Clinical Study on Disposable Sterile Urinary Catheter

Shandong Branden Med.Device

Status

Terminated

Conditions

Urinary Tract Infection

Urinary Catheters

Treatments

Device: disposable urinary catheter

Device: super smooth antibacterial urinary catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT05651217

B201703

Details and patient eligibility

About

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.

Enrollment

136 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18-80 year old patients;
Retained catheter ≥ 7 days;
Patients who were conscious and had good communication skills and volunteered to participate in the study.

Exclusion criteria

Pregnant and lactating female patients;
Diabetes patients;
Patients allergic to sulfadiazine, silica gel and stainless steel;
Urethral malformation, acute urethral injury, prostate disease, intermittent catheterization, suprapubic cystostomy and other patients who are not suitable for catheterization;
Patients who have used urinary catheters for a long time or had catheters retained within one week;
Patients who are participating in other clinical trials that interfere with this trial.