Comparison of Antimicrobial Coated Ureteral Stents With Non-coated Stents

September 12, 2016 updated by: Ahmed R. EL-Nahas, Mansoura University

A Randomized Controlled Trial Comparing Antimicrobial Coated (Silver Sulfadiazine) 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, 35516
        • Urology and nephrology center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
This arm will include patients with non-coated stents
Active Comparator: Antimicrobeal group
This arm will include patients with antimicrobeal coated stents
Device: Antimicrobeal coated stents
Patients in the intervention arm will undergo placement of (Silver Sulphdiazine) antimicrobeal coated stents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of urinary tract infection (UTI)
Time Frame: up to 3 months
UTI will be diagnosed with urine and stent culture of stent removal
up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Director: Ahmed R EL-NAHAS, MD, Assistant Professour, urology department, urology and nephrology center, mansoura university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

October 11, 2014

First Submitted That Met QC Criteria

October 11, 2014

First Posted (Estimate)

October 17, 2014

Study Record Updates

Last Update Posted (Estimate)

September 13, 2016

Last Update Submitted That Met QC Criteria

September 12, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Antimicrobeal ureteral stents

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Quality of Life

Clinical Trials on Antimicrobeal coated stents

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe