Randomized Study of Silq Urinary Catheter

Recruiting at 7 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

158 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a special silicone urinary catheter to see if it reduces bacterial buildup in patients who need catheters for extended periods. The goal is to prevent infections and other complications.

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 data supports the effectiveness of the treatment Silq ClearTract™ 100% Silicone 2-Way Foley 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 need for improved catheter systems due to complications associated with traditional Foley catheters, such as infections and bladder damage. This suggests that new designs, like the Silq ClearTract™, may aim to address these issues. ^{1 2 3 4 5}

Eligibility Criteria

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 am 18 years old or older.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a novel silver-impregnated urinary catheter system for preventing catheter-associated bacteriuria: a pilot randomized clinical trial. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

[Can silicon diffusion from silicone rubber catheters cause urethral stricture?]. [2006]

3. Spain pubmed.ncbi.nlm.nih.gov

[A new solution to the retained Foley catheter]. [2006]

4. United States pubmed.ncbi.nlm.nih.gov

Managing indwelling urethral catheters. [2007]

5. England pubmed.ncbi.nlm.nih.gov

Urinary catheters: history, current status, adverse events and research agenda. [2022]