Back to resultsClinical Trial of New Intermittent Single-use Catheter
Primary Purpose
Urinary Incontinence
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Investigational device - newly developed intermittent catheter
Comparator device #1 - SpeediCath Eve
Comparator device #2 - SpeediCath Compact Plus Female
Sponsored by
About this trial
This is an interventional prevention trial for Urinary Incontinence
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 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
- RigshopsitaletRecruiting
- Sanos ClinicRecruiting
- Odense UniversitetshospitalRecruiting
- Sanos Clinic Vejle
- Hôpital Saint- Philibert
- Hôpital TenonRecruiting
- CHU Toulouse Rangueil
- Synexus Birmingham
- North Bristol NHS Trust
- AddenbrookesRecruiting
- Synexus Merseyside
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Investigational device - newly developed intermittent catheter
Comparator device (#1 OR #2)
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. Randomization will decide the order of investigational device/comparator device and which of the two comparator devices the subject will receive in the comparator study period.
SpeediCath Eve or SpeediCath Compact Plus Female (CH12 and CH14). Both comparators are CE marked Coloplast products. Randomization will decide the order of investigational device/comparator device and which of the two comparator devices the subject will receive in the comparator study period.
Outcomes
Primary Outcome Measures
Residual volume at 1st flow-stop (catheterisation performed by HCP)
Residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile (catheterisation performed by a healthcare professional)
Secondary Outcome Measures
Number of flow-stops (catheterisation profile, catheterisation performed by HCP)
Number of flow-stop episodes derived from a catheterisation profile (catheterisation performed by a healthcare professional)
Number of flow-stops (catheterisation profile, self-catheterisation)
Number of flow-stop episodes derived from a catheterisation profile (self-catheterisation)
Residual volume at 1st flow-stop
Residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile (self-catheterisation)
Average residual volume post catheterisation (bladder scan)
Average residual volume post catheterisation measured with the BladderScanner (triplicate measurements)
Number of Adverse events
Number of Adverse events (number)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05814211
Brief Title
Clinical Trial of New Intermittent Single-use Catheter
Official Title
A Randomized, Open-labelled, Crossover Study Confirming Performance of a New Single-use Compact Intermittent Catheter in a Population of Adult Female Intermittent Catheter Users
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 4, 2023 (Actual)
Primary Completion Date
December 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
A multi-centre, open-labelled, randomised, crossover design. The total study duration for the individual subject will be approximately 4 weeks, consisting of four site visits and two 2-week test periods at home. Visits 0 and 1 can be performed on the same day. For visit 2 and 3, 2 catheterisations will be performed in a hospital setting (one HCP catheterisation and one self-catheterisation) for bladder emptying and user experience assessments. Visit 1 and 2 are followed by a home-use test period, followed by visit 3 which terminates the study.
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
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Investigational device - newly developed intermittent 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.
Randomization will decide the order of investigational device/comparator device and which of the two comparator devices the subject will receive in the comparator study period.
Arm Title
Comparator device (#1 OR #2)
Arm Type
Active Comparator
Arm Description
SpeediCath Eve or SpeediCath Compact Plus Female (CH12 and CH14). Both comparators are CE marked Coloplast products.
Randomization will decide the order of investigational device/comparator device and which of the two comparator devices the subject will receive in the comparator study period.
Intervention Type
Device
Intervention Name(s)
Investigational device - newly developed intermittent catheter
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 #1 - SpeediCath Eve
Intervention Description
During comparator study period, subjects will only receive one of the comparator products. Randomization will decide which one.
Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The comparator device is for single use.
Intervention Type
Device
Intervention Name(s)
Comparator device #2 - SpeediCath Compact Plus Female
Intervention Description
During comparator study period, subjects will only receive one of the comparator products. Randomization will decide which one.
Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The comparator device is for single use.
Primary Outcome Measure Information:
Title
Residual volume at 1st flow-stop (catheterisation performed by HCP)
Description
Residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile (catheterisation performed by a healthcare professional)
Time Frame
Week 2 and 4
Secondary Outcome Measure Information:
Title
Number of flow-stops (catheterisation profile, catheterisation performed by HCP)
Description
Number of flow-stop episodes derived from a catheterisation profile (catheterisation performed by a healthcare professional)
Time Frame
Week 2 and 4
Title
Number of flow-stops (catheterisation profile, self-catheterisation)
Description
Number of flow-stop episodes derived from a catheterisation profile (self-catheterisation)
Time Frame
Week 2 and 4
Title
Residual volume at 1st flow-stop
Description
Residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile (self-catheterisation)
Time Frame
Week 2 and 4
Title
Average residual volume post catheterisation (bladder scan)
Description
Average residual volume post catheterisation measured with the BladderScanner (triplicate measurements)
Time Frame
Week 2 and 4
Title
Number of Adverse events
Description
Number of Adverse events (number)
Time Frame
From Week 0-4
Other Pre-specified Outcome Measures:
Title
Exploratory: Perception questionnaire
Description
Perception questions evaluated on a 5-point scale assessed on V2 and V3 (perception questionnaire). Perception questionary based on perception of catheterisations in test period leading up to the visit
Time Frame
Week 2 and 4
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
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
49112159
Email
dkkabe@coloplast.com
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte Kastberg Levin
Phone
49111925
Email
dkckal@coloplast.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin Andersen, MD
Organizational Affiliation
Odense Universitetshospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshopsitalet
City
Copenhagen
State/Province
København Ø
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Per Bagi, MD
Phone
+45 35452111
Email
per.bagi@rh.regionh.dk
First Name & Middle Initial & Last Name & Degree
Per Bagi, MD
Facility Name
Sanos Clinic
City
Gandrup
State/Province
Nordjylland
ZIP/Postal Code
9362
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecilie Rovsing Jochumsen
First Name & Middle Initial & Last Name & Degree
Cecilie Rovsing Jochumsen
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
First Name & Middle Initial & Last Name & Degree
Karin Andersen
Facility Name
Sanos Clinic Vejle
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsten Bested
First Name & Middle Initial & Last Name & Degree
Kirsten Bested
Facility Name
Hôpital Saint- Philibert
City
Lille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile Donzé
First Name & Middle Initial & Last Name & Degree
Cécile Donzé
Facility Name
Hôpital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerard Amarengo
Facility Name
CHU Toulouse Rangueil
City
Toulouse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier Game
First Name & Middle Initial & Last Name & Degree
Xavier Game
Facility Name
Synexus Birmingham
City
Birmingham
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Faulkner
First Name & Middle Initial & Last Name & Degree
Karen Faulkner
Facility Name
North Bristol NHS Trust
City
Bristol
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hashim Hashim
First Name & Middle Initial & Last Name & Degree
Hashim Hashim
Facility Name
Addenbrookes
City
Cambridge
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikesh Thiruchelvam
Facility Name
Synexus Merseyside
City
Liverpool
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsten Peacey
First Name & Middle Initial & Last Name & Degree
Kirsten Peacey
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial of New Intermittent Single-use Catheter
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