Neurogenic Bladder, Urinary Tract Infections
Conditions
Brief summary
The Uroshield device is a commercially available device with two parts: a disposable actuator which attaches to the external portion of the catheter and a portable battery. The device sends out low-frequency ultrasound waves which run along the surfaces of the catheter. These acoustic waves prevent bacteria from adhering to the catheter and prevent the formation of biofilm. Our objective is to conduct a pilot study to determine if the UroShield device can reduce bacteriuria and catheter biofilm formation among neurogenic bladder patients with an indwelling catheter, as well as improve urinary quality of life and symptoms.
Interventions
DEVICEUroshield
The Uroshield device sends out low-frequency ultrasound waves which run along the surface of the catheter.
DEVICESham Uroshield
The sham Uroshield device is identical to the active machine, but it does not send out low-frequency ultrasound waves along the surface of the catheter.
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. \>18 years of age 2. Spinal cord injury (\>1 year), multiple sclerosis (\>1 year), spina bifida, parkinsons (\>1 year) 3. Indwelling catheter (urethral or suprapubic) for \>3 months, and used as primary bladder management mechanism 4. \>1 urinary tract infection in the last 12 months
Exclusion criteria
1. Intravesical botox in the last 6 months 2. Chronic antibiotic suppressive therapy 3. Active symptomatic UTI on day of randomization 4. Unable to understand written and spoken English 5. Prior/current utilization of the Uroshield device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacteriuria | 30 days | Proportion with bacteriuria \>10\^5 cfu at day 30 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurogenic bladder symptom score (NBSS) | 30 days | Validated symptom score that measures symptoms related to neurogenic bladder dysfunction and urinary quality of life. Total scale ranges from 0-74, and a lower number is considered a better outcome and represents lower symptom burden. |
| Patient subjective rating of amount of sediment/debris at the end of the 30 days | 30 days | — |
| Total bacterial cell counts | 30 days | — |
| Microbiome comparison of biofilms | 30 days | — |
| Scanning electron microscopy of biofilms | 30 days | — |
Countries
Canada
Outcome results
None listed