Clinical and cost-effectiveness of alternative urinary catheter design

  • Research type

    Research Study

  • Full 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)

  • IRAS ID

    316986

  • Contact name

    Catherine Murphy

  • Contact email

    c.murphy@soton.ac.uk

  • Sponsor organisation

    University Hospital Southampton NHS Foundation Trust

  • ISRCTN Number

    ISRCTN11092188

  • Duration of Study in the UK

    2 years, 0 months, 30 days

  • Research summary

    Most patients requiring an indwelling catheter experience problems that impact their work and social lives, including frequent urinary tract infections (UTIs), pain and reduced quality of life. For healthcare providers supporting long-term catheter users, there is considerable strain on resources with 20% of nursing community care related to managing catheter blockage.
    Little innovation has been made in the overall design of indwelling catheters over the past 80 years, with the 'Foley' catheter still remaining the gold standard. Novel design features in inwelling catheters were aimed at reducing the risk of catheter-associated UTIs (CAUTI) back lack evidence base and assessment of cost effectiveness. The ‘Optitip’ catheter is being increasingly used in the NHS despite lack of evidence and higher cost (compare to the ‘Foley’) was determined to have the most potential to reduce the UTI rates for long-term users as well as being cost-effective.
    Patients (aged 18 years or over) using an indwelling catheter long-term will be randomly allocated to one of two groups. One group will receive the standard ‘Foley’ catheter while the second group will receive the ‘Optitip’ catheter from their next planned catheter change for 12 months. Patients will be informed which group they were allocated to. Patients will receive monthly follow-up questionnaires with questions relating to experience UTIs, antibiotic use, catheter changes, adverse events and healthcare service use. Every 3 months, patients will be asked to complete two standardised questionnaires relating to their quality of life.Community nurses will review the patients’ notes every quarter and the patient’s GP will review the patient notes after 12 months.
    We will asses the result of the study by recording the number of UTIs over 12 months based on antibiotics prescribed for UTI treatment and at least one of a list of UTI related symptoms.

  • REC name

    South East Scotland REC 02

  • REC reference

    22/SS/0094

  • Date of REC Opinion

    15 Nov 2022

  • REC opinion

    Further Information Favourable Opinion