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

Last updated: May 12, 2025
Sponsor: Silq Technologies Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Genitourinary Prolapse

Urinary Incontinence

Enuresis

Treatment

SILQ ClearTract 100% Silicone 2-Way Foley Catheter

Clinical Study ID

NCT05931887
STC002
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At least 18 years old

  • Requirement of a 14 Fr, 16Fr, or 18Fr indwelling urethral or suprapubic urinarycatheter (for at least 6 months) for bladder drainage.

  • Able and willing to comply with study procedures

  • Able and willing to give informed consent.

Exclusion

Exclusion Criteria:

  • History of reconstructive bladder surgery such as bladder augmentation or continentcatheterizable stoma.

  • Cognitive deficit limiting the ability to respond to clinical questionnaires.

  • Allergy or sensitivity to any catheter material used in this study.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: SILQ ClearTract 100% Silicone 2-Way Foley Catheter
Phase:
Study Start date:
July 26, 2023
Estimated Completion Date:
July 26, 2025

Study 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.

Connect with a study center

  • Rancho Los Amigos National Rehabilitation Center

    Downey, California 90242
    United States

    Active - Recruiting

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