Clinical and cost-effectiveness of alternative urinary catheter design

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11092188

Enrollment

310

Registered

2022-06-07

Start date

2023-01-09

Completion date

Unknown

Last updated

2023-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urethral catheter-associated urinary tract infection Not Applicable

Interventions

Participants will be randomly allocated to receive either the intervention or control catheter design at their next planned catheter change and will continue to receive the assigned catheter (Optitip

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged =18 years 2. Community-dwelling (own home or residential care, including assisted living) 3. Use of an indwelling urethral catheter (for any reason) for =28 days and anticipated to continue with catheterisation for =1 year 4. Experienced one of more catheter-associated UTIs in the last 12 months 5. Willing to be randomised to either study arm 6. Willing and able to give informed consent

Exclusion criteria

Exclusion criteria: 1. Current therapy for bladder cancer 2. Under surveillance follow-up for previous bladder cancer 3. Current interventional therapy for prostate cancer 4. Previous bladder radiotherapy 5. Unresolved urethral stricture or bladder neck stenosis 6. Traumatic hypospadias 7. Terminally ill 8. Otherwise deemed unsuitable for trial

Design outcomes

Primary

Measure	Time frame
Clinical effectiveness of the Optitip catheter versus standard Foley catheter design measured using the incidence of symptomatic UTIs reported in patient diaries at a 6, 9, and 12 months	—

Secondary

Measure	Time frame
1. 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 measured using the catheter related quality of life at 12 months 2. Cost-effectiveness of the Optitip catheter compared to the standard ‘Foley’ catheter design measured using economic evaluation performed at a 12 months 3. Patient/carer and healthcare professional experience, and the acceptability of the Optitip catheter design measured using health-related quality of life and EQ-5D-5L questionnaires at a 3, 6, 9, and 12 months	—

Measure

Time frame

1. 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 measured using the catheter related quality of life at 12 months 2. Cost-effectiveness of the Optitip catheter compared to the standard ‘Foley’ catheter design measured using economic evaluation performed at a 12 months 3. Patient/carer and healthcare professional experience, and the acceptability of the Optitip catheter design measured using health-related quality of life and EQ-5D-5L questionnaires at a 3, 6, 9, and 12 months

—

Countries

England, Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026