Catheter Blockage, Catheter Calcification, Catheter Infection, Catheter Related Complication
Conditions
Brief 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.
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.
Interventions
DEVICESILQ ClearTract 100% Silicone 2-Way Foley Catheter
A foley catheter is assigned and used according to regular standard of care
Sponsors
Silq Technologies Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Catheter Related Complications | 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
| Measure | Time frame | Description |
|---|---|---|
| Catheter Related Complication Treatment Costs | 6 months | All data related to complications and associated treatments will be tabulated. Corresponding treatment costs for each complication will be tabulated. |
| Catheter Encrustation | 6 months | Quantitative chemical and gravimetric analysis of encrustation of removed catheters |
| Patient Preference | 4 months | During the first exchange after the crossover, subjects will be asked which catheter they would prefer to continue to use |
| Patient Satisfaction | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREvgeniy Kreydin, M.D.
Rancho Los Amigos National Rehabilitation Center
Outcome results
None listed