Catheter-Associated Urinary Tract Infection, Quality of Life
Conditions
Brief 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 participants with urinary catheters (urethral or suprapubic catheters) living in nursing homes (NHs) in Michigan. Participants providing consent 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).
Interventions
DEVICEActive UroShield
Participants will have an active device (i.e., ultrasound energy is being produced by actuator) attached to their urinary catheter tube.
DEVICESham 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.
Sponsors
University of Michigan
Nanovibronix
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as Measured by Recruitment rate | Summarized every month for 6 months, or until the recruitment goal is reached. | Feasibility was determined by the number of participants enrolled out of the number of participants eligible to participate in the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device use adherence | 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). |
| Device accountability | 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. |
| Efficiency of data collection | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLona Mody
University of Michigan
Outcome results
None listed