Silicone Urinary Catheter for Urinary Tract Infection

No longer recruiting at 8 trial locations

Overseen By Brian McVerry, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hydrophilix

Must not be taking: Antibiotics

Disqualifiers: Urethral stricture, UTI, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 28 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of urinary catheter, the Silq ClearTract, to determine if it reduces bacterial buildup more effectively than other catheters. It targets individuals who require long-term catheter use, a tube that helps drain the bladder. Participants must have used a 16Fr Foley catheter for at least a week. The goal is to discover if this new catheter can enhance the quality of life and health for those who depend on these devices. As an unphased trial, this study allows participants to contribute to innovative research that could advance catheter technology and improve patient comfort.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on antibiotics for any infection at the time of catheter implantation.

What prior data suggests that the Silq ClearTract™ 100% Silicone 2-Way Foley Catheter is safe for long-term use?

Research has shown that the Silq ClearTract™ 100% Silicone 2-Way Foley Catheter is FDA-approved for safely draining the bladder. Its design ensures smooth and easy insertion, enhancing comfort and safety for patients.

The catheter has passed strict safety tests, confirming it does not cause harmful reactions in the body.

Past studies indicate that patients generally tolerate silicone catheters like the Silq ClearTract well, with rare unwanted effects. This suggests the catheter is safe for use in people. However, as with any medical device, individual experiences can differ, so discussing any concerns with a doctor is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Silq ClearTract™ 100% Silicone 2-Way Foley Catheter because it offers a fully silicone design, which can reduce the risk of allergic reactions and infections compared to standard latex options. Unlike traditional Foley catheters, which are often silicone-coated latex or silver-coated latex, the Silq ClearTract™ eliminates latex altogether, making it a safer option for patients with latex sensitivities. Additionally, the pure silicone material is known for its durability and biocompatibility, potentially leading to more comfortable and longer-lasting catheterization experiences for patients.

What evidence suggests that the Silq ClearTract™ 100% Silicone 2-Way Foley Catheter is effective for reducing biofilm formation?

Research has shown that the Silq ClearTract™ 100% Silicone 2-Way Foley Catheter, a treatment under study in this trial, might help reduce bacterial build-up. This build-up, known as biofilm, can adhere to surfaces like catheters and may lead to infections. Some early studies suggest that this catheter could lower the risk of complications associated with long-term catheter use. Its silicone composition might attract less bacteria than other materials. While more evidence is still being collected, the catheter aims to improve patient health by reducing these common issues. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

Adults aged 18 or older who need a long-term Foley catheter (16Fr size) for at least 7 days can join. They must be able to follow the study's procedures and give informed consent. People with allergies to catheter materials, urethral strictures, current UTI or other infections treated with antibiotics, needing bladder irrigation during the study, pregnant or breastfeeding women, and those in another trial cannot participate.

Inclusion Criteria

Able and willing to comply with study procedure; and

I need a specific catheter in place for at least a week.

Requiring indwelling 16Fr Foley catheter for at least 7 days;

Exclusion Criteria

Any other condition that, in the opinion of the investigator, precludes study participation or poses a significant hazard in case of study participation

Currently enrolled in another interventional clinical trial

I am on antibiotics for an infection during my catheter placement.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

A randomly assigned catheter will be inserted using standard techniques. Non-surgical subjects will rate the level of pain associated with the insertion procedure using the visual analog scale (VAS). A urine sample will be collected immediately after catheter insertion for baseline urinalysis and urine culture.

28 days

1 visit (in-person) for insertion, 1 visit (in-person) for removal

Follow-up

Follow-up visits will be performed on Day 28, or upon catheter removal, whichever occurs first. The catheter will be removed and processed for analysis. Urine will be collected prior to removal for urinalysis and urine culture. Subjects will rate pain associated with removal using VAS and complete a questionnaire about their experience.

28 days

1 visit (in-person) for follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Other commercially available urinary catheters
• Silq ClearTract™ 100% Silicone 2-Way Foley Catheter

Trial Overview The trial is testing if the Silq ClearTract™ Silicone Foley Catheter is better at preventing biofilm formation compared to standard urinary catheters in patients requiring long-term use. Participants will be randomly assigned to receive either the Silq catheter or a commercial one.

How Is the Trial Designed?

Group I: Silq ClearTract™ 100% Silicone 2-Way Foley Catheter Active Control 1 Intervention

Up to 82 subjects

Group II: Silicone-coated Latex 2-Way Foley catheter Active Control 1 Intervention

Up to 82 subjects

Group III: Silver-coated Latex 2-Way Foley Catheter Active Control 1 Intervention

Up to 82 subjects

Who Is Running the Clinical Trial?

Hydrophilix

Lead Sponsor

Trials

1

Recruited

160+

Silq Technologies Corporation

Lead Sponsor

Trials

2

Recruited

360+

Published Research Related to This Trial

Indwelling urethral (Foley) catheters, designed for bladder drainage, are increasingly used in elderly patients, particularly in home care settings, due to rising numbers of individuals with urinary issues.

Despite their utility, Foley catheters are linked to various complications that can increase patient morbidity and mortality, highlighting the need for effective management strategies and retraining after catheter removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing indwelling urethral catheters. Newman, DK.[2007]

The use of Foley catheters, while common for indwelling bladder drainage, is associated with serious complications such as infections, kidney damage, and significant healthcare costs, amounting to £1.0-2.5 billion annually in the UK and approximately 2100 deaths per year.

There is an urgent need for a new indwelling catheter system that is safer and more effective, with features that allow for easy insertion, reliable retention, and natural bladder function, to reduce the risks associated with current catheter use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urinary catheters: history, current status, adverse events and research agenda. Feneley, RC., Hopley, IB., Wells, PN.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04841226

NCT04841226 | Randomized Study of Silq Urinary Catheter To assess the ability of the Silq ClearTract™ 100% Silicone 2-Way Foley Catheter to reduce biofilm formation in subjects that require a long-term indwelling ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05931887/evaluation-of-the-novel-silq-cleartract-catheter-in-patients-with-chronic-urinary-retention

Evaluation of the Novel Silq ClearTract Catheter in Patients ... To assess the ability of the Silq ClearTract™ 100% Silicone 2-Way Foley Catheter to reduce catheter associated complications in subjects ...

3. withpower.com withpower.com/trial/phase-9-2021-7caae

Randomized Study of Silq Urinary Catheter The research does not provide direct evidence about the effectiveness of the Silq ClearTract™ 100% Silicone 2-Way Foley Catheter, but it does highlight the ...

4. clinconnect.io clinconnect.io/trials/NCT05931887

Evaluation of the Novel Silq ClearTract Catheter in - ClinConnect This clinical trial is studying a new type of catheter called the Silq ClearTract™ 100% Silicone 2-Way Foley Catheter. Researchers want to see if this catheter ...

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K221625.pdf

July 1, 2022 Silq Technologies Corporation Sigi Caron, MBA ... The 2-Way 100% Silicone ClearTract Catheter is intended for drainage of the urinary tract. Catheterization is accomplished by inserting the.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K222118.pdf

December 1, 2022 SILQ Technologies, Corp. Aaron Rogers ... Intended population is adults and pediatrics. The 2-Way 100% Silicone. ClearTract Catheter is intended for drainage of the urinary tract.

7. silq.tech silq.tech/cleartract-foley-catheters

CLEARTRACT CATHETERS FDA Cleared for Urethral, Suprapubic, and Nephrostomy Use. Silq-treated devices meet the most rigorous requirements for biocompatibility testing · Antibiotic ...

8. static.webareacontrol.com static.webareacontrol.com/CommonFile/silq-brochure-1733120544001.pdf

foley catheter SILQT TREATED SILICONE SURFACE. Page 3. ClearTract™ Catheters: Improves Patient Comfort and Safety. SILQ'S TREATMENT INCREASES CATHETER LUBRICITY BY UP TO 18X,.