Indwelling Urinary Catheter UsersNCT04243902
Urinary Catheter 'Fill and Flush' Valve: Safety, Effectiveness, Acceptability and Feasibility Trial
A study testing Fill and Flush Valve in people with Indwelling Urinary Catheter Users, run by University of Southampton at 1 site in United Kingdom.
Trial summary
The fill and flush valve (valve) is an automated valve which is designed to open in response to rising bladder pressure which occurs as the bladder becomes full. The valve is situated between the IDC and the drainage bag as a manual valve would be. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Indwelling Urinary Catheter Users
- What is being tested?
- Fill and Flush Valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Feb 2022to 18 Jul 2023
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IDC-users (urethral or suprapubic), over 18, who have had a catheter in situ for at least one month and use a manual valve or drainage bag to collect urine
- Independent with catheter care needs (e.g. bag emptying or valve opening)
- Able to transfer from bed to chair, stand and walk short distances unaided
- Able to drink moderate levels of fluid (500mls in the first 2 hours and 150mls per hour thereafter)
- Able to provide informed consent (self-report and research nurse assessment)
- Usual medical provider provides confirmation of suitability
Who cannot join
- End stages of a terminal illness
- Current treatment of urinary tract infection
- Has been advised by a urologist against using a valve on clinical grounds
- Lack of bladder sensation (e.g. unable to sense when bladder needs emptying)
- Previous bladder surgery that could affect the integrity of the bladder
- At known risk of autonomic dysreflexia
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Southampton
Southampton, Hampshire, SO16 6RL
About this study
The fill and flush valve (valve) is an automated valve which is designed to open in response to rising bladder pressure which occurs as the bladder becomes full. The valve is situated between the IDC and the drainage bag as a manual valve would be.
Read the detailed description
The objective of this study is to assess preliminary safety, effectiveness, reliability, comfort and user acceptability of the valve with adults who have a long-term IDC and the feasibility of undertaking future community-based evaluation.
To do this the investigators will
- determine if the valve functions reliably i.e. automatically opens to drain urine within acceptable individual bladder volumes with a range of patients;
- determine if the valve functions effectively i.e. allows for the complete bladder emptying (< 100ml post void residual) during rest and daily activities;
- determine if the process of filling and automatic draining is comfortable and acceptable for participants;
- collect preliminary data on the potential for bioburden/biofilm following in human use of the valve;
- assess the feasibility of undertaking a future randomised control trial of the valve.
Group 1 - The investigators will test the valve with participants (n=8) who currently use a standard manual valve (without leg-bag).This first group will include a safety cohort of participants (n=4). All safety data will be reviewed from the initial 4 participants before further participants can undergo the study investigation.
Group 2- The Investigators will test the valve with participants (n=8) who currently use a drainage bag with free drainage.
The data collection process and study procedures will be identical for both groups.
After use(in both groups), the valves will be examined microbiologically in the University of Southampton laboratory to detect bioburden and/or biofilm to ascertain a baseline for future studies.
- Conditions
- Indwelling Urinary Catheter Users
- Being tested
- Fill and Flush Valve
- Keywords
- urinary catheter, IDC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fill and Flush ValveDevice
Also called EM02, EM03, EM04
The fill and flush valve (Figure 1) is an automated valve which is designed to open in response to rising bladder pressure which occurs as the bladder becomes full. The valve is situated between the IDC and the drainage bag as a manual valve would be.
There are three variants of the valve which respond to different degrees of bladder pressure. People's bladders function at different pressure levels. One of the aims of this study is to gain preliminary data on which valve variant works and under which circumstances. Pressure ranges are as follows:
Low: 22 - 49cm H2O Medium: 35 - 61cm H2O High: 53 - 79cm H2O
| Study group | Role | What they receive |
|---|---|---|
| 1 - standard manual valve (without leg-bag) | Experimental | The valve will initially be tested in 8 participants who currently use a standard manual valve (without leg-bag).
This first group will include a safety cohort of participants (n=4). All safety data will be reviewed from the initial 4 participants before further participants can undergo the study investigation. Receives: Device: Fill and Flush Valve |
| 2 - drainage bag with free drainage | Experimental | The valve will then be tested with participants (n=8) who currently use a drainage bag with free drainage. Receives: Device: Fill and Flush Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Reliability
Valve opening - Proportion of observations of automatic valve opening before bladder capacity (500ml or less) is reached - as measured by bladder scanner
Measured: An average of 16 hours in total
Safety: Effectiveness
Bladder emptying - proportion of valve voids with residual urine <100ml - as measured by bladder scanner.
Measured: An average of 16 hours in total
Safety: Effectiveness
Bladder emptying - Participant report (Valve self-report questionnaire)
Measured: An average of 16 hours in total
Comfort
Participant report (Valve self-report questionnaire)
Measured: An average of 16 hours in total
Secondary outcomes (3)
User acceptability
Valve self-report questionnaire (Valve self-report questionnaire)
Measured: An average of 16 hours in total
User acceptability
EQ-5D-5L
Measured: An average of 16 hours in total
User acceptability
Long-term Catheter Quality of Life Tool
Measured: An average of 16 hours in total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start13 Feb 2022
- Primary completion18 Jul 2023
- Study completion18 Jul 2023
Why it stopped: No participants met all the inclusion criteria required within the recruitment time period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indwelling Urinary Catheter UsersStudies 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups, 1 group including interim safety review
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, BlueWind Medical, University Hospital Southampton NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Cathy Murphy, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243902
- Sponsor's protocol ID
- 41448
- Other IDs
- 245818
- Status last verified
- Oct 2023
- First submitted
- 21 Aug 2019
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Catheter 'Fill and Flush' Valve: Safety, Effectiveness, Acceptability and Feasibility Trial
- ClinicalTrials.gov ID
- NCT04243902
- Acronym / sponsor ID
- 41448
- Conditions
- Indwelling Urinary Catheter Users
- Keywords
- urinary catheter, IDC
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants met all the inclusion criteria required within the recruitment time period
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, BlueWind Medical, University Hospital Southampton NHS Foundation Trust
- Study start
- 13 Feb 2022 (actual)
- Primary completion
- 18 Jul 2023 (actual)
- Study completion
- 18 Jul 2023 (actual)
- First posted
- 28 Jan 2020 (actual)
- 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 fill and flush valve (valve) is an automated valve which is designed to open in response to rising bladder pressure which occurs as the bladder becomes full. The valve is situated between the IDC and the drainage bag as a manual valve would be.
