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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
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 catheter
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.
Time frame: 4 weeks + up to 7 days.
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.
Time frame: 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.
Time frame: 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.
Time frame: 56 days (+ up to 14 days)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.