Evaluation of Quality-of-Life Improvements Using UroShield Device
NCT ID: NCT06319352
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2024-04-29
2024-11-01
Brief Summary
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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.
Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DEVICE_FEASIBILITY
QUADRUPLE
Study Groups
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Active UroShield
Active UroShield 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 UroShield
Inactive UroShield 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.
Interventions
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Active UroShield
Participants will have an active device (i.e., ultrasound energy is being produced by actuator) attached to their urinary catheter tube.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Nanovibronix
INDUSTRY
University of Michigan
OTHER
Responsible Party
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Lona Mody
Principal Investigator, Professor of Internal Medicine
Principal Investigators
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Lona Mody
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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Evangelical Home - Saline
Saline, Michigan, United States
Countries
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Other Identifiers
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HUM00243293
Identifier Type: -
Identifier Source: org_study_id