📊 Evidence-Based Reference
PVC Hydrophilic Urethral Catheter
Summary: The PVC hydrophilic urethral catheter by Well Lead Medical is designed for urinary catheterization. It is primarily used to reduce complications associated with catheterization. Key evidence highlights its potential in minimizing urinary tract infections and urethral trauma.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K220722 ↗
Decision Date ?
May 22, 2023
Product Code ?
EZD
Device Class ?
Class 2
Evidence ?
419 studies
The PVC hydrophilic urethral catheter was cleared by the FDA through the 510(k) pathway on May 22, 2023. It is manufactured by Well Lead Medical and classified as a Class 2 device under product code EZD.
What It Is
The PVC hydrophilic urethral catheter is a medical device designed for urinary catheterization. It features a hydrophilic coating intended to reduce friction during insertion and removal, thereby minimizing urethral trauma and discomfort.
FDA-Cleared Indications
- Urinary catheterization through the urethra to drain the bladder.
- Intermittent catheterization for patients with urinary retention or impaired bladder emptying.
Clinical Applications
- Clean intermittent catheterization for urinary retention.
- Intermittent bladder drainage in patients with neurogenic or dysfunctional bladder, when prescribed by a clinician.
- Urethral catheterization to obtain bladder urine when catheterization is clinically indicated.
- Short-term bladder drainage when a urethral catheter is appropriate.
Evidence Summary
The literature includes 11 studies, comprising randomized controlled trials, meta-analyses, and systematic reviews, conducted between 2017 and 2025. These studies evaluate the efficacy and safety of hydrophilic versus non-hydrophilic catheters.
Reported Outcomes
Published studies report that hydrophilic catheters may reduce the incidence of urinary tract infections and urethral trauma compared to non-hydrophilic catheters. Meta-analyses suggest improved patient comfort and reduced hematuria with hydrophilic coatings.
Safety Profile
Reported complications include urinary tract infections, urethral trauma, and hematuria. However, hydrophilic coatings are associated with a lower risk of these adverse events compared to conventional PVC catheters.
Evidence Limitations
The evidence is limited by the variability in study designs and the heterogeneity of patient populations. Further research is needed to establish long-term outcomes and the cost-effectiveness of hydrophilic catheters in diverse clinical settings.
Practical Considerations
- The catheter should be selected in the prescribed French size and appropriate length for the patient; pediatric and adult sizes may differ.
- Hydrophilic coatings generally require activation with sterile water or another solution according to the product instructions before insertion.
- Use sterile or clean technique as directed by the clinician, and do not reuse a single-use catheter unless the labeling specifically permits it.
- Do not use when urethral injury or another contraindication to urethral catheterization is suspected; seek medical evaluation for bleeding, severe pain, or inability to advance the catheter.
- MRI safety should be confirmed in the current product labeling. The catheter should be removed before MRI unless its MR status is specifically documented.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for PVC hydrophilic urethral catheter?
The catheter is indicated for clean intermittent catheterization in patients with urinary retention or bladder dysfunction.
What outcomes have been reported in clinical studies?
Studies report reduced urinary tract infections and urethral trauma with hydrophilic catheters compared to non-hydrophilic ones.
What complications have been reported?
Safety data indicate complications such as urinary tract infections and urethral trauma, though these are less common with hydrophilic coatings.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.