TerminatedNot Applicable

Low Energy Surface Waves for Neurogenic Bladder Patients With Indwelling Catheters

Stopped: Failure to recruit

Canada6 participantsStarted 2019-01-30

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. \>18 years of age
✓. Spinal cord injury (\>1 year), multiple sclerosis (\>1 year), spina bifida, parkinsons (\>1 year)
✓. Indwelling catheter (urethral or suprapubic) for \>3 months, and used as primary bladder management mechanism
✓. \>1 urinary tract infection in the last 12 months

Exclusion criteria

✕. Intravesical botox in the last 6 months
✕. Chronic antibiotic suppressive therapy
✕. Active symptomatic UTI on day of randomization
✕. Unable to understand written and spoken English
✕. Prior/current utilization of the Uroshield device

What they're measuring

Bacteriuria

Timeframe: 30 days

Trial details

NCT IDNCT03785262

SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-30

View on ClinicalTrials.gov More Neurogenic Bladder trials