📊 Evidence-Based Reference
Amsure Hydrophilic Intermittent Catheter
Summary: The Amsure Hydrophilic Intermittent Catheter is designed for intermittent urinary catheterization. It is primarily used to manage urinary retention. Key evidence highlights its cost-effectiveness and user satisfaction.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K181445 ↗
Decision Date ?
October 1, 2018
Product Code ?
EZD
Device Class ?
Class 2
Evidence ?
419 studies
The Amsure Hydrophilic Intermittent Catheter was cleared by the FDA via the 510(k) pathway on October 1, 2018. It is manufactured by Amsino International and classified as a Class 2 device.
What It Is
The Amsure Hydrophilic Intermittent Catheter is a medical device used for intermittent urinary catheterization. It features a hydrophilic coating that is activated by water to facilitate smoother insertion and removal, reducing friction and discomfort.
FDA-Cleared Indications
- For intermittent urinary catheterization to drain the bladder.
- For use in patients who require intermittent catheterization because of urinary retention or incomplete bladder emptying.
Clinical Applications
- Intermittent bladder drainage in patients with neurogenic urinary retention.
- Intermittent bladder drainage in patients with non-neurogenic urinary retention.
- Catheterization for patients with impaired bladder emptying related to conditions such as spinal cord injury or multiple sclerosis, when intermittent catheterization is prescribed.
- Intermittent catheterization when a hydrophilic-coated catheter is selected to facilitate insertion and removal.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials, prospective and retrospective analyses, and meta-analyses. These studies span from 2022 to 2023 and focus on user perception, cost-effectiveness, and comparative efficacy of hydrophilic versus non-hydrophilic catheters.
Reported Outcomes
Published studies report that hydrophilic-coated catheters are associated with higher user satisfaction and preference compared to non-hydrophilic catheters. They also demonstrate cost-effectiveness in long-term use and may reduce the incidence of urinary tract infections and urethral trauma.
Safety Profile
Reported complications include urinary tract infections, urethral trauma, and hematuria. However, hydrophilic coatings are designed to minimize these risks by reducing friction during catheterization.
Evidence Limitations
The evidence is limited by a lack of large-scale, long-term studies directly comparing different types of hydrophilic catheters. Further research is needed to establish definitive safety and efficacy profiles across diverse patient populations.
Practical Considerations
- Catheters are available in different lengths and French sizes; the appropriate size and length depend on the patient, anatomy and prescribing clinician's instructions.
- The hydrophilic coating requires activation with water according to the product instructions before insertion.
- Use only once if labeled as single-use, and follow clean or sterile intermittent-catheterization instructions provided by the clinician.
- Do not use if the package is damaged, expired or contaminated. Patients with urethral trauma, significant obstruction or active urinary infection should be assessed by a clinician before catheterization.
- MRI considerations depend on the specific catheter materials and labeling. Confirm the current product's MRI status with the manufacturer or product instructions rather than assuming it is MRI safe.
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 Amsure Hydrophilic Intermittent Catheter?
The catheter is indicated for patients requiring intermittent catheterization due to urinary retention from neurogenic or non-neurogenic causes.
What outcomes have been reported in clinical studies?
Studies report improved user satisfaction, cost-effectiveness, and a potential reduction in urinary tract infections with hydrophilic-coated catheters.
What complications have been reported?
Safety data indicate risks of urinary tract infections, urethral trauma, and hematuria, though hydrophilic coatings aim to reduce these complications.
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.