Low Energy Surface Waves for Neurogenic Bladder Patients With Indwelling Catheters

NCT03785262 | Terminated

• 1 other identifier: 113221
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurogenic Bladder; Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• Bacteriuria

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

  30 days

Secondary Outcomes (5)

• Neurogenic bladder symptom score (NBSS)

  30 days

• Patient subjective rating of amount of sediment/debris at the end of the 30 days

  30 days

• Total bacterial cell counts

  30 days

• Microbiome comparison of biofilms

  30 days

• Scanning electron microscopy of biofilms

  30 days

Study Arms (2)

Sham

SHAM COMPARATOR

Inactive uroshield device

Device: Sham Uroshield

Active Uroshield

EXPERIMENTAL

Active uroshield device

Device: Uroshield

Interventions

Uroshield DEVICE

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

Active Uroshield

Sham Uroshield 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.

Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

St Josephs Hospital

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Conditions

Urinary Bladder, Neurogenic; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 24, 2018
• Study Start: January 30, 2019
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)