Back to resultsPerformance of a Single-use Intermittent Micro-hole Zone Catheter
Primary Purpose
Urinary Incontinence, Retention, Urinary
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Investigational device - intermittent catheter with a micro-hole zone
Comparator device -VaPro intermittent catheter
Sponsored by
About this trial
This is an interventional prevention trial for Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- Is Male
- Is at least 18 years of age and has full legal capacity
- Has given written informed consent
- Has signed letter of authority (only DK)
- Has used clean intermittent catheterisation CH12 or CH14 for at least one month
- Use intermittent catheterisation as the primary bladder emptying method
- Is able (assessed by investigator) and willing to follow study procedures
Exclusion Criteria:
- Is participating in any other clinical study during this investigation
- Has previous participated in this study
- Has symptoms of urinary tract infection as judged by the investigator 4 Is an individual with history, suspected or showing signs of producing urine with excessive amount of mucus or large/clustered sediments or debris
5. Has any known allergies towards ingredients in the investigational device
Sites / Locations
- Sanos Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Investigational device - intermittent catheter with a micro-hole zone
Comparator device - VaPro intermittent catheter
Arm Description
A ready-to-use, sterile, hydrophilic-coated male catheter for intermittent catheterisation with a flexible tip and a micro-hole zone for urinary drainage in sizes CH12 and CH14. The catheterization was performed by a trained nurse.
Hollister VaPro, a single-use hydrophilic sleeved soft/flexible catheters in the sizes CH12 or CH14. The catheterization was performed by a trained nurse.
Outcomes
Primary Outcome Measures
Flow-stop episodes
Flow-stops were measured with a pressure sensor, which is an electronic device used for monitoring the hydrostatic pressure at the outlet of an intermittent urinary catheter during emptying.
From a sensor curve, flow-stops were identified by two individually trained evaluators as a hydrostatic pressure peak coinciding with a urine flow-stop/ urine dripping (flowrate lower than 0,8 ml/sec).
Results from both evaluators were compared and in case of discrepancy a discussion was performed to extenuate discrepancies and agree on a final interpretation of the curves.
Residual urine
The residual urine at 1st flow-stop during catheterization (performed by a nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying.
Hence, the residual volume at 1st flow-stop was calculated as the total volume post catheterisation minus the volume at 1st flow-stop, derived from a catheterisation profile which was connected to a time-logged weighing [g].
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05485922
Brief Title
Performance of a Single-use Intermittent Micro-hole Zone Catheter
Official Title
A Randomized, Open-labelled, Crossover Study Confirming Performance of a Single-use Intermittent Micro-hole Zone Catheter in a Population of Adult Male Intermittent Catheter Users
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 23, 2022 (Actual)
Primary Completion Date
November 4, 2022 (Actual)
Study Completion Date
November 4, 2022 (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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this randomized, controlled crossover study was to assess the performance of a new micro-hole zone catheter compared to a conventional 2-eyelet catheter in 42 male intermittent catheter users.
The main objective of this study was to demonstrate superiority of the micro-hole zone catheter in terms of number of flow-stop episodes and residual volume at first flow-stop, with the catheterization performed by a health care professional in a hospital setting compared to a conventional two-eyelet catheter.
Detailed Description
The investigation was a single-centre, randomized, controlled crossover study including 42 male IC users comparing the performance of two intermittent catheters.
The study included an information visit (visit 0) and two test visits (visit 1 and 2) in which one catheterization with either the investigational device or the comparator device, according to a randomization scheme, was performed by a health care professional in a hospital setting assessing flow stop episodes, bladder emptying and hematuria. There were 4-14 days between each test visit (visit 1 and 2) and visit 0 and 1 could be held on the same day.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Retention, Urinary
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Investigational device - intermittent catheter with a micro-hole zone
Arm Type
Experimental
Arm Description
A ready-to-use, sterile, hydrophilic-coated male catheter for intermittent catheterisation with a flexible tip and a micro-hole zone for urinary drainage in sizes CH12 and CH14. The catheterization was performed by a trained nurse.
Arm Title
Comparator device - VaPro intermittent catheter
Arm Type
Active Comparator
Arm Description
Hollister VaPro, a single-use hydrophilic sleeved soft/flexible catheters in the sizes CH12 or CH14. The catheterization was performed by a trained nurse.
Intervention Type
Device
Intervention Name(s)
Investigational device - intermittent catheter with a micro-hole zone
Intervention Description
The investigational device was a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.
Intervention Type
Device
Intervention Name(s)
Comparator device -VaPro intermittent catheter
Intervention Description
The comparator device is a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.
Primary Outcome Measure Information:
Title
Flow-stop episodes
Description
Flow-stops were measured with a pressure sensor, which is an electronic device used for monitoring the hydrostatic pressure at the outlet of an intermittent urinary catheter during emptying.
From a sensor curve, flow-stops were identified by two individually trained evaluators as a hydrostatic pressure peak coinciding with a urine flow-stop/ urine dripping (flowrate lower than 0,8 ml/sec).
Results from both evaluators were compared and in case of discrepancy a discussion was performed to extenuate discrepancies and agree on a final interpretation of the curves.
Time Frame
Immediately after the procedure/catheterization, up to 5min
Title
Residual urine
Description
The residual urine at 1st flow-stop during catheterization (performed by a nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying.
Hence, the residual volume at 1st flow-stop was calculated as the total volume post catheterisation minus the volume at 1st flow-stop, derived from a catheterisation profile which was connected to a time-logged weighing [g].
Time Frame
Immediately after the procedure/catheterization, up to 5min
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
The device is a male catheter
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Is Male
Is at least 18 years of age and has full legal capacity
Has given written informed consent
Has signed letter of authority (only DK)
Has used clean intermittent catheterisation CH12 or CH14 for at least one month
Use intermittent catheterisation as the primary bladder emptying method
Is able (assessed by investigator) and willing to follow study procedures
Exclusion Criteria:
Is participating in any other clinical study during this investigation
Has previous participated in this study
Has symptoms of urinary tract infection as judged by the investigator 4 Is an individual with history, suspected or showing signs of producing urine with excessive amount of mucus or large/clustered sediments or debris
5. Has any known allergies towards ingredients in the investigational device
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecilie Rovsing, MD
Organizational Affiliation
Sanos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanos Clinic
City
Gandrup
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Performance of a Single-use Intermittent Micro-hole Zone Catheter
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