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

The study will evaluate device performance and user satisfaction in the UriCap-RM, an FDA cleared non-invasive urine collection device for men.

Study Overview

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

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.

• 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: Male

Description

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

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-RM; 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.

Device: UriCap-RM; 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.; Other Names: non-invasive urine collection device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1-30 days
Patient Comfort	Daily assessment of comfort rated in the "Universal Pain Assessment Scale" of 1-10.	1-30 days
Healthcare provider (HCP) satisfaction in device use	Nurses will fill a "Treatment Satisfaction Questionnaire" once after termination of all study patients	up to 60 days
Patient Satisfaction in Device Use	Administration of a "Treatment Satisfaction Questionnaire" at termination of device use.	1-30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1-30 days
Number of leakage events resulting from device movement		1-30 days
Number of patients with Adverse Events that are related to device use		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): October 1, 2015
• Study Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: August 16, 2015
• First Submitted That Met QC Criteria: August 19, 2015
• First Posted (Estimate): August 20, 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-01M

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No