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

NCT02529371 | Unknown

• 1 other identifier: GRD-01M
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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

Study Arms (1)

UriCap-RM

EXPERIMENTAL

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

Interventions

UriCap-RM DEVICE

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.

Also known as: non-invasive urine collection device

UriCap-RM

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• G.R. Dome Medical Ltd.: lead

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elad Schiff, MD

  no affiliation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2015
• First Posted: August 20, 2015
• Study Start: September 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: September 18, 2015

Record last verified: 2015-09