Low Energy Surface Waves for Neurogenic Bladder Patients With Indwelling Catheters

Not Applicable

Terminated

• Conditions: Neurogenic Bladder; Urinary Tract Infections
• Interventions: Device: Uroshield; Device: Sham Uroshield

• Registration Number: NCT03785262
• Lead Sponsor: Lawson Health Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2018-12-20
• Study First Posted: 2018-12-24
• Study Start: 2019-01-30
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Uroshield	Uroshield	Active uroshield device
Sham	Sham Uroshield	Inactive uroshield device

Primary Outcome Measures

Name	Time	Method
Bacteriuria	30 days	Proportion with bacteriuria \>10\^5 cfu at day 30

Secondary Outcome Measures

Name	Time	Method
Scanning electron microscopy of biofilms	30 days
Total bacterial cell counts	30 days
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
Microbiome comparison of biofilms	30 days

Trial Locations

Locations (1)

St Josephs Hospital; 🇨🇦 London, Ontario, Canada