Investigation of Non-CE Marked Intermittent Catheters.

Retention, Urinary Clinical Trial

Official title:

Exploratory Investigation on Performance and Safety of Newly Developed Intermittent Catheters in Male Users of Intermittent Catheters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04543136
• Other study ID #: CP323
• Status: Completed
• Phase: N/A
• Start date: October 3, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: August 2022
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Retention, Urinary
• Urinary Retention

Intervention

Device:
• SpeediCath® Standard male
Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male.
• New intermittent Variant 1 catheter for males
Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 catheter.
• New intermittent Variant 2 catheter for males
Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 catheter.

Locations

Country	Name	City	State
Denmark	Blegdamsvej 9, Urologisk klinik Afsnit 2112, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Immediately after the procedure/catheterization, up to 5 min.
Primary	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.	Immediately after the procedure/catheterization, up to 5 min.
Secondary	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.	Immediately after the procedure/catheterization, up to 15 min.
Secondary	Post-void Residual Urine After Self-catheterization	The volume of residual urine (urine left in the bladder) post catheterization (performed by the participant) measured in triplicates using an ultrasound scanner.	Immediately after the procedure/catheterization, up to 15 min.
Secondary	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.	Immediately after the procedure/catheterization, up to 5 min.
Secondary	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.	Immediately after the procedure/catheterization, up to 5 min.
Secondary	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.	Immediately after the procedure/catheterization, up to 5 min.
Secondary	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.	Immediately after the procedure/catheterization, up to 5 min.
Secondary	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.	Immediately after the procedure/catheterization, up to 5 min.
Secondary	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.	Immediately after the procedure/catheterization, up to 5 min.
Secondary	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.	Immediately after the procedure/catheterization, up to 5 min.
Secondary	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.	Immediately after the procedure/catheterization, up to 5 min.