A Study to Determine User Acceptability and Laboratory Data Regarding Use of a Novel Indwelling Urinary Catheter: the Optitip Study
Primary Purpose
Urologic Diseases
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Optitip Catheter (LinC Medical)
Foley catheter
Sponsored by
About this trial
This is an interventional other trial for Urologic Diseases focused on measuring Catheter, Pilot, Biofilm
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
First standard Foley catheter than Optitip catheter
First Optitip catheter than standard Foley catheter
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04688541
First Posted
April 21, 2020
Last Updated
December 28, 2021
Sponsor
University of Southampton
1. Study Identification
Unique Protocol Identification Number
NCT04688541
Brief Title
A Study to Determine User Acceptability and Laboratory Data Regarding Use of a Novel Indwelling Urinary Catheter: the Optitip 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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Withdrawn
Why 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.
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southampton
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urologic Diseases
Keywords
Catheter, Pilot, Biofilm
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
First standard Foley catheter than Optitip catheter
Arm Type
Active Comparator
Arm Description
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
Arm Title
First Optitip catheter than standard Foley catheter
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Optitip Catheter (LinC Medical)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Foley catheter
Intervention Description
Foley catheter
Primary Outcome Measure Information:
Title
Number of blockage - accumulation of biofilm
Description
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.
Time Frame
4 weeks + up to 7 days.
Secondary Outcome Measure Information:
Title
Participant completion of the validated quality of life tool - ICIQ-LTCqol.
Description
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.
Time Frame
56 days (+ up to 14 days)
Title
Quantify microorganisms in the urine.
Description
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.
Time Frame
56 days (+ up to 14 days)
Title
Quantify cytokines in the urine.
Description
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.
Time Frame
56 days (+ up to 14 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mandy Fader
Organizational Affiliation
University of Southampton
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Learn more about this trial
A Study to Determine User Acceptability and Laboratory Data Regarding Use of a Novel Indwelling Urinary Catheter: the Optitip Study
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