The Effect of Surface Acoustic Waves on the Prevention of Colonization in Longterm Indwelling Urinary Caatheters

NCT03090373 | Unknown DMC

• 1 other identifier: US-2
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double blinded rct to evaluate the effect of the UroShield SAW transducer on preventing bacterial colonization in longterm indwelling catheters. The duration of the trial is 30 days. The investigator will be quantifying the number of bacterial colonies in the urinary catheter and in the bladder in both the treatment and control group.

Conditions

Baacterial Colonization; Urinary Tract Infections

Keywords

Catheter; UTI's

Outcome Measures

Primary Outcomes (1)

• Bacterial Colonization

  Number of cultured colonies from both the Urinary Catheter and retained urine

  30 days

Study Arms (2)

Control Group

SHAM COMPARATOR

At catheter replacement subjects will have a sham UroShield device attached to the external portion of the catheter and have it activated for 30 days. Standard of care for the upkeep and cleanliness of the catheter will be adhered to. At both the baseline and at the conclusion of 30 days, the distal end of the catheter will be collected as well as a sample of retained urine from the bladder and these samples will be evaluated for bacterial colonization.

Device: UroShield

Treatment Group

ACTIVE COMPARATOR

At catheter replacement subjects will have an active UroShield device attached to the external portion of the catheter and have it activated for 30 days. Standard of care for the upkeep and cleanliness of the catheter will be adhered to. At both the baseline and at the conclusion of 30 days, the distal end of the catheter will be collected as well as a sample of retained urine from the bladder and these samples will be evaluated for bacterial colonization.

Device: UroShield

Interventions

UroShield DEVICE

The UroShield is an externally applied acoustic actuator which generates surface acoustic waves and transmits them along the length of the catheter. The device does not come in direct contact with the subjects.

Also known as: Surface Acoustic Wave Actuator

Control Group; Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently being treated with an indwelling urinary catheter for at least 30 days.
• Ability to sign informed consent or have someone authorized to sign informed consent.

You may not qualify if:

• Currently being treated for an active Urinary Tract infection.
• Previous treatment with Surface Acoustic Waves.

Sponsors & Collaborators

• Rosenblum, Jonathan I., DPM: lead
• Nanovibronix: collaborator

Study Sites (1)

NanoVibronix

Elmsford, New York, 07055, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The UroShield device actuator will activate and create the hum, which is the only sign of its working even in the active device. While the active device will transmit Surface Acoustic Waves, the sham device will work but will not transmit any acoustic waves.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Model Details: This is a double blinded, randomized controlled trial. All involved will be blinded as to whether the supplied UroShield device is active or a sham.

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: March 24, 2017
• Study Start: January 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: March 1, 2018
• Last Updated: March 24, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)