Investigation of New Intermittent Catheters in Healthy Volunteers

Exploratory Investigation on Performance and Safety of New Intermittent Catheters in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Retention, Urinary
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen Ø
    • Copenhagen, Copenhagen Ø, Denmark, 2100
      • Urologisk klinik, Afsnit 2112, Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 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 or female; Participants underwent catheterization with standard of care intermittent catheter. The catheterization was performed by a trained nurse.	Device: SpeediCath® Standard male or female; Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male or female.
Experimental: New intermittent catheter Variant 1 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.	Device: New intermittent Variant 1 catheter for male or female; Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 for male or female.
Experimental: New intermittent catheter Variant 2 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.	Device: New intermittent Variant 2 catheter for male or female; Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 for male or female.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual Urine at 1st Flow-stop	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.	Immediately after the procedure/catheterization, up to 5 min.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-void Residual Urine	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.
Catheterization Insertion Discomfort	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.	Immediately after the procedure/catheterization, up to 5 min.
Catheterization Urination Discomfort	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.	Immediately after the procedure/catheterization, up to 5 min.
Withdrawal Discomfort	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.	Immediately after the procedure/catheterization, up to 5 min.
Overall Catheterization Discomfort	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.	Immediately after the procedure/catheterization, up to 5 min.
Post-catheterization Urination Discomfort	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.	Immediately after the first normal void following 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): March 1, 2020
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (Actual): June 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: August 8, 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: CP322

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