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Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients

Primary Purpose

Urinary Incontinence

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
UriCap-RM
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)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male ≥ 18 years old.
  • Empties the bladder completely on voiding
  • A clinical indication for an indwelling catheter, use of pads or diapers
  • Subject 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 - no discharge, itching, inflammation or skin condition - - on visual examination
  • Subject has no hypersensitivity to silicon.

Exclusion Criteria:

  • 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 subject'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 subject or a family member

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    UriCap-RM

    Arm Description

    The device is comprised of a reusable part and a single use adhesive tape. The device is removed once daily and the reusable part is rinsed, dried and reapplied with a new adhesive tape.

    Outcomes

    Primary Outcome Measures

    Performance of the device in collecting urine
    Multiple variables will be assessed and their measurements aggregated to arrive at number of events reported: Patient's anatomy does not enable application of the device Leakage Pooling of urine in the tubing Tubing disconnections Adhesive tape disconnections Need for repositioning of device Device malfunctions
    Patient Comfort
    Daily assessment of comfort rated in the "Universal Pain Assessment Scale" of 1-10.
    Healthcare provider (HCP) satisfaction in device use
    Nurses will fill a "Treatment Satisfaction Questionnaire" once after termination of all study patients
    Patient Satisfaction in Device Use
    Administration of a "Treatment Satisfaction Questionnaire" at termination of device use.

    Secondary Outcome Measures

    Effectiveness of defined device cleaning procedure
    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, rough edges. The effectiveness of the cleaning procedure will be measured as the average number of days the device can be reused.
    Number of leakage events resulting from device movement
    Number of patients with Adverse Events that are related to device use

    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
    NCT02529371
    Brief Title
    Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients
    Official Title
    Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients
    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
    October 2015 (Anticipated)
    Study Completion Date
    October 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 device performance and user satisfaction in the UriCap-RM, an FDA cleared non-invasive urine collection device for men.
    Detailed Description
    Following various disease conditions such as trauma, orthopedic surgery, and infections etc., patients may be bedridden and unable to void in a bedpan or to make their way to the toilet. Others may be incontinent of urine. In such situations an indwelling catheter is often placed to relieve patients while they are incapacitated; in many cases a catheter is placed 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, or a condom-type urine collection device. These may be associated with skin irritation and infection. The study will evaluate the UriCap-RM non-invasive urine collection device in hospitalized men.

    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-RM
    Arm Type
    Experimental
    Arm Description
    The device is comprised of a reusable part and a single use adhesive tape. The device is removed once daily and the reusable part is rinsed, dried and reapplied with a new adhesive tape.
    Intervention Type
    Device
    Intervention Name(s)
    UriCap-RM
    Other Intervention Name(s)
    non-invasive urine collection device
    Intervention Description
    UriCap-RM is comprised of a reusable part and a single use adhesive tape. The reusable part is applied over the urethral meatus and is held in position by a stabilizer and adhesive tape. It is connected to a standard urine collection bag. The UriCap-RM is used on male patients who would otherwise use diapers, a condom-type urine collection device or an indwelling catheter for urine collection.
    Primary Outcome Measure Information:
    Title
    Performance of the device in collecting urine
    Description
    Multiple variables will be assessed and their measurements aggregated to arrive at number of events reported: Patient's anatomy does not enable application of the device 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 Comfort
    Description
    Daily assessment of comfort rated in the "Universal Pain Assessment Scale" of 1-10.
    Time Frame
    1-30 days
    Title
    Healthcare provider (HCP) satisfaction in device use
    Description
    Nurses will fill a "Treatment Satisfaction Questionnaire" once after termination of all study patients
    Time Frame
    up to 60 days
    Title
    Patient Satisfaction in Device Use
    Description
    Administration of a "Treatment Satisfaction Questionnaire" at termination of device use.
    Time Frame
    1-30 days
    Secondary Outcome Measure Information:
    Title
    Effectiveness of defined device cleaning procedure
    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, rough edges. The 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
    Number of leakage events resulting from device movement
    Time Frame
    1-30 days
    Title
    Number of patients with Adverse Events that are related to device use
    Time Frame
    1-30 days

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male ≥ 18 years old. Empties the bladder completely on voiding A clinical indication for an indwelling catheter, use of pads or diapers Subject 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 - no discharge, itching, inflammation or skin condition - - on visual examination Subject has no hypersensitivity to silicon. Exclusion Criteria: 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 subject'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 subject 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)

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    Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients

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