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OpenTrials
Completed

NCT Number: NCT05931887

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.

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Key information

Conditions

Catheter Infection Catheter Blockage Catheter Calcification Catheter Related Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rancho Los Amigos National Rehabilitation Center

Downey, California, 90242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

SILQ ClearTract 100% Silicone 2-Way Foley Catheter

Device

A foley catheter is assigned and used according to regular standard of care

Primary outcomes

  1. Number of Catheter Related Complications

    Time frame: 6 months

    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

Secondary outcomes

  1. Catheter Related Complication Treatment Costs

    Time frame: 6 months

    All data related to complications and associated treatments will be tabulated. Corresponding treatment costs for each complication will be tabulated.

  2. Catheter Encrustation

    Time frame: 6 months

    Quantitative chemical and gravimetric analysis of encrustation of removed catheters

  3. Patient Preference

    Time frame: 4 months

    During the first exchange after the crossover, subjects will be asked which catheter they would prefer to continue to use

  4. Patient Satisfaction

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Silq Technologies Corporation

Industry

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jul 5, 2023
Registry last updated
Apr 24, 2026

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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