NCT03785262

Low Energy Surface Waves for Neurogenic Bladder Patients With Indwelling Catheters

Low Energy Surface Waves to Prevent Urinary Infections and Catheter Associated Symptoms Among Patients With Neurogenic Bladder Dysfunction

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-01-30
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2018-12-24
• Last updated: 2024-01-12

Locations

1 site across 1 country: Canada