Biofilms, Catheter-Associated Urinary Tract Infections, Urinary Catheterization
Conditions
Keywords
anti-fouling catheter, zwitterionic polymer, long-term catheterisation, pilot and feasibility study
Brief summary
This single-centre randomised pilot and feasibility study assessed whether an anti-fouling zwitterionic silicone urinary catheter can be deployed and evaluated in frail, elderly adults who require long-term indwelling catheterisation. In the experimental catheter, a zwitterionic polymer is blended into the silicone matrix rather than applied as a surface coating. Forty participants were randomly allocated to the anti-fouling catheter or a conventional commercial silicone catheter, with monthly catheter changes for up to eight cycles. The primary aim was to establish feasibility and acceptability (recruitment, retention, specimen completeness, safety and patient/family acceptability) and to obtain exploratory effect-size estimates (catheter-associated urinary tract infection, catheter-removal pain, urinalysis and urine culture) to inform the design of a future confirmatory trial. The study was not powered to test efficacy.
Interventions
DEVICEAnti-fouling zwitterionic silicone urinary catheter
Zwitterionic polymer bulk-blended into the medical-grade silicone matrix (not a surface coating); ethylene-oxide sterilised; changed monthly.
DEVICEConventional silicone urinary catheter
Conventional commercial silicone Foley catheter, identical French size; changed monthly.
Sponsors
National Cheng-Kung University Hospital
Formosa Plastics Corporation
Fortune Medical Instrument Corp.
Medical Device Innovation Center (MDIC), National Cheng Kung University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Experimental and control catheters were identical in appearance and packaging and dispensed by research staff so that participants were masked. Laboratory outcome assessment was masked. Caregivers within the institution were aware of allocation for clinical management.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older * Require long-term indwelling urethral catheterisation * At risk of catheter-associated urinary tract infection * Written informed consent from the participant or a legal representative
Exclusion criteria
* Individuals who are not fully conscious or unable to clearly express their wishes * Individuals who cannot cooperate with urine or blood tests or other related examinations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention through the monthly catheter-change protocol | Up to 8 monthly cycles | Proportion of participants completing at least one, and 5 or more, monthly catheter changes (feasibility outcome) |
| Completeness of longitudinal specimen collection | Up to 8 monthly cycles | Proportion of expected urinalysis and urine-culture specimens collected (feasibility outcome) |
| Device-related adverse events | Up to 8 monthly cycles | Number of device-related adverse events (safety feasibility outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Catheter-associated urinary tract infection (CAUTI) incidence | Up to 8 monthly cycles | Exploratory outcome |
| Catheter-removal pain measured by the Visual Analogue Scale (VAS) | At each monthly catheter change, up to 8 cycles | Pain at catheter removal measured on a Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain); higher scores indicate worse pain (a worse outcome). |
| Urinalysis white blood cell count | At each monthly visit, up to 8 cycles | White blood cells per high-power field on microscopic urinalysis at each monthly visit (exploratory outcome). |
| Urine occult blood | At each monthly visit, up to 8 cycles | Urine occult blood measured semi-quantitatively on dipstick urinalysis at each monthly visit (exploratory outcome). |
| Urinary bacteria on microscopic urinalysis | At each monthly visit, up to 8 cycles | Bacteria graded semi-quantitatively on microscopic urinalysis at each monthly visit (exploratory outcome). |
| Urine nitrite | At each monthly visit, up to 8 cycles | Urine nitrite recorded as positive or negative on dipstick urinalysis at each monthly visit (exploratory outcome). |
| Urine culture positivity | At each monthly visit, up to 8 cycles | Proportion of urine cultures reported as positive at each monthly visit (exploratory outcome). |
Countries
Taiwan
Outcome results
None listed