A randomized, single-blind, multi-center clinical observational study of a new super lubricath coating catheter latex catheters using in urethral catheterization

ABSTRACT

Polymer polyvinylpyrrolidone (PVP) can be described as the main coating. After heating and curing, it is able to build a strong adhesion to the latex catheter for creating a durable and effective hydrophilic coating. In this study, we aim to explore the advantages and disadvantages of the new super lubricath latex catheter PVP coating compared with the common latex catheter. 148 patients who participated in the study were completely randomly divided into two groups, the observation group and the control group. When the urinary catheter was incubated, indwelling in subjects’ body, and removed from the subjects, the researchers accordingly recorded the subjects’ comfort feedback, device safety evaluation and the patient’s vital signs, relevant blood and urine examination index, electrocardiogram (ECG) changes and recorded various adverse events. PVP super lubricath coating latex catheter offered better comfort, less damage to the urethra, and no significant disadvantage in safety compared to regular latex catheters, improving quality of care and patient satisfaction compared to regular latex urinary catheters.

KEYWORDS:

• Polyvinyl pyrrolidone (PVP)
• latex catheter
• comfort level
• safety
• randomized controlled trial

Disclosure statement

No potential conflict of interest was reported by the author(s).

Medical ethics and informed consent

This study was reviewed by the Ethics Committee of Drug (Device) Clinical Trials of Sichuan Academy of Medical Sciences-Sichuan Provincial People’s Hospital, No. NO: Lun Audit (Armament) No. 8–1, 2018, in accordance with the Ministry of Health’s Measures for Ethical Review of Biomedical Research Involving Human Beings (2016), CFDA’s Specifications for Quality Management of Drug Clinical Trials (2003), Medical Device Clinical Trial Quality Management Specification (2016), the Ethical Principles for Ethical Review of Drug Clinical Trials (2010), the WMA Declaration of Helsinki (2013) and the ethical principles of the CIOMS International Ethical Guidelines for Human Biomedical Research (2002). This study had a qualified study protocol, informed consent form, investigator’s manual, and subject rating scale. All subjects and their families were fully informed about the specific classes of this study, voluntarily agreed to participate and signed the informed consent form.

Trial registration

Registration agency: Sichuan Food and Drug Administration

Registration No.: Chuan20180006

Additional information

Funding

The work was supported by the Study on super hydrophilic and super lubricated surface modification of implant/interventional medical catheter and instrument by China Biotechnology Development Center/National Key R&D Project [2020YFC1107300]; Chengdu Dexinan Innovative Medical Technology Co.