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Low Energy Surface Waves for Neurogenic Bladder Patients With Indwelling Catheters

Primary Purpose

Neurogenic Bladder, Urinary Tract Infections

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Uroshield
Sham Uroshield
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neurogenic Bladder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St Josephs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sham

Active Uroshield

Arm Description

Inactive uroshield device

Active uroshield device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Patient subjective rating of amount of sediment/debris at the end of the 30 days
Total bacterial cell counts
Microbiome comparison of biofilms
Scanning electron microscopy of biofilms

Full Information

First Posted
December 20, 2018
Last Updated
December 12, 2022
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03785262
Brief Title
Low Energy Surface Waves for Neurogenic Bladder Patients With Indwelling Catheters
Official Title
Low Energy Surface Waves to Prevent Urinary Infections and Catheter Associated Symptoms Among Patients With Neurogenic Bladder Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 30, 2019 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurogenic Bladder, Urinary Tract Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Inactive uroshield device
Arm Title
Active Uroshield
Arm Type
Experimental
Arm Description
Active uroshield device
Intervention Type
Device
Intervention Name(s)
Uroshield
Intervention Description
The Uroshield device sends out low-frequency ultrasound waves which run along the surface of the catheter.
Intervention Type
Device
Intervention Name(s)
Sham Uroshield
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bacteriuria
Description
Proportion with bacteriuria >10^5 cfu at day 30
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Neurogenic bladder symptom score (NBSS)
Description
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.
Time Frame
30 days
Title
Patient subjective rating of amount of sediment/debris at the end of the 30 days
Time Frame
30 days
Title
Total bacterial cell counts
Time Frame
30 days
Title
Microbiome comparison of biofilms
Time Frame
30 days
Title
Scanning electron microscopy of biofilms
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
St Josephs Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan

Learn more about this trial

Low Energy Surface Waves for Neurogenic Bladder Patients With Indwelling Catheters

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