Clinical trial NCT02530372: Feasibility of the UriCap-F for Urine Collection in Hospitalized Women
Official title: Feasibility of the UriCap-F for Urine Collection in Hospitalized Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: G.R. Dome Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2015-08-21
Enrollment: 30
Sex: FEMALE
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 safety and effectiveness of the UriCap-F, a non-invasive urine collection device for women, in hospitalized patients who would otherwise be treated with an indwelling catheter, pads or diapers.

Detailed description: Following various disease conditions such as trauma, orthopaedic surgery, and infections etc., patients may be bedridden and unable to void in a bedpan or to make their way to the toilet. For lack of a better solution for urinary management, indwelling catheter and diaper use is common in hospitalized patients. There is no externally applied urine collection device on the market today for women. In such situations an indwelling catheter is often placed to relieve patients while they are incapacitated, 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. These may be associated with skin irritation and infection.

The study will evaluate the UriCap-F, non-invasive urine collection devices for women, in hospitalized patients who are able to void or who are incontinent of urine

Eligibility criteria: Inclusion Criteria:

* Female ≥ 18 years old
* Empties the bladder completely on voiding
* A clinical indication for an indwelling catheter, use of pads or diapers
* Patient 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 - vaginal discharge, itching, inflammation or skin condition
* Agrees to genital hair removal.

Exclusion Criteria:

* Pregnant or breastfeeding
* Menstruation at time of enrolment
* 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 patient'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 patient or a family member

Primary outcomes:
measure: Number of Adverse Device Events
timeFrame: 1-30 days
measure: Use Safety as demonstrated by System Usability Score assessed by healthcare providers
timeFrame: 1 week
measure: Effectiveness of the device to collect urine
timeFrame: 1-30 days
measure: Patient satisfaction in device use
timeFrame: 1-30 days
measure: Healthcare provider (HCP) satisfaction
timeFrame: up to 60 days
measure: Patient Comfort
timeFrame: 1-30 days
Secondary outcomes:
measure: Effectiveness of defined device cleaning procedure for reuse
timeFrame: 1-30 days
measure: Leakage as a result of device movement
timeFrame: 1-30 days
Other outcomes:
Locations:
Study officials:
affiliation: No affiliation
name: Elad Schiff, MD
role: PRINCIPAL_INVESTIGATOR
References: