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Clinical Trial of New Single-use Compact Intermittent Catheter

Primary Purpose

Urinary Incontinence

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Investigational device
Comparator device
Sponsored by
Coloplast A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Odense UniversitetshospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Investigational device - newly developed intermittent compact catheter

Hollister Infyna Chic

Arm Description

Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (CH12 and CH14) for urinary drainage. The investigational device is for single use.

The comparator is Hollister Infyna Chic, a CE-marked single-use compact catheter.

Outcomes

Primary Outcome Measures

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]

Secondary Outcome Measures

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].
Resdiual volume post catheterisation
Measure average residual volume post catheterisation (PVR) measured with a bladder scanner (triplicate measurements), [mL],
Number of Adverse events
Count number of Adverse events, [number]

Full Information

First Posted
March 24, 2023
Last Updated
June 30, 2023
Sponsor
Coloplast A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05841004
Brief Title
Clinical Trial of New Single-use Compact Intermittent Catheter
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2023 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coloplast A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
controlled crossover study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Investigational device - newly developed intermittent compact catheter
Arm Type
Experimental
Arm Description
Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (CH12 and CH14) for urinary drainage. The investigational device is for single use.
Arm Title
Hollister Infyna Chic
Arm Type
Active Comparator
Arm Description
The comparator is Hollister Infyna Chic, a CE-marked single-use compact catheter.
Intervention Type
Device
Intervention Name(s)
Investigational device
Intervention Description
Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The investigational device is for single use.
Intervention Type
Device
Intervention Name(s)
Comparator device
Intervention Description
Hollister Infyna Chic, single-use compact catheter.
Primary Outcome Measure Information:
Title
Residual volume at 1st flow-stop (catheterisation performed by HCP)
Description
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]
Time Frame
From June 2023 - October 2023 (Up to 5 months)
Secondary Outcome Measure Information:
Title
Number of flowstops (catheterisation performed by a healthcare professional)
Description
Measure number of flow-stop episodes derived from a catheterisation profile (catheterisation performed by a healthcare professional), [number].
Time Frame
From June 2023 - October 2023 (Up to 5 months)
Title
Resdiual volume post catheterisation
Description
Measure average residual volume post catheterisation (PVR) measured with a bladder scanner (triplicate measurements), [mL],
Time Frame
From June 2023 - October 2023 (Up to 5 months)
Title
Number of Adverse events
Description
Count number of Adverse events, [number]
Time Frame
From June 2023 - October 2023 (Up to 5 months)
Other Pre-specified Outcome Measures:
Title
Discomfort Measure by VAS (Only in DK)
Description
Discomfort at insertion measured using the visual analog scale (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]
Time Frame
From June 2023 - October 2023 (Up to 5 months)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katja Bergenholtz
Phone
+4549112157
Email
dkkabe@coloplast.com
Facility Information:
Facility Name
Odense Universitetshospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karin Andersen
Phone
+4521570468
Email
karin.andersen@rsyd.dk

12. IPD Sharing Statement

Learn more about this trial

Clinical Trial of New Single-use Compact Intermittent Catheter

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