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

G.R. Dome Medical

Status: Unknown

Conditions: Urinary Incontinence

Treatments: Device: UriCap-RM

Study type: Interventional

Funder types: Industry

Identifiers

NCT02529371

GRD-01M

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

UriCap-RM

Experimental group

Description:

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.

Treatment:

Device: UriCap-RM