What is the mechanism of action of this treatment?

Common treatments for Neurogenic Bladder include clean intermittent catheterization, bladder function training, and neural stimulation. The Uroshield Device, which uses low-frequency ultrasound waves to prevent bacterial adhesion and biofilm formation on catheters, is particularly relevant. This mechanism is crucial for Neurogenic Bladder patients as it helps reduce the risk of urinary tract infections, a common complication due to the frequent use of catheters. By preventing biofilm formation, the Uroshield Device can improve the quality of life and reduce the morbidity associated with chronic catheter use.

What side effects are associated with this type of intervention?

Common treatments for neurogenic bladder include catheterization, medications, and devices like the Uroshield. Catheterization can lead to urinary tract infections, bladder stones, and urethral damage. Medications such as anticholinergics may cause dry mouth, constipation, and blurred vision. The Uroshield device, which uses low-frequency ultrasound waves, aims to prevent bacterial adhesion and biofilm formation on catheters, potentially reducing infection rates. However, specific side effects of the Uroshield device are not well-documented, but general risks may include local irritation or discomfort from the device.

What prior FDA approvals exist?

The Uroshield device, which uses low-frequency ultrasound waves to prevent bacterial adhesion and biofilm formation on catheters, represents a novel approach in the management of neurogenic bladder. While specific FDA approvals for similar ultrasound-based devices are not detailed, traditional treatments for neurogenic bladder often include anticholinergic medications, botulinum toxin injections, and sacral nerve stimulation. These treatments focus on managing symptoms and improving bladder function rather than directly preventing infections. The Uroshield device's unique mechanism of preventing catheter-associated infections addresses a significant clinical need in this patient population.

What other types of research exist?

Promising novel alternatives to the Uroshield device for neurogenic bladder patients include percutaneous tibial nerve stimulation (PTNS) using adhesive skin surface electrodes, which has shown effectiveness in managing neurogenic detrusor overactivity. Additionally, the use of bioabsorbable self-reinforced poly L-lactic acid urethral stents combined with medications like finasteride may offer another innovative approach to managing bladder symptoms and preventing complications.

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Low Energy Surface Waves for Neurogenic Bladder

N/A

Waitlist Available

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Summary

This trial is testing a small device called Uroshield that attaches to urinary catheters and uses gentle sound waves to stop bacteria from sticking. It aims to help patients with neurogenic bladder who use catheters by reducing infections and improving their urinary health.

Who is the study for?

This trial is for adults over 18 with neurogenic bladder due to conditions like spinal cord injury, multiple sclerosis, or Parkinson's. They must have used an indwelling catheter for over 3 months and had at least one UTI in the past year. People who don't understand English, already use Uroshield, had recent botox treatments in the bladder, take ongoing antibiotics or have a current UTI can't join.

What is being tested?

The study tests if the Uroshield device can reduce urinary infections and improve life quality for patients with neurogenic bladders using catheters. It compares Uroshield's low-frequency ultrasound waves against a sham (fake) device to see if it prevents bacteria and biofilm on catheters.

What are the potential side effects?

Since this trial involves a non-invasive device that emits ultrasound waves through the catheter, side effects might be minimal but could include discomfort where the actuator attaches or skin irritation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bacteriuria

Secondary study objectives

Neurogenic bladder symptom score (NBSS)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active UroshieldExperimental Treatment1 Intervention

Active uroshield device

Group II: ShamPlacebo Group1 Intervention

Inactive uroshield device

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Neurogenic Bladder include clean intermittent catheterization, bladder function training, and neural stimulation. The Uroshield Device, which uses low-frequency ultrasound waves to prevent bacterial adhesion and biofilm formation on catheters, is particularly relevant. This mechanism is crucial for Neurogenic Bladder patients as it helps reduce the risk of urinary tract infections, a common complication due to the frequent use of catheters. By preventing biofilm formation, the Uroshield Device can improve the quality of life and reduce the morbidity associated with chronic catheter use.

Biofeedback treatment of intermittent urinary retention.A nonsurgical and nonpharmacological care bundle for preventing upper urinary tract damage in patients with spinal cord injury and neurogenic bladder.Does our limited knowledge of the mechanisms of neural stimulation limit its benefits for patients with overactive bladder? ICI-RS 2013.