Randomized Study of Silq Urinary Catheter

Prospective, Multi-Center, Randomized Study to Assess the Ability of the Silq ClearTract™ Urinary Catheter to Reduce Biofilm Formation When Compared to Two Types of Commercially Available Foley Catheters (Silver-Coated Latex and Silicone-coated Latex)

To assess the ability of the Silq ClearTract™ 100% Silicone 2-Way Foley Catheter to reduce biofilm formation in subjects that require a long-term indwelling Foley catheter when compared to other commercially available urinary catheters.

Study Overview

• Status: Active, not recruiting
• Conditions: UTI; Biofilm Formation
• Intervention / Treatment: Device: Long-term indwelling Foley catheter

Detailed Description

A prospective, randomized, multi-center, post-market study in subjects that require a long-term indwelling Foley catheter.

A randomly assigned catheter will be inserted using standard techniques. Non-surgical subjects will rate the level of pain associated with the insertion procedure using the visual analog scale (VAS). A urine sample will be collected immediately after catheter insertion, in order to generate a baseline urinalysis and urine culture.

Follow-up visits will be performed on Day 28, or upon catheter removal, whichever occurs first. The catheter will be removed on Day 28 or earlier if clinically indicated. The removed catheter will be processed and sent to the core laboratory for analysis. Urine will be collected immediately prior to catheter removal in order to conduct urinalysis and urine culture. Subject will rate level of pain associated with the removal procedure using the VAS. The subject will also fill out a questionnaire about their experience with the catheterization immediately after catheter removal. Subjects will then be exited from the study.

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brian McVerry, PhD; Phone Number: 949-735-2614; Email: brianm@silq.tech

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85715
      • Urology Associates of Southern Arizona
  • California
    • Downey, California, United States, 90242
      • Rancho Los Amigos National Rehabilitation Center
    • Los Angeles, California, United States, 90073
      • West Los Angeles VA Medical Center
    • Murrieta, California, United States, 92562
      • Tri Valley Urology Medical Group
    • Santa Monica, California, United States, 90404
      • Providence Saint John's Health Center
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • The Iowa Clinic
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
  • Washington
    • Kirkland, Washington, United States, 98034
      • Evergreen Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female age ≥ 18 years old;
2. Requiring indwelling 16Fr Foley catheter for at least 7 days;
3. Able and willing to comply with study procedure; and,
4. Able and willing to give informed consent.

Exclusion Criteria:

1. Allergy or sensitivity to any catheter materials used in this study;
2. Known urethral stricture which, in the opinion of the investigator, could influence the subject's evaluation of the catheter;
3. Planned Prophylactic use of antibiotics for CAUTI or any other infection beyond day 1 of the study (catheter implantation);
4. Symptomatic UTI being treated with antibiotics (as determined by the study PI, including at least one of the following: fever, chills, headache, burning sensation, burning of urethra or genital area, blood in urine, foul smelling urine and ≥ 10,000 cfu/mL);
5. Any other infection being treated with antibiotics at the time of catheter implantation;
6. Subjects requiring bladder irrigation during the study (an active voiding trial in surgical subjects prior to catheter removal is allowed);
7. Currently enrolled in another interventional clinical trial;
8. Any other condition that, in the opinion of the investigator, precludes study participation or poses a significant hazard in case of study participation; and
9. Females who are pregnant or breastfeeding or who plan to become pregnant during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Silq ClearTract™ 100% Silicone 2-Way Foley Catheter; Up to 82 subjects	Device: Long-term indwelling Foley catheter; Foley Catheter inserted for up to 28-days
Active Comparator: Silver-coated Latex 2-Way Foley Catheter; Up to 82 subjects	Device: Long-term indwelling Foley catheter; Foley Catheter inserted for up to 28-days
Active Comparator: Silicone-coated Latex 2-Way Foley catheter; Up to 82 subjects	Device: Long-term indwelling Foley catheter; Foley Catheter inserted for up to 28-days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biofilm formation	A core lab will use the BacTiter-Glo Microbial Cell Viability Assay, a well characterized method for quantifying active biomass and biofilm, to determine biofilm formation on explanted catheter samples.	5 to 7 days

Collaborators and Investigators

• Sponsor: Silq Technologies Corporation

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2021
• Primary Completion (Estimated): February 29, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 12, 2021

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Urinary Catheter; Foley
• Other Study ID Numbers: STC-001/F

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No