Urologic DiseasesNCT04688541
A Study to Determine User Acceptability and Laboratory Data Regarding Use of a Novel Indwelling Urinary Catheter: the Optitip Study
A study testing Optitip Catheter (LinC Medical) and Foley catheter in people with Urologic Diseases, run by University of Southampton.
Trial summary
In this study, long-term catheter patients in the Community setting (both catheter clinic attenders or home catheter changes) will be invited to participate in a randomised cross-over study to compare their standard Foley catheter with the Optitip catheter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urologic Diseases
- What is being tested?
- Optitip Catheter (LinC Medical) and Foley catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 1 Apr 2020
- 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
- Existing patients of Solent NHS Trust for > 3months
- Capable of giving informed consent
- Adult men or women (≥18)
- Planning to be using a long-term catheter for the duration of the study (3 months)
- Able to attend the clinic on the clinic/research days for catheter changes or have a research nurse visit them at home to do the changes
- Willing to have the next 2 catheter changes at 4 weekly intervals, which may be different from their usual change interval
Who cannot join
- Currently pregnant or planning to become pregnant
- Lack of capacity to consent
- Currently taking antibiotics for any reason (not just UTI) - unless the patient is usually on long term prophylactic antibiotics they may continue as long as they do so for the duration of the trial (unless instructed otherwise by a medical professional)
- Taken antibiotics for any reason in the previous month
- Has frequent catheter blockage ie. requiring catheter changes usually less than 4 weekly or visits for other catheter related reasons more frequently than 4 weekly
- Planned bladder washouts of any frequency
Show all 12Show fewer
- Suprapubic catheter users
- Those who need to visit a urology clinic due to complex catheter changes
- Participation in a related study
- Using a non-standard catheter e.g. not a Foley design
- Using an unusual sized catheter - outside the sizes available (12-18F)
- Unable to complete the assessments in English
About this study
Official title: A Preliminary Randomised Crossover Study to Determine User Acceptability and Laboratory Data Regarding Use of a Novel Indwelling Urinary Catheter: the Optitip Study
In this study, long-term catheter patients in the Community setting (both catheter clinic attenders or home catheter changes) will be invited to participate in a randomised cross-over study to compare their standard Foley catheter with the Optitip catheter. The participants will be randomised to Arm A (Standard Foley catheter then Optitip) or Arm B (Optitip then Standard Foley catheter) and will have each catheter inserted for successive periods of 4 weeks (+ up to 7 days). The catheters will be collected following removal and analysed for presence of biofilm; catheter specimens of urine will also be collected to measure detection/quantity microorganisms and cytokines. The quality of life of participants will be assessed at baseline and the end of each study period using a validated quality of life tool for long-term catheter users - the ICIQ-LTCqol.
Read the detailed description
When normal bladder emptying is not possible due to injury, disease, surgery, or neurological conditions, an indwelling urinary catheter (IUC) may be required. An estimated 90,000 people in the UK require a long-term urinary catheter.
Urinary catheters are associated with significant harm and can cause substantial distress. Furthermore, managing frequent catheter-associated problems is a resource intensive burden to the providers of community healthcare services Currently, most patients use the standard Foley catheter design and experience problems that can constrain work and social lives, lead to UTI and pain and substantially reduce quality of life.
The Optitip catheter became available on the Drug Tariff in 2017. Unlike the Foley catheter design which has a protruding tip, the Optitip has a blunt open end (eyelet) that protrudes slightly beyond a single fluid-filled 10ml balloon. It has an additional drainage eyelet underneath the balloon.
The Optitip therefore has the potential to make important differences to patients by reducing pain/discomfort; reducing blockage frequency and potentially reducing clinical infection.
- Conditions
- Urologic Diseases
- Being tested
- Optitip Catheter (LinC Medical), Foley catheter
- Keywords
- Catheter, Pilot, Biofilm
- Medical subject headings
- Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optitip Catheter (LinC Medical)Device
The Optitip catheter, unlike the Foley catheter design which has a protruding tip, the Optitip has a blunt open end (eyelet) that protrudes slightly beyond a single fluid-filled 10ml balloon. It has an additional drainage eyelet underneath the balloon.
