Explorative Clinical Study on the Performance and Acceptance of New Intermittent Catheters in Healthy Volunteers

Explorative Clinical Study Investigating the Performance and Acceptance of New Intermittent Catheters in Healthy Volunteers

Performance and acceptance of new intermittent catheters tested in healthy volunteers

Study Overview

• Status: Completed
• Conditions: Compliance, Patient
• Intervention / Treatment: Device: Test product 3; Device: Comparator; Device: Test product 2

Detailed Description

This study is a single blinded, randomised, crossover study. The study period consists of an information visit, an inclusion visit, three test visits and a termination visit.

Two prototypes of intermittent catheters (Test product 2 and 3) compared to the standard catheter SpeediCath® Flex (Comparator).

In the investigation ten subjects will be included. The subjects will be catheterised once per visit. The subjects will be catheterised with the two test catheters and comparator in a randomised order. The order of the catheterisations will be randomised to prevent bias.

During the test visits the primary, secondary and explorative endpoints will be registered.

Subjects will be asked to participate in an interview in continuation of their last visit (Test Visit 3). The interviews will be performed by a Coloplast representative asking questions related to their experience with the catheter.

The subjects must sign a separate consent form for this purpose and can participate in the investigation without participating in the interview. In addition, subjects will be asked for consent to tape recording and filming during the interviews, but can participate in interviews without this.

In addition, a Coloplast representative will interview the Investigator and her representatives after LPO with questions related to their experience with the catheters.

The investigation is planned to be conducted in August 2018-Januar 2019. The visit window will be minimum five days between the visits (catheterisations), to ensure time for healing of any potential urethral trauma. However, the maximum time between visits should be adjusted to ensure the subject is terminated before LPO.

No biobank will be established for this investigation. All urine samples in the clinical investigation (for evaluating in- and exclusion criteria and for evaluating end points) will be destructed immediately after analysis.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Humlebæk, Denmark, 3050
    • Coloplast A/S

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

Has given written informed consent and signed letter of authority Is at least 18 years of age and has full legal capacity Is a male Willing to comply without using analgetica up to 24 hours prior to catheterisation visits

Exclusion Criteria:

Has a previous history of genitourinary disease including congenital abnormalities and surgical procedures performed in the urinary tract Has symptoms of urinary tract infections (frequent urination, stinging and pain at urination) Are participating in any other clinical investigation related to urinary tract system during this investigation (inclusion to termination) Known hypersensitivity toward any of the test products

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test product 2; Test catheter 2	Device: Test product 3; Test catheter 3; Device: Comparator; SpeediCath Flex
Experimental: Test product 3; Test catheter 3	Device: Comparator; SpeediCath Flex; Device: Test product 2; Test catheter 2
Active Comparator: Comparator; SpeediCath Flex	Device: Test product 3; Test catheter 3; Device: Test product 2; Test catheter 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine Flow Rate	On day of study visits 1-5 rate of urine flow through catheter measured in mL/s	2 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-void Residual Urine	On day of study visits 1-5 rate volume of urine left in the bladder post catheterisation (in mL)	2 hour
Number of Participants With Hematuria	On day of study visits 1-5 blood in urine post catheterisation (measured as yes/no to blood in urine)	2 hour

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Birte Jakobsen, MD, Coloplast A/S

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2018
• Primary Completion (Actual): December 20, 2018
• Study Completion (Actual): December 20, 2018

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CP290

Drug and device information, study documents

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