Clinical trial NCT02529371: Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients
Official title: Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: G.R. Dome Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2015-08-20
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Performance of the device in collecting urine
timeFrame: 1-30 days
measure: Patient Comfort
timeFrame: 1-30 days
measure: Healthcare provider (HCP) satisfaction in device use
timeFrame: up to 60 days
measure: Patient Satisfaction in Device Use
timeFrame: 1-30 days
Secondary outcomes:
measure: Effectiveness of defined device cleaning procedure
timeFrame: 1-30 days
measure: Number of leakage events resulting from device movement
timeFrame: 1-30 days
measure: Number of patients with Adverse Events that are related to device use
timeFrame: 1-30 days
Other outcomes:
Locations:
Study officials:
affiliation: no affiliation
name: Elad Schiff, MD
role: PRINCIPAL_INVESTIGATOR
References: