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Comparison of Antimicrobial Coated Ureteral Stents With Non-coated Stents

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02266368
Enrollment
110
Registered
2014-10-17
Start date
2014-10-31
Completion date
2016-09-30
Last updated
2016-09-13

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

Conditions

Quality of Life

Keywords

Ureteral stents, Double J stent, Antimicoreal coated stent, USSQ, UTI

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.

Interventions

DEVICEAntimicrobeal coated stents

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

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of urinary tract infection (UTI)up to 3 monthsUTI will be diagnosed with urine and stent culture of stent removal

Secondary

MeasureTime frameDescription
Quality of lifeup to 3 monthsThe impact of stent coating on quality of life will be assissed with ureteral stent symptom questionnaire (USSQ)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026