← Back to Search

Procedure

SILQ ClearTract Catheter for Chronic Urinary Retention

N/A

Recruiting

Led By Evgeniy Kreydin, M.D.

Research Sponsored by Silq Technologies Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Cognitive deficit limiting the ability to respond to clinical questionnaires

History of reconstructive bladder surgery such as bladder augmentation or continent catheterizable stoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial compares the safety of a new Foley catheter to existing ones to reduce medical complications.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort during insertion or removal of the catheter, urinary tract infections, irritation at the insertion site, and possible blockage or calcification of the catheter.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I have been using a specific size urinary catheter for bladder drainage for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I have had surgery to reconstruct my bladder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Catheter Related Complications

Secondary study objectives

Catheter Encrustation

Catheter Related Complication Treatment Costs

Patient Preference

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 4Eligibility criteria met