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Feasibility of the UriCap-F for Urine Collection in Hospitalized Women

Primary Purpose

Urinary Incontinence

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
UriCap-F
Sponsored by
G.R. Dome Medical Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female ≥ 18 years old
  • Empties the bladder completely on voiding
  • A clinical indication for an indwelling catheter, use of pads or diapers
  • Patient has signed an informed consent form, is cooperative and willing to complete all study procedures
  • Absence of localized disease at the site of device application - vaginal discharge, itching, inflammation or skin condition
  • Agrees to genital hair removal.

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Menstruation at time of enrolment
  • Known allergy to silicon
  • Dysuria
  • Urinary retention - Post-void residual urine more than 300cc
  • Hematuria or pyuria (turbidity) on visual inspection, according to investigator judgement.
  • Diagnosed with acute renal failure according, to investigator judgement.
  • Serious or unstable psychological condition (e.g., eating disorders, clinical depression, anxiety, emotionally labile) which, in the opinion of the Investigator, would compromise the patient's well-being or successful participation in the study
  • Participating in another clinical study.
  • Financial interest in the Sponsor Company or a competitor company by patient or a family member

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    UriCap-F

    Arm Description

    The UriCap-F is an FDA cleared Class I device intended for urinary management in women. The device is comprised of a multiple use unit and a single use unit. The multiple use unit is intended to be reused by the same patient for up to 30 days. It is removed every 24 hours, rinsed under running water, dried and re-applied. The UriCap is held in position by means of a single-use medically approved adhesive tape.

    Outcomes

    Primary Outcome Measures

    Number of Adverse Device Events
    Use Safety as demonstrated by System Usability Score assessed by healthcare providers
    Effectiveness of the device to collect urine
    Multiple variables will be assessed and their measurements aggregated to arrive at a number of events reported: Leakage Pooling of urine in the tubing Tubing disconnections Adhesive tape disconnections Need for repositioning of device Device malfunctions
    Patient satisfaction in device use
    Overall treatment satisfaction will be assessed by means of a "Treatment Satisfaction Questionnaire" administered at termination of device use.
    Healthcare provider (HCP) satisfaction
    Treatment satisfaction will be assessed by means of a "Treatment Satisfaction Questionnaire" administered after termination of all study patients
    Patient Comfort
    Comfort will be assessed by means of the "Universal Pain Assessment Scale" of 1-10, At every device application, every removal, and when patient complains of discomfort or pain.

    Secondary Outcome Measures

    Effectiveness of defined device cleaning procedure for reuse
    The reusable part will be visually inspected after cleaning for suitability for reuse. Devices which exhibit any of the following properties will be discarded: color change, residual soiling, loss of mechanical integrity, torn or rough edges. Effectiveness of the cleaning procedure will be measured as the average number of days the device can be reused.
    Leakage as a result of device movement
    To evaluate the correlation between leakage and device repositioning data

    Full Information

    First Posted
    August 16, 2015
    Last Updated
    September 17, 2015
    Sponsor
    G.R. Dome Medical Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02530372
    Brief Title
    Feasibility of the UriCap-F for Urine Collection in Hospitalized Women
    Official Title
    Feasibility of the UriCap-F for Urine Collection in Hospitalized Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    November 2015 (Anticipated)
    Study Completion Date
    November 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    G.R. Dome Medical Ltd.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study will evaluate safety and effectiveness of the UriCap-F, a non-invasive urine collection device for women, in hospitalized patients who would otherwise be treated with an indwelling catheter, pads or diapers.
    Detailed Description
    Following various disease conditions such as trauma, orthopaedic surgery, and infections etc., patients may be bedridden and unable to void in a bedpan or to make their way to the toilet. For lack of a better solution for urinary management, indwelling catheter and diaper use is common in hospitalized patients. There is no externally applied urine collection device on the market today for women. In such situations an indwelling catheter is often placed to relieve patients while they are incapacitated, despite lack of urinary retention. Indwelling catheters, although effective, are associated with discomfort, pain, and urinary tract infections. In other cases diapers or absorbent pads may be used. These may be associated with skin irritation and infection. The study will evaluate the UriCap-F, non-invasive urine collection devices for women, in hospitalized patients who are able to void or who are incontinent of urine

