Evaluation of the Novel Silq ClearTract Catheter in Patients With Chronic Urinary Retention

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

Study Overview

• Status: Completed
• Conditions: Catheter Infection; Catheter Blockage; Catheter Related Complication; Catheter Calcification
• Intervention / Treatment: Device: SILQ ClearTract 100% Silicone 2-Way Foley Catheter

Detailed Description

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

Neurogenic bladder is commonly managed with indwelling catheters (urethral or suprapubic). Indwelling catheters are associated with multiple complications, including recurrent urinary tract infections and catheter obstruction. A randomly assigned catheter will be inserted using standard techniques. The assigned catheters will either be the SILQ ClearTract 100% Silicone 2-Way Foley Catheter or the current standard of care catheter. Subjects will continue to use the assigned catheter for a period of approximately 3 months following regular standard of care. Subjects will then be assigned the alternative catheter for an additional 3 month period after which they will be exited from the study

The purpose of the study is to compare the incidence of catheter-related complications between the SILQ treated catheter and the current standard of care catheter(s). Because these complications lead to more frequent interventions and associated treatment costs, the study will also calculate the economic impact of the use of SILQ treated catheters compared to standard of care catheters. Patient-reported outcomes will also be measured via questionnaires upon each study visit. Explanted catheter samples will also be sent to a core lab for quantification of the calcification present on the catheter surface.

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Downey, California, United States, 90242
      • Rancho Los Amigos National Rehabilitation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• At least 18 years old
• Requirement of a 14 Fr, 16Fr, or 18Fr indwelling urethral or suprapubic urinary catheter (for at least 6 months) for bladder drainage.
• Able and willing to comply with study procedures
• Able and willing to give informed consent.

Exclusion Criteria:

• History of reconstructive bladder surgery such as bladder augmentation or continent catheterizable stoma.
• Cognitive deficit limiting the ability to respond to clinical questionnaires.
• Allergy or sensitivity to any catheter material used in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SILQ ClearTract 100% Silicone 2-Way Foley Catheter; Subjects in this arm will receive the SILQ ClearTract 100% Silicone 2-Way Foley Catheter for approximately the first 3 month period of enrollment. In a subsequent period of approximately 3 months subjects in this arm will receive their current standard of care catheter.	Device: SILQ ClearTract 100% Silicone 2-Way Foley Catheter; A foley catheter is assigned and used according to regular standard of care
Active Comparator: Standard of Care Catheter; Subjects in this arm will receive their current Standard of Care Catheter for the first 3 month period of enrollment. In a subsequent period of approximately 3 months subjects in this arm will receive the SILQ ClearTract 100% Silicone 2-Way Foley Catheter	Device: SILQ ClearTract 100% Silicone 2-Way Foley Catheter; A foley catheter is assigned and used according to regular standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Catheter Related Complications	Catheter Related Complications can be classified as: i. Symptomatic Catheter Associated Urinary Tract Infection ii. Catheter Blockage iii. General Premature Interventions: Patient sought care for a catheter-related issue prior to their scheduled catheter exchange	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Catheter Related Complication Treatment Costs	All data related to complications and associated treatments will be tabulated. Corresponding treatment costs for each complication will be tabulated.	6 months
Catheter Encrustation	Quantitative chemical and gravimetric analysis of encrustation of removed catheters	6 months
Patient Preference	During the first exchange after the crossover, subjects will be asked which catheter they would prefer to continue to use	4 months
Patient Satisfaction	Pain and discomfort will be assessed upon each foley catheter removal using a 5 point scale. A score of 1 indicates no pain or discomfort and a score of 5 indicates severe pain or discomfort.	6 months

Collaborators and Investigators

• Sponsor: Silq Technologies Corporation
• Investigators: Principal Investigator: Evgeniy Kreydin, M.D., Rancho Los Amigos National Rehabilitation Center

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2023
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): April 18, 2026

Study Registration Dates

• First Submitted: June 16, 2023
• First Submitted That Met QC Criteria: June 30, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Urinary Retention
• Other Study ID Numbers: STC002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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