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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.

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This trial is funded by a National Institute for Health and Care Research Health Technology Assessment (HTA) grant (award reference no. NIHR131172)

Essential Trial Documents

CaDeT - Protocol, v4 11-Jan-2024

CaDeT - PIS v4 22-Feb-2024 Ìý

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

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Recruitment Poster

CaDeT - Digital Recruitment Clinic Poster V1 27 Sep 2023

CaDeT - Recruitment Clinic Poster V1 27 Sep 2023

CaDeT - QR code

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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

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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

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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

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Site Refresher Training

CaDeT - Refresher Training v2 05 Sep 2023

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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

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Hertfordshire

CaDeT - Recruitment Clinic Poster V1 27-Sep-2023 (AM) LLV

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Hertfordshire (Stevenage)

CaDeT - Recruitment Clinic Poster V1 27-Sep-2023(AM)_Stevenage

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Lanarkshire

CaDeT - Digital Recruitment Clinic Poster V1 27 Sep 2023 - NHS Lanarkshire

CaDeT - Recruitment Clinic Poster V1 27 Sep 2023 - NHS Lanarkshire

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Bradford

CaDeT - Catheter Accountability log v1 05-Dec-2022 Bradford

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Shropshire

CaDeT - Catheter Accountability log v1 05-Dec-2022_Shropshire

CaDeT - Recruitment Clinic Poster V1 27 Sep 2023(AM)

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Fife

CaDeT - Cover letter for remote consent v2 02-Mar-2023

CaDeT - Cover letter for posting Optitip catheter supply v1 16-Feb-2023

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Nottingham City Care

CaDeT - Digital Recruitment Clinic Poster V1 27 Sep 2023 - NCCP

CaDeT - Recruitment Clinic Poster V1 27 Sep 2023(AM) - NCCP

CaDeT - Cover letter for remote consent v2 02-Mar-2023_clean - NCCP personalised - updated contact details 29.12.23

CaDeT - Reminder of invitation letter v1 16-Feb-2023 - NCCP personalised. Updated contact details 22.12.23

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Central London

CaDeT - Digital Recruitment Clinic Poster V1 27 Sep 2023

CaDeT - Recruitment Clinic Poster V1 27 Sep 2023

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Central and North West London

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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

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Press releases, video clips and other external websites:

(University of Southampton cannot accept responsibility for external websites)