The study will evaluate device performance and user satisfaction in the UriCap-RM, an FDA cleared non-invasive urine collection device for men.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
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.
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
Time frame: 1-30 days
Patient Comfort
Daily assessment of comfort rated in the "Universal Pain Assessment Scale" of 1-10.
Time frame: 1-30 days
Healthcare provider (HCP) satisfaction in device use
Nurses will fill a "Treatment Satisfaction Questionnaire" once after termination of all study patients
Time frame: up to 60 days
Patient Satisfaction in Device Use
Administration of a "Treatment Satisfaction Questionnaire" at termination of device use.
Time frame: 1-30 days
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.
Time frame: 1-30 days
Number of leakage events resulting from device movement
Time frame: 1-30 days
Number of patients with Adverse Events that are related to device use
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Time frame: 1-30 days