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

Catheter Related Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05931887
• Other study ID #: STC002
• Status: Recruiting
• Phase: N/A
• Start date: July 26, 2023
• Est. completion date: December 26, 2024

Study information

• Verified date: July 2023
• Source: Silq Technologies Corporation
• Contact: Ethan Rao
• Phone: 424-309-8496
• Email: EthanR[@]silq.tech
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 26, 2024
• Est. primary completion date: October 26, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Catheter Blockage
• Catheter Infection
• Catheter Related Complication
• Urinary Retention

Intervention

Device:
• SILQ ClearTract 100% Silicone 2-Way Foley Catheter
A foley catheter is assigned and used according to regular standard of care

Locations

Country	Name	City	State
United States	Rancho Los Amigos National Rehabilitation Center	Downey	California

Sponsors (1)

Lead Sponsor	Collaborator
Silq Technologies Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Catheter Encrustation	Quantitative chemical and gravimetric analysis of encrustation of removed catheters	6 months
Secondary	Patient Preference	During the first exchange after the crossover, subjects will be asked which catheter they would prefer to continue to use	4 months
Secondary	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