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Evaluation of Quality-of-Life Improvements Using UroShield Device
Sponsor: University of Michigan
Summary
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.
Official title: Evaluation of Quality-of-Life Improvements Using UroShield for Patients Living in Long Term Care Facilities With Indwelling Urinary Catheters - A Pilot Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2024-04-29
Completion Date
2024-11-01
Last Updated
2026-07-29
Healthy Volunteers
Yes
Interventions
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.
Locations (1)
Evangelical Home - Saline
Saline, Michigan, United States