Low Energy Surface Waves for Neurogenic Bladder Patients With Indwelling Catheters

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03785262
• Other study ID #: 113221
• Status: Terminated
• Phase: N/A
• Start date: January 30, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: January 2024
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Neurogenic Bladder
• Urinary Bladder, Neurogenic
• Urinary Tract Infections

Intervention

Device:
• Uroshield
The Uroshield device sends out low-frequency ultrasound waves which run along the surface of the catheter.
• Sham 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.

Locations

Country	Name	City	State
Canada	St Josephs Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacteriuria	Proportion with bacteriuria >10^5 cfu at day 30	30 days
Secondary	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
Secondary	Patient subjective rating of amount of sediment/debris at the end of the 30 days		30 days
Secondary	Total bacterial cell counts		30 days
Secondary	Microbiome comparison of biofilms		30 days
Secondary	Scanning electron microscopy of biofilms		30 days