after the procedure/catheterization, up to 5 min.	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.
Overall Catheterization Discomfort	Immediately after the procedure/catheterization, up to 5 min.	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.