Title: Multicentre trial of the clinical and cost effectiveness of a novel urinary catheter design in reducing catheter-associated urinary tract infection compared with the traditional Foley design for adults requiring long-term catheterisation (CADET)
Funder: Department of Health and Social Care

Abstract: Background and aim: In the UK, around 90,000 people use catheters (flexible tubes inserted into the bladder to drain urine). As people are living longer, we expect the number of people using catheters will rise. Catheters are necessary for people who are unable to control or empty their bladder, such as men with prostate problems. But catheters can cause considerable difficulties. Most people using catheters develop an infection involving their urinary tract at least once a year, and some develop a severe infection (called sepsis) which can lead to organ failure and death. Catheters can also become blocked, leading to severe pain, urgent catheter change or emergency hospital admission. Patients and carers have told us that catheters are distressing and disruptive to their lives. _x000D_ _x000D_ Surprisingly, the design of urinary catheters has remained largely unchanged for 80 years. Recently new catheters have been designed to try and reduce the risk of infection and blockage alongside other problems such as pain and leakage. There is very little research to tell us how helpful and safe the new designs are which is why we need this study. We looked at new catheter designs and innovations worldwide and chose to study the new Optitip catheter as it has design features which might help reduce infection and other problems. We will compare the Optitip with the Foley catheter which is the standard catheter most patients worldwide currently use. We think the Optitip catheter would be better for patients because its special design is intended to reduce infections. This could also save the NHS money. _x000D_ _x000D_ How we will do this study: We will invite current catheter users who are planning to have a catheter for the next year to take part in the CaDET clinical trial. People agreeing to take part will be placed at random (like tossing a coin to decide) into one of 2 groups (to receive either Optitip or Foley catheters). We will collect information on infections, number of catheter changes needed, blockages and hospital stays over a year to see which design is best. We will ask people who used the Optitip catheter about their experiences. We will also see which catheter offers the NHS the best value for money. _x000D_ _x000D_ Involving patients and the public: Our team includes a person who uses a catheter and someone with experience of caring for a catheter user. We have also talked with 8 men and women who use, or care for someone who uses catheters. Their views helped design this study. We will set up a panel of catheter users and carers to work with the research team throughout the study. A PPI member contributed significantly to this summary. _x000D_ _x000D_ At the end of the study we will make sure our findings are shared with people who use catheters, their carers, medical staff and people who plan services

Lay abstract: BACKGROUND: 90,000 people in the UK use long-term indwelling catheters that often cause infection and other complications._x000D_ AIM: To determine whether the Optitip catheter provides a clinically and cost effective alternative to the traditional ‘Foley’ style catheter for reducing symptomatic catheter associated urinary tract infection (CAUTI) and other complications for community dwelling adults requiring long-term urinary urethral catheterisation._x000D_ DESIGN: Multicentre randomised controlled superiority trial with two parallel arms, incorporating internal pilot._x000D_ SETTING: Community dwelling long-term catheter users from 3 recruitment hubs comprising 10 sites in the UK. _x000D_ PARTICIPANTS: Adults using an indwelling urethral catheter for >28 days, anticipated to have the device for >1 year and have experienced one or more UTIs in the last 12 months._x000D_ INTERVENTION: Use Optitip catheters use for 12 months. _x000D_ COMPARATOR: Use standard ‘Foley’ catheters for 12 months._x000D_ PRIMARY OUTCOME: Number of symptomatic UTIs over 12 months defined as antibiotics prescribed for the treatment of UTI AND at least one of the following: New or worsening fever, rigors, altered mental status, malaise, flank pain, pelvic discomfort, costovertebral angle tenderness and acute haematuria._x000D_ SECONDARY OUTCOMES: 1) Number of confirmed symptomatic UTIs over 12 months definition as above plus microbiological confirmation (1000 colony-forming units (cfu)/mL of 1 bacterial species in a single catheter urine specimen); 2) UTI versus proportion remaining UTI free (definition as primary), 3) catheter related quality of life (baseline and 12 months); 4) catheter changes (dates and reasons for planned and unplanned changes); 5) Patient, carer and healthcare professional experience with trial catheter use (qualitative and participant reported); 6) Adverse events e.g. pain, blockage, spasm; 7) EQ-5D-5L health related quality of life (baseline and quarterly); plus within-trial cost effectiveness evaluation of the intervention catheters against the comparator from an NHS perspective; 8) Antibiotic use (for any reason) over 12 months._x000D_ SAMPLE SIZE: A sample size of 310 participants (155 per arm allowing for 10% loss to followup) will be required to detect a 25% absolute reduction in the mean rate of CAUTI in 12 months from 2 in the control arm based on 90% power and two-sided alpha 5%._x000D_ INTERNAL PILOT: All sites opened in a schedule drawn up by the Clinical Trials Unit (CTU) who will monitor performance continually, with a formal review of accrual, and fidelity occurring 6 months after the first site opens to recruitment with pre-set stop/go criteria._x000D_ HEALTH ECONOMICS: Within-trial cost effectiveness analysis of the intervention compared to the control from an NHS perspective._x000D_ PROJECT TIMETABLE: The CaDET trial will take place over 39 months, with trial recruitment starting in month 10 and review of trial progression criteria after 6 months recruitment. We expect all Hubs to be recruiting by month 16 and recruitment to continue for 12 months, until month 21. Follow up will last for 12 months, the last data expected in month 33 with 6 months for close down, data analysis and write up._x000D_ IMPACT: Results will show if the Optitip catheter can reduce rates of UTI and other catheter associated harms compared to the standard Foley design and whether the Optitip is cost effective. If yes, we anticipate it will become the new UK standard of care.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: INFECTION;RENAL AND UROGENITAL