Clinical trial NCT05931887: Evaluation of the Novel Silq ClearTract Catheter in Patients With Chronic Urinary Retention
Official title: Evaluation of the Novel Silq ClearTract Catheter in Patients With Chronic Urinary Retention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Catheter Infection
Catheter Blockage
Catheter Related Complication
Catheter Calcification
Lead sponsor: Silq Technologies Corporation
Sponsor class: INDUSTRY
First posted: 2023-07-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Catheter Related Complications
timeFrame: 6 months
Secondary outcomes:
measure: Catheter Related Complication Treatment Costs
timeFrame: 6 months
measure: Catheter Encrustation
timeFrame: 6 months
measure: Patient Preference
timeFrame: 4 months
measure: Patient Satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Downey
country: United States
facility: Rancho Los Amigos National Rehabilitation Center
state: California
Study officials:
affiliation: Rancho Los Amigos National Rehabilitation Center
name: Evgeniy Kreydin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: