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

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.

Study Overview

• Status: Unknown
• Conditions: Urinary Incontinence
• Intervention / Treatment: Device: UriCap-F

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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: UriCap-F; 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.

Device: UriCap-F; non-invasive urine collection device for women

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Device Events		1-30 days
Use Safety as demonstrated by System Usability Score assessed by healthcare providers		1 week
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	1-30 days
Patient satisfaction in device use	Overall treatment satisfaction will be assessed by means of a "Treatment Satisfaction Questionnaire" administered at termination of device use.	1-30 days
Healthcare provider (HCP) satisfaction	Treatment satisfaction will be assessed by means of a "Treatment Satisfaction Questionnaire" administered after termination of all study patients	up to 60 days
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.	1-30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1-30 days
Leakage as a result of device movement	To evaluate the correlation between leakage and device repositioning data	1-30 days

Collaborators and Investigators

• Sponsor: G.R. Dome Medical Ltd.
• Investigators: Principal Investigator: Elad Schiff, MD, no affiliation

Publications and helpful links

Helpful Links

• Center for Disease Control (CDC) Resource for Catheter-associated Urinary Tract Infections (CAUTI)

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): November 1, 2015
• Study Completion (Anticipated): November 1, 2015

Study Registration Dates

• First Submitted: August 16, 2015
• First Submitted That Met QC Criteria: August 20, 2015
• First Posted (Estimate): August 21, 2015

Study Record Updates

• Last Update Posted (Estimate): September 18, 2015
• Last Update Submitted That Met QC Criteria: September 17, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence
• Other Study ID Numbers: GRD-01F