Urinary IncontinenceNCT02529371
Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients
A study testing UriCap-RM in people with Urinary Incontinence, run by G.R. Dome Medical Ltd..
Trial summary
The study will evaluate device performance and user satisfaction in the UriCap-RM, an FDA cleared non-invasive urine collection device for men. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- UriCap-RM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
The study will evaluate device performance and user satisfaction in the UriCap-RM, an FDA cleared non-invasive urine collection device for men.
Read the 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.
- Conditions
- Urinary Incontinence
- Being tested
- UriCap-RM
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UriCap-RMDevice
Also called non-invasive urine collection 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: UriCap-RM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-30 days
Patient Comfort
Daily assessment of comfort rated in the "Universal Pain Assessment Scale" of 1-10.
Measured: 1-30 days
Healthcare provider (HCP) satisfaction in device use
Nurses will fill a "Treatment Satisfaction Questionnaire" once after termination of all study patients
Measured: up to 60 days
Patient Satisfaction in Device Use
Administration of a "Treatment Satisfaction Questionnaire" at termination of device use.
Measured: 1-30 days
Secondary outcomes (3)
Effectiveness of defined device cleaning procedure
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, rough edges. The effectiveness of the cleaning procedure will be measured as the average number of days the device can be reused.
Measured: 1-30 days
Number of leakage events resulting from device movement
Measured: 1-30 days
Number of patients with Adverse Events that are related to device use
Measured: 1-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G.R. Dome Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elad Schiff, MD, Principal investigator, no affiliation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529371
- Sponsor's protocol ID
- GRD-01M
- Status last verified
- Sep 2015
- First submitted
- 16 Aug 2015
- Last updated
- 18 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients
- ClinicalTrials.gov ID
- NCT02529371
- Acronym / sponsor ID
- GRD-01M
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- G.R. Dome Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 20 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UriCap-RM | Experimental | Device: UriCap-RMThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UriCap-RMAlso: non-invasive urine collection deviceUriCap-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. | Device | UriCap-RM |
Primary outcome
Performance of the device in collecting urine
Time frame: 1-30 days
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
Patient Comfort
Time frame: 1-30 days
Daily assessment of comfort rated in the "Universal Pain Assessment Scale" of 1-10.
Healthcare provider (HCP) satisfaction in device use
Time frame: up to 60 days
Nurses will fill a "Treatment Satisfaction Questionnaire" once after termination of all study patients
Patient Satisfaction in Device Use
Time frame: 1-30 days
Administration of a "Treatment Satisfaction Questionnaire" at termination of device use.
3 secondary outcomes
Effectiveness of defined device cleaning procedure
Time frame: 1-30 days
Number of leakage events resulting from device movement
Time frame: 1-30 days
Number of patients with Adverse Events that are related to device use
Time frame: 1-30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elad Schiff, MD principal investigator
no affiliation
Questions about this trial
What is this clinical trial studying?
A study testing UriCap-RM in people with Urinary Incontinence, run by G.R. Dome Medical Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the device in collecting urine (time frame: 1-30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2015.