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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02529371
• Other study ID #: GRD-01M
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 16, 2015
• Last updated: September 17, 2015
• Start date: September 2015
• Est. completion date: October 2015

Study information

• Verified date: September 2015
• Source: G.R. Dome Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
G.R. Dome Medical Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Patient Comfort	Daily assessment of comfort rated in the "Universal Pain Assessment Scale" of 1-10.	1-30 days	No
Primary	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	No
Primary	Patient Satisfaction in Device Use	Administration of a "Treatment Satisfaction Questionnaire" at termination of device use.	1-30 days	No
Secondary	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	No
Secondary	Number of leakage events resulting from device movement		1-30 days	No
Secondary	Number of patients with Adverse Events that are related to device use		1-30 days	Yes

External Links

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