Catheter-associated complications Nervous System Diseases
Conditions
Interventions
The researchers are recruiting 600 people who have a LTC from primary care, secondary care and care homes. They are randomising participants to one of three groups:
1. Saline washouts. A policy of wee
Sponsors
NHS Grampian
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged =18 years 2. Catheter has been in-situ for =28 days 3. No plan for discontinuation of LTC at the time of recruitment 4. Able to undertake catheter washouts or has a designated person able to perform washouts 5. Able to complete the trial documentation or has a proxy able to complete the trial documentation 6. Any type and route of LTC can be included
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 22/04/2022: 1. Intermittent self-catheterisation 2. Pregnant or contemplating pregnancy 3. Spinal cord injury at or above the sixth thoracic vertebra (T6) (risk of Autonomic Dysreflexia - AD) 4. Ongoing S-CAUTI (until treatment is complete) 5. Visible hematuria (unless investigated/ treated) 6. Known allergies to either of the catheter washout solutions 7. Current bladder cancer (until treatment is complete and patient discharged from cancer surveillance program) 8. Known bladder stones (until treatment is complete) 9. Unable to provide consent due to incapacity 10. Any other clinical and social reasons that would be deemed by the recruitment team to be unsuitable for the study If a participant stops using a long-term catheter (no catheter in situ) >=28 days. All data collected up to the point of stopping long term catheter use are retained and used in the analysis Previous participant exclusion criteria: 1. Intermittent self-catheterisation 2. Pregnant or contemplating pregnancy 3. Spinal cord injury at or above the sixth thoracic vertebra (T6) (risk of Autonomic Dysreflexia - AD) 4. Ongoing S-CAUTI (until treatment is complete) 5. Visible hematuria (unless investigated/ treated) 6. Known allergies to either of the catheter washout solutions 7. Current bladder cancer (until treatment is complete and patient discharged from cancer surveillance program) 8. Known bladder stones (until treatment is complete) 9. Any other clinical and social reasons that would be deemed by the recruitment team to be unsuitable for the study If a participant stops using a long-term catheter (no catheter in situ) >=28 days. All data collected up to the point of stopping long term catheter use are retained and used in the analysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any catheter blockage requiring intervention up to 24 months post randomisation, from the question ‘Have you had any catheter blockages since we last spoke to you?’ from patient-reported monthly phone call CRF (monthly for 24 months) (Intervention is defined as any of the following: unplanned catheter removal or change or washout performed by the participant/ designated person or required unplanned visits to/from any healthcare provider, or hospital admission) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 22/04/2022: 1. S-CAUTI requiring antibiotics use from the questions ‘Have you had a urine infection since we last spoke to you?’ and ‘How many infections required antibiotics?’ from patient-reported monthly phone call CRF (monthly for 24 months) 2. Duration of LTC in situ, catheter change due to other reasons than blockage, discontinuation of LTC use; from the questions ‘Has there been discontinuation of long-term catheter use?’, ‘For the (reported problem), what treatment did you have?’ and Answers ‘Catheter change’ from patient-reported monthly phone call CRF (monthly for 24 months) 3. Adverse events; where participant has reported a treatment in the patient-reported monthly phone call CRF (monthly for 24 months) and the question of the clinical team is asked ‘Is this a SAE? Please tick’ 4. Hospital admissions, GP/nurse outpatient visits for catheter-related complications from the questions ‘Since we last spoke to you, have you had to stay in hospital overnight for any of the problems related to your catheter?’, ‘For the (reported problem), where did you have treatment or a consultation with a doctor or nurse?’ and possible answers ‘GP at home, Nurse at home, care home staff, GP at surgery, Nurse at practice, Self/informal carer, Staff at hospital’ from patient-reported monthly phone call CRF (monthly for 24 months) 5. Generic quality of life assessed by EQ-5D-5L17 (EuroQol questionnaire – 5 dimensions – 5 levels) patient-reported questionnaire; Timepoint(s): 0, 6, 12, 18, 24 months post-randomisation 6. Condition-specific quality of life assessed by ICIQ-LTCqol18 (International Consultation on Incontinence Modular Questionnaire – Long Term Catheter quality of life) patient-reported questionnaire; Timepoint(s): 0, 6, 12, 18, 24 months post-randomisation 7. Adherence to allocated interventions,events changing type and/or frequency (or cessation) of catheter washouts in arms A and B and rates of commencing on prophylactic wa | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed