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

NCT ID: NCT02530372

Last Updated: 2015-09-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2015-11-30

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

Conditions

Urinary Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

UriCap-F

The UriCap-F is an FDA cleared Class I device intended for urinary management in women.

The device is comprised of a multiple use unit and a single use unit. The multiple use unit is intended to be reused by the same patient for up to 30 days. It is removed every 24 hours, rinsed under running water, dried and re-applied.

The UriCap is held in position by means of a single-use medically approved adhesive tape.

Group Type: EXPERIMENTAL

UriCap-F

Intervention Type: DEVICE

non-invasive urine collection device for women

Interventions

UriCap-F

non-invasive urine collection device for women

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

G.R. Dome Medical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elad Schiff, MD

Role: PRINCIPAL_INVESTIGATOR

No affiliation

Other Identifiers

GRD-01F

Identifier Type: -

Identifier Source: org_study_id