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Low Energy Surface Waves for Neurogenic Bladder Patients With Indwelling Catheters

NCT03785262 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-01-12

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Uroshield

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

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.

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-30
Primary Completion
2023-12-30
Completion
2023-12-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03785262 on ClinicalTrials.gov