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

G.R. Dome Medical Ltd.30 enrolled

Overview

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.

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

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Urinary Incontinence

Interventions

UriCap-FDEVICE

non-invasive urine collection device for women

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Adverse Device Events

Time frame: 1-30 days

Use Safety as demonstrated by System Usability Score assessed by healthcare providers

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 1-30 days

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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