Low Energy Surface Waves for Neurogenic Bladder Patients With Indwelling Catheters

Lawson Health Research Institute

Status: Terminated

Conditions: Urinary Tract Infections; Neurogenic Bladder

Treatments: Device: Sham Uroshield; Device: Uroshield

Study type: Interventional

Funder types: Other

Identifiers

NCT03785262

113221

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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6 participants in 2 patient groups

Sham

Sham Comparator group

Description:

Inactive uroshield device

Treatment:

Device: Sham Uroshield

Active Uroshield

Experimental group

Description:

Active uroshield device

Treatment:

Device: Uroshield