Low Energy Surface Waves for Neurogenic Bladder Patients... | NCT03785262

Studies
Low Energy Surface Waves for Neurogenic Bladder Patients With Indwelling Catheters

NCT03785262

Sponsor

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

Status

Terminated

Last Update Posted

Jan 12, 2024Actual

Enrollment

6Actual

Phase

Not Applicable

Conditions

Neurogenic Bladder
Urinary Tract Infections

Interventions

Uroshield
Sham Uroshield

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Failure to recruit

Expanded Access Info

Start Date

Jan 30, 2019Actual

Primary Completion Date

Dec 30, 2023Actual

Completion Date

Dec 30, 2023Actual

First Submitted Date

Dec 20, 2018

First Submission Date that Met QC Criteria

Dec 20, 2018

First Posted Date

Dec 24, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2024

Last Update Posted Date

Jan 12, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sham	Sham Comparator	Inactive uroshield device	Device: Sham Uroshield
Active Uroshield	Experimental	Active uroshield device	Device: Uroshield

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Uroshield	Device	The Uroshield device sends out low-frequency ultrasound waves which run along the surface of the catheter.	Active Uroshield

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bacteriuria	Proportion with bacteriuria >10^5 cfu at day 30	30 days

Secondary Outcomes

Measure	Description	Time Frame
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.	30 days
Patient subjective rating of amount of sediment/debris at the end of the 30 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Josephs Hospital		London	Ontario	N6A 4V2	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

No plan

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001750	Urinary Bladder, Neurogenic
D014552	Urinary Tract Infections

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided