Low Energy Surface Waves for Neurogenic Bladder Patients With Indwelling Catheters

January 10, 2024 updated by: Lawson Health Research Institute

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • St Josephs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bacteriuria
Time Frame: 30 days
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)
Time Frame: 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.
30 days
Patient subjective rating of amount of sediment/debris at the end of the 30 days
Time Frame: 30 days
30 days
Total bacterial cell counts
Time Frame: 30 days
30 days
Microbiome comparison of biofilms
Time Frame: 30 days
30 days
Scanning electron microscopy of biofilms
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2019

Primary Completion (Actual)

December 30, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

December 20, 2018

First Submitted That Met QC Criteria

December 20, 2018

First Posted (Actual)

December 24, 2018

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 113221

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Urinary Tract Infections

Clinical Trials on Sham Uroshield

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe