Randomized Study of Silq Urinary Catheter
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.12345
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
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.
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.
Treatment Details
Interventions
- Other commercially available urinary catheters
- Silq ClearTract™ 100% Silicone 2-Way Foley Catheter
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hydrophilix
Lead Sponsor
Silq Technologies Corporation
Lead Sponsor