NCT06319352

Evaluation of Quality-of-Life Improvements Using UroShield Device

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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).

Conditions

• Quality of Life
• Catheter-Associated Urinary Tract Infection

Interventions

Type	Name	Description
DEVICE	Active UroShield	Participants will have an active device (i.e., ultrasound energy is being produced by actuator) attached to their urinary catheter tube.
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.

Timeline

• Start date: 2024-04-29
• Primary completion: 2024-10-18
• Completion: 2024-11-01
• First posted: 2024-03-20
• Last updated: 2024-11-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study