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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Device: UriCap-RM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UriCap-RM<br>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. | Device: UriCap-RM<br>* 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.<br>* Other names: non-invasive urine collection device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1-30 days | 
| Patient Comfort | Daily assessment of comfort rated in the Universal Pain Assessment Scale of 1-10. | 1-30 days | 
| Healthcare provider (HCP) satisfaction in device use | Nurses will fill a Treatment Satisfaction Questionnaire once after termination of all study patients | up to 60 days | 
| Patient Satisfaction in Device Use | Administration of a Treatment Satisfaction Questionnaire at termination of device use. | 1-30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1-30 days | 
| Number of leakage events resulting from device movement |  | 1-30 days | 
| Number of patients with Adverse Events that are related to device use |  | 1-30 days |