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Completed

NCT Number: NCT02266368

Comparison of Antimicrobial Coated Ureteral Stents With Non-coated Stents

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

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Key information

Conditions

Quality of Life

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Urology and Nephrology Center

Al Mansurah, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Antimicrobeal coated stents

Device

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

Primary outcomes

  1. Incidence of urinary tract infection (UTI)

    Time frame: up to 3 months

    UTI will be diagnosed with urine and stent culture of stent removal

Secondary outcomes

  1. Quality of life

    Time frame: up to 3 months

    The impact of stent coating on quality of life will be assissed with ureteral stent symptom questionnaire (USSQ)

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 17, 2014
Registry last updated
Sep 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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