Urinary Incontinence Clinical Trial
Official title:
Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients
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.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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