Evaluation of Quality-of-Life Improvements Using UroShield Device
Completed · Not applicable · Has a placebo group
Conditions studied: Quality of Life, Catheter-Associated Urinary Tract Infection
In brief
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.
Key facts
- Study ID
- NCT06319352
- Run by
- University of Michigan
- People needed
- 18
- Starts
- 2024-04-29
- Expected to finish
- 2024-11-01
- Last updated by the study team
- 2026-07-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Evangelical Home - Saline — Saline, Michigan, United States
Full record on ClinicalTrials.gov
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