Low Energy Surface Waves for Neurogenic Bladder Patients With Indwelling Catheters

Sponsor

Lawson Health Research Institute (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03785262

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neurogenic Bladder Urinary Tract Infections	Device: Uroshield Device: Sham Uroshield	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 30, 2019

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Feb 28, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Sham Comparator: Sham

Inactive uroshield device

Device: 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.

Experimental: Active Uroshield

Active uroshield device

Device: Uroshield

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

Outcome Measures

Primary Outcome Measures

Bacteriuria [30 days]
Proportion with bacteriuria >10^5 cfu at day 30

Secondary Outcome Measures

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]
Total bacterial cell counts [30 days]
Microbiome comparison of biofilms [30 days]
Scanning electron microscopy of biofilms [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Josephs Hospital	London	Ontario	Canada	N6A 4V2

Sponsors and Collaborators

Lawson Health Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lawson Health Research Institute

ClinicalTrials.gov Identifier:

NCT03785262

Other Study ID Numbers:

113221

First Posted:

Dec 24, 2018

Last Update Posted:

Jun 10, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infections

Urinary Tract Infections

Urinary Bladder, Neurogenic

Study Results

No Results Posted as of Jun 10, 2022