Clinical trial NCT06319352: Evaluation of Quality-of-Life Improvements Using UroShield Device
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Catheter-Associated Urinary Tract Infection
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Nanovibronix
First posted: 2024-03-20
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

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 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).

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate
timeFrame: Summarized every month for 6 months, or until the recruitment goal is reached.
Secondary outcomes:
measure: Device use adherence
timeFrame: Summarized every month for at least 6 months, or until the recruitment goal is reached.
measure: Device accountability
timeFrame: Summarized every month for at least 6 months, or until the recruitment goal is reached.
measure: Efficiency of data collection
timeFrame: Summarized every month for at least 6 months, or until the recruitment goal is reached.
Other outcomes:
Locations:
city: Saline
country: United States
facility: Evangelical Home - Saline
state: Michigan
Study officials:
affiliation: University of Michigan
name: Lona Mody
role: PRINCIPAL_INVESTIGATOR
References: