NCT05651217

Clinical Study on Disposable Sterile Urinary Catheter

A Multicenter, Prospective, Randomized Controlled Clinical Study to Evaluate the Safety and Effectiveness of Disposable Sterile Urinary Catheter

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Shandong Branden Med.Device Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized controlled study, with the urinary tract infection rate at the time of catheter insertion for 1 week as the primary end point. By comparing the clinical safety and effectiveness of two kinds of urethral catheters, to evaluate the clinical application effect of one kind of urethral catheters.

Conditions

• Urinary Catheters
• Urinary Tract Infection

Interventions

Type	Name	Description
DEVICE	disposable urinary catheter	The trial group was intervened with disposable sterile urinary catheter. The model of the trial group includes two chamber type (Fr8, Fr10, Fr12, Fr14, Fr16, Fr18, Fr20, Fr22, Fr24) and three chamber type (Fr16, Fr18, Fr20, Fr22, Fr24).
DEVICE	super smooth antibacterial urinary catheter	the control group was intervened with ultra smooth antibacterial catheter. The control group models include single chamber (6Fr, 8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr, 20Fr, 22Fr, 24Fr), double chamber (6Fr, 8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr, 20Fr, 22Fr, 24Fr, 26Fr, 28Fr, 30Fr), and three chamber (16Fr, 18Fr, 20Fr, 22Fr, 24Fr, 26Fr)

Timeline

• Start date: 2019-12-11
• Primary completion: 2021-09-12
• Completion: 2023-02-10
• First posted: 2022-12-14
• Last updated: 2023-02-21

Locations

1 site across 1 country: China