Trial Overview
Trial Team
Essential Trial Documentation
Newsletters
Other Media
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.
Description
CaDeT is randomised controlled superiority trial which aims to determine whether the Optitip catheter provides a clinically and cost-effective alternative to the traditional ‘Foley’ style catheter for community dwelling adults requiring long-term urinary urethral catheterisation.
Objectives
Overall Objective:
- To determine whether the Optitip catheter provides a clinically and cost-effective alternative to the traditional ‘Foley’ style catheter for reducing catheter associated urinary tract infection (CAUTI) and other complications for community dwelling (own home or residential care) adults requiring long-term urinary urethral catheterisation.
Primary:
- To assess the clinical effectiveness of the Optitip catheter versus standard Foley catheter design at reducing the incidence of symptomatic CAUTIs.
Secondary:
- To assess the clinical effectiveness of the Optitip catheter versus standard Foley catheter design at reducing catheter related issues, including unplanned catheter change and impact on quality of life.
- To undertake an economic evaluation to determine the cost effectiveness of the Optitip catheter compared to the standard ‘Foley’ catheter design.
- To understand the patient/carer and healthcare professional experience, and the acceptability of the Optitip catheter design.
Trial Design
A phase III multicentre randomised controlled superiority trial with two parallel arms, incorporating an internal pilot.
Trial Status
Closed to recruitment
Population
Adult long-term indwelling urethral catheter users who have experienced one or more catheter associated UTIs in the last 12 months.
.jpg)
This trial is funded by a National Institute for Health and Care Research Health Technology Assessment (HTA) grant (award reference no. NIHR131172)
Senior Trial Manager:
Frances Webley
Trial Manager:
Alannah Morgan
Trial Coordinator:
Katy Courtnell
Data Manager:
Katie Bishop
Data Coordinator:
Uroosha Ali
Contact Information for trial queries:
Email: cadet@soton.ac.uk
SAE Reporting:
Email: ctu@soton.ac.uk
Essential Trial Documents
CaDeT - Protocol, v4 11-Jan-2024
CaDeT - PIS (patient interview) v2 01-Nov-2023
CaDeT - screening conversation script, v2 09-Aug-2022
CaDeT - End of Study form, v1 21-Jul-2022
CaDeT - End of Treatment form, v2 26-Mar-2024
CaDeT - pregnancy report form, v1 21-Jul-2022
CaDeT - Baseline CRF, v03 08-Dec-2022
CaDeT - Eligibility-Registration form, v3 12-Dec-2022
CaDeT - Patient and GP contact details proforma, v3 13-Dec-2022
CaDeT - month 3 community nursing records review, v3 09-Dec-2022
CaDeT - month 6 community nursing records review, v3 09-Dec-2022
CaDeT - month 9 community nursing records review, v3 09-Dec-2022
CaDeT - month 12 community nursing records review, v3 09-Dec-2022
CaDeT - GP records review, v2 08Dec2022
CaDeT - GP Letter v3 20-Nov-2023
CaDeT - GP Letter_study changes v1 11-Apr-2024
CaDeT - Invite Letter v6 01-Feb-2024
CaDeT - Reply Slip v2 22-Feb-2024
CaDET - Informed Consent Form (quali interview with patient) v3 01-Nov-2023
CaDET - Informed Consent Form (England) v5 22-Feb-2024
CaDET - Informed Consent Form (Scotland) v3 22-Feb-2024
CaDeT - Randomised Patient Letter_study changes v1 11-Apr-2024
CaDeT - Awaiting Randomisation Patient Letter_study changes v1 11-Apr-2024
Recruitment Poster
CaDeT - Digital Recruitment Clinic Poster V1 27 Sep 2023
CaDeT - Recruitment Clinic Poster V1 27 Sep 2023
.png){kind=link}
User manuals
CaDeT - TextAnywhere Templates v4 27-Sep-2023_clean
CaDeT - How to upload documents via SafeSent and send to Southampton CTU, v1 22-Nov-2022
CaDeT - eConsent platform guidance for sites v2 02-Mar-2023
CADET - TENALEA User Manual v1 21-Oct-22
CADET - eCRF Completion Guidance v2.0 17-Feb-2023
CaDeT - prompt sheet v2 13-Jan-2023 England_clean
Investigator site file documents
CaDeT - delegation log template, v2 21-Nov-2022
CaDeT – site training log template v1 08-Sep-2022
CaDeT – Screening Log v5 22 May 2023
CaDeT – Accountability Log v2 14 July 2023
Safety reporting
CaDeT - instructions for completing SAE form, v1 23-Nov-2022
CaDeT - SAE Report Form v1 29 Sep 2022
CaDeT - Adverse Event Form, v1 09-Dec-2022
Site Refresher Training
CaDeT - Refresher Training v2 05 Sep 2023
Norfolk
CaDeT – catheter accountability log, v1 05-Dec-2022_Norfolk
CaDeT - Recruitment Clinic Poster V1 27 Sep 2023(AM) NCHC
CaDeT - Digital Recruitment Clinic Poster V1 27 Sep 2023 NCHC
Hertfordshire
CaDeT - Recruitment Clinic Poster V1 27-Sep-2023 (AM) LLV
Hertfordshire (Stevenage)
CaDeT - Recruitment Clinic Poster V1 27-Sep-2023(AM)_Stevenage
Lanarkshire
CaDeT - Digital Recruitment Clinic Poster V1 27 Sep 2023 - NHS Lanarkshire
CaDeT - Recruitment Clinic Poster V1 27 Sep 2023 - NHS Lanarkshire
Bradford
CaDeT - Catheter Accountability log v1 05-Dec-2022 Bradford
Shropshire
CaDeT - Catheter Accountability log v1 05-Dec-2022_Shropshire
CaDeT - Recruitment Clinic Poster V1 27 Sep 2023(AM)
Fife
CaDeT - Cover letter for remote consent v2 02-Mar-2023
CaDeT - Cover letter for posting Optitip catheter supply v1 16-Feb-2023
Nottingham City Care
CaDeT - Digital Recruitment Clinic Poster V1 27 Sep 2023 - NCCP
CaDeT - Recruitment Clinic Poster V1 27 Sep 2023(AM) - NCCP
Central London
CaDeT - Digital Recruitment Clinic Poster V1 27 Sep 2023
CaDeT - Recruitment Clinic Poster V1 27 Sep 2023
Central and North West London
Newsletters
CaDeT - Newsletter, February 2024, v1 26-Feb-2024
CaDeT - Christmas Newsletter v1 19-Dec-2023
CaDeT - Newsletter, October 2023, v1 06 Oct 2023
CaDeT - Newsletter, June 2023, v1 30-Jun-23
CaDeT - Newsletter, May 2023 v1 23-May-23
CaDeT - Newsletter, March 2023, v0.1 07-Mar-2023
CaDeT - Newsletter, February 2023, v2 09-Feb-2023
Press releases, video clips and other external websites:
(University of Southampton cannot accept responsibility for external websites)