Back to resultsIntermittent Catheterisation on the Bladder Mucosa of Healthy Volunteers With a Micro Hole Zone Catheter (CP341)
Primary Purpose
Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nautilus Catheter
Comparator
Sponsored by
About this trial
This is an interventional prevention trial for Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- Has given written informed consent
- Is at least 18 years and have full legal capacity
- Is female
- Has a negative urine Multistix dipstick test for erythrocytes (haematuria)
Exclusion Criteria:
- Has used an internal urinary catheter or cystoscopy within the past month
- Has prior history of bladder surgery
- Is symptomatic and/or on medication for overactive bladder
- Has evidence of ongoing, active, symptomatic UTI (assessed by PI, or delegate)
- Is pregnant and/or breast-feeding
- Is participating in other clinical investigations during this investigation
- Is menstruating during study period
Sites / Locations
- American Health Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test Catheter
Comparator Catheter
Arm Description
Healthy volunteers to test the investigational intermittent catheter.
Healthy volunteers to test the comparator.
Outcomes
Primary Outcome Measures
Change in appearance of the bladder mucosa (pre- and post-catheterization) (∆), rated on a 4-point scale following visit 2 (Day 2).
Change in appearance of the bladder mucosa (pre- and post-catheterization) (∆), rated on a 4-point scale following visit 2 (Day 2).
The 4-point scale defined as such:
no lesions evident;
minor mucosal and blood vessel lesions;
major blood vessel lesions, and
major mucosal and blood vessel lesions,
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05224544
Brief Title
Intermittent Catheterisation on the Bladder Mucosa of Healthy Volunteers With a Micro Hole Zone Catheter
Acronym
CP341
Official Title
Exploratory Study Investigating the Acute Effect of Intermittent Catheterisation on the Bladder Mucosa of Healthy Volunteers With a Micro Hole Zone Catheter Compared to a Conventional 2-eyelet Catheter
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
March 31, 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
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This investigation is a randomized, single-blinded, parallel, single-center investigation. In total, up to 50 subjects (40 completers) will be included and each subject will have two test visits overseen by the Principal Investigator (PI), or designee. Each subject will be enrolled in the investigation, which can be up to 3 days (if Day 0 and Day 1 are not on same day). The subjects will be randomly assigned to test either the test product or the comparator product, with at least 20 subjects assigned to each product.
Detailed Description
This investigation is a randomized, single-blinded, parallel, single-center investigation. Up to 50 subjects (40 completers) will be included and each subject will have two test visits overseen by the Principal Investigator (PI), or designee. Each subject will be enrolled in the investigation, which can be up to 3 days (if Day 0 and Day 1 are not on same day). The subjects will be randomly assigned to test either the test product or the comparator product, with at least 20 subjects assigned to each product. The subjects will undergo cystoscopy and catheterization.
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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Catheter
Arm Type
Experimental
Arm Description
Healthy volunteers to test the investigational intermittent catheter.
Arm Title
Comparator Catheter
Arm Type
Active Comparator
Arm Description
Healthy volunteers to test the comparator.
Intervention Type
Device
Intervention Name(s)
Nautilus Catheter
Intervention Description
The test product is a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.
Intervention Type
Device
Intervention Name(s)
Comparator
Other Intervention Name(s)
Infyna Chic - Hollister
Intervention Description
The comparator is a urinary catheter for bladder drainage through the urethra.
Primary Outcome Measure Information:
Title
Change in appearance of the bladder mucosa (pre- and post-catheterization) (∆), rated on a 4-point scale following visit 2 (Day 2).
Description
Change in appearance of the bladder mucosa (pre- and post-catheterization) (∆), rated on a 4-point scale following visit 2 (Day 2).
The 4-point scale defined as such:
no lesions evident;
minor mucosal and blood vessel lesions;
major blood vessel lesions, and
major mucosal and blood vessel lesions,
Time Frame
Day 2
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
This device is a female catheter.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Has given written informed consent
Is at least 18 years and have full legal capacity
Is female
Has a negative urine Multistix dipstick test for erythrocytes (haematuria)
Exclusion Criteria:
Has used an internal urinary catheter or cystoscopy within the past month
Has prior history of bladder surgery
Is symptomatic and/or on medication for overactive bladder
Has evidence of ongoing, active, symptomatic UTI (assessed by PI, or delegate)
Is pregnant and/or breast-feeding
Is participating in other clinical investigations during this investigation
Is menstruating during study period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selwyn Spangenthal, MD
Organizational Affiliation
American Health Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
American Health Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intermittent Catheterisation on the Bladder Mucosa of Healthy Volunteers With a Micro Hole Zone Catheter
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