NCT02266368

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_4 quality-of-life

Timeline
Completed

Started Oct 2014

Typical duration for phase_4 quality-of-life

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

1.8 years

First QC Date

October 11, 2014

Last Update Submit

September 12, 2016

Conditions

Quality of Life

Keywords

Ureteral stentsDouble J stentAntimicoreal coated stentUSSQUTI

Outcome Measures

Primary Outcomes (1)

  • Incidence of urinary tract infection (UTI)

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

    up to 3 months

Secondary Outcomes (1)

  • Quality of life

    up to 3 months

Study Arms (2)

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

Antimicrobeal coated stentsDEVICE

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

Antimicrobeal group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who will undergo ureteral stent placement

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, 35516, Egypt

Location

Study Officials

  • Ahmed R EL-NAHAS, MD

    Assistant Professour, urology department, urology and nephrology center, mansoura university

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Professor

Study Record Dates

First Submitted

October 11, 2014

First Posted

October 17, 2014

Study Start

October 1, 2014

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

September 13, 2016

Record last verified: 2016-09

Locations

EG(1)