Comparison of Antimicrobial Coated Ureteral Stents With Non-coated Stents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-09-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Control group

This arm will include patients with non-coated stents

Group Type NO_INTERVENTION

No interventions assigned to this group

Antimicrobeal group

This arm will include patients with antimicrobeal coated stents

Group Type ACTIVE_COMPARATOR

Antimicrobeal coated stents

Intervention Type DEVICE

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

Interventions

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Antimicrobeal coated stents

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No