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CP341: Intermittent Catheterisation on the Bladder Mucosa of Healthy Volunteers With a Micro Hole Zone Catheter

Sponsor
Coloplast A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT05224544
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
1.9
Actual Duration (Months)
20.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Nautilus Catheter
  • Device: Comparator
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jan 31, 2022
Actual Primary Completion Date :
Mar 31, 2022
Actual Study Completion Date :
Mar 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Test Catheter

Healthy volunteers to test the investigational intermittent catheter.

Device: Nautilus Catheter
The test product is a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.
Active Comparator: Comparator Catheter

Healthy volunteers to test the comparator.

Device: Comparator
The comparator is a urinary catheter for bladder drainage through the urethra.
Other Names:
  • Infyna Chic - Hollister

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in appearance of the bladder mucosa (pre- and post-catheterization) (∆), rated on a 4-point scale following visit 2 (Day 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,

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 110 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Has given written informed consent

    2. Is at least 18 years and have full legal capacity

    3. Is female

    4. Has a negative urine Multistix dipstick test for erythrocytes (haematuria)

    Exclusion Criteria:

    1. Has used an internal urinary catheter or cystoscopy within the past month

    2. Has prior history of bladder surgery

    3. Is symptomatic and/or on medication for overactive bladder

    4. Has evidence of ongoing, active, symptomatic UTI (assessed by PI, or delegate)

    5. Is pregnant and/or breast-feeding

    6. Is participating in other clinical investigations during this investigation

    7. Is menstruating during study period

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 American Health Research Charlotte North Carolina United States 28277

    Sponsors and Collaborators

    • Coloplast A/S

    Investigators

    • Principal Investigator: Selwyn Spangenthal, MD, American Health Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Coloplast A/S
    ClinicalTrials.gov Identifier:
    NCT05224544
    Other Study ID Numbers:
    • CP341
    First Posted:
    Feb 4, 2022
    Last Update Posted:
    Apr 20, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Urinary Incontinence

    Study Results

    No Results Posted as of Apr 20, 2022