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Clinical Trials/NCT02530372
NCT02530372UnknownNot Applicable

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

G.R. Dome Medical Ltd.0 sites30 target enrollmentStarted: September 1, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
30
Primary Endpoint
Number of Adverse Device Events

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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
  • 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

Time Frame: 1-30 days

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

Time Frame: 1-30 days

Overall treatment satisfaction will be assessed by means of a "Treatment Satisfaction Questionnaire" administered at termination of device use.

Healthcare provider (HCP) satisfaction

Time Frame: up to 60 days

Treatment satisfaction will be assessed by means of a "Treatment Satisfaction Questionnaire" administered after termination of all study patients

Patient Comfort

Time Frame: 1-30 days

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 Outcomes

  • Effectiveness of defined device cleaning procedure for reuse(1-30 days)
  • Leakage as a result of device movement(1-30 days)

Investigators

Sponsor
G.R. Dome Medical Ltd.
Sponsor Class
Industry
Responsible Party
Sponsor

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