    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
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    UriCap-F
    Arm Type
    Experimental
    Arm Description
    The UriCap-F is an FDA cleared Class I device intended for urinary management in women. The device is comprised of a multiple use unit and a single use unit. The multiple use unit is intended to be reused by the same patient for up to 30 days. It is removed every 24 hours, rinsed under running water, dried and re-applied. The UriCap is held in position by means of a single-use medically approved adhesive tape.
    Intervention Type
    Device
    Intervention Name(s)
    UriCap-F
    Intervention Description
    non-invasive urine collection device for women
    Primary Outcome Measure Information:
    Title
    Number of Adverse Device Events
    Time Frame
    1-30 days
    Title
    Use Safety as demonstrated by System Usability Score assessed by healthcare providers
    Time Frame
    1 week
    Title
    Effectiveness of the device to collect urine
    Description
    Multiple variables will be assessed and their measurements aggregated to arrive at a number of events reported: Leakage Pooling of urine in the tubing Tubing disconnections Adhesive tape disconnections Need for repositioning of device Device malfunctions
    Time Frame
    1-30 days
    Title
    Patient satisfaction in device use
    Description
    Overall treatment satisfaction will be assessed by means of a "Treatment Satisfaction Questionnaire" administered at termination of device use.
    Time Frame
    1-30 days
    Title
    Healthcare provider (HCP) satisfaction
    Description
    Treatment satisfaction will be assessed by means of a "Treatment Satisfaction Questionnaire" administered after termination of all study patients
    Time Frame
    up to 60 days
    Title
    Patient Comfort
    Description
    Comfort will be assessed by means of the "Universal Pain Assessment Scale" of 1-10, At every device application, every removal, and when patient complains of discomfort or pain.
    Time Frame
    1-30 days
    Secondary Outcome Measure Information:
    Title
    Effectiveness of defined device cleaning procedure for reuse
    Description
    The reusable part will be visually inspected after cleaning for suitability for reuse. Devices which exhibit any of the following properties will be discarded: color change, residual soiling, loss of mechanical integrity, torn or rough edges. Effectiveness of the cleaning procedure will be measured as the average number of days the device can be reused.
    Time Frame
    1-30 days
    Title
    Leakage as a result of device movement
    Description
    To evaluate the correlation between leakage and device repositioning data
    Time Frame
    1-30 days

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Female ≥ 18 years old Empties the bladder completely on voiding A clinical indication for an indwelling catheter, use of pads or diapers Patient has signed an informed consent form, is cooperative and willing to complete all study procedures Absence of localized disease at the site of device application - vaginal discharge, itching, inflammation or skin condition Agrees to genital hair removal. Exclusion Criteria: Pregnant or breastfeeding Menstruation at time of enrolment Known allergy to silicon Dysuria Urinary retention - Post-void residual urine more than 300cc Hematuria or pyuria (turbidity) on visual inspection, according to investigator judgement. Diagnosed with acute renal failure according, to investigator judgement. Serious or unstable psychological condition (e.g., eating disorders, clinical depression, anxiety, emotionally labile) which, in the opinion of the Investigator, would compromise the patient's well-being or successful participation in the study Participating in another clinical study. Financial interest in the Sponsor Company or a competitor company by patient or a family member
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elad Schiff, MD
    Organizational Affiliation
    No affiliation
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.cdc.gov/HAI/ca_uti/uti.html
    Description
    Center for Disease Control (CDC) Resource for Catheter-associated Urinary Tract Infections (CAUTI)

    Learn more about this trial

    Feasibility of the UriCap-F for Urine Collection in Hospitalized Women

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