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

Silq Technologies

Status: Enrolling

Conditions: Catheter Calcification; Catheter Related Complication; Catheter Blockage; Catheter Infection

Treatments: Device: SILQ ClearTract 100% Silicone 2-Way Foley Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT05931887

STC002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

SILQ ClearTract 100% Silicone 2-Way Foley Catheter

Active Comparator group

Description:

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.

Treatment:

Device: SILQ ClearTract 100% Silicone 2-Way Foley Catheter

Standard of Care Catheter

Active Comparator group

Description:

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

Treatment:

Device: SILQ ClearTract 100% Silicone 2-Way Foley Catheter