Urinary IncontinenceNCT02530372
Feasibility of the UriCap-F for Urine Collection in Hospitalized Women
A study testing UriCap-F in people with Urinary Incontinence, run by G.R. Dome Medical Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- UriCap-F
- 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 Nov 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
About this study
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.
Read the 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
- Conditions
- Urinary Incontinence
- Being tested
- UriCap-F
- 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-FDevice
non-invasive urine collection device for women
| Study group | Role | What they receive |
|---|---|---|
| UriCap-F | Experimental | 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. Receives: Device: UriCap-F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Device Events
Measured: 1-30 days
Use Safety as demonstrated by System Usability Score assessed by healthcare providers
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 1-30 days
Secondary outcomes (2)
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.
Measured: 1-30 days
Leakage as a result of device movement
To evaluate the correlation between leakage and device repositioning data
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 posted21 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2015 (estimated)
- Study completionNov 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
- NCT02530372
- Sponsor's protocol ID
- GRD-01F
- 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
- Feasibility of the UriCap-F for Urine Collection in Hospitalized Women
- ClinicalTrials.gov ID
- NCT02530372
- Acronym / sponsor ID
- GRD-01F
- 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
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 21 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 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
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-F | Experimental | Device: UriCap-FThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- Pregnant or breastfeeding
- Menstruation at time of enrolment
- Known allergy to silicon
- Dysuria
- Urinary retention - Post-void residual urine more than 300cc
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-Fnon-invasive urine collection device for women | Device | UriCap-F |
Primary outcome
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
Time frame: 1-30 days
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
Patient satisfaction in device use
Time frame: 1-30 days
Overall treatment satisfaction will be assessed by means of a "Treatment Satisfaction Questionnaire" administered at termination of device use.
Healthcare provider (HCP) satisfaction
Time frame: up to 60 days
Treatment satisfaction will be assessed by means of a "Treatment Satisfaction Questionnaire" administered after termination of all study patients
Patient Comfort
Time frame: 1-30 days
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.
2 secondary outcomes
Effectiveness of defined device cleaning procedure for reuse
Time frame: 1-30 days
Leakage as a result of device movement
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-F 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 10 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?
Number of Adverse Device Events (time frame: 1-30 days). The study lists 6 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.