Clinical Trial of New Single-use Compact Intermittent Catheter

A Randomized, Crossover Study Confirming Performance of a New Single-use Compact Intermittent Catheter vs. Infyna Chic in a Pop-ulation of Adult Female Intermittent Catheter Users.

The study is a randomised, single-blinded, controlled crossover study. The total study duration for the individual subject will be between two days - two weeks, consisting of three site visits. Visits 0 and 1 can be performed on the same day. Visit 2 can be performed the day after visit 1. For visit 1 and 2, catheterizations will be performed in a hospital setting by a health care professional for bladder emptying assessment and collection of urine samples for haematuria assessment. A sub-group of subjects (all enrolled subjects at DK sites) will be asked to conduct a self-catheterization at visit 2 after hcp catheterization and evaluate discomfort and PVR.

The total study duration for the individual subject will be up to 14 days.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Device: Investigational device; Device: Comparator device

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Odense Universitetshospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Is Female
• Is at least 18 years of age and has full legal capacity
• Has signed an informed consent form
• Has used clean intermittent self-catheterisation (CISC) (CH12 or CH14) for at least one month up to inclusion
• Is using intermittent self-catheterisation for a minimum of 3 times per day for bladder emptying
• Has used a compact catheter 50% of the time (or more) for the last two weeks prior to entering the study
• Has the ability (assessed by investigator) and willingness to follow study procedures or is able to use a compact catheter assessed by investigator

Exclusion Criteria:

• Is participating in any other clinical study during this investigation
• Has previously participated in this study
• Has symptoms of urinary tract infection at time of inclusion, as judged by the investigator (if the patient recovers within the recruitment period, a second inclusion is allowed, under a different subject id)
• Is an individual with a history of - suspected to be - or showing signs of producing an excessive amount of mucus or large/clustered sediments or debris
• Has any known allergies towards ingredients in the investigational device
• Is pregnant
• Is breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational device - newly developed intermittent compact catheter; Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (CH12 and CH14) for urinary drainage. The investigational device is for single use.	Device: Investigational device; Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The investigational device is for single use.; Device: Comparator device; Hollister Infyna Chic, single-use compact catheter.
Active Comparator: Hollister Infyna Chic; The comparator is Hollister Infyna Chic, a CE-marked single-use compact catheter.	Device: Investigational device; Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The investigational device is for single use.; Device: Comparator device; Hollister Infyna Chic, single-use compact catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP)	Measure residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile, [mL]	At Visit 1 and Visit 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Flowstops (Catheterisation Performed by a Healthcare Professional)	Measure number of flow-stop episodes derived from a catheterisation profile (catheterisation performed by a healthcare professional), [number].	At Visit 1 and Visit 2
Residual Volume Post Catheterisation	Measure average residual volume post catheterisation (PVR) measured with a bladder scanner (triplicate measurements), [mL],	At Visit 1 and Visit 2
Number of Adverse Events	Count number of Adverse events, [number]	At Visit 1 and Visit 2

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discomfort Measure by VAS (Only in DK)	Discomfort is measured by Visual Analogue Scale (VAS), which is measured on a 10 cm horizontal scale ranging from "no discomfort" at 0 cm to "worst possible discomfort" at 10 cm caused by the catheter, by drawing a vertical line indicating how the subject experienced the catheterization divided into the four following categories: Discomfort at insertion measured using the VAS (VAS) [cm] Discomfort at withdrawal measured using the VAS, [cm] Discomfort during emptying of bladder measured using the VAS, [cm] Discomfort at end of emptying the bladder measured using the VAS, [cm]	At Visit 1 and Visit 2

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Karin Andersen, MD, Odense Universitetshospital

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2023
• Primary Completion (Actual): September 14, 2023
• Study Completion (Actual): September 14, 2023

Study Registration Dates

• First Submitted: March 24, 2023
• First Submitted That Met QC Criteria: April 21, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Incontinence
• Other Study ID Numbers: CP356

Drug and device information, study documents

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