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UroShield Device for Urinary Tract Infections
N/A
Waitlist Available
Led By Lona Mody
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Antibiotic use in past 10 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up summarized every month for 6 months, or until the recruitment goal is reached.
Summary
"This trial is a small study to test different aspects of a larger study that will happen later. They want to see how easy it is to find and keep participants, how well participants follow the study rules
Who is the study for?
This trial is for adults 18+ with a urinary catheter in place who can follow the study's requirements. They must be able to give written consent or have it provided by their legal representative.
What is being tested?
The study tests the UroShield device, comparing an active version against a sham (inactive) one. It aims to improve quality of life and reduce urinary tract infections, focusing on practical aspects like recruitment, adherence, component replacement frequency, and data collection efficiency.
What are the potential side effects?
Since this is a pilot study primarily focused on feasibility rather than medical outcomes, specific side effects are not detailed. However, potential risks may relate to using the device itself which will be monitored throughout the trial.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not taken antibiotics in the last 10 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ summarized every month for 6 months, or until the recruitment goal is reached.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~summarized every month for 6 months, or until the recruitment goal is reached.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Recruitment rate
Secondary study objectives
Device accountability
Device use adherence
Efficiency of data collection
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active UroShieldExperimental Treatment1 Intervention
Active UroShield Device
Group II: Sham UroShieldPlacebo Group1 Intervention
Inactive UroShield device
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,857 Previous Clinical Trials
6,437,632 Total Patients Enrolled
2 Trials studying Urinary Tract Infection
240 Patients Enrolled for Urinary Tract Infection
NanovibronixIndustry Sponsor
6 Previous Clinical Trials
451 Total Patients Enrolled
2 Trials studying Urinary Tract Infection
224 Patients Enrolled for Urinary Tract Infection
Lona ModyPrincipal InvestigatorUniversity of Michigan
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