A study to test a sensor for giving early warning of urinary catheter blockage
Not Applicable
Completed
- Conditions
- Patients requiring catheterisingUrological and Genital Diseases
- Registration Number
- ISRCTN51644058
- Lead Sponsor
- niversity of Bath
- Brief Summary
2022 Preprint results in https://doi.org/10.1101/2022.10.25.22281351 (added 14/02/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
1. Patients with long term in-dwelling urinary catheters
2. Adult aged >18 years old
3. Attendance at a weekly urology clinic
4. Consent gained for study
Exclusion Criteria
1. Consent not gained for study
2. Child aged < 18 years old
3. Adult without mental capacity to consent
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Correlation of technology result against the retrospective clinical decision of patient infection condition (time to catheter blockage following urine donation), measured using the case report form (CRF) and telephone interview at the time of donation and 3 weeks later<br> 2. To correlate sensor switch-on with patient-reported quality of life measured using the ICIQ-Long Term Catheter quality of life (ICIQ-LTCqol) questionnaire and sensor turn-on at the time of donation, and 24 h later<br>
- Secondary Outcome Measures
Name Time Method <br> Feasibility of study design with a view to a larger trial:<br> 1. Practicalities of sample collection and viewing technology ‘switch-on’ / colour change in urine collection bags measured using visual assessment at 24 h<br> 2. pH measure of all donated urine measured using a pH meter as soon as practicable<br> 3. Presence of Proteus mirabilis in urine measured using standard microbiological testing of a bacterial swab taken at the time of donation. Individual bacterial species are visually identified, and freezer stocks are made. 16S rRNA sequencing was completed on the freezer stocks. The initial analysis is undertaken within 24 h and the final 16S rRNA sequencing within 6 months.<br>