Comparison of Antimicrobial Coated Ureteral Stents With Non-coated Stents

Phase 4

Completed

• Conditions: Quality of Life
• Interventions: Device: Antimicrobeal coated stents

• Registration Number: NCT02266368
• Lead Sponsor: Mansoura University

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-11
• Study First Submitted QC: 2014-10-11
• Study First Posted: 2014-10-17
• Primary Completion: 2016-08
• Status Verified: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-12
• Last Update Posted: 2016-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antimicrobeal group	Antimicrobeal coated stents	This arm will include patients with antimicrobeal coated stents

Primary Outcome Measures

Name	Time	Method
Incidence of urinary tract infection (UTI)	up to 3 months	UTI will be diagnosed with urine and stent culture of stent removal

Secondary Outcome Measures

Name	Time	Method
Quality of life	up to 3 months	The impact of stent coating on quality of life will be assissed with ureteral stent symptom questionnaire (USSQ)

Trial Locations

Locations (1)

Urology and Nephrology Center; 🇪🇬 Mansoura, Egypt