Evaluating a new catheter for chronic urinary retention
Evaluation of the Novel Silq ClearTract Catheter in Patients With Chronic Urinary Retention
NA · Silq Technologies Corporation · NCT05931887
This study is testing a new type of silicone catheter to see if it causes fewer problems for people with chronic urinary retention compared to standard catheters.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Silq Technologies Corporation (industry) |
| Locations | 1 site (Downey, California) |
| Trial ID | NCT05931887 on ClinicalTrials.gov |
What this trial studies
This study assesses the effectiveness of the Silq ClearTract 100% Silicone 2-Way Foley Catheter in reducing complications associated with long-term indwelling catheters compared to standard catheters. It is a prospective, randomized, multi-center study where participants will use either the Silq catheter or a standard catheter for approximately three months, followed by a crossover to the alternative catheter for another three months. The study will measure the incidence of catheter-related complications, economic impacts, and patient-reported outcomes throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who require a long-term indwelling urinary catheter for bladder drainage.
Not a fit: Patients with a history of reconstructive bladder surgery or cognitive deficits that limit their ability to participate may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a reduction in catheter-related complications and improve the quality of life for patients requiring long-term catheterization.
How similar studies have performed: While this approach is novel, similar studies have indicated the potential for improved outcomes with advanced catheter technologies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * Able and willing to comply with study procedures * Able and willing to give informed consent. Exclusion Criteria: * History of reconstructive bladder surgery such as bladder augmentation or continent catheterizable stoma. * Cognitive deficit limiting the ability to respond to clinical questionnaires. * Allergy or sensitivity to any catheter material used in this study.
Where this trial is running
Downey, California
- Rancho Los Amigos National Rehabilitation Center — Downey, California, United States (RECRUITING)
Study contacts
- Principal investigator: Evgeniy Kreydin, M.D. — Rancho Los Amigos National Rehabilitation Center
- Study coordinator: Ethan Rao
- Email: EthanR@silq.tech
- Phone: 424-309-8496
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Catheter Infection, Catheter Blockage, Catheter Related Complication, Catheter Calcification