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

NCT ID: NCT02529371

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: 2015-10-31

Brief Summary

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

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.

Conditions

Urinary Incontinence

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

UriCap-RM

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

non-invasive urine collection device

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• 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-01M

Identifier Type: -

Identifier Source: org_study_id