Back to resultsAn Exploratory Investigation of the Effects of Single Use vs. Reuse Catheters in Intermittent Catheterization
Primary Purpose
Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
CLINY catheter
Sponsored by
About this trial
This is an interventional other trial for Urinary Incontinence
Eligibility Criteria
Inclusion Criteria: ≥18 years of age and has full legal capacity Signed informed consent form Use clean intermittent catheterization to the greatest extent possible (at least three times daily) for at least the last 1 month prior to inclusion Ability (assessed by the investigator) and willingness to participate in a 4-week study period with at least three catheterizations a day using the investigational test product Self-catheterize using a single use hydrophilic coated catheter for at least 1 month prior to inclusion Exclusion Criteria: Participation in any other clinical intervention study during this investigation Previous participation in this investigation Any known allergies towards ingredients in the investigational device Symptoms of UTI at time of inclusion, as judged by the investigator Antibiotic treatment within 2 weeks prior to the Baseline visit (V1) Pregnancy Breastfeeding
Sites / Locations
- Odense Universitetshospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CLINY reusable catheter 28 days
Arm Description
The investigation is designed as an open-labelled, single-arm investigation, in which the reuse CLINY catheter will be compared to single use catheters at baseline.
Outcomes
Primary Outcome Measures
Health-related quality of life (HR-QoL) measured by the intermittent self-catheterization questionnaire, (ISC-Q) index score
Subjects will complete the questionnaire at inclusion and termination
Secondary Outcome Measures
Adverse events
Number of Adverse Events during the study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05626686
Brief Title
An Exploratory Investigation of the Effects of Single Use vs. Reuse Catheters in Intermittent Catheterization
Official Title
An Exploratory Investigation of the Effects of Single Use vs. Reuse Catheters in Intermittent Catheterization
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 12, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
March 30, 2023 (Actual)
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 overall aim of the investigation is to investigate the effect of repeated reuse of intermittent urinary catheters and to observe the impact of switch from single use to multiple reuse catheters.
Detailed Description
Throughout the investigation, the impact of switch from single use to multiple reuse catheters will be observed and compared with respect to health-related quality of life (HR-QoL), satisfaction, perception, and preference in female and male catheter-users, who use clean intermittent catheterization (CIC) for bladder management.
Furthermore, the investigation intends to identify microbial contamination of reused catheters and compare proportions to a control single use catheter.
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
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The investigation is designed as an open-labelled, single-arm investigation including subjects currently using single use catheters.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CLINY reusable catheter 28 days
Arm Type
Experimental
Arm Description
The investigation is designed as an open-labelled, single-arm investigation, in which the reuse CLINY catheter will be compared to single use catheters at baseline.
Intervention Type
Device
Intervention Name(s)
CLINY catheter
Intervention Description
Subjects using a single use catheter for bladder management at inclusion. During the study period, subjects will use the reusable CLINY catheter for 28 test-days
Primary Outcome Measure Information:
Title
Health-related quality of life (HR-QoL) measured by the intermittent self-catheterization questionnaire, (ISC-Q) index score
Description
Subjects will complete the questionnaire at inclusion and termination
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Adverse events
Description
Number of Adverse Events during the study
Time Frame
28 days
Other Pre-specified Outcome Measures:
Title
Intermittent Catheterization Satisfaction (InCaSa) questionnaire score
Description
Subjects will complete the questionnaire at inclusion and termination
Time Frame
28 days
Title
Perception questions (evaluated on a 6-point scale)
Description
Subjects will answer questions at termination
Time Frame
28 days
Title
Total catheter-associated bacterial count (CFU/mL)
Description
Lab assessment on all used catheters during the study
Time Frame
28 days
Title
Number of bacterial-positive catheter samples
Description
Lab assessment on all used catheters during the study
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥18 years of age and has full legal capacity
Signed informed consent form
Use clean intermittent catheterization to the greatest extent possible (at least three times daily) for at least the last 1 month prior to inclusion
Ability (assessed by the investigator) and willingness to participate in a 4-week study period with at least three catheterizations a day using the investigational test product
Self-catheterize using a single use hydrophilic coated catheter for at least 1 month prior to inclusion
Exclusion Criteria:
Participation in any other clinical intervention study during this investigation
Previous participation in this investigation
Any known allergies towards ingredients in the investigational device
Symptoms of UTI at time of inclusion, as judged by the investigator
Antibiotic treatment within 2 weeks prior to the Baseline visit (V1)
Pregnancy
Breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin Andersen
Organizational Affiliation
Odense Universitetshospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nessn Azawi
Organizational Affiliation
Zealand University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brian Kloster
Organizational Affiliation
Ålborg Universitetshospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odense Universitetshospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Exploratory Investigation of the Effects of Single Use vs. Reuse Catheters in Intermittent Catheterization
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