Investigation of Non-CE Marked Intermittent Catheters.

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

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

Study Overview

• Status: Completed
• Conditions: Retention, Urinary
• Intervention / Treatment: Device: SpeediCath® Standard male; Device: New intermittent Variant 1 catheter for males; Device: New intermittent Variant 2 catheter for males

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Blegdamsvej 9, Urologisk klinik Afsnit 2112, Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intermittent catheter; 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.	Device: SpeediCath® Standard male; Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male.
Experimental: New intermittent catheter Variant 1 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.	Device: New intermittent Variant 1 catheter for males; Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 catheter.
Experimental: New intermittent catheter Variant 2 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.	Device: New intermittent Variant 2 catheter for males; Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Per Bagi, MD, Blegdamsvej 9, Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2020
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: September 2, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: August 12, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Retention
• Other Study ID Numbers: CP323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No