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Efficacy and safety study of the disposable antibacterial silicone urinary catheter

Efficacy and safety of the disposable antibacterial silicone urinary catheter:a prospective multicenter randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068030
Enrollment
Unknown
Registered
2023-02-03
Start date
2023-02-06
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter-associated urinary tract infection

Interventions

experimental group:device: antibacterial silicone urinary catheter
control group:device: BIP Foley Catheter

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients need to indwelling urinary catheter for over 24 hours in the clinic; 2. Patients aged between 18 and 75 years old; 3. Patients who can do well communicated with investigators; 4. Patients who are willing to participate in the study and are able to comply with study procedures and visits.

Exclusion criteria

Exclusion criteria: 1. Patients who had allergies to catheter material; 2. Patients who are suffering from acute urethritis, acute prostatitis or epididymitis; 3. Patients who had urethrostenosis or urinary diversion; 4. Patients who had urethral injury; 5. Patients who had been long-term indwelling urinary catheter, ureteral stent, nephrostomy tube or suprapubic catheter before operation; 6. Patients who had urinary system infection, systemic infection or bacteriuria in the previous 72 hours before indwelling urinary catheter. 7. Patients who are participating in other clinical trials or had been participating other clinical trials in the previous month; 8. Female patients who are in the menstrual period, pregnancy, or lactation; 9. Patients who are suffering from mental diseases; 10. Patients who are not recommended by investigators.

Design outcomes

Primary

MeasureTime frame
Bacteriuria;

Secondary

MeasureTime frame
the colony forming unit of per surface area of the body of catheter;

Countries

China

Contacts

Public ContactKai Zhang

Peking University First Hospital

Kaizhangpku@163.com+86 139 1080 1997

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026