Patients requiring catheterising Urological and Genital Diseases
Conditions
Interventions
URINOSTICS lozenge - lab prototype is inserted into the urinary leg bag after patients have donated them, i.e. not part of patient pathway.
Observational:
Feasibility
Sponsors
University of Bath
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. Consent not gained for study 2. Child aged < 18 years old 3. Adult without mental capacity to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility of study design with a view to a larger trial: 1. Practicalities of sample collection and viewing technology ‘switch-on’ / colour change in urine collection bags measured using visual assessment at 24 h 2. pH measure of all donated urine measured using a pH meter as soon as practicable 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. | — |
Countries
England, United Kingdom
Outcome results
None listed