Detailed description
The objective of this study is to assess preliminary safety, effectiveness, reliability, comfort and user acceptability of the valve with adults who have a long-term IDC and the feasibility of undertaking future community-based evaluation.
To do this the investigators will
- determine if the valve functions reliably i.e. automatically opens to drain urine within acceptable individual bladder volumes with a range of patients;
- determine if the valve functions effectively i.e. allows for the complete bladder emptying (< 100ml post void residual) during rest and daily activities;
- determine if the process of filling and automatic draining is comfortable and acceptable for participants;
- collect preliminary data on the potential for bioburden/biofilm following in human use of the valve;
- assess the feasibility of undertaking a future randomised control trial of the valve.
Group 1 - The investigators will test the valve with participants (n=8) who currently use a standard manual valve (without leg-bag).This first group will include a safety cohort of participants (n=4). All safety data will be reviewed from the initial 4 participants before further participants can undergo the study investigation.
Group 2- The Investigators will test the valve with participants (n=8) who currently use a drainage bag with free drainage.
The data collection process and study procedures will be identical for both groups.
After use(in both groups), the valves will be examined microbiologically in the University of Southampton laboratory to detect bioburden and/or biofilm to ascertain a baseline for future studies.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 groups, 1 group including interim safety review
| Arm | Type | Receives |
|---|---|---|
| 1 - standard manual valve (without leg-bag) | Experimental | Device: Fill and Flush ValveThe valve will initially be tested in 8 participants who currently use a standard manual valve (without leg-bag). This first group will include a safety cohort of participants (n=4). All safety data will be reviewed from the initial 4 participants before further participants can undergo the study investigation. |
| 2 - drainage bag with free drainage | Experimental | Device: Fill and Flush ValveThe valve will then be tested with participants (n=8) who currently use a drainage bag with free drainage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- IDC-users (urethral or suprapubic), over 18, who have had a catheter in situ for at least one month and use a manual valve or drainage bag to collect urine
- Independent with catheter care needs (e.g. bag emptying or valve opening)
- Able to transfer from bed to chair, stand and walk short distances unaided
- Able to drink moderate levels of fluid (500mls in the first 2 hours and 150mls per hour thereafter)
- Able to provide informed consent (self-report and research nurse assessment)
Key exclusion criteria (6 listed)
- End stages of a terminal illness
- Current treatment of urinary tract infection
- Has been advised by a urologist against using a valve on clinical grounds
- Lack of bladder sensation (e.g. unable to sense when bladder needs emptying)
- Previous bladder surgery that could affect the integrity of the bladder
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 |
|---|---|---|
| Fill and Flush ValveAlso: EM02, EM03, EM04The fill and flush valve (Figure 1) is an automated valve which is designed to open in response to rising bladder pressure which occurs as the bladder becomes full. The valve is situated between the IDC and the drainage bag as a manual valve would be. There are three variants of the valve which respond to different degrees of bladder pressure. People's bladders function at different pressure levels. One of the aims of this study is to gain preliminary data on which valve variant works and under which circumstances. Pressure ranges are as follows: Low: 22 - 49cm H2O Medium: 35 - 61cm H2O High: 53 - 79cm H2O | Device | 1 - standard manual valve (without leg-bag), 2 - drainage bag with free drainage |
Primary outcome
Safety: Reliability
Time frame: An average of 16 hours in total
Valve opening - Proportion of observations of automatic valve opening before bladder capacity (500ml or less) is reached - as measured by bladder scanner
Safety: Effectiveness
Time frame: An average of 16 hours in total
Bladder emptying - proportion of valve voids with residual urine <100ml - as measured by bladder scanner.
Safety: Effectiveness
Time frame: An average of 16 hours in total
Bladder emptying - Participant report (Valve self-report questionnaire)
Comfort
Time frame: An average of 16 hours in total
Participant report (Valve self-report questionnaire)
3 secondary outcomes
User acceptability
Time frame: An average of 16 hours in total
User acceptability
Time frame: An average of 16 hours in total
User acceptability
Time frame: An average of 16 hours in total
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Indwelling Urinary Catheter Users
Recruiting
Effectiveness of the NowCath Foley in Reducing Catheter-Associated UTIs and Blockages in Long-Term Indwelling Catheter Users (REDUCE)
Urinary Catheters, Urinary Catheterization
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.
Cathy Murphy principal investigator
University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fill and Flush Valve in people with Indwelling Urinary Catheter Users, run by University of Southampton at 1 site in United Kingdom.
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 6 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: withdrawn, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Safety: Reliability (time frame: An average of 16 hours in total). 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 6 Oct 2023.