Comparison of Antimicrobial Coated Ureteral Stents With N... | NCT02266368

Studies
Comparison of Antimicrobial Coated Ureteral Stents With Non-coated Stents

NCT02266368

Sponsor

Mansoura University

Status

Completed

Last Update Posted

Sep 13, 2016Estimated

Enrollment

110Actual

Phase

Phase 4

Conditions

Quality of Life

Interventions

Antimicrobeal coated stents

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Aug 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Oct 11, 2014

First Submission Date that Met QC Criteria

Oct 11, 2014

First Posted Date

Oct 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2016

Last Update Posted Date

Sep 13, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Antimicrobeal coated stents	Device	Patients in the intervention arm will undergo placement of (Silver Sulphdiazine) antimicrobeal coated stents	Antimicrobeal group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Quality of life	The impact of stent coating on quality of life will be assissed with ureteral stent symptom questionnaire (USSQ)	up to 3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmed R EL-NAHAS, MD	Assistant Professour, urology department, urology and nephrology center, mansoura university	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Urology and Nephrology Center		Al Mansurah		35516	Egypt