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Comparison of Antimicrobial Coated Ureteral Stents With Non-coated Stents

M

Mansoura University

Status and phase

Completed
Phase 4

Conditions

Quality of Life

Treatments

Device: Antimicrobeal coated stents

Study type

Interventional

Funder types

Other

Identifiers

NCT02266368
Antimicrobeal ureteral stents

Details and patient eligibility

About

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

Full 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.

Enrollment

110 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

110 participants in 2 patient groups

Control group
No Intervention group
Description:
This arm will include patients with non-coated stents
Antimicrobeal group
Active Comparator group
Description:
This arm will include patients with antimicrobeal coated stents
Treatment:
Device: Antimicrobeal coated stents

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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