Low Energy Surface Waves for Neurogenic Bladder Patients With Indwelling Catheters

NCT ID: NCT03785262

Last Updated: 2024-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-30

Study Completion Date

2023-12-30

Brief Summary

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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

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Conditions

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Neurogenic Bladder Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sham

Inactive uroshield device

Group Type SHAM_COMPARATOR

Sham Uroshield

Intervention Type DEVICE

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.

Active Uroshield

Active uroshield device

Group Type EXPERIMENTAL

Uroshield

Intervention Type DEVICE

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

Interventions

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Uroshield

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

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St Josephs Hospital

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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113221

Identifier Type: -

Identifier Source: org_study_id

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