NCT02529371|Unknown
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Sponsor study identifier
interventional
30
0 countries
N/A
Study Start
September 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The study will evaluate device performance and user satisfaction in the UriCap-RM, an FDA cleared non-invasive urine collection device for men.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 16, 2015
Actual (reported)August 20, 2015
Actual (reported)September 2015
Date type not reportedThis date has not been verified as actual or estimated.
October 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Effectiveness of defined device cleaning procedure
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
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Elad Schiff, MD
no affiliation
First Submitted
August 16, 2015
First Posted
August 20, 2015
Study Start
September 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2015
Estimated (date passed)Whole Body Vibration and Pelvic Floor Exercises on Urinary Incontinence
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 18, 2015
Record last verified: 2015-09
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Source: ClinicalTrials.gov.
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