Comparison of Antimicrobial Coated Ureteral Stents With Non-coated Stents

Quality of Life Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Antimicrobial Coated (Silver Sulfadiazine) Ureteral Stents With Non-coated Stents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02266368
• Other study ID #: Antimicrobeal ureteral stents
• Status: Completed
• Phase: Phase 4
• First received: October 11, 2014
• Last updated: September 12, 2016
• Start date: October 2014
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

This study will be conducted to compare the efficacy of antimicrobial coated ureteral stent with non-coated stents in prevention of UTI in patients with ureteral stents

Description:

The efficacy of antimicrobial coated of ureteral stent with silver sulphadiazine in prevention of UTI in patients with ureteral stents will be studied by comparining the results of urine and stent cultures with patients who had non-coated ureteral stents. The impact of antimicrobeal stent coating on patients' quality of life will be evaluated with comparing the scores of ureteral stent symptom questionnaire between both groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients who will undergo ureteral stent placement

Exclusion Criteria:

• Patients allergic to sulpha containing medications

• Ureteral stent insertion for infected hydronephrosis

• Patients who developed septic complications requiring antibiotic treatment after stent placement

• Patients who need bilateral stents

• Patients with chronic kidney disease grade IV and V (GFR <30ml/min)

• Immunocompromised patients as those with malignancy or organ transplantation.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Quality of Life

Intervention

Device:
• Antimicrobeal coated stents
Patients in the intervention arm will undergo placement of (Silver Sulphdiazine) antimicrobeal coated stents

Locations

Country	Name	City	State
Egypt	Urology and Nephrology Center	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of urinary tract infection (UTI)	UTI will be diagnosed with urine and stent culture of stent removal	up to 3 months	No
Secondary	Quality of life	The impact of stent coating on quality of life will be assissed with ureteral stent symptom questionnaire (USSQ)	up to 3 months	No