SILQ ClearTract Catheter for Chronic Urinary Retention

Recruiting in Palo Alto (17 mi)

Overseen byEvgeniy Kreydin, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Silq Technologies Corporation

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults over 18 who need a long-term urinary catheter (14Fr, 16Fr, or 18Fr) for bladder drainage and can follow the study's procedures. They must be able to consent to participate. People with past bladder reconstruction surgery, allergies to catheter materials, or cognitive issues affecting questionnaire responses cannot join.

Inclusion Criteria

I am 18 years old or older.

Able and willing to comply with study procedures

Able and willing to give informed consent

+1 more

Exclusion Criteria

I have difficulty understanding or answering questions due to cognitive issues.

I have had surgery to reconstruct my bladder.

Allergy or sensitivity to any catheter material used in this study

Participant Groups

The trial is testing the Silq ClearTract™ Silicone Foley Catheter's effectiveness in reducing complications like infections and blockages compared to other Foley catheters in patients requiring long-term use.

2Treatment groups

Active Control

Group I: SILQ ClearTract 100% Silicone 2-Way Foley CatheterActive Control1 Intervention

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.

Group II: Standard of Care CatheterActive Control1 Intervention

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