Low Energy Surface Waves for Neurogenic Bladder Patients With Indwelling Catheters

Study Overview
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Brief Summary
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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.

Official Title
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Low Energy Surface Waves to Prevent Urinary Infections and Catheter Associated Symptoms Among Patients With Neurogenic Bladder Dysfunction

Conditions
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Neurogenic Bladder, Urinary Tract Infections

Intervention / Treatment
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* Device: Uroshield
* Device: Sham Uroshield


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham<br>Inactive uroshield device | Device: Sham Uroshield<br>* 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.<br>|
| Experimental: Active Uroshield<br>Active uroshield device | Device: Uroshield<br>* The Uroshield device sends out low-frequency ultrasound waves which run along the surface of the catheter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacteriuria | Proportion with bacteriuria >10^5 cfu at day 30 | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurogenic bladder symptom score (NBSS) | 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. | 30 days | 
| 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 |