CaDeT

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

Open to recruitment

Population

Adult long-term indwelling urethral catheter users who have experienced one or more catheter associated UTIs in the last 12 months.

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