Clinical and cost-effectiveness of alternative urinary catheter design
| ISRCTN | ISRCTN11092188 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11092188 |
| ClinicalTrials.gov (NCT) | Nil Known |
| Clinical Trials Information System (CTIS) | Nil Known |
| Integrated Research Application System (IRAS) | 316989 |
| Protocol serial number | IRAS 316989, HTA - NIHR131172 |
| Sponsor | University Hospital Southampton NHS Foundation Trust |
| Funder | Health Technology Assessment Programme |
- Submission date
- 01/06/2022
- Registration date
- 07/06/2022
- Last edited
- 14/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
A catheter is a flexible hollow tube, which is passed into the bladder to drain urine. In this study, we will be comparing 2 types of catheters (the Foley catheter and the Optitip catheter) 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.
Who can participate?
Adult long-term indwelling urethral catheter users who have experienced one or more catheter-associated UTIs in the last 12 months.
What does the study involve?
Participants will be randomly allocated to one of two groups. In addition to usual care, participants will either be assigned to an optitip catheter or foley catheter (control). Participants will be given the assigned catheter at their next planned catheter change and will continue to receive the assigned catheter (Optitip or Foley) for 12 months in addition to all other catheter-related care. Participants will be asked to fill out a diary with any occurrence of UTIs in the past month, any other symptoms that they think could be caused by their catheter, and any catheter changes they had. They will also be asked to fill out questionnaires and express their experiences using the Optitip catheter and taking part in the trial.
What are the possible benefits and risks of participating?
Participants may see a reduction in symptoms associated with long-term catheter use and will be helping to further our knowledge of other benefits of the Optitip catheter (if any) that may benefit other catheter users in the future. However, a possible risk is that the study catheter may not improve the participant's catheter-related symptoms. Participants will need to complete data collection calls/visits at baseline, and monthly throughout the trial, which they would not do if they were not taking part in the study.
Where is the study run from?
University Hospital Southampton NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run?
From September 2021 to November 2024
Who is funding the study?
National Institute for Health and Care Research (UK)
Who is the main contact?
Dr. Susanne Renz, cadet@soton.ac.uk
Contact information
Scientific
Southampton university
Highfield campus
Southampton
SO17 1BJ
United Kingdom
| Phone | +44 (023) 8120 6552 |
|---|---|
| C.Murphy@soton.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomized controlled superiority trial with two parallel arms, incorporating an internal pilot |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific 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 |
| Study acronym | CaDeT |
| Study objectives | To determine whether the Optitip catheter provides a clinically and cost-effective alternative to the traditional ‘Foley’ style catheter for reducing symptomatic catheter-associated urinary tract infection (CAUTI) and other complications for community dwelling adults requiring long-term urinary urethral catheterisation. |
| Ethics approval(s) | Approved 15/11/2022, South East Scotland Research Ethics Committee 02 (2nd Floor, Waverly Gate, 2-4 Waterloo Place, Edinburgh, EH1 3EG; +44 (0)7814 764 241; Ruth.Fraser4@nhslothian.scot.nhs.uk), ref: 22/SS/0094 |
| Health condition(s) or problem(s) studied | Urethral catheter-associated urinary tract infection |
| Intervention | 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 or Foley) for 12 months in addition to all other standard catheter-related care. Patients will be randomised in a 1:1 ratio through a web-based system using a minimisation algorithm incorporating a random element to either the intervention or control. Factors used for minimisation will be gender, use of prophylactic antibiotics at baseline, and Trust/Partnership. Patients will be informed of allocation prior to their next catheter change. Intervention: 12 months’ use of the Optitip novel catheter design. Control: 12 months’ use of the Foley catheter design. |
| Intervention type | Device |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Foley catheter, Optitip catheter |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
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 |
| Completion date | 30/11/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 310 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 09/01/2023 |
| Date of final enrolment | 09/01/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
- Scotland
Study participating centres
Victoria Road
Saltaire
Shipley
BD18 3LD
United Kingdom
Bowthorpe Road
Norwich
NR2 3TU
United Kingdom
Hamilton
ML3 0TA
United Kingdom
14 Tewin Road
Welwyn Garden City
AL7 1BW
United Kingdom
William Farr House
Mytton Oak Road
Shrewsbury
SY3 8XL
United Kingdom
Hayfield Road
Kirkcaldy
KY2 5AH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication. Individual investigators may not publish data concerning their patients that are directly relevant to questions posed by the trial until the Trial Management Group (TMG) has published its report. The TMG will form the basis of the Writing Committee and advise on the nature of publications. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/02/2023: Shropshire Community Health NHS Trust and NHS Fife were added as trial participating centres.
09/01/2023: The following changes have been made:
1. The recruitment start date has been changed from 01/11/2022 to 09/01/2023.
2. The recruitment end date has been changed from 31/10/2023 to 09/01/2024.
3. The ethics approval has been added.
4. The participant information sheet information has been updated.
5. Southern Health NHS Foundation Trust, University Hospitals Coventry and Warwickshire NHS Trust, Cambridgeshire and Peterborough NHS Foundation Trust and NHS Ayrshire and Arran have been removed from the trial participating centres and Hertfordshire Community NHS Trust added.
12/08/2022: The following changes have been made:
1. The recruitment start date has been changed from 01/08/2022 to 01/11/2022.
2. The recruitment end date has been changed from 31/07/2023 to 31/10/2023.
06/06/2022: Trial’s existence confirmed by the National Institute for Health and Care Research.
