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NCT Number: NCT06319352

Evaluation of Quality-of-Life Improvements Using UroShield Device

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.

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Key information

Conditions

Quality of Life Catheter-Associated Urinary Tract Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Evangelical Home - Saline

Saline, Michigan, 48176, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active UroShield

Device

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

Sham UroShield

Device

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.

Primary outcomes

  1. Recruitment rate

    Time frame: Summarized every month for 6 months, or until the recruitment goal is reached.

    Number of patients enrolled out of number of patients eligible to participate in the study.

Secondary outcomes

  1. Device use adherence

    Time frame: 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).

  2. Device accountability

    Time frame: 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.

  3. Efficiency of data collection

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Nanovibronix

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 20, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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