Evaluation of Quality-of-Life Improvements Using UroShield Device

November 27, 2024 updated by: Lona Mody, University of Michigan

Evaluation of Quality-of-Life Improvements Using UroShield for Patients Living in Long Term Care Facilities With Indwelling Urinary Catheters - A Pilot Study

The goal of this pilot study is to test key elements of the full study that will follow, including recruitment and retention strategies, intervention delivery, laboratory testing, data collection methods, and adherence to study protocol.

The main questions the investigators aim to answer focus on implementation and practicality:

  • Recruitment feasibility and time to recruit
  • How well do participants adhere to device protocol?
  • How often do device components (i.e., actuators and drivers) have to be replaced?
  • How much time is required for data collection and what sources or methods for data collection are used?

Results of this pilot study will inform the investigators as to necessary protocol modifications and overall feasibility for the larger randomized clinical trial to follow.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The UroShield® device works by generating ultrasonic waves to interfere with attachment of bacteria inside the catheter, preventing biofilm formation and subsequent infections.

This double-blind pilot study aims to recruit 10-20 patients with urinary catheters (urethral or suprapubic catheters) living in nursing homes (NHs) in Michigan. Patients who consent to participate in the study will be randomized to either the treatment or control group and will have either an active treatment UroShield® device attached or a sham UroShield® device attached to the external tubing of their urinary catheter. Participants will wear the device continuously for a maximum of 90 days. Assessments of pain and quality-of-life will be conducted by study staff over a maximum of 6 study visits, along with clinical data collection via medical record review. A urine sample and catheter sample will also be collected by study staff at each catheter change (approximately every 30 days).

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Saline, Michigan, United States, 48176
        • Evangelical Home - Saline

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male or female age 18+
  • Indwelling urinary catheter (urethral or suprapubic) in place
  • Written informed consent (and assent, when applicable) obtained from participant or participant's legal representative
  • Able to comply with the requirements of the study

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • Antibiotic use in past 10 days
  • Ineligible catheter type in place (e.g., antimicrobial coated, 3-way catheter, condom catheter, nephrostomy tube, wicking device)
  • Participation in another drug or device study in past 30 days
  • History of poor compliance to medical treatment regimens
  • Conditions that may severely compromise their ability to complete the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active UroShield
Active UroShield Device
Device: Active UroShield
Participants will have an active device (i.e., ultrasound energy is being produced by actuator) attached to their urinary catheter tube.
Sham Comparator: Sham UroShield
Inactive UroShield device
Device: Sham UroShield
Participants will have an inactive device (i.e., no ultrasound energy being produced by the actuator) attached to their urinary catheter tube. All other aspects of the sham device (look, weight, feel, sound, and operation) are identical to the active device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: Summarized every month for 6 months, or until the recruitment goal is reached.
Number of patients enrolled out of number of patients eligible to participate in the study.
Summarized every month for 6 months, or until the recruitment goal is reached.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device use adherence
Time Frame: Summarized every month for at least 6 months, or until the recruitment goal is reached.
Number of patients with at least 80% adherence out of total patients enrolled. Device adherence will be assessed via direct observation by study staff as well as patient/caregiver/clinician-reported (via written documentation or phone/email correspondence).
Summarized every month for at least 6 months, or until the recruitment goal is reached.
Device accountability
Time Frame: Summarized every month for at least 6 months, or until the recruitment goal is reached.
Number of devices used out of the number of devices received. Extra components of the device (i.e., actuators) will be available to the study team; monitoring their use will validate amount and type of resources needed for intervention implementation.
Summarized every month for at least 6 months, or until the recruitment goal is reached.
Efficiency of data collection
Time Frame: Summarized every month for at least 6 months, or until the recruitment goal is reached.
Time required for survey completion and data abstraction via chart review (actual time/expected time).
Summarized every month for at least 6 months, or until the recruitment goal is reached.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Nanovibronix

Investigators

  • Principal Investigator: Lona Mody, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2024

Primary Completion (Actual)

October 18, 2024

Study Completion (Actual)

November 1, 2024

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 20, 2024

Study Record Updates

Last Update Posted (Actual)

November 29, 2024

Last Update Submitted That Met QC Criteria

November 27, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00243293

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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