Randomised controlled trial comparing the clinical and cost-effectiveness of various washout policies versus no washout policy in preventing catheter-associated complications in adults living with long-term catheters

Not Applicable

Completed

• Conditions: Catheter-associated complications; Nervous System Diseases

• Registration Number: ISRCTN17116445
• Lead Sponsor: HS Grampian

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35927733/ (added 05/08/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-06
• Study Completion: 2023-09-14
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified