An interventional study of UriCap-F in Urinary Incontinence, sponsored by G.R. Dome Medical Ltd.. Status unknown. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-18.
Sponsored by G.R. Dome Medical Ltd. · Not applicable, Interventional, and Supportive care
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.
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
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's planned enrollment of 30 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →G.R. Dome Medical Ltd. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The UriCap-F is an FDA cleared Class I device intended for urinary management in women. The device is comprised of a multiple use unit and a single use unit. The multiple use unit is intended to be reused by the same patient for up to 30 days. It is removed every 24 hours, rinsed under running water, dried and re-applied. The UriCap is held in position by means of a single-use medically approved adhesive tape.
Device: UriCap-F
non-invasive urine collection device for women
Number of Adverse Device Events
Time frame: 1-30 days
Use Safety as demonstrated by System Usability Score assessed by healthcare providers
Time frame: 1 week
Effectiveness of the device to collect urine
Multiple variables will be assessed and their measurements aggregated to arrive at a number of events reported: * 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 satisfaction in device use
Overall treatment satisfaction will be assessed by means of a "Treatment Satisfaction Questionnaire" administered at termination of device use.
Time frame: 1-30 days
Healthcare provider (HCP) satisfaction
Treatment satisfaction will be assessed by means of a "Treatment Satisfaction Questionnaire" administered after termination of all study patients
Time frame: up to 60 days
Patient Comfort
Comfort will be assessed by means of the "Universal Pain Assessment Scale" of 1-10, At every device application, every removal, and when patient complains of discomfort or pain.
Time frame: 1-30 days
Effectiveness of defined device cleaning procedure for reuse
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 or rough edges. Effectiveness of the cleaning procedure will be measured as the average number of days the device can be reused.
Time frame: 1-30 days
Leakage as a result of device movement
To evaluate the correlation between leakage and device repositioning data
Time frame: 1-30 days
No study locations are listed for this record.
This study is status unknown, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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G.R. Dome Medical Ltd.