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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02530372
• Other study ID #: GRD-01F
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 16, 2015
• Last updated: September 17, 2015
• Start date: September 2015
• Est. completion date: November 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 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.

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

Recruitment information / eligibility

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

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

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

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	Number of Adverse Device Events		1-30 days	Yes
Primary	Use Safety as demonstrated by System Usability Score assessed by healthcare providers		1 week	Yes
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	Leakage as a result of device movement	To evaluate the correlation between leakage and device repositioning data	1-30 days	No

External Links

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