Evaluation of the Novel Silq ClearTract Catheter in Patients With Chronic Urinary Retention
1 other identifier
interventional
115
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2023
CompletedFirst Posted
Study publicly available on registry
July 5, 2023
CompletedStudy Start
First participant enrolled
July 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 18, 2026
CompletedApril 24, 2026
April 1, 2026
2.4 years
June 16, 2023
April 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Catheter Related Complication Treatment Costs
6 months
Catheter Encrustation
6 months
Patient Preference
4 months
Patient Satisfaction
6 months
Study Arms (2)
SILQ ClearTract 100% Silicone 2-Way Foley Catheter
ACTIVE COMPARATORSubjects 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.
Standard of Care Catheter
ACTIVE COMPARATORSubjects 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
Interventions
A foley catheter is assigned and used according to regular standard of care
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Evgeniy Kreydin, M.D.
Rancho Los Amigos National Rehabilitation Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2023
First Posted
July 5, 2023
Study Start
July 26, 2023
Primary Completion
December 31, 2025
Study Completion
April 18, 2026
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share