Foley catheterDevice
Foley catheter
| Study group | Role | What they receive |
|---|---|---|
| First standard Foley catheter than Optitip catheter | Active comparator | Each participant is given the 2 trial catheters for successive periods of 4 weeks (+ up to 7 days) for each treatment period:
Study period 1 = Standard Foley catheter Study period 2 = Optitip catheter Receives: Device: Optitip Catheter (LinC Medical); Device: Foley catheter |
| First Optitip catheter than standard Foley catheter | Active comparator | Each participant is given the 2 trial catheters for successive periods of 4 weeks (+ up to 7 days) for each treatment period:
Study period 1 = Optitip catheter Study period 2 = Standard Foley catheter Receives: Device: Optitip Catheter (LinC Medical); Device: Foley catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of blockage - accumulation of biofilm
To compare the accumulation of biofilm on the catheter surface as a marker for the likelihood of blockage following 4 weeks insertion of an Optitip catheter to 4 weeks insertion of a standard Foley catheter. The 2 catheters (Foley and Optitip) will be collected and sent to the laboratory immediately after removal - the insertion period is 4 weeks + up to 7 days.
Measured: 4 weeks + up to 7 days.
Secondary outcomes (3)
Participant completion of the validated quality of life tool - ICIQ-LTCqol.
To determine whether there is any difference in patient reported quality of life score after using an Optitip catheter compared with a standard Foley catheter. Catheter function and concern 0-42 score, Lifestyle impact 0-15. Higher score better quality of life.
Measured: 56 days (+ up to 14 days)
Quantify microorganisms in the urine.
Analysis of CSU for micro-organisms. To determine whether there is any difference in micro-organism in urine samples collected following the use of an Optitip catheter compared to a standard Foley catheter.
Measured: 56 days (+ up to 14 days)
Quantify cytokines in the urine.
Analysis of CSU for cytokines. To determine whether there is any difference in cytokines in urine samples collected following the use of an Optitip catheter compared to a standard Foley catheter.
Measured: 56 days (+ up to 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 Apr 2020
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Why it stopped: Consequence of COVID-19 pandemic all staff working on this study were moved elsewhere and never returned to complete this work. Full RCT 'CADET' looking into Optitip use now taking place, so this pilot work is no longer required.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic DiseasesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mandy Fader, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688541
- Sponsor's protocol ID
- ERGO 53798
- Status last verified
- Oct 2021
- First submitted
- 21 Apr 2020
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At all times throughout the study, confidentiality will be observed by all parties. All data shall be secured against unauthorised access whilst privacy and confidentiality of information about each participant shall be preserved in reports and any publication. Each participant will be assigned a unique identification number at the time of enrolment. The investigator will maintain a confidential study enrolment list. This will contain the unique assigned identification number and name. The investigator bears the responsibility of keeping this list confidential.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Randomised Crossover Study to Determine User Acceptability and Laboratory Data Regarding Use of a Novel Indwelling Urinary Catheter: the Optitip Study
- ClinicalTrials.gov ID
- NCT04688541
- Acronym / sponsor ID
- ERGO 53798
- Conditions
- Urologic Diseases
- Keywords
- Catheter, Pilot, Biofilm
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Consequence of COVID-19 pandemic all staff working on this study were moved elsewhere and never returned to complete this work. Full RCT 'CADET' looking into Optitip use now taking place, so this pilot work is no longer required.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 30 Dec 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.
In this study, long-term catheter patients in the Community setting (both catheter clinic attenders or home catheter changes) will be invited to participate in a randomised cross-over study to compare their standard Foley catheter with the Optitip catheter. The participants will be randomised to Arm A (Standard Foley catheter then Optitip) or Arm B (Optitip then Standard Foley catheter) and will have each catheter inserted for successive periods of 4 weeks (+ up to 7 days). The catheters will be collected following removal and analysed for presence of biofilm; catheter specimens of urine will also be collected to measure detection/quantity microorganisms and cytokines. The quality of life of participants will be assessed at baseline and the end of each study period using a validated quality of life tool for long-term catheter users - the ICIQ-LTCqol.
Detailed description
When normal bladder emptying is not possible due to injury, disease, surgery, or neurological conditions, an indwelling urinary catheter (IUC) may be required. An estimated 90,000 people in the UK require a long-term urinary catheter.
Urinary catheters are associated with significant harm and can cause substantial distress. Furthermore, managing frequent catheter-associated problems is a resource intensive burden to the providers of community healthcare services Currently, most patients use the standard Foley catheter design and experience problems that can constrain work and social lives, lead to UTI and pain and substantially reduce quality of life.
The Optitip catheter became available on the Drug Tariff in 2017. Unlike the Foley catheter design which has a protruding tip, the Optitip has a blunt open end (eyelet) that protrudes slightly beyond a single fluid-filled 10ml balloon. It has an additional drainage eyelet underneath the balloon.
The Optitip therefore has the potential to make important differences to patients by reducing pain/discomfort; reducing blockage frequency and potentially reducing clinical infection.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First standard Foley catheter than Optitip catheter | Active comparator | Device: Optitip Catheter (LinC Medical), Device: Foley catheterEach participant is given the 2 trial catheters for successive periods of 4 weeks (+ up to 7 days) for each treatment period: Study period 1 = Standard Foley catheter Study period 2 = Optitip catheter |
| First Optitip catheter than standard Foley catheter | Active comparator | Device: Optitip Catheter (LinC Medical), Device: Foley catheterEach participant is given the 2 trial catheters for successive periods of 4 weeks (+ up to 7 days) for each treatment period: Study period 1 = Optitip catheter Study period 2 = Standard Foley catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Existing patients of Solent NHS Trust for > 3months
- Capable of giving informed consent
- Adult men or women (≥18)
- Planning to be using a long-term catheter for the duration of the study (3 months)
- Able to attend the clinic on the clinic/research days for catheter changes or have a research nurse visit them at home to do the changes
Key exclusion criteria (12 listed)
- Currently pregnant or planning to become pregnant
- Lack of capacity to consent
- Currently taking antibiotics for any reason (not just UTI) - unless the patient is usually on long term prophylactic antibiotics they may continue as long as they do so for the duration of the trial (unless instructed otherwise by a medical professional)
- Taken antibiotics for any reason in the previous month
- Has frequent catheter blockage ie. requiring catheter changes usually less than 4 weekly or visits for other catheter related reasons more frequently than 4 weekly
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 |
|---|---|---|
| Optitip Catheter (LinC Medical)The Optitip catheter, unlike the Foley catheter design which has a protruding tip, the Optitip has a blunt open end (eyelet) that protrudes slightly beyond a single fluid-filled 10ml balloon. It has an additional drainage eyelet underneath the balloon. | Device | First Optitip catheter than standard Foley catheter, First standard Foley catheter than Optitip catheter |
| Foley catheterFoley catheter | Device | First Optitip catheter than standard Foley catheter, First standard Foley catheter than Optitip catheter |
Primary outcome
Number of blockage - accumulation of biofilm
Time frame: 4 weeks + up to 7 days.
To compare the accumulation of biofilm on the catheter surface as a marker for the likelihood of blockage following 4 weeks insertion of an Optitip catheter to 4 weeks insertion of a standard Foley catheter. The 2 catheters (Foley and Optitip) will be collected and sent to the laboratory immediately after removal - the insertion period is 4 weeks + up to 7 days.
3 secondary outcomes
Participant completion of the validated quality of life tool - ICIQ-LTCqol.
Time frame: 56 days (+ up to 14 days)
Quantify microorganisms in the urine.
Time frame: 56 days (+ up to 14 days)
Quantify cytokines in the urine.
Time frame: 56 days (+ up to 14 days)
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 14 Jan 2022.
- Individual participant dataSharing planned: No. At all times throughout the study, confidentiality will be observed by all parties. All data shall be secured against unauthorised access whilst privacy and confidentiality of information about each participant shall be preserved in reports and any publication. Each participant will be assigned a unique identification number at the time of enrolment. The investigator will maintain a confidential study enrolment list. This will contain the unique assigned identification number and name. The investigator bears the responsibility of keeping this list confidential.
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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.
Mandy Fader principal investigator
University of Southampton
Questions about this trial
What is this clinical trial studying?
A study testing Optitip Catheter (LinC Medical) and Foley catheter in people with Urologic Diseases, run by University of Southampton.
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 12 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 14 Jan 2022. 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?
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?
Number of blockage - accumulation of biofilm (time frame: 4 weeks + up to 7 days.). 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 14 Jan 2022.